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Code · REGISTER · 2007-08-24 · Department of Veterans Affairs · Notices

Notices. Notice

122,406 words·~556 min read·/register/2007/08/24/07-4123

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BILLING CODE 1137-00-M DEPARTMENT OF VETERANS AFFAIRS Determinations Concerning Illnesses Discussed in National Academy of Sciences Report on Gulf War and Health AGENCY: Department of Veterans Affairs. ACTION: Notice. SUMMARY: As required by law, the Department of Veterans Affairs
(VA)hereby gives notice that the Secretary of Veterans Affairs, under the authority granted by the Persian Gulf War Veterans Act of 1998, Public Law 105-277, title XVI, 112 Stat. 2681-742 through 2681-749 (codified at 38 U.S.C. 1118), has determined not to establish a presumption of service connection at this time, based on exposure to insecticides or solvents during service in the Persian Gulf during the Persian Gulf War, for any of the diseases, illnesses, or health effects discussed in the February 18, 2003, report of the National Academy of Sciences, titled “Gulf War and Health, Volume 2. Insecticides and Solvents.” This determination does not in any way preclude VA from granting service connection for any disease, including those specifically discussed in this notice, nor does it change any existing rights or procedures. FOR FURTHER INFORMATION CONTACT: David Barrans, Attorney, Office of the General Counsel, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, telephone
(202)273-6332. SUPPLEMENTARY INFORMATION: I. Statutory Requirements The Persian Gulf War Veterans Act of 1998, Public Law 105-277, title XVI, 112 Stat. 2681-742 through 2681-749 (codified at 38 U.S.C. 1118), and the Veterans Programs Enhancement Act of 1998, Public Law 105-368, 112 Stat. 3315, directed the Secretary to seek to enter into an agreement with the National Academy of Sciences
(NAS)to review and evaluate the available scientific evidence regarding associations between illnesses and exposure to toxic agents, environmental or wartime hazards, or preventive medicines or vaccines to which service members may have been exposed during service in the Persian Gulf during the Gulf War. Congress prescribed the inquiry it expected NAS to carry out in the event such an agreement was reached. Congress directed NAS to identify agents, hazards, medicines, and vaccines to which service members may have been exposed during service in the Persian Gulf during the Gulf War, but also directed NAS to consider a number of specific substances, including solvents and several insecticides used during the Gulf War. Congress mandated that NAS determine, to the extent possible:
(1)Whether there is a statistical association between exposure to the agent, hazard, medicine, or vaccine and the illness, taking into account the strength of the scientific evidence and the appropriateness of the scientific methodology used to detect the association;
(2)the increased risk of illness among individuals exposed to the agent, hazard, medicine, or vaccine; and
(3)whether a plausible biological mechanism or other evidence of a causal relationship exists between exposure to the agent, hazard, medicine, or vaccine and the illness. These laws also require that NAS submit reports on its activities to the Veterans Affairs Committees of the U.S. Senate and House of Representatives and to the Secretary of Veterans Affairs every 2 years (as measured from the date of the first report) for a 10-year period. Section 1602 of Public Law 105-277 provides that whenever the Secretary receives a report from NAS, the Secretary must determine whether a presumption of service connection is warranted for any illness covered by that report. The statute provides that a presumption will be warranted when the Secretary determines that there is a positive association (i.e., the credible evidence for an association is equal to or outweighs the credible evidence against an association) between exposure of humans or animals to a biological, chemical, or other toxic agent, environmental or wartime hazard, or preventive medicine or vaccine known or presumed to be associated with service in the Southwest Asia theater of operations during the Persian Gulf War and the occurrence of a diagnosed or undiagnosed illness in humans or animals. If the Secretary determines that a presumption of service connection is not warranted, he is to publish a notice of that determination, including an explanation of the scientific basis for that determination. II. The National Academy of Sciences Report NAS issued its initial report, titled “Gulf War and Health, Volume 1. Depleted Uranium, Sarin, Pyridostigmine Bromide, Vaccines,” on September 7, 2000. In that report, NAS limited its analysis to the health effects of depleted uranium, the chemical warfare agent sarin, vaccinations against botulism toxin and anthrax, and pyridostigmine bromide, which was used in the Gulf War as a pretreatment for possible exposure to nerve agents. On July 6, 2001, VA published a notice in the **Federal Register** announcing the Secretary's determination that the available evidence did not warrant a presumption of service connection for any disease discussed in that report. 66 FR 35702 (2001). NAS issued its second report, titled “Gulf War and Health, Volume 2. Insecticides and Solvents,” on February 18, 2003. In that report, NAS focused on the health effects of insecticides and solvents that were shipped to the Persian Gulf during the Persian Gulf War. The pesticides considered by the NAS were organophosphorous compounds (malathion, diazinon, chlorpyrifos, dichlorvos, and azamethiphos), carbamates (carbaryl, propoxur, and methomyl), pyrethrins and pyrethyroids (permethrin and d-phenothrin), lindane, and N,N-diethyl-3-methylbenzamide (DEET). NAS considered 53 solvents in 8 groups: aromatic hydrocarbons (including benzene), halogenated hydrocarbons (including tetrachloroethylene and dry-cleaning solvents), alcohols, glycols, glycol esters, esters, ketones, and petroleum distillates. In its report, NAS organized its conclusions into five categories, representing different degrees of association between illness and exposure to insecticides or solvents. The categories NAS used are “Sufficient Evidence of a Causal Relationship,” “Sufficient Evidence of an Association,” “Limited/Suggestive Evidence of an Association,” “Inadequate/Insufficient Evidence to Determine Whether an Association Exists,” and “Limited/Suggestive Evidence of No Association.” NAS found “Sufficient Evidence of a Causal Association” between chronic exposure to the solvent benzene and two diseases, acute leukemia and aplastic anemia. NAS found the criteria for its next-highest category, “Sufficient Evidence of an Association” satisfied for three associations:
(1)Chronic exposure to benzene and adult leukemia;
(2)chronic exposure to solvents and acute leukemia; and
(3)exposure to the solvent propylene glycol and allergic contact dermatitis resulting from sensitization to the compound and subsequent reexposure. NAS listed 16 findings in the category “Limited/Suggestive Evidence of an Association”:
(1)Chronic exposure to tetrachloroethylene and dry-cleaning solvents and bladder cancer;
(2)chronic exposure to solvents and bladder cancer;
(3)chronic exposure to tetrachloroethylene and dry-cleaning solvents and kidney cancer;
(4)chronic exposure to organophosphorous insecticides and non-Hodgkin's lymphoma;
(5)chronic exposure to carbamates and non-Hodgkin's lymphoma;
(6)chronic exposure to benzene and non-Hodgkin's lymphoma;
(7)chronic exposure to solvents and multiple myeloma;
(8)chronic exposure to organophosphorous insecticides and adult leukemia;
(9)chronic exposure to solvents and adult leukemia;
(10)chronic exposure to solvents and myelodyplastic syndromes;
(11)exposure to organophosphorous insecticides at doses sufficient to cause poisoning and long-term neurobehavioral effects ( *i.e.* , abnormal results on neurobehavioral test batteries and symptom findings);
(12)chronic exposure to solvents and neurobehavioral effects ( *i.e.* , abnormal results on neurobehavioral test batteries and symptom findings);
(13)high-level exposure to solvents and reactive airways dysfunction syndrome that would be evident with exposure and could persist for months or years;
(14)chronic exposure to solvents and hepatic steatosis;
(15)chronic exposure to solvents and chronic glomerulonephritis; and
(16)exposure to insecticides and allergic contact dermatitis that results from sensitization to the compounds and subsequent reexposure. NAS stated 48 findings in the category “Inadequate/Insufficient Evidence to Determine Whether an Association Exists,” and stated no findings in the category “Limited/Suggestive Evidence of No Association.” Additionally, NAS stated that it was unable to reach a consensus view with respect to nine exposure and disease, illness, or health effect associations it considered and therefore did not place them in any of the five categories. Seventeen of the 21 associations in the highest three categories are limited to cases involving “chronic” exposure to the insecticides or solvents involved. Although its report does not define the term “chronic,” NAS stated that the studies it reviewed were primarily occupational studies, meaning studies of workers who were exposed to the substances in question in the course of their employment, such as in a chemical plant or in a position requiring routine use of solvents or insecticides. Of the four remaining associations in those categories, one was limited to cases involving exposure to organophosphorous insecticides at doses sufficient to cause poisoning at the time of exposure and another involved an association between high-level exposure to organic solvents and reactive airways dysfunction syndrome which would be evident with exposure or shortly thereafter. The other two involve allergic contact dermatitis that would be present with exposure and may resolve with cessation of exposure. III. VA's Actions in Response to the Second NAS Report After receiving and reviewing the second NAS report, VA determined that the report presented uniquely difficult issues as compared to the first NAS report and similar NAS reports provided to VA under the Agent Orange Act of 1991, Public Law 102-4. The second NAS report was unique in that the substances considered in that report were not substances used exclusively or predominantly in combat deployments or operations, but were substances commonly present in military and civilian life. It was also unique in that most of the associations NAS identified were limited to circumstances involving chronic occupational exposure to the insecticides and solvents in question, as distinguished from acute or subchronic exposures. Although the NAS report did not define the term “chronic,” that term commonly means “marked by long duration” (Webster's Third New International Dictionary 402 (1976)) or “persisting over a long period of time” (Dorland's Illustrated Medical Dictionary 328 (38th ed 1994)). Further, virtually all of the health effects identified by NAS were previously well known. VA determined that these circumstances raised questions concerning, among other things, whether exposure to these common substances during the Persian Gulf War differed significantly from exposures experienced by other military and civilian populations, and whether military personnel could be expected to have experienced “chronic” exposure to such substances during service in the Persian Gulf War. For that reason, and also because VA's determinations regarding the health effects of relatively common exposures might be viewed as having broader implications for public health policy, VA determined that it was necessary to seek additional information before making its determinations under Public Law 105-277. VA met with representatives of NAS and requested that NAS conduct an additional review to address issues pertaining to the correlation between exposures of different types and durations and the increased risk of health effects. Although NAS gave serious consideration to VA's request, it ultimately declined to provide any further information requested by VA. IV. VA's Determination This notice conveys the Secretary's determination that a presumption of service connection is not warranted at the present time for any disease, illness, or health effect discussed in the NAS report, based on association with any substance known or suspected to be associated with service in the Gulf War. The Secretary has determined that there is not sufficient evidence available to support a conclusion that the insecticides and solvents covered in the NAS report are, in isolation, agents “known or presumed to be associated with service in the Southwest Asia theater of operations during the Persian Gulf War,” for purposes of section 1602 of Public Law 105-277 (codified in pertinent part at 38 U.S.C. 1118(a)(2)(A) and (b)(1)(B)). As an initial matter, we want to make clear that VA's determination does not in any way preclude VA from granting service connection for any disease, including those specifically discussed in this notice, nor does it change any existing rights or procedures. VA generally may grant service connection either on a “direct” basis or, in some circumstances, on a “presumptive” basis. “Direct” service connection means simply that the evidence in relation to a claim makes it as likely as not that a disease or injury was incurred or aggravated in service. “Presumptive” service connection means that a statute or regulation creates a special rule allowing VA to presume that a particular disease was incurred or aggravated in service even if the evidence does not directly establish that fact. Pursuant to 38 U.S.C. 1110, VA may grant direct service connection for any disease that was incurred or aggravated in service. Accordingly, if the evidence in connection with any benefit claim makes it as likely as not that a disease was caused or aggravated by exposure to insecticides or solvents in service, VA may grant service connection. As required by law, VA will assist claimants in obtaining evidence necessary to substantiate their claims. The recent NAS report does not limit this authority in any way. In fact, the report itself may assist claimants seeking to establish service connection, by providing evidence linking certain diseases with exposure to certain insecticides and solvents. This notice is intended only to explain that VA will not, at this time, establish a new presumption of service connection for any disease. Section 1602 of Public Law 105-277 requires presumptions of service connection for illnesses that have a “positive association with exposure to a biological, chemical or other toxic agent, environmental or wartime hazard, or preventive medicine or vaccine known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War.” This standard refers to two distinct types of association necessary to a presumption. First, it must be determined that the agent, hazard, medicine, or vaccine is known or presumed to be associated with service in the Southwest Asia theater of operations during the Persian Gulf War. Second, it must be determined that an illness is associated with exposure to such agent, hazard, medicine, or vaccine. With respect to the first NAS report on Gulf War and Health, it was clear that the substances NAS considered (depleted uranium, sarin, vaccinations against botulism toxin and anthrax, and pyridostigmine bromide) were associated with service in the Persian Gulf during the Gulf War because the presence and use of those substances during such service was documented and resulted in exposures unique to veterans of such service. Accordingly, the notice of VA's determinations concerning that NAS report focused exclusively on the second element of association—i.e., the association between illnesses and exposure to the substances in question. With respect to the second NAS report, however, we believe it is necessary to address the threshold matter of whether the insecticides and solvents considered by NAS properly may be considered substances associated with service in the Southwest Asia theater of operations during the Persian Gulf War within the meaning of Public Law 105-277. In section 1603 of Public Law 105-277, Congress directed NAS to consider the health effects of solvents and several specific pesticides, although Congress did not provide an indication as to whether or how those substances were used in the Gulf War. NAS focused its review on solvents and pesticides that the Department of Defense shipped to the Persian Gulf during the Persian Gulf War. As discussed below, however, there is insufficient information concerning the use of such solvents and pesticides during service in the Persian Gulf War upon which to conclude that veterans of such service may have encountered exposures unique to such service. In contrast to the substances addressed in the first NAS report (depleted uranium, sarin, vaccinations against botulism toxin and anthrax, and pyridostigmine bromide), the insecticides and solvents that Congress identified in Public Law 105-277 and NAS discussed in the second report, are not unique to service in the Gulf War or to any particular period or location of service. Rather, those insecticides and solvents are prevalent in military and civilian life outside the Gulf War theater of operations. For example, the solvent benzene, which is included either by name or by general reference to “solvents” in 13 of the 21 findings in the 3 highest NAS categories of association, is 1 of the 20 most commonly produced chemicals in the United States and is present in many consumer solvents and paint products, gasoline, automobile exhaust, and tobacco smoke. Most Americans are exposed to small amounts of benzene on a daily basis through breathing air containing gasoline fumes, automobile exhaust, tobacco smoke, and industrial emissions. (Agency for Toxic Substances and Disease Registry (ATSDR), *Public Health Statement for Benzene* CAS#71-43-2 (U.S. Dept. of Health and Human Services, Public Health Service, ATSDR, Sept. 1997)). Dry-cleaning solvents are included in 12 of the 21 findings in the top 3 categories, either specifically or as a component of the general class of solvents. Military and civilian personnel who use dry cleaning services or reside near dry cleaning businesses are exposed to those substances. The solvent propylene glycol, which fits into 10 of the 21 findings in the top 3 categories, is present commercially in cosmetics and food and is used as a vehicle for drug delivery. Other solvents considered by NAS are commonly used in the United States as fumigants for food products, as flavoring agents, as components of antifreeze, brake fluids, deicing fluids, paints, typewriter correction fluid, cosmetics, lacquers, and adhesives, or as solvents available for household use in degreasing and cleaning. The NAS report notes that little information is available to characterize the use of solvents in the Gulf War. Military uses of solvents include vehicle maintenance, cleaning and degreasing, and NAS noted that wartime use of solvents in these capacities probably paralleled stateside military or civilian uses, although operating conditions (such as ventilation and the use of masks) may have varied widely from stateside working conditions. All insecticides shipped to the Gulf War had been approved by the U.S. Environmental Protection Agency or the U.S. Food and Drug Administration for general use in the United States at that time, although EPA has since placed restrictions on some of the insecticides used during the Gulf War. Most of those insecticides are available in consumer pest-control products sold for home use. The two insecticides distributed to service members during the Gulf War for individual use—DEET and permethrin—are common components of consumer insect repellents, and were not linked to any diseases in the top three NAS categories other than allergic contact dermatitis. Of the 21 health effects NAS identified in its 3 highest categories, 17 are generally well known health risks of chronic occupational exposure to the insecticides and solvents in question. (The other four health effects are also generally well known, but are associated with certain non-chronic exposures.) For example, the fact that chronic occupational exposure to benzene is associated with an increased risk of aplastic anemia and acute leukemia is widely recognized. *See* 29 CFR 1910.1028 appendix A (summarizing known health effects of chronic benzene exposure). As NAS' findings indicate, an increased risk of disease may occur with chronic or sufficient exposure to the insecticides and solvents in question. Those conclusions are based on scientific studies of persons exposed to the insecticides and solvents in occupational settings involving the production or use of those substances, with frequent exposures for periods of years in most cases. Neither the NAS report, nor the scientific studies that NAS reviewed identify an increased risk of disease based on temporary or episodic exposure to the insecticides or solvents in question, except in particular circumstances of organophosphorous insecticide poisoning associated with long-term neurobehavioral effects, high-level solvent exposure associated with reactive airways dysfunction syndrome, and allergic dermatological reactions coincident with exposure to propylene glycol or insecticides. In briefing VA on its findings in February 2003, NAS indicated that it did not limit its inquiry to health effects of only chronic exposure, but sought all available information on the health effects of exposure to the insecticides and solvents in question. Insofar as the NAS report states no conclusions as to whether many of the diseases discussed in the report are associated with less-than-chronic exposure to insecticides or solvents, we believe the absence of such findings most likely reflects the absence of study data sufficient to make any determination. As indicated above, the insecticides and solvents considered by NAS were in common use in stateside military and civilian populations at the time of the Gulf War, not only with respect to workers occupationally exposed to those substances, but also with respect to the broader spectrum of persons exposed through use of consumer products, inhalation of polluted air, or other means. Sufficient data do not exist to show that exposure to those insecticides and solvents alone at levels below chronic occupational exposure or below levels sufficient to constitute poisoning is associated with the occurrence of disease, other than allergic contact dermatitis. Further, as explained below, VA believes that there is currently insufficient information available to indicate that the uses of insecticides and solvents during the Gulf War, or the risks associated with such exposure to such substances, differed in any substantial degree from the use of those substances in stateside military and civilian populations or the risk experienced by such stateside populations. The Department of Defense
(DoD)has indicated that the insecticides and solvents considered by NAS were shipped to the Persian Gulf during the Gulf War, but that relatively little information is currently available concerning the extent to which those substances were used. DoD has indicated that insecticides were used in the Gulf War for their ordinary purposes, including personal application by individual service members to their bodies and clothing, as well as area spraying by pesticide applicators. (OSAGWI (Office of the Special Assistant for Gulf War Illnesses), *Environmental Exposure Report—Pesticides. Final Report* (U.S. Department of Defense, OSAGWI, April 2003)). DoD concluded that most soldiers were likely exposed to some amount of insecticides and that military personnel whose occupational specialty involved pesticide spraying likely incurred greater amounts of exposures. DoD has indicated that the most thoroughly documented exposure to solvents occurred during the Gulf War among service members assigned to apply chemical-agent-resistant coating
(CARC)to military vehicles, as well as in the process of cleaning painting equipment and tools with solvents. (OSAGWI, *Environmental Exposure Report: Chemical Agent Resistant Coating. Final Report* (U.S. Department of Defense, OSAGWI, July 2000). DoD also indicated that not all personnel were trained in these processes and some may not have had all the necessary personal protective equipment (OSAGWI, 2000). NAS indicated that the wartime use of solvents, such as in vehicle maintenance and repair, cleaning, and degreasing, probably paralleled stateside military and civilian use of solvents, but acknowledged the possibility of wide variations in operating conditions. DoD's Directorate for Deployment Health Support has prepared an “exposure assessment” designed to estimate the possible levels of insecticide exposures during the Gulf War. (OSAGWI 2003 at 42, 110). That assessment was based on information gathered from interviews with Gulf War veterans and exposure-scenario models based on methodologies used by the Environmental Protection Agency. *Id* . at 110-112. Among other things, DoD concluded that “[m]ost pesticide product exposures during the Gulf War were acute/subacute and subchronic; however, there were probably a small number of chronic exposures as well.” *Id* . at 151. For purposes of that analysis, DoD defined chronic exposure as exposure lasting more than 180 days. DoD also stated that, “[i]n many cases, pesticide formulation exposures during deployment would have been very similar to exposures normally occurring in the U.S. at the time. On the other hand, there were certainly conditions existing some of the time that would have contributed to higher-than-normal, or otherwise unusual exposures for some servicemembers.” *Id* . at 143. For instance, DoD indicated that higher exposures may have occurred in areas of extreme pest infestation or in the delousing of prisoners of war conducted by approximately 200 service members. DoD also concluded that “It is likely that at least 41,000 service members overall may have had some overexposure to pesticides.” *Id* . at 57. That conclusion was based in part on the results of a survey asking veterans to recollect their pesticide experiences 7 to 9 years after the fact. *Id* . at 111. DoD stated that its analysis involved significant levels of uncertainty, due to the lack of direct exposure data, and that it relied on assumptions that tended to overestimate exposures. *Id* . at 57, 111. Further, DoD's conclusions regarding potential overexposures do not, in our view, clearly indicate that pesticide exposures in the Persian Gulf War differed significantly from other civilian and military populations. The largest group of potential overexposures identified by DoD consisted of approximately 30,500 veterans who “may have been at elevated risk for short-term health effects because of exposure to pest strips” containing the pesticide dichlorvos. *Id* . at 57. In the survey of Gulf War veterans, approximately 7% of veterans interviewed reported using or observing use of pest strips, and approximately 5% to 8% of those who had used pest strips reported using them in a manner exceeding the manufacturer's recommendation of one strip per 1000 cubic feet of space. (Fricker, RD *et al., Pesticide Use During the Gulf War: A Survey of Gulf War Veterans* (Rand 2000)). DoD concluded that “[e]ven when dichlorvos-containing pest strips are used according to current label directions and military guidance, many personnel may be exposed to unhealthful levels” of dichlorvos. (OSAGWI 2003 at 65). DoD noted that its conclusion was similar to a finding by the Environmental Protection Agency's Office of Pesticide Programs, which found that all residential use of pest strips was of concern. *Id* . at 65. Pest strips have long been available for residential use in the United States, and DoD's finding does not suggest that Gulf War exposures to pest strips differed significantly from stateside exposures. The conclusion that use of pest strips in accordance with the label directions may cause overexposure would appear to be equally applicable to stateside use. DoD also noted that approximately 3,500 to 4,500 pesticide applicators probably made up one of the more highly exposed groups, and that as many as 7,000 service members may have been overexposed to pesticides as the result of spraying operations. *Id* . at 57. However, DoD also noted that “[m]ost pesticide product exposures during the Gulf War were acute/subacute and subchronic” rather than chronic in nature, and that “veteran interviews suggest that fewer than 10 veterans sought treatment for pesticide exposure.” *Id* . at 56, 151. For these reasons, the DoD report's findings regarding possible overexposures during the Gulf War do not, in our view, establish that potential exposures to pesticides during the Gulf War differed significantly from exposures in other civilian and military populations. With respect to service members who were exposed to pesticides due to their military occupation as pesticide applicators, we note that the potentially chronic nature of such occupational exposures, coupled with the findings in the NAS report and other medical literature documenting potential health effects of chronic exposure, as well as the effects of organophosphorous insecticide poisoning (acute cholinergic syndrome), may provide a sufficient basis for awarding direct service connection for such health effects under existing law. Although there is little direct data on pesticide use in the Gulf War, we note that DoD had issued comprehensive directives and policies governing pesticide use. In a 1996 report, the Presidential Advisory Committee on Gulf War Veterans' Illnesses
(PAC)noted that DoD policies and directives on pesticide use at the time of the Gulf War closely paralleled or exceeded those established by regulations of the Environmental Protection Agency and the Food and Drug Administration for domestic pesticide use. (Presidential Advisory Committee on Gulf War Veterans' Illnesses: Final Report (Washington, DC, U.S. Government Printing Office, December 1996) . The PAC reported that, according to DoD policy, the majority of U.S. service members had access to two pesticides: Permethrin in a spray can (for treating uniforms) and DEET liquid or stick for use as a personal mosquito and fly repellant. By DoD policy, all other pesticides shipped to the Gulf region were to be used only by specifically trained pesticide applicators or for special applications. For example, lindane was apparently used by security personnel almost exclusively on Iraqi prisoners of war as a delousing agent. In contrast, no similar restrictions applied to home use of those pesticides within the United States. There is little information concerning the extent to which there may have been departures from DoD policy in particular instances during the Persian Gulf War. The PAC also noted that only limited data exists on the exposure of Gulf War veterans to solvents, including benzene. The PAC described one study by the Centers for Disease Control and Prevention that involved chemical analysis of biological samples collected from troops or other personnel residing in Kuwait about two months after the cease-fire while the oil well fires were burning. (Etzel, RA and Ashley, DL, *Volatile Organic Compounds in the Blood of Persons in Kuwait During the Oil Fires* , International Archives of Occupational and Environmental Health, 66:125-29, 1994). The study focused on possible exposure of U.S. military employees to the oil-well fire smoke, which is known to contain benzene. They reported that although blood levels of volatile organic compounds
(VOCs)including benzene were higher in firefighters than in a reference population of U.S. civilians, DoD employees in nearby Kuwait City had VOC levels about the same or lower than the reference population. Benzene levels in the DoD employees in Kuwait City were about half those of the U.S. civilian reference population. This data is limited by small sample size, the short half-life of VOCs in service members' blood and the focus specifically on potential exposure from oil-well fires rather than overall environmental exposure. Nevertheless, the report stated that “VOC's are also widespread in the modern environment. Americans are exposed to numerous volatile organic compounds in the home and at work environment, but exposure to some of them was not prevalent in post-war Kuwait City, where many American personnel were temporarily housed in local hotel rooms.” The PAC report described a second relevant study conducted by DoD during the Gulf War, which among other things measured VOCs including benzene in blood samples collected from a group of U.S. service members before, during, and after their 1991 deployment to Kuwait. (U.S. Army Hygeine Agency, *Final Report: Kuwait Oil Fire Health Risk Assessment, 5 May—3 December 1991, Report No. 39-26-L192-91* , February 1994). The population studied in this report consisted of as many as 4,700 soldiers who were deployed from Germany to the Kuwait theater on or around September 20, 1991. Blood samples from a small subset of this group were taken before and after deployment, and during deployment in August 1991, and were analyzed for VOCs including benzene. Benzene levels were found to be slightly lower during deployment as compared to pre and post-deployment levels. Other solvents, including ethylbenzene, chlorobenzene, and styrene, were substantially elevated in predeployment blood samples when compared to reference levels in the United States. Some solvents, including ethylbenzene, xylene isomers, styrene, and toluene, were lower in the blood samples taken during deployment. Tetrachloroethylene levels were significantly higher in the blood samples taken during deployment. However, the mean level of the solvent in the blood was “orders of magnitude below those levels noted in the literature as causing health effects with short term exposure.” The report concluded that “the levels of VOCs measured in blood specimens of soldiers while in Kuwait are denotative of miniscule exposures” and that “[t]he exposure to most compounds that can be inferred from these measurements is, in fact, very similar to accepted U.S. normal background levels.” The limited data available do not provide a basis for concluding at this time that potential exposures to insecticides and solvents during the Gulf War differed significantly from potential exposures in other military and civilian populations at that time. We recognize the possibility that conditions of use may have varied in some circumstances, but we have insufficient evidence to infer that variations, such as those resulting from failure to use prescribed protective equipment, were common or resulted in exposures significantly different from those in other military and civilian populations. Although DoD noted that one pesticide (lindane) was used for the unique purpose of delousing enemy prisoners of war, it also noted that only about 200 service members engaged in that duty. Additionally, we do not believe that insecticide or solvent exposure during the Gulf War can be equated as a general matter with the type of chronic occupational exposure involved in most of the associations found by NAS. With respect to insecticides, as noted above, DoD has indicated that most exposures in the Gulf War were non-chronic. As in civilian populations, service members whose military occupation involved consistent exposure to insecticides or solvents may have incurred above-average exposures. The likelihood of such occupational exposures, however, is not unique to service in the Southwest theater of operations during the Persian Gulf War. As discussed below, any veteran who had chronic or sufficient exposure to insecticides or solvents during service may be eligible for direct service connection for the known health effects of such exposure, whether or not such service was in the Persian Gulf during the Gulf War. Public Law 105-277 requires the Secretary to determine whether a presumption of service connection is warranted by reason of a disease having a positive association with exposure to a biological, chemical, or other toxic agent, environmental or wartime hazard, or preventive medicine or vaccine “known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War.” Public Law 105-277 1602 (codified in pertinent part at 38 U.S.C. 1118(a)(2)(A) and (b)(1)(B)). The statute does not explain the meaning of the phrase “known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War,” and there is no legislative history explaining the meaning of that phrase. We conclude that the statutory phrase “associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War” is most reasonably construed to refer to a relationship between the substance or hazard and the specific circumstance of service in the Southwest Asia theater of operations during the Persian Gulf War, as distinguished from features of military or civilian life in general that are not unique to service in the Gulf War. The phrase “associated with” clearly connotes a direct relationship, and the requirement that the substance or hazard be associated with service at a particular time and place indicates an intent to distinguish between substances and hazards associated with general military or civilian life and those unique to service at the specified time and place. If civilian and military populations are commonly exposed to a substance, we believe it would be unreasonable to conclude that the substance is “associated with” service in the Persian Gulf during the Gulf War merely because it was present and used for its ordinary purpose, and exposures occurred in an ordinary way, during such service. We do not believe that Congress intended VA to establish presumptions for the known health effects of all substances common to military or civilian life. Rather, the requirement that the substance be “associated with” Gulf War service makes clear that VA's task is to focus on the unique exposure environment in the Persian Gulf during the Persian Gulf War. This reading of the statutory language comports with the clear purpose of both Public Law 105-277 and Public Law 105-368. Both statutes reflect the Government's commitment to addressing the unique health issues presented by Gulf War veterans, by establishing a process for identifying diseases and illnesses that may be associated with Gulf War Service. It is by now well known that many Gulf War veterans have reported a variety of similar symptoms that cannot presently be identified with a known diagnosis or cause and that were not considered “diseases” for the purposes of the statutes generally authorizing VA to pay compensation for service-connected disability or death due to disease or injury. Congress responded initially to that situation by authorizing VA to pay compensation for “undiagnosed illness” in such veterans. The process established by Public Law 105-277 and Public Law 105-368 reflects a further effort to bridge the existing gaps in medical and scientific knowledge and to ensure that Gulf War veterans may obtain compensation for diagnosed or undiagnosed illnesses that may have been caused by the unique exposures or hazards of service during the Gulf War. Establishing presumptions of service connection for illnesses associated with exposures or hazards specifically related to Gulf War service obviously would further that objective. In contrast, establishing presumptions of service connection for the exclusive benefit of Gulf War veterans based solely on the well-known health effects of exposures shared in common with the general veteran population would not significantly further the purposes of those statutes. Moreover, establishing such presumptions would create significant inequities in the veterans' benefits system that Congress could not have intended. Public Law 105-277 requires VA to establish presumptions of service connection, when the statutory requirements are met, exclusively for veterans who served in the Southwest Asia theater of operations during the Persian Gulf War. If the statute were construed to require presumptions based on exposure in the Persian Gulf War to substances to which other veterans serving at other times and places are commonly exposed at similar levels, it would raise significant concerns of fairness and reasonableness. For example, veterans exposed or presumably exposed to insecticides during the Gulf War might be entitled to presumptive service connection for certain diseases associated with insecticide exposure, while veterans who served stateside and had equal or greater insecticide exposure—including veterans who served as pesticide applicators—would not be entitled to presumptive service connection for those diseases. Similarly, veterans exposed or presumably exposed to benzene during Gulf War service might be entitled to presumptive service connection for acute leukemia or other disease by virtue of such exposure, while veterans exposed to benzene during service at other times or places would not be entitled to presumptive service connection for the same diseases, even though they may have had significantly greater potential for benzene exposure due to their military occupation ( *e.g.* , as a mechanic). The fact that most service members, and most civilians, routinely incur some degree of background exposure to benzene and certain other substances NAS considered in accordance with Public Law 105-277 further underscores the arbitrariness that would attach to establishing presumptions for a limited class of veterans based on such common exposures. Apart from the fact—discussed in greater detail below—that it is generally unnecessary to establish presumptions of service connection for health effects that are well documented in the medical literature, establishing presumptions applicable only to a small percentage of the veteran population potentially exposed to the relevant substances would have significant adverse effects on the veterans benefits system. Providing by statute and regulation for the disparate treatment of similarly situated veterans would substantially undermine confidence in the objectivity and fairness of the veterans benefits system. Additionally, establishing different adjudicative rules for the claims of similarly situated veterans without any reasoned basis for the distinction would undoubtedly cause confusion to the VA personnel responsible for deciding claims, as well as to veterans and their representatives in presenting and supporting their claims. We do not believe that Congress intended VA to establish presumptions unique to Gulf War veterans based on the well-known health effects of exposures common to military and civilian life outside the Gulf War theater of operations. As explained above, the language and purpose of Public Law 105-277 and Public Law 105-368 indicate that Congress did not intend such a result, and we believe it is reasonable to presume that Congress did not intend arbitrary or unfair distinctions. We note that statutes generally must be construed to avoid serious constitutional concerns. *See Edward J. DeBartolo Corp.* v. *Florida Gulf Coast Building & Construction Trades Council* , 485 U.S. 568, 575 (1988). We cannot say it is beyond Congress' power to establish presumptions exclusively for Gulf War veterans based on exposures not known to differ significantly from service outside the Gulf War. However, the apparent unfairness, in our view, of that result supports the conclusion that Congress did not intend such a result. We recognize that even common substances might be used in certain circumstances, such as in combat situations, in an uncommon manner that may create a unique risk. As explained above, however, there is presently insufficient evidence to indicate that the solvents or insecticides considered by NAS were used in the Gulf War in a manner that differed significantly from their usage in other military and civilian populations. Of course, if evidence is found indicating that insecticide or solvent use during the Gulf War differed significantly in kind or degree from use elsewhere in military service or civilian life, such information could provide a basis for concluding that such insecticides or solvents are substances associated with service in the Persian Gulf during the Gulf War. We also recognize that Public Law 105-277 and Public Law 105-368 both required NAS to consider the health effects of exposure to insecticides and solvents as part of its investigations of illnesses potentially associated with Gulf War service. However, the direction to consider those substances does not compel the conclusion that those substances, considered in isolation, are themselves agents “known or presumed to be associated with service in the Southwest Asia theater of operations during the Persian Gulf War” for purposes of VA's duty to establish presumptions of service connection. Section 1603 of Public Law 105-277 describes the scope of NAS' inquiry. Section 1603(c)(1) directs NAS to “identify the biological, chemical, or other toxic agents, environmental or wartime hazards, or preventive medicines or vaccines to which members of the Armed Forces who served in the Southwest Asia Theater of operations during the Persian Gulf War may have been exposed by reason of such service.” Section 1603(d) of that statute provides that, in identifying substances to which Gulf War veterans “may have been exposed,” NAS will consider, among other things, solvents and several specifically enumerated pesticides. In contrast, section 1602 of Public Law 105-277 does not direct the Secretary to establish presumptions of service connection for the health effects of every substance to which Gulf War veterans “may have been exposed,” but requires presumptions only for the health effects of exposure to substances known or presumed to be “associated with” service in the Gulf War. Congress used different language in section 1602 and 1603 of Public Law 105-277, and we must conclude that the different language was intended to have different meanings. *See Bank of America National Trust & Savings Ass'n* v. * 203 N. LaSalle St. Partnership * , 526 U.S. 434, 450 (1999); *Russello* v. *United States* , 464 U.S. 16, 23 (1983). Congress reasonably defined the scope of NAS' inquiry broadly, to include consideration of all substances to which veterans may have been exposed during the Gulf War, irrespective of whether the exposures were unique to Gulf War service or common to all service. In defining VA's regulation-writing obligations, however, Congress reasonably required VA to establish presumptions of service connection only for the health effects of substances that are “associated with” Gulf War service. As noted above, that limitation furthers Congress' purpose of establishing presumptions for the unique health concerns of Gulf War veterans and also avoids the inequity of establishing presumptions exclusively for Gulf War veterans based on exposures that are common to most veterans. Although the Secretary has determined that presumptions of service connection cannot be made at this time for the health effects of exposure to insecticides and solvents discussed in the NAS report, we want to make clear that this determination will not preclude the granting of service connection for those health effects. The health effects which NAS found to be supported by sufficient or limited/suggestive evidence are generally well-known health effects of exposure to the insecticides and solvents in question and were documented in the medical literature prior to the NAS' review, which essentially summarizes and synthesizes the existing literature. The established associations between insecticide or solvent exposure and certain diseases provide a sufficient basis for examining physicians and VA adjudicators to determine whether a veteran's disease is associated with exposure to insecticides or solvents in service. As noted, the insecticides and solvents discussed in the report generally are not associated with diseases unless the exposure was chronic in nature or due to organophosphorous insecticide poisoning. If any veteran had chronic or sufficient exposure to the insecticides or solvents in question, as may occur where the veteran worked as a mechanic or pesticide applicator in service, and developed a disease associated with such exposure, the veteran could pursue a claim for direct service connection regardless of the existence of a presumption. Additionally, insofar as certain NAS findings relate to conditions that would be present concurrent with exposure, as in the case of allergic contact dermatitis, acute pesticide poisoning, and reactive airways dysfunction syndromes, the fact that such conditions are observable at the time of exposure in service would ordinarily be sufficient to establish service connection, irrespective of any presumption. We note further that our conclusion that the solvents and insecticides in question, in isolation, cannot at this time be determined to be “associated with” Gulf War service is not intended to suggest that they are irrelevant to further investigations of Gulf War veterans' health or that they may not in any circumstance form the basis for presumptions of service connection under Public Law 105-277. Several authorities, including NAS, have noted the possibility that the synergistic effects of exposure to multiple substances could lead to risks that would not be associated with exposure to the substances individually. NAS noted the existence of two studies suggesting that combined exposure to pyridostigmine bromide and certain pesticides may produce greater neurotoxicity than exposure to comparable doses of those substances individually. A 1996 report of the Presidential Advisory Committee on Gulf War Veterans' Illnesses and a 2003 Report from DoD's Office of the Special Assistant for Gulf War Illnesses suggested the need for further research on the possible effects of such multiple exposures. (OSAGWI 2003); (Presidential Advisory Committee on Gulf War Veterans' Ilnnesses 1996). In the event future evidence links any illnesses to a combination of exposures associated with Gulf War service, whether or not including exposure to insecticides or solvents, VA may establish presumptions of service connections for such illnesses pursuant to Public Law 105-277. IV. Conclusion For the reasons stated above, the Secretary has determined that a presumption of service connection is not warranted at this time for any of the diseases, illnesses, or health effects discussed in the NAS report issued on February 18, 2003, titled “Gulf War and Health, Volume 2. Insecticides and Solvents.” Approved: August 17, 2007. R. James Nicholson, Secretary of Veterans Affairs. [FR Doc. E7-16733 Filed 8-23-07; 8:45 am] BILLING CODE 8320-01-P 72 164 Friday, August 24, 2007 CORRECTIONS !!!Ben!!! SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 232, 239, 270, and 274 [Release Nos. 33-8823; IC-27884; File Number S7-05-07] RIN 3235-AJ59 Extension of Interactive Data Voluntary Reporting Program on the Edgar System To Include Mutual Fund Risk/Return Summary Information Correction In rule document E7-13738 beginning on page 39290 in the issue of Tuesday, July 17, 2007, make the following corrections: 1. On page 39291, in the third column, in the last paragraph, in the eighth line, “Form N 1A” should read “Form N-1A”. 2. On page 39293, in the first column, in the last paragraph, in the sixth line, “Form N 1A” should read “Form N-1A”. 3. On page 39293, in the third column, in the first full paragraph, in the tenth line, “Form N 1A” should read “Form N-1A”. § 232.401 [Corrected] 4. On page 39299, in the second column, in § 232.401(a), in the eleventh line, “Form N 1A” should read “Form N-1A”. 5. On the same page, in the same column, in § 232.401(b)(1)(iv), in the third and fourth lines, “Form N 1A” should read “Form N-1A”. PART 274 [Corrected] 6. On page 39300, in the third column, in amendatory instruction 8, in the second line, “Form N 1A” should read “Form N-1A”. [FR Doc. Z7-13738 Filed 8-23-07; 8:45 am] BILLING CODE 1505-01-D Dominique DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9344] 1545-BG24 Change to Office to Which Notices of Nonjudical Sale and Requests for Return of Wrongfully Levied Property Must Be Sent Correction In rule document E7-14053 beginning on page 39737 in the issue of Friday, July 20, 2007, make the following correction: § 301.7425-3T [Corrected] On page 39740, in the first column, in § 301.7425-3T(c), in the first line, “(c) *Sale of perishable goodS”* , should read “(c) *Sale of perishable good”* . [FR Doc. Z7-14053 Filed 8-23-07; 8:45 am] BILLING CODE 1505-01-D Dominique DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9349] 1545-BF01 Employee Benefits - Cafeteria Plans Correction In rule document E7-14823 appearing on page 41891 in the issue of Wednesday, August 1, 2007, make the following correction: On page 41891, in the second column, under the SUMMARY heading, in the sixth line “the ≤” should read “the ”. [FR Doc. Z7-14823 Filed 8-23-07; 8:45 am] BILLING CODE 1505-01-D 72 164 Friday, August 24, 2007 Notices Part II Department of Housing and Urban Development Federal Property Suitable as Facilities To Assist the Homeless; Notice DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5125-N-34] Federal Property Suitable as Facilities To Assist the Homeless AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7266, Washington, DC 20410; telephone
(202)708-1234; TTY number for the hearing- and speech-impaired
(202)708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at
(800)927-7588. SUPPLEMENTARY INFORMATION: In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in *National Coalition for the Homeless* v. *Veterans Administration* , No. 88-2503-OG (D.D.C.). Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD:
(1)Its intention to make the property available for use to assist the homeless,
(2)its intention to declare the property excess to the agency's needs, or
(3)a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless. Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to John Hicks, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857;
(301)443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581. For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable. For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available. Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the **Federal Register** , the landholding agency, and the property number. For more information regarding particular properties identified in this Notice ( *i.e.* , acreage, floor plan, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following addresses: *Coast Guard:* Commandant, U.S. Coast Guard, Attn: Teresa Sheinberg, 2100 Second St., SW., Rm 6109, Washington, DC 20593-0001;
(202)267-6142; *Energy:* Mr. John Watson, Department of Energy, Office of Engineering & Construction Management, ME-90, 1000 Independence Ave., SW., Washington, DC 20585;
(202)586-0072; *GSA:* Mr. John E.B. Smith, Deputy Assistant Commissioner, General Services Administration, Office of Property Disposal, 18th and F Streets, NW., Washington, DC 20405;
(202)501-0084; *Navy:* Mr. Warren Meekins, Associate Director, Department of the Navy, Real Estate Services, Naval Facilities Engineering Command, Washington Navy Yard, 1322 Patterson Ave., SE., Suite 1000, Washington, DC 20374-5065;
(202)685-9305; (These are not toll-free numbers). Dated: August 16, 2007. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. Title V, Federal Surplus Property Program Federal Register Report for 08/24/2007 Suitable/Available Properties Land New Hampshire Blackburn Tract Harding St. Berlin, NH 03246 Landholding Agency: GSA Property Number: 54200730012 Status: Surplus GSA Number: 1-A-NH-0498-1A Comments: 0.11 acre Suitable/Unavailable Properties Building Hawaii Bldg. 2652 Navy Aloha Center Pearl Harbor, HI 96860 Landholding Agency: Navy Property Number: 77200710039 Status: Underutilized Comments: 9125 sq. ft., most recent use—office Unsuitable Properties Building Alaska Radar Tower Potato Point Comm Site Valdez, AK Landholding Agency: Coast Guard Property Number: 88200710001 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material, Not accessible by road Radar Tower Spit Site Comm Site Valdez, AK Landholding Agency: Coast Guard Property Number: 88200710002 Status: Excess Reasons: Secured Area California Bldgs. M03, MO14, MO17 Sandia National Lab Livermore Co: Alameda, CA 94550 Landholding Agency: Energy Property Number: 41200220001 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. C920, C921, C922 Sandia Natl Laboratories Livermore Co: Alameda, CA 94551 Landholding Agency: Energy Property Number: 41200540001 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 175 Livermore National Lab Livermore, CA Landholding Agency: Energy Property Number: 41200630001 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Trailer 1403 Livermore National Lab Livermore, CA Landholding Agency: Energy Property Number: 41200630003 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Trailer 3703 Livermore National Lab Livermore, CA Landholding Agency: Energy Property Number: 41200630004 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building California Bldg. 363 National Laboratory Livermore, CA Landholding Agency: Energy Property Number: 41200710001 Status: Excess Reasons: Secured Area Bldgs. 436, 446 National Laboratory Livermore, CA Landholding Agency: Energy Property Number: 41200710002 Status: Excess Reasons: Secured Area Bldg. 3520 National Laboratory Livermore, CA Landholding Agency: Energy Property Number: 41200710003 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 4182, 4184, 4187 National Laboratory Livermore, CA Landholding Agency: Energy Property Number: 41200710004 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building California Bldg. 5974 National Laboratory Livermore, CA Landholding Agency: Energy Property Number: 41200710005 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 194A, 198 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720007 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldgs. 213, 280 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720008 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldgs. 312, 345 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720009 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building California Bldgs. 2177, 2178 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720010 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 2687, 3777 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720011 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 263, 419 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720012 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 1401, 1402, 1404 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720013 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Unsuitable Properties Building California Bldgs. 1405, 1406, 1407 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720014 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldgs. 1408, 1413, 1456 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720015 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 2684 Lawrence Livermore Natl Lab Livermore, CA Landholding Agency: Energy Property Number: 41200720016 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 2533 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520005 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldg. 13111 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520006 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 53325, 53326 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520007 Status: Excess Reasons: Extensive deterioration, Secured Area 5 Bldgs. Marine Corps Base 53421, 53424 thru 53427 Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520008 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldgs. 61311, 61313, 61314 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520009 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 61320-61324, 61326 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520010 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 62711 thru 62717 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200520011 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 4 Naval Submarine Base Point Loma, CA Landholding Agency: Navy Property Number: 77200520014 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. 8915, 8931 Naval Weapons Station Seal Beach, CA 90740 Landholding Agency: Navy Property Number: 77200530004 Status: Excess Reasons: Extensive deterioration Bldgs. 11, 112 Naval Weapons Station Seal Beach, CA 90740 Landholding Agency: Navy Property Number: 77200530005 Status: Unutilized Reasons: Extensive deterioration Bldg. 805 Naval Weapons Station Seal Beach, CA 90740 Landholding Agency: Navy Property Number: 77200530006 Status: Unutilized Reasons: Extensive deterioration Bldgs. 810 thru 823 Naval Weapons Station Seal Beach, CA 90740 Landholding Agency: Navy Property Number: 77200530007 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. 851, 859, 864 Naval Weapons Station Seal Beach, CA 90740 Landholding Agency: Navy Property Number: 77200530008 Status: Unutilized Reasons: Extensive deterioration Bldg. 1146 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200530009 Status: Unutilized Reasons: Extensive deterioration Bldgs. 1370, 1371, 1372 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200530011 Status: Unutilized Reasons: Extensive deterioration Bldg. 115 Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200530012 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 1674 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530027 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 2636, 2651, 2658 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530028 Status: Excess Reasons: Extensive deterioration, Secured Area 4 Bldgs. Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530029 Status: Excess Directions: 26053, 26054, 26056, 26059 Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldgs. 53333, 53334 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530030 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 53507, 53569 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530031 Status: Excess Reasons: Secured Area, Extensive deterioration Bldg. 170111 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200530032 Status: Excess Reasons: Extensive deterioration, Secured Area Bldg. PM4-3 Naval Base Oxnard Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200530033 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 1781 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200540001 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 398, 399, 404 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200540003 Status: Unutilized Reasons: Extensive deterioration Bldgs. 388, 389, 390, 391 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200540004 Status: Unutilized Reasons: Extensive deterioration Bldg. 16 Naval Submarine Base San Diego, CA Landholding Agency: Navy Property Number: 77200540017 Status: Unutilized Reasons: Extensive deterioration, Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building California Bldg. 325 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200610001 Status: Unutilized Reasons: Extensive deterioration, Secured Area, Within airport runway clear zone Bldgs. 1647, 1648 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610010 Status: Excess Reasons: Extensive deterioration Bldg. 1713 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610011 Status: Excess Reasons: Extensive deterioration Bldg. 16171 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610012 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 2100576 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610013 Status: Excess Reasons: Extensive deterioration Bldg. 220189 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610014 Status: Excess Reasons: Extensive deterioration Bldg. 2295 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610015 Status: Excess Reasons: Extensive deterioration Bldgs. 22115, 22116, 22117 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610016 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 143 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610017 Status: Excess Reasons: Extensive deterioration Bldgs. 213, 243, 273 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610018 Status: Excess Reasons: Extensive deterioration Bldg. 303 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610019 Status: Excess Reasons: Extensive deterioration Bldg. 471 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610020 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. 979, 928, 930 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610021 Status: Excess Reasons: Extensive deterioration Bldgs. 999, 1000 Naval Air Station Lemoore, CA Landholding Agency: Navy Property Number: 77200610022 Status: Excess Reasons: Extensive deterioration Bldgs. 305, 353 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200610023 Status: Unutilized Reasons: Extensive deterioration Bldgs. 358, 359, 360, 361 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200610024 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 581 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200610026 Status: Unutilized Reasons: Extensive deterioration Bldgs. A25, A27 Naval Base Point Loma San Diego, CA Landholding Agency: Navy Property Number: 77200610027 Status: Unutilized Reasons: Extensive deterioration Bldgs. 31926, 31927, 31928 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610058 Status: Excess Reasons: Extensive deterioration Bldg. 41326 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610059 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 41816 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200610060 Status: Excess Reasons: Extensive deterioration Bldgs. 1468, 1469 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630002 Status: Unutilized Reasons: Secured Area Bldg. 30869 Naval Air Weapons Station China Lake, CA 93555 Landholding Agency: Navy Property Number: 77200630005 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 2-8, 3-10 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630009 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldgs. 6-11, 6-12, 6-819 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630010 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 85 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630011 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 120, 123 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630012 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 724 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630013 Status: Unutilized Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building California Bldg. 764 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630014 Status: Unutilized Reasons: Secured Area Bldg. 115 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630015 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 323 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630016 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 488 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630017 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldg. 842 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630018 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 927 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630019 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 1150 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630020 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 1361 Naval Base Port Hueneme Co: Ventura, CA 93042 Landholding Agency: Navy Property Number: 77200630021 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldg. PH546 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200640027 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. PH425 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200710001 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. PM 134 Naval Base Point Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200710023 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. PH837, PH1372 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200710024 Status: Unutilized Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building California Bldg. 523107 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710025 Status: Excess Reasons: Extensive deterioration 6 Bldgs. Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710026 Status: Excess Directions: 523112, 523113, 523114, 523115, 523116, 523117 Reasons: Extensive deterioration 6 Bldgs. Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710027 Status: Excess Directions: 523122, 523123, 523124, 523125, 523126, 523127 Reasons: Extensive deterioration Unsuitable Properties Building California 6 Bldgs. Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710028 Status: Excess Directions: 523132, 523133, 523134, 523135, 523136, 523137 Reasons: Extensive deterioration 6 Bldgs. Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710029 Status: Excess Directions: 523142, 523143, 523144, 523145, 523146, 523147 Reasons: Extensive deterioration Bldgs. 523156, 523157 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200710030 Status: Excess Reasons: Extensive deterioration Bldg. 30726 Naval Air Weapons China Lake, CA 93555 Landholding Agency: Navy Property Number: 77200710047 Status: Excess Reasons: Secured Area Unsuitable Properties Building California Bldgs. PH284, PH339 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720001 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. PH805, PH1179 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720002 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. PH1207, PH1264, PH1288 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720003 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. PM 3-53, PM129, PM402 Naval Base Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720004 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building California Bldg. LP908 Naval Base Laguna Peak Port Mugu Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720005 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. PM790 Naval Base Oxnard, CA 93043 Landholding Agency: Navy Property Number: 77200720006 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 53402 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200720007 Status: Excess Reasons: Extensive deterioration, Secured Area Bldg. 307 Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200720009 Status: Excess Reasons: Secured Area Unsuitable Properties Building California Bldg. 3135 Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200720010 Status: Excess Reasons: Secured Area Bldgs. 30727, 31409 Naval Air Weapons Station China Lake, CA 93555 Landholding Agency: Navy Property Number: 77200720011 Status: Excess Reasons: Secured Area Bldgs. 60142, 60158 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720012 Status: Unutilized Reasons: Extensive deterioration, Not accessible by road Bldgs. 60160, 60162, 60164 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720013 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. 60203, 60210, 60211 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720014 Status: Unutilized Reasons: Extensive deterioration Bldgs. 60214, 60215 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720015 Status: Unutilized Reasons: Extensive deterioration Bldgs. 60227, 60243, 60250 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720016 Status: Unutilized Reasons: Extensive deterioration Bldg. 60313 Naval Base Coronado San Clemente Island, CA Landholding Agency: Navy Property Number: 77200720017 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building California Bldg. 404 Naval Air Station North Island, CA Landholding Agency: Navy Property Number: 77200720032 Status: Unutilized Reasons: Extensive deterioration Bldg. 3267 Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200720039 Status: Unutilized Reasons: Secured Area Bldgs. 11090, 98033 Naval Air Weapons China Lake, CA 93555 Landholding Agency: Navy Property Number: 77200720054 Status: Excess Reasons: Secured Area, Extensive deterioration Bldgs. 41314, 41362 Marine Corps Base Camp Pendleton, CA 92055 Landholding Agency: Navy Property Number: 77200720055 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building California Bldgs. 192, 193, 410 Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200720063 Status: Excess Reasons: Secured Area Quarters/Garages Lighthouse Station Trinidad CA, 95570 Landholding Agency: Coast Guard Property Number: 88200720001 Status: Unutilized Reasons: Extensive deterioration Connecticut Bldgs. 25 and 26 Prospect Hill Road Windsor Co: Hartford, CT 06095 Landholding Agency: Energy Property Number: 41199440003 Status: Excess Reasons: Secured Area 9 Bldgs. Knolls Atomic Power Lab, Windsor Site Windsor Co: Hartford, CT 06095 Landholding Agency: Energy Property Number: 41199540004 Status: Excess Reasons: Secured Area Unsuitable Properties Building Connecticut Bldg. 8, Windsor Site Knolls Atomic Power Lab Windsor Co: Hartford, CT 06095 Landholding Agency: Energy Property Number: 41199830006 Status: Unutilized Reasons: Extensive deterioration District of Columbia Bldg. 396 Naval Support Facility Anacostia Annex, DC 20373 Landholding Agency: Navy Property Number: 77200630008 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Florida Bldg. U-150 Naval Air Station Key West Co: Monroe, FL 33040 Landholding Agency: Navy Property Number: 77200520044 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Florida Bldgs. V1221 A Naval Air Station Sigsbee Park Key West Co: Monroe, FL 33040 Landholding Agency: Navy Property Number: 77200530013 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 969 Naval Air Station Jacksonville Co: Duval, FL 32212 Landholding Agency: Navy Property Number: 77200540014 Status: Unutilized Reasons: Secured Area Bldgs. 1759, 1760 Naval Air Station Jacksonville Co: Duval, FL Landholding Agency: Navy Property Number: 77200540015 Status: Unutilized Reasons: Secured Area Bldg. 1917 Naval Air Station Jacksonville Co: Duval, FL 32212 Landholding Agency: Navy Property Number: 77200540016 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Florida Bldgs. 1, 2 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540018 Status: Excess Reasons: Extensive deterioration, Secured Area, Floodway Bldg. 24 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540019 Status: Excess Reasons: Floodway, Secured Area, Extensive deterioration Bldg. 66 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540020 Status: Excess Reasons: Extensive deterioration, Secured Area, Floodway Unsuitable Properties Building Florida Bldg. 216 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540021 Status: Excess Reasons: Floodway, Secured Area, Extensive deterioration Bldgs. 437, 450 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540022 Status: Excess Reasons: Extensive deterioration, Floodway, Secured Area Bldgs. 1234, 1235 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200540023 Status: Excess Reasons: Floodway, Secured Area, Extensive deterioration Unsuitable Properties Building Florida Bldg. 212 Naval Station Mayport Co: Duval, FL 32228 Landholding Agency: Navy Property Number: 77200620011 Status: Unutilized Reasons: Floodway, Extensive deterioration, Secured Area Bldg. 508 Naval Station Mayport, FL 32228 Landholding Agency: Navy Property Number: 77200620035 Status: Unutilized Reasons: Floodway, Secured Area Bldg. 834 Naval Air Station Pensacola Co: Escambia, FL 32508 Landholding Agency: Navy Property Number: 77200630022 Status: Unutilized Reasons: Extensive deterioration Bldg. 2658 Naval Air Station Pensacola Co: Escambia, FL 32508 Landholding Agency: Navy Property Number: 77200630023 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building Florida Bldg. 3483 Naval Air Station Pensacola Co: Escambia, FL 32508 Landholding Agency: Navy Property Number: 77200630024 Status: Unutilized Reasons: Extensive deterioration Bldg. 6144 Naval Air Station Pensacola Co: Escambia, FL 32508 Landholding Agency: Navy Property Number: 77200630025 Status: Unutilized Reasons: Extensive deterioration Bldg. F11 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630026 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. A225, A409 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630027 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Florida Bldg. A515 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630028 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. A635 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630029 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. A993, A994 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630030 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. A1068 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630031 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Florida Bldg. A4021 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630032 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 4080 Naval Air Station Key West, FL 33040 Landholding Agency: Navy Property Number: 77200630033 Status: Unutilized Reasons: Secured Area, Extensive deterioration Georgia Bldg. 5101 Naval Submarine Base Kings Bay Co: Camden, GA 31547 Landholding Agency: Navy Property Number: 77200520004 Status: Unutilized Reasons: Floodway, Extensive deterioration, Secured Area Unsuitable Properties Building Georgia Bldg. 0038 Naval Submarine Base Kings Bay, GA 31547 Landholding Agency: Navy Property Number: 77200620036 Status: Unutilized Reasons: Extensive deterioration, Secured Area 7 Bldgs. Marine Logistics Base Albany, GA Landholding Agency: Navy Property Number: 77200720040 Status: Excess Directions: 7100, 7106, 7108, 7110, 5584, 7964, 7966 Reasons: Secured Area Guam Bldg. B-32 Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520023 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building Guam Bldgs. 76, 77, 79 Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520024 Status: Unutilized Reasons: Extensive deterioration 4 Bldgs. Naval Forces 261, 262, 263, 269 Marianas, GU Landholding Agency: Navy Property Number: 77200520025 Status: Unutilized Reasons: Extensive deterioration Bldg. 404NM Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520026 Status: Unutilized Reasons: Extensive deterioration Bldgs. 3150, 3268 Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520030 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building Guam Bldgs. 5409, 5412, 5413 Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520031 Status: Unutilized Reasons: Extensive deterioration Bldg. 5500 Naval Forces Marianas, GU Landholding Agency: Navy Property Number: 77200520032 Status: Unutilized Reasons: Extensive deterioration 73 Bldgs. Naval Computer Station Marianas, GU Landholding Agency: Navy Property Number: 77200520045 Status: Excess Directions: A700-A716, A725, A728, A735, A741-A784, A803-A805, A811-A813, A829-A831 Reasons: Extensive deterioration, Secured Area Bldgs. 2006, 2009 Naval Ship Repair Facility Marianas, GU Landholding Agency: Navy Property Number: 77200520048 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Guam Bldgs. 2014, 2916 Naval Ship Repair Facility Marianas, GU Landholding Agency: Navy Property Number: 77200520049 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 277, 308 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610028 Status: Excess Reasons: Secured Area Bldgs. 1686, 1689, 1690 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610029 Status: Excess Reasons: Secured Area Bldgs. 1714, 1767, 1768 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610030 Status: Excess Reasons: Secured Area Unsuitable Properties Building Guam Bldgs. 1771, 1772, 1773 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610031 Status: Excess Reasons: Secured Area Bldgs. 1791, 1792 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610032 Status: Excess Reasons: Secured Area Bldgs. 3000, 3001 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610033 Status: Excess Reasons: Secured Area Bldgs. 3002, 3004, 3005 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610034 Status: Excess Reasons: Secured Area Unsuitable Properties Building Guam Bldgs. 3006, 3007 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610035 Status: Excess Reasons: Secured Area Steam Plant Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200610036 Status: Excess Reasons: Secured Area Bldgs. 403, 404 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620013 Status: Unutilized Reasons: Secured Area Bldgs. 464, 729 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620014 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Guam Bldgs. 836, 837 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620015 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 11XC7 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620016 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. 23YC1, 23YC2, 23YC3 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620017 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 23YC4, 23YC5 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620018 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Guam Bldgs. 24YC7, 24YC8 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620019 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 26YC3, 26YC5 Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620020 Status: Unutilized Reasons: Secured Area, Extensive deterioration Old Bus Stop Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620021 Status: Unutilized Reasons: Extensive deterioration, Secured Area 2 Guard Houses Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620022 Status: Unutilized Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Guam 9 Magazines Marianas Support Activity Santa Rita Co: Naval Magazine, GU Landholding Agency: Navy Property Number: 77200620023 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 151, 152, 153 Naval Forces Marianas Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200630001 Status: Unutilized Reasons: Extensive deterioration Bldg. 4 Naval Base Barrigada, GU Landholding Agency: Navy Property Number: 77200710002 Status: Unutilized Reasons: Extensive deterioration Bldg. C115 Naval Base Barrigada, GU Landholding Agency: Navy Property Number: 77200710003 Status: Unutilized Reasons: Extensive deterioration Unsuitable Properties Building Guam Bldg. 160 Naval Base Barrigada, GU Landholding Agency: Navy Property Number: 77200710004 Status: Unutilized Reasons: Extensive deterioration Bldg. 176 Naval Base Barrigada, GU Landholding Agency: Navy Property Number: 77200710005 Status: Unutilized Reasons: Extensive deterioration Bldg. 33 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710006 Status: Excess Reasons: Extensive deterioration Bldg. 219 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710007 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Guam Bldg. 950 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710008 Status: Excess Reasons: Extensive deterioration Bldg. 1769 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710009 Status: Excess Reasons: Extensive deterioration Bldgs. 3186, 3187, 3188 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710010 Status: Excess Reasons: Extensive deterioration Bldgs. 4408, 4409 Naval Base Santa Rita Co: Apra Harbor, GU Landholding Agency: Navy Property Number: 77200710011 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Guam Hazmat Storage Naval Base Polaris Point Santa Rita Co: Apra Harbor GU Landholding Agency: Navy Property Number: 77200710012 Status: Excess Reasons: Extensive deterioration Storage Bldg. Naval Base Polaris Point Santa Rita Co: Apra Harbor GU Landholding Agency: Navy Property Number: 77200710013 Status: Excess Reasons: Extensive deterioration Hawaii Bldg. 346 Naval Station Pearl Harbor, HI 96860 Landholding Agency: Navy Property Number: 77200610002 Status: Excess Reasons: Extensive deterioration Bldg. 408 Naval Station Pearl Harbor, HI 96860 Landholding Agency: Navy Property Number: 77200720058 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Idaho Bldg. CPP-691 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610003 Status: Unutilized Reasons: Secured Area Bldg. TRA-669 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610013 Status: Unutilized Reasons: Secured Area Bldg. TRA-673 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610018 Status: Unutilized Reasons: Secured Area Bldg. PBF-620 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610019 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Idaho Bldg. PBF-619 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610022 Status: Unutilized Reasons: Secured Area Bldg. TRA-641 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610034 Status: Unutilized Reasons: Secured Area Bldg. CF-606 Idaho National Engineering Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41199610037 Status: Unutilized Reasons: Secured Area Bldgs. CPP638, CPP642 Idaho Natl Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200410014 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldg. CPP 743 Idaho Natl Eng lab Scoville Co: Butte, ID 83-415 Landholding Agency: Energy Property Number: 41200410020 Status: Excess Reasons: Secured Area Bldgs. CPP1647, 1653 Idaho Natl Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200410022 Status: Excess Reasons: Secured Area Bldg. CPP1677 Idaho Natl Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200410023 Status: Excess Reasons: Secured Area Bldg. 694 Idaho Natl Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200410034 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP1604-CPP1608 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430071 Status: Excess Reasons: Secured Area Bldgs. CPP1617-CPP1619 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430072 Status: Excess Reasons: Secured Area 6 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430073 Status: Excess Directions: CPP1631, CPP1634, CPP1635, CPP1636, CPP1637, CPP1638 Reasons: Secured Area 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430074 Status: Excess Directions: CPP1642, CPP1643, CPP1644, CPP1646, CPP1649 Reasons: Secured Area Unsuitable Properties Building Idaho 3 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430075 Status: Excess Directions: CPP1650, CPP1651, CPP1656 Reasons: Secured Area 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430076 Status: Excess Directions: CPP1662, CPP1663, CPP1671, CPP1673, CPP1674 Reasons: Secured Area 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430077 Status: Excess Directions: CPP1678, CPP1682, CPP1683, CPP1684, CPP1686 Reasons: Secured Area Unsuitable Properties Building Idaho 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430078 Status: Excess Directions: CPP1713, CPP1749, CPP1750, CPP1767, CPP1769 Reasons: Secured Area 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430079 Status: Excess Directions: CPP1770, CPP1771, CPP1772, CPP1774, CPP1776 Reasons: Secured Area 4 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430081 Status: Excess Directions: CPP1789, CPP1790, CPP1792, CPP1794 Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP2701, CPP2706 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430082 Status: Excess Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430089 Status: Excess Directions: TRA603, TRA604, TRA610 Reasons: Secured Area Bldg. TAN611 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430090 Status: Excess Reasons: Secured Area 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430091 Status: Excess Directions: TRA626, TRA635, TRA642, TRA648, TRA654 Reasons: Secured Area Unsuitable Properties Building Idaho Bldg. TAN655 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430092 Status: Excess Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430093 Status: Excess Directions: TRA657, TRA661, TRA668 Reasons: Secured Area Bldg. TAN711 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430094 Status: Excess Reasons: Secured Area 6 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430095 Status: Excess Directions: CPP602-CPP606, CPP609 Reasons: Secured Area Unsuitable Properties Building Idaho 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430096 Status: Excess Directions: CPP611-CPP614, CPP616 Reasons: Secured Area 4 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430097 Status: Excess Directions: CPP621, CPP626, CPP630, CPP639 Reasons: Secured Area 4 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430098 Status: Excess Directions: CPP641, CPP644, CPP645, CPP649 Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP651-CPP655 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200430099 Status: Excess Reasons: Secured Area Bldgs. CPP659-CPP663 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440001 Status: Excess Reasons: Secured Area Bldgs. CPP666, CPP668 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440002 Status: Excess Reasons: Secured Area 1 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440004 Status: Excess Directions: CPP684 Reasons: Secured Area Unsuitable Properties Building Idaho 5 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440005 Status: Excess Directions: CPP692, CPP694, CPP697-CPP699 Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440006 Status: Excess Directions: CPP701, CPP701A, CPP708 Reasons: Secured Area Bldgs. 711, 719A Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440007 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho 4 Bldgs. Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440008 Status: Excess Directions: CPP724-CPP726, CPP728 Reasons: Secured Area Bldg. CPP729/741 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440012 Status: Excess Reasons: Secured Area Bldgs. CPP733, CPP736 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440013 Status: Excess Reasons: Secured Area Bldgs. CPP740, CPP742 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440014 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP746, CPP748 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440015 Status: Excess Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab CPP750, CPP751, CPP752 Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440016 Status: Excess Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab CPP753, CPP753A, CPP754 Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440017 Status: Excess Reasons: Secured Area Bldgs. CPP760, CPP763 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440018 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP764, CPP765 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440019 Status: Excess Reasons: Secured Area Bldgs. CPP767, CPP768 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440020 Status: Excess Reasons: Secured Area Bldgs. CPP791, CPP795 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440021 Status: Excess Reasons: Secured Area 3 Bldgs. Idaho National Eng Lab CPP796, CPP797, CPP799 Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440022 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. CPP701B, CPP719 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440023 Status: Excess Reasons: Secured Area Bldgs. CPP720A, CPP720B Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440024 Status: Excess Reasons: Secured Area Bldg. CPP1781 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440025 Status: Excess Reasons: Secured Area 2 Bldgs. Idaho National Eng Lab CPP0000VES-UTI-111, VES-UTI-112 Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440026 Status: Excess Reasons: Secured Area Unsuitable Properties Building Idaho Bldgs. TAN704, TAN733 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440028 Status: Excess Reasons: Secured Area Bldgs. TAN1611, TAN1614 Idaho National Eng Lab Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200440029 Status: Excess Reasons: Secured Area Bldg. CF633 Idaho Natl Laboratory Scoville Co: Butte, ID 83415 Landholding Agency: Energy Property Number: 41200520005 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Illinois Bldgs. 306A, B, C, TR-5 Argonne National Lab Argonne, IL 60439 Landholding Agency: Energy Property Number: 41200720017 Status: Excess Reasons: Secured Area Bldg. 42 Naval Station Great Lakes, IL 60088 Landholding Agency: Navy Property Number: 77200520055 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 25 Naval Station Great Lakes, IL 60088 Landholding Agency: Navy Property Number: 77200530001 Status: Excess Reasons: Extensive deterioration Bldg. 42 Naval Station Great Lakes, IL 60088 Landholding Agency: Navy Property Number: 77200530014 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Illinois Bldg. 2C Naval Station Great Lakes, IL 60088-2900 Landholding Agency: Navy Property Number: 77200540005 Status: Excess Reasons: Secured Area Bldg. 3312 Naval Station Great Lakes, IL 60085 Landholding Agency: Navy Property Number: 77200640028 Status: Excess Reasons: Secured Area Bldg. 220 Naval Station Great Lakes, IL 60085 Landholding Agency: Navy Property Number: 77200640029 Status: Excess Reasons: Secured Area Bldg. B-912 Naval Station Great Lakes, IL 60088 Landholding Agency: Navy Property Number: 77200710042 Status: Excess Reasons: Secured Area Unsuitable Properties Building Indiana Bldgs. 1871, 2636 Naval Support Activity Crane Co: Martin, IN 47522 Landholding Agency: Navy Property Number: 77200530015 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Extensive deterioration, Secured Area Bldg. 1820 Naval Support Activity Crane Co: Martin, IN 47522 Landholding Agency: Navy Property Number: 77200540028 Status: Unutilized Reasons: Extensive deterioration Bldg. 2694 Naval Support Activity Crane Co: Martin, IN 47522 Landholding Agency: Navy Property Number: 77200540029 Status: Unutilized Reasons: Extensive deterioration Bldg. 2796 Naval Support Activity Crane Co: Martin, IN 47522 Landholding Agency: Navy Property Number: 77200620001 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area, Extensive deterioration Unsuitable Properties Building Maryland Bldg. 84NS Naval Support Activity Annapolis Co: Anne Arundel, MD 21402 Landholding Agency: Navy Property Number: 77200610038 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Floodway Bldg. 2075 Naval Surface Warfare Indian Head, MD Landholding Agency: Navy Property Number: 77200630043 Status: Excess Reasons: Extensive deterioration Michigan Admin. Bldg. Station Saginaw River Essexville Co: Bay, MI 48732 Landholding Agency: Coast Guard Property Number: 88200510001 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Mississippi Bldg. 9 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610039 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 22, 27, 41 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610040 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. 108, 181, 183 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610041 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 201 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610042 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Mississippi Bldgs. 270, 270A-1, 270A-2 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610043 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 375, 420 Construction Battalion Center Gulfport, MS Landholding Agency: Navy Property Number: 77200610044 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 95, 96 Naval Air Station Meridian, MS 39309 Landholding Agency: Navy Property Number: 77200720046 Status: Unutilized Reasons: Secured Area, Within airport runway clear zone, Within 2000 ft. of flammable or explosive material Bldg. 167 Naval Air Station Meridian, MS 39309 Landholding Agency: Navy Property Number: 77200720047 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Mississippi Bldgs. 212, 228 Naval Air Station Meridian, MS 39309 Landholding Agency: Navy Property Number: 77200720048 Status: Unutilized Reasons: Secured Area Bldgs. 266, 267 Naval Air Station Meridian, MS 39309 Landholding Agency: Navy Property Number: 77200720049 Status: Unutilized Reasons: Secured Area Bldgs. 351, 445 Naval Air Station Meridian, MS 39309 Landholding Agency: Navy Property Number: 77200720050 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Nevada 28 Facilities Nevada Test Site Mercury Co: Nye, NV 89023 Landholding Agency: Energy Property Number: 41200310018 Status: Excess Reasons: Secured Area, Other—contamination 31 Bldgs./Facilities Nellis AFB Tonopah Test Range Tonopah Co: Nye, NV 89049 Landholding Agency: Energy Property Number: 41200330003 Status: Unutilized Reasons: Secured Area 42 Bldgs. Nellis Air Force Base Tonopah Co: Nye, NV 89049 Landholding Agency: Energy Property Number: 41200410029 Status: Unutilized Directions: 49-01, NM104, NM105, 03-35A-H, 03-35J-N, 03-36A-C, 03-36E-H, 03-36J-N, 03-36R, 03-37, 15036, 03-44A-D, 03-46, 03-47, 03-49, 03-88, 03-89, 03-90 Reasons: Secured Area Unsuitable Properties Building Nevada 241 Bldgs. Tonopah Test Range Tonopah Co: Nye, NV 89049 Landholding Agency: Energy Property Number: 41200440036 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material 10 Bldgs. Nevada Test Site Mercury Co: Nye, NV 89023 Landholding Agency: Energy Property Number: 41200610003 Status: Excess Reasons: Secured Area 3 Bldgs. Nevada Test Site 23-790, 06-CP50, 26-2107 Mercury Co: Nye, NV 89023 Landholding Agency: Navy Property Number: 77200510025 Status: Excess Reasons: Secured Area, Other—contamination Units 501-521 Naval Air Station Fallon, NV Landholding Agency: Navy Property Number: 77200710017 Status: Excess Reasons: Secured Area Unsuitable Properties Building New Mexico Bldgs. 9252, 9268 Kirtland Air Force Base Albuquerque Co: Bernalillo, NM 87185 Landholding Agency: Energy Property Number: 41199430002 Status: Unutilized Reasons: Extensive deterioration Tech Area II Kirtland Air Force Base Albuquerque Co: Bernalillo, NM 87105 Landholding Agency: Energy Property Number: 41199630004 Status: Unutilized Reasons: Extensive deterioration, Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 26, TA-33 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810004 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 2, TA-21 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810008 Status: Underutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 5, TA-21 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810011 Status: Unutilized Reasons: Secured Area Bldg. 116, TA-21 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810013 Status: Unutilized Reasons: Secured Area Bldg. 286, TA-21 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810016 Status: Unutilized Reasons: Secured Area Bldg. 516, TA-16 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810021 Status: Unutilized Reasons: Secured Area, Extensive deterioration, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building New Mexico Bldg. 517, TA-16 Los Alamos National Laboratory Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199810022 Status: Unutilized Reasons: Extensive deterioration, Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 31 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199930003 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 38, TA-14 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940004 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 9, TA-15 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940006 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 141, TA-15 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940008 Status: Unutilized Reasons: Secured Area Bldg. 44, TA-15 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940009 Status: Unutilized Reasons: Secured Area Bldg. 2, TA-18 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940010 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 5, TA-18 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940011 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building New Mexico Bldg. 186, TA-18 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940012 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 188, TA-18 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940013 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 45, TA-36 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940016 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building New Mexico Bldg. 258, TA-46 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41199940019 Status: Unutilized Reasons: Extensive deterioration, Secured Area TA-3, Bldg. 208 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010010 Status: Unutilized Reasons: Extensive deterioration, Secured Area TA-14, Bldg. 5 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010019 Status: Unutilized Reasons: Secured Area TA-21, Bldg. 150 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010020 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 149, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010024 Status: Unutilized Reasons: Secured Area Bldg. 312, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010025 Status: Unutilized Reasons: Secured Area Bldg. 313, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010026 Status: Unutilized Reasons: Secured Area Bldg. 314, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010027 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 315, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010028 Status: Unutilized Reasons: Secured Area Bldg. 1, TA-8 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010029 Status: Unutilized Reasons: Secured Area Bldg. 2, TA-8 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200010030 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 3, TA-8 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020001 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building New Mexico Bldg. 51, TA-9 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020002 Status: Unutilized Reasons: Secured Area Bldg. 30, TA-14 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020003 Status: Unutilized Reasons: Secured Area Bldg. 16, TA-3 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020009 Status: Unutilized Reasons: Secured Area Bldg. 48, TA-55 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020017 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 125, TA-55 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020018 Status: Unutilized Reasons: Secured Area Bldg. 162, TA-55 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020019 Status: Unutilized Reasons: Secured Area Bldg. 22, TA-33 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020022 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 23, TA-49 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020023 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldg. 37, TA-53 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020024 Status: Unutilized Reasons: Secured Area Bldg. 121, TA-49 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200020025 Status: Unutilized Reasons: Secured Area Bldg. B117 Kirtland Operations Albuquerque Co: Bernalillo, NM 87117 Landholding Agency: Energy Property Number: 41200220032 Status: Excess Reasons: Extensive deterioration Bldg. B118 Kirtland Operations Albuquerque Co: Bernalillo, NM 87117 Landholding Agency: Energy Property Number: 41200220033 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building New Mexico Bldg. B119 Kirtland Operations Albuquerque Co: Bernalillo, NM 87117 Landholding Agency: Energy Property Number: 41200220034 Status: Excess Reasons: Extensive deterioration Bldg. 2, TA-11 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200240004 Status: Unutilized Reasons: Secured Area Bldg. 4, TA-41 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200240005 Status: Unutilized Reasons: Secured Area Bldg. 116, TA-21 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200310003 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New Mexico Bldgs. 1, 2, 3, 4, 5, TA-28 Los Alamos National Lab Los Alamos, NM 87545 Landholding Agency: Energy Property Number: 41200310004 Status: Unutilized Reasons: Secured Area Bldgs. 447, 1483 Los Alamos Natl Laboratory Los Alamos, NM Landholding Agency: Energy Property Number: 41200410002 Status: Excess Reasons: Extensive deterioration, Secured Area Bldg. 99650 Sandia National Laboratory Albuquerque Co: Bernalillo, NM 87185 Landholding Agency: Energy Property Number: 41200510004 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building New York Bldgs. 0087, 0100 Brookhaven Natl Laboratory Upton, NY 11973 Landholding Agency: Energy Property Number: 41200720002 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 0134A, 0179A Brookhaven Natl Laboratory Upton, NY 11973 Landholding Agency: Energy Property Number: 41200720003 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 0210, 0211 Brookhaven Natl Laboratory Upton, NY 11973 Landholding Agency: Energy Property Number: 41200720004 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldgs. 0475, 0481 Brookhaven Natl Laboratory Upton, NY 11973 Landholding Agency: Energy Property Number: 41200720005 Status: Excess Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building New York Bldgs. 0629, 0952 Brookhaven Natl Laboratory Upton, NY 11973 Landholding Agency: Energy Property Number: 41200720006 Status: Excess Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 0096 Brookhaven National Lab Upton, NY 11973 Landholding Agency: Energy Property Number: 41200730004 Status: Unutilized Reasons: Secured Area, Extensive deterioration North Carolina Bldg. 82 Marine Corps Air Station Cherry Point Co: Craven, NC 28533 Landholding Agency: Navy Property Number: 77200510009 Status: Underutilized Reasons: Secured Area Bldg. 4314 Marine Corps Air Station Cherry Point Co: Craven, NC 28533 Landholding Agency: Navy Property Number: 77200510010 Status: Underutilized Reasons: Secured Area Unsuitable Properties Building North Carolina Bldg. 124 Marine Corps Air Station Cherry Point Co: Craven, NC 28533 Landholding Agency: Navy Property Number: 77200510023 Status: Underutilized Reasons: Secured Area Bldgs. 73, 95, 1018 Marine Corps Air Station Cherry Point, NC Landholding Agency: Navy Property Number: 77200620003 Status: Unutilized Reasons: Secured Area Bldg. 499 Marine Corps Air Station Cherry Point, NC Landholding Agency: Navy Property Number: 77200620038 Status: Unutilized Reasons: Secured Area Bldgs. 3177, 3885 Marine Corps Air Station Cherry Point, NC Landholding Agency: Navy Property Number: 77200620039 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building North Carolina Bldg. 4473 Marine Corps Air Station Cherry Point, NC Landholding Agency: Navy Property Number: 77200620040 Status: Unutilized Reasons: Secured Area Bldg. 4523 Marine Corps Air Station Cherry Point, NC Landholding Agency: Navy Property Number: 77200620041 Status: Unutilized Reasons: Secured Area RPFN 0S1 Group Cape Hatteras Buxton Co: Dare, NC 27902 Landholding Agency: Coast Guard Property Number: 88200540001 Status: Unutilized Reasons: Extensive deterioration, Secured Area RPFN 053 Sector N.C. Atlantic Beach Co: Carteret, NC 28512 Landholding Agency: Coast Guard Property Number: 88200540002 Status: Unutilized Reasons: Extensive deterioration Secured Area Unsuitable Properties Building North Carolina Equip. Bldg. Coast Guard Station 11101 Station St. Emerald Isle, NC Landholding Agency: Coast Guard Property Number: 88200630001 Status: Unutilized Reasons: Secured Area Pennsylvania Z-Bldg. Bettis Atomic Power Lab West Mifflin Co: Allegheny, PA 15122-0109 Landholding Agency: Energy Property Number: 41199720002 Status: Excess Reasons: Extensive deterioration South Carolina Bldg. 701-6G Jackson Barricade Jackson, SC Landholding Agency: Energy Property Number: 41200420010 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 211-000F Nuclear Materials Processing Facility Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200420011 Status: Excess Reasons: Secured Area Bldg. 221-001F Nuclear Materials Processing Facility Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200420015 Status: Excess Reasons: Secured Area Bldg. 190-K Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200420030 Status: Unutilized Reasons: Secured Area Bldg. 710-015N Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430002 Status: Excess Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 713-000N Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430003 Status: Excess Reasons: Secured Area Bldgs. 80-9G, 10G Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430006 Status: Excess Reasons: Secured Area Bldgs. 105-P, 105-R Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430007 Status: Excess Reasons: Secured Area Bldg. 183-003L Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430009 Status: Excess Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 221-016F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430014 Status: Excess Reasons: Secured Area Bldgs. 221-053F, 054F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430016 Status: Excess Reasons: Secured Area Bldgs. 252-003F, 005F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430017 Status: Excess Reasons: Secured Area Bldg. 315-M Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430030 Status: Excess Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 716-002A Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430040 Status: Excess Reasons: Secured Area Bldgs. 221-21F, 22F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430042 Status: Excess Reasons: Secured Area Bldg. 221-033F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430043 Status: Excess Reasons: Secured Area Bldg. 254-007F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430044 Status: Excess Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 281-001F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430045 Status: Excess Reasons: Secured Area Bldg. 281-004F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430046 Status: Excess Reasons: Secured Area Bldg. 281-006F Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430047 Status: Excess Reasons: Secured Area Bldg. 703-045A Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430050 Status: Excess Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 703-071A Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430051 Status: Excess Reasons: Secured Area Bldg. 754-008A Savannah River Operations Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430058 Status: Excess Reasons: Secured Area Bldg. 186-R Savannah River Site Aiken, SC Landholding Agency: Energy Property Number: 41200430063 Status: Unutilized Reasons: Secured Area 4 Bldgs. Savannah River Site #281-2F, 281-5F, 285-F, 285-5F Aiken, SC Landholding Agency: Energy Property Number: 41200430066 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 701-000M Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200430084 Status: Unutilized Reasons: Secured Area Bldg. 690-000N Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200440032 Status: Underutilized Reasons: Secured Area Facility 701-5G Savannah River Site New Ellenton, SC Landholding Agency: Energy Property Number: 41200530003 Status: Unutilized Reasons: Extensive deterioration Bldg. 714-000A Savannah River Site Aiken, SC Landholding Agency: Energy Property Number: 41200620014 Status: Underutilized Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 777-018A Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200620022 Status: Excess Reasons: Secured Area Bldgs. 108-1P, 108-2P Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200630007 Status: Unutilized Reasons: Secured Area Bldg. 701-001P Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200640002 Status: Unutilized Reasons: Secured Area Bldgs. 151-1P, 151-2P Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200640004 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building South Carolina Bldg. 191-P Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200640005 Status: Unutilized Reasons: Secured Area Bldg. 710-P Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200640006 Status: Unutilized Reasons: Secured Area Bldg. 614-63G Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200710006 Status: Unutilized Reasons: Secured Area Bldgs. 701-2G, -905-117G Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200710007 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building South Carolina Bldgs. 108-1R, 108-2R Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200710010 Status: Unutilized Reasons: Secured Area Bldgs. 717-003S, 717-010S Savannah River Site Aiken, SC 29802 Landholding Agency: Energy Property Number: 41200710011 Status: Unutilized Reasons: Secured Area Bldgs. 1000 thru 1021 Naval Weapons Station Goose Creek Co: Berkeley, SC 29445 Landholding Agency: Navy Property Number: 77200440018 Status: Unutilized Reasons: Secured Area Bldg. 102 Marine Corps Recruit Depot Parris Island Co: Beaufort, SC 29905 Landholding Agency: Navy Property Number: 77200530017 Status: Unutilized Reasons: Floodway, Secured Area Extensive deterioration Unsuitable Properties Building South Carolina 21 Bldgs. Naval Weapons Station Goose Creek Co: Berkely, SC 29445 Landholding Agency: Navy Property Number: 77200620034 Status: Unutilized Directions: 4, 167C, 174, 180, 350, 383, 400, 410, 769, 790, 823, 824, 904, 930, 930A, 953, 953A, 971, 975, 2305, 3526 Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 1148 Naval Weapons Station Goose Creek Co: Berkeley, SC 29445 Landholding Agency: Navy Property Number: 77200630044 Status: Excess Reasons: Extensive deterioration Bldg. 200 Marine Corps Recruit Depot Parris Island, SC 29905 Landholding Agency: Navy Property Number: 77200720018 Status: Unutilized Reasons: Floodway, Secured Area Unsuitable Properties Building Tennessee Bldg. 9418-1 Y-12 Plant Oak Ridge Co: Anderson, TN 37831 Landholding Agency: Energy Property Number: 41199810026 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 2010 Oak Ridge Natl Laboratory Oak Ridge, TN 37831 Landholding Agency: Energy Property Number: 41200710009 Status: Excess Reasons: Extensive deterioration, Secured Area 3 Bldgs. Y-12 Natl Nuclear Security Complex Oak Ridge, TN 37831 Landholding Agency: Energy Property Number: 41200720001 Status: Unutilized Directions: 9104-01, 9104-02, 9104-03 Reasons: Secured Area Unsuitable Properties Building Tennessee 17 Buildings Naval Support Activity Mid-South Millington, TN 38054 Landholding Agency: Navy Property Number: 77200520012 Status: Excess Directions: 892-893, 1704, 1487, 2020, 2035, 2044-2045, 2071, 2074, 2079-2082, 2094, 2096, 2063 Reasons: Secured Area Bldgs. 2, 3, 5 Naval/Marine Corps Rsv Ctr Knoxville Co: Knox, TN 37920 Landholding Agency: Navy Property Number: 77200530018 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. 9720-03, 9720-06 Y-12 Natl Nuclear Security Complex Oak Ridge, TN 37831 Landholding Agency: Navy Property Number: 77200720038 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Texas Zone 12, Bldg. 12-20 Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200220053 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 12-017E, 12-019E Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200320010 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area 4 Bldgs. NNSA Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200540002 Status: Unutilized Directions: 12-009, 12-009A, 12-R-009A, 12-R-009B Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Unsuitable Properties Building Texas Bldg. 12-011A NNSA Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200540003 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 12-097 NNSA Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200540004 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 11-54, 11-54A Zone 11 Plantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200630008 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building Texas Bldg. 12-002B Zone 12 Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200630009 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area 4 Bldgs. 12-003, 12-R-003, 12-003L Zone 12, Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200630010 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 12-014 Zone 12 Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200630011 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Unsuitable Properties Building Texas Bldg. 12-24E Zone 12 Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200630012 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 11-029, Zone 11 Pantex Plant Amarillo Co: Carson, TX 79120 Landholding Agency: Energy Property Number: 41200640007 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 1732 Naval Air Station Corpus Christi Co: Nueces, TX Landholding Agency: Navy Property Number: 77200540007 Status: Excess Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Texas Bldg. 243 Naval Air Station Joint Reserve Base Ft. Worth Co: Tarrant, TX 76127 Landholding Agency: Navy Property Number: 77200640035 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 1430 Naval Air Station Joint Reserve Base Ft. Worth Co: Tarrant, TX 76127 Landholding Agency: Navy Property Number: 77200640036 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldg. 1500 Naval Air Station Joint Reserve Base Ft. Worth Co: Tarrant, TX 76127 Landholding Agency: Navy Property Number: 77200640037 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 4151 Naval Air Station Joint Reserve Base Ft. Worth Co: Tarrant, TX 76127 Landholding Agency: Navy Property Number: 77200640038 Status: Unutilized Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Utah 5 Bldgs. Naval Industrial Ordinance Plant Magna, UT 84044 Landholding Agency: Navy Property Number: 77200720033 Status: Unutilized Directions: 4D, 6A, 6C, 8C, 10B Reasons: Within 2000 ft. of flammable or explosive material, Secured Area 4 Bldgs. Naval Industrial Ordinance Plant Magna, UT 84044 Landholding Agency: Navy Property Number: 77200720034 Status: Unutilized Directions: 11, 15, 16, 19 Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 22A, 22B, 22C Naval Industrial Ordinance Plant Magna, UT 84044 Landholding Agency: Navy Property Number: 77200720035 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building Utah Bldgs. 23A, 23B, 23C Naval Industrial Ordinance Plant Magna, UT 84044 Landholding Agency: Navy Property Number: 77200720036 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material 4 Bldgs. Naval Industrial Ordinance Plant Magna, UT 84044 Landholding Agency: Navy Property Number: 77200720037 Status: Unutilized Directions: 33, 45B, 45C, 46D Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Virginia Bldg. U63 Naval Amphibious Base Little Creek Co: Norfolk, VA 23521 Landholding Agency: Navy Property Number: 77200610007 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Virginia Bldg. 3660 Naval Amphibious Base Little Creek Co: Norfolk, VA 23521 Landholding Agency: Navy Property Number: 77200610008 Status: Excess Reasons: Extensive deterioration Bldg. 3830 Naval Amphibious Base Little Creek Co: Norfolk, VA 23521 Landholding Agency: Navy Property Number: 77200610009 Status: Excess Reasons: Extensive deterioration Bldgs. 500, 501 Naval Weapon Station Yorktown, VA 23691 Landholding Agency: Navy Property Number: 77200640012 Status: Excess Reasons: Extensive deterioration Bldg. 628 Naval Weapon Station Yorktown, VA 23691 Landholding Agency: Navy Property Number: 77200640013 Status: Excess Reasons: Extensive deterioration Unsuitable Properties Building Virginia Bldg. CAD-RR Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720024 Status: Excess Reasons: Extensive deterioration, Secured Area Bldgs. 25, 30, 99 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720025 Status: Excess Reasons: Secured Area, Extensive deterioration Bldgs. 141, 142, 143 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720026 Status: Excess Reasons: Secured Area, Extensive deterioration Bldgs. 144, 145, 146, 147 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720027 Status: Excess Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Virginia 7 Bldgs. Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720028 Status: Excess Directions: 151, 152, 153, 154, 155, 156, 157 Reasons: Extensive deterioration, Secured Area Bldgs. 406, 533, 724 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720029 Status: Excess Reasons: Secured Area, Extensive deterioration Bldgs. 1748, 1749 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720030 Status: Excess Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Virginia Bldgs. 1981, 2018 Naval Weapon Station Yorktown, VA Landholding Agency: Navy Property Number: 77200720031 Status: Excess Reasons: Extensive deterioration, Secured Area Training Bldg. USCG Integrated Support Ctr Portsmouth Co: Norfolk, VA 43703 Landholding Agency: Coast Guard Property Number: 88200530001 Status: Excess Reasons: Secured Area Bldg. 011 Integrated Support Center Portsmouth Co: Norfolk, VA 43703 Landholding Agency: Coast Guard Property Number: 88200620002 Status: Excess Reasons: Secured Area Unsuitable Properties Building Washington 79 Structures Hanford Site 100, 300, 400 Richland Co: Benton, WA 99352 Landholding Agency: Energy Property Number: 41200620010 Status: Excess Directions: Infrastructure Facilities Reasons: Secured Area 87 Structures Hanford Site 100, 300, 400 Richland Co: Benton, WA 99351 Landholding Agency: Energy Property Number: 41200620011 Status: Excess Directions: Mobile Offices Reasons: Secured Area 139 Structures Hanford Site 100, 300, 400 Richland Co: Benton, WA 99352 Landholding Agency: Energy Property Number: 41200620012 Status: Excess Directions: Offices Facilities Reasons: Secured Area Unsuitable Properties Building Washington 122 Structures Hanford Site 100, 300, 400 Richland Co: Benton, WA 99352 Landholding Agency: Energy Property Number: 41200620013 Status: Excess Directions: Process Facilities Reasons: Secured Area Bldg. 529 Puget Sound Naval Shipyard Bremerton, WA 98314-5000 Landholding Agency: Navy Property Number: 77200040020 Status: Excess Reasons: Secured Area Bldg. 8 Naval Reserve Center Spokane, WA 99205 Landholding Agency: Navy Property Number: 77200430025 Status: Excess Reasons: Secured Area, Extensive deterioration Bldgs. 10, 11 Naval Reserve Center Spokane, WA 99205 Landholding Agency: Navy Property Number: 77200430026 Status: Excess Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Washington Bldgs. 2656-2658 Naval Air Station Lake Hancock Coupeville Co: Island, WA 98239 Landholding Agency: Navy Property Number: 77200430027 Status: Unutilized Reasons: Secured Area Bldgs. 2652, 2705 Naval Air Station Whidbey Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440010 Status: Unutilized Reasons: Secured Area Bldgs. 79, 884 NAS Whidbey Island Seaplane Base Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440011 Status: Unutilized Reasons: Secured Area Bldg. 121 NAS Whidbey Island Ault Field Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440012 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Washington Bldg. 419 NAS Whidbey Island Ault Field Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440013 Status: Unutilized Reasons: Secured Area Bldgs. 2609, 2610 NAS Whidbey Island Ault Field Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440014 Status: Unutilized Reasons: Secured Area Bldg. 2753 NAS Whidbey Island Ault Field Oak Harbor, WA 98277 Landholding Agency: Navy Property Number: 77200440015 Status: Unutilized Reasons: Secured Area Bldg. 108 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200510015 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Washington Bldg. 351 Puget Sound Naval Shipyard Bremerton, WA 98314 Landholding Agency: Navy Property Number: 77200530026 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldg. 1032 Naval Base Bangor Tower Site Silverdale, WA 98315 Landholding Agency: Navy Property Number: 77200630045 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 71 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200640007 Status: Unutilized Reasons: Extensive deterioration, Secured Area Unsuitable Properties Building Washington Bldgs. 82, 83 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200640008 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldgs. 168, 188 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200640009 Status: Unutilized Reasons: Extensive deterioration, Secured Area Bldg. 729 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200640010 Status: Unutilized Reasons: Secured Area, Extensive deterioration Bldgs. 910, 921 Naval Magazine Port Hadlock Co: Jefferson, WA 98339-9723 Landholding Agency: Navy Property Number: 77200640011 Status: Unutilized Reasons: Secured Area, Extensive deterioration Unsuitable Properties Building Washington Bldgs. 407, 447 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200640014 Status: Excess Reasons: Secured Area Bldg. 867 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200640015 Status: Excess Reasons: Secured Area Bldgs. 937, 975 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200640016 Status: Excess Reasons: Secured Area Bldg. 1449 Naval Base Silverdale Co: Kitsap, WA 98315 Landholding Agency: Navy Property Number: 77200640017 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Washington Bldg. 1670 Naval Base Silverdale Co: Kitsap, WA 98315 Landholding Agency: Navy Property Number: 77200640018 Status: Unutilized Reasons: Secured Area Bldgs. 2007, 2801 Naval Base Silverdale Co: Kitsap, WA 98315 Landholding Agency: Navy Property Number: 77200640019 Status: Unutilized Reasons: Secured Area Bldgs. 6021, 6095 Naval Base Silverdale Co: Kitsap, WA 98315 Landholding Agency: Navy Property Number: 77200640020 Status: Unutilized Reasons: Secured Area Bldgs. 6606, 6661 Naval Base Silverdale Co: Kitsap, WA 98315 Landholding Agency: Navy Property Number: 77200640021 Status: Unutilized Reasons: Secured Area Unsuitable Properties Building Washington Bldgs. 726, 727, 734 Naval Undersea Warfare Keyport Co: Kitsap, WA 98345 Landholding Agency: Navy Property Number: 77200640022 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 901, 911 Naval Undersea Warfare Keyport Co: Kitsap, WA 98345 Landholding Agency: Navy Property Number: 77200640023 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldgs. 925, 938 Naval Undersea Warfare Keyport Co: Kitsap, WA 98345 Landholding Agency: Navy Property Number: 77200640024 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Bldg. 1020 Naval Undersea Warfare Keyport Co: Kitsap, WA 98345 Landholding Agency: Navy Property Number: 77200640025 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Unsuitable Properties Building Washington Fisher Transit Site Easement Jefferson, WA Landholding Agency: Navy Property Number: 77200710015 Status: Excess Reasons: Other—Remote Location Bldgs. 437, 853 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200710018 Status: Unutilized Reasons: Secured Area Bldg. 1039 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200710019 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 1400, 1461 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200710020 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Unsuitable Properties Building Washington Bldg. 6026 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200710021 Status: Unutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Bldgs. 6608, 6609, 6904 Naval Base Bremerton Co: Kitsap, WA 98310 Landholding Agency: Navy Property Number: 77200710022 Status: Unutilized Reasons: Secured Area, Within 2000 ft. of flammable or explosive material Wisconsin Station Building Coast Guard Station Sheboygan, WI Landholding Agency: Coast Guard Property Number: 88200610001 Status: Underutilized Reasons: Secured Area Bldg. OV1 USCG Station Bayfield, WI 54814 Landholding Agency: Coast Guard Property Number: 88200620001 Status: Excess Reasons: Secured Area Unsuitable Properties Land California Trailer Space Naval Base San Diego, CA Landholding Agency: Navy Property Number: 77200520013 Status: Unutilized Reasons: Secured Area Parcels 1, 2, 3, 4 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630003 Status: Underutilized Reasons: Secured Area Parcels 11, 12, 13, 14, 15 Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200630004 Status: Underutilized Reasons: Secured Area Sand Spit Naval Base Port Hueneme Co: Ventura, CA 93043 Landholding Agency: Navy Property Number: 77200720008 Status: Underutilized Reasons: Floodway Unsuitable Properties Land Washington 405 sq. ft./Land Naval Base Kitsap Bangor, WA Landholding Agency: Navy Property Number: 77200520060 Status: Unutilized Reasons: Secured Area 230 sq. ft. land Naval Magazine Indian Island, WA Landholding Agency: Navy Property Number: 77200620037 Status: Underutilized Reasons: Within 2000 ft. of flammable or explosive material, Secured Area Tabook Transit Site Easement Jefferson, WA Landholding Agency: Navy Property Number: 77200710016 Status: Excess Reasons: Other—Remote Location [FR Doc. E7-16489 Filed 8-23-07; 8:45 am] BILLING CODE 4210-67-P 72 164 Friday, August 24, 2007 Rules and Regulations Part III Department of Health and Human Services Food and Drug Administration 21 CFR Parts 606 and 610 Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”); Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 606 and 610 [Docket No. 1999N-2337 (formerly Docket No. 99N-2337)] RIN 0910-AB76 Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”) AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus
(HCV)infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus
(HIV)“lookback” requirements for greater consistency with the HCV “lookback” requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a guidance document entitled “Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV” (the “lookback” guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services
(CMS)elsewhere in this issue of the **Federal Register** . DATES: This rule is effective February 20, 2008. FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Background B. Legal Authority II. Highlights and Summary of the Final Rule A. Restructuring of the Proposed Rule B. Summary of the Final Rule C. Changes to Related Regulations III. Comments on the Proposed Rule and FDA's Responses A. General Comments B. Records C. HIV and HCV “Lookback” IV. Analysis of Impacts A. Economic Impact 3 B. Benefits of the Final Rule C. Impact on Small Entities V. The Paperwork Reduction Act of 1995 A. Annual Reporting Burden B. Estimated One-Time Reporting Burden C. Estimated Annual and One-Time Recordkeeping Burden VI. Environmental Impact VII. Federalism VIII. References I. Introduction A. Background As a result of extensive screening and testing procedures and other layers of safety used to help ensure a safe blood supply, the risk of transmitting infection through blood transfusion is very low. Despite the best practices of blood establishments 1 , however, a person may donate blood and blood components early in an infection, during the period when the testable marker is not detectable by a screening test, but the infectious agent is present in the donor's blood (a “window” period). Such products are considered as having an increased risk of transmitting infection. We are issuing this final rule to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components possibly donated during a “window” period, which therefore may be at increased risk of transmitting infection. 1 The term “establishment” is defined in FDA's blood regulations at 21 CFR 607.3(c). Chronic hepatitis due to HCV is a major health problem in the United States. The infection is usually asymptomatic for decades despite possible progression. Thus, individuals with chronic, active hepatitis C can remain unaware that they have a serious infection until symptoms develop late in the course of the disease. Five to twenty percent of infected persons might develop cirrhosis of the liver over a period of 20 to 30 years and one to five percent might die from the consequences of long term infection (liver cancer or cirrhosis). As a result, infected people typically are unaware of their disease. Although transfusion-transmitted infections account for only a small proportion of HCV infections, it is possible to identify and “lookback” at prior donations collected during the “window” period from donors later identified as reactive on a test for evidence of HCV infection. Further information on existing donor screening and testing requirements and a history of HCV testing is provided in the proposed rule entitled “Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (‘Lookback’)” (the HCV “lookback” proposed rule) (November 16, 2000, 65 FR 69378 at 69379). In an August 1993 memorandum to all registered blood establishments entitled “Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),” we did not recommend a “lookback” program, pending the outcome of discussions on the issue at the December 1993 Blood Product Advisory Committee
(BPAC)meeting. Following the discussions on HCV at the meeting in December 1993, the BPAC unanimously recommended product quarantine of prior collections from a donor who later tests repeatedly reactive for antibody to HCV and tests positive or indeterminate on a supplemental (additional, more specific) test. However, BPAC only marginally endorsed consignee 2 notification for the purpose of transfusion recipient notification, and reiterated many of the reservations regarding the lack of an established public health benefit in performing this activity. We issued in July 1996 a memorandum to all registered blood establishments entitled “Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I)” (the July 1996 memorandum). The July 1996 memorandum recommended testing, consignee notification, and quarantine of affected products, but did not provide recommendations for the notification of recipients of such donations because the public health benefit of such notification was not clear. 2 We use the term “consignee” to refer to the person or entity to whom the blood is shipped. The Department of Health and Human Services Advisory Committee on Blood Safety and Availability (the HHS Advisory Committee) discussed improvements in the treatment and management of HCV infection and improvements in testing for antibody to HCV at public meetings held on April 24 and 25, 1997, and August 11 and 12, 1997. The DHHS Advisory Committee discussed the public health benefits of notification of transfusion recipients receiving prior collections from a donor who subsequently tests reactive for evidence of HCV infection and made recommendations for HCV “lookback.” Following acceptance by the Department of Health and Human Services
(DHHS)of the DHHS Advisory Committee's recommendations for HCV “lookback,” we issued a notice in the **Federal Register** of March 20, 1998 (63 FR 13675), announcing the availability of a document entitled “Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)” (the March 1998 guidance) in which we recommended that blood establishments implement HCV “lookback” procedures. In the March 1998 guidance, we recommended that donors currently testing repeatedly reactive for antibody to HCV by a licensed test be further tested for antibody to HCV using a licensed, multi-antigen supplemental test. Additionally, we recommended that consignees of certain blood and blood components collected since January 1, 1988, which were anti-HCV negative or untested, be notified when donors subsequently test repeatedly reactive for anti-HCV by a licensed multiantigen-based antibody screening test and reactive by a licensed or investigational supplemental test. This notification would enable consignees to inform recipients that they were transfused with units that may have contained HCV, so that they might obtain further medical counseling and treatment. The March 1998 guidance provided our recommendations for donor screening, a review of past testing records, further testing for antibody to HCV, notification of consignees, and transfusion recipient notification and counseling by physicians regarding transfusion with blood or blood components at increased risk of transmitting HCV. The March 1998 guidance was intended to supplement the July 1996 memorandum. In response to comments received, the March 1998 guidance was withdrawn on September 8, 1998, and we issued a revised guidance dated September 1998, on October 21, 1998 (63 FR 56198), entitled “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components:
(1)Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV);
(2)Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV,” (the September 1998 guidance). The September 1998 guidance provided recommendations to enable quarantine and disposition of blood and blood components from prior collections from donors with repeatedly reactive screening test results. The September 1998 guidance addressed several significant comments and requests from industry: • We revised several time periods for “lookback” actions in response to concerns about the impact on industry and the need for additional time for testing due to availability problems with certain test kits, and to allow time for the completion of physician education (ensuring that counseling messages would be available for use in notification of recipients); • We clarified options for further testing with an HCV enzyme linked immunosorbent assay 3.0 (HCV EIA 3.0 screening test); • We clarified our recommendations on labeling of the blood and blood components released from quarantine and for consistency with existing regulations on product labeling; • We provided flow chart diagrams to assist industry in implementing procedures contained in the guidance; and • We recommended the option of transfusion services notifying the transfusion recipient directly as an alternative to notifying the transfusion recipient's physician of record, to permit easier, more rapid notification of the recipient. At public meetings on November 24, 1998, and January 28, 1999, the DHHS Advisory Committee reconsidered the issue of recipient notification related to repeatedly reactive results by the single antigen-based antibody screening test. The DHHS Advisory Committee recommended that targeted “lookback” be initiated based on a repeatedly reactive HCV EIA 1.0 screening test result on a repeat donor except in the following conditions:
(1)A supplemental (additional, more specific) test was performed and the result did not indicate increased risk of HCV infection;
(2)in the absence of a supplemental test result, the signal to cut-off (S/CO) value of the repeatedly reactive HCV EIA 1.0 screening test was less than 2.5; or
(3)followup testing of the donor was negative. We published a notice in the **Federal Register** of June 22, 1999 (64 FR 33309), announcing the availability of a draft guidance entitled “Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components:
(1)Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV);
(2)Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)” (the June 1999 draft guidance). Consistent with the recommendations of the DHHS Advisory Committee, this revised draft guidance addressed “lookback” actions related to donor screening by HCV EIA 1.0 and also recommended that the search of historical test records of prior donations from donors with repeatedly reactive EIA 1.0, EIA 2.0, or EIA 3.0 screening tests for HCV should extend back indefinitely to the extent that electronic records exist. In addition, we revised the flowchart diagrams to reflect the changes to the guidance. We added specific recommendations for prior collections from a repeatedly reactive autologous donor and clarified recommendations on implementing “lookback” for repeatedly reactive plasma donations. On November 16, 2000, FDA and the Health Care Financing Administration, now known as the Centers for Medicare and Medicaid Services (CMS), issued proposed rules that would further protect the blood supply and notify recipients of the possibility that they may have received blood or blood components with an increased risk of transmitting HCV. FDA's HCV “lookback” proposed rule, along with CMS's companion proposed rule (November 16, 2000, 65 FR 69416), proposed to require establishments involved in the collection, processing, and distribution of blood and blood components to quarantine certain blood and blood components and to inform the consignee. The consignee, as appropriate, would inform the recipient's physician of record or the recipient of the possibility that blood used for transfusion was obtained from a donor who subsequently tested repeatedly reactive for antibody to HCV. Elsewhere in this issue of the **Federal Register** , we are announcing the availability of a guidance document entitled “Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV” (the “lookback” guidance). We prepared the “lookback” guidance based on comments received on the June 1999 draft guidance and comments received on the HCV “lookback” proposed rule and issued the guidance document for implementation by the agency. The guidance document does not create or impose any legal rights or requirements, rather, it represents our current thinking on methods for satisfying the requirements now imposed by this rule and addresses actions that could be taken based on results of screening and supplemental testing. It supercedes the September 1998 guidance and the HCV sections of the July 1996 memorandum. B. Legal Authority We are issuing this final rule under the authority of sections 351 and 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act (the act), which apply to drugs (section 201 of the act *et seq.* (21 U.S.C. 321 *et seq.* )). Under section 361 of the PHS Act, by delegation from the Secretary of Health and Human Services, we may make and enforce regulations necessary to prevent the introduction, transmission, and spread of communicable disease between the States or from foreign countries into the States. Intrastate transactions may also be regulated under section 361 of the PHS Act. (See *Louisiana* v. *Mathew* , 427 F. Supp. 174, 176 (E. D. La. 1977).) Because a major purpose of the HCV “lookback” final rule is to prevent the introduction, transmission, and spread of HCV, a communicable disease, section 361 of the PHS Act provides the primary legal authority for this final rule, including the rule's provisions on standard operating procedures, records, donor deferral, and “lookback” requirements, for manufacturers, including collecting establishments, and consignees. All blood and blood components introduced or delivered for introduction into interstate commerce also are subject to section 351 of the PHS Act. Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacture into injectable products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations, designed to ensure the continued safety, purity, and potency of the blood. Moreover, section 351(a)(2)(A) of the PHS Act gives us, by delegation from the Secretary of Health and Human Services, authority to establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. This final rule establishes such requirements for blood and blood components intended for further manufacture into injectable products. Our license revocation regulations provide that we may initiate revocation proceedings, among other reasons, if an establishment or product fails to conform to the standards in the license application or in the regulations designed to ensure the continued safety, purity, or potency of the product (21 CFR 601.5). The requirements of this final rule are designed to ensure the continued safety, purity and potency of donated blood and blood products. Section 351 of the PHS Act also provides for civil and criminal penalties for violation of the laws governing biological products. Violations can be punishable by fines, imprisonment, or both. Section 351(j) of the PHS Act states that the Federal, Food, Drug, and Cosmetic Act also applies to biological products. Blood and blood components for transfusion or for further manufacture into injectable products are drugs, as that term is defined in section 201(g)(1) of the act. (See *United States* v. *Calise* , 217 F. Supp. 705, 709 (S.D.N.Y. 1962)). Because blood and blood components are drugs under the act, blood and plasma establishments must comply with the substantive provisions and related regulatory scheme of the act. For example, under section 501 of the act (21 U.S.C. 351), drugs are deemed “adulterated” if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice (CGMP). Under this final rule, the CGMP regulations for manufacturers of blood and blood components are amended to require those establishments to develop standard operating procedures
(SOPs)for HCV “lookback,” identification, quarantine of affected blood and blood components, and consignee and transfusion recipient notification. A blood or plasma establishment that fails to comply with HCV “lookback” procedures would not be in compliance with CGMP requirements and, therefore, would be subject to the act's enforcement provisions. II. Highlights and Summary of the Final Rule We are issuing this final rule in conjunction with a companion interim final rule published by CMS elsewhere in this issue of the **Federal Register** . This final rule and the CMS interim final rule provide steps designed to further protect the blood supply and to notify recipients of the possibility that they may have received blood or blood components at increased risk of transmitting HIV or HCV. The phrase “blood and blood components,” as used in this rulemaking, includes Source Plasma and Source Leukocytes. A. Restructuring of the Proposed Rule After careful review of the proposed rule, and in response to comments submitted to the docket, we have revised the codified section of the proposed rule as follows: • We combined proposed §§ 610.46 and 610.47 into requirements under new § 610.46 for prospective HIV “lookback.” • We combined proposed §§ 610.48 and 610.49 into requirements under new § 610.47 for prospective HCV “lookback.” • We removed the requirements for retrospective HCV “lookback” from proposed §§ 610.48 and 610.49 and placed them under new § 610.48. • Each section separates provisions for collecting establishments and for consignees. • The codified section lists objective actions and eliminates the prescriptive language in the proposed rule. • The sections for prospective HIV and HCV “lookback” (§§ 610.46 and 610.47) are analogous in their requirements. • The final rule establishes a “cut-off” date for retrospective HCV “lookback.” B. Summary of the Final Rule 1. HIV and HCV “Lookback” (§§ 610.46 and 610.47, respectively) a. *Responsibilities of the collecting establishment* . In §§ 610.46 and 610.47, respectively, the final rule requires collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV prospective “lookback” when a donor tests reactive for evidence of HIV or HCV infection (see § 610.40(a) and
(b)(21 CFR 610.40(a) and (b))), or when the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (“prospective lookback”) (§§ 610.46(a)(1) and 610.47(a)(1)). The requirement for “an appropriate system” states the intention of the requirement and replaces the more prescriptive language of the proposed rule. This provision requires the collecting establishment to design SOPs to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection (see section II.C.4 of this document for further discussion of the term “reactive”). Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must take the following actions: • Review all records, required to be maintained under § 606.160(d), to identify blood and blood components previously donated by such a donor. For those blood and blood components collected 12 months and less before the donor's most recent nonreactive screening tests for HIV or HCV, or 12 months and less before the donor's reactive direct viral detection test, e.g., nucleic acid test
(NAT)(HIV and HCV) or HIV p24 antigen test (HIV), and a nonreactive antibody screening test for HIV or HCV, whichever is a lesser period (§§ 610.46(a)(1)(i) and (a)(1)(ii), and 610.47(a)(1)(i) and (a)(1)(ii)), the collecting establishment must do the following: • Quarantine all identified previously collected in-date blood and blood components if intended for use in another person or for further manufacturing into injectable products (§§ 610.46(a)(1)(ii)(A) and 610.47(a)(1)(ii)(A)). Pooled blood components solely intended for further manufacturing into products that are manufactured using validated clearance (i.e., inactivation and removal) procedures are not subject to quarantine; and • Notify consignees to quarantine all identified previously collected in-date blood and blood components (§§ 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)). The consignee's pooled blood components solely intended for further manufacturing into products that are manufactured using validated viral clearance (i.e., inactivation and removal) procedures also are not subject to quarantine. Within 45 calendar days of the reactive screening test, the collecting establishment must perform a supplemental additional, more specific) test on the reactive donation (§ 610.40(e)) for HIV (§ 610.46(a)(2)) or HCV (§ 610.47(a)(2)), and must notify the consignees of the supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (§§ 610.46(a)(3) and 610.47(a)(3)). Thus, if we have not approved a supplemental test for a required screening test, you must notify consignees of the results of the reactive screening test. Similarly, if there is a shortage of an approved supplemental test such that they are not available for commercial purchase, you must notify consignees of the results of the reactive screening test. By adding the term “available” to the codified language, we are not authorizing blood establishments to simply choose to notify consignees of the result of a reactive screening test if the establishment has simply run out of the approved supplemental test. Rather, the test must be unavailable commercially. We are also adding “or if under an IND or IDE, is exempted for such use by FDA” so that we have the ability to authorize the use of a supplemental test under an investigational new drug application
(IND)or an investigational device exemption
(IDE)under certain circumstances. In such cases, we will issue guidance on alternative product use under conditions where approved supplemental tests are unavailable, or when a product under IND or IDE is exempted for such use. Currently, there are FDA-approved supplemental tests for all antibody and antigen screening tests for HIV and HCV, except NAT. Therefore, if a donor tests reactive by NAT and nonreactive by an antibody screening test, the results would be reported to the consignee without further testing. Notification must include the supplemental test results for all identified blood and blood components previously collected from donors who later test reactive for evidence of HIV or HCV infection. Once the collecting establishment receives the supplemental test results and notifies the consignees, then the collecting establishments must release, destroy, or relabel quarantined in-date blood and blood components consistent with the supplemental test results or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (§§ 610.46(a)(4) and 610.47(a)(4)). Our current thinking on the appropriate actions of releasing, destroying, and relabeling is discussed in the “lookback” guidance. b. *Responsibilities of the consignees* . The consignee must also establish, maintain, and follow an appropriate system (as described in section II.B.1.a of this document) for performing HIV and HCV “lookback” when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (§§ 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for the following actions: • Quarantining consigned in-date blood and blood components when notified by the collecting establishment (§§ 610.46(b)(1) and 610.47(b)(1)). • Releasing, destroying, or relabeling quarantined in-date blood and blood components consistent with the supplemental test results or a reactive screening test if there is no available supplemental test that is approved for such use by FDA or exempted for such use by FDA (§§ 610.46(b)(2) and 610.47(b)(2)). • Notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA. Notification of the recipient is necessary in order to permit testing, counseling, and (if necessary) treatment for recipients who received blood or blood components potentially at risk of transmitting HIV or HCV (§§ 610.46(b)(3) and 610.47(b)(3)). c. *No recall action* . We have added a statement in §§ 610.46(c), 610.47(c), and 610.48(d) that “lookback” does not constitute a recall as defined in 21 CFR 7.3. Discussion of the differences between a recall action and a “lookback” action may be found in the HCV “lookback” proposed rule (65 FR 69378 at 69391). FDA recognizes that a “lookback” action does not mean that an establishment has erred or that it did not meet its obligations under the regulations and the statute in assuring the safety of the blood supply. However, failure to comply with the “lookback” regulations is a regulatory violation and may merit enforcement action. 2. HCV “Lookback” Requirements Based on Review of Historical Testing Records (§ 610.48) As previously described, we have removed the requirements for the review of historical testing records from proposed §§ 610.48 and 610.49 and placed them under final § 610.48 *Hepatitis C virus
(HCV)“lookback” requirements based on review of historical testing records* . It is important to identify and notify recipients previously transfused with blood or blood components at increased risk of transmitting HCV infection because HCV is a chronic, often asymptomatic disease that may ultimately have serious consequences. Therefore, we are requiring the review of historical HCV testing records of donors so that blood and blood components previously collected from donors who later test reactive for evidence of HCV infection are identified, and recipients of such blood and blood components are notified of the possibility of being infected with HCV. With this information, the recipients can be tested and, if infected, pursue treatment and counseling, and take preventive measures to avoid transmitting HCV to others. The requirements for historical review of HCV testing records or “retrospective review” are the same as the requirements for the prospective review of HCV testing records, except for variations in the required time for completion of the actions, the extent of record review, and a distinction regarding the specimen that may be used for further testing (either a frozen sample from the same reactive donation or a fresh sample from the same donor). a. *Completion of required actions* . To permit adequate time to perform the requirement for the review of historical HCV testing records, § 610.48(a) requires that the collecting establishments complete the actions prescribed in § 610.48(b) within 1 year of the effective date of this final rule. Consignees must complete the actions prescribed in § 610.48(c) within 1 year of the date of notification by the collecting establishment. We have also established a date for the conclusion of historical record review of HCV testing in § 610.48(b)(1)(i). The historical record review must include all HCV testing performed before February 20, 2008, the effective date of this rule. The requirements under § 610.48 will remain in effect for 8 years after the date of publication in the **Federal Register** . b. *Extent of record review* . When performing the historical record review, under § 610.48(b)(1)(i), the establishment must review all HCV testing from February 20, 2008 back indefinitely for computerized electronic records, and to January 1, 1988, for all other records. Once a reactive screening test is found, you must identify for further action blood and blood components collected 12 months and less before the donor's most recent nonreactive screening tests, or 12 months and less before the donor's reactive direct viral detection test and nonreactive antibody screening test, whichever is the lesser period (§ 610.48(b)(1)(ii) and (b)(1)(iii)). To prevent unnecessary repetition of already completed “lookback” actions, we have added an exemption stating that any “lookback” action performed before the effective date of the final rule that otherwise satisfies the requirements for prospective “lookback” in final § 610.47, is exempt from the retrospective “lookback” requirements in final § 610.48. We recognize that, without this exemption, when this final rule becomes effective, collecting establishments that already performed prospective “lookback” actions that comport with the recommendations set forth in the “lookback” guidance could face a situation in which they would be compelled under the final rule to repeat these already completed “lookback” actions under the retrospective “lookback” provisions. As this would mandate an obvious waste of effort and would penalize establishments that conducted expeditious prospective “lookback” actions guided by our recommendations in the “lookback” guidance, we have added the exemption for completed adequate “lookback.” c. *Further testing* . Under § 610.48(b)(1)(ii), quarantine and consignee notification are not required when donors, who tested reactive by a screening test, test negative on the same donation by an appropriate supplemental (additional, more specific) test for evidence of HCV infection. In the context of this rule, an appropriate supplemental test for a reactive antibody screening test is a test for antibody, i.e., the recombinant immuno-blot assay (RIBA). At this time, an appropriate supplemental test for NAT does not exist. However, when a supplemental test becomes appropriate for NAT, we will notify the public on its use through guidance. Under § 610.48(b)(2), if a supplemental (additional, more specific) test for HCV is not performed on the same donation at the time of the reactive screening test, the collecting establishment may choose to perform the supplemental test or a licensed screening test (e.g., an EIA 3.0) with known greater sensitivity than the test of record (e.g., an EIA 2.0) on a frozen sample from the same reactive donation, or may collect and test a fresh sample from the same donor, if obtainable. If a supplemental test for a reactive screening test is not approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA, a suitable test is unavailable, or the collecting establishment does not perform further testing due to the unavailability of a sample, then the collecting establishment must proceed with quarantine and consignee notification under § 610.48(b)(3), (b)(4), and (b)(5). A variation between §§ 610.47(a)(3) (prospective review) and 610.48(b)(4) (retrospective review) is the event initiating the notification of the consignee of the test results within 45 calendar days. Under § 610.47(a)(3), the collecting establishment must notify the consignee of the supplemental test results within 45 calendar days after the donor tests reactive for evidence of HCV infection. Under § 610.48(b)(4), the collecting establishment must notify the consignee of the supplemental test results within 45 calendar days of completing the supplemental tests. d. *Notification of transfusion recipients* . Under § 610.48(c)(3), the consignee is required to notify the transfusion recipient under any of the following conditions: • The supplemental (additional, more specific) test for HCV is positive; or • The supplemental test is indeterminate, but the supplemental test is know to be less sensitive than the screening test; or • The screening test is reactive and there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA; or • The supplemental testing is not performed. • Transfusion recipients do not need to be notified if there is a negative result by an alternative licensed screening test with known greater sensitivity than the test of record, and that the alternative screening test was performed on the original reactive donor sample or a fresh sample from the same donor. C. Changes to Related Regulations 1. Standard Operating Procedures (§ 606.100(b)(19)) We are requiring that collecting establishments and consignees establish, maintain, and follow procedures: • For identifying previously donated blood and blood components from a donor who later tests reactive for evidence of infection with HIV or HCV, or when the collecting establishment becomes aware of other reliable test results or information indicating evidence of infection; • For quarantining such in-date blood and blood components, intended for use in another person or for further manufacture into injectable products, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance (i.e., inactivation and removal) procedures; • For notifying consignees to quarantine such in-date blood and blood components, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance (i.e., inactivation and removal) procedures; • For determining the suitability of the quarantined blood or blood components for release, destruction, or relabeling; • For notifying the consignees of the test results for HIV or HCV performed on donors of such blood and blood components; and • For notifying the recipient of such blood or blood components, the recipient's physician of record, or the recipient's legal representative by the consignee that the recipient received blood or blood components which may have been at increased risk of transmitting HIV or HCV, respectively. 2. Recordkeeping (§ 606.160(b)(1)(viii)) Collecting establishments and consignees must keep records concerning the requirements of this final rule. This includes any records relating to quarantine; notification of consignees; testing; notification of the transfusion recipient, the recipient's physician of record, or the recipient's legal representative; and disposition of the identified blood and blood components. 3. Retention of Records (§ 606.160(d)) Current § 606.160(d) requires the retention of records no less than 5 years after the records of processing are completed or 6 months after the latest expiration date for the individual product, whichever is the latest date. In § 606.160(d), we are changing the requirement for record retention from 5 years to 10 years. There can be a prolonged time between exposure to an agent and development of symptoms, as is the case for HIV and HCV. A longer record retention time will allow establishments to trace recipients of blood from donors who had not been regular donors. This change is also consistent with industry standards for record retention by blood establishments for “lookback” to identify recipients who may have been infected with HIV or HCV (AABB Standards for Blood Banks and Transfusion Services; 23rd edition). Because of the widespread use of electronic recordkeeping, it is now practical to search records for up to 10 years. This change accommodates the advances in medical diagnosis and therapy that have created opportunities for disease prevention or treatment many years after recipient exposure to a donor later determined to be at increased risk of transmitting disease by transfusion. 4. Donor Deferral (§ 610.41(c)) In the **Federal Register** of June 11, 2001 (66 FR 31146), we published a final rule entitled “Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents” (the June 2001 final rule). Under § 610.41(a), any donor of blood and blood components who tests reactive for a communicable disease agent described in § 610.40(a) or reactive with a serological test for syphilis must be deferred from donation. Section 610.41(b) permits the reentry of a deferred donor into the donor pool when the donor is requalified by a process or method approved for such use by FDA. We have moved proposed § 610.40(g) to § 610.41(c) in this final rule. Section 610.41(c) requires collecting establishments to perform “lookback” when a donor tests reactive by a screening test for HIV or HCV, or when the establishment becomes aware of other reliable tests results or information indicating evidence of infection with HIV or HCV. To be consistent with the language used in the June 2001 final rule, we refer in this final rule to screening tests as “reactive” instead of “repeatedly reactive,” to accommodate the different testing algorithms established for NAT and other screening tests. In cases where the testing algorithm requires initial and repeat testing as part of a single screening procedure, we would interpret the term “reactive” to mean “repeatedly reactive.” III. Comments on the Proposed Rule and FDA's Responses Twelve blood establishments, i.e., blood banks, blood centers, and blood industry trade associations, submitted comments raising multiple issues with the proposed rule. The following comments and responses are grouped by subject matter rather than by sections of the proposed rule because many comments generally relate to both HIV and HCV prospective review (§§ 610.46 and 610.47, respectively), and HCV retrospective review (§ 610.48). When the comment or response is particular to HIV, HCV, prospective review, or retrospective review, we specify it when we describe the comment. Five comments expressed general approval of the proposed rule. Another comment noted that the proposed rule was in keeping with the commenter's mission to provide the best possible health care. One comment stated that the proposed rule goes beyond the current guidance issued in September 1998, i.e., to include the prior donations from individuals identified as HCV-infected through their reactivity on the HCV screening test by EIA 1.0, and extending multi-antigen “lookback” further back in time. Another comment supported extending the requirement for HCV “lookback” beyond the September 1998 guidance. We also received comments on the specific prescriptive language of the proposed rule for quarantining, releasing from quarantine, relabeling, appropriate algorithms for proceeding with HCV “lookback” resulting from the historical record review, the interpretation of the signal to cutoff values used in interpreting the results of the EIA 1.0 test, and the use of unlicensed tests in the algorithms. However, because in preparing this final rule, we opted to set forth requirements rather than specific procedures for achieving those requirements, we have not responded specifically to comments on prescriptive language that is not in the final rule. We reviewed and considered all comments in preparing the “lookback” guidance. Although the “lookback” guidance does not prescribe the sole means to comply with this final rule, it does discuss measures that would satisfy the final rule's requirements. A summary of the comments and our responses follows. A. General Comments (Comment 1) Several comments stated that the proposed rule is too long and complex, making it difficult to find cross-referenced relevant provisions within the proposed rule, and that a flowchart or table would make the requirements easier to follow and understand. Many comments pointed out that certain testing outcomes are not adequately addressed in the proposed rule's prescriptive language. One comment urged FDA to create an appropriate mechanism, allowing blood establishments to modify “lookback” timeframes and procedures as new tests or new generations of viral tests become available. One comment suggested that FDA modify the proposed rule by issuing requirements that would apply to donors who test reactive by screening tests for HCV (prospective “lookback”) as of the effective date of the final rule, and that the September 1998 guidance would apply to all other “lookback” actions (retrospective “lookback”). (Response) We agree that the proposed rule was long, complex, and difficult to understand. When we issued the proposed rule, we provided reference tables to help readers understand the proposed requirements due to the complexity of the codified section. The tables showed the various tests performed for HCV, steps of the “lookback” process, and applicable provisions of proposed §§ 610.48 and 610.49. As described in section II.A of this document, and in response to the comments, we have restructured the codified section of the final rule to make it easier to understand and follow. We have constructed the requirements by listing the objective actions that must be performed and by eliminating the prescriptive language in the final rule. In other words, the regulation now tells you what to do, not how to do it. We considered the comments on testing outcomes in the proposed rule when revising the September 1998 guidance document. We are issuing the “lookback” guidance, which represents our current thinking on how to conduct HCV “lookback.” We have not prescribed specifically how you must comply with the final rule's requirements, though the guidance discusses the agency's current thinking and offers an explanation of some satisfactory approaches. We provide flowcharts and tables in the guidance document to assist you in performing the “lookback” actions. As new tests or new generations of viral tests become available, we can revise or modify the companion guidance to assist you in complying with the required “lookback” actions. As requested, we have provided a date in § 610.48(b)(1)(i), which defines the period of record review under § 610.48. Consistent with the “lookback” guidance, establishments could already be performing the review now required under §§ 610.47 and 610.48 by the time this final rule becomes effective. However, we want to reiterate that, whereas the “lookback” guidance offers only our current thinking on some satisfactory approaches, it is this final rule that imposes a date to define record review and creates an enforceable requirement. (Comment 2) Another comment expressed concern regarding the adverse consequences of informing donors of potential HCV infected status when such a donor tests reactive by a screening test for HCV. The comment pointed out the scientific uncertainty in treating HCV-infected individuals and asked FDA to be mindful of these facts when issuing the final rule. The comment further explained that treatment protocols are ambiguous for many infected individuals and response rates are variable. The comment was concerned that the donor's infectious status may not result in high risk behavior change, especially where no clinical symptoms are present, and that there may be personal ramifications of informing a donor of an infectious status, i.e., personal disruption or trauma and potential for discrimination against the donor. (Response) Although this rulemaking does not address notification of donors at increased risk of transmitting HCV, we are very aware of the consequences of informing donors (required under 21 CFR 630.6), as well as recipients, of their increased risk of being infected with HCV. However, in the interest of protecting individual and public health, we believe it is imperative that such individuals be informed so that they may pursue further testing and counseling. Through such means the recipient can monitor the disease process, if infected, and can take precautions to prevent infecting others. Notification of the individual also is necessary because some infected individuals with a progressive, but treatable liver disease, remain asymptomatic for many years and are not being treated because of a lack of awareness of their condition. The agency cannot regulate the behavior of the individual if infected, nor eliminate the trauma of notification, but notifying the individual, recommending further testing, and permitting an opportunity for counseling and treatment can help minimize any adverse outcome and is necessary to protect the health of others. B. Records Proposed § 606.160(d) would require that blood establishments keep records no less than 10 years after the completion of the processing of records or 6 months after the latest expiration date for the individual product, whichever is later. (Comment 3) One comment agreed with the proposed requirement. The comment further suggested that prospective “lookback” be confined to a “rolling” 10-year period, which would be consistent with the CMS companion interim final rule requiring transfusion services to maintain records of disposition for 10 years. The comment also requested that FDA establish an expiration date for recovered plasma to prevent the retention of records indefinitely as required for such products in current § 606.160(d). (Response) We agree that the 10-year recordkeeping period should be a “rolling” 10-year period. The final rule requires collecting establishments to retain records for 10 years from the date of completion of the processing records or 6 months after the latest expiration date for the individual product, whichever is later (§ 606.160(d)). A “rolling” 10-year record retention period is described as the establishment increasing the record retention period yearly until 10 years of records from the date of disposition have accrued. For example, if you currently have records dating back 5 years, then the first year after the effective date of this regulation you must have 6 years of records, the second year after the effective date, you must have 7 years of records, etc., until 10 years have been reached. However, if you already retain 10 years of records, then the 10-year record retention period is immediately satisfied. As for the comment's suggestion regarding an expiration date for recovered plasma, the comment raises significant issues beyond the scope of this rulemaking. We decline to establish an expiration date for recovered plasma at this time, but we will take the comment's suggestion under consideration. C. HIV and HCV “Lookback” 1. Initiation of Record Review Proposed §§ 610.46(a) and 610.48(a) would require that the collecting establishment initiate HIV or HCV “lookback,” respectively, when a donor tests reactive by a screening test for evidence of HIV or HCV infection. Collecting establishments would also initiate record review when the establishment becomes aware of other test results indicating evidence of HIV or HCV infection, provided that the testing was performed by a laboratory certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), using a test approved by FDA. (Comment 4) One comment suggested deleting from proposed §§ 610.46(a) and 610.48(a), the requirement to conduct prospective record review when a blood establishment is “made aware of other test results” indicating evidence of HIV or HCV infection. The comment explained that the language is too vague as to the nature, source, and reliability of the information, and requested clarification of what constitutes “made aware” and “evidence.” The comment also considered determining a lab's CLIA certification status as problematic because there is no available database for searching such information. (Response) We decline to delete the requirement. In the preamble of the proposed rule (65 FR 69378 at 69383), we explained that this provision clarifies the existing language in § 610.46, which requires HIV “lookback” when the donor is determined otherwise to be unsuitable when tested under 21 CFR 610.45. However, we added the term “reliable” as describing other test results that initiate record review. We consider other “reliable” test results to be information that, if known to the collecting establishment, would indicate that the donor is unsuitable or should be deferred from donation. A collecting establishment does not routinely receive information that a donor is unsuitable for donation unless the screening and testing occurs in the same collecting establishment. However, we are aware that donors may inform collecting establishments when they test reactive for evidence of HIV or HCV as a result of a physical examination or if they donate at another collecting establishment. In the final rule, therefore, we have removed the provision from proposed §§ 610.46(a) and 610.48(a) for the testing laboratory to be certified under CLIA and for the other information to be based on a test approved by FDA, and have described our thoughts about the relevant laboratory qualification information in the “lookback” guidance. These qualifications are already required under § 610.40(f). Such qualifying information can be obtained by asking if the laboratory is a Medicare participant. 2. Extent of Record Review Proposed §§ 610.46(a) and 610.48(a) would require that the collecting establishment review HIV or HCV testing records and identify blood and blood components previously collected from a donor who subsequently tests reactive for evidence of infection with HIV or HCV. Record review would include all available records. Proposed § 610.48(c) would require collecting establishments to perform a review of records for HCV testing prior to the effective date of the final rule. These records would date back indefinitely for computerized electronic records, and to January 1, 1988, for all other readily retrievable records, or to the date 12 months before the most recent negative screening test for HCV, whichever is the lesser period. (Comment 5) Several comments asked for revisions to the codified section to clarify the extent of prospective record review. One comment requested a fixed date for “lookback” regardless of the establishment's method of recordkeeping. The comment stated that the proposed rule penalizes establishments that keep records longer and agreed that the rule is a deterrent for keeping good computerized records. The other comment interpreted the language of the proposed prospective HIV and HCV record review, i.e., “whenever records are available,” as resulting in an open-ended, continuous search. The comments preferred the description of the retrospective HCV record review and suggested modifying the prospective HIV and HCV record review language to reflect similar language, or, as one comment suggested, changing the record review period to 10 years for transfusable products and 6 months for recovered plasma intended for further manufacturing use. The comment reasoned that, because recovered plasma does not have an expiration date, the blood establishment would have to search records that are 20 to 30 years old. Another comment recommended limiting the record review to computerized electronic records. For retrospective review, one comment recommended that we base the “lookback” on a record review that extends as far back as computerized records exist for donation and distribution, or back to January 1, 1988, whichever is longer. (Response) In regards to the extent of record review required under final §§ 610.46(a)(1) and 610.47(a)(1) (prospective review), we recognize the difficulty in interpretation and we have eliminated the phrase “whenever records are available.” In its place, we have inserted a reference to the requirements under § 606.160(d) for the record retention period (10 years). Any affected blood or blood components collected before the required record retention period will most likely be outdated; or collected more than 12 months before the donor's most recent nonreactive screening tests for HIV or HCV, or more than 12 months before the donor's reactive direct viral detection test, e.g., NAT (HIV and HCV) or HIV p24 antigen test (HIV), and nonreactive antibody screening test for HIV or HCV, and will not need to be quarantined. If the establishment retains records beyond the required retention period, we suggest that the establishment search such records as appropriate in the “lookback” requirements to identify blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection. Our intention is not to penalize those establishments that keep records longer than required, but to help ensure that recipients are notified that they may have received blood or blood components at increased risk of transmitting infection so that they may seek testing, counseling, and (if necessary) treatment. We decline to make the suggested change for retrospective record review because not all establishments' records are computerized. (Comment 6) Three comments requested clarification of certain terms used in the proposed rule. One comment requested that the prospective and retrospective “lookback” be consistent with regard to the form and content of the reviewed records, i.e., “computerized electronic records” and “readily retrievable records.” The comment also suggested defining “available” in the prospective “lookback” as synonymous with “computerized electronic” in the retrospective “lookback.” Another comment contended that nonconformity in such language might lead to different interpretations between the blood establishments and FDA investigators. A third comment requested clarification of the term “readily.” (Response) We acknowledge that the descriptive terminology used in the proposed codified section relating to the extent of record review could lead to differences in interpretation. However, we decline to use the same terms for prospective review and retrospective review due to the different events initiating the review, i.e., a donor's reactive screening test for HIV or HCV in prospective review or the final rule's requirement for historical HCV testing record review. However, to lessen confusion, we are changing the description of the prospective record review in §§ 610.46(a)(1)(i) and 610.47(a)(1)(i) from “whenever records are available” to “records required under § 606.160(d).” In this final rule, records must be available for 10 years after the records of processing are completed or 6 months after the latest expiration date for the individual product, whichever is later. Because the current regulation requires a 5-year record retention period, the 10-year record retention period is a “rolling” 10 years, as previously discussed in comment 3 of this document. Prospective record review must include all records required under § 606.160(d), including computerized electronic records. We have removed the term “readily retrievable” from the final rule. 3. Quarantine Proposed §§ 610.46(a) and 610.48(a) and
(c)would require the collecting establishment to quarantine in-date blood and blood components identified during the record review. Because the identified in-date blood and blood components are considered at risk for transmitting HIV or HCV infection and are still in inventory, they would be required to be removed from inventory and isolated in quarantine so that they may not be transfused or used for further manufacture into injectable products. The proposal would require collecting establishments to notify consignees to quarantine such blood and blood components, removing the possibility of infecting others. The proposed rule would require the collecting establishment to complete these actions within 3 calendar days of the donor testing reactive for evidence of HIV or HCV infection. We specifically requested comments on the appropriateness of 3 calendar days to complete quarantine and notification of consignees. (Comment 7) Several comments requested that FDA revise § 610.46(a) to be consistent with § 610.48(a) by limiting quarantine and notification of consignees to in-date products, and that the retrospective review in proposed § 610.48(e) be limited to in-date products only. Another comment suggested eliminating the action of quarantine for outdated products for both prospective and retrospective record review. The same comment asked whether in-date and outdated products are to be treated identically. (Response) We agree with the comment that the requirements for HIV “lookback” in proposed § 610.46(a) and the requirements for HCV “lookback” in proposed § 610.48(a) should be consistent and have made the change. The action of quarantining identified blood and blood components by the collecting establishment and the initial notification of the consignees to quarantine such products is limited to in-date blood and blood components because they are available for transfusion or use for further manufacturing into injectable products if they remain in inventory. Quarantine by the collecting establishment or consignee does not apply to outdated blood and blood components because they should no longer be in the establishment's releasable inventory. However, we want to clarify that the prospective HIV and HCV “lookback” (final §§ 610.46 and 610.47) must identify both in-date and outdated blood and blood components previously donated by a donor with a reactive screening test for HIV or HCV. This identification is necessary so that recipients of such blood and blood components can be notified for the purpose of testing, counseling, and treatment if indicated by the supplemental (additional, more specific) test results. These actions also apply to the requirements of historical HCV testing record review under final § 610.48. (Comment 8) One comment urged FDA to modify the time period of 12 months for the quarantine of identified prior collections of blood and blood components from the most recent reactive screening test for evidence of HIV infection in proposed § 610.46(c). The comment suggested changing the time period from 12 to 3 months to remain consistent with current guidance for donors testing reactive for HIV-1 antigen in a Blood Memorandum to All Registered Blood and Plasma Establishments entitled “Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen” (August 1995 memorandum). (Response) We understand the comment's request for consistency with existing guidance. However, we decline to make the change for the following reason. Since 1995, industry has collected additional scientific information showing that donors infected with HIV may experience intermittent viremias for a variable period of time prior to a persistently detectable viremia or an antibody response. Because these episodes of transient viremia may extend over a longer window period than previously estimated, we are requiring a record review period of 12 months before the donor's reactive direct viral detection test with a nonreactive antibody screening test or 12 months prior to the most recent nonreactive screening tests, whichever is the lesser period. A 12-month timeframe is necessary to encompass with sufficient confidence the window period for HIV prior to the detection of antibody. We have elected not to address an alternative (possibly shorter) “lookback” period based on the last negative direct viral test in order to minimize operational complexity and because the appropriate period has not been well established scientifically. This requirement supersedes the 3-month “lookback” recommendation for donors testing reactive for HIV p24 antigen in the August 1995 memorandum and is for prospective application. However, we recommend that collecting establishments “lookback” 12 months before the few previously identified reactive HIV p24 antigen tests with a nonreactive antibody screening test that were confirmed as infected with HIV. (Comment 9) One comment interpreted “quarantine” as gaining control of distributed prior collections of blood and blood components from a donor who subsequently tests reactive by a screening test for evidence of HIV or HCV infection. (Response) We disagree with the comment's interpretation of “quarantine.” The requirement for “quarantine” simply means the removal of the identified in-date blood and blood components from the collecting establishment's or consignee's inventory and their placement into isolation to prevent transfusion or use for further manufacture into injectable products. It is not intended to require the collecting establishment to physically retrieve the identified blood and blood components from the consignee, though such action is permissible. It also is permissible for the consignee to return to the collecting establishment any in-date blood and blood components identified for quarantine. (Comment 10) Five comments considered the timeframe of 3 calendar days in proposed §§ 610.46 and 610.48 to be inadequate for the quarantine of all prior collections of blood and blood components from donors testing reactive by a screening test for evidence of HIV or HCV infection, and for consignee notification, especially if the quarantine action is initiated by information from an outside source (prospective record review). Another comment stated that 3 calendar days is appropriate for quarantining in-date blood and blood components, but that additional time is needed for consignee notification. Several comments suggested 7 calendar days, 3 working days, or 5 business days as alternative timeframes for quarantine and consignee notification. Two comments suggested that the time period start once the prior collections of the donor with the reactive screening test are identified, not when the reactive screening test occurs. (Response) We decline to change the timeframe. Our objective is to minimize the possibility of transmitting an HIV or HCV infection to an individual due to his or her exposure to blood and blood components at risk of transmitting HIV or HCV. It is important that consignee notification and quarantine of such blood and blood components be performed expeditiously within a reasonable timeframe and we believe that 3 calendar days is reasonable. We define “3 calendar days” as the period ending at the close of business 3 full days after a donor tests reactive. So, for example, if a donor testing reactive by a screening test for HIV or HCV on the first day (e.g., Friday), then quarantine by the collecting establishment and notification of consignees to quarantine must occur by close of business on the fourth day (e.g., Monday). (Comment 11) Several comments suggested adjusting the time period for quarantine and notification for the HCV retrospective review requirements in proposed § 610.48(e) and (f). Suggested changes ranged from 3 working days, to 7 calendar or 5 business days, to 1 year for quarantine of prior collections and consignee notification. Another comment requested a change from 3 calendar days to 3 working days for outdated products. One comment suggested deleting proposed § 610.48(f)(2), which addresses the review of historical records based on screening performed using a single antigen-base antibody screening test during 1990 to 1992. The comment said that there would be few in-date products that would necessitate immediate quarantine and notification of the consignee. (Response) We decline to make the suggested changes for the reason stated in response to comment 10 of this document. We want to clarify that these actions are initiated by the identification of a reactive screening test on a donor upon review of historical records. The 3-calendar day timeframe is required only when in-date blood and blood components are identified. If the review does not identify in-date blood and blood components, then the quarantine and notification of consignees to quarantine is unnecessary. We agree with the comment to delete proposed § 610.48(f)(2) based on the reason that there would be few in-date products that would necessitate quarantine and notification of consignees. This revision is not necessary because of our restructuring of the codified section. 4. Exemptions From Quarantine Proposed §§ 610.46(c) and 610.48(g) would permit exemption from quarantine of blood and blood components collected more than 12 months before the donor's most recent negative screening test for HIV or HCV infection. (Comment 12) One comment suggested that FDA make an exception to HIV and HCV “lookback” for autologous donations that have a reactive screening test for HIV or HCV if the donor did not make any prior donations for allogeneic use, and if the blood establishment receiving those prior autologous donations from the donor did not have a crossover program, i.e., unused autologous donations put into inventory for allogeneic use. (Response) We agree that such autologous donations should be exempt from “lookback” because the risk of transmitting HIV and HCV infection to a recipient does not exist because the autologous donor has not donated blood or blood components that will be used by others. We have clarified in the final rule that “lookback” applies to blood and blood components “intended for use in another person.” (Comment 13) One comment requests that we exempt products previously quarantined under FDA guidance and other existing regulations for “lookback” from new quarantine requirements. The comment suggested that we consider previous “lookback” actions as prospective and not impose further review requirements on these cases that would make the same reviews retrospective. The comment also claimed that retrospective record review is a one-time process and that it is too cumbersome to have retrospective requirements intertwined with the continuous process of prospective records review requirements. (Response) If actions performed pursuant to the “lookback” guidance or requirements for quarantine fulfill the requirements of this final rule, then they are considered completed. As discussed in section II.B.2.b and comment 1 of this document, we established a date distinguishing the end of the retrospective review period and an exemption in certain circumstances, thereby eliminating any overlap of retrospective review and prospective review. (Comment 14) Four comments asked us to include blood and blood components already pooled for further manufacturing use in the exception to quarantine in proposed §§ 610.46 and 610.48. The comments also asked if these sections include historical or retrospective record review in addition to the prospective record review. (Response) We agree with the comment and have added the exemption from quarantine for pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance (i.e., inactivation and removal) procedures in the requirements for prospective review, in final §§ 610.46(a)(1)(ii), 610.47(a)(1)(ii), and in the requirement for retrospective record review in final § 610.48(b)(3)(i) and (c)(1). Pooled components intended solely for further manufacturing are exempted because it is impractical to retrieve such pools and, additionally, the manufacturing process is designed to remove or inactivate HIV and HCV. 5. Notification of Consignee Proposed §§ 610.46(a)(1)(ii), 610.48(a)(1)(ii), and 610.48(e)(2) and (f)(2) would require the collecting establishment to notify the consignee to quarantine in-date blood and blood components previously collected from a donor who later tested reactive for evidence of HIV or HCV infection. Notification would be required to occur within 3 calendar days after the date a donor tests reactive by a screening test for HIV or HCV, or after the date of identification of the donor's reactive screening test for HCV. In proposed §§ 610.46(b) and 610.48(b) (prospective review), the collecting establishment would notify the consignee of the results of further testing within 45 days after the donor tested reactive by a screening test for HIV or HCV. Under proposed § 610.48(h)(3) (retrospective review), the collecting establishment would notify the consignee of the results of further testing within 45 days following completion of further testing and prior to 1 year after the effective date of the final rule. (Comment 15) Two comments requested clarification of the notification responsibilities in general. One comment suggested listing all the conditions that trigger quarantine and consignee notification in one section of the codified section of the final rule. The comment also requested clarification of the different criteria that trigger consignee notification versus recipient notification. The second comment recommended that the consignee be notified after the confirmatory test is completed to make the notification more effective by supplying all the necessary information and to reduce the number of contacts. (Response) We agree with the comment to group separately the requirements specific to consignee notification and recipient notification. Consequently, we have restructured the final rule into specific actions for the collecting establishment, which is responsible for consignee notification, and the consignee, who is responsible for the recipient notification. However, we do not agree with the recommendation that the collecting establishment limit notifying the consignee until after all the testing is completed. We clarified that the collecting establishment must notify the consignee when in-date blood and blood components distributed to the consignee are identified for the purpose of quarantine, and notify the consignee again with the results of the completed further testing. The consignee must notify the transfusion recipient if indicated by the results of the supplemental tests for HIV or HCV infection or when the donor's screening test is reactive and there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA. (Comment 16) One comment suggested that we create an exemption for notifying the consignee when the consignee gives documentation to the blood establishment showing that records no longer exist for products during a specified time period. The comment said that if the blood establishment knows that records do not exist, then it would be ineffective to notify the consignee to quarantine the products. (Response) We agree that it would be ineffective to notify the consignee to quarantine blood and blood components if records do not exist. However, initial notification of the consignee is for the purpose of quarantining in-date blood and blood components. Such consignees of blood and blood components must have existing records under § 606.160(d). The final rule requires the collecting establishment to notify the consignee of further testing results for both in-date and outdated blood and blood components identified as at increased risk of transmitting HIV or HCV infection for the purpose of recipient notification. (Comment 17) A few comments asked that we clarify, in proposed § 610.48(g), that it is not necessary to notify the consignee when prior collections from a donor with a reactive screening test for HCV are exempt due to the supplemental test results. (Response) In the preamble to the proposed rule (65 FR 69378 at 69387), we explained that when an appropriate supplemental (additional, more specific) test for HCV is negative and is completed within the 3 calendar days provided for the completion of quarantine and consignee notification, consignee notification is not necessary. In the final rule, if the supplemental test is negative within the provided 3 calendar days, then the reactive screening test result is interpreted as a “false reactive,” HCV infection is not indicated, and the identified blood and blood components are considered not at increased risk of transmitting HCV. If, however, the supplemental test is completed more than the provided 3 calendar days after the date of the reactive screening test for HCV infection, the collecting establishment must quarantine identified in-date blood and blood components, and notify consignees to quarantine identified in-date blood and blood components, but may release the blood and blood components from quarantine if the supplemental test is negative. This applies to a donor testing reactive by a screening test for HIV infection as well. For retrospective record review, when a collecting establishment identifies a donor testing reactive by a HCV screening test, and if an appropriate supplemental test is negative, then quarantine and consignee notification is unnecessary. However, if additional supplemental testing or testing with a licensed screening test with known greater sensitivity than the test of record is necessary to establish the infectious status of the identified blood and blood components, then quarantine and consignee notification of in-date blood and blood components must occur within the provided 3 calendar days until further testing is completed. 6. Further Testing and Consignee Notification of Test Results In the case of prospective record review, proposed §§ 610.46(b) and 610.48(b) would require that the collecting establishment perform further testing on the donor's blood and notify the consignee of the results within 45 calendar days after the date on which the donor tested reactive by a screening test for evidence of HIV or HCV infection. While performing retrospective record review, proposed § 610.48(h) and
(i)would require the collecting establishment to perform further testing, if not previously performed. The collecting establishment would perform the further testing either on a frozen sample from the reactive donation, if available, or on a fresh specimen from the donor, if obtainable. The collecting establishments would then notify the consignees of the results within 45 calendar days following the completion of further testing and prior to 1 year after the effective date of the final rule. (Comment 18) One comment suggested changing “shall” to “may” in proposed § 610.48(h)(1) and (i)(1) to give the establishment the option of immediately performing quarantine and notification rather than locating the donor for further testing. (Response) We agree with the comment and have revised final § 610.48(b)(2) by changing “shall” to “may” to permit the collecting establishment to choose between either immediate quarantine and consignee notification, or obtaining a sample for further testing from the donor. However, we emphasize the benefit of further testing when recipient notification is indicated, and reiterate that every effort should be made to complete further testing. (Comment 19) One comment suggested alternatives for the 45-calendar day time period for notifying consignees of the results of further testing in both prospective and retrospective review. For proposed §§ 610.46(b) and 610.48(h)(3)(i), the comment suggested exempting completely the requirement of notifying the consignee of further HIV or HCV testing results within 45 days when prior collections are returned to the blood establishment or destroyed. The comment suggested extending the time period to 90 days in proposed § 610.48(b) for notifying consignees of further HCV testing results when the products from prior collections of the donor are outdated. The 90-day time period would permit the blood establishment to retrieve records that are stored offsite and in varying forms, or to give additional search and review efforts to records not as readily accessible for in-date products. The comment further suggested that notification for outdated products made from prior collections should occur within 1 year of the effective date of the final rule and only if the test results indicate that consignees must take action to notify the recipients. (Response) We agree that it is not necessary to notify the consignee of the results of further testing within 45 calendar days if the blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection are returned to the collecting establishment or destroyed by the consignee. We decline to extend the time period of 45 calendar days to 90 calendar days in final § 610.48(b) as suggested by the comment. Although the comment reasoned that a longer time period would enable the collecting establishment to retrieve records that are stored offsite and in varying forms or enhance additional search and review efforts to records not as readily accessible as those for in-date products, we believe that 45 calendar days is adequate for such purposes and that it is imperative that consignees obtain such information, which may necessitate recipient notification, in a reasonable time period. 7. Notification of Transfusion Recipient Proposed §§ 610.47 and 610.49 would require consignees (transfusion services) to notify recipients that they received blood and blood components previously collected from a donor later determined to be unsuitable when tested for evidence of infection with HIV or HCV. The transfusion service would notify the recipient's physician of record (i.e., physician of record or physician who ordered the blood or blood component) and ask the physician to inform the recipient of the need for HIV or HCV testing and counseling. If the physician is not available or declines to notify the recipient, the transfusion service would be required to notify the recipient and inform the recipient of the need for HIV or HCV testing and counseling. The notification process would include a minimum of three attempts within a maximum of 12 weeks of receipt of the result of the supplemental test. If the recipient is adjudged incompetent by a State court, or the recipient is competent but State law permits notification of a legal representative or relative, or if the recipient is a minor, then the transfusion service would notify the legal representative, relative, or recipient's physician of record. If the recipient is deceased, proposed § 610.47(c) for HIV would have the notification process continue, and the transfusion service or the recipient's physician of record would notify the legal representative or relative. Under proposed § 610.49(c) for HCV, if the recipient were deceased, then the notification process would be terminated. (Comment 20) One comment urged FDA to remove the exceptions for recipient notification by the transfusion service/consignee in proposed § 610.49(a) and place them in the section that pertains to the blood establishment. The comment stated that the requirement, as proposed, would require the blood establishment to notify the consignee even when the further testing results show that the donor is not at increased risk of transmitting HCV. The comment said that the suggested change would allow blood establishments to avoid notification of the consignees in cases that require no recipient notification, would streamline the final rule, and would have no ill effect on public health. (Response) We have accommodated the comment's request by restructuring the codified section, requiring objective actions for collecting establishments and consignees, and removing the prescriptive language. In this process, we removed proposed § 610.49. (Comment 21) Several comments sought changes to proposed § 610.49(b). One comment interpreted the proposed section as requiring concurrent notification of the recipient's physician of record and the recipient. Some comments stated that the recipient's physician of record at a transfusion service often does not have an ongoing relationship with the recipient and that the most common reason for notifying the recipient directly is because the physician of record refuses to notify the recipient. The comments would revise proposed § 610.49(b) to require the recipient's physician of record, not the transfusion service, to notify the recipient and would make the transfusion service responsible for notification only if the recipient's physician requests it or is unavailable. One comment said that the transfusion services are not in the position to provide patient counseling and further testing of the recipient for diagnostic purposes, and that the physician's decision should not be overridden by the transfusion service. (Response) The comments misread the proposed rule. Proposed § 610.49(b) stated that “[T]he transfusion service shall either notify the recipient directly or notify the recipient's physician of record * * * and ask him or her to inform the recipient of the need for HCV testing and counseling.” The proposal, therefore, did not propose concurrent notification of the recipient's physician and the recipient. In the final rule we require that the transfusion service notify the transfusion recipient of blood and blood components at increased risk of transmitting HCV, or the recipient's physician of record (§ 610.47(b)(3)). Whether the transfusion service or the recipient's physician of record notifies the recipient, the recipient must be informed of the need for testing and counseling. At a minimum, the notifying party should inform the recipient of his or her increased risk of HCV infection and advise the recipient to seek testing, counseling, and treatment if necessary. (Comment 22) Several comments expressed concern regarding the requirement in proposed § 610.49(b) that would require a minimum of 3 attempts to notify the recipient. The comments asked for the flexibility to discontinue the attempts once the transfusion service has obtained solid information indicating that further attempts are not necessary or would not be fruitful, and documentation is kept. Two comments would revise proposed § 610.49(b) to require only one attempt at notification using a traceable method, i.e., certified mail, return receipt. The comments asserted that there is a tremendous cost associated with more than one attempt and that we should permit the transfusion services to show good faith effort at notification if they use the information available in the patient record. (Response) The final rule clarifies, in § 610.47(b)(3), that a consignee must make reasonable attempts to notify the recipient or the recipient's physician of record. We eliminated the requirement for three attempts; however, we emphasize that a consignee should continue attempting to notify the recipient or the recipient's physician of record until it is clear that further attempts would not be successful. If the initial attempt or attempts are unsuccessful, a consignee may need to try other methods to contact the recipient or the recipient's physician of record. If a consignee is successful in notifying a recipient or physician of record, then, obviously, no other attempts are necessary. We have also clarified this requirement in §§ 610.46(b)(3) and 610.48(c)(3). Consignees, under § 606.160(b)(1)(viii), must document their attempts to notify recipients or physicians of record and maintain a record of these attempts, whether successful or not. (Comment 23) Two comments requested consistency in proposed §§ 610.47(c) (HIV “lookback”) and 610.49(c) (HCV prospective “lookback”) regarding the notification of the legal representative or relative when a transfusion recipient is deceased. Proposed § 610.47(c) for HIV would require notification to continue if the transfusion recipient is deceased, and proposed § 610.49(c) for HCV would discontinue the process if the transfusion recipient were deceased. Another comment requested that we eliminate the requirement in proposed § 610.49(c) to notify the legal representative or relative of a recipient who is incompetent or deceased. The comment said the risk of secondary transmission under such circumstances is slim and such notification wastes resources. (Response) The final rule, in § 610.46(b)(3), continues to require the consignee to notify the legal representative or relative of a deceased recipient who received blood and blood components determined to be at risk of transmitting HIV infection. Requiring notification of the legal representative or relative when the recipient is deceased may help prevent the further spread of HIV, which the donor may have spread to a spouse or significant other before death. With this information, the spouse or significant other may be tested for the communicable disease, receive counseling, and take precautions not to spread it to others, if infected. We do not believe that the notification requirement is necessary in §§ 610.47(b)(3) and 610.48(c)(3) for HCV “lookback” because direct percutaneous exposure to infectious blood, particularly in the setting of drug abuse, accounts for the majority of HCV infections acquired in the United States; secondary transmission of HCV to sexual partners, care providers, or others with close contact is very unlikely. IV. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is an economically significant regulatory action under section 3(f)(1) of the Executive order, since it may lead to impacts of greater than $100 million in any one year. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the average annualized costs for small entities will be less than 0.3 percent of average annual revenues, the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. The final rule will provide information to consignees and recipients of blood and blood components that may be at increased risk of transmitting HCV infection. Based on the following analysis, FDA projects that one-time costs will total approximately $73.5 million and annual costs will be approximately $1.7 million. Benefits of the final rule are measured as the gains in quality-adjusted life years (QALYs) of blood transfusion recipients who receive treatment for newly-identified post-transfusion hepatitis C virus infections that would otherwise go untreated in the absence of “lookback.” The value of this potential one-time gain in quality-adjusted life years ranges from $264 million to $1,228 million depending on the societal value of a quality-adjusted life year, or from $30.9 million to $143.9 million when annualized over 10 years with a 3 percent discount rate. Benefits could not be estimated with a 7 percent discount rate. With total annualized costs of $10.3 million, the net annualized benefits of the final rule are between $20.6 million and $133.6 million with a 3 percent discount rate over 10 years. Thus, FDA has determined that the final rule will be economically significant as defined by the Executive Order, because the final rule might generate benefits that exceed $100 million in a single year. A. Economic Impact 3 3 The final rule revises the HIV “lookback” requirements to make them consistent with the HCV “lookback” requirements. Because these revisions do not change the level of effort required for HIV “lookback,” an economic impact for the HIV “lookback” is not provided. The economic analysis for the HIV “lookback” requirements is addressed in the **Federal Register** issued September 9, 1996 (61 FR 47420). The purpose of the final rule is to ensure the continued safety of the Nation's blood supply by removing blood previously donated by individuals who test reactive for evidence of the HCV infection and by notifying recipients that these blood and blood components are at increased risk of transmitting the infection. Although blood is screened for several infectious diseases, including HCV, it is possible for a donor to give blood in the early stages of an infection before a screening test can detect its presence. Blood given during this window period has an increased risk of transmitting disease. The need for this final rule stems from the information failure caused by the inability of screening tests to identify infections in the early stages. HCV “lookback” will ensure that blood transfusion recipients be notified in the rare event that they receive at-risk blood. In addition to the proposed rule, the agency has issued several draft guidances on HCV “lookback.” The final rule, however, outlines the set of actions blood collection establishments and consignees (i.e., transfusion service establishments) must follow when tests show that an allogeneic blood donation from a repeat donor may be at increased risk for HCV infection. Because industry guidance can be updated more quickly as technologies advance, much of the prescriptive language in the proposed rule has been removed from the final rule. In response to the agency's guidance documents, much of the blood industry has voluntarily adopted HCV “lookback” as a standard business practice. Nevertheless, some establishments have not implemented all elements of “lookback,” specifically recipient notification. Without the final rule, partial implementation of “lookback” would likely persist with some blood transfusion recipients not being notified that they received blood components at increased risk for HCV infection. The agency further notes that the costs and benefits of the FDA and CMS interim final rule are not additive, as the impacts considered in the CMS interim final rule are also accounted for in the FDA final rule. 1. Annual Number of Blood Donations and Blood Components Affected a. *Number of donations from repeat donors confirmed HCV positive* . At a May 2, 2003, meeting of the DHHS Advisory Committee, the agency reported that previously unpublished American Red Cross
(ARC)data show the HCV prevalence rate for repeat donors was 0.007 percent in 2000 (Ref. 1). This estimate implies that with approximately 11.2 million donations annually from repeat donors (14 million donations x 80 percent of donations from repeat donors), blood banks will find an estimated 780 donations from HCV-infected donors (11.2 million donations x 0.007 percent infected with HCV) per year. We note the reported prevalence rate has declined since 1997 when the ARC reported an HCV prevalence rate of 0.03 percent for repeat donors (Ref. 2). If prevalence rates continue to decline, we would expect even fewer donations from HCV-infected donors in the future. b. *Number of previously donated components* . A blood donation is normally separated into multiple components. Based on 1999 Center for Disease Control and Prevention
(CDC)survey findings, we initially estimated that an average of 1.1 previously donated components would be found for each donor triggering “lookback” (Ref. 3). Several comments from blood banks affiliated with the America's Blood Centers
(ABC)disagreed with the CDC survey findings and cited their experience that a review of donation records for a donor testing reactive to evidence of HCV infection can uncover up to 10 previously donated components. The wording of some survey questions may partially explain why CDC found fewer components. Blood banks reported the number of repeat donors who triggered “lookback” according to the type of screening test used, and the total number of blood components for these donors that had been previously shipped to transfusion services. However, some blood banks may have held or destroyed donations with abnormal surrogate markers for HCV even though the blood screened negative for HCV. These blood banks would report fewer components previously shipped to transfusion services (Ref. 3, p. 1180). The agency accepts that some collecting establishments may have more previously donated components than suggested by the CDC data. However, ABC establishments receive only about half of the annual donations in the United States. We assume that the CDC survey findings are representative of the remaining blood donations. Taking the average of the midpoint of the range reported in comments on the proposed rule (i.e., 5 components) and the CDC survey findings (i.e., 1.112 components), we increase the estimated average number of previously donated components for each donation from 1.1 to 3.1 (3.06 = (5 + 1.112) / 2). 2. The Number and Type of Entities Affected The final rule will affect establishments that collect, process, and ship blood and blood components, and establishments that transfuse those products. The affected entities include commercial plasma centers, regional and community blood collection or donation centers, hospitals that operate blood collection centers, and facilities that transfuse blood products. In the United States, there are 981 registered blood collection establishments and 60 licensed plasma collection establishments listed with FDA's Office of Blood Research and Review
(OBRR)(i.e., a total of 1,041 establishments). CMS has records of another 4,980 establishments that transfuse blood and blood components. With the exception of hospitals that both collect and transfuse blood products, establishments affected by the final rule will either act as a blood collection establishment or as a consignee (i.e., a transfusion service), but not both. To distinguish the impact of the requirements on blood collection establishments and consignees, the final rule provisions affecting each type of establishment will be treated separately in the analysis that follows. 3. Estimated Impact on Blood and Plasma Collection Establishments First, we present the costs that are the same for all collection establishments, regardless of the number of “lookbacks” performed. Second, we discuss the costs that vary according to how many “lookbacks” occur. a. *Fixed costs—Standard operating procedures and record retention* . Each blood or plasma collection establishment must perform a one-time review and reconcile its current SOPs with the requirements of the final rule. In the analysis for the proposed rule, FDA estimated a staff medical technologist will need an additional 40 hours to review and update SOPs for the following actions:
(1)Record review;
(2)product quarantine;
(3)consignee notification to quarantine identified products;
(4)consignee notification of supplemental (additional, more specific) test results;
(5)release, destruction, or relabeling of quarantined products; and
(6)donor and blood product recordkeeping. No comments on this estimate were submitted to the agency. Using the original time burden and the revised loaded hourly wage of $33.84 (Ref. 4), each establishment will incur one-time costs of $1,354, resulting in an industry-wide cost of approximately $1.4 million (40 hours x $33.84 per hour x 1,041 establishments). The final rule requires that blood and plasma collection establishments extend the length of time they keep individual product records from 5 to 10 years after the records of processing have been completed, or 6 months after the expiration date for the individual product, whichever is the later date. According to the AABB (formerly known as the American Association of Blood Banks), all establishments collecting blood in the United States, including the American Red Cross and America's Blood Centers, are accredited by their organization and comply with their standards. Current AABB standards require that establishments retain records 10 years. Because the final rule will not affect current industry practices, the blood collection industry will incur no additional compliance costs for this provision. b. *Variable costs—HCV “lookback.”* The agency has issued several draft guidances describing the specific actions blood collection establishments should take when a donor's screening test is reactive for HCV or if the blood collection establishment becomes aware of other reliable test results or information indicating evidence of HCV infection. When these activities are initiated by a current blood donation, the current donation is destroyed and the set of actions required of the collection establishment is called a prospective “lookback.” However, when “lookback” is triggered by an historical review of blood donor testing records, the set of actions is called an historical or retrospective “lookback.” Although the actions required by the prospective and retrospective “lookback” provisions of the final rule are similar, the timing of these actions differs between the two “lookbacks.” In general, for donors with reactive test results for HCV, the collection establishment must take the following actions:
(1)Review records to identify any other blood donations from these donors,
(2)quarantine all previously collected in-date components from the donors that were intended for use in another person or for further manufacture into injectable products, and
(3)notify consignees to quarantine all previously collected in-date components at increased risk of transmitting the virus. A collection establishment must perform a supplemental test (i.e., a test more specific than the screening test as described in the current industry guidance) for HCV on the current reactive blood sample. For reactive donations identified by an historical review of donor testing records, if no supplemental test was performed when the donation was collected, a collection establishment may perform a supplemental test on a frozen sample from the same reactive donation or a fresh sample from the same donor. If no further supplemental testing is possible for the retrospective “lookback”, a blood collection establishment must send the reactive test results to the consignee. Once supplemental or other required test results are received, both types of “lookback” require that the collecting establishment do the following:
(1)Notify consignees of these test results for both in-date and outdated previously collected components,
(2)identify quarantined in-date components, and
(3)take the appropriate action (i.e., release from quarantine, destroy the quarantined components, or relabel the components) indicated by the test results. However, collections taken more than 12 months before the donor's most recent nonreactive screening tests, or 12 months before the donor's reactive direct viral detection test and nonreactive antibody screening test for HCV are exempt from the required record review. Some comments requested that FDA specify how the final rule will affect plasma establishments because HCV is inactivated when pooled plasma is further manufactured. The “lookback” requirements of the final rule will only affect plasma establishments that store and distribute unpooled units to consignees. The number of firms in this category is expected to be small. Comments from a plasma industry trade organization support the agency's initial analysis that plasma establishments will only be minimally affected by these requirements. i. *Prospective HCV “lookbacks.”* At the May 2003 DHHS Advisory Committee meeting, the agency reported that FDA-inspected blood collection establishments voluntarily follow the agency's draft guidance and perform prospective “lookback” as part of their standard business practices (Ref. 1). No parties present at the meeting dissented from this statement. Because these provisions of the final rule will not require blood collection establishments to change their current practices, the blood collection industry will not incur any additional compliance costs for prospective “lookback.” ii. *Retrospective HCV “lookback.”* The final rule requires a review of historical testing records for donations collected prior to the effective date of the final rule. Within 1 year of the effective date of the final rule, blood establishments must complete the retrospective “lookback” as described previously in this document. Because industry did not comment on the agency's initial estimate of the compliance costs for the retrospective “lookback,” the cost per consignee notification remains unchanged from the initial analysis (65 FR 69378 at 69396). Published and unpublished data from CDC suggest that 188,448 components from donors screened with single-antigen screening tests and 105,706 components from donors screened with multi-antigen screening tests require retrospective “lookback” by blood collection establishments (Ref. 3). In their survey of the blood industry, CDC found that by 1999, blood collection establishments had completed about 85 percent of the retrospective “lookback” based on reactive multi-antigen tests or approximately 30 percent of the entire retrospective “lookback” (Ref. 3). Adjusting our initial estimate to account for completion of 85 percent of blood collection establishments' “lookbacks” based on reactive multi-antigen test results, blood collection establishments must conduct no more than 204,000 “lookbacks” [188,448 components screened with single-antigen tests + ((100 percent - 85 percent) x 105,706 components screened with multi-antigen tests)]. At the estimated cost of $113 per notification, blood collection establishments will spend about $23 million (i.e., $22.9 million = 203,775 components x $112.50) to comply with the retrospective “lookback” provisions of the final rule, or $2.7 million per year when annualized for 10 years at a 3 percent discount rate and $3.3 million when annualized at 7 percent. Furthermore, “lookback” efforts have continued since the CDC survey was conducted. Although CDC has not conducted a follow-up survey, informal contacts with the blood collection industry have indicated that a substantial portion of the retrospective “lookback” has already been completed. Thus, $23 million represents an upper bound for the compliance costs of the retrospective “lookback.” If, for example, “lookback” based on multi-antigen screening tests has been completed, the one-time cost for “lookback” based on the older single-antigen screening test will be $21 million (188,448 components x $112.50 per component), or $2.5 million annualized for 10 years at a 3 percent discount rate and $3.0 million annualized at 7 percent. c. *Total costs for blood collection establishments* . The costs of the final rule for blood collection establishments are shown in table 1 of this document. FDA estimates that the blood collection industry will incur total one-time costs to revise SOPs and complete the retrospective “lookback” of up to $24.3 million. Over 10 years, the annualized costs equal about $2.9 million at a 3 percent discount rate and $3.5 million at a 7 percent discount rate. **Table 1.—Costs of the Final Rule for Blood Collection Establishments** 1 Number Affected Current Compliance Rate (percent) One-Time Costs ($ million) Annualized Costs ($ million) 3 percent 7 percent Review and revise SOPs 1,041 0 1.4 0.2 0.2 Retain records for 10 years 1,041 100 — — — Prospective “lookback” 981 100 — — — Retrospective “lookback” 2 981 30+ 22.9 2.7 3.3 Total 24.3 2.9 3.5 1 Numbers may not sum due to rounding. 2 This upper bound estimate assumes that at least 30 percent of the retrospective “lookback” has been completed, including 85 percent of the “lookback” based on the multi-antigen screening test and no “lookbacks” based on the single-antigen screening test. 4. Estimated Impact on Blood Product Consignees (Transfusion Services) Similar to the analysis for blood and plasma collection establishments, we focus first on the costs that are independent of the number of “lookbacks” conducted and then on the costs that vary according to how many “lookbacks“ consignees perform. a. *Fixed costs—Standard operating procedures and record retention* . Similar to blood collection establishments, consignees must also review and adapt their current SOPs to the requirements of the final rule. Specifically, consignees must have procedures for the required set of actions to take when notified by a blood collection establishment that the consignee received blood products at increased risk of transmitting HCV infection. These actions include the following:
(1)Identifying and quarantining affected in-date unpooled blood components, and
(2)processing quarantined in-date unpooled blood components according to the results of a supplemental test. Moreover, when the supplemental test for HCV is positive or there is no available supplemental test for a reactive screening test, the consignee must notify blood transfusion recipients that they received blood products at increased risk of transmitting the HCV infection. Because consignees already have SOPs in place for HIV “lookback,” FDA estimated that an average of 16 additional hours would be needed by each consignee to adapt or modify current procedures. We did not receive any comments on the estimate of this time burden; therefore it remains unchanged for the final analysis. At the revised hourly wage of $33.84 with benefits for a staff medical technologist (Ref. 4), each consignee will incur one-time costs of $541, or about $2.7 million for the entire industry ($33.84 per hour x 16 hours x 4,980 consignees). The final rule requires that consignees increase the time they keep records from 5 to 10 years. Although the agency did not include the annual cost of keeping records for a longer period in the analysis for the proposed rule, it may take 40 hours for a computer programmer to perform routine maintenance of these additional records. At a wage of $34.00 per hour including benefits (Ref. 5), a consignee would spend an additional $1,360 annually to conform to this provision of the final rule. However, according to the AABB, 80 percent of the consignees are accredited by the AABB and already comply with their standards, including retaining records for 10 years. Taking AABB compliance into account, the final economic analysis includes additional costs of maintaining records for 20 percent of the consignees, a total annual cost of $1.4 million ($34.00 per hour x 40 hours x 4,980 consignees x 20 percent). b. *Variable costs—HCV “lookback.”* The prospective and retrospective provisions of the final rule require a similar set of actions by the consignee, although the amount of time a consignee may take to complete an action varies. The HCV “lookback” provisions of the final rule require that upon notification that a consignee was shipped blood or blood components at increased risk of transmitting HCV infection, the consignee must quarantine all identified in-date unpooled blood components, and make a reasonable effort to notify any recipients of blood components from donors confirmed HCV positive of the increased risk posed by these products. The consignees may notify the recipient's physician of record or notify the recipient directly. If the transfusion recipient is a minor or adjudged incompetent by a State court, the consignees would be required to notify the recipient's legal representative or the recipient's physician of record. Once supplemental test results on quarantined in-date unpooled products are received, the consignee must take the appropriate action indicated by those results (i.e., release from quarantine, destruction, or relabeling of affected blood products). Consignee costs can be separated into product quarantine costs and recipient notification costs. Based on the amount of time required to complete the different actions, the agency estimates that the product quarantine accounts for about 40 percent of the unit cost ($66 = 40 percent x $165) while the recipient notification accounts for the other 60 percent of the unit cost ($99 = 60 percent x $165). Although consignees did not comment on the agency's initial estimate that it would cost $165 to comply with all of the “lookback” provisions for each affected component, Los Angeles County recently reported that a vendor was paid $118 per patient to abstract health records, locate and notify transfusion recipients, and give pretest counseling (Ref. 6). Without other data, for both the prospective and retrospective “lookbacks,” we continue to use $66 as the cost of product quarantine, but increase the cost of recipient notification from $99 to $118, based on the experience of the Los Angeles County. i. *Prospective HCV “lookback.”* According to agency inspectors, FDA-inspected consignees voluntarily follow the agency's draft guidance and currently comply with all requirements of prospective “lookback.” Although we have no data that directly measure the number of “lookbacks” FDA-inspected establishments conduct, we expect the number will be proportional to the number of transfusions given in these establishments. Using data from the American Hospital Association, Healthcare Cost and Utilization Project, and FDA's Center for Biologics Evaluation and Research's registration list, we estimate that FDA-inspected establishments give between 25 percent and 35 percent of all transfusions (Refs. 7 and 8). We assume for this analysis that CMS-inspected establishments account for between 65 percent and 75 percent of all transfusions. Some CMS-inspected establishments currently conduct prospective “lookback;” in the absence of data on the actual number, we assume for this analysis that all CMS-inspected establishments will need to comply with the requirements of prospective “lookback.” This assumption may overstate the actual costs of prospective “lookback” by no more than $120,000 annually. Consignees will quarantine blood components when notified that they received components from a donor who subsequently tested reactive on a screening test for HCV. All other “lookback” actions would be triggered when the consignee receives supplemental test results for the donor. When notified that they received blood components from donors who are confirmed HCV positive with a supplemental test, consignees must attempt to notify recipients of those blood components. The proposed rule would have required consignees make at least three attempts to notify a transfusion recipient. Several comments expressed concern that it would be costly to continue attempts to contact an individual who no longer resides at the last known address in the recipient's medical records. In response to these comments, the final rule removes the prescriptive language concerning the number of notification attempts. Under the final rule, consignees must make a reasonable attempt to contact any affected transfusion recipient within 12 weeks of receipt from the collecting establishment of the donor's supplemental test results indicating evidence of HCV infection, or receipt of the reactive screening test if a supplemental test result is not available. Based on the HCV prevalence levels reported by the American Red Cross for 2000, about 2,400 components could trigger “lookback” (780 donations from HCV-infected donors x 3.1 components per donation) (Ref. 1). The CDC survey found that on average about 85 percent of the at-risk components sent to consignees were transfused (Ref. 3). For the analysis of the proposed rule, we assumed that no patient would receive more than one affected component. This assumption suggests that consignees will quarantine about 2,400 components and attempt about 2,050 recipient notifications (780 HCV positive donors x 3.1 components per donor x 85 percent transfused). Because CMS-inspected consignees account for about 65 percent to 75 percent of the number of transfusions, the annual costs for consignees to conduct the prospective “lookback” actions range from $260,000 to $300,000 [65 percent by CMS-inspected establishments x (2,400 components annually triggering quarantine x $66 per component quarantine + 2,050 components annually triggering recipient notification x $118 per recipient notification) to 75 percent by CMS-inspected establishments x (2,400 components annually triggering quarantine x $66 per component quarantine + 2,050 components annually triggering recipient notification x $118 per recipient notification)]. 4 4 With 10 components, we estimate that consignees attempt from 4,350 to 5,020 recipient notifications at an annual “lookback” cost from $800,000 to $925,000. ii. *Retrospective HCV “lookback.”* Retrospective “lookback” will be triggered when a blood collecting establishment notifies a consignee that a review of historical records for blood donations screened with multi-antigen or single-antigen tests shows that an at-risk blood component may have been sent to the consignee. For consignees that also collect blood, it is likely that these consignees will identify additional at-risk components among their historical donor testing records. Once the consignee becomes aware that it received an at-risk blood component, it must complete the required “lookback” actions within 1 year. From their interim survey findings published in 1999, CDC estimated that 115,228 components screened with multi-antigen tests will trigger retrospective “lookback” by consignees. However, CDC also estimated that consignees had completed 80 percent of retrospective “lookback,” including recipient notification, for these components 5 (Ref. 3). According to unpublished CDC data, an additional 188,448 components from donors screened with the single-antigen tests could trigger “lookback” by consignees. We lack information to estimate the total number of “lookbacks” that will be based on single-antigen tests and thus retain the number of components screened with single-antigen tests (i.e., 188,448 components) used in the analysis of the proposed rule. Adjusting our initial estimate of the number of components screened with multi-antigen tests by 80 percent to account for “lookbacks” completed by 1999, consignees have no more than 212,000 components [188,448 components screened with single-antigen tests + ((100 percent - 80 percent completion rate) x 115,228 components screened with multi-antigen tests)] requiring action. At a total unit cost of $184 ($66 + $118) per component triggering “lookback”, the estimated one-time cost associated with the review of historical testing records is about $39 million (211,494 components x $184 / component). If all retrospective “lookbacks” based on the multi-antigen screening test have been completed, consignees will only incur additional one-time costs of $35 million (188,448 components x $184 / component). 5 This differs from the 105,706 components that CDC estimated for collection establishments because some consignees identified, among their own collections, additional at-risk components that had been screened with multi-antigen tests. Moreover, CDC found that completion rates for retrospective “lookback” based on multi-antigen tests varied for blood collection establishments (i.e., 85 percent completion rate) and consignees (i.e., 80 percent completion rate). c. *Total costs for consignees* . Table 2 of this document shows the costs of the final rule for blood product consignees. Industry will incur up to $1.7 million in annual costs for the prospective “lookback” provisions and to retain records for 10 years, and up to $42 million in one-time costs for SOPs and the retrospective “lookback” based on historical review of records. The annualized costs of the final rule over 10 years at 3 and 7 percent interest rates will be $6.5 and $7.6 million. **Table 2.—Costs of the Final Rule for Consignees (Transfusion Services)** 1 Current Compliance Rate (percent) One-Time Costs ($ million) Annual Costs ($ million) Annualized Costs ($ million) 3 percent 7 percent Review and revise SOPs 0 2.7 0.3 0.4 Retain records for 10 years 80 1.4 1.4 1.4 Prospective “lookback” 25 to 35 0.3 - 0.3 0.3 - 0.3 0.3 - 0.3 Retrospective “lookback” 2 30+ 38.9 4.6 5.5 Total 41.6 1.6 - 1.7 6.5 - 6.5 7.5 - 7.6 1 Numbers may not add due to rounding. 2 This upper bound estimate assumes that at least 30 percent of the retrospective “lookback” has been completed, including 80 percent of the “lookbacks” based on the multi-antigen screening test and no “lookbacks” based on the single antigen screening test. 5. Summary of SOP, Record Retention and “Lookback” Costs Table 3 of this document summarizes the estimated costs of the final rule for blood collection establishments and consignees. The one-time costs for retrospective “lookback” and to revise procedures will be $65.9 million. Because blood collecting establishments have 1 year after the effective date of the final rule to complete their review of historical records and consignees have 1 year after being notified by collecting establishments to complete their recipient notifications, we expect that the one-time costs will be incurred over a 2 year period. Over 10 years, the total annualized costs of these activities will range from $9.3 million to $9.4 million for a 3 percent discount rate and $11.0 million for a 7 percent discount rate. We estimate the testing and treatment costs for transfusion recipients in the benefits section. **Table 3.—SOP, Record Retention and “Lookback” Costs of the Final Rule** 1 One-Time Costs ($ million) Annual Costs ($ million) Annualized Costs ($ million) 3 percent 7 percent Review and revise SOPs 4.1 0.5 0.6 Retain records for 10 years 1.4 1.4 1.4 Prospective “lookback” 0.3 - 0.3 0.3 - 0.3 0.3 - 0.3 Retrospective “lookback” 61.8 7.2 8.8 Total 65.9 1.6 - 1.7 9.3 - 9.4 11.0 - 11.0 1 Numbers may not add due to rounding. B. Benefits of the Final Rule 1. Overview The final rule will help ensure the continued safety of the blood supply. FDA is requiring specific blood safety procedures designed to minimize risk to the blood supply and, in the rare cases that patients receive at-risk blood or blood components, to inform those recipients. Prior to 1990, with no reliable test licensed to screen blood donations for HCV, the risk of transmission from blood transfusion was 1:200 according to CDC. Improvements in test accuracy have reduced these risks dramatically so that current repeat donor screening tests based on nucleic acid amplification technology are associated with a less than a 1:1.6 million risk of transfusion-related transmission of HCV (Ref. 9). Even though transfusion of HCV-infected blood components is no longer one of the primary ways people acquire the infection, HCV can still go undetected in blood collected from donors during the window period before screening tests can detect the presence of the virus. Because 70 to 75 percent of HCV infections are asymptomatic, if recipients of blood products at increased risk of HCV transmission become infected, most would not show any symptoms of the infection for several years and would not know to seek treatment in the early stages of the infection. Once information becomes available that blood from an infected donor may have entered the blood supply, it is medically ethical to inform identified transfusion recipients of their HCV risk. Timely notification of possible HCV infection gives recipients the chance to be tested and, if infected, obtain treatment and counseling, and take preventive measures to avoid transmitting HCV to others. When treatment is initiated early in an infection, the best and most cost effective outcomes are achieved. For example, Bennett and others showed that the years of life gained and cost effectiveness of interferon-alpha2b treatment decreased as the age of the patient increased, from 3.1 years at $500 per year of life extended
(YLE)for 20-year-old patients to 22 days at $62,000 per YLE for 70-year-old patients (Ref. 10). Moreover, because HCV infection may be associated with chronic liver disease, cirrhosis and hepatocellular carcinoma, an informed recipient can take steps to protect his or her liver function, such as decreasing or eliminating alcohol consumption and carefully monitoring the hepatic effects of any prescription or over-the-counter drugs and herbal supplements. Notification will cause some recipients to seek testing and medical advice. Once diagnosed with HCV infection, some people will obtain treatment that would otherwise not have been received in the absence of “lookback.” These treatments lead to the health benefits from this final rule. In what follows, we have estimated these benefits, and the medical and other health-care costs. 2. Estimate of Improved Patient Outcomes: Gains in Quality-Adjusted Life Years Newly identified recipients who test positive for HCV may receive drug therapy for the previously unknown HCV infection. Markov models based on the results of clinical trials suggest that, in many cases, drug therapy will improve patient outcomes, measured as a gain in quality-adjusted life years. 6 However, drug therapy is not recommended for all patients with chronic HCV infection. Most clinical trials exclude up to two-thirds of the patients with an HCV infection (Ref. 11). We expect that newly identified recipients infected with HCV would not differ from HCV-infected individuals in the general population. Therefore, in contrast to the initial estimate, this analysis assumes that only 33 percent of the newly identified recipients would receive drug therapy. 6 A cost-effectiveness model (i.e., Markov model) of a drug therapy begins at a defined health state and follows how a drug therapy affects patient outcomes and lifetime health care costs. Models use transitional probabilities between health states to simulate the timing of patient outcomes. Each health state is assigned a
(1)health care cost per unit of time and
(2)quality of life utility between 0 and 1. The quality-adjusted life years are defined as the number of years that a patient remains in a particular health state, adjusted by the quality of life utility for that health state. Summing the quality-adjusted life years for all health states totals the quality-adjusted life years for a particular drug therapy. The health care costs for a particular health state are the product of the health care costs per unit time and the amount of time the patient remains in the health state. Summing the health care costs for all health states totals the health care costs for a particular drug therapy. The cost per quality-adjusted life year is the total health care costs divided by the number of quality-adjusted life years. Treatment costs and changes in quality-adjusted life years associated with different therapies can be used to compare the cost-effectiveness of different drug therapies for the same condition. For the proposed rule we used the Markov model from Kim and others that predicted a gain of 0.25 quality-adjusted life years with 6 months of interferon monotherapy (Ref. 12). 7 No comments were received on the method we used to estimate the gain in quality-adjusted life years. However, newer studies have found that treatment with interferon and ribavirin yield better outcomes than treatment with interferon alone. Because the Kim model only examines gains from treatment with now-obsolete therapies, our initial analysis predicts lower benefits than would be achieved with current treatment regimes. 7 Kim and others developed a Markov model that compares the long-term outcomes for treatment of HCV between:
(1)No treatment and
(2)treatment with interferon-alpha for 6 months. Beginning with a state of chronic HCV infection, patients may be cured or transition to other health states including compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, orthotopic liver transplantation, and death. Each simulation run includes 4,000 patients, stratified by age (30, 40, 50 and 60 years old). Age cohorts were further divided equally by:
(1)Gender, and
(2)virulence of the infection. Quality of life utilities for each health state were elicited from medical professionals with a generic instrument. Models on the effects of combination therapy predict gains ranging from 0.3 to 2.8 quality-adjusted life years per person treated (Ref. 13). Differences in how models simulate the progression of chronic HCV infection make comparison of published models difficult. For this analysis, we have selected the model by Younossi and others (Ref. 14) because it estimates a disease progression similar to that used by Kim and others (Ref. 12). 8 8 Although the Younossi model simulates long-term outcomes of six drug treatment regimes compared with the no treatment option, for this analysis we only compare the results of:
(1)No treatment, and
(2)combination treatment with interferon and ribavirin following virus genotyping. Similar to the Kim model, the Younossi model begins with chronic HCV infection. Some transitional probabilities differ between the two models, because Younossi and others based their probabilities on different published findings. The Younossi model simulates outcomes for cohorts of identical patients, using a 45-year-old man as the reference patient. Sensitivity analyses using two alternate ages for the reference patient (30 and 60 years of age) had relatively little effect on the outcomes of the model. Similar to Kim's parameter for infection virulence, genotyping of the hepatitis C virus introduces a variation in treatment response into the model. When possible, Younossi and others used quality of life utilities elicited directly from patients using the Health Utility Index Mark III, a multi-attribute health status classification system (Ref. 18). Costs and health states of the model were discounted at 3 percent. Our assumption about the proportion of newly identified recipients who would seek treatment accounts for potential gender differences between the Kim and Younossi models. Moreover, since “lookback” will only identify living recipients, presumably those healthy or young enough to survive the medical condition requiring the transfusion, the Younossi model is likely to be representative of those newly identified recipients with asymptomatic chronic hepatitis C. 3. Costs of Diagnostic Testing a. *Cost of screening tests* . Screening recipients for HCV infection would cost about $49 for the screening test, including $30 for the laboratory test (Ref. 15), and $19 for 15 minutes of a physician's time at hourly wages plus benefits of $77 ($30 + (0.25 hours x $59.04 per hour x 1.3)). Although it is uncertain how much time consumers will lose taking this test, we estimate about 1 hour with an average value of $22.61. b. *Cost of supplemental tests* . Because about 35 percent of reactive screening results are false positives, the cost of the supplemental test will vary depending on whether medical counseling is provided. When a test result is positive, supplemental testing costs about $158, including $81 for the laboratory test (Ref. 15), and about $77 for 1 hour of a physician's time ($81+ (1 hour x $59.04 per hour x 1.3)). With the additional time for counseling, a patient might lose up to 2 hours valued at $45.22 (2 hours x $22.61 per hour). With a negative supplemental test result (i.e., a false positive reactive screening result), medical counseling is unnecessary, reducing the cost to about $100, including $81 for the laboratory test and $19 for 15 minutes of a physician's time ($81 + (0.25 hours x $59.04 per hour x 1.3)). Moreover, patients would lose about 1 hour for a cost of about $22.61. c. *Cost of HCV genotype testing* . Accounting for about 75 percent of all chronic HCV infections, genotype 1 HCV is more difficult to treat than other genotypes and requires a longer course of drugs. Viral genotyping will cost about $486 for the laboratory test. Similar to other diagnostic blood work, patients can lose up to $22.61 for 1 hour of time. d. *Cost of liver biopsy* . A liver biopsy can measure whether an HCV infection has progressed to liver disease. Needle biopsies account for about 95 percent of the diagnostic liver biopsies associated with HCV infection. In about 5 percent of cases, a more invasive procedure such as a wedge biopsy may be required. The needle biopsy costs about $560, including $455 for the facilities and $105 for the physician's time (82 minutes / 60 minutes per hour x $59.04 per hour x 1.3). In addition, patients might lose up to 2.5 hours with a value of $56.50 ($22.61 per hour x 2.5 hours). In contrast to the needle biopsy, the wedge biopsy requires a median stay of 4 days in the hospital and can cost about $10,280, including $9,858 for hospital charges (Ref. 16) and about $422 for a physician to follow-up after the biopsy (5.5 hours x $59.04 per hour x 1.3) (Ref. 17). Moreover, because some mortality risk exists with this procedure, patients and their families may experience anxiety before the surgery. However, we have no data quantifying the value to avoid this anxiety or any pain associated with the biopsy. e. *Summary of testing costs* . Table 4 of this document summarizes the costs of the diagnostic tests used in the benefits analysis. The table also includes the average number of hours that patients lose for each test. **Table 4.—Costs of Diagnostic Tests and Lost Time** 1 Type of Test Laboratory Cost Physician Time (minutes) Cost of Physician Time 2 Lost Patient Time Value of Lost Time 3 Total Cost HCV screening test $30 15 $19 1 hr $23 $72 Supplemental test: Negative results $81 15 $19 1 hr $23 $123 Positive results $81 60 $77 2 hr $45 $203 HCV genotyping $486 0 0 1 hr $23 $509 Liver biopsy: Needle biopsy $455 82 $105 2.5 hr $57 $616 Wedge biopsy $9,858 330 $422 4 days $2,224 4 $12,504 1 Numbers may not sum or multiply due to rounding. 2 Valued at a loaded hourly wage of $76.75 ($59.04 per hour with 30 percent benefits). 3 Valued at $22.61 per hour. 4 This includes the willingness to pay to avoid a 0.03 percent mortality risk, using $5 million as the value of a statistical life. 4. Benefits of Prospective “Lookback” The economic benefit of a public health action normally relates to the risk reduction associated with that action. Because the current risk of transfusion-transmitted HCV infection is already very low (i.e., less than 1:1.6 million), we anticipate that prospective “lookback” will occur infrequently. However, in the rare case when “lookback” is necessary, this action will be relatively cost-effective. To assess the cost-effectiveness of prospective “lookback,” we first estimate the number of transfusion recipients that would be newly identified, then estimate the testing costs associated with “lookback.” a. *The number of HCV positive transfusion recipients identified by “lookback.”* FDA cannot precisely determine the number of HCV positive individuals who could be newly identified by “lookback,” although this analysis suggests that it would vary from one-half dozen to two dozen per year. As discussed in the section on the costs of prospective “lookback” (i.e., section IV.A.4.b.i of this document), about 2,050 affected components may trigger recipient “lookback” each year. Taking into account notifications already being made by FDA-inspected consignees, the final rule will require that consignees attempt from approximately 1,330 (2,050 x 65 percent noncompliance) to 1,540 (2,050 x 75 percent noncompliance) recipient notifications. 9 9 We note that if there are 10 affected components for each donor triggering “lookback,” consignees would attempt from 4,350 to 5,020 recipient notifications and might newly identify from 14 to 59 HCV positive recipients, of which from 4 to 20 could seek treatment and potentially gain from 3 QALYs to 56 QALYs. For the analysis of the proposed rule, we based the probability of finding a newly infected transfusion recipient on the CDC survey findings for recipients transfused within 3 years of the survey (i.e., 1996 to 1999) (Ref. 3). Therefore, using these CDC findings, we estimate that from 568 recipients (1,330 x 48 percent living x 89 percent successfully notified) to 656 recipients (1,540 x 48 percent living x 89 percent successfully notified) will be successfully notified by “lookback.” Once recipients are successfully notified that they received at-risk blood, about 307 (568 recipients x 54 percent tested) to 354 (656 recipients x 54 percent tested) will decide to seek testing to determine if they are infected with HCV. We predict that about 35 percent of the reactive screening tests will have false positive results. As shown in table 5 of this document, the estimated number of negative supplemental test results varies from 107 (307 x 35 percent) to 124 (354 x 35 percent), depending on the current noncompliance rate. Because NAT pooled testing has reduced the risk of transfusion-related HCV infection, the HCV positive rate of recipients notified by “lookback” may be lower than the 10 percent suggested by the CDC survey findings for 1996—1999 (table 2 in Ref. 3). In table 5 of this document, therefore, we present upper and lower bound estimates of the number of individuals that would potentially test HCV positive. As discussed earlier, the CDC survey found that about one-third of the HCV positive recipients will already know about their infection (Ref. 3). Therefore, fewer infected individuals will be newly identified by “lookback” than test positive for HCV. The possible range of newly identified recipients that would be expected from prospective “lookback” each year extends from 6 to 24, depending on the noncompliance rate and the HCV positive rate. **Table 5.—Estimated Annual Number of Diagnostic Tests and Newly Identified Recipients With Prospective “Lookback”** 1 65 Percent CMS-Inspected 75 Percent CMS-Inspected HCV screening tests 307 354 Negative supplemental tests (i.e., false positive screening result) 107 124 HCV Positive Rate 2.7 percent 2 10 percent 3 2.7 percent 2 10 percent 3 Positive supplemental tests 8 31 10 35 Newly identified HCV infected recipients 4 6 21 7 24 1 Recipient estimates are rounded to the nearest integer; numbers may not sum or multiply due to rounding. 2 Derived as the ratio of the “window” period and the inter-donation period. For this example we assume a 10-day window period with NAT screening and a 365-day median inter-donation interval (0.027 = 10/365). 3 Based on the CDC survey findings that 10 percent of the newly identified blood recipients transfused in 1996-1999, were confirmed HCV antibody-positive with the third generation serological tests (see table 2 in Ref. 3). 4 Sixty-eight percent of the recipients that test HCV positive do not already know about their infection. b. *Testing costs of prospective “lookback.”* Even though some individuals contacted by “lookback” will already know about their HCV positive status, for this analysis we assume that all recipients successfully contacted will receive diagnostic testing. Because Younossi and others found negative incremental treatment costs (i.e., a lifetime cost savings over the no treatment option), we exclude all treatment costs from this analysis (Ref. 14). Table 6 of this document summarizes the total testing costs of prospective “lookback” for all recipients. **Table 6.—Total Costs of Testing and Lost Patient Time of Prospective “Lookback”** 1,2 65 Percent CMS-Inspected 75 Percent CMS-Inspected HCV screening tests $22,049 $25,442 Negative supplemental tests (i.e., false positive screening result) $13,199 $15,230 HCV Positive Rate 2.7 percent 10 percent 2.7 percent 10 percent Positive supplemental tests $1,708 $6,233 $1,970 $7,192 Total testing costs $36,956 $41,482 $42,642 $47,864 1 Numbers may not sum due to rounding. 2 Derived from tables 4 and 5 of this document. c. *Cost-effectiveness of prospective “lookback.”* Because the costs of “lookback” and the number of newly identified infected recipients are essentially proportional, the cost-effectiveness of recipient notification does not vary with changes in the number of prospective “lookbacks.” Total annual “lookback” and testing costs for the prospective “lookback” range from $300,000 to $350,000 (see sections IV.A.4.b.i and IV.B.4.b) of this document), depending on the proportion of CMS-inspected consignees already performing prospective “lookback” (i.e., 65 to 75 percent). As shown in table 7 of this document, the cost per newly identified transfusion recipient infected with HCV ranges from about $14,400, if the HCV positive rate is 10 percent and to about $51,900, if the HCV positive rate is 2.7 percent. We note again that these cost-effectiveness ratios hold regardless of the number of donations from repeat donors that trigger prospective “lookback.” **Table 7.—Cost-Effectiveness of Recipient Notification for Prospective “Lookback”** 1 65 Percent CMS-Inspected 75 Percent CMS-Inspected HCV Positive Rate 2.7 percent 10 percent 2.7 percent 10 percent Costs of Testing & Lost Patient Time $36,956 $41,482 $42,642 $47,864 “Lookback” costs $260,006 $260,006 $300,007 $300,007 Total costs $296,963 $301,488 $342,649 $347,871 Newly identified HCV infected recipients 2 6 21 7 24 Cost per newly identified recipient 3 $51,897 $14,435 $51,897 $14,435 1 Numbers may not sum or multiply due to rounding. 2 Recipient estimates are rounded to the nearest integer. 3 Calculated with the non-rounded number of newly identified recipients (i.e., 5.7, 20.9, 6.6, and 24.1). 5. Benefits of Retrospective “Lookback” Because the one-time retrospective “lookback” has the potential to newly identify thousands of infected transfusion recipients, the key benefit of “lookback” is the health improvement that newly identified individuals would enjoy as a result of timely treatment. We estimate this benefit by looking first at the number of newly identified recipients chronically infected with the hepatitis C virus. Using the published Younossi model of disease progression, we then estimate the number of quality-adjusted life years that each person could gain from interferon and ribavirin treatment of their HCV infection. Then we estimate the value that society might place on this health improvement. Next we quantify the potential costs of diagnostic testing and treatment. Finally we report the cost-effectiveness of this one-time public health initiative. a. *The number of HCV positive transfusion recipients identified by “lookback.”* For the analysis of the proposed rule, we estimated that about 2 percent (30 percent living x 74 percent successfully notified x 51 percent tested x 25 percent positive for HCV x 68 percent unknown infection) of the 258,125 recipient notifications 10 performed under retrospective “lookback” (i.e., about 5,000 recipients) would newly identify individuals who test positive for the hepatitis C virus. As discussed previously, consignees completed at least 80 percent of the retrospective “lookback” based on multi-antigen screening by 1999. Subtracting the recipient notifications that have been completed (i.e., 80 percent), table 8 of this document shows the potential number of HCV-positive recipients that retrospective “lookback” might newly identify, and the corresponding number of diagnostic tests that might be performed. 10 “Lookback” actions for consignees include product quarantine and recipient notification. Based on their interim survey findings, CDC estimated that only about 85 percent of the components received by consignees are transfused. Based on this CDC data, consignees will perform product quarantine for about 269,100 components and perform about 258,100 recipient notifications. **Table 8.—Estimated One-Time Number of Diagnostic Tests and Newly Identified Recipients With Retrospective “Lookback”** 1 Multi-Antigen Screening Results 2 Single-Antigen Screening Results 3 Total HCV screening tests 2,353 17,819 20,172 Negative supplemental tests (i.e., false positive screening result) 4 824 6,237 7,060 Positive supplemental tests 447 5,168 5,615 Newly identified HCV-positive recipients 5 304 3,514 3,818 1 Recipient estimates are rounded to the nearest integer; numbers may not sum or multiply due to rounding. 2 Adjusting the number of components triggering “lookback” based on multi-antigen tests (i.e., 115,228 components) by the transfusion rate (i.e., 85 percent transfused) and the completion rate (80 percent of completed), consignees will attempt about 19,674 transfusion recipient notifications. Estimates were derived using the findings in table 3 of Ref. 3: 31 percent would be living, 78 percent would be successfully notified, 50 percent would be tested, and a 19 percent HCV positive rate. 3 Adjusting the number of components triggering “lookback” based on single-antigen tests (i.e., 188,448) by the transfusion rate (i.e., 85 percent transfused), consignees will attempt about 160,879 transfusion recipient notifications. Estimates were derived using the findings in table 2 for transfusions in 1988-1989 of Ref. 3: 30 percent would be living, 72 percent would be successfully notified, 52 percent would be tested, 29 percent HCV positive rate. 4 Based on 35 percent false positive rate for screening tests. 5 Based on CDC survey findings that 68 percent of the HCV positive recipients did not already know about their infection. b. *Number of Quality-Adjusted Life Years gained* . Benefits of the retrospective “lookback” come from treating post-transfusion hepatitis C virus infections, and in doing so, delaying or reducing adverse health outcomes from illnesses that would be caused by untreated hepatitis C virus infections. We use a quality-adjusted life year as the measure of this gain in health outcomes and estimate the number of quality-adjusted life years that newly identified infected recipients can gain from treatment of their chronic HCV infections. Adjusting for the 75 percent chronic infection rate, about 2,865 chronically infected recipients would be newly identified by retrospective “lookback” (3,818 newly identified recipients x 75 percent chronic infection rate). As noted previously, to estimate the gain in quality-adjusted life years, we selected the Markov model of Younossi and others (Ref. 14). Their findings predict that patients receiving combination therapy with standard interferon could gain 2.8 quality-adjusted life years, compared with receiving no treatment for the infection. For this analysis, we assume that newly identified transfusion recipients are similar to the general population in terms of genotype of the hepatitis C virus (i.e., 75 percent are infected by genotype 1 HCV) and suitability for treatment (33 percent of HCV positive individuals would receive drug therapy). Accounting for these factors, an estimated 945 individuals (2,864 patients x 33 percent treated) would gain 2,640 quality-adjusted life years (2.79 quality-adjusted life years/patient x 945 patients). c. *The societal value of “lookback”.* The preferred measure of the value of the benefit of retrospective “lookback” is the average willingness to pay to reduce the probability of adverse health outcomes from untreated post-transfusion HCV infections. Such measures are not readily available for most illnesses, including those caused by hepatitis C virus infection. In the absence of the direct measures recommended in the literature (Ref. 18), we assign a monetary value to a quality-adjusted life year as a proxy for willingness to pay. We recognize, however, that there is no unique, accepted societal monetary value for a quality-adjusted life year gained, and some economists are skeptical that this measure of public health improvement is even sufficiently consistent with consumer preferences to permit systematic estimates of its monetary value. To reflect the uncertainty about the value of a quality-adjusted life year, FDA uses a range of dollar amounts. As a lower bound, FDA uses $100,000 per quality-adjusted life year, an amount similar to that used by Cutler and Richardson (Ref. 19). We derive other values for a quality-adjusted life year from estimates of the value of a statistical life. A number of empirical studies indicate a societal willingness to pay from $1.6 million to $11.6 million to avoid a statistical death. Although there is not necessarily a direct link between the willingness to pay to reduce the probability of a particular illness (or set of symptoms) and the willingness to pay to reduce the probability of death, the value of a statistical life—the sum of individual willingness to pay to avoid small risks of premature death that together add up to one expected life saved—bounds the value of a quality-adjusted life year, which is used in this analysis as a proxy for the sum of individual willingness to pay to avoid small risks of being undiagnosed as HCV positive and suffering additional morbidity impacts. Current estimates of the value of a statistical life run from $1 million to $11 million (Ref. 20). In recent regulatory analyses, we have used values of $5 million and $6.5 million, which fall within that range. Because the Younossi model was developed with a 3 percent discount rate, we use this discount rate to estimate the value of a statistical life year. Annualizing $6.5 million over 35 years at 3 percent implies a value of $300,000 for an additional statistical life year and to develop an upper bound, annualizing $10 million over 35 years at 3 percent discount rates implies a value of $465,000 for an additional statistical life year. 11 We therefore calculate estimated benefits from this final rule with three possible values of a quality-adjusted life year: $100,000, $300,000 and $465,000. This range of values is consistent with a reasonable interpretation of studies of willingness to pay to reduce mortality risks (Ref. 20). 11 We could, however, generate these same two values with many different combinations of values of a statistical life, discount rates, and years. At $100,000 per quality-adjusted life year gained, the retrospective “lookback” would yield one-time benefits to society of $264 million (2,640 quality-adjusted life years x $100,000 per quality-adjusted life year). At $300,000 per quality-adjusted life year gained, the retrospective “lookback” would yield one-time benefits to society of $792 million (2,640 quality-adjusted life years x $300,000 per quality-adjusted life year). At $465,000 per quality-adjusted life year gained, the retrospective “lookback” would yield one-time benefits to society of $1,228 million (2,640 quality-adjusted life years x $465,000 per quality-adjusted life year). d. *Testing costs of retrospective “lookback.”* Table 9 of this document summarizes the potential diagnostic testing costs associated with retrospective “lookback.” Diagnostic costs are based on the number of newly identified recipients with a hepatitis C virus infection, the related testing frequencies, and the unit costs for diagnostic tests and lost time for patients. As noted previously, we selected the Markov model of Younossi and others for our analysis (Ref. 14). Because Younossi's simulation begins after a patient has received a liver biopsy and uses HCV genotype to determine the duration of therapy, we also estimate these costs. All recipients infected with the hepatitis C virus would receive genotyping, however, only those infected with the genotype 1 virus (i.e., 75 percent) would undergo a liver biopsy. We exclude all treatment costs from this analysis because Younossi and others found negative incremental treatment costs (i.e., a lifetime cost savings over the no treatment option) (Ref. 14). **Table 9.—Total Costs of Diagnostic Testing and Lost Patient Time of Retrospective “Lookback”** 1 Type Diagnostic Tests Cost of Diagnostic Tests 2 ($ mil) HCV screening tests 3 1.4 Negative supplemental tests (i.e., false positive screening result) 3 0.9 Positive supplemental tests 3 1.1 Hepatitis C virus genotype tests 4 1.5 Liver biopsy 5 2.6 Total 7.5 1 Numbers may not sum or multiply due to rounding. 2 Unit costs for diagnostic tests are from table 4 of this document. 3 Number of diagnostic tests are from table 8 of this document. 4 We assume that seventy-five percent of the recipients with positive supplemental tests are chronically infected with the hepatitis C virus and have HCV genotype testing. 5 The prevalence rate for hepatitis C virus genotype 1 is approximately 75 percent; ninety-five percent of recipients infected with genotype 1 have a needle biopsy, and 5 percent of recipients infected with genotype 1 have a wedge biopsy. e. *Cost-effectiveness of retrospective “lookback.”* The cost-effectiveness of retrospective “lookback” can be expressed as the cost per newly identified transfusion recipient or as the cost per quality-adjusted life year gained. Compliance with the retrospective “lookback” will cost about $61.8 million (see table 3 of this document). Accounting for these compliance costs and the screening and supplemental test costs in table 9 of this document, the one-time retrospective “lookback” will cost about $17,100 per newly identified HCV positive person (($1.4 million screening tests + $0.9 million negative supplemental tests + $1.1 million positive supplemental tests + $61.8 million compliance costs) / 3,818 recipients). Including all testing costs, the retrospective “lookback” provisions of the final rule would cost approximately $69.4 million ($61.8 million “lookback” costs + $7.5 million total testing costs) with a cost-effectiveness of $26,300 per quality-adjusted life year gained ($69.4 million/2,640 quality-adjusted life years). Younossi's article reports an incremental treatment cost savings, but we do not have sufficient information to include these savings in the cost per quality-adjusted life year (Ref. 14) and therefore ignore all treatment costs in our analysis. To the extent that we exclude these cost savings, the cost-effectiveness ratio is overstated. 6. Summary of Benefits and Costs of the Final Rule Recent public reviews of blood supply issues have recognized the importance of ensuring safety. Although the current risk of transfusion-transmitted HCV infection is already very low (i.e., less than 1:1.6 million), one-time retrospective “lookback” has the potential to newly identify thousands of infected transfusion recipients. In contrast, because we anticipate that prospective “lookback” will occur infrequently, in most years, between 0 and 5 newly identified recipients might seek treatment and benefit from a gain in quality-adjusted life years. The size of this gain is so small, however, that it is captured in the rounding for the retrospective “lookback” analysis. Therefore, we exclude these gains from this analysis of the final rule and quantify only the benefits of gains in quality-adjusted life years from the retrospective “lookback.” The final rule can be expected to gain a one-time total of 2,640 quality-adjusted life years with an estimated discounted value that ranges from $264 million to $1,228 million. As presented in table 10, over 10 years the annualized net benefits of all provisions of the final rule, including direct and diagnostic costs for both retrospective “lookback” and prospective “lookback,” will range from about $20.6 million ($31.0 million annualized benefits-$10.3 million annualized costs) to $133.6 million ($143.9 million annualized benefits-$10.3 million annualized costs). For all provisions of the final rule, the present value of all costs equals $87.6 million and is the sum of
(1)The one-time “lookback” costs ($65.9 million) and one-time diagnostic costs ($7.5 million) for the retrospective “lookback”, and
(2)the present value of the annual direct and diagnostic costs for the prospective “lookback” over 10 years at a 3 percent discount rate ($13.8 million in direct costs + $0.4 million in diagnostic costs). The cost-effectiveness of the entire final rule equals $33,200 per quality-adjusted life year ($87.6 million / 2,640 quality-adjusted life years) as shown in table 10. **Table 10.—Summary of Net Benefits and Cost Per QALY** 1 Annualized Costs 2 : Prospective and Retrospective “Lookback” $9.4 Testing and Lost Patient Time $0.9 Total Annualized Costs $10.3 Low value of QALY Medium value of QALY High value of QALY Annualized Benefits 3 : Value of QALYs gained $31.0 $92.9 $143.9 Total Annualized Net Benefits $20.6 $82.5 $133.6 Cost-Effectiveness: Present Value of Total Costs 4 $87.6 Number of QALYs gained 5 2,640 Cost per QALY ($) $33,200 1 Some numbers are rounded. Unless noted, all dollar amounts are $ million. Costs and benefits annualized over 10 years at 3 percent discount rate. 2 Includes costs to comply with all provisions of the final rule, all costs associated with the gain in QALYs from the retrospective “lookback,” and the costs of screening and confirmatory tests to newly identify HCV positive recipients with prospective “lookback.” 3 Includes only quantifiable benefits of retrospective “lookback.” QALYs are valued at $100,000, $300,000 and $465,000. 4 Includes one-time costs and the present value of annual costs over 10 years at 3 percent. 5 Because so few individuals would be newly identified from prospective “lookback,” the summary benefits equal the gains through retrospective “lookback.” Note that prospective effects, should they exist, unambiguously increase benefits but the size of this gain would be so small that it is captured in the rounding for the retrospective “lookback” analysis. 7. Alternatives Considered for HCV “Lookback” FDA finds that the targeted “lookback” approach is the most effective alternative when evaluated in terms of ethical, cost, and effectiveness criteria. The following provides a discussion of the baseline for the analysis and the alternatives that have been considered. a. *Baseline: No regulatory action* . FDA has already issued an industry guidance concerning HCV “lookback.” Because FDA can only recommend a process and timeframe with a guidance, with no means of enforcing it, some establishments might decide not to perform “lookback” or to adopt a more extended timeframe to perform the “lookback” based on the review of historical testing records to spread the costs of this effort. Such delay, however, would increase each recipient's risk of serious disease complications. b. *Alternative: Use of general “lookback.”* General “lookback” is an alternative approach that has the potential to reach all patients who received transfusions during the period covered by “lookback.” The cost and ultimate effectiveness of general “lookback” would vary depending on the program structure and the risk message. Because general “lookback” would not be based on identification of at-risk donations, the risk message would communicate the average risk of HCV infection from a blood transfusion. To be effective, the risk message should reach those recipients who would have been contacted by targeted “lookback” and motivate them to seek testing, but not to unnecessarily alarm and burden the majority of recipients who would never be contacted by targeted “lookback” and who face an extremely low risk of being infected by HCV from a transfusion. Compared with targeted “lookback,” general “lookback” programs shift costs from blood collection establishments and consignees to:
(1)The entity conducting the general “lookback” program; and
(2)recipients, health-care providers and payers. No nationwide general “lookback” campaign has been conducted in the United States, although some limited programs have been initiated. For example, a CDC Web site offers educational materials about hepatitis C ( *www.cdc.gov/hepatitis* ). In 1999, CDC pilot-tested an HCV general “lookback” with public service announcement posters in the public transit systems of two cities, and also distributed an audio- and videotaped general “lookback” message by the surgeon general to radio and television stations in 2000. The effectiveness of these programs is unknown. In the United States, few articles have been published on the outcomes of general “lookback” programs. Although several general and targeted “lookback” programs have been conducted in Canada, there has been no standardization of outcomes or cost estimates in that country. The authors of an article reviewing general “lookback” programs in Canada concluded that without standardized data, it is impossible to compare the cost-effectiveness of Canadian targeted and general “lookback” programs (Ref. 21). Moreover, it is uncertain whether the Canadian experience would be comparable to what would happen in the United States. Nevertheless, in Canada, general “lookback” programs missed some recipients that were identified by targeted “lookback.” For example, a Canadian hospital had completed a general letter “lookback” for HCV when the Canadian Red Cross Society began targeted “lookback” in 1995. By April of 1998, at least 13 new seropositive recipients had been identified by targeted “lookback” who were missed by general “lookback” (Ref. 22). As a result, targeted “lookback” raised the number of HCV-positive recipients tested at that hospital by at least 9 percent over general “lookback.” In 2000, the Alaska Native Medical Center—a hospital providing services to Alaska Natives—began a general “lookback” program to contact adults and children who had received transfusions between January 1980 and July 1992 (Ref. 23). Patients identified by the record review were sent letters notifying them of their transfusion history and encouraged them to seek testing for HCV infection. In a study of that program, the study's authors estimate that the entire program cost $129,000, a total that includes $56 for each patient notification. They note that a similar program in a private sector health care setting would cost substantially more than their results suggest. Another general “lookback” program conducted in Alaska notified patients who had received transfusions in a neonatal intensive care unit between January 1975 and July 1992. These patients may have been unaware of the previous transfusion event. As a regional referral center located in Anchorage, the neonatal intensive care unit provided care for patients from the Alaska Native Medical Center (i.e., integrated health-care setting) and for patients of private sector health-care providers. Results of general “lookback” varied significantly between the two health-care settings, with a higher percentage of patients identified and screened in the integrated health care setting than in the private sector setting (Ref. 24). As shown in table 11 of this document, 63 percent of the patients in the integrated health-care setting sought testing for hepatitis C virus infection, compared with 17 percent of the patients in the private sector health-care setting. This difference illustrates the uncertainty about the yield of a general “lookback” program in the United States. Characteristics of each health-care setting might explain some of the differences in yields between health-care settings. For example, patient records in the integrated health-care setting contain the results of hepatitis C tests. In contrast, private sector patients had to report the results of their hepatitis C tests on an anonymous questionnaire. With the results of the two Alaskan programs we provide a rough estimate of the potential costs and outcomes of a nationwide general “lookback” program for patients who received transfusions between 1988 and mid-1992 (i.e., a similar timeframe to the retrospective targeted “lookback” based on single-antigen tests). Published data suggests that about 15.2 million patients received red blood cell or whole blood transfusions during this period (Refs. 25, 26, and 27). We apply the transitional probabilities from the two Alaskan “lookback” programs, shown in table 11 of this document, to the total number of patients transfused, to estimate the number of patients that might be identified at each stage of the general “lookback” program. With this information, we estimate a type of general “lookback” program similar to the recipient notification programs conducted in Canada and calculate an estimate of the total potential “lookback” and diagnostic costs. **Table 11.—Yields of Three “Lookback” Programs** 1 Percentage of Patients from the Prior Stage of “Lookback” (number of patients) Published Results of General “Lookback” Programs Integrated Health Care Setting 2 Private Sector Health Care Setting 3 Targeted “Lookback” 4 Transfused 100% (3,169) 100% (1,396) 100% (160,879) Sent notice 38% (1,213) 27%
(374)21% (34,267) Notified who were screened 63%
(764)17%
(64)52% (17,819) Screened who tested HCV+ 2%
(19)2%
(1)29% (5,168) 1 Numbers may not sum or multiply due to rounding. 2 Based on the results from Ref. 23. 3 Based on the results from Ref. 24. 4 Based on the CDC interim survey results for transfusions from 1988 to 1989 (Ref. 3). Comparing the yield of a nationwide general “lookback” program in a private sector health care setting to the yield of a nationwide general “lookback” program in an integrated health care setting gives us a range of potential outcomes for a general “lookback” program for recipients who received transfusions between 1988 and mid-1992. It should be noted that the Alaskan programs include some recipients who received blood transfusions prior to 1988, before blood donations were routinely screened for HCV. In addition, applying the transitional probabilities from the Alaskan programs to recipients transfused between 1988 and mid-1992, when the risk of transfusion-related HCV infection was falling, overestimates the potential yield of general “lookback.” A general “lookback” program with recipient notification requires far more resources than targeted “lookback.” As shown in Table 12 of this document our analysis suggests that a general transfusion recipient notification program could cost more than $500 million and newly identify between 3,600 and 30,000 recipients of tranfusions who are infected with the hepatitis C virus and who choose to receive treatment. However, these results should be interpreted with caution. CDC estimated that about 300,000 people might have been infected by blood transfusions in the 20 years prior to donor screening for HCV (Ref. 3). Our analysis suggests that general “lookback” might newly identify from 1.2 percent to 10 percent of those people who were infected with HCV from a blood transfusion even though we only include transfusion recipients between 1988 and mid-1992. However, in the United States, about 3.9 million people are infected with the hepatitis C virus (Ref. 28). Because general “lookback” contacts more persons than targeted “lookback,” the program might identify persons who were infected with the hepatitis C virus by other routes than transfusions. Thus, general “lookback” is likely to generate benefits not directly related to at-risk transfusions. “Lookback” programs can take many forms and target different at-risk populations. General “lookback” activities, such as those tested by CDC, can play an important role in efforts to reach the population at risk due to parental drug use or other risk behaviors not involving blood transfusion (Ref. 3). We have considered an Alaskan-type general “lookback” here as a potential alternative to a targeted “lookback.” If further evidence or analysis shows that the yield of the Alaskan-type program is representative of the potential yield of a nationwide general “lookback” program, then a general “lookback” program might be a cost-effective public health initiative to complement a targeted “lookback” and notify a subset of transfusion recipients who might be missed by the targeted “lookback” (e.g. patients who received transfusions before blood donations were screened for HCV; patients who were transfused as infants but who are unaware of the transfusion event and who respond only after receiving the second “lookback” notification). To understand the potential yield of a general “lookback” that complements targeted “lookback,” we use the numbers shown in table 12 to adjust our estimate of the total costs and number of quality-adjusted life years gained. This approach assumes that the targeted “lookback” program is completed before the general “lookback” program begins. We also assume that all of the infected persons identified by the targeted “lookback” would be included within the set of infected persons identified by general “lookback” programs. To adjust the yields, we subtract the diagnostic costs and quality-adjusted life years gained from targeted “lookback” from the diagnostic costs and quality-adjusted life years gained from general “lookback.” The adjusted total costs for a general recipient notification “lookback” that complements the targeted “lookback” range from $487.3 million (= $494.1 million - $6.8 million) to $735.1 million (= $741.9 million - $6.8 million), and the adjusted gain in quality-adjusted life years range from 7,567 quality-adjusted life years (= 9,992 quality-adjusted life years - 2,425 quality-adjusted life years) to 81,205 quality-adjusted life years (= 83,630 quality-adjusted life years - 2,425 quality-adjusted life years). Thus, the potential cost per quality-adjusted life year for a general “lookback” program that complements targeted “lookback” range from $9,050 to $64,400. We therefore conclude that the targeted “lookback” analyzed here is the preferred alternative for this final rule, but an Alaskan-type general “lookback” could be a cost-effective HCV policy. c. *Final: Use of targeted “lookback.”* The “lookback” provisions of the final rule can be characterized as a targeted “lookback” program, meaning that the notification of infection risk is limited to, or targeted at, individuals identified as recipients of blood from donors subsequently found to be infected with HCV. Targeted “lookback” requires that the transfusion service be aware that the donor subsequently tested positive, donor and product disposition records be available to link blood components with the identified donors, and the physician or transfusion service know the recipient's current whereabouts. Blood consignees would locate recipient records for all transfused units from an affected donor, and send out notifications to the most recent address. Ideally, the recipient will still be alive and be able to receive testing and treatment, if appropriate. Despite the difficulties of implementing targeted “lookback,” FDA concludes that this alternative remains the most reliable means of reaching people at increased risk of HCV infection from a transfusion. However, in response to comments on the proposed rule, some of the more prescriptive language was moved from the codified section to the accompanying guidance for industry. Therefore, the final rule lists the objective actions required of industry, and the timeframe in which they must be taken to give individual establishments the flexibility to accomplish these actions in the most cost effective manner. d. *Limited comparison of regulatory alternatives* . The purpose of this final rule is to contact recipients who received transfusions of blood or blood components that were at risk of transmitting the hepatitis C virus. Table 12 of this document presents a comparison of the retrospective targeted “lookback” based on single-antigen tests and possible general “lookback” programs for recipients of transfusions between 1988 and mid-1992. The two general “lookback” estimates illustrate the uncertainty of general “lookback” and the likelihood that this program would identify people who were infected by other routes than transfusion events. The cost-effectiveness of the targeted “lookback” program falls in between the cost-effectiveness of the two general programs. The estimated effectiveness of targeted “lookback” is less uncertain than the estimated effectiveness of general “lookback”, and is therefore more likely to achieve the goals of this final rule. **Table 12.—Comparison of the Targeted “Lookback” Program Based on Single-Antigen Screening Tests and Two General “Lookback” Programs for Recipients Who Received Transfusions Between 1988 and mid-1992** 1 Targeted “Lookback” for donations screened with single antigen test Estimate of a Nationwide General “Lookback” Program for Recipients Transfused Between 1988 and mid-1992 Private sector health care setting Integrated health care setting Number of patients transfused 160,879 15.2 million 15.2 million Number of “lookback” notifications 34,267 4,058,811 5,798,974 Number of screening tests 17,819 694,556 3,652,446 Number of supplemental tests 11,405 10,852 181,666 Number of HCV+ patients 5,168 10,852 90,833 Number of HCV+ patients treated 869 3,581 29,975 “Lookback” costs ($ mil) $55.9 2 $426.2 3 $324.7 4 Diagnostic costs 5 ($ mil) $6.8 $67.9 $417.2 Total costs ($ mil) $62.7 $494.1 $741.9 Number of QALYs gained 2,425 9,992 83,630 Cost per QALY gained ($) $25,862 6 $49,449 $8,871 *Incremental cost per QALY gained between targeted and the upper and lower bounds of general “lookback”* — *$57,011* *$8,364* 1 Unless noted, all dollar amounts are $ million. 2 “Lookback” costs of $113 for blood collection establishments and $184 for transfusion establishments. 3 “Lookback” costs of $105 based on Ref. 24. 4 “Lookback” costs of $56 based on Ref. 23. 5 Unit costs for diagnostic tests are shown in table 4 of this document. 6 For this example, we report the cost-effectiveness of the retrospective “lookback” based on single-antigen tests. This differs from the cost-effectiveness of the entire retrospective “lookback” reported in section 6.e. of this document. C. Impact on Small Entities No comments were received on the initial regulatory flexibility analysis or the agency's request for specific information essential to estimate the final rule's impact on small entities. Because information on the affected industries is limited, the agency cannot predict the extent of the economic impact of the final rule on small entities and, therefore, performed a final regulatory flexibility analysis. The final rule will help ensure the continued safety of the blood supply and will help ensure that consignees and recipients who received blood and blood components at increased risk of transmitting HCV are informed. Affected entities include commercial plasma centers, community and hospital blood banks, and hospital transfusion services that collect or receive blood and blood components. For the regulatory flexibility analysis affected firms are considered small if they are:
(1)A for-profit firm with annual receipts or revenue less than the current Small Business Administration
(SBA)industry size standards;
(2)an independently owned and operated, not-for-profit enterprise which is not dominant in its field; or
(3)operated by a small governmental jurisdiction with a population of less than 50,000 individuals. Aggregate information about hospitals and blood banks are available under SIC (Standard Industrial Classification) group 80 for health services. However, the North American Industry Classification System (NAICS) reports information at the blood and organ banks level. Similarly, more detailed general medical and surgical hospital information is available with NAICS than with the SIC system. To estimate the economic impact of the final rule on these different types of small entities, the costs per firm shown in table 13 of this document are expressed as a percentage of average annual revenue in tables 14, 15, and 16 of this document. **Table 13.—Estimated Per Firm Regulatory Costs by Type of Small Entity** 1 Type of Small Entity Share of “Lookback” Costs Annual Costs 2 One-Time Costs 3 Total Annualized Costs 3 percent 7 percent Plasma collection N/A — $1,350 $160 $190 Blood collection 0.04% — $10,210 $1,200 $1,450 For-profit hospital 0.02% $1,410 $7,370 $2,270 $2,460 Not-for-profit hospital 0.02% $1,410 $7,060 $2,240 $2,420 Government hospital 0.00% $1,370 $1,420 $1,540 $1,570 1 Numbers may not add due to rounding. 2 Although 80 percent of hospitals already retain records for 10 years, this analysis assumes small hospitals are not in compliance with this provision of the final rule. Blood collection establishments currently comply with these provisions of the final rule. 3 Includes one-time cost for SOPs and historical “lookback” actions. In the United States, most plasma establishments are owned by large, for-profit companies, whereas almost all blood collection establishments are not-for-profit organizations. The SBA size standards in effect since December 6, 2005, define as small any blood and organ bank (NAICS 621991) with an annual income of less than $9 million. Although the 1997 Economic Census lists 449 blood and organ banks (including plasma collection establishments) owned by 173 for-profit firms and 721 blood and organ banks owned by 300 not-for-profit firms (NAICS 621991), this data has limited use because it includes organ banks, excludes any blood collection establishment operating as part of a hospital, and uses different receipt sizes than the SBA. FDA estimates the final rule will affect 60 commercial plasma collection establishments and 981 blood collection establishments. The FDA registry of blood establishments does not provide an indication of the size of the registered entities. However, previously the agency estimated that 37 small plasma establishments collect approximately 8 percent of the plasma and 906 small blood banks collect 35 percent of the donated blood (66 FR 31146 at 31159). Each affected establishment will incur the one-time cost to revise SOPs. Blood and plasma collection establishments have had procedures in place for HIV “lookback” for years. Thus, no additional skills are required because each establishment has existing personnel experienced in preparation of SOPs and the establishment would update existing SOPs by including HCV into the “lookback” procedures. Using 1997 Economic Census data on for-profit firms included in NAICS 621991, table 14 of this document illustrates that the annualized costs of the SOPs will be less than 0.5 percent of average receipts for all small plasma entities, illustrating that the average impact of the final rule will not be significant for small plasma entities. **Table 14.—One-Time and Annualized Costs of the Final Rule on For-Profit Plasma Centers Operating All Year** 1 Receipts Size of Firm 1 Number of Firms 1 Receipts 1 ($1,000) Average Receipt per Firm 1 ($1,000) Per Firm One-Time Costs as Percent of Average Receipts 2 Per Firm Annualized Costs as Percent of Average Receipts 2 3 percent 7 percent < $100,000 28 1,714 61.2 2.2% 0.3% 0.3% $100,000 to $249,999 21 3,257 155.1 0.9% 0.1% 0.1% $250,000 to $499,999 16 5,737 358.6 0.4% 0.0% 0.1% $500,000 to $999,999 30 21,626 720.9 0.2% 0.0% 0.0% $1,000,000 to $2,499,999 37 56,837 1,536.1 0.1% 0.0% 0.0% $2,500,000 to $4,999,999 16 55,677 3,479.8 0.0% 0.0% 0.0% $5,000,000 to $9,999,999 5 37,124 7,424.8 0.0% 0.0% 0.0% $10,000,000 + 20 804,559 NA NA NA Total 173 986,531 1 Source: U.S. Department of Commerce, Economics and Statistics Administration, U.S. Census Bureau, “1997 Economic Census, Health Care and Social Assistance, Subject Series: Establishment and Firm Size,” EC97S62S-SZ, October 2000, table 4a, NAICS 621991 (blood and organ banks). 2 Per firm costs from table 13 of this document. In addition to the cost of revising SOPs, the one-time costs of the retrospective “lookback” will be proportional to the volume of blood collected by blood establishments. Therefore, small entities collecting few donations will incur the lowest “lookback” costs. Because 906 small entities collect about 35 percent of the blood, the proportion of “lookback” costs for each entity will be small. For example, if blood donations are distributed evenly among small blood collection establishments, each small organization would incur only 0.04 percent (0.04 percent = 35 percent / 906) of the “lookback” costs and collect approximately 5,400 donations each year (5,408 donations / establishment = 14 million donations x 35 percent / 906 establishments). Using $96 as the price for a unit of red blood cells, small blood collection establishments average a minimum annual revenue of approximately $520,000 (Ref. 29). Table 15 of this document summarizes the one-time and annualized costs of the final rule as a percentage of this minimum average revenue for small blood collection organizations. **Table 15.—One-Time and Annualized Costs of the Final Rule on Not-For-Profit Blood Collection Organizations** Number of Small Organizations Average Annual Revenue 1 Per Firm One-Time Costs as Percent of Average Revenue 2 Per Firm Annualized Costs as Percent of Average Revenue 2 3 percent 7 percent 906 $519,200 2.0% 0.2% 0.3% 1 5,370 units x $96/unit of red blood cells = $515,520. A unit of whole blood can be separated into non-red blood cell components that yield additional revenues in excess of $135. 2 Per firm costs from table 13 of this document. An estimated 4,980 hospitals perform transfusion services in the United States. The SBA defines as small any general medical and surgical hospital (NAICS 622110) with annual receipts less than $31.5 million. Similar to blood banks, the census uses receipt sizes that differ from those of the SBA. Therefore, in this analysis, for-profit hospitals with annual receipts less than $25 million are treated as small businesses. Furthermore, not-for-profit, non-government hospitals that have no more than one establishment are treated as small organizations. Similarly, the number of government hospitals (NAICS 6221101) classified as single-unit firms, or firms with one establishment, provides an estimate of the number of small government hospitals. This approach most likely overestimates the number of hospitals operated by small government jurisdictions, because many urban county hospitals (i.e., with populations greater than 50,000) may have only one establishment. In contrast to blood banks, the 1997 Economic Census reports data separately on 774 for-profit hospitals (NAICS 622110), 1,571 government hospitals (NAICS 6221101), and 3,076 non-government, not-for-profit hospitals (NAICS 6221102). Each hospital transfusion service will incur the cost of preparing SOPs and 20 percent will spend more to retain records an additional 5 years. Hospitals have experience preparing SOPs and have already been performing an historical “lookback” under an agency guidance to industry. Thus compliance with the final rule requires no new skills. Similar to blood banks, “lookback” costs are proportional to transfusion volume. Unlike blood banks, however, data from several sources provides sufficient information to distribute transfusion volume to different types of small entities. National statistics from the Healthcare Cost and Utilization Project
(HCUP)on in-hospital blood transfusions in 1997 (i.e., clinical classifications software procedure category 222) give a reasonable estimate of the volume of blood transfused by hospitals categorized by ownership (i.e., government; private, not-for-profit; and private, for-profit) (Ref. 8). Furthermore, HCUP provides data on the number of transfusions by ownership category and bed size. In 1997, HCUP defined bed size category based on location and teaching status of the hospital. Thus small bed size refers to the following:
(1)1 to 49 beds for rural hospitals;
(2)1 to 99 beds for urban, non-teaching hospitals; and
(3)1 to 299 beds for urban, teaching hospitals. However, most teaching hospitals are affiliated with public or private, not-for-profit colleges or universities which would be considered organizations. Using the HCUP definition, small for-profit hospitals are assumed to have no more than 99 beds. Data from a 1998 American Hospital Association
(AHA)survey on hospitals in the United States shows that hospitals with less than 100 beds had average revenues of $27.7 million or less (Ref. 7). The HCUP data on the number of transfusions given in small, for-profit hospitals is used, therefore, to estimate the share of total transfusion for small businesses. In contrast, small not-for-profit or government hospitals may not necessarily be classified as small based on HCUP bed size. Thus for these small entities, revenue shares calculated from the 1997 Economic Census data serve as proxies for transfusion volume. Table 16 of this document shows the average one-time and annual costs incurred by small hospitals as a percentage of annual receipts or revenue. In all cases, one-time costs are less than one percent of average revenue or receipts and annualized costs are less than 0.2 percent of average revenue or receipts. Therefore, the final rule does not have a significant economic impact on these small entities. **Table 16.—Hospital Industry One-Time and Annual Costs as a Percentage of Average Annual Revenue by Size and Type of Firm** 1,2 Receipt Size of Firm Number of Firms Receipts ($1,000) Average Receipt Per Firm ($1,000) Per Firm One-Time Costs as Percent of Average Receipts Per Firm Annualized Costs as Percent of Average Receipts 3 percent 7 percent For-Profit Hospitals Operating All Year: 3 $0 to $999,999 0 $1,000,000 to $2,499,999 6 9,737 1,622.8 0.5% 0.1% 0.2% $2,500,000 to $4,999,999 21 73,777 3,513.2 0.2% 0.1% 0.1% $5,000,000 to $9,999,999 43 316,631 7,363.5 0.1% 0.0% 0.0% $10,000,000 to $24,999,999 38 630,189 16,583.9 0.0% 0.0% 0.0% $25,000,000 + 66 NA NA NA Total 174 33,782,805 Size Category (share of total revenue) Number of Firms Revenue ($1,000) Average Revenue Per Firm ($1,000) Per Firm One-Time Costs as Percent of Average Revenue Per Firm Annualized Costs as Percent of Average Revenue 3 percent 7 percent Not-For-Profit Hospitals Operating All Year: 4 Single-unit firm (14%) 918 44,832,121 48,836.7 0.0% 0.0% 0.0% One establishment (23%) 813 74,651,556 91,822.3 0.0% 0.0% 0.0% Total 2,034 242,896,322 Government Hospitals Operating All Year: 5 Single-unit firm (7%) 994 23,175,491 23,315.4 0.0% 0.0% 0.0% One establishment (14%) 515 43,739,763 84,931.6 0.0% 0.0% 0.0% Total 1,537 77,024,061 1 Source: U.S. Department of Commerce, Economics and Statistics Administration, U.S. Census Bureau, “1997 Economic Census, Health Care and Social Assistance, Subject Series: Establishment and Firm Size,” EC97S62S-SZ, October 2000. 2 Per firm costs from table 13 of this document. 3 1997 Economic Census, table 4a, NAICS 622110. Based on 1997 HCUP data, small private for-profit hospitals account for approximately 2 percent of the annual transfusion volume (1.8% = 23,182 / 1,296,723). 4 1997 Economic Census, table 3b, NAICS 6221102. HCUP data shows private, not-for-profit hospitals account for 71% of all transfusions (= 924,730 / 1,296,723). According to 1997 Economic Census data, hospitals with less than two establishments account for 37% of total revenues for all private, not-for-profit hospitals. Therefore small, private, not-for-profit hospitals will incur about 27% (27% = 71% x 37%) of the consignee “lookback” costs. Costs as a percent of revenue less than 0.05 percent are rounded to 0.0 percent. 5 1997 Economic Census, table 3b, NAICS 6221101, HCUP data shows government hospitals account for 15% of all transfusions (= 193,679 / 1,296,723). According to 1997 Economic Census data, government hospitals with less than two establishments account for 21% of total revenues for all government hospitals. Therefore, small government hospitals will incur about 3% (3% = 15% x 21%) of the consignee “lookback” costs. Costs as a percent of revenue less than 0.05 percent are rounded to 0.0 percent. As described earlier, FDA has considered several alternatives, and considers that a targeted “lookback” will be the most effective approach to inform recipients of HCV-infected blood products. Because “lookback” costs are proportional to blood collection or transfusion volume, the smallest entities will incur the lowest costs. Furthermore, the agency allows for flexibility in an establishment's individual approach to compliance by moving the prescriptive language of the proposed rule to an industry guidance document and specifying only the objective actions required by an establishment in the final rule. This will enable each entity to develop procedures that are most appropriate and cost-effective given the particular situation and the resources available. In addition, the agency has specified a limited time frame for notification to provide a clear endpoint to facilitate efforts related to the historical “lookback.” The agency concludes that this final rule will ensure the safety of the blood supply and meet public health goals in the least intrusive and most cost-effective way. Therefore, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. V. The Paperwork Reduction Act of 1995 This final rule contains information collection provisions that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). A description of these provisions, with an estimate of the annual reporting and recordkeeping burden, follows. Included in the estimate is the time for reviewing the instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. *Title* : Current Good Manufacturing Practices for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”). *Description* : This final rule requires collecting establishments and consignees to prepare and follow written procedures when a donor who tests reactive for evidence of HIV or HCV infection either on a repeat donation or after a review of historical testing records (recordkeeping burden in § 606.100(b)(19)). Such collections may be at increased risk of transmitting HIV or HCV infection. We are requiring collecting establishments to review testing records, to quarantine prior in-date blood and blood components from such a donor, to perform further testing on the donor, and to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes (reporting burden in §§ 610.46(a)(1)(ii)(B), 610.47(a)(1)(ii)(B), and 610.48(b)(3)(ii) and (b)(3)(iii)) and to notify consignees of further testing results (reporting burden in §§ 610.46(a)(3), 610.47(a)(3), and 610.48(b)(4)). We also are requiring consignees to notify transfusion recipients, the recipients' physicians of record, or the recipients' legal representatives that the recipient received blood and blood components at increased risk of transmitting HIV or HCV (reporting burden in §§ 610.46(b)(3), 610.47(b)(3), and 610.48(c)(3)). Records of these actions must be kept (recordkeeping burden in § 606.160(b)(1)(viii)). We also are extending record retention under § 606.160(d) from 5 to 10 years. *Description of Respondents* : Collecting establishments (business and not-for-profit) and consignees of collecting establishments, including hospitals, transfusion services, and physicians. As required by section 3506(c)(2)(B) of the PRA, we provided an opportunity for public comment on the information collection requirements of the HCV “lookback” proposed rule (65 FR 69378). In accordance with the PRA, OMB reserved approval of the information collection burden in the proposed rule, stating it will make an assessment in light of public comments received on the proposed rule. No comments on the information collection requirements were submitted to OMB or the docket. The total reporting and recordkeeping burden for the first year is estimated to be 495,309.5 hours. However, of this total approximately 456,280 hours would be expended on a one-time basis for establishing the written procedures and doing the one-time retrospective review of historical HCV testing records. Therefore, 39,029.5 hours is estimated as the ongoing annual burden related to these regulations. The total ongoing annual burden for collecting establishments under §§ 610.46(a)(1)(ii)(B), 610.46(a)(3), 610.46(b)(3), and 606.160(b)(1)(viii) for HIV “lookback” is estimated to be 12,763 hours. The total ongoing annual burden for collecting establishments under §§ 610.47(a)(1)(ii)(B), 610.47(a)(3), 610.47(b)(3), and 606.160(b)(1)(viii) for HCV “lookback” is estimated to be 26,266.5 hours. Based on information retrieved from FDA's registration database and as discussed in section IV of this document, there are approximately 1,041 FDA registered establishments (60 licensed plasma establishments and 981 registered collecting establishments) in the United States that collect approximately 27 million donations annually: 13 million donations of Source Plasma and 14 million donations of Whole Blood, including approximately 695,000 autologous units. As calculated in section IV of this document, there are approximately 11.2 million donations of Whole Blood from repeat donors per year. As previously discussed in section IV.A.3.b of this document, the Source Plasma industry will only be minimally affected by these requirements. Therefore, we are only estimating burden for Source Plasma collecting establishments in regards to § 606.100(b)(19). The following reporting and recordkeeping estimates are based on information provided by industry and FDA experience. A. Annual Reporting Burden 1. HIV Reporting Burden In table 17 of this document, we estimate that approximately 3,500 repeat donors will test reactive on a screening test for HIV. We estimate that an average of three components were made from each donation. Under § 610.46(a)(1)(ii)(B) and 610.46(a)(3), this estimate results in 10,500 (3,500 x 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 10,500 (3,500 x 3) notifications to consignees of subsequent test results. We estimate an average of 10 minutes per notification of consignees. The estimate for consignee notifications in the final rule is higher than the estimate in the proposed rule because we based our calculations in the final rule on the number of components at risk of transmitting HCV infection rather than the number of reactive donors. We also have increased the number of components per donation from two to three. In addition, we estimate that § 610.46(b)(3) will require 4,980 consignees to notify transfusion recipients or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors x 3) notifications. In the proposed rule, we estimated 0.5 hours as the average time for a reasonable attempt to notify recipients by consignees. However, under § 610.46(b)(3), we are increasing the estimate to 1 hour to accommodate the time to gather test results and the recipient's records and to accommodate multiple attempts to contact the recipient. 2. HCV Reporting Burden We estimate that approximately 7,800 repeat donors per year would test reactive for antibody to HCV (780 repeat donors confirmed HCV positive / 0.1 rate for repeat donors confirmed HCV positive / repeat donors with reactive tests = 7,800 repeat donors with reactive tests). Under §§ 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would notify the consignee two times for each of the 23,400 (7,800 x 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 46,800 notifications as an annual ongoing burden. Under § 610.47(b)(3), we estimate that approximately 4,980 consignees would notify approximately 2,050 recipients (calculated in section IV.A.4.b.i of this document) or their physicians of record annually. The estimated average 1 hour to complete notification is based on the criteria discussed in the previous section on HIV Reporting Burden. B. Estimated One-Time Reporting Burden Based on estimates from CDC, we expect that for the one-time retrospective review of historical testing records, as many as approximately 212,000 blood components (calculated in section IV.A.4.b.ii of this document) would be at increased risk for transmitting HCV. For each of these products, under §§ 610.48(b)(3)(ii) and (b)(3)(iii), and 610.48(b)(4) collecting establishments would notify consignees to quarantine these products and report additional HCV test results to consignees, and, under § 610.48(c)(3), consignees would notify transfusion recipients or recipients' physicians of record. CDC estimated that there could be approximately 212,000 transfusion recipients that would be notified after a one-time retrospective review of historical test results for HCV screening. The numbers in the “Hours per Response” column of table 18 of this document are the same as the burden for table 7 of this document. C. Estimated Annual and One-Time Recordkeeping Burden In the recordkeeping tables (tables 19 and 20 of this document), the numbers in the “Hours per Record” column are based on our estimate of the time to complete one record. We also estimate that each documentation of consignee and recipient notification takes approximately 5 minutes. In table 20 of this document, we estimate that it will take collecting establishments approximately 40 hours to establish the written procedures required under § 606.100(b)(19) and consignees approximately 16 hours to establish written procedures under § 606.100(b)(19). In table 19 of this document, the estimate for annual recordkeeping is based on the estimate that it takes approximately 10 minutes to document and maintain the records to relate the donor with the unit number of each previous donation for both the collecting establishment and the consignee. The time required for recordkeeping under § 606.160(b)(1)(viii) is estimated to be approximately 10 minutes for each HIV or HCV reactive donation record and approximately 10 minutes per transfusion recipient record required under §§ 610.46(b)(3), 610.47(b)(3), and 610.48(c)(3). Because the final rule will not affect current industry practice of retaining “lookback” records for 10 years, no burden is calculated for § 606.160(d). We estimate the burden for this collection of information as follows: **Table 17.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 610.46(a)(1)(ii)(B) 981 10.7 10,500 0.17 1,785 610.46(a)(3) 981 10.7 10,500 0.17 1,785 610.46(b)(3) 4,980 0.35 1,755 1.0 1,755 610.47(a)(1)(ii)(B) 981 23.85 23,400 0.17 3,978 610.47(a)(3) 981 23.85 23,400 0.17 3,978 610.47(b)(3) 4,980 0.41 42,050 1.0 2,050 Total 15,331 1 There are no capital or operating and maintenance costs associated with this collection of information. **Table 18.—Estimated One-Time Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 610.48(b)(3)(ii) and (b)(3)(iii) 981 216.1 212,000 0.17 36,040 610.48(b)(4) 981 216.1 212,000 0.17 36,040 610.48(c)(3) 4,980 42.57 212,000 1.0 212,000 Total 284,080 1 There are no capital or operating and maintenance costs associated with this collection of information. **Table 19.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 606.160(b)(1)(viii) HIV consignee notification 981 21.4 21,000 .17 3,570 4,980 4.2 21,000 .17 3,570 HCV consignee notification 981 47.71 46,800 .17 7,956 4,980 9.4 46,800 .17 7,956 HIV recipient notification 4,980 0.35 1,755 .17 298 HCV recipient notification 4,980 0.41 2,050 .17 348.5 Total 23,698.5 1 There are no capital or operating and maintenance costs associated with this collection of information. **Table 20.—Estimated One-Time Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 606.100(b)(19) 1,041 1 1,041 40 41,640 606.100(b)(19) 4,980 1 4,980 16 79,680 606.160(b)(1)(viii) 1,041 203.65 212,000 .08 16,960 606.160(b)(1)(viii) 4,980 42.57 212,000 .08 16,960 610.48(c)(3) 4,980 42.57 212,000 .08 16,960 Total 172,200 1 There are no capital or operating and maintenance costs associated with this collection of information. The information collection provisions of this final rule have been submitted to OMB for review. Before the final rule becomes effective, we will publish a notice in the **Federal Register** announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. VI. Environmental Impact The agency has determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required. VII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required. VIII. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the **Federal Register** .) 1. U.S. Department of Health and Human Services, Transcript of DHHS Advisory Committee on Blood Safety and Availability, “The Economics of Blood and Where Blood Fits in the Overall Cost of Healthcare,” p. 78, May 2, 2003, *http://www.hhs.gov/bloodsafety/transcripts/0502bloo.pdf* . 2. Dodd, R.Y., S.L. Stramer, J. Aberle-Grasse, and E. Notari, “Risk of Hepatitis and Retroviral Infections Among Blood Donors and Introduction of Nucleic Acid Testing (NAT),” Advances in Transfusion Safety, International Symposium: Proceedings, *Developments in Biologicals* , 102:19-27, 1999. 3. Culver, D.H., M.J. Alter, R.J. Mullan, and H.S. Margolis. 2000. “Evaluation of the Effectiveness of Targeted Lookback for HCV Infection in the United States-Interim Results,” *Transfusion* , 40:1176-81. 4. U.S. Department of Labor, Bureau of Labor Statistics, “Table 20. Private Industry Workers, Health Services, by Occupational Group: Employer Costs per Hour Worked for Employee Compensation and Costs as a Percent of Total Compensation, 1994-2001,” p. 176, *ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ecechist.pdf* . 5. U.S. Department of Labor, Bureau of Labor Statistics, “Table 13. Private Industry Workers, Service-Producing Industries, by Occupational Group: Employer Costs per Hour Worked for Employee Compensation and Costs as a Percent of Total Compensation, 1988-2001,” p. 112, *ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ecechist.pdf* . 6. Saxena, S, et al., “Retrospective Targeted HCV Lookback Using Centralized Contracted Notification Service,” *Transfusion* , 43:799-806, 2003. 7. American Hospital Association, Healthcare InfoSource, Inc., *Hospital Statistics* , Chicago, IL, 1998. 8. U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, “HCUPnet, Healthcare Cost and Utilization Project, 1997 National Statistics.” 9. Stramer, S.L., “US NAT yield: Where Are We After 2 Years?” *Transfusion Medicine* , 12:243-53, 2002. 10. Bennett, W.G., Y. Inoue, J.R. Beck, et al., “Estimates of the Cost-Effectiveness of a Single Course of Interferon-alpha-2b in Patients with Histologically Mild Chronic Hepatitis C,” *Annals of Internal Medicine* , 127:855-65, November 15, 1997. 11. Strader, D.B., “Understudied Populations with Hepatitis C,” *Hepatology* , 36:S226-36, 2002. 12. Kim, W.R., J.J. Poterucha, J.E. Hermans, et al., “Cost-Effectiveness of 6 and 12 Months of Interferon-alpha Therapy for Chronic Hepatitis C,” *Annals of Internal Medicine* , 127:866-74, November 15, 1997. 13. Salomon, J.A., M.C. Weinstein, J.K. Hammitt and S.J. Goldie, “Cost-effectiveness of Treatment for Chronic Hepatitis C Infection in an Evolving Patient Population,” *Journal of the American Medical Association* , 290:228-37, July 9, 2003. 14. Younossi, Z.M., M. E. Singer, J.G. McHutchison and K.M. Shermock, “Cost Effectiveness of Interferon a2b Combined with Ribavirin for the Treatment of Chronic Hepatitis C,” *Hepatology* , 30:1318-24, 1999. 15. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, “Clinical Laboratory Fee Schedule for CY2003.” 16. U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, “HCUPnet, Healthcare Cost and Utilization Project, 2001 National Statistics—Cross-Classifying Diagnoses or Procedures.” 17. U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, “2003 Medicare Physician Fee Schedule (MPFS).” 18. Institute of Medicine, 2006, *Valuing Health for Regulatory Cost-Effectiveness Analysis* , Washington, DC: National Academies Press. 19. Cutler, David M. and Elizabeth Richardson, 1997, “Measuring the Health of the U.S. Population,” *Brookings Papers on Economic Activity, Microeconomics* : 217-271. 20. Viscusi, W. Kip and Joseph E. Aldy, 2003, “The Value of a Statistical Life: A Critical Review of Market Estimates throughout the World,” *Journal of Risk and Uncertainty* , 27: 5-76. 21. Bowker, S.L., L.J. Smith, R.J. Rosychuk and J.K. Preiksaitis, 2004, “A Review of General Hepatitis C Virus Lookbacks in Canada,” *Vox Sanguinis* , 86: 21-7. 22. Goldman, Mindy, Sylvia Juodvalkis, Peter Gill and Gwendoline Spurll, 1998, “Hepatitis C Lookback,” *Transfusion Medicine Reviews* , 12: 84-93. 23. Williams, James L., Henry H. Cagle, Carol J. Christensen, Leslie K. Fox-Leyva and Brian J. McMahon. 2005. “Results of a Hepatitis C General Transfusion Lookback Program for Patients Who Received Blood Products Before July 1992,” *Transfusion* , 45: 1020-6. 24. Cagle, Henry H., Jack Jacob, Chriss E. Homan, James L. Williams, Carol J. Christensen and Brian J. McMahon, 2007, “Results of a General Hepatitis C Lookback Program for Persons Who Received Blood Transfusions in a Neonatal Intensive Care Unit Between January 1975 and July 1992,” *Archives of Pediatric and Adolescent Medicine* , 161: 125-30. 25. Surgenor, Douglas M., Edward L. Wallace, Steven H.S. Hao, and Richard H. Chapman, 1990, “Collection and Transfusion of Blood in the United States, 1982-1988,” *The New England Journal of Medicine* , 322: 1646-51. 26. Wallace, E.L., D.M. Surgenor, H.S. Hao, R.H. Chapman and W.H. Churchill. 1993. “Collection and Transfusion of Blood and Blood Components in the United States, 1989,” *Transfusion* , 33: 139-44. 27. Wallace, E.L., W.H. Churchill, D.M. Surgenor, J. An, G. Cho, S. McGurk and L. Murphy. 1995. “Collection and Transfusion of Blood and Blood Components in the United States, 1992,” *Transfusion* , 35: 802-12. 28. Alter, M.J., D. Kruszon-Moran, O.V. Nainan, G.M. McQuillan, F. Gao, L.A. Moyer, R.A. Kaslow and H.S. Margolis, 1999, “The Prevalence of Hepatitis C Virus Infection in the United States, 1988 Through 1994,” *The New England Journal of Medicine* , 341(8): 556-62. 29. America's Blood Centers, “Financial Impact of Technologies to Improve Blood Safety-Charts 1 and 2,” October 19, 2001. Lists of Subjects 21 CFR Part 606 Blood, Labeling, Laboratories, Reporting and recordkeeping requirements. 21 CFR Part 610 Biologics, Labeling, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 606 and 610 are amended as follows: PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS 1. The authority citation for 21 CFR part 606 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. Section 606.100 is amended by revising paragraph (b)(19) to read as follows: § 606.100 Standard operating procedures.
(b)* * *
(19)Procedures under §§ 610.46, 610.47, and 610.48 of this chapter:
(i)To identify previously donated blood and blood components from a donor who later tests reactive for evidence of human immunodeficiency virus
(HIV)infection or hepatitis C virus
(HCV)infection when tested under § 610.40 of this chapter, or when a blood establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection;
(ii)To quarantine in-date blood and blood components previously donated by such a donor that are intended for use in another person or further manufacture into injectable products, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(iii)To notify consignees to quarantine in-date blood and blood components previously donated by such a donor intended for use in another person or for further manufacture into injectable products, except pooled components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(iv)To determine the suitability for release, destruction, or relabeling of quarantined in-date blood and blood components;
(v)To notify consignees of the results of the HIV or HCV testing performed on the donors of such blood and blood components;
(vi)To notify the transfusion recipient, the recipient's physician of record, or the recipient's legal representative that the recipient received blood or blood components at increased risk of transmitting HIV or HCV, respectively. 3. Section 606.160 is amended by revising paragraph (b)(1)(viii) and the second sentence of paragraph
(d)to read as follows: § 606.160 Records.
(b)* * *
(1)* * *
(viii)Records concerning the following activities performed under §§ 610.46, 610.47, and 610.48 of this chapter: Quarantine; consignee notification; testing; notification of a transfusion recipient, the recipient's physician of record, or the recipient's legal representative; and disposition.
(d)* * * You must retain individual product records no less than 10 years after the records of processing are completed or 6 months after the latest expiration date for the individual product, whichever is the later date. * * * PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS 4. The authority citation for 21 CFR part 610 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264. 5. Section 610.41 is amended by adding paragraph
(c)to read as follows: § 610.41 Donor deferral.
(c)You must comply with the requirements under §§ 610.46 and 610.47 when a donor tests reactive by a screening test for HIV or HCV required under § 610.40(a) and (b), or when you are aware of other reliable test results or information indicating evidence of HIV or HCV infection. 6. Section 610.46 is revised to read as follows: § 610.46 Human immunodeficiency virus
(HIV)“lookback” requirements.
(a)If you are an establishment that collects Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions:
(1)Within 3 calendar days after a donor tests reactive for evidence of human immunodeficiency virus
(HIV)infection when tested under § 610.40(a) and
(b)or when you are made aware of other reliable test results or information indicating evidence of HIV infection, you must review all records required under § 606.160(d) of this chapter, to identify blood and blood components previously donated by such a donor. For those identified blood and blood components collected:
(i)Twelve months and less before the donor's most recent nonreactive screening tests, or
(ii)Twelve months and less before the donor's reactive direct viral detection test, e.g., nucleic acid test or HIV p24 antigen test, and nonreactive antibody screening test, whichever is the lesser period, you must:
(A)Quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures; and
(B)Notify consignees to quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(2)You must perform a supplemental (additional, more specific) test for HIV as required under § 610.40(e) of this chapter on the reactive donation.
(3)You must notify consignees of the supplemental (additional, more specific) test results for HIV, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application
(IND)or investigational device exemption (IDE), is exempted for such use by FDA, within 45 calendar days after the donor tests reactive for evidence of HIV infection under § 610.40(a) and
(b)of this chapter. Notification of consignees must include the test results for blood and blood components identified under paragraph (a)(1) of this section that were previously collected from donors who later test reactive for evidence of HIV infection.
(4)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components, consistent with the results of the supplemental (additional, more specific) test performed under paragraph (a)(2) of this section or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, exempted for such use by FDA.
(b)If you are a consignee of Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions:
(1)You must quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures, when notified by the collecting establishment.
(2)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components consistent with the results of the supplemental (additional, more specific) test performed under paragraph (a)(2) of this section, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA.
(3)When the supplemental (additional, more specific) test for HIV is positive or when the screening test is reactive and there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE is exempted for such use by FDA, you must notify transfusion recipients of previous collections of blood and blood components at increased risk of transmitting HIV infection, or the recipient's physician of record, of the need for recipient HIV testing and counseling. You must notify the recipient's physician of record or a legal representative or relative if the recipient is a minor, deceased, adjudged incompetent by a State court, or, if the recipient is competent but State law permits a legal representative or relative to receive information on behalf of the recipient. You must make reasonable attempts to perform the notification within 12 weeks after receiving the supplemental (additional, more specific) test results for evidence of HIV infection from the collecting establishment, or after receiving the donor's reactive screening test result for HIV if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE is exempted for such use by FDA.
(c)Actions under this section do not constitute a recall as defined in § 7.3 of this chapter. 7. Section 610.47 is revised to read as follows: § 610.47 Hepatitis C virus
(HCV)“lookback” requirements.
(a)If you are an establishment that collects Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions:
(1)Within 3 calendar days after a donor tests reactive for evidence of hepatitis C virus
(HCV)infection when tested under § 610.40(a) and
(b)of this chapter or when you are made aware of other reliable test results or information indicating evidence of HCV infection, you must review all records required under § 606.160(d) of this chapter, to identify blood and blood components previously donated by such a donor. For those identified blood and blood components collected:
(i)Twelve months and less before the donor's most recent nonreactive screening tests, or
(ii)Twelve months and less before the donor's reactive direct viral detection test, e.g., nucleic acid test and nonreactive antibody screening test, whichever is the lesser period, you must:
(A)Quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures; and
(B)Notify consignees to quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures;
(2)You must perform a supplemental (additional, more specific) test for HCV as required under § 610.40(e) on the reactive donation.
(3)You must notify consignees of the supplemental (additional, more specific) test results for HCV, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application
(IND)or investigational device exemption (IDE), is exempted for such use by FDA, within 45 calendar days after the donor tests reactive for evidence of HCV infection under § 610.40(a) and (b). Notification of consignees must include the test results for blood and blood components identified under paragraph (a)(1) of this section that were previously collected from donors who later test reactive for evidence of HCV infection.
(4)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components consistent with the results of the supplemental (additional, more specific) test performed under paragraph (a)(2) of this section, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, exempted for such use by FDA.
(b)If you are a consignee of Whole Blood or blood components, including Source Plasma or Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions:
(1)You must quarantine all previously collected in-date blood and blood components identified under paragraph (a)(1) of this section, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures, when notified by the collecting establishment.
(2)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components, consistent with the results of the supplemental (additional, more specific) test performed under paragraph (a)(2) of this section, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA.
(3)When the supplemental (additional, more specific) test for HCV is positive or when the screening test is reactive and there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA, you must notify transfusion recipients of previous collections of blood and blood components at increased risk of transmitting HCV infection, or the recipient's physician of record, of the need for recipient HCV testing and counseling. You must notify the recipient's physician of record or a legal representative or relative if the recipient is a minor, adjudged incompetent by a State court, or if the recipient is competent but State law permits a legal representative or relative to receive information on behalf of the recipient. You must make reasonable attempts to perform the notification within 12 weeks after receiving the supplemental (additional, more specific) test results for evidence of HCV infection from the collecting establishment, or after receiving the donor's reactive screening test result for HCV if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA.
(c)Actions under this section do not constitute a recall as defined in § 7.3 of this chapter. 8. Section 610.48 is added to subpart E to read as follows: § 610.48 Hepatitis C virus
(HCV)“lookback” requirements based on review of historical testing records.
(a)Establishments that collect Whole Blood or blood components, including Source Plasma and Source Leukocytes, must complete the following actions by February 19, 2009.
(b)If you are an establishment that collects Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions:
(1)You must:
(i)Review all records of donor testing for hepatitis C virus
(HCV)performed before February 20, 2008. The review must include records dating back indefinitely for computerized electronic records, and to January 1, 1988, for all other records. Record review, quarantine, testing, notification, and disposition performed before February 20, 2008 that otherwise satisfy the requirements under § 610.47, are exempt from this section.
(ii)Identify donors who tested reactive for evidence of HCV infection. Donors who tested reactive by a screening test and negative by an appropriate supplemental (additional, more specific) test under § 610.40(e) for evidence of HCV infection on the same donation are not subject to further action.
(iii)Identify the blood and blood components previously collected from such donors:
(A)Twelve months and less before the donor's most recent nonreactive screening tests, or
(B)Twelve months and less before the donor's reactive direct viral detection test, e.g., nucleic acid test and nonreactive antibody screening test, whichever is the lesser period.
(2)If you did not perform a supplemental (additional, more specific) test at the time of the reactive donation, you may perform a supplemental test or a licensed screening test with known greater sensitivity than the test of record using either a frozen sample from the same reactive donation or a fresh sample from the same donor, if obtainable. If neither is available, proceed with paragraphs (b)(3), (b)(4), and (b)(5) of this section.
(3)You must, within 3 calendar days after identifying the blood and blood components previously collected from donors who tested reactive for evidence of HCV infection:
(i)Quarantine all previously collected in-date blood and blood components identified under paragraph (b)(1)(iii) of this section if intended for use in another person or for further manufacture into injectable products, except pooled components solely intended for further manufacturing into products that are manufactured using validated viral clearance procedures.
(ii)Notify consignees to quarantine all previously collected in-date blood and blood components identified under paragraph (b)(1)(iii) of this section if intended for use in another person or for further manufacture into injectable products, except pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures; and
(iii)Notify consignees of the donor's test results, including the results of a supplemental (additional, more specific) test or a licensed screening test with known greater sensitivity than the test of record, if available at that time.
(4)You must notify consignees of the results of the supplemental (additional, more specific) test or the licensed screening test with known greater sensitivity than the test of record for HCV, if performed, within 45 calendar days of completing the further testing. Notification of consignees must include the test results for blood and blood components identified under paragraph (b)(1)(iii) of this section that were previously collected from a donor who later tests reactive for evidence of HCV infection.
(5)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components consistent with the results of the further testing performed under paragraph (b)(2) of this section or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application
(IND)or investigational device exemption (IDE), is exempted for such use by FDA.
(c)If you are a consignee of Whole Blood or blood components, including Source Plasma and Source Leukocytes, you must establish, maintain, and follow an appropriate system for the following actions, which you must complete within 1 year of the date of notification by the collecting establishment:
(1)You must quarantine all previously collected in-date blood and blood components identified under paragraph (b)(1)(iii) of this section, except pooled blood components solely intended for further manufacturing into products that are manufactured using validated viral clearance procedures, when notified by the collecting establishment.
(2)You must release from quarantine, destroy, or relabel quarantined in-date blood and blood components, consistent with the results of the further testing performed under paragraph (b)(2) of this section, or the results of the reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE is exempted for such use by FDA.
(3)When the supplemental (additional, more specific) test for HCV is positive; or the supplemental test is indeterminate, but the supplemental test is known to be less sensitive than the screening test; or the screening test is reactive and there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA; or if supplemental testing is not performed, you must make reasonable attempts to notify transfusion recipients of previous collections of blood and blood components at increased risk of transmitting HCV infection, or the recipient's physician of record, of the need for recipient HCV testing and counseling. You must notify the recipient's physician of record or a legal representative or relative if the recipient is a minor, adjudged incompetent by a State court, or if the recipient is competent but State law permits a legal representative or relative to receive information on behalf of the recipient.
(d)Actions under this section do not constitute a recall as defined in § 7.3 of this chapter.
(e)This section will expire on August 24, 2015. Dated: July 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-16607 Filed 8-23-07; 8:45 am] BILLING CODE 4160-01-S 72 164 Friday, August 24, 2007 Notices Part IV Department of Housing and Urban Development Additional Common Waivers Granted to and Alternative Requirements for CDBG Disaster Recovery Grantees Under Public Laws 109-148 and 109-234; Notice DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5089-N-05] Additional Common Waivers Granted to and Alternative Requirements for CDBG Disaster Recovery Grantees Under Public Laws 109-148 and 109-234 AGENCY: Office of the Secretary, HUD. ACTION: Notice of waivers and alternative requirements. SUMMARY: As described in the Supplementary Information section of this Notice, HUD is authorized by statute to waive statutory and regulatory requirements and specify alternative requirements for disaster recovery grants, upon the request of the state grantee(s). This Notice describes the additional waivers for the disaster recovery grants made to the States of Alabama, Florida, Louisiana, Mississippi, and Texas (the States), which are the Community Development Block Grant Program
(CDBG)disaster recovery grantees under the subject appropriations acts. DATES: *Effective Date:* August 29, 2007. FOR FURTHER INFORMATION CONTACT: Jessie Handforth Kome, Director, Disaster Recovery and Special Issues Division, Office of Block Grant Assistance, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7286, Washington, DC 20410, telephone number
(202)708-3587. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at
(800)877-8339. FAX inquiries may be sent to Ms. Kome at
(202)401-2044. (Except for the “800” number, these telephone numbers are not toll-free.) SUPPLEMENTARY INFORMATION: Authority To Grant Waivers The first federal Fiscal Year
(FY)2006 supplemental appropriation for the CDBG program was the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006 (Pub. L. 109-148, approved December 30, 2005). The second 2006 supplemental appropriation was Chapter 9 of Title II of the Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and Hurricane Recovery, 2006 (Pub. L. 109-234, approved June 15, 2006), which appropriates $5.2 billion in CDBG funds for necessary expenses related to disaster relief, long-term recovery, and restoration of infrastructure directly related to the consequences of the covered disasters. These 2006 Acts (collectively “the supplemental Acts”) authorize the Secretary to waive, or specify alternative requirements for, any provision of any statute or regulation that the Secretary administers in connection with the obligation by the Secretary or use by the recipient of these funds or guarantees, except for requirements related to fair housing, nondiscrimination, labor standards, and the environment, upon a request by a state and a finding by the Secretary that such a waiver would not be inconsistent with the overall purpose of the statute. The waiver authorizations differ in that while Public Law 109-148 directs that the Secretary “shall” make the waivers in response to a state's request and a consistency finding; Public Law 109-234 states that the Secretary “may” make such waivers. The following waivers and alternative requirements for funds provided under either 2006 Act are in response to requests from all five states receiving CDBG disaster recovery grants under those Acts. In accordance with the states' earlier requests for administrative consistency to the extent feasible (noted in 71 FR 63337, published October 30, 2006), each waiver or alternative requirement will apply to assistance provided under either Act. The Secretary finds that the following waivers and alternative requirements, as described below, are not inconsistent with the overall purpose of Title I of the Housing and Community Development Act of 1974, as amended, or the Cranston-Gonzalez National Affordable Housing Act, as amended. Under the requirements of the Department of Housing and Urban Development Act, as amended (42 U.S.C. 3535(q)), regulatory waivers must be published in the **Federal Register** . Further, under the supplemental Acts, the Secretary must publish, in the **Federal Register** , any waiver of any statute or regulation that the Secretary administers pursuant to Title I of the Housing and Community Development Act of 1974, no later than 5 days before the effective date of such waiver. Except as described in this and other notices applicable to these grants, statutory and regulatory provisions governing the CDBG program for states, including those at 24 CFR part 570, shall apply to the use of these funds. In accordance with the 2006 Acts, HUD will reconsider every waiver in this Notice on the 2-year anniversary of the day this Notice is published. Waiver Justification In general, waivers already granted to the States of Alabama, Florida, Louisiana, Mississippi, and Texas and alternative requirements already specified for CDBG disaster recovery grant funds provided under Public Law 109-148 and Public Law 109-234 apply. The notices in which these prior waivers and alternative requirements appear are shown in the table below. Notice Publication date Applicability 71 FR 7666, FR-5051-N-01 02/13/2006 Common Allocation/Application for $11.5 billion. 71 FR 34448, FR-5051-N-02 06/14/2006 State of Alabama. 71 FR 34451, FR-5051-N-04 06/14/2006 State of Louisiana. 71 FR 34457, FR-5051-N-03 06/14/2006 State of Mississippi. 71 FR 43622, FR-5051-N-05 08/01/2006 State of Texas. 71 FR 51678, FR-5051-N-06 08/30/2006 State of Florida. 71 FR 62372, FR-5051-N-07 10/24/2006 State of Mississippi. 71 FR 63337, FR-5089-N-01 10/30/2006 Common Allocation/Application, and Applicability of Prior Waivers for $5.2 billion. 72 FR 10014, FR-5089-N-03 03/06/2007 State of Louisiana. 72 FR 10020, FR-5089-N-03 03/06/2007 State of Mississippi. The provisions of this Notice do not apply to funds provided under the regular CDBG program or other HUD or federally funded programs. The provisions provide additional flexibility in program design and implementation and implement statutory requirements unique to these appropriations. Section 414 of the Stafford Act The states have requested a waiver of section 414 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, as amended, for all their disaster recovery programs. This Notice grants, in part, the states' requests that the Secretary waive that section and provides alternative requirements more consistent with the purpose of the supplemental Acts, which is to assist and support disaster recovery in the areas most impacted by the effects of the hurricanes of 2005 in the Gulf Coast. Hurricanes Katrina, Rita, and Wilma resulted in unprecedented destruction in the Gulf States, which will require reconstruction for many years (and possibly decades) to come. The Department has surveyed other federal agencies' administration of section 414 and found varying interpretations for long-term, post-disaster projects involving the acquisition, rehabilitation, or demolition of disaster-damaged housing. The five Gulf States, in the meantime, are launching programs, such as rental rehabilitation, that could be affected by this statute and urgently need a conclusion and clear direction in order to restore affordable rental housing to the devastated areas. Therefore, to avoid possible risk to the recovery effort by further delay in providing the States with a definitive answer, the Department is issuing this Notice, which includes a partial statutory waiver and specifies alternative requirements. For programs or projects covered by this waiver (“covered programs or projects”) that are initiated within 3 years after the applicable disaster, the State must select one of the two alternative requirements specified in this Notice. Alternative One The state may provide relocation assistance to a former residential occupant whose former dwelling is acquired, rehabilitated, or demolished for a covered program or project initiated within 3 years after the disaster, even though the actual displacements were caused by the effects of the disaster. To the extent practicable, such relocation assistance must be offered in a manner consistent with the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, as amended
(URA)and its implementing regulations, except as modified by applicable waivers and alternative requirements. Alternative Two If the state determines that the first alternative would substantially conflict with meeting the disaster recovery purposes of the supplemental Acts, the state may establish a re-housing plan for a covered program or project initiated within 3 years after the disaster. Such determinations must be made on a program or project basis (not person or household). The re-housing plan must include, at minimum, the following: 1. A description of the class(es) of persons eligible for assistance, including all persons displaced from their residences by particular enumerated, or all, effects of the disaster, and including all persons still receiving temporary housing assistance from FEMA for the covered disaster(s); 2. A description of the types and amount of financial assistance to be offered, if any; 3. A description of other services to be made available, including, at minimum, outreach efforts to eligible persons and housing counseling providing information about available housing resources. Outreach efforts and housing counseling information should be provided in languages other than English to persons with limited English proficiency; and 4. Contact information and a description of any applicable application process, including any deadlines. 5. If the program or project involves rental housing, the re-housing plan must also include the following:
(i)Placement services for former and prospective tenants;
(ii)A public registry of available rental units assisted with CDBG disaster recovery and/or other funds; and
(iii)Application materials, award letters, and operating procedures requiring property owners to make reasonable attempts to contact their former residential tenants and offer a unit upon completion to those tenants meeting the program's eligibility requirements. Justification for Waiver The reasons for granting this waiver are several, and are ably represented by the States in their requests. The principal reasons are highlighted here: • Hurricanes Katrina, Rita, and Wilma caused unprecedented destruction in the Gulf Coast region. The magnitude of destruction resulted in massive displacements and decimated the region's affordable housing stock. Continued ambiguity on section 414's applicability may cause substantial delays in long-term recovery along the Gulf Coast, particularly in Louisiana, Mississippi, and Texas; • URA assistance may duplicate insurance proceeds and federal, state, or local housing assistance that has already been disbursed; and • Simplify the administration of disaster recovery projects or programs initiated years following the disaster. Persons in physical occupancy who are displaced by a HUD-assisted disaster recovery project will continue to be eligible for URA assistance. Persons displaced by the effects of the disaster may continue to apply for assistance under the States' approved disaster recovery programs, which are designed to bring affordable housing to the affected areas. This waiver does not address programs or projects receiving other HUD funding, or funding from other federal sources. A state may already be performing some elements of a re-housing plan, such as providing a public rental registry or undertaking outreach and placement services to those former residents still receiving FEMA housing assistance. Description in the re-housing plan of how those existing efforts will be available for covered programs or projects may be used in satisfying the requirements of this Notice. Applicable Rules, Statutes, Waivers, and Alternative Requirements 1. *General note.* Except as described in this Notice, the statutory, regulatory, and notice provisions that shall apply to the use of these funds are: a. Those governing the funds appropriated under Public Law 109-148 and Public Law 109-234 (the “supplemental Acts”) and already published in the **Federal Register** . b. Those governing the CDBG program for states, including those at 42 U.S.C. 5301 *et seq.* and 24 CFR part 570. 2. *Section 414 of the Stafford Act waiver and alternative requirements.* a. Section 414 of the Stafford Act, 42 U.S.C. 5181 (including its implementing regulation at 49 CFR 24.403(d)), is waived to the extent that it would apply to CDBG disaster recovery-funded programs or projects initiated at least one year after Hurricanes Katrina, Rita, or Wilma (as applicable) by the States of Alabama, Florida, Louisiana, Mississippi, and Texas under an approved Action Plan for Disaster Recovery for its grants under Public Law 109-148 or Public Law 109-234; provided that such program or project was not planned, approved, or otherwise underway prior to the disaster. b. For all programs or projects covered by this waiver (“covered programs or projects”) that are initiated within 3 years after the applicable disaster, the States of Alabama, Florida, Louisiana, Mississippi, and Texas must comply with one of the following two alternative requirements: 1. *Relocation Assistance.* The state may provide relocation assistance to a former residential occupant whose former dwelling is acquired, rehabilitated, or demolished for a covered program or project initiated within 3 years after the disaster, even though the actual displacements were caused by the effects of the disaster. To the extent practicable, such relocation assistance must be offered in a manner consistent with the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, as amended, and its implementing regulations, except as modified by prior waivers and alternative requirements granted to the States. 2. *Re-housing Plan.* If the state determines that the first alternative would substantially conflict with meeting the disaster recovery purposes of the supplemental Acts, the grantee may establish a re-housing plan for a covered program or project initiated within 3 years after the disaster. Such a determination must be made on a program or project basis (not person or household). The re-housing plan must include, at minimum, the following: i. A description of the class(es) of persons eligible for assistance, including all residents displaced from their residences by certain enumerated or all effects of the covered disaster, and including all disaster-displaced residents still receiving temporary housing assistance from FEMA for the covered disasters; ii. A description of the types and amount of financial assistance to be provided, if any; iii. A description of other services to be made available, including, at minimum, outreach efforts to eligible persons and housing counseling that provide information about available housing resources; iv. Contact information for additional program information; v. A description of any applicable application process, including any deadlines; and vi. If the program or project covered by this waiver involves rental housing, the grantee shall establish procedures for the following: A. Application materials, award letters, and operating procedures that require property owners to make reasonable attempts to contact their former tenants and to offer a unit upon completion to those tenants meeting the program's eligibility requirements; B. Placement services for former and prospective tenants; and C. A public registry of available rental units assisted with CDBG disaster recovery and/or other funds. c. Eligible Project Costs. The cost of relocation assistance and the re-occupancy plan are eligible project costs in the same manner and to the same extent as other projects costs authorized under the supplemental Acts. For covered programs or projects involving affordable rental housing, the relocation and planning costs required by this Notice may be paid from funds reserved for the affordable rental housing stock in the impacted areas under Public Law 109-234. 2. *Information collection approval note.* The information collection requirements contained in this Notice have been approved by the Office of Management and Budget (OMB), in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), and assigned OMB control number 2506-0165. In accordance with the Paperwork Reduction Act, HUD may not conduct or sponsor, nor is a person required to respond to, a collection of information, unless the collection displays a valid control number. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers for the disaster recovery grants under this Notice are as follows: 14.219; 14.228. Finding of No Significant Impact A Finding of No Significant Impact (FONSI) with respect to the environment has been made, in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Office of the Rules Docket Clerk, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the FONSI must be scheduled by calling the Regulations Division at
(202)708-3055 (this is not a toll-free number). Dated: August 16, 2007. Roy A. Bernardi, Deputy Secretary. [FR Doc. E7-16631 Filed 8-23-07; 8:45 am] BILLING CODE 4210-67-P 72 164 Friday, August 24, 2007 Notices Part V Department of Housing and Urban Development Additional Waivers Granted to and Alternative Requirements for the State of Mississippi Under Public Law 109-148; Notice DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5051-N-08] Additional Waivers Granted to and Alternative Requirements for the State of Mississippi Under Public Law 109-148 AGENCY: Office of the Secretary, HUD. ACTION: Notice of waivers, and alternative requirements. SUMMARY: As described in the Supplementary Information section of this Notice, HUD is authorized by statute to waive statutory and regulatory requirements and specify alternative requirements for this grant, upon the request of the state grantee. This Notice describes the additional waivers approved by HUD for a $600 million infrastructure program to be funded from the disaster recovery grant made to the State of Mississippi under the subject appropriations act. DATES: *Effective Date:* August 29, 2007. FOR FURTHER INFORMATION CONTACT: Jessie Handforth Kome, Director, Disaster Recovery and Special Issues Division, Office of Block Grant Assistance, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7286, Washington, DC 20410, telephone number
(202)708-3587. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at
(800)877-8339. FAX inquiries may be sent to Ms. Kome at
(202)401-2044. (Except for the “800” number, these telephone numbers are not toll-free.) SUPPLEMENTARY INFORMATION: Authority To Grant Waivers A federal Fiscal Year 2006 supplemental appropriation for the Community Development Block Grant
(CDBG)program was in the Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006 (Pub. L. 109-148, approved December 30, 2005) (the 2006 Act), that appropriated $11.5 billion for necessary expenses related to disaster relief, long-term recovery, and restoration of infrastructure in the most impacted and distressed areas related to the consequences of the covered disasters. The 2006 Act authorizes the Secretary to waive, or specify alternative requirements for, any provision of any statute or regulation that the Secretary administers in connection with the obligation by the Secretary or use by the recipient of these funds and guarantees, except for requirements related to fair housing, nondiscrimination, labor standards, and the environment, upon a request by the state and a finding by the Secretary that such a waiver would not be inconsistent with the overall purpose of the statute. The following additional waivers and alternative requirements for funds provided under the 2006 Act are in response to a request from the State of Mississippi. For reasons described below, the Secretary finds that the following waivers and alternative requirements are not inconsistent with the overall purpose of Title I of the Housing and Community Development Act of 1974, as amended (the 1974 Act), or the Cranston-Gonzalez National Affordable Housing Act, as amended. Under the requirements of the Department of Housing and Urban Development Act, as amended (42 U.S.C. 3535(q)), regulatory waivers must be published in the **Federal Register** . Except as described in this and other notices applicable to this grant, statutory and regulatory provisions governing the CDBG program for states, including those at 24 CFR part 570, shall apply to the use of these funds. In accordance with the appropriations act cited above, HUD will reconsider every waiver in this Notice on the 2-year anniversary of the day this Notice is published. Waiver Justification In general, waivers already granted to the State of Mississippi and alternative requirements already specified for CDBG disaster recovery grant funds provided under P.L. 109-148 apply. The notices in which these prior waivers and alternative requirements applicable to Mississippi are: • 71 FR 7666, published February 13, 2006; • 71 FR 34457, published June 14, 2006; • 71 FR 62372, published October 24, 2006; • 71 FR 63337, published October 30, 2006; and • 72 FR 10020, published March 6, 2007. The provisions of this Notice do not apply to funds provided under the annual CDBG program or to the grant made under Public Law 109-234. The provisions provide additional flexibility in program design and implementation, and implement statutory requirements unique to this appropriation. Overall Benefit to Low- and Moderate-Income Persons The State of Mississippi has repeated its request that the Secretary waive the requirement that 50 percent of the CDBG funds received by the state under the grant made under Public Law 109-148 be for activities that benefit persons of low and moderate income. The Secretary has responded to the state's prior requests by waiving the overall benefit requirement to the extent necessary to permit funding of certain activities in identified action plans. To grant this waiver, the Secretary must find that it is “not inconsistent” with the CDBG program's primary purpose. This purpose is stated at 42 U.S.C. 5301(c): “The primary objective of this chapter and of the community development program of each grantee under this chapter is the development of viable urban communities, by providing decent housing and a suitable living environment and expanding economic opportunities, principally for persons of low and moderate income.” Further, Public Law 109-148 stipulates that, to decrease or eliminate the overall benefit requirement below 50 percent, the Secretary of HUD must also make a finding of “compelling need” for the waiver. Waivers of the overall benefit test described above are identified in the table below. Table—MS Activities With Overall Benefit Waivers and Alternative Requirements Activity or program Budget Waiver date National objective Economic Development and Community Revitalization $500,000,000 March 6, 2007 By project, either urgent need or low/mod. Regional Infrastructure Program—Master Plan and Emergency Infrastructure $33,075,000 October 24, 2006 Urgent need. Ratepayer and Windpool Mitigation $410,000,000 October 24, 2006 Urgent need. Compensation for housing loss $3.4 billion for Phase I of homeowner program, since amended to approximately $1 billion June 14, 2006 Urgent need or low/mod. The State of Mississippi's current request is for a waiver of overall benefit requirements so that the proposed $600 million infrastructure program will not cause the state to fail to meet the requirement. This program follows a CDBG-funded master plan for infrastructure recovery whose goals include extending water and sewer service into areas with lower exposure to future natural disasters while helping the state recover from the effects of Hurricane Katrina. As mentioned in a prior Notice (71 FR 62372, published October 24, 2006), to allow for recovery from severe ice storms, the Secretary allowed the State of Maine an overall benefit waiver that permitted the State of Maine to use its entire grant to assist private utilities with uninsured service restoration costs. In analyzing that request, HUD considered how low- and moderate-income persons would benefit from the proposed activity. Logically, a utility grid or service area cannot be restored for one income group alone, and a disaster that damages infrastructure regionally affects almost everyone in an area, regardless of income. There was no practical methodology in the Maine example for allocating costs among income groups. HUD found that Maine's waiver supported an activity that resulted in providing long-term disaster recovery benefit to a large number of low- and moderate-income persons. In this context, because the CDBG program and the disaster supplemental legislation largely leave the selection of activities to the grantees, HUD granted the waiver based on acceptance of the state's policy decision that this activity met both the purposes of the CDBG Act, and was necessary for the affected community to meet its unmet disaster recovery needs. The case of the infrastructure program in Mississippi meets many of the same conditions that existed in Maine. As in Maine, people across a widespread region of Mississippi were affected regardless of income, and the proposed restoration and recovery infrastructure projects will enable recovery across wide geographic areas. The planned Mississippi projects under the master plan depart from the Maine case in that the Mississippi plan focuses not only on restoration of service to some heavily impacted areas, but also on guiding settlement during the recovery into locations that were less affected by the storm, likely to be less affected by future events, and likely to have more affordable housing and access to required insurance in the long-term. According to the state, this pattern of leading redevelopment away from the coast will provide the backbone for a long-term recovery that will provide more suitable living opportunities for residents of the Mississippi coastal area. Based on HUD review of the published plan at *http://www.msgulfregionplan.org/* , the master plan provides both for restoration of infrastructure in certain impacted locations that are critical to recovery, and for long-term recovery in feasible locations further from the coast but still within the coastal labor market areas. According to the master plan, most of the selected inland locations did not have adequate utility services for the population they had prior to the disaster, let alone the population surge they have experienced as former coastal residents moved inland after the hurricanes. The planned infrastructure also allows for some further long-term economic expansion in the most impacted counties, should they recover. In considering the effects of granting the Mississippi waivers, HUD reviewed the income data from the Census and provided by the state on the percentages of low- and moderate-income persons for the service area of each of the projects identified in the master plan and proposed for funding under this grant. _ Mississippi planned water and sewer project descriptions Total population of the service area Low/mod population of the service area Water Projects W1—Pearl River—Poplarville Regional Water Supply System 5,700 2,721 W2—Pearl River—Picayune Regional Water Supply System 18,476 6,891 W3—Hancock—Pearlington—Port Bienville Regional Water Supply System, W4—Hancock Pearlington Water Distribution System 1,931 849 W5—Hancock—Kiln Regional Water Supply, W6—Hancock—Kiln Water Distribution System, W7—Hancock—Eastern Hancock County Regional Water Supply, W8—Hancock—Hancock County Water and Sewer District Water Distribution System, W9—Hancock—Waveland U.S. 90 Water System Improvements 25,295 12,029 W10—Stone—Southern Stone County Regional Water System 1,564 606 W11—Harrison—Central Harrison County Regional Water Supply, W18—Harrison—Eastern Harrison County Regional Water Supply 19,362 8,693 W12—Harrison—Pass Christian Water System Improvements, W13—Harrison—Western Harrison County Regional Water Supply, W14—Harrison—Long Beach Water System, W15—Harrison—North Gulfport/Lyman Regional Water Supply 55,406 18,949 W16—Harrison—Gulfport VA Area Water System Improvements, W17—Harrison—South Gulfport Regional Water Supply, W19—Harrison—Biloxi Broadwater Water System Improvements 3,469 1,643 W20—Jackson—Western Jackson County Regional Water Supply, W21—Jackson—Ocean Springs Water Transmission Improvements 8,501 3,745 W22—Jackson—Gautier Water Transmission Improvements 15,156 5,232 W23—Jackson—Eastern Jackson County Regional Water System 5,772 2,393 W24—Jackson—Moss Point—Three Rivers Regional Water Treatment and Transmission System 10,239 4,501 W25—Jackson—Pascagoula—River Park Water Transmission Improvements 471 156 W26—Jackson—Pascagoula—Chipley Water Transmission Improvements 3,927 1,580 W27—Jackson—Pascagoula—Beach Boulevard Water Transmission Improvements 3,232 945 Sewer Projects S1—Pearl River—Poplarville Regional WWTF and Transmission System 6,170 2,403 S2—Pearl River—Picayune Regional WWTF and Transmission System 1,931 849 S3—Hancock—Western Regional WWTF 21,270 9,101 S4—Hancock—Pearlington Wastewater Collection System 1,052 554 S5—Hancock—Northern Regional WWTF 5,173 1,911 S6—Hancock—Kiln Wastewater Collection System 829 312 S7—Hancock—Bay St. Louis—Cedar Point and I-10 Wastewater System Improvements 17,539 7,494 S8—Stone—Wiggins Regional WWTF and Transmission System 2,721 1,281 S9—Stone—South Stone County WWTF 2,264 843 S10—Harrison—Saucier WWTF and Riverbend/Robinwood Forest Transmission System, S11—Harrison—East Central Harrison County Regional WWTF 7,726 3,244 S12—Harrison—DeLisle WWTF, Long Beach/Pass Christian WWTF, and Transmission System 4,422 1,988 S13—Harrison—Pass Christian Wastewater System Improvements, S14—Harrison—West Gulfport Regional Interceptor, S16—Harrison—Long Beach Wastewater System Improvements 30,966 10,450 S15—Harrison—West Gulfport Regional Transmission System 4,078 1,550 S17—Harrison—Gulfport VA Area Wastewater System Improvement 7,486 3,646 S18—Harrison—South Gulfport Regional Transmission System 5,936 2,075 S21—Harrison—Biloxi Broadwater Wastewater System Improvements 5,962 2,768 S19—Harrison—South Woolmarket WWTF and Transmission Mains 16,853 5,694 S20—Harrison—D'Iberville WWTF and Transmission System, S22—Harrison—D'Iberville Waterfront Wastewater System Improvements 7,509 3,136 S23—Jackson—West Jackson Regional WWTF and Transmission Mains, S24—Jackson—Ocean Springs Wastewater Transmission Improvements, S25—Jackson—Gulf Park and Ocean Beach Areas Transmission Improvements 29,018 7,756 S26—Jackson—North Jackson County Decentralized WWTFs 5,975 2,018 S27—Jackson—Gautier Wastewater Transmission Improvements, S28—Jackson—Gautier Regional WWTF Improvements 16,113 5,654 S29—Jackson—Escatawpa Regional WWTF Improvements 15,751 7,349 S30—Jackson—Pascagoula—River Park Wastewater Transmission Improvements, S31—Jackson—Pascagoula—Shortcut Road Transmission System Improvements, S32—Jackson—Pascagoula—Chipley Wastewater Transmission Improvements, S33—Jackson—Pascagoula—Beach Boulevard Wastewater Transmission Improvement 3,044 1,425 Note about the table: Because some of the project service areas overlap, the numeric columns were not totaled. Nevertheless, despite qualifying under the “urgent need” national objective, the projects proposed under the master plan will generate benefits to low- and moderate-income persons for a long period of time for a relatively small amount of funds per person served. The data demonstrate the classic pattern also illustrated in the cases in which HUD granted prior waivers of this provision to Maine and the City of Grand Forks, North Dakota, in which the grantee would be unable to provide the infrastructure to support disaster recovery for low- and moderate-income households without also benefiting a majority of persons who are not income-qualified. In the Mississippi case, as in prior this ones, HUD has determined that granting this waiver will result in provision of disaster recovery benefits to low- and moderate-income persons that cannot be provided only to low- and moderate-income persons, or in such a way as to assure that the majority of persons served are income-qualified. Further, HUD has determined that, in the context of using supplemental funds appropriated for the purpose of supporting recovery from a major disaster, granting this waiver is consistent with the overall purpose of the 1974 Act. Based on the above and the compelling need presented by the State of Mississippi for the activities already included in the Action Plan for Disaster Recovery for the grant made under Public Law 109-148, HUD is granting the state a waiver of the requirement that at least 50 percent of the supplemental CDBG grant funds provided under Public Law 109-148 primarily benefit persons of low and moderate income, to the extent necessary to permit Mississippi to carry out the activities contained in its March 26, 2007, Action Plan submission for Regional Infrastructure, provided that the state must give reasonable priority for the balance of its funds to activities that will primarily benefit persons of low and moderate income. HUD expects the grantee to maintain low- and moderate-income benefit documentation for any activity assisted with this grant that directly provides such a benefit. This waiver of overall benefit requirements does not alter previous waivers of the overall benefit requirements or cover activities that may be added or modified under a substantial amendment to the activities mentioned in the Action Plan submissions listed above. Previously, the state agreed to examine other housing needs and to pursue other sources of funding to provide assistance for other compelling housing needs, such as for homeless and special needs populations, for low-income renters, and for uninsured low-income homeowners. HUD expects the state to continue these efforts. HUD expects the state to principally benefit low- and moderate-income persons in activities where such design is feasible and reasonable, and to design its activities to otherwise meet the “slum-blight” or urgent-need national objective. HUD also reminds the state that, pursuant to the instruction in Public Law 109-148, all waivers in this Notice must be reconsidered on the 2-year anniversary date of this notice. Applicable Rules, Statutes, Waivers, and Alternative Requirements 1. *General note* . Except as described in this Notice, the statutory, regulatory, and notice provisions that shall apply to the use of these funds are: a. Those governing the funds appropriated under Public Law 109-148 and already published in the **Federal Register** , including those in Notices 71 FR 7666, published February 13, 2006; 71 FR 34457, published June 14, 2006; 71 FR 62372, published October 24, 2006; 71 FR 63337, published October 30, 2006; and 72 FR 10020, published March 6, 2007; and b. Those governing the CDBG program for states, including those at 42 U.S.C. 5301 *et seq.* and 24 CFR part 570. 2. *Overall benefit.* 42 U.S.C. 5301(c) and 5304(b)(3), and 24 CFR 570.484 and 24 CFR 91.325(b)(4)(ii), with respect to the overall benefit requirement, are waived to the extent necessary to permit Mississippi to carry out the activities contained in its March 26, 2007, Action Plan submissions, provided that: a. The state must give reasonable priority for the balance of its funds to activities that will primarily benefit persons of low and moderate income; and b. The state will maintain documentation of the low- and moderate-income benefit attributable to each assisted activity, if feasible, and report on such benefit to HUD as part of the regular quarterly reports. 3. *Information collection approval note.* The information collection requirements contained in this Notice have been approved by the Office of Management and Budget
(OMB)in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2506-0165. In accordance with the Paperwork Reduction Act, HUD may not conduct or sponsor, nor is a person required to respond to, a collection of information, unless the collection displays a valid control number. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers for the disaster recovery grants under this Notice are as follows: 14.219; 14.228. Finding of No Significant Impact A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the finding by calling the Regulations Division at
(202)708-3055 (this is not a toll-free number). Dated: August 16, 2007. Roy A. Bernardi, Deputy Secretary. [FR Doc. E7-16632 Filed 8-23-07; 8:45 am] BILLING CODE 4210-67-P 72 164 Friday, August 24, 2007 Rules and Regulations Part VI Federal Communications Commission 47 CFR Parts 0, 1, 2, 27 and 90 Service Rules for the 698-806 MHz Band, Revision of the Commission's Rules Regarding Public Safety Spectrum Requirements, and a Declaratory Ruling on Reporting Requirement under the Commission's Anti-Collusion Rule; Final Rule FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 0, 1, 2, 27, and 90 [WT Docket No. 06-150; CC Docket No. 94-102, WT Docket No. 01-309, WT Docket No. 03-264, WT Docket No. 06-169; PS Docket No. 06-229; WT Docket No. 96-86; WT Docket No. 07-166; FCC No. 07-132] Service Rules for the 698-806 MHz Band, Revision of the Commission's Rules Regarding Public Safety Spectrum Requirements, and a Declaratory Ruling on Reporting Requirement under the Commission's Anti-Collusion Rule AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In this document, the Federal Communications Commission
(FCC)adopts final rules governing wireless licenses in the 698-806 MHz Band ( *i.e.* , the 700 MHz Band). This spectrum is currently occupied by television broadcasters and is being made available for wireless services, including public safety and commercial services, as a result of the digital television (“DTV”) transition. DATES: Effective October 23, 2007, except for the amendments to §§ 27.14, 27.15, 27.50, and 90.176 which contain information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the **Federal Register** announcing the effective date. FOR FURTHER INFORMATION CONTACT: Paul Moon at
(202)418-1793, *paul.moon@fcc.gov,* Mobility Division, Wireless Telecommunications Bureau; Peter Trachtenberg at
(202)418-7369, at *peter.trachtenberg@fcc.gov,* Spectrum and Competition Policy Division, Wireless Telecommunications Bureau; Jeff Cohen at
(202)418-0799, *jeff.cohen@fcc.gov,* Public Safety and Homeland Security Bureau. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Second Report and Order, WT Docket No. 06-150; CC Docket No. 94-102, WT Docket No. 01-309, WT Docket No. 03-264, WT Docket No. 06-169; PS Docket No. 06-229; WT Docket No. 96-86; WT Docket No. 07-166; FCC No. 07-132, adopted July 31, 2007 and released August 10, 2007. The full text of the Second Report and Order is available for public inspection on the Commission's Internet site at *http://www.fcc.gov.* It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone
(202)488-5300; fax
(202)488-5563; e-mail *FCC@BCPIWEB.COM* . Synopsis In this Second Report and Order, the Commission establishes rules governing wireless licenses in the 698-806 MHz Band (herein, the “700 MHz Band”). This spectrum currently is occupied by television broadcasters in TV Channels 52-69. It is being made available for wireless services, including public safety and commercial services, as a result of the digital television (“DTV”) transition. In passing the Digital Television Transition and Public Safety Act of 2005 (“DTV Act”), Congress accelerated the DTV transition by providing a date certain, February 17, 2009, for the end of the transition. 1 The Commission has been considering rules related to the use of this spectrum in three ongoing proceedings:
(1)The 700 MHz Commercial Services proceeding, 71 FR 48506 (2006), 2
(2)the 700 MHz Guard Bands proceeding, 71 FR 57455, 3 and
(3)the 700 MHz Public Safety proceeding, 72 FR 1201 (2007); 71 FR 17786 (2006). 4 Recognizing the interrelationship of these proceedings, the Commission recently combined these proceedings and in April 2007 issued a single Report and Order and Further Notice of Proposed Rulemaking (the 700 MHz Report and Order, 72 FR 27688 (2007), and 700 MHz Further/NPRM, FR 24238 (2007), respectively) addressing all three proceedings. 5 Accordingly, the Commission addresses the rules regarding access to 700 MHz Band spectrum and the provision of service across the country, as well as opportunities for broadband service for Public Safety users in this Second Report and Order. 1 *See* Deficit Reduction Act of 2005, Pub. L. 109-171, 120 Stat. 4
(2006)(“DRA”). Title III of the DRA is the DTV Act. 2 *See* Service Rules for the 698-749, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems and Section 68.4(a) of the Commission's rules Governing Hearing Aid-Compatible Telephones, CC Docket No. 94-102, WT Docket No. 01-309, *Notice of Proposed Rule Making* , *Fourth Further Notice of Proposed Rule Making,* and *Second Further Notice of Proposed Rule Making,* 71 FR 48506
(2006)( *700 MHz Commercial Services NPRM* ). 3 *See* Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's Rules, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket Nos. 06-169 and 96-86, *Notice of Proposed Rule Making,* 71 FR 57455
(2006)( *700 MHz Guard Bands NPRM* ). 4 *See* Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, PS Docket No. 06-229, WT Docket No. 96-86, *Ninth Notice of Proposed Rulemaking,* 72 FR 1201
(2006)( *700 MHz Public Safety Ninth NPRM* ); Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket No. 96-86, *Eighth Notice of Proposed Rulemaking,* 71 FR 17786
(2006)( *700 MHz Public Safety Eighth NPRM* ). 5 Service Rules for the 698-746, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, Section 68.4(a) of the Commission's rules Governing Hearing Aid-Compatible Telephones, WT Docket No. 01-309, Biennial Regulatory Review—Amendment of Parts 1, 22, 24, 27, and 90 to Streamline and Harmonize Various Rules Affecting Wireless Radio Services, WT Docket 03-264, Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's rules, WT Docket No. 06-169, Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, PS Docket No. 06-229, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket No. 96-86, *Report and Order* and *Further Notice of Proposed Rulemaking,* 22 FCC Rcd 8064
(2007)( *700 MHz Report and Order* and *700 MHz Further NPRM,* respectively). I. Discussion A. Commercial 700 MHz Band, Including 700 MHz Guard Bands 1. Band Plan a. Commercial Spectrum (Excluding Guard Bands Spectrum) 1. In the *700 MHz Report and Order,* the Commission determined that a balanced mix of geographic service area licenses—CMAs, EAs, and REAGs—would be appropriate for the commercial 700 MHz Band licenses that will be auctioned. The Commission reaffirms that determination for all of this commercial spectrum except for that associated with the 10-megahertz commercial license (comprised of paired 5-megahertz blocks) which will be auctioned on a nationwide basis for use as part of the 700 MHz Public/Private Partnership with the Public Safety Broadband Licensee. The Commission further determines that a mix of spectrum block sizes, including one large 22-megahertz block (comprised of paired 11-megahertz blocks), is appropriate for the 700 MHz Band licenses that remain to be auctioned. 2. The Commission will license three commercial blocks of paired spectrum—one 12-megahertz block (comprised of paired 6-megahertz blocks) licensed on a CMA basis, one 12-megahertz block (comprised of paired 6-megahertz blocks) on an EA basis, and one 22-megahertz block (comprised of paired 11-megahertz blocks) on a REAG basis—as well as one 6-megahertz block of unpaired spectrum on an EA basis. First, the Commission will license one additional 12-Megahertz Spectrum Block (comprised of paired 6-Megahertz blocks) in the 700 MHz Band on a CMA basis, to be located in the B Block of the Lower 700 MHz Band immediately adjacent to the existing CMA-based licenses. Second, the Commission will license a 22-megahertz block (comprised of paired 11-Megahertz blocks) on a REAG basis located in the C Block in the Upper 700 MHz Band. Third, the Commission will license a 12-Megahertz block (comprised of paired 6-megahertz blocks) on an EA basis located in Block A of the Lower 700 MHz Band. Finally, the Commission adopts EAs for the unpaired 6-megahertz E Block of the Lower 700 MHz Band. b. Guard Bands Spectrum 3. The Commission adopts a revised band plan for the 700 MHz Guard Bands spectrum and the Upper 700 MHz Band, which includes features of Cyren Call's additional band plan proposal and the July 6, 2007 Guard Bands Proposal. Additionally, the Commission determines that it lacks legal authority to adopt the Broadband Optimization Plan (BOP), Critical Infrastructure Industries (CII), or the Ericsson proposals because they propose a reallocation of commercial spectrum to public safety, and assignment of commercial licenses from the Commission's auction inventory without competitive bidding. The Commission also rejects the most recent Ericsson band plan proposal, as well as the Access Spectrum/Pegasus Alternative Proposal and the Cyren Call proposals to the extent they are inconsistent with the Commission's actions in this Second Report and Order.
(a)Revisions to Upper 700 MHz Band Plan for Guard Bands 4. The Commission adopts the July 6, 2007 Guard Bands Proposal based on the agreement of all Guard Band licensees except PTPMS II, whose two Guard Band B Block licenses the Commission grandfathers, and whose one Guard Band A Block license the Commission repacks into the reconfigured Guard Band A Block. The Commission concludes that the existing Guard Band B Block is no longer needed as a guard band to protect the adjacent 700 MHz public safety users, and to the extent possible, should be consolidated with the remaining commercial spectrum for more efficient and effective use. The Commission finds that the public interest is best served by adoption of features of the Cyren Call and July 6, 2007 proposals because it removes the “repacked” Guard Band A Block from the critical juncture between the Upper 700 MHz D Block and the public safety broadband spectrum, which together will be used as the foundation for the 700 MHz Public/Private Partnership. 5. *Funding for Public Safety Reconfiguration.* The Commission finds that the proximity of the public safety broadband spectrum to the adjacent D block will provide significant benefits to the D Block licensee. Accordingly, the Commission concludes that the D Block licensee must pay the costs of consolidating the 700 MHz public safety narrowband channels to the upper half of the 700 MHz Public Safety Band. 6. *License Modifications.* The Commission finds that the public interest, convenience, and necessity will be served by relocating all existing Guard Band A licenses to the reconfigured Guard Band A Block located at 757-758 MHz and 787-788 MHz. With the exception of PTPMS II, which holds one A Block license and two B Block licenses, the license modifications that the Commission effects today are consensual. 7. These license modifications are consistent with Sections 337 and 309 of the Act, because the 4 megahertz of remaining Guard Bands spectrum remains commercial spectrum subject to auction. Specifically, the 2 megahertz from 746-747 MHz and 776-777 MHz will be added to, and auctioned as part of, the Upper 700 MHz Band C Block in the forthcoming 700 MHz Band auction. The lower portion of the reconfigured commercial Guard Band B Block at 775-776 MHz will provide a necessary guard band between public safety narrowband communications and adjacent commercial services. The Commission will be able to determine other potential uses of this spectrum, and the related portion of the B Block at 805-806 MHz, at a future date. 8. *Spectrum Use Agreements.* Pursuant to Section 309(f) of the Act, the Commission hereby grants Access Spectrum 180-day special temporary authorizations for MEAs 20, 26, 32, 37, 44, and 52 for the current Guard Band A Block (746-747 MHz, 776-777 MHz). In the event that Access Spectrum cannot complete the transition of the CII system during the 180-day period, it may seek an appropriate extension of the STA upon a proper showing. Because the Commission modifies (repack and relocate) the Guard Band A Block MEA licenses held by Access Spectrum, Pegasus, and Dominion upon the effective date of this Second Report and Order, the six STA grants to Access Spectrum will be granted upon the effective date as well. 9. *PTPMS II.* To ensure that critical interoperable public safety communications are uniform throughout the continental United States, the Commission hereby modifies PTPMS II's Guard Band A Block license in Buffalo (MEA 003), pursuant to Sections 316, 301, 303, and 4(i) of the Act, to operate in the same geographic area but in the reconfigured A Block at 757-758 MHz and 787-788 MHz. The Commission also modifies PTPMS II's B Block licenses in Des Moines—Quad Cities (MEA 021) and El Paso—Albuquerque (MEA 039) by shifting them down by 1 megahertz, so that PTPMS II is authorized to operate at 761-763 MHz and 791-793 MHz. These modifications should not burden PTPMS II because it does not have any operations associated with the three licenses. 10. As a result of the foregoing modifications, the new nationwide Upper 700 MHz Band D Block license, at 758-763 MHz and 788-793 MHz, will be authorized in Des Moines—Quad Cities (MEA 021) and El Paso—Albuquerque (MEA 039) on a secondary basis to PTPMS II. As such, the D Block licensee may not cause interference to primary operations of PTPMS II or claim protection from harmful interference from any operations of PTPMS II in those MEAs. The D Block licensee must cease operations on the spectrum assigned to PTPMS II in these two markets if it poses an interference problem to PTPMS II. In the event that PTPMS II, or a successor or an assign of PTPMS II, elects to cancel either of its grandfathered licenses, or if either license cancels automatically, or is terminated by the Commission, then the licensed geographic area will revert, without further action by the Commission, to the D Block licensee. This reversionary interest will include the right to operate under the D Block technical rules. 11. Further, the Commission grandfathers PTPMS II's two B Block licenses without any renewal expectancy, and does not extend the term of its licenses as the Commission has for the reconfigured Guard Band A Block licenses. The Commission will afford PTPMS II's Guard Band A Block license the modified (less stringent) technical rules that the Commission adopts below for all other Guard Band A Block licenses. 12. Accordingly, pursuant to Section 316 of the Act and Section 1.87 of the Commission's rules, PTPMS II has 30 days from the effective date of this Second Report and Order to protest the foregoing license modifications. Additionally, as stated in their July 6, 2007 *Ex Parte,* the other Guard Bands licensees have waived their protest rights.
(b)Broadband Optimization Plan (BOP), Critical Infrastructure Industries
(CII)and Ericsson Proposals 13. For the reasons discussed in the *700 MHz Further NPRM,* the Commission denies the BOP and CII proposals. Further, the Commission concludes that the additional Ericsson band plan proposal is not in the public interest. 2. Service Rules a. Commercial Services (Excluding Guard Bands and Upper 700 MHz D Block)
(i)Performance Requirements 14. In order to better promote access to spectrum and the provision of service, especially in rural areas, the Commission replaces the current “substantial service” requirements for the 700 MHz Band licenses that have not been auctioned with significantly more stringent performance requirements. These requirements include the use of interim and end-of-term benchmarks, with geographic area benchmarks for CMA and EA licenses, and population benchmarks for REAG licenses. Licensees must meet the interim requirement within four years of the end of the DTV transition ( *i.e.* , February 17, 2013). Failure to meet the interim requirement will result in a two-year reduction in license term, as well as possible enforcement action, including forfeitures. The Commission also reserves the right to impose a proportional reduction in the size of the license area of a licensee that fails to meet its interim benchmarks. Licensees that fail to meet the end-of-term benchmarks will be subject to a “keep-what-you-use” rule, under which the licensee will lose its authorization for unserved portions of its license area, which will be returned to the Commission for reassignment. They may also be subject to potential enforcement action, including possible forfeitures or cancellation of license. The Commission also imposes certain reporting requirements intended to help the Commission monitor build-out progress during the license term. The Commission expects that licensees will take these construction requirements seriously and proceed toward providing service with utmost diligence. As such, the Commission does not envision granting waivers or extensions of construction periods except where unavoidable circumstances beyond the licensee's control delay construction. 15. *Specific Performance Requirements for CMA and EA Licenses.* The Commission concludes that, for licenses based on CMAs and EAs, licensees must provide signal coverage and offer service to:
(1)At least 35 percent of the geographic area of their license within four years of the end of the DTV transition, and
(2)at least 70 percent of the geographic area of their license at the end of the license term. In determining the relevant geographic area, the Commission concludes that, in applying geographic benchmarks, the Commission should not generally consider the relevant area of service to include government lands. CMA or EA licensees that fail to meet the interim requirement within their license areas will have their license terms reduced by two years, from ten to eight years, thus requiring these licensees to meet the end-of-term benchmark at an accelerated schedule. For those CMAs or EAs in which the end-of-term performance requirements have not been met, the unused portion of the license will terminate automatically without Commission action and will become available for reassignment by the Commission subject to the “keep-what-you-use” rules described below. 16. To the extent the licensee employs a signal level and provides service to land that is owned or leased by government, the licensee may count this land area and coverage as part of its service area for purposes of measuring compliance with the build-out benchmark, but it also must add the covered government land to the total geographic area used for measurement purposes. 17. *Specific Performance Requirements for REAG Licenses.* The Commission concludes that, for licenses based on REAGs, licensees must provide signal coverage and offer service to:
(1)At least 40 percent of the population of the license area within four years, and
(2)at least 75 percent of the population of the license area by the end of the license term. Licensees must use the most recently available U.S. Census Data at the time of measurement to meet these population based build-out requirements. 18. In addition, for licenses based on REAGs, the Commission will apply its performance requirements on an EA basis. Accordingly, to meet their benchmarks, REAG licensees must provide signal coverage and offer service to at least 40 percent of the population in each EA in its license area within four years and 75 percent of the population of each of these EAs at the end of the license term. REAG licensees that fail to meet the interim requirement in any EA within their license areas will have their license term for the entire REAG reduced by two years, from ten to eight years, thus requiring these licensees to meet the end-of-term benchmark at an accelerated schedule. In applying the end-of-term coverage requirement to REAG licensees, the Commission will evaluate the licensee's coverage on an EA-by-EA basis. For those EAs in which the end-of-term performance requirements have not been met, the unused portion of the license will terminate automatically without Commission action and will become available for reassignment by the Commission subject to the “keep-what-you-use” regime described below. 19. *Reporting Requirements.* In connection with the performance requirements adopted in this Second Report and Order, the Commission adopts an interim reporting requirement that will obligate licensees to provide the Commission with information concerning the status of their efforts to meet the performance requirements and the manner in which their spectrum is being utilized. In addition, this information will be useful to monitor whether further assessment of the rules or other actions are necessary in the event spectrum is being stockpiled or warehoused, or if it is otherwise not being made available despite existing demand. All licensees will file the first of these reports at the end of the second year following the end of the DTV Transition, *i.e.* , February 17, 2011. Licensees that do not meet their interim benchmarks will file their second report following the sixth year after the end of the DTV Transition, *i.e.* , February 17, 2015, while licensees that do meet their interim benchmarks will have until the end of the seventh year to file, *i.e.* , February 17, 2016. For licensees that do not meet their interim benchmarks and have their license terms reduced, the second report will be filed at the end of the sixth year following the end of the DTV Transition, *i.e.* , February 17, 2015. The information to be reported will include a description of the steps the licensee has taken toward meeting its construction obligations in a timely manner, including the technology or technologies and service(s) being provided and the areas in which those services are available. 20. *Procedures for Implementation.* Licensees must demonstrate compliance with the Commission's interim and end-of-term construction benchmarks by filing a construction notification with the Commission within 15 days of the relevant benchmark certifying that they have met the Commission's performance requirements or, if they have not met the Commission's performance requirements, they must file a description and certification of the areas for which they are providing service. The information contained in the licensee's construction notification must include electronic coverage maps and other supporting documentation. The Commission recognizes that demonstrations of coverage may vary across licensees. Accordingly, the Commission delegates to the Wireless Bureau the responsibility for establishing the specifications for filing maps and other documents ( *e.g.* , file format and appropriate data) needed to determine a licensee's geographic coverage area. The Commission recognizes that coverage determinations may need to be made on a case-by-case basis so as to account for the potentially wide variety of services and technologies that may be offered in the band. 21. The electronic coverage maps must clearly and accurately depict the boundaries of each EA or CMA in the licensee's service territory, and the areas where the licensee is providing signal coverage and offering service. If the licensee's signal does not provide service to the entire EA or CMA, the map must clearly and accurately display the boundaries of the area or areas within each EA or CMA not being served. 22. In addition to filing electronic coverage maps, each licensee must file supporting documentation certifying the type of service it is providing for each EA or CMA within its license service territory and the type of technology it is utilizing to provide this service for each EA or CMA in its service territory. The supporting documentation also must provide the assumptions used by the licensee to create the coverage maps, including the propagation model and the signal strength necessary to provide service with the licensee's technology. 23. When the licensee files its construction notification, including its coverage maps and supporting documentation, the public will be given an opportunity to review and comment on the construction notification, including the maps provided by the licensee and the technical assumptions used to create the maps. After examining the notification and public comments, Commission staff will make a final determination as to what areas within EAs and CMAs are, and are not, deemed “served.” If the Commission determines that a licensee meets the applicable interim benchmark, it will not have its license term reduced by two years. Likewise, if the Commission determines that a licensee meets its applicable end of term benchmark requirement, the licensee will be deemed to have met the Commission's construction build-out requirement. 24. Under the Commission's “keep-what-you-use” rule, if a licensee fails to meet its end of term benchmark, its authorization to operate will terminate automatically without Commission action for those geographic areas in which the licensee is not providing service, and those unserved areas will become available for reassignment by the Commission. The Commission will update its Universal Licensing System records to reflect those geographic areas for which the licensee retains authority to operate, as well as those geographic areas that will be made available for reassignment. 25. For purposes of reassigning these licenses, the Wireless Bureau is delegated authority to announce by public notice that these licenses will be made available and establish a 30-day window during which third parties may file license applications to serve these areas. During this 30-day period, the licensee that failed to serve the area may not file an application to regain the license authorization for that area. Applications filed by third parties that propose areas overlapping with other applications will be deemed mutually exclusive, and will be resolved through an auction. The Wireless Bureau, by public notice, may specify a limited period before the filing of short-form applications (FCC Form 175) during which applicants may enter into a settlement to resolve their mutual exclusivity. 26. Following this 30-day period, the original licensee and third parties can file license applications for remaining unserved areas where licenses have not been issued or there are no pending applications. If the original licensee or a third party files an application, that application will be placed on public notice for 30 days. If no mutually exclusive application is filed, the application will be granted, provided that a grant is found to be in the public interest. If a mutually exclusive application is filed, it will be resolved through an auction. The Wireless Bureau, by public notice, may specify a limited period before the filing of short-form applications (FCC Form 175) during which applicants may enter into a settlement to resolve their mutual exclusivity. 27. A licensee obtaining spectrum that was lost through the Commission's “keep-what-you-use” rule will have one year from the date it is issued a license to complete its construction and provide signal coverage and offer service to the entire new license area. If the licensee fails to meet this construction requirement, its license will automatically cancel without Commission action and it will not be eligible to apply to provide service to this area on the same frequencies at any future date. 28. Under the Commission's “keep-what-you-use” rules, the Commission will determine whether an area is unserved by applying a *de minimis* standard similar to that applied to cellular service, which provides that the geographic service area to be made available to new entrants must include a contiguous area of at least 130 square kilometers (50 square miles). Areas smaller than this will not be deemed unserved by the Commission, because auctioning and licensing smaller areas to new licensees could result in harmful interference to incumbent licensees. Accordingly, unserved areas that are smaller than 130 square kilometers will continue to be a part of the licensee's license area. In those geographic areas that the Commission deems as served, the licensee will retain its exclusive spectrum rights, including the ability to transfer and lease these areas. The licensee also will have the opportunity to expand its service into the unused parts of its original license area.
(ii)Partitioning and Disaggregation 29. *Partitioning.* Under the Commission's modifications of the Section 27.15(d) rules relating to geographic partitioning of new 700 MHz Commercial Services licenses, the Commission establishes two options for partitioners and partitionees with regard to the newly adopted performance requirements discussed above. 30. Under the first option, the partitioner and partitionee must each certify to the Commission that they will share responsibility for meeting the performance requirements for the entire original geographic license area. Under this option, the partitioner, partitionee, or both the partitioner and partitionee working together, can meet the four-year and end-of-term construction benchmarks for the entire geographic license area. If the parties fail to meet the four-year benchmark, they will each have their license term reduced by two years. If the parties meet the end-of-term construction benchmarks, they will retain the ability to continue to build out the unserved portion of their license areas. Parties that fail to meet the end-of-term benchmarks will be subject to a “keep-what-you-use” rule, under which they will each lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment. 31. Under the second option, the partitioner and partitionee must each certify that it will independently meet the applicable performance requirements for its respective partitioned service area. If the partitioner or partitionee fails to meet the four-year build-out requirement for its respective partitioned service area, then its license term will be reduced by two years. If the parties meet the end-of-term construction benchmarks, they will retain the ability to continue to build out the unserved portion of their license areas. Parties that fail to meet the end-of-term benchmarks will be subject to a “keep-what-you-use” rule, under which they will lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment. 32. *Disaggregation.* With regard to the rules relating to disaggregation of new 700 MHz Commercial Services Band licenses, the Commission modifies Section 27.15(d) to provide that the disaggregator, disaggregatee, or both the disaggregator and disaggregatee working together, can meet the four-year and end-of-term construction benchmarks for the entire geographic license area. If either of the parties meets the four-year build-out requirement, then this requirement is considered to be satisfied for both parties. If neither of the parties meets the four-year build-out requirement, then each of their license terms will be reduced by two years. Similarly, if either of the parties meets the end-of-term build-out requirement, then this requirement is considered to be satisfied for both parties and they will retain the ability to continue to build out the unserved portion of their license areas. However, parties that fail to meet the end-of-term benchmarks will be subject to an automatic “keep-what-you-use” rule, under which they will lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment.
(iii)Open Platforms for Devices and Applications 33. The Commission determines that for one commercial spectrum block in the 700 MHz Band—the Upper 700 MHz Band C Block (700 MHz C Block)—the Commission will require licensees to allow customers, device manufacturers, third-party application developers and others to use or develop the devices and applications of their choice, subject to certain conditions, so long as they meet all applicable regulatory requirements and comply with reasonable conditions related to management of the wireless network ( *i.e.* , do not cause harm to the network), as described further below. The Commission concludes, however, that it would not serve the public interest to mandate, at this time, requirements for open platforms for devices and applications for all unauctioned commercial 700 MHz spectrum, or to impose broader openness requirements, such as wholesale or interconnection requirements, for the 700 MHz C Block. 34. *Scope of Requirement for open platforms for devices and applications.* 700 MHz C Block licensees subject to this requirement will not be allowed to disable features or functionality in handsets, such as “locking” handsets to prevent their transfer from one system to another, where such action is not related to reasonable network management and protection, or compliance with applicable regulatory requirements. In addition, 700 MHz C Block licensees may not establish network standards that block Wi-Fi access, MP3 playback ringtone capability, or other services that compete with wireless service providers' own offerings. Standards for third-party applications or devices that are more stringent than those used by the provider itself would likewise be prohibited. In addition, 700 MHz C Block licensees cannot exclude applications or devices solely on the basis that such applications or devices would unreasonably increase bandwidth demands. The Commission emphasizes that 700 MHz C Block licensees may not impose any discriminatory charges (one-time or recurring) or conditions on customers who seek to use devices or applications outside of those provided by the licensee. Further, 700 MHz C Block licensees may not deny access to a customer's device solely because that device makes use of other wireless spectrum bands, such as cellular or PCS spectrum. However, in accepting a multi-band device on its network, a 700 MHz C Block licensee is not required to extend the requirement for open platforms for devices and applications to other spectrum bands on which the provider operates. 35. *Reasonable network requirements permitted.* The Commission emphasizes that it is not requiring wireless service providers to allow the unrestricted use of *any* devices or applications on their networks. Wireless service providers may continue to use their own certification standards and processes to approve use of devices and applications on their networks so long as those standards are confined to reasonable network management. For example, providers are free to choose their air interface technology, and to deny service to devices or applications that cannot operate on the same technology, and may restrict particular non-carrier devices and applications on their networks, specifically to ensure the safety and integrity of their networks. In particular, it is reasonable for wireless service providers to maintain network control features that permit dynamic management of network operations, including the management of devices operating on the network, and to restrict use of the network to devices compatible with these network control features. Standards to ensure that network performance will not be significantly degraded would also be appropriate. 36. The Commission does not specify a particular process for 700 MHz C Block licensees to develop reasonable network management and openness standards, but the Commission requires certain minimum steps to ensure that device manufacturers and application developers have the ability to design products for this spectrum in a timely manner. Specifically, a 700 MHz C Block licensee must publish standards no later than the time at which it makes such standards available to any preferred vendors ( *i.e.* , vendors with whom provider has a relationship to design products for the provider's network). The 700 MHz C Block licensee must also provide to potential customers notice of the customers' rights to request the attachment of a device or application to the licensee's network, and notice of the licensee's process for customers to make such requests, including the relevant network criteria. These network standards are expected to be non-proprietary, such that the standards would be open to any third party vendors and that the standards applied to third parties will be no more restrictive than those applied to the provider's preferred vendors. Providers must also establish a reasonable process for expeditiously reviewing requests from manufacturers, application developers and consumers to employ devices and applications on their networks. If a provider denies such a request, it must offer a specific explanation and an opportunity for amendment of the request to accommodate the provider's concerns. 37. The Commission encourages the development of industry-wide standards by an appropriate standards-setting body at the earliest possible date. 38. *Other regulatory requirements continue.* The requirement to provide an open platform for devices and applications the Commission is imposing shall not override wireless service providers' obligations to ensure that their networks and devices comply with applicable regulatory requirements ( *e.g.* , power and emission limits, E911, CALEA, etc.). For example, with respect to E911, if a network provider accepts a non-carrier device or application and if the device or application subsequently causes a violation of the Commission's rules, the Commission will apply the same third-party liability provisions as in the wireline context. 39. The Commission finds that a wireless carrier's obligations under its hearing aid compatibility rule, section 20.19 of the Commission's rules, are not affected by the openness obligations for 700 MHz C Block licensees. Under the Commission's rules, the extent of a carrier's compliance with the hearing aid compatibility obligations is not affected by handsets that connect to its network but it does not itself “offer” to its subscribers. Thus, the need to comply with section 20.19 of the Commission's rules would not justify a provider's refusal to connect a device. Further, the Commission declines to alter its hearing aid compatibility obligations to specifically impose an obligation on 700 MHz C Block licensees to ensure the hearing aid compatibility of handsets that are connected to the network but not offered by the provider. 40. *Enforcement processes.* The Commission intends to vigorously enforce the requirement to provide an open platform for devices and applications adopted for 700 MHz C Block licensees. The Commission will take appropriate enforcement action where necessary pursuant to the remedies available under its statutory authority, including forfeitures, license revocations, and cease-and-desist orders. A person or entity who believes a 700 MHz C Block licensee's refusal to attach a proposed device or application is a violation of the open platform rules adopted may file a complaint pursuant to the Commission's enforcement rules, including the Commission's formal and informal complaint processes, where applicable. The Commission sets forth certain presumptions for these complaints. Specifically, once a complainant sets forth a *prima facie* case that the 700 MHz C Block licensee has refused to attach a device or application in violation of the open platform requirements adopted, the licensee shall have the burden of proof to demonstrate that it has adopted reasonable network standards and reasonably applied those standards in the complainant's case. Further, where the 700 MHz C Block licensee bases its network restrictions on industry-wide consensus standards, the restrictions are afforded a presumption of reasonableness. The Commission commits to rule on any complaints filed within 180 days of receipt of such complaints. Interested parties also may file a petition for declaratory ruling where a particular practice has broad market impact. Through review of complaints and other relevant information, the Commission will monitor the ability of consumers, device manufacturers, and application developers to use or develop devices and applications for 700 MHz C Block networks.
(iv)Use of Dynamic Spectrum Management Techniques 41. In response to Google's first request, the Commission affirms that nothing in the Commission's rules generally prohibits 700 MHz licensees from using dynamic spectrum management practices. In response to Google's second suggestion, the Commission declines to mandate the use of dynamic spectrum management practices for 700 MHz Band licensees. 42. The Commission concludes that licensees should retain significant flexibility with regard to the precise mechanisms they utilize when it comes to managing spectrum access to the network and among users. Of course, to the extent any licensee believes that the specific spectrum management mechanisms that Google proposes is appropriate or preferable, it is free to choose to utilize these mechanisms, consistent with the Commission's guidance above.
(v)Protection of 700 MHz Public Safety Operations 43. The Commission shall continue to require Upper 700 MHz Band C Block licensees to meet the 76 + 10 log P and 65 + 10 log P out-of-band emission
(OOBE)limits with respect to the public safety bands. However, the Commission will not require the Upper 700 MHz Band D Block licensee to meet OOBE limits with respect to the public safety broadband spectrum. 44. The D Block licensee will still, however, be required to satisfy the 76 and 65 + 10 log P OOBE limits with respect to the narrowband portion of the public safety spectrum. Additionally, the Commission shall not require the D Block licensee and Public Safety Broadband Licensee to coordinate with one another to address potential overload interference, even though such licensees will be authorized on adjacent spectrum, because under the public/private partnership, as discussed above, the D Block licensee and Public Safety Broadband Licensee will be sharing the same infrastructure.
(vi)Licensee Eligibility 45. The Commission declines to impose eligibility restrictions for the licenses in the 700 MHz Band. Given the number of actual wireless providers and potential broadband competitors, it is unlikely that incumbent local exchange carriers (ILECs), cable providers, or large wireless carriers would be able to behave in an anticompetitive manner as a result of any potential acquisition of 700 MHz spectrum. b. 700 MHz Guard Bands
(i)Treatment of Reconfigured A Block 46. Because the reconfigured Guard Band A Block will now be located at 757-758/787-788 MHz between the Upper 700 MHz Band C and D Blocks, and will no longer be adjacent to public safety narrowband spectrum, the Commission concludes that it is no longer necessary to apply the adjacent channel power
(ACP)emissions criteria to the A Block. Instead, the Commission will apply OOBE limits, which are consistent with emission limits applicable to the C Block. Thus, A Block licensees are required to attenuate out-of-band by at least 43 +10log P dB. Further, the Commission finds that heightened OOBE criteria should continue to apply in order to provide adequate protection to public safety. Therefore A Block transmitter power must be attenuated to at least 76 + 10log P dB, in a 6.25 kilohertz bandwidth for base stations at 763 MHz, and 65 + 10log P dB for mobile units at 793 MHz. 47. *Frequency Coordination and the Cellular Architecture Prohibition.* The Commission will no longer apply sections 27.601(d) and 27.2(b) (requiring guard band users to employ frequency coordination procedures in cooperation with 700 MHz public safety coordinators, and prohibiting the use of cellular architectures in the Guard Bands) to reconfigured A Block licenses. 48. *Removal of the 746-747 MHz A Block Guard Band.* The Commission finds that it is unnecessary to retain the A Block Guard Band at 746-747 MHz to shield Upper 700 MHz Band C Block operations from interference from high power operations allowed in the Lower 700 MHz Band C Block.
(ii)Treatment of Reconfigured B Block 49. The Commission finds that it would not be prudent to make any changes that would introduce the possibility of increased interference to adjacent public safety operations. Any future operations in the Guard Band B Block will continue to be bound by the Commission's existing Guard Bands technical rules requiring frequency coordination and prohibiting the use of cellular system architectures. These continued technical restrictions on the B Block can be fully taken into account as the Commission considers future uses for the block. The Commission will, however, create additional flexibility by providing operations in the reconfigured B Block the option of employing either the existing ACP limits set forth in Section 27.53(d) of the Commission's rules, or the same OOBE limits used by other commercial licensees to protect public safety, *i.e.* , 76 + 10log P dB per 6.25 kHz for base stations, and 65 + 10log P dB per 6.25 kHz for mobile units.
(iii)Treatment of PTPMS II Licenses 50. To ensure interoperability in border areas with Canada, the Commission is modifying the PTPMS II licenses by relocating its Guard Band A Block license to 757-758 MHz and 787-788 MHz along with the “repacked” Guard Band A Block licenses, and by shifting its Guard Band B Block licenses down 1 megahertz to 761-763 MHz and 791-793 MHz. Although PTPMS II has elected to remain under the existing terms of its licenses, the Commission concludes that, for purposes of regulatory parity, the Commission should apply to the PTPMS II A Block licenses the same technical rules that will apply to the reconfigured A Block licenses. The Commission also concludes that the existing B Block technical rules continue to apply to PTPMS II's B Block licenses given their adjacency with public safety spectrum.
(iv)License Terms 51. The license terms for the A Block licenses, including the PTPMS II A Block licenses, shall extend to 10 years after the end of the DTV transition, through February 17, 2019, and subsequent license terms will be 10 years. However, the Commission will retain the existing license terms for the grandfathered PTPMS II B Block licenses, rather than extending them to match the other commercial licensees. Furthermore, the Commission does not provide a renewal expectancy to the PTPMS II B Block licenses, the terms of which will expire in 2015. 3. Auctions-Related Issues a. Anonymous Bidding 52. The Commission concludes that the public interest will be served if the upcoming auction of new 700 MHz Band licenses for which service rules are established today is conducted using anonymous bidding procedures. The Commission further concludes that implementation of anonymous bidding procedures during the upcoming auction of new 700 MHz Band licenses should not be contingent on a pre-auction measurement of likely competition based on an eligibility ratio. The Commission has delegated to the Wireless Bureau authority to establish auction procedures based on comment solicited shortly prior to the auction. Consistent with that authority, the Commission delegates to the Wireless Bureau the discretion to adopt specific procedures implementing these conclusions, taking into account the further record developed during our standard pre-auction process for establishing auction procedures and the possibility that alternative licenses may be offered at auction as described below. 53. Additionally, the Commission concludes that the record regarding the available 700 MHz Band licenses and the Commission's recent experience with anonymous bidding in other auctions indicate that the Commission's statutory mandates under Section 309(j)(3) of the Act would be better served by adopting anonymous bidding procedures for the upcoming auction of 700 MHz Band licenses. Such procedures should withhold from public release until after the auction closes any information that may indicate specific applicants' interests in the auction, including information such as their license selections and the identities of bidders placing bids or taking other bidding-related actions, such as withdrawals. The Commission further concludes that the implementation of anonymous bidding procedures in the upcoming auction of new 700 MHz Band licenses should not be contingent on the likely level of auction competition indicated by pre-auction bidder eligibility. Accordingly, the Commission directs the Wireless Bureau to propose and seek comment on detailed anonymous bidding procedures for the upcoming auction of the 700 MHz Band licenses consistent with these conclusions, including how anonymous bidding would impact a potential re-auction of one or more spectrum blocks if the reserve prices for the individual blocks are not met, and any additional continuation or alteration to the anonymous bidding rules necessary to preserve the integrity of the subsequent auction. b. Declaratory Ruling on Anti-Collusion Rule Reporting Requirement 54. To further its policy of preventing collusive behavior in Commission auctions, the Commission clarifies by declaratory ruling and conforming textual edit the obligation that applicants in Commission auctions have to report any communications of bids or bidding strategies that are prohibited by Section 1.2105(c)(1) of the Commission's rules. Pursuant to Section 1.2105(c)(6), any applicant that makes or receives such a communication shall report such communication in writing to the Commission immediately, and in no case later than five business days after the communication occurs. As noted in the Commission's Order adopting Section 1.2105(c)(6), the Commission cannot “take on the impossible task of screening all applicant communications” and, therefore, “the responsibility for identifying potentially unauthorized communications [must fall] on auction applicants.” The reports provided by applicants are essential to the Commission's ability to enforce its rule. Absent such reports, parties might find it easy to evade enforcement for extended periods of time, and possibly altogether. 55. Accordingly, the reporting requirement “obligate[s] parties to notify the Commission of communications that appear to violate the anti-collusion rule and to allow the Commission to determine whether a violation has occurred.” Consistent with this purpose, applicants have a continuous obligation to make such reports extending beyond the five business days after the communication occurs. This declaratory ruling, and the conforming modification of Section 1.2105(c)(6) of the Commission's rules, expressly states the continuing nature of this obligation. The Commission can and will enforce the obligation so long as it remains unfulfilled. The Commission emphasizes the continuing nature of the duty to report to preclude any attempt to evade the obligation by waiting out the expiration of the statute of limitations applicable for the enforcement of forfeitures and to reinforce the Commission's ability to detect collusion, which is critical to the Commission's ability to enforce and thereby discourage collusive behavior in Commission auctions. c. Package Bidding 56. The Commission concludes that package bidding with respect to licenses in the Upper 700 MHz Band C Block would serve the public interest by reducing the exposure problem that might otherwise inhibit bidders seeking to create a nationwide footprint. Accordingly, the Commission directs the Wireless Bureau, pursuant to its delegated authority and pre-auction process, to propose and implement detailed package bidding procedures for the auction of the Upper 700 MHz Band C Block licenses, taking into account the goals the Commission has articulated for package bidding and the concerns raised in this record. More specifically, the Wireless Bureau should propose an auction design that includes package bidding for the C Block licenses to facilitate the entry of a new nationwide competitor, without causing undue difficulty for bidders that are not interested in a nationwide license. The Wireless Bureau should also explore the use of package bidding for any blocks subject to re-auction in the event that a reserve price is not met. 57. The Wireless Bureau, consistent with its delegated authority and pre-auction process, may revise its proposal prior to implementation in the auction. In order to facilitate compliance with the statutory deadlines applicable to the auction of 700 MHz Band licenses, the Wireless Bureau has delegated authority to conduct an auction without package bidding for the Upper 700 MHz Band C Block licenses in the event that currently unforeseen difficulties make it impracticable to implement package bidding for the C Block consistent with the goals the Commission has articulated here. Finally, consistent with its conclusions today, the Commission directs the Wireless Bureau to adopt procedures for the auction of licenses in other blocks of 700 MHz Band spectrum without the use of package bidding. d. “New Entrant” Bidding Credit 58. The Commission concludes that it is not necessary to compound the discounts already offered to small new entrants by existing designated entity bidding credits, or to offer large, nationwide new entrants significant discounts on their bids. e. Reserve Prices 59. The Commission concludes that it should provide for separate aggregate reserve prices for each block of licenses to promote the Commission's statutory objective of recovering for the public a portion of the value of the public spectrum resource. If the auction results for the licenses in any block satisfy the aggregate reserve for that block, all licenses in the block will be assigned based on the auction results, subject to completion of the licensing process, including review of applicants' qualifications. The separate aggregate reserve prices should, taken together, reflect current assessments of the potential market value of this spectrum based on various factors including, but not limited to, the characteristics of this band and the value of other recently auctioned licenses, such as licenses for Advanced Wireless Services. In addition, the view of Congress as to the value of this spectrum, as reflected by the Congressional mandates for proceeds from the auction, should be given appropriate consideration. 60. In the event that licenses are not assigned because the applicable block-specific aggregate reserve is not met, the Commission provides for a prompt auction of alternative, less restrictive licenses for the A, B, C, and E Blocks, subject to the same applicable reserves. The Commission's rules also provide for the possibility of re-offering the D Block license in a subsequent auction. 61. *Block-Specific Aggregate Reserve Price.* The Commission concludes that the public interest requires a separate aggregate reserve price for each block of the 700 MHz Band licenses subject to competitive bidding in the upcoming auction. The reserve prices will be in addition to, and separate and apart from, any minimum opening bid amounts that may be established for purposes of the upcoming auction. If the aggregate reserve is met for any block, all licenses in that block that receive winning bids will be eligible for licensing subject to the completion of the Commission's review of long-form license applications. 62. The Commission also concludes that it is appropriate to assess interest in licenses in this context on a block-by-block basis. The Commission directs the Wireless Bureau to adopt and publicly disclose block-specific aggregate reserve prices, pursuant to its existing delegated authority and its regular pre-auction process, consistent with the Commission's conclusions. Given the Commission's intent that the reserve prices should maximize the possibility of recovering an appropriate portion of the value of the public spectrum resource while enabling licensing as promptly as possible, the Wireless Bureau should establish the particular amounts of the block-specific aggregate reserves by taking into account a conservative estimate of market value based on auction results for AWS-1 spectrum licenses. More specifically, the Wireless Bureau should consider the following factors when setting the block-specific aggregate reserves. The detailed rules regarding the D Block license, the D Block licensee's required construction of a network to be shared by public safety service users, and the resulting limitations on the flexibility of the D Block licensee, should be given substantial weight in assessing the D Block's value. Based solely on geographic area and spectrum block size, AWS-1 auction results might suggest a D Block reserve of $1.7 billion. However, in light of the D Block license conditions essential to the public safety purpose of the public/private partnership, it might be appropriate to expect the D Block licensee to contribute only about 75 percent to 80 percent of such an amount, or about $1.33 billion. In addition, when determining relative valuation of other blocks, the Wireless Bureau should consider the relative valuation of differing blocks in the recent auction of AWS-1 licenses. 63. *Subsequent Auction of Alternative Licenses.* The Commission recognizes that it is possible that the auction results may not satisfy one or more of the block-specific reserves. In that event, the Commission establishes a process to enable the assignment of alternative licenses for the A, B, C, and E Blocks of the 700 MHz Band as soon as possible in order to promote the speedy deployment of services utilizing 700 MHz Band spectrum. Under the Commission's rules, the license for the D Block may also be re-offered in a subsequent auction.. 64. The Commission also establishes a process to enable the assignment of alternative licenses as soon as possible in the event that the relevant block-specific aggregate reserve price is not met when those licenses are first offered. Specifically, the Commission will offer the more flexible, less conditioned licenses described below in the A, B, C, and E Blocks as soon as possible after the first auction. Given the unique character of the D Block license conditions, the Commission leaves open the possibilities of reevaluating those conditions or of promptly offering that license again in a subsequent auction, in the event the D Block-specific reserve is not met. 65. The Commission also provides that the auction of alternative licenses shall be subject to the same applicable reserve prices as the initial auction of licenses. The Wireless Bureau has delegated authority, however, to determine the appropriate means of reapportioning the reserve associated with the C Block in light of the Commission's determination to split the block into two blocks should a re-auction occur. This assures both that any initial and subsequent auctions will be as similar as possible (other than with respect to particular license terms) and also that the final assignment of the licenses will be based only on which licenses are able to serve the statutory goal of recovering a portion of the value of the public spectrum resource fixed in advance of the auction. Therefore, the Commission anticipates that the reserve price for the C Block would be approximately $4.6 billion. 66. *Performance Requirements for Alternative Licenses.* The Commission concludes that a failure of the auction results for the A, B, and E Block licenses to satisfy the applicable block-specific aggregate reserve should result in a prompt offering of alternative licenses for the relevant block(s) that are subject to performance requirements with the population benchmark regime the Commission has adopted for the C Block licenses. 67. *Changes to Alternative C Block Licenses.* The Commission concludes that in the event that auction results for conditioned Upper 700 MHz C Block licenses do not satisfy the aggregate reserve price for the C Block, the Commission will offer as soon as possible licenses for the C Block without the open platform conditions. The Commission will also modify the C Block band plan. The Commission will reconfigure the bandwidth of the licenses to create two paired blocks of 6 and 5 megahertz each, which the Commission will label the C1 and C2 Blocks. Further, the Commission will license the C1 Block based on EAs and the C2 Block based on REAGs. 68. *D Block License.* The Commission concludes that it should not alter the conditions it has adopted today for the D Block license based solely on auction results. The Commission believes that a D Block-specific aggregate reserve of approximately $1.33 billion is appropriate given the Commission's goal of enabling the recovery of a portion of the value of the spectrum while also permitting licensing to proceed as quickly as possible. If, however, the D Block-specific aggregate reserve is not met, the Commission concludes that it should leave open the possibility of re-offering the license on the same terms in a subsequent auction, as well as the possibility of re-evaluating all or some of the applicable license conditions. 69. *Auction Procedures.* The Commission directs the Wireless Bureau to adopt for the auction of 700 MHz Band licenses, consistent with its delegated authority and pursuant to its routine pre-auction process, procedures that will enable a prompt subsequent auction of alternative licenses for any block in the event that the relevant block-specific aggregate reserve price is not met. This order's provisions with respect to the procedures for the initial auction, including with respect to anonymous and package bidding, will continue to apply in any subsequent auction. Furthermore, the same applicable reserve prices for each block of licenses shall apply in both the initial and subsequent auctions, recognizing that the Wireless Bureau will be required to determine how to allocate the block-specific reserve price for the C Block upon reauction under the split block plan. The Commission directs the Wireless Bureau, consistent with its delegated authority to adopt procedures that will comply with this order and preserve the integrity of any necessary reauction. 70. The Commission directs the Wireless Bureau to establish procedures that limit qualified bidders in a subsequent auction of alternative licenses to those bidders that qualify to bid in the upcoming auction offering 700 MHz Band licenses in all of these blocks. Additionally, the Commission finds that the applicable “down payment deadline” for purposes of the Commission's anti-collusion rule shall be the “down payment deadline” established for the subsequent auction. In addition, because licenses for the same spectrum will be offered in both auctions, and the auctions will take place relatively close in time, the Commission concludes that the purpose of the Commission's anti-collusion rule requires that the provisions of that rule continue to apply until the down payment deadline for the subsequent auction. To assure that bidders will have sufficient bidding eligibility to pursue various bidding strategies, the Commission directs the Wireless Bureau to propose and adopt procedures that give applicants an opportunity to obtain bidding eligibility specifically for the alternative licenses, in addition to the initial licenses. 71. The Wireless Bureau also should consider any additional procedures within its delegated authority that may enhance the effectiveness of the Commission's auction of 700 MHz Band licenses in either the initial or subsequent auction. In this regard, the Commission directs the Wireless Bureau to consider what procedures may be appropriate to deter bidders from actions that might thwart the assignment of licenses in either auction. f. Statutory Deposit Deadline 72. The Commission will deposit payments made by successful bidders towards their respective winning bids for their licenses—including upfront payments, deposits, and final payments held on deposit pending the completion of licensing—as of the deposit deadline, June 30, 2008, even in instances where the licensing process for those licenses has not yet been completed. B. 700 MHz Public Safety Spectrum 73. *700 MHz Public Safety Spectrum.* The Commission adopts a revised band plan for the 700 MHz Public Safety Band. The Commission designates the lower five-megahertz paired (ten megahertz total) segment of the 700 MHz Public Safety Band for broadband communications. The Commission consolidates the public safety narrowband operations in the upper paired 6-megahertz blocks (twelve megahertz total) of the 700 MHz Public Safety Band. The Commission adopts a one-megahertz paired guard band (768-769/798-799 MHz) between the broadband and narrowband segments. The Commission further concludes that in order to maximize the benefits of the 700 MHz Public/Private Partnership to deploy a nationwide, interoperable broadband communications network, narrowband operations presently in channels 63 and 68 (and the upper one megahertz of channels 64 and 69) must be cleared no later than the DTV transition date. 74. The Commission requires the Upper 700 MHz Band D Block licensee to pay the costs associated with relocating public safety narrowband operations to the consolidated channels, in recognition of the significant benefits that will accrue to the D Block licensee. To facilitate the relocation, the Commission requires every 700 MHz Band public safety licensee, whether holding individual narrowband authorizations or operating pursuant to a State License, to provide the following information:
(1)The total number of narrowband mobile and portable handsets in operation in channels 63 and 68, and the upper one megahertz of channels 64 and 69,
(2)the total number of narrowband base stations serving these handsets in operation,
(3)contact information for each identified set of handsets and base stations, as appropriate,
(4)the areas of operation of the mobile and portable units (such as defined by the jurisdictional boundaries of the relevant public safety departments), and
(5)the location, in latitude and longitude, of the base stations, all as of August 30, 2007. This information must be filed with the Commission by October 23, 2007 and must include a certification, signed by an authorized party, stating that the information provided therein is true, complete, correct, and made in good faith. The Public Safety and Homeland Security Bureau will issue a public notice in advance of the effective date announcing the deadline for this certification requirement. 75. The Commission prohibits authorization, whether pursuant to individual license or State License, of any new narrowband operations in channels 63 and 68, or in the upper one megahertz of channels 64 and 69, as of August 30, 2007. The Commission cautions that any equipment deployed in these frequencies subsequent to August 30, 2007 will be ineligible for relocation funding. 76. The Commission requires all Regional Planning Committees with approved plans or plans on file to submit amended plans consistent with the decisions herein by November 23, 2007. 77. *Public Safety Broadband Licensee.* The Commission concludes that the public interest is best served by establishing a single nationwide Public Safety Broadband License for the 700 MHz public safety broadband spectrum. The Commission will assign this license to a single Public Safety Broadband Licensee that will be responsible for implementing the 700 MHz public safety nationwide interoperable broadband network. This network will serve to provide public safety entities access to new broadband technologies across the country. Further, the Commission provides that the Upper 700 MHz D Block Licensee will gain access to the 700 MHz public safety broadband spectrum on a secondary preemptible basis through a spectrum leasing arrangement with the Public Safety Broadband Licensee. 78. The Commission adopts its proposal to license the 700 MHz public safety broadband spectrum as a 10-megahertz block (comprised of paired, 5-megahertz blocks) under a nationwide geographic area license, and the Commission will assign this license to the Public Safety Broadband Licensee. The Commission establishes a variety of eligibility criteria for this entity and sets out a variety of responsibilities, including negotiating the Network Sharing Agreement with the winning bidder of the Upper 700 MHz Band D Block license. The Commission delegates authority to the Chief of the PSHSB to issue a public notice within thirty days of the release of this Second Report and Order soliciting applications for the Public Safety Broadband Licensee. The public notice shall specify the baseline criteria the Commission establishes herein, and describe the procedures and other requirements for submitting applications. The Commission will select the Public Safety Broadband Licensee and grant to it the Public Safety Broadband License consistent with the requirements and considerations set forth herein. 700 MHz Public/Private Partnership 1. Adoption of the 700 MHz Public/Private Partnership 79. The Commission designates the D Block in the Upper 700 MHz Band to be licensed to a commercial entity on a nationwide basis for the purpose of entering into the 700 MHz Public/Private Partnership with the Public Safety Broadband Licensee, and the Commission adopts a number of conditions, requirements, and procedures to safeguard services to public safety entities and address concerns about the success of the partnership, as discussed more fully below. 2. Essential Components of Public/Private Partnership a. Shared Wireless Broadband Network 80. In order to have a successful public/private partnership with a shared nationwide interoperable broadband network infrastructure that meets the needs of public safety, the Commission adopts certain network requirements. The public/private partnership network will serve as the nation's public safety wireless broadband network infrastructure, so it must meet the requirements of a public safety communications network. Accordingly, the Commission requires that the network incorporate, at a minimum, the following: • Specifications for a broadband technology platform that provides mobile voice, video, and data capability that is seamlessly interoperable across agencies, jurisdictions, and geographic areas. The platform should also include current and evolving state-of-the-art technologies reasonably made available in the commercial marketplace with features beneficial to the public safety community ( *e.g.,* increased bandwidth). • Sufficient signal coverage to ensure reliable operation throughout the service area consistent with typical public safety communications systems ( *i.e.* , 99.7 percent or better reliability). • Sufficient robustness to meet the reliability and performance requirements of public safety. To meet this standard, network specifications must include features such as hardening of transmission facilities and antenna towers to withstand harsh weather and disaster conditions, and backup power sufficient to maintain operations for an extended period of time. • Sufficient capacity to meet the needs of public safety, particularly during emergency and disaster situations, so that public safety applications are not degraded ( *i.e.* , increased blockage rates and/or transmission times or reduced data speeds) during periods of heavy usage. In considering this requirement, the Commission expects the network to employ spectrum efficient techniques, such as frequency reuse and sectorized or adaptive antennas. • Security and encryption consistent with state-of-the-art technologies. • A mechanism to automatically prioritize public safety communications over commercial uses on a real-time basis and to assign the highest priority to communications involving safety of life and property and homeland security consistent with the requirements adopted in this Second Report and Order. • Operational capabilities consistent with features and requirements specified by the Public Safety Broadband Licensee that are typical of current and evolving state-of-the-art public safety systems (such as connection to the PSTN, push-to-talk, one-to-one and one-to-many communications, etc.). • Operational controls of the network by the Public Safety Broadband Licensee to the extent necessary to ensure public safety requirements are met. • The Public Safety Broadband Licensee shall have the right to determine and approve the specifications of public safety equipment that is used on the network, and the right to purchase its own subscriber equipment from any vendor it chooses, to the extent such specifications and equipment are consistent with reasonable network control requirements established in the NSA. • A requirement, as explained more fully herein, that the Upper 700 MHz D Block licensee make available to the Public Safety Broadband Licensee at least one handset that would be suitable for public safety use and include an integrated satellite solution capable of operating both on the 700 MHz public safety spectrum and on satellite frequencies. 81. These requirements are to be implemented by the parties through the NSA, which will also include the detailed specifications of the network that the D Block licensee will construct. By allowing the parties to determine specific details, including the technologies that will be used, subject to approval by the Commission, the Commission provides them with flexibility to evaluate the cost and performance of all available solutions while ensuring that the shared wireless broadband network has all the capabilities and attributes needed for a public safety broadband network. b. Spectrum Use 82. The Commission permits the Public Safety Broadband Licensee to provide access on a secondary and preemptible basis to this spectrum, pursuant to the spectrum lease specified herein, for the purpose of enabling commercial operations within the band devoted to primary public safety broadband use. The Upper 700 MHz D Block licensee will gain access to this public safety broadband spectrum by means of a spectrum leasing arrangement with the Public Safety Broadband Licensee. The Commission also places additional conditions regarding the use of the D Block spectrum, including a requirement that the D Block licensee provide the Public Safety Broadband Licensee with priority access to the D Block license spectrum during emergencies. 83. In addition, the Commission concludes that Section 337(a)(1) does not prohibit the Public Safety Broadband Licensee from entering into the lease for commercial operations, on a limited and preemptible basis as specified herein, of spectrum that is allocated for public safety services. Further, the Commission finds that Section 337(a)(2), which directs the Commission to allocate 36 megahertz “for commercial use,” does not prohibit the Commission from requiring the D Block licensee to provide public safety users with priority access to D Block license spectrum in an emergency. Priority service, although provided to public safety, will still be commercial, and will not appreciably impair the D Block licensee's ability to provide commercial services to other parties. 84. *Commercial Operations in Public Safety Spectrum on a Secondary Basis.* The Commission permits the leasing of the Upper 700 MHz Band spectrum currently allocated for public safety services to commercial providers on a secondary, unconditionally preemptible basis. The Public Safety Broadband Licensee will be required to lease the public safety spectrum for use by the D Block licensee on a secondary basis pursuant to the requirements set forth in the NSA and established in this Second Report and Order. Thus, under the 700 MHz Public/Private Partnership framework adopted here, the D Block licensee will be obligated to construct a broadband network capable of operating on the public safety broadband spectrum for the benefit of the Public Safety Broadband Licensee, and the Public Safety Broadband Licensee will be obligated to permit secondary commercial operations on the public safety broadband spectrum pursuant to the spectrum leasing arrangement. 85. The Commission will require that this spectrum leasing arrangement take the form of a long-term spectrum manager leasing arrangement for the full term of the license. By limiting the D Block licensee's secondary use of the Public Safety Broadband Licensee's spectrum to leased access under a spectrum manager leasing arrangement, subject to the conditions the Commission is placing on the nature of that access, the Commission thus ensures that the Public Safety Broadband Licensee has the regulatory means (and obligation) to preserve the fundamental public safety function of the band. Moreover, the Public Safety Broadband Licensee's ultimate control over the D Block licensee's use of this band, coupled with the operational flexibility accorded the D Block licensee under a spectrum manager leasing arrangement, should provide an appropriate balance between commercial and public safety operations in the public safety broadband spectrum. Specifically, the spectrum manager leasing arrangement permits the D Block licensee to construct a network to serve its business needs, yet preserves the network infrastructure required for primary public safety use in the Public Safety Broadband Licensee's band. 86. As further conditions on the spectrum leasing arrangement authorized here, the D Block licensee's commercial operations in the public safety spectrum must not cause interference to primary users ( *i.e.* , public safety users) and must accept interference from primary users at all times. To help ensure that commercial secondary use complies with these limitations, in the public safety broadband spectrum the Commission will require that the network be designed so as to automatically assign priority to public safety users, to the exclusion and/or immediate preemption of any commercial use on a dynamic, real-time priority basis, and that network specifications are sufficient to guarantee that public safety users suffer no harmful interference or interruption or degradation of service due to commercial operations in the public safety broadband spectrum. 87. *Priority Public Safety Access to Commercial Spectrum During Emergencies.* As part of its responsibilities in managing the shared wireless broadband network, the Commission requires the D Block licensee to provide the Public Safety Broadband Licensee with priority access, during emergencies, to the spectrum associated with the D Block license (in addition to the 700 MHz public safety broadband spectrum). In determining what constitutes an emergency, the Commission agrees with Frontline that the definition of an “emergency” for this purpose should be left to negotiation between the parties. The Commission requires the parties to define “emergency” for purposes of priority access to D Block license spectrum as part of the NSA. 88. The Commission recognizes that there may be occasions when the parties are unable to agree that an emergency situation requires priority access to the D Block license spectrum, especially in circumstances that do not clearly fall within the definition of “emergency” negotiated by the parties in the NSA. On these occasions, the Public Safety Broadband Licensee may request that the Commission declare, on an expedited basis, that particular circumstances warrant emergency priority access. In order to facilitate this process and ensure a prompt response, the Commission delegates authority to the Defense Commissioner to decide these requests and amends Section 0.181 of the Commission's rules to reflect this new duty. 89. Under emergency conditions, all public safety entities in the affected area will have real-time access, as needed, to all D Block license spectrum on a priority basis over commercial traffic and will preempt ongoing commercial traffic to the extent necessary. In this regard, the Commission requires the D Block licensee to provide appropriate warnings to its commercial customers about the potential interruption of their service during emergencies due to preemption by public safety users. The NSA should address how the D Block licensee will satisfy this obligation, including, for example, encouraging the use of devices that can access spectrum other than the D Block. The NSA must also recognize that emergency 911 calls from commercial users also play a critical role in safeguarding public safety and should be accorded some level of priority, which may be lower priority than public safety communications but will not be subject to interruption of ongoing calls by public safety users and will have priority over all other commercial uses. 90. *Secondary Markets Rules.* In permitting the Public Safety Broadband Licensee to enter into this spectrum leasing arrangement subject to the conditions set out in this order, the Commission waives the spectrum leasing policies and rules insofar as they prohibit public safety licensees from entering into spectrum leasing arrangements for commercial operations. c. Performance Requirements 91. The Commission adopts specific performance requirements that include three population-based build-out benchmarks that cover the nationwide D Block license area. Specifically, the Commission will require the D Block licensee to provide signal coverage and offer service to at least 75 percent of the population of the nationwide D Block license area by the end of the fourth year, 95 percent of the population of the nationwide license area by the end of the seventh year, and 99.3 percent of the population of the nationwide license area by the end of the tenth year. To meet these requirements, the D Block licensee must use the most recently available U.S. Census Data. The Commission concludes that the build-out requirements being imposed will ensure that public safety needs are met. 92. In order to ensure that less populous areas are not neglected in the D Block licensee's build-out efforts, the Commission adopts certain additional measures to encourage coverage in those areas. Accordingly, the Commission requires that the D Block licensee meet the Commission's initial population benchmarks based on a build-out schedule specified in the NSA consistent with the public safety needs. The Commission also requires the D Block licensee to offer at least one handset suitable for public safety use that includes an integrated satellite solution pursuant to the terms, conditions, and timeframes set forth in the NSA. 93. The Commission's three population-based construction benchmarks will take effect beginning on February 17, 2009. This is the statutorily imposed DTV transition date and is the same date that build-out obligations for the other unauctioned commercial 700 MHz Band licensees will begin to take effect. Thus, the Commission's four, seven, and ten year construction benchmarks for the D Block licensee will be calculated as starting from February 17, 2009. Use of this date provides regulatory parity and it recognizes that the DTV transition will not be completed until this date. The Commission notes that the D Block licensee may begin constructing its system prior to February 17, 2009, and may begin operating its system prior to that date so long as it provides appropriate interference protection to incumbent co-channel and adjacent channel broadcasters. 94. The Commission will apply the three population-based construction benchmarks over the nationwide D Block license area. Accordingly, the D Block licensee must employ a signal level sufficient to provide adequate service to the relevant percentage of the population over the nationwide D Block license area. Moreover, the Commission requires that the network and signal levels employed to meet these benchmarks be adequate for public safety use, as defined in the Shared Wireless Broadband Network sub-section herein and further defined by the NSA, and that the services made available be appropriate for public safety entities in those areas. In particular, the Commission requires as a mandatory provision of the NSA that the D Block licensee and Public Safety Broadband Licensee negotiate inclusion into the build-out schedule coverage of major highways and interstates, as well as incorporated communities with a population in excess of 3,000, as suggested by APCO, IACP and IAFC. In addition, to the extent that the D Block licensee chooses to provide commercial services to population levels in excess of the relevant benchmarks, the D Block licensee will be required to make the same level of service available to public safety entities. 95. In certain limited circumstances, the Commission will permit the D Block licensee to modify these population-based construction benchmarks where the D Block licensee and the Public Safety Broadband Licensee reach agreement and the full Commission gives its prior approval for a modification. As with other commercial 700 MHz Band licensees, the D Block licensee will be required to demonstrate compliance with the Commission's adopted benchmarks by filing with the Commission within 15 days of passage of the relevant benchmarks a construction notification comprised of maps and other supporting documents certifying that they have met the Commission's performance requirements. The construction notification, including the coverage maps and supporting documents, must be truthful and accurate and not omit material information that is necessary for the Commission to make a determination of compliance with the Commission's performance requirements. However, unlike the other commercial licenses and because of the nature of the partnership established herein, the D Block licensee will not be subject to a “keep-what-you-use” rule. Rather, the Commission will strictly enforce these build-out requirements and, if the D Block licensee fails to meet a construction benchmark, the Commission may cancel its license, depending on the circumstances. d. Network Sharing Agreement
(NSA)and Mandatory Provisions 96. The Commission establishes that the relationship between the Public Safety Broadband Licensee and the D Block licensee will be governed by the Network Sharing Agreement
(NSA)to be negotiated by the parties, and such other separate agreements as the Commission may require or allow, and the Commission provides that compliance with the terms of the NSA shall be a regulatory condition of the D Block license. Breach of this licensing condition may, at the determination of the Commission, result in remedies including, but not limited to, cancellation and subsequent award of the license. The Commission also requires all the parties to negotiate in good faith and finds that many of the details of their agreement are appropriately left to them to negotiate and reach agreement on (subject to ultimate Commission approval of the NSA). In the discussion that follows, certain elements that the Commission requires the parties to address in the NSA are enumerated. 97. *Rights and Obligations Under the Public/Private Partnership.* The NSA must incorporate all of the substantive rights and obligations of the parties that the Commission has established in this Second Report and Order that are relevant to the Public/Private Partnership. Once the NSA is approved by the Commission and executed by the parties, assuming all other licensing requirements are met, the Commission will grant the D Block license to the winning bidder and compliance with the terms and conditions of the NSA will be license conditions for both the D Block license and the Public Safety Broadband License. The Commission requires the parties to submit an executed NSA within 10 business days of the Commission's approval of the agreement, and if the parties fail to submit the NSA, the Commission will deny granting the D Block license until the NSA is submitted. 98. *Term of Agreement.* The NSA must have a term not to exceed 10 years from February 17, 2009, which coincides with the term of the D Block license established elsewhere in this Second Report and Order. At the conclusion of the initial, and subsequent, term of the agreement, the NSA may be renewed along with the D Block license, subject to Commission approval. The Commission finds it appropriate to ensure that consideration of whether to renew the D Block license and whether to renew or modify the NSA whose performance is a condition of that license should occur at the same time. 99. *Service Fees.* The Commission finds that all service fees for public safety service should be specified in the NSA, including any applicable fees for normal network service and fees for priority access to the D Block in an emergency. The Commission finds that the parties should be left to negotiate reasonable rates in good faith, taking into account all appropriate factors, including but not limited to the public/private nature of the partnership. The Commission expects, however, that the parties will negotiate a fee structure for priority access to the D Block in an emergency that will protect public safety users from incurring unforeseen (and unbudgeted) payment obligations in the event that a serious emergency necessitates preemption for a sustained period. The Commission also encourages the parties to negotiate a fee agreement that incorporates financial incentives for the commercial licensee based on the number of public safety entities and localities that subscribe to the service. 100. The Commission also expects that fees will be such that public safety entities are able to afford the services that they require for their public safety functions, and that the terms will best serve the public interest goals established in this Second Report and Order regarding the public/private partnership. Should it prove necessary, the Commission has established various remedies to resolve disputes over NSA terms, and the Commission can exercise one of these options to ensure that fees charged are reasonable. 101. *Detailed Build-Out Schedule.* The NSA must include a detailed build-out schedule that is consistent with the mandatory national build-out and performance benchmarks that the Commission has established for the D Block licensee elsewhere in this Second Report and Order. The Commission expects the NSA to identify the specific areas of the country that will be built out by each of the construction deadlines that the Commission has established. Because the Commission must ensure that smaller towns and rural areas are not neglected in the D Block licensee's build-out efforts, the Commission requires the D Block licensee to meet the Commission's initial population benchmarks by not exclusively concentrating on building out high population areas. In this regard, the Commission agrees with public safety commenters to the extent that the Commission requires the parties to include in the NSA coverage for major highways and interstates, as well as such additional areas that are necessary to provide coverage for all incorporated communities with a population in excess of 3,000, unless the Public Safety Broadband Licensee and the D Block licensee jointly determine, in consultation with a relevant community, that such additional coverage will not provide significant public benefit. The Commission also requires an estimated cost for each specified area of the build-out, which will assist the Commission in efforts to ensure that the build-out schedule is achieved. 102. *Modifications to the NSA.* The Commission obligates the parties to act in good faith in all dealings with each other and to abide by the terms of the agreement. The NSA must specify that any major modifications to the terms of the NSA, related agreements or documents, or such other agreements as the Commission may require or allow, require not only the agreement of the parties, but also prior Commission approval. All other modifications require prior approval by the Chiefs of the Wireless Bureau and the Public Safety and Homeland Security Bureau on delegated authority. e. License Term and Renewal Expectancy for the Public/Private Partnership 103. Consistent with the decision made for other commercial licensees in the *700 MHz Report and Order,* the Commission decides that a term not to exceed 10 years from February 17, 2009, should be used for initial authorization in the D Block license. The D Block license would be auctioned as a single, nationwide license to provide for commercial service in the “D Block,” and to build and operate a joint broadband public safety and commercial network for public safety use. 104. At the end of the 10 year term, the D Block licensee will be allowed to apply for license renewal, although its renewal will be subject to its success in meeting the material requirements set forth in the NSA as well as all other license conditions, including meeting the performance benchmark requirements. Because the initial NSA term will expire at the same time, the D Block licensee must also file a renewed or modified NSA for Commission approval at the time of its license renewal application. Given these detailed license renewal requirements, the Commission declines to impose a separate substantial service showing. 105. The material requirements set forth in the NSA are conditions of the D Block license, including the network build-out schedule and satisfaction of the agreed-upon public safety specifications regarding the network construction and operations, in order to obtain a renewal of the license. Regarding the D Block license renewal application, the Commission finds the material requirements in the NSA to be those requirements that are the “essence” of the agreement between the parties, including but not limited to the build-out schedule for the public safety network and other provisions that serve the fundamental purpose of the NSA, as well as any time limits on the performance of those provisions. f. Public Safety Satellite Support 106. The Commission requires that the D Block licensee make available to public safety users at least one handset that includes a seamlessly integrated satellite solution. The Commission does not require that this handset use any specific technology, only that it be capable of operating both on the 700 MHz public safety spectrum and on the satellite frequency bands and/or systems of the satellite service providers with which the Public Safety Broadband Licensee has contracted for satellite service. The Commission does not, however, require that the D Block licensee incorporate support for satellite communications into the infrastructure of the shared terrestrial network. 107. The Commission expects that the D Block licensee, satellite companies, and handset manufacturers will take steps to facilitate the development of handsets with seamlessly integrated satellite solutions. However, the Commission does not establish an immediate obligation upon the D Block licensee to make satellite-capable handsets available. Rather, the Commission will require the D Block licensee to begin offering at least one handset suitable for public safety use that includes a seamlessly integrated satellite solution pursuant to the terms, conditions, and timeframes set forth in the NSA. 108. The Commission declines to mandate the incorporation of support for satellite communications by the D Block licensee into the infrastructure of the shared network. The Commission believes that the D Block licensee and the Public Safety Broadband Licensee will be in the best position to determine whether and when satellite support within the terrestrial infrastructure is appropriate, and by what method it should be implemented, such as by negotiating a side-agreement with existing satellite service providers to use their excess capacity for public safety communications. g. Local Public Safety Build-Out and Operation 109. The Commission concludes that no public safety entity will be required to use the 700 MHz public safety broadband network, and that any participation in the 700 MHz nationwide public safety network by individual public safety entities will be entirely voluntary. The Commission also concludes, however, that the Upper 700 MHz Band D Block licensee should have the exclusive right to build and operate the shared wireless broadband network using the 700 MHz public safety broadband spectrum, except that the Commission permits public safety entities to construct local broadband networks in the 700 MHz public safety spectrum in two limited circumstances subject to conditions specified below. The Commission further concludes that public safety entities should have a limited right to build out wideband networks, again with conditions and restrictions. 110. *Rights to Early Build-out in Areas with a Build-out Commitment.* First, in an area where the D Block licensee has, in the NSA, committed to build out by a certain date, but where a public safety entity wishes a more immediate build-out, the public safety entity may, with the pre-approval of the Public Safety Broadband Licensee, have the network constructed in that area at the public safety entity's own expense. The network must be capable of operating on the shared, interoperable broadband network that operates on both the D Block licensee's commercial block and the public safety 700 MHz broadband spectrum, and must meet all of the same requirements and specifications as the shared network required under the NSA. 111. The Commission authorizes two options for implementing the early build-out of an area of the broadband network at the discretion of the public safety entity. Under the first option, the public safety entity (or the Public Safety Broadband Licensee acting on its behalf) may construct the network in that area. Upon construction, it must transfer the network to the D Block licensee, which shall integrate that network into the shared national broadband network constructed pursuant to the NSA. Under the second option, the public safety entity may require the D Block licensee to construct the network in that area earlier than scheduled, but the public safety entity must provide all funds necessary for the early construction of the network, including any and all additional resource and personnel costs. As with the first option, upon construction, the D Block licensee will operate and manage the network as an integrated part of the larger shared national broadband network. 112. In either case, the Public Safety Broadband Licensee, the D Block licensee, and the public safety entity must, prior to any construction, negotiate an amendment to the NSA regarding this part of the network, specifying ownership rights, fees, and other terms, which may be distinct from the analogous terms governing the shared national broadband network. Absent agreement to the contrary, the amendment must provide that by a date no later than the build-out date specified for that area in the NSA, the D Block licensee will receive full ownership rights and will in turn compensate the public safety entity (or the Public Safety Broadband Licensee, where appropriate) for the construction of the network. The right to compensation for the build-out shall be limited, again absent agreement to the contrary, to the cost that would have been incurred had the D Block licensee constructed the network itself in accordance with the original terms and specifications of the NSA. 113. The Commission points out that early build-out in this scenario is a right to construct only. Operations may not commence on the network until the network is transferred to the D Block licensee. Operations on early build-out networks would then be conducted under the authority of the Public Safety Broadband Licensee's license, in the same manner as any network operations that occur following construction by the D Block licensee under the build-out schedule contained in the NSA. 114. Starting on the date of compensation for build-out, or on the build-out due date of the NSA if there is no specified date of compensation, the D Block licensee may include the early build-out for purposes of determining whether it has met its national build-out benchmarks and the build-out requirements of the NSA. 115. The Commission notes that the National Capital Region
(NCR)has commenced construction and operation of a broadband network in the 700 MHz Band pursuant to an experimental license and has been granted a waiver in anticipation of its application for a license to operate such system. The NCR consists of eighteen jurisdictions: The District of Columbia, Montgomery and Prince Georges Counties of Maryland, and the cities of Gaithersburg, Rockville, Takoma Park, Bowie, College Park, and Greenbelt; Arlington, Fairfax, Loudon and Prince William Counties of Virginia, and the cities of Alexandria, Falls Church, Town of Leesburg, Manassas, and Manassas Park. Although NCR cannot now obtain a license, as such license will be held by the Public Safety Broadband Licensee, nothing herein should be construed as preventing or limiting NCR's ability to continue to operate the broadband network they have built within the 700 MHz broadband allocation (subject to NCR properly obtaining a grant of a request for Special Temporary Authority for such continued operation) until such time as the NCR network is integrated into the nationwide, interoperable broadband network in accordance with the build-out plan set forth in the NSA. 116. The Commission advises the Public Safety Broadband Licensee to consult NCR in negotiating the build-out date for the nationwide, interoperable network, as the build-out plan in the NSA should allow NCR a reasonable time to make any modifications necessary to incorporate its network into the nationwide, interoperable broadband network by the date set forth in the NSA for build out of the portion of the nationwide, interoperable broadband network in the NCR. NCR will, of course, be expected to comply with the requirements set forth herein for public safety entities exercising the right to early build out, and NCR shall be entitled to the same rights and compensation as set forth herein for public safety entities electing to exercise their right to early build out. 117. The Spectrum Coalition would have the Commission give local public safety entities, including NCR, the ability to “opt-out” of the national, interoperable broadband network, yet operate individual systems in the 700 MHz Band. The Commission flatly rejects such arguments; local public safety entities do not have to participate in the nationwide network, but they may not “opt-out” in favor of using the 700 MHz broadband spectrum for individual networks. As a general matter, as we have discussed above, there are numerous benefits to having a single Public Safety Broadband Licensee. 118. *Rights to Build Out and Operate In Areas without a Build-out Commitment.* The Commission acknowledges that, even under the stringent population-based build-out requirements that the Commission is adopting, there will be areas of the nation in which the NSA does not require the D Block licensee to build out the shared broadband network. In such areas, under the policies and procedures discussed below, the Commission provides that a public safety entity may build out and operate a separate, exclusive network in the 700 MHz public safety broadband spectrum at any time, provided the public safety entity has received the approval of the Public Safety Broadband Licensee and operates its independent network pursuant to a spectrum leasing arrangement into which the public safety entity has entered with the Public Safety Broadband Licensee. 119. Under this option, the public safety entity need not obtain any agreement with the D Block licensee. The Public Safety Broadband Licensee must, however, provide the D Block licensee with notice of the public safety entity's intent to construct in that area within 30 days of receipt of a request from a public safety entity wishing to exercise this option, and shall inform the D Block licensee of the public safety entity's anticipated build-out date(s). This affords the D Block licensee the opportunity, in conjunction with the Public Safety Broadband Licensee, to reconsider whether the NSA should be revised to include a commitment to build out the area that the public safety entity has identified. Further, if within 30 days of receiving such notice the D Block licensee certifies in writing to the Public Safety Broadband Licensee that it will build out the shared network in the area, within a reasonable time of the anticipated build-out date(s), as determined by the Public Safety Broadband Licensee, then the public safety entity shall not have the option of building out and operating its own separate exclusive network in the area. Under this circumstance, the D Block licensee, working with the Public Safety Broadband Licensee, must then adopt an appropriate amendment to the NSA, and such commitment would become enforceable against the D Block licensee as part of its build-out requirements. The Commission also notes that, as an alternative in such cases, the public safety entity would be able to complete early build-out under the procedures discussed above. 120. If the public safety entity pursues this option to build out a separate network, the Public Safety Broadband Licensee and public safety entity, as its spectrum lessee, must file a spectrum leasing arrangement with the Commission prior to the public safety entity commencing any operations. The Commission will require that the spectrum leasing arrangement take the form of a spectrum manager leasing arrangement under the Commission's spectrum leasing rules. The Commission will not permit such arrangements to take the form of long-term *de facto* transfer spectrum leasing arrangements. The Commission believes that it is necessary that the Public Safety Broadband Licensee retain not only *de jure* control of all of the spectrum associated with the Public Safety Broadband License, even in areas not scheduled for build-out, but also *de facto* control of the spectrum leased for use by public safety entities. As a result, the Commission finds it essential that, as provided under the spectrum manager leasing rules and as distinguished from the long-term *de facto* transfer leasing arrangement, the Public Safety Broadband Licensee maintain actual oversight and working knowledge of its spectrum lessees' activities in order to ensure compliance with all requirements of the Communications Act, the Commission's rules, and the obligations set forth in this Second Report and Order. 121. In addition to compliance with the Commission's spectrum leasing requirements, the public safety spectrum lessee must ensure that the following conditions are met:
(1)The network must provide broadband operations;
(2)the network must be fully interoperable with the shared national broadband network required by the NSA;
(3)the network must be available for use by any public safety agency in the area; and
(4)the network must satisfy any other terms or conditions required by the Public Safety Broadband Licensee. These conditions specifically must be included in the spectrum manager lease agreement entered between the Public Safety Broadband Licensee and the public safety entity. Consistent with Section 90.551 of the Commission's rules, which contains the general 700 MHz public safety spectrum construction requirements, the lease agreement between the parties must specify that the public safety entity must construct and place into operation its network within one year of the effective date of the spectrum manager leasing arrangement, and if not, then the Public Safety Broadband Licensee will terminate the spectrum leasing arrangement pursuant to the Commission's rules. The separate network need not, however, meet the other specifications of the D Block licensee's shared national network. In particular, absent agreement of the public safety entity, the Public Safety Broadband Licensee, and the D Block licensee, the separate network may not operate using any spectrum associated with the D Block license. Finally, as required by the Commission's spectrum leasing rules, the Public Safety Broadband Licensee must notify the Commission of the spectrum manager leasing arrangement as part of the Commission's spectrum manager lease notification procedures. The notice must identify the public safety entity leasing the spectrum and the particular areas of spectrum leased as part of this build-out option. 122. The Commission emphasizes that under no conditions may a public safety entity construct a network using 700 MHz public safety broadband spectrum in an area absent the approval of the Public Safety Broadband Licensee. Nothing in this determination should be construed, however, to prohibit the Public Safety Broadband Licensee from being responsive to requests from localities to opt out and provide separate network services pursuant to a spectrum lease approved by the Public Safety Broadband Licensee and the Commission. 123. *Conditions for Waiver to Allow Limited and Temporary Wideband Operations.* The Commission prohibits wideband operations in the public safety allocation of the 700 MHz Band, subject to the limited exceptions set forth herein. The Commission will require public safety entities seeking to deploy wideband systems to satisfy the following conditions and restrictions. 124. First, wideband operations in the 700 MHz public safety spectrum will be permitted only upon grant of a properly supported request for waiver of the requirement to conform to the band plan the Commission adopts herein, *i.e.* , one that permits only broadband or narrowband operations. In the interests of ensuring the integrity of the public/private partnership for construction of a nationwide broadband, interoperable network, the Commission finds it necessary to consider requests to deploy wideband only in a waiver context. Requests for waiver to conduct wideband operations must be accompanied by an application for authorization. 125. Second, any petition for waiver must be accompanied by a letter from the Public Safety Broadband Licensee, confirming that the proposed wideband deployment is not inconsistent with the broadband deployment plan for the affected or adjacent service areas. The Commission encourages public safety entities seeking such waivers to cooperate with the Public Safety Broadband Licensee to reach agreement on the conditions, if any, to be placed on any wideband deployment, including the appropriate plan for transition to the nationwide broadband, interoperable network. All requests for waiver must include any agreed-upon conditions and transition plan. 126. Third, except as discussed below, the Commission will restrict grants of waiver to the deployment of a wideband system in the consolidated narrowband spectrum or the internal public safety guard band. The Commission must limit any wideband operations in this manner in order to ensure the full preservation of the broadband segment. The Commission also believes that the regional planning committees will continue to serve an important role in overseeing and crafting appropriate spectrum use; to that end, petitions for waiver in the narrowband spectrum must also include a letter from the appropriate regional planning committee or state licensee confirming that the proposed wideband deployment will not disrupt any regional or state planning efforts that are underway. The Commission encourages the Public Safety Broadband Licensee to coordinate with the applicable regional planning committee or state licensee when these entities are asked to consider any wideband deployment in the narrowband portion of the public safety spectrum, to ensure proper coordination with existing and pending narrowband applications. 127. If there are instances where spectrum in the narrowband segment or internal guard band is unavailable for wideband operations, the Commission will permit submission of request for waiver to operate in the upper 1.25 megahertz of the broadband allocation. The Commission emphasizes, however, that applicants seeking waiver relief to deploy wideband networks in the public safety broadband spectrum face a very high hurdle. As a threshold requirement, the Commission will consider requests for waiver to conduct wideband operations in the broadband allocation only upon submission of a substantially supported, detailed technical showing demonstrating why there is insufficient spectrum in the narrowband allocation or internal guard band to support the desired wideband operations. As with requests to conduct wideband operations in the narrowband segment or internal guard band, any request for waiver to conduct wideband operations in the upper 1.25 megahertz of the broadband allocation must be accompanied by a letter from the Public Safety Broadband Licensee confirming that the proposed wideband deployment is not inconsistent with the broadband deployment plan for the affected or adjacent service areas, and all requests for waiver must reflect any conditions and transition plan agreed upon by the petitioner and the Public Safety Broadband Licensee. The public safety entity seeking to establish wideband operations in the broadband segment must have first issued a request for proposal
(RFP)that permitted interested parties to submit broadband proposals that are technically consistent with the Public Safety Broadband Licensee network. Finally, the wideband applicant must include with its waiver request proof that responses to the RFP proposing a broadband network were more costly, provided less coverage as measured by throughput at the network edge, or were otherwise inferior to the accepted wideband proposal. 128. Notwithstanding anything herein to the contrary, the Commission will not entertain any request for waiver seeking to permit wideband operations in the broadband segment in areas scheduled for broadband deployment within the first three years of the build-out plan for the national public safety broadband network. In addition, consistent with the waiver discussion herein, the Commission will not grant any waiver request for any wideband deployment in the broadband segment that does not include a detailed plan, accompanied by attestation, specifying how and by what date the wideband applicant will integrate its proposed wideband system into the national broadband network. The Commission shall condition any waiver relief for wideband operations in the broadband segment upon acceptance of the applicant's integration plan. As a further condition of any wideband operations proposed in the broadband segment, the Commission will require all devices operating on the wideband system to be designed such that they also must be interoperable with the nationwide, broadband network. In order to ensure that the Commission's goals for the deployment of the nationwide broadband network are met, the authority granted for any wideband operations in the broadband segment will expire automatically upon the D Block licensee's initiation of service in areas where wideband has been deployed. Further, any Grandfathered Wideband STA operations or wideband authority granted by waiver in the public safety segment of the 700 MHz Band shall be secondary to primary narrowband or broadband applications, as applicable. Finally, as a condition of the grant of waiver allowing deployment of a wideband system in the broadband segment, a public safety entity must certify in its application and waiver request its acknowledgement that it may not seek reimbursement for any costs involved in converting the wideband system to the national broadband network upon completion of the broadband network in the subject area. 129. License terms for wideband operations granted under waiver—whether they are in the narrowband, internal guard band, or broadband segments of the 700 MHz public safety spectrum—will be limited to no more than five years, and may be granted for less time depending on the particular circumstances presented. The Commission must receive requests for renewal of the license granted pursuant to waiver request not less than 180 days prior to expiration of the license. Renewal requests must include a showing that continued operation of the wideband system is in the public interest. Renewal requests for wideband operations in the broadband segment also must be accompanied by a letter from the Public Safety Broadband Licensee confirming that continuing wideband operations are not inconsistent with the broadband deployment plan for the affected or adjacent service areas. The license term for any renewal of waiver will not exceed three years and a wideband waiver licensee may only receive a single extension. Any renewal of a wideband authorization shall continue to be on a secondary basis only to primary narrowband or broadband applications, as applicable. Finally, in light of the waiver process described above, the Commission finds it unnecessary to adopt any particular wideband interoperability standard. 3. Safeguards Relating to the Public/Private Partnership a. Rules for Establishment, Execution and Application of the NSA 130. The Commission specifically conditions the D Block license on the following requirements to ensure the establishment and execution of the NSA in a timely manner while safeguarding the public interest. 131. *Approval of NSA as Pre-Condition for Granting the D Block license.* Because the terms of the NSA are critical to the success of the partnership, the D Block license will not be issued until the Commission has approved the NSA and following such approval, the parties execute the NSA and file an executed copy with the Commission. 132. The Commission recognizes that the D Block licensee will be subject to an aggressive build-out schedule, and an applicant for the license may wish to commence certain initial construction activities prior to the grant of an authorization. The Commission does not prohibit the winning bidder of the D Block license from engaging in network build-out during the NSA negotiation period and prior to grant of the license, but to ensure that such build-out does not frustrate the interests of public safety or preempt the negotiations regarding the appropriate build-out schedule, the Commission requires that any such build-out occur only with the approval of the Public Safety Broadband Licensee. Similar to service rules for other spectrum licenses, such construction is conducted at the sole risk of the applicant, is subject to the Commission's authority to provide notification to stop such build-out, and cannot result in commercial operation unless and until the Commission has granted the D Block license. 133. *Timeframe for Negotiation.* The Commission requires the parties to commence negotiations on the terms of the NSA on the date that the winning bidder of the D Block license files its long form application or the date on which the Commission designates the Public Safety Broadband Licensee, whichever is later, and the Commission further requires the parties to conclude negotiations not later than six months after the commencement date. As soon as the parties have reached an agreement on all the terms of the NSA, but not later than five days after the six month period for negotiation has expired, they must submit for Commission approval the NSA together with all agreements and other documents referred to in the NSA, including the agreement reached on the broadband technology standard. The Commission will act on the NSA within 60 days of receipt. If the parties have not reached agreement on all terms of the NSA by the end of the six-month period, they must notify the Commission not later than five days after the expiration of the six-month period of the terms agreed upon, the nature of the remaining issues and each party's position on each issue (whether in the form of final best offers, or a characterization of the parties jointly on the positions of the parties and reason for impasse), whether additional negotiation is likely to produce an agreement, and, if so, a proposed deadline for completing the agreement. 134. *Requirement of Good Faith.* The Commission requires the parties to negotiate in good faith the specific terms of the NSA pursuant to the conditions, requirements, and guidance established in this Second Report and Order. The Commission also requires the parties to act in good faith in the performance of the NSA. To provide additional assurance that negotiations are proceeding in good faith, and except as explicitly set forth herein, the Commission will oversee the negotiation of the NSA, and will play an active role in the resolution of any disputes among the relevant parties (including the winning bidder for the D Block; its wholly owned subsidiary; the D Block licensee; the Operating Company; the Network Assets Holder; and the Public Safety Broadband Licensee), both resulting from the negotiations and once the parties are operating under the terms of the NSA. 135. *Progress Reports During Negotiations.* The winning bidder for the D Block license shall file an initial report within 10 days of the commencement of the negotiations period certifying that active and good faith negotiations have begun, providing the date on which they commenced, and providing a schedule of the initial dates on which the parties intend to meet for active negotiations, covering at a minimum the first 30-day period. The Commission requires that two members of the Commission's staff, one from the Wireless Bureau, and one from the Public Safety and Homeland Security Bureau, be present at all stages of the negotiation of the NSA as neutral observers. The Commission does not intend, however that the staff act as arbitrators. Disputes must still come to the Commission for resolution. Beginning three months from the triggering of the six-month negotiation period, the winning bidder for the D Block license and the Public Safety Broadband Licensee must jointly provide detailed reports, on a monthly basis and subject to a request for confidential treatment, on the progress of the negotiations throughout the remainder of the negotiations. These reports should include descriptions of all material issues that the parties have yet to resolve. The monthly reports will enable the Commission to identify any areas of significant disagreement between the winning bidder for the D Block license and the Public Safety Broadband Licensee. The Commission also reserves the right to require the parties to meet with Commission staff to discuss their negotiations or reports at any time during the negotiation process. 136. If the Commission determines that parties are unlikely to reach an agreement or they violate certain obligations ( *e.g.* , good faith negotiation obligations), the Commission (or the Bureaus) may take, on its own motion, actions pertaining to dispute resolution before the NSA approval, described elsewhere in this Second Report and Order, without waiting for the six-month negotiation period to fully elapse. 137. *Resolution of Negotiation Disputes.* Either upon notice of a dispute at the end of the six-month negotiation period, or on their own motion at any time, if the Chiefs of PSHSB and WTB determine that negotiations have reached a likely impasse, the Commission delegates authority to the Chiefs of PSHSB and WTB to take certain actions jointly in the public interest to adjudicate the dispute. As appropriate, these actions may include but are not limited to one or more of the following:
(1)Granting additional time for negotiation;
(2)issuing a decision on the disputed issues and requiring the submission of a draft agreement consistent with their decision;
(3)directing the parties to further brief the remaining issues in full for immediate Commission decision; and/or
(4)immediate denial of the long-form application filed by the winning bidder for the D Block license. Remedies shall not, however, include ordering private third-party arbitration. In the event that the long-form application filed by the winning bidder for the D Block license is denied, the winning bidder for the D Block license will be deemed to have defaulted under Section 1.2109(c) of the Commission's rules, it will be liable for the default payment set forth in § 1.2104(g), and the full Commission, at its discretion, shall decide whether to offer a new license for the spectrum to existing or new applicants, offer a new license to the other highest bidders (in descending order) at their final bids, or choose any other process within the Commission's statutory authority to reassign the license, in light of the public interest goals served by the Public/Private Partnership. 138. The Commission believes that it would be inappropriate to have issues regarding the use of public safety spectrum resolved by a private party and precludes that option as a remedy. The Commission finds, however, that the Commission should not at this time preclude the option of disputes being adjudicated by the Commission. Rather, providing the Commission with discretion to choose from a range of remedies will enable the Commission to choose the most appropriate option in the context of the specific concerns raised by the parties. 139. *Licensing Rules and Procedures Applicable to the D Block license.* Except as provided herein, the Commission's competitive bidding rules applicable to other commercial licenses in the 700 MHz Bands will apply to the winning bidder for the Public/Private Partnership License, including the practices and procedures listed in Part 1 of the Commission's rules. For example, the down payment requirement, the obligation of the winning bidder for the D Block license to file a “long form” license application, and the consequences of a default prior to grant of the license will be in accordance with Sections 1.2104, 1.2105, 1.2106, 1.2107, and 1.2109 of the Commission's rules. 140. If the long form application is denied, the procedures under Section 1.2109 of the Commission's rules will generally apply. The Commission may complete review of the long form application and deny the application without regard to the NSA, if the application is deficient or the grant of the license would otherwise be inconsistent with the Commission's rules. The Commission further clarifies that if the winning bidder for the D Block license fails to comply with the procedures the Commission establishes for negotiation or dispute resolution, fails to receive final Commission approval of an NSA, or fails to execute an approved NSA,
(a)it shall be disqualified from holding the D Block license,
(b)the license application will be denied, and
(c)it will be deemed to have defaulted and will be subject to all payments and obligations under Section 1.2109 of the Commission's rules. 141. *Process for Final Approval.* The Commission will review and approve the NSA. To facilitate our review, the Commission may seek input from the parties, or invite public comment on the proposed NSA, subject to redactions to protect a legitimate need for confidentiality. After conducting its review, the Commission may approve the NSA in its entirety, approve it with modifications, or require the parties to address additional terms or re-draft existing terms within a specified timeframe. Following approval with or without modifications, the parties shall execute the NSA and submit a copy of the executed NSA to the Commission within 10 days of approval. b. Ongoing Conditions for the Protection of Public Safety Service 142. *Requirements Relating to Organization and Structure of the Public/Private Partnership.* To support continued construction and operation of the shared wireless broadband network by reducing the risk that the D Block license or the network assets will be drawn into a bankruptcy proceeding, the Commission requires the winning bidder for the D Block license to form separate special purpose entities, which will be bankruptcy remote, to hold the D Block license and the network assets, respectively. The Commission also requires the winning bidder of the D Block licensee to form another vehicle that will also be a bankruptcy remote, special purpose entity (Operating Company). The D Block licensee will lease the spectrum rights associated with the D Block license to the Operating Company pursuant to the Commission's spectrum leasing rules. The spectrum leasing arrangement will be for the entire term of the D Block license and will be renewable, provided that the Commission renews the underlying D Block license. These license transactions will occur following the granting of the D Block license and should follow existing Commission procedures applicable to such transactions. The Operating Company will also be leased secondary use rights associated with the primary license held by the Public Safety Broadband Licensee. To ensure that these requirements have been met, the D Block auction winner shall submit the proposed organizational structure to the Commission and demonstrate to the Commission's satisfaction that each of the constituent entities is appropriately bankruptcy remote. Finally, it shall be a condition of the D Block license and the Public Safety Broadband License that all special purpose entities and any leasing or other commercial agreements created to implement the public/private partnership will be subject to the Act and the Commission's rules and regulations, and the parties to the NSA shall acknowledge such regulatory authority in a form acceptable to the Commission. 143. The D Block licensee and other entities authorized and required in this Second Report and Order or the NSA will have the obligation to build out the nationwide, shared interoperable broadband network operating on the spectrum associated with the D Block license and the Public Safety Broadband License. 144. In connection with establishing the bankruptcy remote special purpose entities required hereunder, the Commission requires the issuance of one or more legal opinion letters, at the cost of the winning bidder of the D Block license, from bankruptcy counsel chosen by the winning bidder of the D Block license and acceptable to the Commission, and such other parties as the Commission may designate, that clearly states, subject only to customary assumptions, limitations and qualifications that none of the winning bidder, the Operating Company, or any party to the NSA or other related agreements will be substantively consolidated with any entity. The scope of this opinion letter shall also cover such other opinions as the Commission may request. 145. *Prohibition on Discontinuance of Public Safety Operations.* The Commission prohibits the D Block licensee from discontinuing or degrading the broadband network service provided to the Public Safety Broadband Licensee or to public safety entities unless either at the request of the entity or entities in question or it has first obtained the approval of the Commission. Further, the D Block licensee must notify the affected public safety entity or entities and the Public Safety Broadband Licensee at least 30 days prior to any unrequested discontinuance or degradation of network service. 146. *Failure to Comply with the NSA or the Commission's Rules.* The Commission establishes rules to address how the Commission will remedy failures by either the D Block licensee or the Public Safety Broadband Licensee to comply with the NSA or the Commission's rules. First, with regard to the D Block licensee, the Commission has conditioned the D Block license on compliance with the NSA. Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the D Block license, depending on the circumstances, and awarding it to a new licensee. In particular, the full Commission will decide whether to cancel and reassign the D Block license in the event that the D Block licensee either cannot or will not fulfill the critical responsibilities that are being given to it. 147. In the event that the Commission determines that the D Block license must be cancelled consistent with the Act and the requirements herein, an order shall be issued cancelling the license and announcing the process for awarding rights to the spectrum to a new licensee. However, pending the award to a new licensee, the Operating Company will be issued a special temporary authority
(STA)to continue to provide both commercial and public safety service in the Public/Private Partnership spectrum. 148. To further ensure that services to public safety are not threatened by cancellation, or otherwise, the NSA shall require, in a separate agreement, the granting of
(a)an irrevocable and assignable right of first refusal if the network and network assets are otherwise to be sold; and
(b)an irrevocable and assignable option in favor of the Public Safety Broadband Licensee to acquire the network and all network assets if and whenever the D Block license is cancelled or terminated, by reason of default or for any other reason, for a consideration equivalent to the fair market value
(FMV)of the tangible and intangible assets sold. This option shall be senior to, and have priority over, any other right, claim, or interest in or to the network or the network assets. An event of default includes any default of the D Block licensee of a material obligation under the NSA, as determined by the Commission. Valuation will be performed pursuant to a FMV methodology to be agreed upon by the parties and set forth in the NSA. Valuation shall be performed immediately following the occurrence of a triggering event and completed within a reasonable time thereafter. The NSA must further provide that, in the event that the D Block license is awarded to a new entity, the Public Safety Broadband Licensee's right to purchase the network assets shall be reassigned to the new D Block licensee. Thereafter, the Public Safety Broadband Licensee's right to purchase shall be extinguished unless and until a new triggering event described above occurs, as the primary purpose of the right, to enable a smooth transition in the event of a default, would be achieved, and because maintaining the right might adversely impact the incentive of the new D Block licensee to invest in its network. 149. The Commission provides that, in the event that the D Block license is cancelled, the Commission may choose any process within the Commission's statutory authority to reassign the license, in light of the public interest goals served by the Public/Private Partnership. Upon grant of a new license, the Commission, or the Bureaus acting on delegated authority, shall, in coordination with the former licensee and the new licensee, as well as the Public Safety Broadband Licensee, establishes the terms and timing under which the temporary authorization shall be cancelled and the new D Block licensee assume the construction and operation of the network. This decision shall take into account, among other factors, any exercise by the new licensee of its right to purchase the network assets. 150. With regard to the Public Safety Broadband Licensee, in the event that the Public Safety Broadband Licensee fails to adhere to the terms of the NSA, or comply with the Commission's rules or any requirements contained in this Second Report and Order, to an extent giving rise to license cancellation, the Commission delegates authority to the Chiefs, PSHSB and WTB jointly to determine an appropriate remedy. The potential remedies include, but are not limited to, cancelling the license, assigning the license to another entity, directing the Public Safety Broadband Licensee to transfer the assignable option to purchase the assets at fair market value, ordering specific performance, or ordering removal and replacement of individual officers, directors or member organizations of the Public Safety Broadband Licensee. 151. *Resolution of Disputes after Grant of the D Block license.* The Commission finds that the Commission should assume primary responsibility and jurisdiction for adjudicating intractable disputes that arise once the parties are operating pursuant to the terms of the NSA. While the Commission strongly encourages the parties to first attempt to resolve any disagreements themselves through voluntary means, the parties to the NSA may at any time bring a complaint based on a claim that the other party has deviated from the terms of the NSA, or a petition for a declaratory ruling to resolve the proper interpretation of an NSA term or provision. The Commission emphasizes that these shall be the exclusive remedies for claims seeking the interpretation of the NSA in the first instance. The Commission may, however, as an alternative to adjudicating the issues, require the parties to first seek a settlement to the dispute or authorize them to resolve the dispute through litigation or other means, particularly if the dispute is found to involve no significant public concerns, and the Commission will consider any request by the parties to authorize such means. 152. In the event the Commission decides to adjudicate the issues, the Commission provides that the Commission will have full authority to interpret not only the Commission's rules but all of the provisions of the NSA. The Commission further provides that, if the Commission finds a material breach of the NSA, it may apply any remedy or enforcement mechanism within its authority. As with adjudication of disputes during the NSA negotiation process, the Chiefs of PSHSB and WTB are delegated joint responsibility for adjudicating any disputes that arise during performance of the NSA. Bureau level adjudications of NSA disputes must be completed within 45 days. The parties may seek review by the Commission of any bureau-level adjudication. Finally, the Commission establishes that, if a breach of the NSA occurs but is not brought to the Commission for resolution, the Commission retains authority to apply all appropriate remedies on its own initiative at any time after the breach occurs. 153. *Reporting Obligations.* Once the NSA is approved by the Commission and executed by the parties, the parties must jointly file quarterly reports with the Commission. These reports must include detailed information on the areas where broadband service has been deployed, how the specific requirements of public safety are being met, audited financial statements, which public safety entities ( *e.g.* , police, fire departments) are using the broadband network in each area of operation; what types of applications ( *e.g.* , voice, data, video) are in use in each area of operation to the extent known; and the number of declared emergencies in each area of operation. The Commission anticipates that this information will be readily available from the billing systems used for the shared network, and reserve the right to specify additional information that the quarterly reports must include at a later date. The D Block licensee and Public Safety Broadband Licensee also have joint responsibility to register the base station locations with the Commission, providing basic technical information, including geographic location. Such registrations may be filed with a request for confidential treatment by the Commission. In this regard, the Commission delegates to the Wireless Bureau authority to adopt rules and procedures to implement this requirement, as well as authority to modify ULS to accept such filings and to issue a public notice describing any such modifications and relevant filing procedures. The Commission delegates to the Wireless Bureau the authority to adopt filing rules and procedures not inconsistent with this Second Report and Order to facilitate these reporting obligations. 4. Other Issues a. Bidding Credits 154. In order to encourage the widest range of potentially qualified applicants to participate in bidding for the D Block license, the Commission will provide eligible bidders for the D Block license with the existing 15 and 25 percent bidding credits, as the credits may be necessary to create incentives for investors to provide innovative small businesses with the capital necessary to compete for the D Block license at auction. Pursuant to the Commission's existing small business size standards, eligible bidders with average attributable gross revenues for the last three years not exceeding $15 million or $40 million, respectively, may be eligible for bidding credits of 25 percent or 15 percent, respectively. b. License Partitioning, Disaggregation, Assignment, and Transfer 155. The Commission decides to prohibit geographic partitioning and spectrum disaggregation for the D Block licensee. The Public Safety Broadband Licensee is also prohibited from partitioning and disaggregation. The Commission recognizes that the Commission's existing Secondary Markets rules governing transfers and assignments would be applicable to the D Block licensee, providing further flexibility to the licensee. Thus, the D Block licensee would be permitted to assign or transfer its licensee subject to the Commission review and prior approval. c. Commercial Service Issues
(i)Wholesale and Open Access Proposals 156. The Commission declines to restrict the D Block licensee to operating exclusively on a “wholesale” or “open access” basis. Instead, the Commission provides the D Block licensee with flexibility to provide wholesale or retail services or other types of access to its network that comply with the Commission's rules and the NSA.
(ii)Roaming Proposal 157. The Commission concludes that it should defer to the broader context of the pending roaming proceeding the determination of whether there are public interest benefits in also requiring automatic roaming to be provided by other commercial licensees. The Commission will therefore not at this time impose any special roaming requirements on the D Block licensee.
(iii)Applicability of CALEA, E911, and Other Requirements 158. The Commission declines to categorically exempt services offered by the D Block licensee from E911, CALEA, and other regulatory requirements. Instead, the Commission clarifies that E911, CALEA, and other regulatory requirements will apply to services provided using Public/Private Partnership spectrum to the extent and only to the extent that these requirements apply to similar services provided elsewhere in the 700 MHz Band. The Commission has only recently concluded that the E911 requirements established in Section 20.18 of the Commission's rules will apply to all commercial mobile radio services, including such services throughout the 700 MHz Band, that meet the functional criteria in Section 20.18(a), and the Commission sees no reason to revisit that decision. The Commission defers any further examination of regulatory applicability to a more concrete and particular context, *e.g.* , if service providers seek clarification regarding the applicability of a specific regulatory requirement to their specific service. 159. The Commission also notes that, even though the D Block license for spectrum in the “D Block” band will be issued pursuant to Part 27 of the Commission's rules, the licensee will be required to comply with other rule parts, which are applicable to the other commercial 700 MHz bands, unless otherwise stated in this Second Report and Order. Some of these rule parts will be applicable by virtue of the fact that they apply to all licensees and others will apply depending on the type of services the D Block licensee provides. II. Procedural Matters A. Regulatory Flexibility Act 160. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 6 an Initial Regulatory Flexibility Analysis
(IRFA)was included in the *700 MHz Further Notice* 7 in WT Docket No. 06-150, WT Docket No. 01-309; WT Docket No. 06-169, WT Docket No. 03-264, CC Docket No. 94-102, PS Docket No. 06-229, and WT Docket No. 96-86. 8 The Commission sought written public comment on the proposals in these dockets, including comment on the IRFA. This Final Regulatory Flexibility Analysis
(FRFA)conforms to the RFA. 9 6 *See* 5 U.S.C. 603. The RFA, *see* 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Pub. L. 104-121, Title II, 110 Stat. 857 (1996). 7 *See* Service Rules for the 698-746, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, Section 68.4(a) of the Commission's Rules Governing Hearing Aid-Compatible Telephones, WT Docket No. 01-309, Biennial Regulatory Review—Amendment of Parts 1, 22, 24, 27, and 90 to Streamline and Harmonize Various Rules Affecting Wireless Radio Services, WT Docket 03-264, Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's Rules, WT Docket No. 06-169, Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, PS Docket No. 06-229, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket No. 96-86, *Report and Order* and *Further Notice of Proposed Rulemaking,* 22 FCC Rcd 8064
(2007)( *700 MHz Report and Order* and *700 MHz Further NPRM,* respectively). 8 *See* Service Rules for the 698-749746, 747-762 and 777-792 MHz Bands, WT Docket No. 06-150, Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems, CC Docket No. 94-102, and Section 68.4(a) of the Commission's Rules Governing Hearing Aid-Compatible Telephones, WT Docket No. 01-309, *Notice of Proposed Rule Making, Fourth Further Notice of Proposed Rule Making,* and *Second Further Notice of Proposed Rule Making,* 21 FCC Rcd 9345, 9394
(2006)(“ *700 MHz Commercial Services Notice* ”); Former Nextel Communications, Inc. 01-309, Biennial Regulatory Review—Amendment of Parts 1, 22, 24, 27, and 90 to Streamline and Harmonize Various Rules Affecting Wireless Radio Services, WT Docket 03-264, Former Nextel Communications, Inc. Upper 700 MHz Guard Band Licenses and Revisions to Part 27 of the Commission's Rules, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket Nos. 06-169 and 96-86, *Notice of Proposed Rule Making,* 21 FCC Rcd 10413, 10440
(2006)(“ *700 MHz Guard Bands Notice* ”); Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band, PS Docket No. 06-229, Development of Operational, Technical and Spectrum Requirements for Meeting Federal, State and Local Public Safety Communications Requirements Through the Year 2010, WT Docket No. 96-86, *Ninth Report and Order* and *Further Notice of Proposed Rule Making* , 22 FCC Rcd 14837, 14853
(2006)(“8064
(2007)( *700 MHz Public Safety Ninth Report and Order* and *700 MHz Further NPRM* ”, respectively). 9 *See* 5 U.S.C. 604. 161. Although Section 213 of the Consolidated Appropriations Act of 2000 provides that the RFA shall not apply to the rules and competitive bidding procedures for frequencies in the 746-806 MHz Band, 10 the Commission believes that it would serve the public interest to analyze the possible significant economic impact of the proposed policy and rule changes in this band on small entities. Accordingly, this FRFA contains an analysis of this impact in connection with all spectrum that falls within the scope of this *Second Report and Order,* including spectrum in the 746-806 MHz Band. 10 In particular, this exemption extends to the requirements imposed by Chapter 6 of Title 5, United States Code, Section 3 of the Small Business Act (15 U.S.C. 632) and Sections 3507 and 3512 of Title 44, United States Code. Consolidated Appropriations Act 2000, Pub. L. 106-113, 113 Stat. 2502, Appendix E, Sec. 213(a)(4)(A)-(B); *see* 145 Cong. Rec. H12493-94 (Nov. 17, 1999); 47 U.S.C.A. 337 note at Sec. 213(a)(4)(A)-(B). 1. Need for, and Objectives of, the Rules 162. In the *Second Report and Order,* the Commission takes a number of steps to facilitate access to spectrum and the provision of service to consumers, especially those in rural areas, and to simplify and clarify our rules related to the commercial 700 MHz spectrum. It designates a spectrum block in the upper portions of the commercial spectrum for a commercial licensee that will be part of a public/private partnership (the “700 MHz Public/Private Partnership”) with a national public safety broadband licensee for the public safety broadband spectrum (hereinafter, the Public Safety Broadband Licensee). The Commission reconfigures the 700 MHz Public Safety Band, to promote the development of nationwide interoperable broadband services for public safety users. The Commission also changes the location of the existing 700 MHz Guard Band licenses, provides for a one megahertz shift of the other commercial spectrum blocks in the Upper 700 MHz Band and the 700 MHz Public Safety Band, and reduces the size of the Guard Band B Block to make two additional megahertz of commercial spectrum available for auction. 163. The band plan provides a balanced mix of geographic service area licenses and spectrum block sizes for the 62 megahertz of commercial spectrum to be auctioned. The Commission determined that it will auction two 12-megahertz spectrum blocks (comprised of paired 6-megahertz blocks), one licensed by Cellular Market Areas
(CMAs)and one by Economic Areas (EAs); one 22-megahertz spectrum block (paired 11-megahertz blocks) by Regional Economic Area Groupings (REAGs); and one 6-megahertz unpaired spectrum block by EAs. It also designates one 10-megahertz spectrum block (paired 5-megahertz blocks), the Upper 700 MHz Band D Block, to be licensed on a nationwide basis and used as part of the 700 MHz Public/Private Partnership between this commercial licensee and the Public Safety Broadband Licensee that will be assigned the public safety broadband spectrum. 164. In addition, the Commission replaces the current “substantial service” requirements for 700 MHz Band commercial licenses that have not been auctioned with significantly more stringent performance requirements, and makes unserved areas available to third parties who wish to provide service to these areas. By adopting these more rigorous requirements, the Commission ensures that the 700 MHz Commercial Services licensees put the spectrum to use throughout the course of their license terms and serve the majority of users in their license areas Additionally, for one commercial spectrum block in the 700 MHz Band—the Upper 700 MHz C Block (700 MHz C Block)—the Commission imposes requirements on those licensees to provide open platforms for devices and applications, and concludes that it would not serve the public interest at this time to mandate broader openness requirements. 165. The *Second Report and Order* also revises the 700 MHz band plan with respect to the Upper 700 MHz Guard Bands, such that all existing A Block licenses relocate to a reconfigured A Block between the C and D Blocks, pursuant to an agreement between all but one of the Guard Bands licensees. As part of this agreement, the existing B Block licenses are relinquished, and the B Block is reconfigured from 4 to 2 megahertz and located immediately above the public safety narrowband spectrum. The reconfigured B Block serves as a guard band to protect the public safety narrowband channels, and remains empty as a commercial allocation at this time. With respect to the Guard Bands licensee that did not participate in the agreement, its one A Block license and two B Block licenses are grandfathered, with minor modifications to facilitate the overall revised band plan. In addition to these band plan issues with respect to the Guard Bands, the *Second Report and Order* also revises the service rules with respect to the reconfigured A Block, bringing it largely into parity with the adjacent Commercial Services spectrum given the new spectral location and its relationship to the rest of the band including the public safety spectrum. 166. Further, the Second Report and Order seeks to achieve broadband communications capabilities consistent with a nationwide interoperability standard for public safety. The Commission expects that modern public safety services will increasingly depend on the advanced communications capabilities afforded by wireless broadband technologies, which should enable first responders to perform their vital safety-of-life and other critical roles. The Second Report and Order re-designates the wideband spectrum to broadband use consistent with a nationwide interoperability standard, and prohibits wideband operations on a going forward basis in the newly designated broadband spectrum. The Second Report and Order also consolidates the narrowband spectrum to the top of the Public Safety Band, locates the broadband spectrum at the bottom of the Public Safety Band, and divides these segments with an internal guard band. This reconfiguration reduces the amount of spectrum necessary to separate and protect the public safety broadband and narrowband allocations, and facilitates partnerships between public safety broadband operations and adjacent commercial broadband technologies, thereby optimizing the 700 MHz public safety band plan. Finally, in order to promote the rapid deployment of a nationwide, interoperable broadband public safety network, the Second Report and Order creates a single nationwide geographic area Public Safety Broadband License which will be administered by a single Public Safety Broadband Licensee. 167. With regard to auctions-related issues, the Commission decides to utilize anonymous bidding to enhance the effectiveness of the auction of 700 MHz licenses, as well as allow package bidding for the Upper 700 MHz Band C Block, and decides not to grant a “new entrant” bidding credit for the 700 MHz Band licenses. The Commission also declines to impose eligibility restrictions for the licenses in the 700 MHz Band. Finally, the Commission will offer bidding credits in the D Block, as described fully below. 2. Summary of Significant Issues Raised by Public Comments in Response to the IRFA 168. No comments specifically addressed the IRFAs from any of the respective proceedings. We have nonetheless addressed small entity issues found in comments in this FRFA. 3. Description and Estimate of the Number of Small Entities to Which the Rules Will Apply 169. The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. 11 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 12 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 13 A “small business concern” is one which:
(1)Is independently owned and operated;
(2)is not dominant in its field of operation; and
(3)satisfies any additional criteria established by the Small Business Administration (SBA). 14 11 5 U.S.C. 604(a)(3). 12 5 U.S.C. 601(6). 13 5 U.S.C. 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the **Federal Register** .” 14 15 U.S.C. 632. 170. *Small Businesses* . Nationwide, there are a total of approximately 22.4 million small businesses, according to SBA data. 15 15 *See* SBA, Programs and Services, SBA Pamphlet No. CO-0028, at page 40 (July 2002). 171. *Small Organizations.* Nationwide, there are approximately 1.6 million small organizations. 16 16 Independent Sector, The New Nonprofit Almanac & Desk Reference (2002). 172. *Governmental Entities.* The term “small governmental jurisdiction” is defined as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” 17 As of 2002, there were approximately 87,525 governmental jurisdictions in the United States. 18 This number includes 38,967 county governments, municipalities, and townships, of which 37,373 (approximately 95.9%) have populations of fewer than 50,000, and of which 1,594 have populations of 50,000 or more. Thus, we estimate the number of small governmental jurisdictions overall to be 85,931 or fewer. 17 5 U.S.C. 601(5). 18 U.S. Census Bureau, Statistical Abstract of the United States: 2006, Section 8, pages 272-273, Tables 415 and 417. 173. *Wireless Service Providers.* The SBA has developed a small business size standard for wireless firms within the two broad economic census categories of “Paging” 19 and “Cellular and Other Wireless Telecommunications.” 20 Under both categories, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. 21 Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. 22 Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. 23 Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. 24 Thus, under this second category and size standard, the majority of firms can, again, be considered small. 19 13 CFR 121.201, NAICS code 517211. 20 13 CFR 121.201, NAICS code 517212. 21 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Establishment and Firm Size (Including Legal Form of Organization,” Table 5, NAICS code 517211 (issued Nov. 2005). 22 *Id.* The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with “1000 employees or more.” 23 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Establishment and Firm Size (Including Legal Form of Organization,” Table 5, NAICS code 517212 (issued Nov. 2005). 24 *Id.* The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with “1000 employees or more.” 174. When identifying small entities that could be affected by the Commission's new rules, this FRFA provides information describing auctions results, including the number of small entities that were winning bidders. However, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily reflect the total number of small entities currently in a particular service. The Commission does not generally require that licensees later provide business size information, except in the context of an assignment or transfer of control application where unjust enrichment issues are implicated. 175. *700 MHz Guard Band Licenses.* The Commission previously adopted size standards for “small businesses” and “very small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. 25 A small business in this service is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. 26 Additionally, a “very small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. 27 SBA approval of these definitions is not required. 28 An auction of 52 Major Economic Area
(MEA)licenses commenced on September 6, 2000, and closed on September 21, 2000. 29 Of the 104 licenses auctioned, 96 licenses were sold to nine bidders. Five of these bidders were small businesses that won a total of 26 licenses. A second auction of 700 MHz Guard Band licenses commenced on February 13, 2001, and closed on February 21, 2001. All eight of the licenses auctioned were sold to three bidders. One of these bidders was a small business that won a total of two licenses. 30 25 *See* Service Rules for the 746-764 MHz Bands, and Revisions to Part 27 of the Commission's rules, *Second Report and Order,* 15 FCC Rcd 5299 (2000). 26 *Id.* at 5343 para. 108. 27 *Id.* 28 *Id.* at 5343 para. 108 n.246 (for the 746-764 MHz and 776-704 MHz bands, the Commission is exempt from 15 U.S.C. 632, which requires Federal agencies to obtain SBA approval before adopting small business size standards). 29 *See* “700 MHz Guard Bands Auction Closes: Winning Bidders Announced,” *Public Notice,* 15 FCC Rcd 18026 (2000). 30 *See* “700 MHz Guard Bands Auctions Closes: Winning Bidders Announced,” *Public Notice,* 16 FCC Rcd 4590 (WTB 2001). 176. *Upper 700 MHz Band Licenses.* The Commission released a *Report and Order* authorizing service in the Upper 700 MHz band. 31 An auction for these licenses, previously scheduled for January 13, 2003, was postponed. 32 31 Service Rules for the 746-764 and 776-794 MHz Bands, and Revisions to Part 27 of the Commission's Rules, *Second Memorandum Opinion and Order,* 16 FCC Rcd 1239 (2001). 32 *See* “Auction of Licenses for 747-762 and 777-792 MHz Bands (Auction No. 31) Is Rescheduled,” *Public Notice,* 16 FCC Rcd 13079 (WTB 2003). 177. *Lower 700 MHz Band Licenses.* The Commission adopted criteria for defining three groups of small businesses for purposes of determining their eligibility for special provisions such as bidding credits. 33 The Commission has defined a small business as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. 34 A very small business is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. 35 Additionally, the Lower 700 MHz Band has a third category of small business status that may be claimed for Metropolitan/Rural Service Area (MSA/RSA) licenses. The third category is entrepreneur, which is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. 36 The SBA has approved these small size standards. 37 An auction of 740 licenses (one license in each of the 734 MSAs/RSAs and one license in each of the six Economic Area Groupings (EAGs)) commenced on August 27, 2002, and closed on September 18, 2002. Of the 740 licenses available for auction, 484 licenses were sold to 102 winning bidders. Seventy-two of the winning bidders claimed small business, very small business or entrepreneur status and won a total of 329 licenses. 38 A second auction commenced on May 28, 2003, and closed on June 13, 2003, and included 256 licenses: 5 EAG licenses and 476 CMA licenses. 39 Seventeen winning bidders claimed small or very small business status and won sixty licenses, and nine winning bidders claimed entrepreneur status and won 154 licenses. 40 33 *See* Reallocation and Service Rules for the 698-746 MHz Spectrum Band (Television Channels 52-59), *Report and Order* , 17 FCC Rcd 1022 (2002). 34 *Id.* at 1087-88 para. 172. 35 *Id.* 36 *Id.* at 1088 para. 173. 37 *See* Letter to Thomas Sugrue, Chief, Wireless Telecommunications Bureau, Federal Communications Commission, from Aida Alvarez, Administrator, SBA, dated August 10, 1999. 38 *See* “Lower 700 MHz Band Auction Closes,” *Public Notice* , 17 FCC Rcd 17272 (WTB 2002). 39 *See* “Lower 700 MHz Band Auction Closes,” *Public Notice* , 18 FCC Rcd 11873 (WTB 2003). 40 *Id* . 178. *Public Safety Radio Licensees.* As a general matter, public safety radio licensees include police, fire, local government, forestry conservation, highway maintenance, and emergency medical services. 41 The SBA rules contain a small business size standard for cellular and other wireless telecommunications companies that encompasses business entities engaged in wireless communications employing no more than 1,500 persons. 42 According to Census Bureau data for 2002, in this category there were 8,863 firms that operated for the entire year. 43 Of this total, 401 firms had 100 or more employees, and the remainder had fewer than 100 employees. 44 With respect to local governments, in particular, since many governmental entities as well as private businesses comprise the licensees for these services, we include under public safety services the number of government entities affected. 41 *See* subparts A and B of Part 90 of the Commission's Rules, 47 CFR 90.1-90.22. Police licensees include 26,608 licensees that serve state, county, and municipal enforcement through telephony (voice), telegraphy (code), and teletype and facsimile (printed material). Fire licensees include 22,677 licensees comprised of private volunteer or professional fire companies, as well as units under governmental control. Public Safety Radio Pool licensees also include 40,512 licensees that are state, county, or municipal entities that use radio for official purposes. There are also 7,325 forestry service licensees comprised of licensees from state departments of conservation and private forest organizations that set up communications networks among fire lookout towers and ground crews. The 9,480 state and local governments are highway maintenance licensees that provide emergency and routine communications to aid other public safety services to keep main roads safe for vehicular traffic. Emergency medical licensees (1,460) use these channels for emergency medical service communications related to the delivery of emergency medical treatment. Another 19,478 licensees include medical services, rescue organizations, veterinarians, persons with disabilities, disaster relief organizations, school buses, beach patrols, establishments in isolated areas, communications standby facilities, and emergency repair of public communications facilities. 42 *See* 13 CFR 121.201 (NAICS code 517212); U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Employment Size of Establishments for the United States: 2002,” Table 2, NAICS code 517212. 43 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Employment Size of Establishments for the United States: 2002,” Table 2, NAICS code 517212. 44 *Id* . 179. *Wireless Communications Equipment Manufacturers: Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.* While these entities are merely indirectly affected the Commission's actions, the Commission describes them to achieve a fuller record. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” 45 The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: All such firms having 750 or fewer employees. 46 According to Census Bureau data for 2002, there were a total of 1,041 establishments in this category that operated for the entire year. 47 Of this total, 1,010 had employment of less than 500, and an additional 13 had employment of 500 to 999. 48 Thus, under this size standard, the majority of firms can be considered small. 45 U.S. Census Bureau, 2002 NAICS Definitions, “334220 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing”; *http://www.census.gov/epcd/naics02/def/NDEF334.HTM#N3342.* 46 13 CFR 121.201, NAICS code 334220. 47 U.S. Census Bureau, American FactFinder, 2002 Economic Census, Industry Series, Industry Statistics by Employment Size, NAICS code 334220 (released May 26, 2005); *http://factfinder.census.gov.* The number of “establishments” is a less helpful indicator of small business prevalence in this context than would be the number of “firms” or “companies,” because the latter take into account the concept of common ownership or control. Any single physical location for an entity is an establishment, even though that location may be owned by a different establishment. Thus, the numbers given may reflect inflated numbers of businesses in this category, including the numbers of small businesses. In this category, the Census breaks-out data for firms or companies only to give the total number of such entities for 2002, which was 929. 48 *Id.* An additional 18 establishments had employment of 1,000 or more. 180. *Software Publishers.* While these entities are merely indirectly affected by our action, we are describing them to achieve a fuller record. These companies may design, develop or publish software and may provide other support services to software purchasers, such as providing documentation or assisting in installation. The companies may also design software to meet the needs of specific users. 49 The SBA has developed a small business size standard of $23 million or less in average annual receipts for the category of Software Publishers. 50 For Software Publishers, Census Bureau data for 2002 indicate that there were 6,155 firms in the category that operated for the entire year. 51 Of these, 7,633 had annual receipts of under $10 million, and an additional 403 firms had receipts of between $10 million and $24,999,999. For providers of Custom Computer Programming Services, the Census Bureau data indicate that there were 32,269 firms that operated for the entire year. 52 Of these, 31,416 had annual receipts of under $10 million, and an additional 565 firms had receipts of between $10 million and $24,999,999. Consequently, we estimate that the majority of the firms in this category are small entities that may be affected by our action. 49 *See* U.S. Census Bureau, “2002 NAICS Definitions: 511210 Software Publishers”; *http://www.census.gov/epcd/naics02/def/NDEF511.HTM.* 50 13 CFR 121.201, NAICS code 511210. 51 U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, “Establishment and Firm Size (Including Legal Form of Organization),” Table 4, NAICS code 511210 (issued Nov. 2005). 52 U.S. Census Bureau, 2002 Economic Census, Subject Series: Professional, Scientific, and Technical Services, “Establishment and Firm Size (Including Legal Form of Organization),” Table 4, NAICS code 541511 (issued Nov. 2005). 4. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities 181. The projected reporting, recordkeeping, and other compliance requirements resulting from the *Second Report and Order* will apply to all entities in the same manner. The Commission believes that applying the same rules equally to all entities in this context promotes fairness. The Commission does not believe that the costs and/or administrative burdens associated with the rules will unduly burden small entities. The revisions the Commission adopts should benefit small entities by giving them more information, more flexibility, and more options for gaining access to valuable wireless spectrum. 182. *Performance Requirements.* In this *Second Report and Order,* the Commission replaces the current “substantial service” requirements for the 700 MHz Band commercial licenses that have not been auctioned with significantly more stringent performance requirements. These include the use of interim and end-of-term benchmarks, with geographic area benchmarks for licenses based on CMAs and EAs, and population benchmarks for licenses based on REAGs. Licensees must meet the interim requirement within four years of the end of the DTV transition. Failure to meet the interim requirement will result in a two-year reduction in license term, as well as possible enforcement action, including forfeitures. Licensees that fail to meet the end-of-term benchmarks will be subject to a “keep-what-you-use” rule, under which the licensee will lose its authorization for unserved portions of its license area, which will be automatically returned to the Commission for reassignment. 183. Licensees must demonstrate compliance with the Commission's interim and end-of-term construction benchmarks by filing a construction notification with the Commission within 15 days of the passage of the relevant benchmark certifying that they have met our performance requirements. However, if they have not met the Commission's performance requirements, they must file a description and certification of the areas for which they are providing service. The information contained in the licensee's construction notification must include electronic coverage maps and other supporting documentation. The electronic coverage maps must clearly and accurately depict the boundaries of each EA or CMA in the licensee's service territory, and the areas where the licensee's signal strength is sufficient to provide service to users. In addition to filing electronic coverage maps, each licensee must file supporting documentation certifying the type of service it is providing for each EA or CMA within its license service territory. 184. *Guard Band Issues.* The *Second Report and Order* relocates the A Block away from the public safety narrowband spectrum with respect to the upper half of the original paired A Block. Accordingly, the reconfigured A Block no longer serves as a guard band to protect the public safety spectrum from commercial operations. The existing frequency coordination requirement, which was created to protect public safety operations from Guard Bands operations, is therefore eliminated with respect to the reconfigured A Block. 185. *Open Platforms for Devices and Applications.* In this *Second Report and Order,* the Commission adopts a requirement for the 700 MHz C Block licensees to provide open platforms for devices and applications. 700 MHz C Block licensees must allow customers, device manufacturers, third-party application developers and others to use or develop the devices and applications of their choosing on the 700 MHz C Block network so long as they meet all applicable regulatory requirements and comply with reasonable conditions related to the management of the wireless network. The Commission does not, at this time, specify a particular process for wireless service providers to develop reasonable network management and openness standards, including through participation in standards setting organizations. The Commission expects licensees to publish their standards once adopted, which will be non-proprietary, such that they would be open to any third party vendors and that the standards applied to third parties will be no more restrictive than those applied to the provider's preferred vendors. 186. The Commission also requires 700 MHz C Block licensees to provide to potential customers notice of the customers' rights to request the attachment of a device or application to the licensee's network, and notice of the licensee's process for customers to make such requests, including the relevant network criteria. In addition, 700 MHz C Block licensees are required to establish a reasonable process for expeditiously reviewing and processing requests to employ devices and applications on the licensee's network and offer a specific explanation for denial of any such request, and an opportunity for amendment of the request to accommodate the provider's concerns. 187. The Commission also provides for its existing complaint procedures to be invoked if a violation of this requirement occurs. Once a complainant sets forth a *prima facie* case that the 700 MHz C Block licensee has refused to attach a device or application in violation of the requirement or has otherwise violated the rule, the 700 MHz C Block licensee shall have the burden of proof to demonstrate that it has adopted reasonable network standards and reasonably applied those standards in the complainant's case. The Commission commits to rule on these complaints within 180 days. 188. *Public Safety Broadband.* The *Second Report and Order* re-designates the wideband spectrum to broadband use consistent with a nationwide interoperability standard, and prohibits wideband operations on a going forward basis. The Commission will only grant limited exceptions to this rule through a waiver process. As a result of the decision to prohibit wideband operations outside of this waiver process, Regional Planning Committee plans already approved or on file with the Commission will require amendment. The *Second Report and Order* also consolidates the narrowband channels to the top of the public safety band, locates the broadband spectrum at the bottom of the public safety band, divides these segments with an internal guard band, and creates a single Public Safety Broadband License/Licensee to promote the rapid deployment of a nationwide, interoperable broadband public safety network. The relocation of public safety narrowband operations in the consolidated channels will entail some additional reporting, recordkeeping and compliance efforts by existing public safety entities with regard to the number and location of their affected narrowband handsets and base stations. The *Second Report and Order* does not otherwise propose any additional reporting, recordkeeping or other compliance requirements. 5. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered 189. The RFA requires an agency to describe in the IRFA any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives:
(1)The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(2)the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities;
(3)the use of performance, rather than design, standards; and
(4)an exemption from coverage of the rule, or any part thereof, for small entities. 53 The Commission hereby incorporates by reference the discussion in the Second Report and Order of our consideration of the impact on small entities of the rules the Commission adopts here. 53 5 U.S.C. 603(c). 190. *Band Plan Issues.* The *Second Report and Order* revises the 700 MHz band plan for the commercial services and public safety services in a manner that will improve the opportunity of small entities to obtain valuable wireless spectrum by providing smaller licensing areas that better meet the needs of small entities. The Commission's goals for the 700 MHz Band are to promote dissemination of licenses among a wide variety of applicants, including small entities, accommodate the competing need for both large and small licensing areas, meet the various needs expressed by potential entrants seeking access to spectrum and incumbents seeking additional spectrum, and provide for large spectrum blocks that can facilitate broadband deployment in the band. To achieve these goals the revised plan provides for two 12-megahertz spectrum blocks (comprised of paired 6-megahertz blocks), one licensed by CMAs and one by EAs; one 22-megahertz spectrum block (paired 11-megahertz blocks) by REAGs; and one 6-megahertz unpaired spectrum block by EAs. The revision also designates one 10-megahertz spectrum block (paired 5-megahertz blocks), the Upper 700 MHz D Block, to be licensed on a nationwide basis and used as part of the 700 MHz Public/Private Partnership. 191. Providing for an additional 700 MHz Band spectrum block licensed on a CMA basis (the B Block) will increase the opportunity of small entities to obtain smaller license areas that meet their needs while avoiding the transaction costs associated with obtaining access to spectrum in the secondary market, costs that are incurred when these small providers must arrange the terms by which another licensee grants access to its spectrum by means of partitioning, disaggregation, or spectrum leasing. 192. In addition, the Commission adopts EAs as the geographic service area for licenses in Block A of the Lower 700 MHz Band, making 176 licenses available in this block. The Commission also adopts EAs for the unpaired 6-megahertz E block of the Lower 700 MHz Band which further enhances the mix of geographic sizes for licenses in the band. These decisions will also create opportunities for small entities to acquire licenses for small geographic service areas in the Lower 700 MHz Band. 193. *Frequency Coordination and the Guard Bands.* The service area definition for the Upper 700 MHz Guard Bands is the MEA, which is a smaller license area and therefore can provide greater opportunities for small entrants than larger service area definitions such as the REAG. Accordingly, among the licensed Guard Bands and the lessees currently using their spectrum, there may be a significant number of small entities. Additionally, continued operations in the Guard Bands A Block may continue to involve a significant number of small entities through Secondary Markets arrangements. Since the *Second Report and Order* removes the requirement for all A Block operations to be frequency coordinated with public safety entities, any small entity engaged in ownership of, or operations on, the A Block will find the frequency coordination burden lifted to their significant benefit. 194. *Performance Requirements.* In this *Second Report and Order,* the Commission adopts stringent performance requirements for the 700 MHz Commercial Services licenses in order to promote the provision of innovative services to consumers throughout the license areas, including in rural areas. With regard to geographic-based benchmarks for licenses based on CMAs and EAs, the Commission seeks to promote service across as much of the geographic area of the country as is practicable. Parties that seek to acquire licenses based on CMAs and EAs may be small and rural providers that are less likely to provide regional or nationwide service, but they nonetheless play an important role in bringing new services to consumers in many of these more rural areas. 195. The use of small license areas such as CMAs will create opportunities for small and rural businesses and will foster the deployment of competitive wireless broadband services in rural areas. Because the Commission adopts smaller geographic license areas such as CMAs to facilitate the provision of service, including broadband, in rural areas, it also adopts performance requirements that are designed to ensure that service is offered to consumers in these areas. Because of the 700 MHz band's excellent propagation characteristics and suitability for delivering advanced wireless services to rural areas, the Commission establishes benchmarks that require build-out to a significant portion of the geographic area in those markets. In addition, the performance requirements adopted here will discourage larger entities from purchasing spectrum for the purpose of warehousing it and thus may provide small entities with a greater chance of obtaining valuable spectrum. 196. In the *Second Report and Order,* the Commission adopts population-based benchmarks for REAG licensees with large geographic areas in order to facilitate the deployment of advanced services on a nationwide or regional basis. Because of the significant capital investment and logistical challenges associated with building a regional or nationwide system without existing infrastructure, population benchmarks, rather than geographic benchmarks, will best allow a potential new entrant to achieve the economies of scale needed for a viable business model, while also ensuring that a majority of the population in a given region may have access to these services. Moreover, the performance requirements adopted here will discourage larger entities from purchasing spectrum for the purpose of warehousing it and thus may provide small entities with a greater chance of obtaining valuable spectrum. 197. Additionally, the “keep-what-you-use” rule is pro-competitive and provides another method for smaller license areas to be made available to small businesses, thus promoting access to spectrum and the provision of service, especially in rural areas. This rule ensures that spectrum covering areas that are not adequately built out is returned to the Commission and others are given an opportunity to acquire licenses for this spectrum. Because the license areas returned to the Commission under the “keep-what-you-use” rule are likely to be smaller in nature, this rule will provide small entities with an additional opportunity to obtain valuable wireless spectrum. 198. Although the Commission recognizes that the performance and reporting requirements for the 700 MHz Commercial Services licenses places burdens on both large and small businesses alike, these requirements will further several important policy objectives including taking advantage of the excellent propagation characteristics of the spectrum in the 700 MHz Band enabling broader coverage at lower costs, promoting the provision of innovative services to consumers throughout the license areas, including rural areas, and allowing large license areas to be served at lower infrastructure costs. Moreover, the inclusion of interim benchmark reporting requirements ensures that licensees provide service to consumers as early as possible. Because of the importance of these requirements, we do not believe that they should be applied on a differential basis to large and small business. Neither do we believe that such requirements will impose an unacceptable burden on small entities. 199. *License Terms.* The *Second Report and Order* extends the license terms of all the existing A Block licensees, given the changed circumstances of the band plan and service rules, as the licensees are relocated to the reconfigured A Block. This license term extension will benefit any Guard Bands licensees, and any lessees currently using their spectrum, that may be small entities as they will have more flexibility in the use of their spectrum with a longer period of time within which to make use of the spectrum. 200. *Partitioning and Disaggregation.* In this *Second Report and Order,* the Commission concludes that Section 27.15(d) of its rules regarding partitioning and disaggregation should be amended to clarify how the performance obligations will apply to the partitioning and disaggregation of the 700 MHz Commercial Services licenses that remain to be auctioned. These modifications seek to continue to provide flexibility to licensees and third parties to enter into partitioning and disaggregation arrangements that will facilitate the provision of new services to consumers, including consumers in unserved and underserved areas. 201. Under the modifications of the Section 27.15(d) rule relating to geographic partitioning of new 700 MHz Commercial Services licenses, the Commission establishes two options for partitioners and partitionees with regard to the newly adopted performance requirements. Under the first option, the partitioner and partitionee must each certify to the Commission that they will share responsibility for meeting the performance requirements for the entire geographic license area. If the parties meet the end-of-term construction benchmarks, they will retain the ability to continue to build out the unserved portion of their license areas. Parties that fail to meet the end-of-term benchmarks will be subject to a “keep-what-you-use” rule, under which they will lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment. This option enables parties to share the cost of meeting the stricter build-out benchmarks as required by the Commission under its new performance requirements, while ensuring that build-out will occur over the original license area to the same extent as it would have occurred had the licensee never partitioned the license. Under the second option, the partitioner and partitionee must each certify that it will independently meet the applicable performance requirements for its respective partitioned service area. If the partitioner or partitionee fails to meet the four-year build-out requirement for its respective area, then its license term will be reduced by two years. If the parties meet the end-of-term construction benchmarks, they will retain the ability to continue to build out the unserved portion of their license areas. Parties that fail to meet the end-of-term benchmarks will be subject to an automatic “keep-what-you-use” rule, under which they will lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment. This option provides a way for partitioners and partitionees to ensure that their licenses will not be affected by the other party's conduct with regard to meeting the applicable performance requirements. 202. Under the modifications of the Section 27.15(d) rule relating to disaggregation of new 700 MHz Commercial Services band licenses, the Commission provides that the disaggregator, disaggregate, or both the disaggregator and disaggregate working together, can meet the four-year and end-of-term construction benchmarks for the entire geographic license area. If either party meets the performance requirement, then the requirement will be satisfied for both parties. If neither party meets the four-year build-out requirement, then each of their license terms will be reduced by two years. If either of the parties meets the end-of-term build-out requirement, then this requirement is considered to be satisfied for both parties. Those parties that meet the end-of-term construction benchmarks will retain the ability to continue to build out the unserved portion of their license areas. Parties that fail to meet the end-of-term benchmarks will be subject to an automatic “keep-what-you-use” rule, under which they will lose their authorization for unserved portions of their license areas, which will automatically cancel and return to the Commission for reassignment. 203. Partitioning and disaggregation allow smaller or newly-formed entities to enter the market for the first time, because they will be able to negotiate for portions of original licenses at costs that are proportionately less than the entire license. Moreover, these modifications provide the opportunity for small businesses to enter into partitioning and disaggregation agreements that would enable them to share the cost of meeting the more stringent performance requirements for the unauctioned commercial 700 MHz Band spectrum. 204. *Open Platforms for Devices and Applications.* In order to promote innovation in the 700 MHz Band from the outset, the Commission is imposing certain conditions on the 700 MHz C Block to provide open platforms for devices and applications. The C Block—a large 22-megahertz block (comprised of paired 11-megahertz blocks)—is of sufficient size and scope to provide an environment conducive for the development and deployment of 4G services designed to compete with other broadband alternatives, and to provide an opportunity for innovators and entrepreneurs to develop equipment and applications that require substantial bandwidth to realize their full potential. The requirements should also provide sufficient potential market penetration to attract investment and achieve economies of scale in the equipment marketplace. In addition, we believe that the open platform requirement for devices and applications will provide additional opportunities for small entities to participate in the device and application market, since such a requirement will make it easier for customers, device manufacturers, third-party application developers, and others to use or develop devices and applications made by small entities on the network of the C Block licensee. 205. In adopting this requirement for the 700 MHz C Block, the Commission has taken a targeted, focused approach to achieve benefits to consumers. In particular, the Commission declines to impose additional openness requirements on the 700 MHz C Block, including wholesale and interconnection requirements. In addition, the Commission declines at this time to impose the requirement to provide open platforms for devices and applications or other openness obligations broadly in the 700 MHz Band, or in other spectrum bands. 206. *Licensee Eligibility.* The Commission declines to impose eligibility restrictions for the licenses in the 700 MHz band. The record does not demonstrate that open eligibility is likely to result in substantial competitive harm in the provision of broadband services. There are numerous actual and potential broadband service providers, and currently, consumers can obtain broadband service from wireline providers, cable companies, satellite, and wireless providers. Given this number of providers, it is unlikely that incumbent local exchange carriers, cable providers, or large wireless carriers would be able to behave in an anticompetitive manner as a result of any potential acquisition of 700 MHz spectrum. Furthermore, there are potential competitive benefits to not imposing eligibility requirements. First, allowing incumbents to hold 700 MHz band licenses will provide opportunities for these carriers to extend service into rural and hard-to-serve areas, which is a major goal the Commission seeks to achieve. Also, an incumbent service provider may already be a rural provider and to limit their eligibility would be contrary to the Commission's goals. We also do not believe that imposing eligibility restrictions for licenses in the 700 MHz band is necessary to provide small entities with the opportunity to obtain such licenses. As discussed above, among other things, the smaller licensing areas made available here will increase opportunities for small entities. 207. *Anonymous Bidding.* In response to its request for comments on whether to use anonymous bidding (or “limited information”) procedures in the auction of the new 700 MHz band licenses, the Commission received comments both in support of and in opposition to such procedures. One of the supporters is a small licensee who argued that anonymous bidding would bring about a more level playing field between large and small bidders. 54 The Commission further concludes that the many uncertainties regarding the technologies that will be used in the 700 MHz band will result in the potential anti-competitive use of detailed information regarding bidding outweighing the benefit to some bidders of having such information. 54 *See* McBride *700 MHz Further NPRM* Comments at 11. 208. The Commission further concludes that anonymous bidding should be employed even if the pre-auction eligibility ratio indicates that competition in the auction will be significant. Even in an auction with many competitors individual bidders could still use retaliatory bidding unilaterally to block the market, and it is important to avoid that from occurring especially given that the 700 MHz auction is going to offer multiple, substitutable blocks of licenses for sale, with prices relatively high, and the outcome having possible significant effects on post-auction market structure. 209. The Commission does not believe that anonymous bidding will have a detrimental effect on small entities. First, as discussed in Section III.A.3.a of the Second Report and Order, the potential benefit to bidders, such as small entities, of knowing the identity of other parties placing bids for particular licenses appears likely to be less in this auction than in past Commission auctions, in light of the early stage of development with respect to new services in these frequencies. Second, because bidding information can be used by incumbents to deter or exclude new entrants, we believe that anonymous bidding will increase the opportunities for new entrants, including small entities, to obtain licenses. 210. *Package Bidding.* Commenters are divided on the issue of package bidding for the upcoming auction of the 700 MHz band spectrum. While some commenters support package bidding because they feel it is essential for a new entrant seeking to aggregate licenses and offer service nationwide, 55 there are other commenters who feel that package bidding will disadvantage bidders not bidding on packages, which are more likely to be small entities. 56 55 *See, e.g.* , Google *700 MHz Further NPRM* Comments at 7-8. 56 *See* Aloha *700 MHz Further Notice* Comments at 7-8; Blooston *700 MHz Further Notice* Comments at 10; Cellular South *700 MHz Further Notice* Comments at 16; Leap *700 MHz Further Notice* Comments at 9; MetroPCS *700 MHz Further Notice* Comments at 22; RCA *700 MHz Further Notice* Comments at 18; RTG *700 MHz Further Notice* Comments at 16. 211. The Commission concludes that package bidding, with respect to the Upper 700 MHz Band C Block, would serve the public interest by reducing the exposure problem that might otherwise inhibit bidders seeking to create a nationwide footprint. Absent package bidding, the exposure problem creates an opportunity for competitors to block a would-be package bidder without actually competing for all the licenses in the package. 57 57 Frontline *700 MHz Further Notice* Comments, Exhibit 1 at 22-23. 212. Minimizing the exposure problem, by implementing package bidding, should facilitate the entry of applicants whose business plans require the economies of scale that only can be obtained with nationwide operation. The Commission further concludes that package bidding solely with respect to licenses for the Upper 700 MHz Band C Block provides sufficient opportunities to bid with minimal risk of an exposure problem. However, we limit package bidding to the C Block so that bidders, including small entities, who are unwilling or unable to compete against package bids will not be deterred from participating in the auction. The variety of blocks and licenses that are not subjected to package bidding will provide any such bidders, including small entities, with a wide array of opportunities. 213. *“New Entrant” Bidding Credit.* The possibility of granting “new entrant” bidding credits attracted far less comment than other issues relating to the auction of the 700 MHz licenses, and those parties that did respond were divided on the issue. The Commission concludes that a “new entrant” bidding credit for the 700 MHz Band licenses is not needed to facilitate the entry of new service providers. The Commission already offers substantial bidding credits to small entities, many of which may be new entrants in the spectrum services market, and we therefore do not believe that there is a need for an additional “new entrant” bidding credit. In addition, the availability of multiple licenses in each and every market with varied geographic sizes, coupled with the large number of licenses should offer new ventures, including small entities, a variety of opportunities to provide service. 214. *Bidding Credits for the 700 MHz Public/Private Partnership.* A number of small entities have proposed, in their comments, that the Commission should offer designated entities bidding credits with regards to the license that has been proposed by Frontline. 58 In brief, these commenters maintain that bidding credits will help potential applicants overcome efforts by incumbents to prevent others from winning newly available licenses. 58 *See, e.g.* , McBride Spectrum Partners, LLC *700 MHz Further Notice* Comments at 4-8; Blooston Rural Carriers *700 MHz Further NPRM* Comments at 7; Council Tree Communications, Inc. *700 MHz Further Notice Reply* Comments at 5-7. 215. The Commission concludes that it should provide applicants that are eligible to be licensed as designated entities with bidding credits in the auction of the D Block license, consistent with the Commission's prior decision regarding bidding credits for 700 MHz band licenses and our current designated entities rules. This decision will improve the opportunity for small entities to successfully bid for the D Block license. 216. *Public Safety Broadband.* The *Second Report and Order* reallocates the wideband spectrum to broadband use consistent with a nationwide interoperability standard, and prohibits wideband operations within the newly designated broadband spectrum on a going forward basis. The public safety community expressed broad support for a broadband allocation to enable advanced communications capabilities. The availability of a contiguous block of broadband spectrum, subject to a nationwide interoperability standard, enables partnerships with commercial licensees in adjacent broadband spectrum. As a result, the band plan ultimately enables public safety entities to utilize the 700 MHz band spectrum in a more cost-effective and spectrally efficient manner to address their homeland security and emergency response roles. In particular, the Commission believes that the interoperable broadband network will be of benefit to smaller governmental entities that would otherwise be unlikely to have the resources to construct such a network. Because the Commission does not anticipate that this reallocation will impose additional economic burdens on public safety, and is in fact designed to reduce economic burdens on public safety, the Commission has taken steps to minimize any adverse impact of the rule changes. 217. The *Second Report and Order* also consolidates the narrowband spectrum to the top of the public safety band and locates the broadband spectrum at the bottom of the public safety band, in light of the potentially significant benefits such reconfiguration will afford the public safety community. The alternative would have been to retain the existing band plan. The *Further NPRM* sought comment on how to implement reconfiguration of the narrowband channels with minimum disruption to incumbent operations. The *Second Report and Order* accommodates public safety operations in the border areas with Canada and Mexico, and defrays the costs of relocation by providing that such costs will be covered by the D Block Licensee. This defrayal of costs should be of particular benefit to small governmental entities, which are less likely to have the resources to fund such a relocation on their own. The Commission expects that the number of entities impacted and the expected reconfiguration cost should be relatively minor. In order to receive reimbursement for the transition costs, however, affected public safety entities are required to provide information regarding the narrowband radios and base stations that they have deployed. We do not believe that such a reporting requirement will place an unacceptable burden on small governmental entities. 6. Report to Congress 218. The Commission will send a copy of the *Second Report and Order,* including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. 59 In addition, the Commission will send a copy of the *Second Report and Order,* including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the *Second Report and Order* and FRFA (or summaries thereof) will also be published in the **Federal Register** . 60 59 *See* 5 U.S.C. 801(a)(1)(A). 60 *See* 5 U.S.C. 604(b). B. Paperwork Reduction Act of 1995 219. The Second Report and Order contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget
(OMB)for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. Comments should address the following:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility;
(b)the accuracy of the Commission's burden estimates;
(c)ways to enhance the quality, utility, and clarity of the information collected; and
(d)ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, *see* 44 U.S.C. 3506(c)(4), the Commission previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” In this present document, the Commission has assessed the potential effects of the various policy changes with regard to information collection burdens on small business concerns, and finds that there are no results specific to businesses with fewer than 25 employees. In addition, the Commission has described impacts that might affect small businesses, which includes most businesses with fewer than 25 employees, in the FRFA in Appendix C, *infra.* The Commission notes, however, that Section 213 of the Consolidated Appropriations Act 2000 provides that rules governing frequencies in the 36 megahertz of the spectrum in the 746-806 MHz Band allocated for commercial use become effective immediately upon publication in the **Federal Register** without regard to certain sections of the Paperwork Reduction Act. The Commission is therefore not inviting comment on any information collections that concern those frequencies. The Commission also notes that it is seeking emergency processing under the Paperwork Reduction Act for the information collection requiring 700 MHz Band public safety licensees, whether holding individual narrowband authorizations or operating pursuant to a State License, to provide the total number of narrowband mobile and portable handsets and narrowband base stations in operation in channels 63 and 68, and the upper 1 megahertz of channels 64 and 69, as of August 30, 2007, along with the related information specified herein. Public and agency comments related to this request are due August 31, 2007. III. Ordering Clauses 220. Accordingly, *it is ordered* that pursuant to Sections 1, 4(i), 5, 7, 10, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 229, 251(e)(3), 301, 303, 307, 308, 309, 310, 311, 312, 316, 324, 331, 332, 333, 336, 337, 403, 503, and 610, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 155, 157, 160, 201, 202, 208, 214, 215, 222(d)(4)(A)-(C), 222(f), 222(g), 222(h)(1)(A), 222(h)(4)-(5), 251(e)(3), 229, 301, 303, 307, 308, 309, 310, 311, 312, 316, 324, 331, 332, 333, 336, 337, 403, 503, and 610, and Section 102 of the Communications Assistance for Law Enforcement Act, 18 U.S.C. 1001, this *Second Report and Order* in WT Docket No. 06-150, CC Docket No. 94-102, WT Docket No. 01-309, WT Docket No. 03-264, WT Docket No. 06-169, PS Docket No. 06-229, and WT Docket No. 96-86 is *adopted,* and that Part 2, 27, and 90 of the Commission's rules, 47 CFR Parts 2, 27, and 90, are *amended* as set forth in Appendix B. This *Second Report and Order* shall become effective October 23, 2007, except for the amendments to §§ 27.14, 27.15, 27.50, and 90.176 which contain information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the **Federal Register** announcing the effective date. 221. *It is further ordered that,* pursuant to Section 5(c) of the Communications Act of 1934, as amended, 47 U.S.C. 5(c), the Wireless Telecommunications Bureau and Public Safety and Homeland Security Bureau *are granted delegated authority* to implement the policies set forth in this *Second Report and Order* and the rules, as revised, set forth in Appendix B hereto. 222. *It is ordered* that, pursuant to Sections 4(i), 309, and 316(a) of the Communications Act, as amended, 47 U.S.C. 154(i), 309, 316(a), the 700 MHz Guard Band A Block licenses of Access 700, LLC, Pegasus Guard Band, LLC, and Dominion 700, Inc. *are modified,* as specified in Appendix D, upon the effective date of this *Second Report and Order.* 223. *It is ordered* that, pursuant to Sections 4(i), 309, and 316(a) of the Communications Act, as amended, 47 U.S.C. 154(i), 309, 316(a), Access 700 Holdings, LLC, Pegasus Guard Band, LLC, and Radiofone Nationwide PCS, LLC shall surrender their 700 MHz Guard Band B Block licenses to the Commission no later than 5 days from the effective date of this *Second Report and Order.* 224. *It is ordered* that, pursuant to Sections 4(i), and 309(f) of the Communications Act, as amended, 47 U.S.C. 154(i), 309(f), Access 700, LLC is granted special temporary authority for a period of 180 days, upon the effective date of this *Second Report and Order,* for frequencies 746.000-747.000 and 776.000-777.000 MHz in Major Economic Areas 20, 26, 32, 37, 44, and 52. The Wireless Telecommunications Bureau is delegated authority to issue such authorizations and to resolve any request for an extension of such authorizations as specified in this *Second Report and Order.* 225. *It is ordered* that, pursuant to Sections 4(i), 309, and 316(a) of the Communications Act, as amended, 47 U.S.C. 154(i), 309, 316(a) and Section 1.87 of the Commission's rules, 47 CFR 1.87, the 700 MHz Guard Band A Block license for Station WPRV447, licensed to PTPMS II Communications, L.L.C., *will be modified* by changing the authorized frequencies from 746.000-747.000 and 776.000-777.000 MHz, to 757.000-758.000 and 787.000-788.000 MHz. 226. *It is ordered* that, pursuant to Sections 4(i), 309, and 316(a) of the Communications Act, as amended, 47 U.S.C. 154(i), 309, 316(a) and Section 1.87 of the Commission's rules, 47 CFR 1.87, the 700 MHz Guard Band B Block licenses for Stations WPRV448 and WPRV449, licensed to PTPMS II Communications, L.L.C., *will be modified* by changing the authorized frequencies from 762.000-764.000 and 792.000-794.000 MHz, to 761.000-763.000 and 791.000-793.000 MHz. 227. *It is ordered* that, pursuant to Sections 309 and 316 of the Communications Act of 1934, as amended, 47 U.S.C. 309, 316, the modifications of Stations WPRV447, WPRV448, and WPRV449, licensed to PTPMS II Communications, L.L.C., specified in paragraphs 167 and 168, supra, shall become final and effective 30 days from the effective date of this *Second Report and Order* if no protests are filed within that period. The Wireless Telecommunications Bureau is delegated authority to resolve any such protests that may arise and to modify such licenses as specified in this *Second Report and Order.* 228. *It is ordered,* pursuant to Sections 1 and 4(i) of the Communications Act, as amended, 47 U.S.C. 151, 154(i), that by October 23, 2007, all 700 MHz Band public safety licensees, whether holding individual narrowband authorizations or operating pursuant to a State License, *shall provide* the total number of narrowband mobile and portable handsets and narrowband base stations in operation in channels 63 and 68, and the upper 1 megahertz of channels 64 and 69, as of August 30, 2007, along with the related information specified herein. 229. *It is further ordered* that the Wireless Telecommunications Bureau *shall send* a copy of this *Second Report and Order,* by certified mail, return receipt requested, to Alfred Angelo, President, PTPMS II Communications, L.L.C., 340 North Avenue East, Cranford, New Jersey 07016, and James H. Barker, Esq., 1001 Pennsylvania Avenue, NW., Suite 1300, Washington, DC 20004-2505. 230. *It is further ordered* that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, *shall send* a copy of this *Second Report and Order,* including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. 231. *It is further ordered* that the Commission *shall send* a copy of this *Second Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects 47 CFR Part 0 Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements. 47 CFR Part 1 Administrative practice and procedure, Communications common carriers, Penalties, Radio, Reporting and recordkeeping requirements, Satellites, Telecommunications, Television. 47 CFR Part 2 Communications equipment, Disaster assistance, Radio, Reporting and recordkeeping requirements, Telecommunications, Television. 47 CFR Part 27 Communications common carriers, Radio, Wireless radio services. 47 CFR Part 90 Civil defense, Common carriers, Emergency medical services, Radio, Reporting and recordkeeping requirements. Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rules For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 0, 1, 2, 27 and 90 as follows: PART 0—COMMISSION ORGANIZATION 1. The authority citation for part 0 continues to read as follows: Authority: Secs. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155. 2. Section 0.181 is amended by adding paragraph
(k)to read as follows: § 0.181 The Defense Commissioner.
(k)To decide, in response to a request by the Public Safety Broadband Licensee whether circumstances warrant emergency priority access by first responder public safety entities to the Upper 700 MHz D Block license spectrum. PART 1—PRACTICE AND PROCEDURE 3. The authority citation for part 1 continues to read as follows: Authority: 15 U.S.C. 79 *et seq.* ; 47 U.S.C. 151, 154(i), 154(j), 155, 157, 225, 303(r), and 309. 4. Section 1.946 is amended by revising paragraph
(c)to read as follows: § 1.946 Construction and coverage requirements.
(c)*Termination of authorizations.* If a licensee fails to commence service or operations by the expiration of its construction period or to meet its coverage or substantial service obligations by the expiration of its coverage period, its authorization terminates automatically (in whole or in part as set forth in the service rules), without specific Commission action, on the date the construction or coverage period expires. 5. Section 1.955 is amended by revising paragraph (a)(2) to read as follows: § 1.955 Terminations of authorizations.
(a)* * *
(2)*Failure to meet construction or coverage requirements.* Authorizations automatically terminate (in whole or in part as set forth in the service rules), without specific Commission action, if the licensee fails to meet applicable construction or coverage requirements. *See* § 1.946(c). 6. Section 1.2105 is amended by revising paragraph (c)(6) to read as follows: § 1.2105 Bidding application and certification procedures; prohibition of collusion.
(c)* * *
(6)Any applicant that makes or receives a communication of bids or bidding strategies prohibited under paragraph (c)(1) of this section shall report such communication in writing to the Commission immediately, and in no case later than five business days after the communication occurs. An applicant's obligation to make such a report continues until the report has been made. Such reports shall be filed with the Office of the Secretary, and a copy shall be sent to the Chief of the Auctions and Spectrum Access Division, Wireless Telecommunications Bureau. 7. Section 1.9005 is amended by revising paragraph
(k)to read as follows: § 1.9005 Included services.
(k)The Wireless Communications Service in the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands (part 27 of this chapter); PART 2—FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES AND REGULATIONS 8. The authority citation for part 2 continues to read as follows: Authority: 47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted. 9. Section 2.103 is amended by revising paragraphs
(a)introductory text and
(b)introductory text and adding paragraph
(c)to read as follows: § 2.103 Federal use of non-Federal frequencies.
(a)Federal stations may be authorized to use non-Federal frequencies in the bands above 25 MHz (except the 763-775 MHz and 793-805 MHz public safety bands) if the Commission finds that such use is necessary for coordination of Federal and non-Federal activities: Provided, however, that:
(b)Federal stations may be authorized to use channels in the 769-775 MHz, 799-805 MHz and 4940-4990 MHz public safety bands with non-Federal entities if the Commission finds such use necessary; where:
(c)Federal stations may be authorized to use channels in the 763-768 MHz and 793-798 MHz public safety bands with non-Federal entities where:
(1)The Federal entity obtains the prior approval of the Public Safety Broadband Licensee (and such approval granted by the Public Safety Broadband Licensee is consistent with the terms and conditions of the Network Sharing Agreement under 90.1406 of this chapter); and
(2)Federal operation is in accordance with the Commission's rules governing operation of this band and conforms to any conditions agreed upon by the Commission and NTIA. PART 27—MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES 10. The authority citation for part 27 continues to read as follows: Authority: 47 U.S.C. 154, 301, 302, 303, 307, 309, 332, 336, and 337 unless otherwise noted. 11. Section 27.1 is amended by revising paragraph (b)(2) to read as follows: § 27.1 Basis and purpose.
(b)* * *
(2)746-763 MHz, 775-793 MHz, and 805-806 MHz. 12. Section 27.2 is amended by revising paragraph
(b)to read as follows: § 27.2 Permissible communications.
(b)*775-776 MHz and 805-806 MHz bands.* Operators in the 775-776 MHz and 805-806 MHz bands may not employ a cellular system architecture. A cellular system architecture is defined, for purposes of this part, as one that consists of many small areas or cells (segmented from a larger geographic service area), each of which uses its own base station, to enable frequencies to be reused at relatively short distances. 13. Section 27.4 is amended by adding the following definitions in alphabetical order to read as follows: § 27.4 Terms and definitions. *700 MHz Public/Private Partnership.* The public/private partnership established for the development and operation of a nationwide, shared interoperable wireless broadband network operating on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands in accordance with the Commission's rules. *Network Assets Holder.* The Network Assets Holder is a Special Purpose Bankruptcy Remote Entity that is formed to hold the assets of the shared wireless broadband network associated with the 700 MHz Public/Private Partnership, in accordance with the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Network Sharing Agreement (NSA).* An agreement entered into between the winning bidder, the Upper 700 MHz D Block licensee, the Network Assets Holder, the Operating Company, the Public Safety Broadband Licensee, and any other related entities that the Commission may require or allow regarding the shared wireless broadband network associated with the 700 MHz Public/Private Partnership that will operate on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands. *Operating Company.* The Operating Company is a Special Purpose Bankruptcy Remote Entity that is formed to build and operate the shared wireless broadband network associated with the 700 MHz Public/Private Partnership, in accordance with the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Public Safety Broadband License.* The Public Safety Broadband License authorizes public safety broadband services in the 763-768 MHz and 793-798 MHz bands. *Public Safety Broadband Licensee.* The licensee of the Public Safety Broadband License in the 763-768 MHz and 793-798 MHz bands. *Shared Wireless Broadband Network.* Wireless broadband network associated with the 700 MHz Band Public/Private Partnership that operates on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands pursuant to the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Special Purpose Bankruptcy Remote Entity.* A “special purpose entity” is a legal entity created for a special limited purpose, in this context primarily to hold the Upper 700 MHz D Block license or the network assets, or to conduct the construction or operation of the shared wireless broadband network associated with the 700 MHz Public/Private Partnership. A special purpose entity is “bankruptcy remote” if that entity is unlikely to become insolvent as a result of its own activities, is adequately insulated from the consequences of a related party's insolvency, and contains certain characteristics which enhance the likelihood that it will not become the subject of an insolvency proceeding. *Upper 700 MHz D Block license.* The Upper 700 MHz D Block license is the nationwide license associated with the 758-763 MHz and 788-793 MHz bands. *Upper 700 MHz D Block licensee.* The Special Purpose Bankruptcy Remote Entity to which the Upper 700 MHz D Block license must be transferred upon execution of the Network Sharing Agreement. References herein to the rights and obligations of the Upper 700 MHz D Block licensee include the exercise or discharge of such rights or obligations, respectively, by related entities as are provided for in the NSA or otherwise as authorized by the Commission. 14. Section 27.5 is amended by revising paragraph
(b)to read as follows: § 27.5 Frequencies.
(b)*746-763 MHz, 775-793 MHz, and 805-806 MHz bands.* The following frequencies are available for licensing pursuant to this part in the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands:
(1)Two paired channels of 1 megahertz each are available for assignment in Block A in the 757-758 MHz and 787-788 MHz bands.
(2)Two paired channels of 1 megahertz each are available for assignment in Block B in the 775-776 MHz and 805-806 MHz bands.
(3)Two paired channels of 11 megahertz each are available for assignment in Block C in the 746-757 MHz and 776-787 MHz bands. In the event that no licenses for two channels in this Block C are assigned based on the results of the first auction in which such licenses were offered because the auction results do not satisfy the applicable reserve price, the spectrum in the 746-757 MHz and 776-787 MHz bands will instead be made available for assignment at a subsequent auction as follows:
(i)Two paired channels of 6 megahertz each available for assignment in Block C1 in the 746-752 MHz and 776-782 MHz bands.
(ii)Two paired channels of 5 megahertz each available for assignment in Block C2 in the 752-757 MHz and 782-787 MHz bands.
(4)Two paired channels of 5 megahertz each are available for assignment in Block D in the 758-763 MHz and 788-793 MHz bands. 15. Section 27.6 is amended by revising paragraphs
(a)introductory text, (b), (c), and
(e)to read as follows: § 27.6 Service Areas.
(a)WCS service areas include Economic Areas (EAs), Major Economic Areas (MEAs), Regional Economic Area Groupings (REAGs), cellular markets comprising Metropolitan Statistical Areas
(MSAs)and Rural Service Areas (RSAs), and a nationwide area. MEAs and REAGs are defined in the Table immediately following paragraph (a)(1) of this section. Both MEAs and REAGs are based on the U.S. Department of Commerce's EAs. *See* 60 FR 13114 (March 10, 1995). In addition, the Commission shall separately license Guam and the Northern Mariana Islands, Puerto Rico and the United States Virgin Islands, American Samoa, and the Gulf of Mexico, which have been assigned Commission-created EA numbers 173-176, respectively. The nationwide area is composed of the contiguous 48 states, Alaska, Hawaii, the Gulf of Mexico, and the U.S. territories. Maps of the EAs, MEAs, MSAs, RSAs, and REAGs and the **Federal Register** Notice that established the 172 EAs are available for public inspection and copying at the Reference Information Center, Consumer and Governmental Affairs Bureau, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
(b)*746-763 MHz, 775-793 MHz, and 805-806 MHz bands.* WCS service areas for the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands are as follows.
(1)Service areas for Block A in the 757-758 MHz and 787-788 MHz bands and Block B in the 775-776 MHz and 805-806 MHz bands are based on Major Economic Areas (MEAs), as defined in paragraphs (a)(1) and (a)(2) of this section.
(2)Service areas for Block C in the 746-757 MHz and 776-787 MHz bands are based on Regional Economic Area Groupings (REAGs) as defined by paragraph
(a)of this section. In the event that no licenses with respect to service areas for Block C in the 746-757 MHz and 776-787 MHz bands are assigned based on the results of the first auction in which such licenses are offered because the auction results do not satisfy the applicable reserve price, then service areas for the spectrum at 746-757 MHz and 776-787 MHz will instead be available for assignment as follows:
(i)Service areas for Block C1 in the 746-752 MHz and 776-782 MHz bands are based on Economic Areas
(EAs)as defined in paragraph
(a)of this section.
(ii)Service areas for Block C2 in the 752-757 MHz and 782-787 MHz bands are based on Regional Economic Area Groupings (REAGs) as defined by paragraph
(a)of this section.
(3)Service area for Block D in the 758-763 MHz and 788-793 MHz bands is a nationwide area as defined in paragraph (a)(1) of this section.
(c)*698-746 MHz band.* WCS service areas for the 698-746 MHz band are as follows.
(1)Service areas for Block A in the 698-704 MHz and 728-734 MHz bands and Block E in the 722-728 MHz band are based on Economic Areas
(EAs)as defined in paragraph
(a)of this section.
(2)Service areas for Block B in the 704-710 MHz and 734-740 MHz bands and Block C in the 710-716 MHz and 740-746 MHz bands are based on cellular markets comprising Metropolitan Statistical Areas
(MSAs)and Rural Service Areas
(RSAs)as defined by Public Notice Report No. CL-92-40 “Common Carrier Public Mobile Services Information, Cellular MSA/RSA Markets and Counties,” dated January 24, 1992, DA 92-109, 7 FCC Rcd 742 (1992), with the following modifications:
(i)The service areas of cellular markets that border the U.S. coastline of the Gulf of Mexico extend 12 nautical miles from the U.S. Gulf coastline.
(ii)The service area of cellular market 306 that comprises the water area of the Gulf of Mexico extends from 12 nautical miles off the U.S. Gulf coast outward into the Gulf.
(3)Service areas for Block D in the 716-722 MHz band are based on Economic Area Groupings
(EAGs)as defined by the Federal Communications Commission. *See* 62 FR 15978 (April 3, 1997) extended with the Gulf of Mexico. *See also* paragraphs (a)(1) and (a)(2) of this section and 62 FR 9636 (March 3, 1997), in which the Commission created an additional four economic area-like areas for a total of 176. Maps of the EAGs and the **Federal Register** notice that established the 172 Economic Areas
(EAs)are available for public inspection and copying at the Reference Center, Room CY A-257, 445 12th St., SW., Washington, DC 20554. These maps and data are also available on the FCC Web site at *http://www.fcc.gov/oet/info/maps/areas/.*
(i)There are 6 EAGs, which are composed of multiple EAs as defined in the table below: Economic area groupings Name Economic areas EAG001 Northeast 1-11, 54. EAG002 Mid-Atlantic 12-26, 41, 42, 44-53, 70. EAG003 Southeast 27-40, 43, 69, 71-86, 88-90, 95, 96, 174, 176 (part). EAG004 Great Lakes 55-68, 97, 100-109. EAG005 Central/Mountain 87, 91-94, 98, 99, 110-146, 148, 149, 152, 154-159, 176 (part). EAG006 Pacific 147, 150, 151, 153, 160-173, 175. Note 1 to paragraph (c)(3)(i): Economic Area Groupings are defined by the Federal Communications Commission; *see* 62 FR 15978 (April 3, 1997) extended with the Gulf of Mexico. Note 2 to paragraph (c)(3)(i): Economic Areas are defined by the Regional Economic Analysis Division, Bureau of Economic Analysis, U.S. Department of Commerce February 1995 and extended by the Federal Communications Commission, *see* 62 FR 9636 (March 3, 1997).
(ii)For purposes of paragraph (c)(3)(i) of this section, EA 176 (the Gulf of Mexico) will be divided between EAG003 (the Southeast EAG) and EAG005 (the Central/Mountain EAG) in accordance with the configuration of the Eastern/Central and Western Planning Area established by the Mineral Management Services Bureau of the Department of the Interior (MMS). That portion of EA 176 contained in the Eastern and Central Planning Areas as defined by MMS will be included in EAG003; that portion of EA 176 contained in the Western Planning Area as defined by MMS will be included in EAG005. Maps of these areas may be found on the MMS Web site: *http://www.gomr.mms.gov/homepg/offshore/offshore.html.*
(e)*The paired 1392-1395 and 1432-1435 MHz bands.* Service areas for the paired 1392-1395 and 1432-1435 MHz bands are as follows. Service areas for Block A in the 1392-1393.5 MHz and 1432-1433.5 MHz bands and Block B in the 1393.5-1395 MHz and 1433.5-1435 MHz bands are based on Economic Area Groupings
(EAGs)as defined in paragraph (c)(3) of this section. 16. Section 27.11 is amended by revising paragraphs
(c)and
(d)to read as follows: § 27.11 Initial authorization.
(c)*746-763 MHz, 775-793 MHz, and 805-806 MHz bands.* Initial authorizations for the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands shall be for paired channels of 1, 5, 6, or 11 megahertz of spectrum in accordance with § 27.5(b).
(1)Authorizations for Block A, consisting of two paired channels of 1 megahertz each, will be based on those geographic areas specified in § 27.6(b)(1).
(2)Authorizations for Block B, consisting of two paired channels of 1 megahertz each, will be based on those geographic areas specified in § 27.6(b)(1).
(3)Authorizations for Block C, consisting of two paired channels of 11 megahertz each, will be based on those geographic areas specified in § 27.6(b)(2). In the event that no licenses granting authorizations for Block C, consisting of two paired channels of 11 megahertz each, are assigned based on the results of the first auction in which such licenses are offered because the auction results do not satisfy the applicable reserve price, then the authorizations for the spectrum in the 746-757 MHz and 776-787 MHz bands will instead be as follows:
(i)Authorizations for Block C1, consisting of two paired channels of 6 megahertz each in the 746-752 MHz and 776-782 MHz bands, will be based on those geographic areas specified in § 27.6(b)(2)(i).
(ii)Authorizations for Block C2, consisting of two paired channels of 5 megahertz each in the 752-757 MHz and 782-787 MHz bands, will be based on those geographic areas specified in § 27.6(b)(2)(ii).
(4)The authorization for Block D, consisting of two paired channels of 5 megahertz each, will be based on the geographic area specified in § 27.6(b)(3).
(d)*698-746 MHz band.* Initial authorizations for the 698-746 MHz band shall be for 6 or 12 megahertz of spectrum in accordance with § 27.5(c).
(1)Authorizations for Block A, consisting of two paired channels of 6 megahertz each, will be based on those geographic areas specified in § 27.6(c)(1).
(2)Authorizations for Block B, consisting of two paired channels of 6 megahertz each, will be based on those geographic areas specified in § 27.6(c)(2).
(3)Authorizations for Block C, consisting of two paired channels of 6 megahertz each, will be based on those geographic areas specified in § 27.6(c)(2).
(4)Authorizations for Block D, consisting of an unpaired channel block of 6 megahertz, will be based on those geographic areas specified in § 27.6(c)(3).
(5)Authorizations for Block E, consisting of an unpaired channel block of 6 megahertz, will be based on those geographic areas specified in § 27.6(c)(1). 17. Section 27.13 is amended by revising the paragraph heading and the first and second sentence in paragraph
(b)to read as follows: § 27.13 License period.
(b)*698-763 MHz and 776-793 MHz bands.* Initial authorizations for the 698-763 MHz and 776-793 MHz bands will extend for a term not to exceed ten years from February 17, 2009, except that initial authorizations for a part 27 licensee that provides broadcast services, whether exclusively or in combination with other services, will not exceed eight years. Initial authorizations for the 775-776 MHz and 805-806 MHz bands shall not exceed January 1, 2015. * * * § 27.14 [Amended] 18. Amend § 27.14 as follows: a. Revise paragraph (a). b. Remove paragraph (f). c. Redesignate paragraph
(e)as paragraph (f). d. Add new paragraphs (e), (g), (h), (i), (j), (k), (l), (m), and (n). § 27.14 Construction requirements; criteria for renewal.
(a)AWS and WCS licensees, with the exception of WCS licensees holding authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, Block B in the 704-710 MHz and 734-740 MHz bands, Block E in the 722-728 MHz band, Block C in the 746-757 MHz and 776-787 MHz, and Block D in the 758-763 MHz and 788-793 MHz bands must, as a performance requirement, make a showing of “substantial service” in their license area within the prescribed license term set forth in § 27.13. “Substantial service” is defined as service which is sound, favorable and substantially above a level of mediocre service which just might minimally warrant renewal. Failure by any licensee to meet this requirement will result in forfeiture of the license and the licensee will be ineligible to regain it.
(e)Comparative renewal proceedings do not apply to WCS licensees holding authorizations for the 698-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands. These licensees must file a renewal application in accordance with the provisions set forth in § 1.949 of this chapter, and must make a showing of substantial service, independent of its performance requirements, as a condition for renewal at the end of each license term.
(g)WCS licensees holding EA authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, cellular market authorizations for Block B in the 704-710 MHz and 734-740 MHz bands, and EA authorizations for Block E in the 722-728 MHz band, if the results of the first auction in which licenses for such authorizations are offered satisfy the reserve price for the applicable block, shall provide signal coverage and offer service over at least 35 percent of the geographic area of each of their license authorizations no later than February 17, 2013 (or within four years of initial license grant if the initial authorization in a market is granted after February 17, 2009), and shall provide such service over at least 70 percent of the geographic area of each of these authorizations by the end of the license term. In applying these geographic benchmarks, licensees are not required to include land owned or administered by government as a part of the relevant service area. Licensees may count covered government land for purposes of meeting their geographic construction benchmark, but are required to add the covered government land to the total geographic area used for measurement purposes. Licensees are required to include those populated lands held by tribal governments and those held by the Federal Government in trust or for the benefit of a recognized tribe.
(1)If an EA or CMA licensee holding an authorization in these particular blocks fails to provide signal coverage and offer service over at least 35 percent of the geographic area of its license authorization by no later than February 17, 2013 (or within four years of initial license grant, if the initial authorization in a market is granted after February 17, 2009), the term of that license authorization will be reduced by two years and such licensee may be subject to enforcement action, including forfeitures. In addition, such an EA or CMA licensee may lose authority to operate in part of the remaining unserved areas of the license.
(2)If any such EA or CMA licensee fails to provide signal coverage and offer service to at least 70 percent of the geographic area of its license authorization by the end of the license term, that licensee's authorization will terminate automatically without Commission action for those geographic portions of its license in which the licensee is not providing service, and those unserved areas will become available for reassignment by the Commission. Such licensee may also be subject to enforcement action, including forfeitures. In addition, an EA or CMA licensee that provides signal coverage and offers service at a level that is below the end-of-term benchmark may be subject to license termination. In the event that a licensee's authority to operate in a license area terminates automatically without Commission action, such areas will become available for reassignment pursuant to the procedures in paragraph
(j)of this section.
(3)For licenses under paragraphs (g), (h), and (i), of this section, the geographic service area to be made available to new entrants must include a contiguous area of at least 130 square kilometers (50 square miles), and areas smaller than a contiguous area of at least 130 square kilometers (50 square miles) will not be deemed unserved.
(h)WCS licensees holding authorizations for Block C in the 746-757 MHz and 776-787 MHz bands shall provide signal coverage and offer service over at least 40 percent of the population in each EA comprising the REAG license area no later than February 17, 2013 (or within four years of initial license grant, if the initial authorization in a market is granted after February 17, 2009), and shall provide such service over at least 75 percent of the population of each of these EAs by the end of the license term. For purposes of compliance with this requirement, licensees should determine population based on the most recently available U.S. Census Data.
(1)If a licensee holding a Block C authorization fails to provide signal coverage and offer service over at least 40 percent of the population in each EA comprising the REAG license area by no later than February 17, 2013 (or within four years of initial license grant if the initial authorization in a market is granted after February 17, 2009), the term of the license authorization will be reduced by two years and such licensee may be subject to enforcement action, including forfeitures. In addition, a licensee that provides signal coverage and offers service at a level that is below the interim benchmark may lose authority to operate in part of the remaining unserved areas of the license.
(2)If a licensee holding a Block C authorization fails to provide signal coverage and offer service over at least 75 percent of the population in any EA comprising the REAG license area by the end of the license term, for each such EA that licensee's authorization will terminate automatically without Commission action for those geographic portions of its license in which the licensee is not providing service. Such licensee may also be subject to enforcement action, including forfeitures. In the event that a licensee's authority to operate in a license area terminates automatically without Commission action, such areas will become available for reassignment pursuant to the procedures in paragraph
(j)of this section. In addition, a REAG licensee that provides signal coverage and offers service at a level that is below the end-of-term benchmark within any EA may be subject to license termination within that EA.
(i)WCS licensees holding EA authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, cellular market authorizations for Block B in the 704-710 MHz and 734-740 MHz bands, and EA authorizations for Block E in the 722-728 MHz band, if the results of the first auction in which licenses for such authorizations in Blocks A, B, and E are offered do not satisfy the reserve price for the applicable block, as well as EA authorizations for Block C1 in the 746-752 MHz and 776-782 MHz bands and REAG authorizations for Block C2 in the 752-757 MHz and 782-787 MHz bands, are subject to the following:
(1)If a licensee holding a cellular market area or EA authorization subject to this paragraph
(i)fails to provide signal coverage and offer service over at least 40 percent of the population in its license area by no later than February 17, 2013 (or within four years of initial license grant, if the initial authorization in a market is granted after February 17, 2009), the term of that license authorization will be reduced by two years and such licensee may be subject to enforcement action, including forfeitures. In addition, such licensee that provides signal coverage and offers service at a level that is below the interim benchmark may lose authority to operate in part of the remaining unserved areas of the license. For purposes of compliance with this requirement, licensees should determine population based on the most recently available U.S. Census Data.
(2)If a licensee holding a cellular market area or EA authorization subject to this paragraph
(i)fails to provide signal coverage and offer service over at least 75 percent of the population in its license area by the end of the license term, that licensee's authorization will terminate automatically without Commission action for those geographic portions of its license in which the licensee is not providing service, and those unserved areas will become available for reassignment by the Commission. Such licensee may also be subject to enforcement action, including forfeitures. In the event that a licensee's authority to operate in a license area terminates automatically without Commission action, such areas will become available for reassignment pursuant to the procedures in paragraph
(j)of this section. In addition, such a licensee that provides signal coverage and offers service at a level that is below the end-of-term benchmark may be subject to license termination. For purposes of compliance with this requirement, licensees should determine population based on the most recently available U.S. Census Data.
(3)Licensee's holding an authorization in Block C2 will be subject to the requirements in paragraph
(h)of this section.
(j)In the event that a licensee's authority to operate in a license area terminates automatically under paragraphs (g), (h), or
(i)of this section, such areas will become available for reassignment pursuant to the following procedures:
(1)The Wireless Telecommunications Bureau is delegated authority to announce by public notice that these license areas will be made available and establish a 30-day window during which third parties may file license applications to serve these areas. During this 30-day period, licensees that had their authority to operate terminate automatically for unserved areas may not file applications to provide service to these areas. Applications filed by third parties that propose areas overlapping with other applications will be deemed mutually exclusive, and will be resolved through an auction. The Wireless Telecommunications Bureau, by public notice, may specify a limited period before the filing of short-form applications (FCC Form 175) during which applicants may enter into a settlement to resolve their mutual exclusivity, subject to the provisions of § 1.935 of this chapter.
(2)Following this 30-day period, the original licensee and third parties can file license applications for remaining unserved areas where licenses have not been issued or for which there are no pending applications. If the original licensee or a third party files an application, that application will be placed on public notice for 30 days. If no mutually exclusive application is filed, the application will be granted, provided that a grant is found to be in the public interest. If a mutually exclusive application is filed, it will be resolved through an auction. The Wireless Telecommunications Bureau, by public notice, may specify a limited period before the filing of short-form applications (FCC Form 175) during which applicants may enter into a settlement to resolve their mutual exclusivity, subject to the provisions of § 1.935 of this chapter.
(3)The licensee will have one year from the date the new license is issued to complete its construction and provide signal coverage and offer service over 100 percent of the geographic area of the new license area. If the licensee fails to meet this construction requirement, its license will automatically terminate without Commission action and it will not be eligible to apply to provide service to this area at any future date.
(k)WCS licensees with authorizations in the spectrum blocks enumerated in paragraphs (g), (h), or (i), of this section, including any licensee that obtained its license pursuant to the procedures set forth in paragraph
(j)of this section, shall demonstrate compliance with performance requirements by filing a construction notification with the Commission, within 15 days of the expiration of the relevant benchmark, in accordance with the provisions set forth in § 1.946(d) of this chapter. The licensee must certify whether it has met the relevant performance requirement. All licensees must file a description and certification of the areas for which they are providing service. The construction notifications must include electronic coverage maps, supporting technical documentation and any other information as the Wireless Telecommunications Bureau may prescribe by public notice.
(l)WCS licensees with authorizations in the spectrum blocks enumerated in paragraphs (g), (h), or (i), of this section, excluding any licensee that obtained its license pursuant to the procedures set forth in paragraph (j), of this section, shall file interim reports with the Commission that provide the Commission, at a minimum, with information concerning the status of their efforts to meet the performance requirements applicable to their authorizations in such spectrum blocks and the manner in which that spectrum is being utilized. The information to be reported will include the date the license term commenced, a description of the steps the licensee has taken toward meeting its construction obligations in a timely manner, including the technology or technologies and service(s) being provided, and the areas within their license areas in which those services are available. These licensees shall file their first interim report with the Commission no later than February 17, 2011 and no sooner than 30 days prior to this date. Licensees that meet their interim benchmarks shall file a second interim report with the Commission no later than February 17, 2016 and no sooner than 30 days prior to this date. Licensees that do not meet their interim benchmarks shall file their second interim report no later than on February 17, 2015 and no sooner than 30 days prior to this date.
(m)The WCS licensee holding the authorization for the D Block at 758-763 MHz and 788-793 MHz (the Upper 700 MHz D Block licensee) shall comply with the following construction requirements.
(1)The Upper 700 MHz D Block licensee shall provide a signal coverage and offer service over at least 75 percent of the population of the nationwide Upper 700 MHz D Block license area within four years from February 17, 2009, 95 percent of the population of the nationwide license area within seven years, and 99.3 percent of the population of the nationwide license area within ten years.
(2)The Upper 700 MHz D Block licensee may modify, to a limited degree, its population-based construction benchmarks with the agreement of the Public Safety Broadband Licensee and the prior approval of the Commission, where such a modification would better serve to meet commercial and public safety needs.
(3)The Upper 700 MHz D Block licensee shall meet the population benchmarks based on a performance schedule specified in the Network Sharing Agreement, taking into account performance pursuant to § 27.1327 as appropriate under that rule, and using the most recently available U.S. Census Data. The network and signal levels employed to meet these benchmarks must be adequate for public safety use, as defined in the Network Sharing Agreement, and the services made available must include those appropriate for public safety entities that operate in those areas. The schedule shall include coverage for major highways and interstates, as well as such additional areas that are necessary to provide coverage for all incorporated communities with a population in excess of 3,000, unless the Public Safety Broadband Licensee and the Upper 700 MHz D Block licensee jointly determine, in consultation with a relevant community, that such additional coverage will not provide significant public benefit.
(4)The Upper 700 MHz D Block licensee shall demonstrate compliance with performance requirements by filing a construction notification with the Commission within 15 days of the expiration of the relevant benchmark, in accordance with the provisions set forth in § 1.946(d) of this chapter. The licensee must certify whether it has met the relevant performance requirement and must file a description and certification of the areas for which it is providing service. The construction notifications must include the following:
(i)Certifications of the areas that were scheduled for construction and service by that date under the Network Sharing Agreement for which it is providing service, the type of service it is providing for each area, and the type of technology it is utilizing to provide this service.
(ii)Electronic coverage maps and supporting technical documentation providing the assumptions used by the licensee to create the coverage maps, including the propagation model and the signal strength necessary to provide service.
(n)At the end of its license term, the Upper 700 MHz D Block licensee must, in order to renew its license, make a showing of its success in meeting the material requirements set forth in the Network Sharing Agreement as well as all other license conditions, including the performance benchmark requirements set forth in this section. § 27.15 [Amended] 19. Amend § 27.15 by revising paragraph
(d)to read as follows: § 27.15 Geographic partitioning and spectrum disaggregation.
(d)*Compliance with construction requirements* —(1) *Partitioning.*
(i)Except for WCS licensees holding authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, Block B in the 704-710 MHz and 734-740 MHz bands, Block E in the 722-728 MHz band, Blocks C, C1, and C2 in the 746-757 MHz and 776-787 MHz bands, and Block D in the 758-763 MHz and 788-793 MHz bands, the following rules apply to WCS and AWS licensees holding authorizations for purposes of implementing the construction requirements set forth in § 27.14. Parties to partitioning agreements have two options for satisfying the construction requirements set forth in § 27.14. Under the first option, the partitioner and partitionee each certifies that it will independently satisfy the substantial service requirement for its respective partitioned area. If a licensee subsequently fails to meet its substantial service requirement, its license will be subject to automatic cancellation without further Commission action. Under the section option, the partitioner certifies that it has met or will meet the substantial service requirement for the entire, pre-partitioned geographic service area. If the partitioner subsequently fails to meet its substantial service requirement, only its license will be subject to automatic cancellation without further Commission action.
(ii)For WCS licensees holding authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, Block B in the 704-710 MHz and 734-740 MHz bands, Block E in the 722-728 MHz band, and Blocks C, C1, and C2 in the 746-757 MHz and 776-787 MHz bands, the following rules apply for purposes of implementing the construction requirements set forth in § 27.14. Parties to partitioning agreements have two options for satisfying the construction requirements set forth in § 27.14. Under the first option, the partitioner and partitionee each certifies that they will collectively share responsibility for meeting the construction requirement for the entire pre-partition geographic license area. If the partitioner and partitionee collectively fail to meet the construction requirement, then both the partitioner and partitionee will be subject to the consequences enumerated in § 27.14(g) and
(h)for this failure. Under the second option, the partitioner and partitionee each certifies that it will independently meet the construction requirement for its respective partitioned license area. If the partitioner or partitionee fails to meet the construction requirement for its respective partitioned license area, then the consequences for this failure shall be those enumerated in § 27.14(g) and (h).
(2)*Disaggregation.*
(i)Except for WCS licensees holding authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, Block B in the 704-710 MHz and 734-740 MHz bands, Block E in the 722-728 MHz band, and Blocks C, C1, and C2 in the 746-757 MHz and 776-787 MHz bands, and Block D in the 758-763 MHz and 788-793 MHz bands, the following rules apply to WCS and AWS licensees holding authorizations for purposes of implementing the construction requirements set forth in § 27.14. Parties to disaggregation agreements have two options for satisfying the construction requirements set forth in § 27.14. Under the first option, the disaggregator and disaggregatee each certifies that it will share responsibility for meeting the substantial service requirement for the geographic service area. If the parties choose this option and either party subsequently fails to satisfy its substantial service responsibility, both parties' licenses will be subject to forfeiture without further Commission action. Under the second option, both parties certify either that the disaggregator or the disaggregatee will meet the substantial service requirement for the geographic service area. If the parties choose this option, and the party responsible subsequently fails to meet the substantial service requirement, only that party's license will be subject to forfeiture without further Commission action.
(ii)For WCS licensees holding authorizations for Block A in the 698-704 MHz and 728-734 MHz bands, Block B in the 704-710 MHz and 734-740 MHz bands, Block E in the 722-728 MHz band, and Blocks C, C1, and C2 in the 746-757 MHz and 776-787 MHz bands, the following rules apply for purposes of implementing the construction requirements set forth in § 27.14. If either the disaggregator or the disaggregatee meets the construction requirements set forth in § 27.14, then these requirements will be considered to be satisfied for both parties. If neither the disaggregator nor the disaggregatee meets the construction requirements, then both parties will be subject to the consequences enumerated in § 27.14(g) and
(h)for this failure. 20. Add § 27.16 to subpart B to read as follows: § 27.16 Network access requirements for Block C in the 746-757 and 776-787 MHz bands.
(a)*Applicability.* This section shall apply only to the authorizations for Block C in the 746-757 and 776-787 MHz bands assigned and only if the results of the first auction in which licenses for such authorizations are offered satisfied the applicable reserve price.
(b)*Use of devices and applications.* Licensees offering service on spectrum subject to this section shall not deny, limit, or restrict the ability of their customers to use the devices and applications of their choice on the licensee's C Block network, except:
(1)Insofar as such use would not be compliant with published technical standards reasonably necessary for the management or protection of the licensee's network, or
(2)As required to comply with statute or applicable government regulation.
(c)*Technical standards.* For purposes of paragraph (b)(1) of this section:
(1)Standards shall include technical requirements reasonably necessary for third parties to access a licensee's network via devices or applications without causing objectionable interference to other spectrum users or jeopardizing network security. The potential for excessive bandwidth demand alone shall not constitute grounds for denying, limiting or restricting access to the network.
(2)To the extent a licensee relies on standards established by an independent standards-setting body which is open to participation by representatives of service providers, equipment manufacturers, application developers, consumer organizations, and other interested parties, the standards will carry a presumption of reasonableness.
(3)A licensee shall publish its technical standards, which shall be non-proprietary, no later than the time at which it makes such standards available to any preferred vendors, so that the standards are readily available to customers, equipment manufacturers, application developers, and other parties interested in using or developing products for use on a licensee's networks.
(d)*Access requests.*
(1)Licensees shall establish and publish clear and reasonable procedures for parties to seek approval to use devices or applications on the licensees' networks. A licensee must also provide to potential customers notice of the customers' rights to request the attachment of a device or application to the licensee's network, and notice of the licensee's process for customers to make such requests, including the relevant network criteria.
(2)If a licensee determines that a request for access would violate its technical standards or regulatory requirements, the licensee shall expeditiously provide a written response to the requester specifying the basis for denying access and providing an opportunity for the requester to modify its request to satisfy the licensee's concerns.
(e)*Handset locking prohibited.* No licensee may disable features on handsets it provides to customers, to the extent such features are compliant with the licensee's standards pursuant to paragraph (b)of this section, nor configure handsets it provides to prohibit use of such handsets on other providers' networks.
(f)*Burden of proof.* Once a complainant sets forth a prima facie case that the C Block licensee has refused to attach a device or application in violation of the requirements adopted in this section, the licensee shall have the burden of proof to demonstrate that it has adopted reasonable network standards and reasonably applied those standards in the complainant's case. Where the licensee bases its network restrictions on industry-wide consensus standards, such restrictions would be presumed reasonable. 21. Section 27.50 is amended by revising paragraphs (b)(1) through (b)(12), (c)(5), (c)(7), (c)(8), (c)(11), and by revising tables 1, 2, 3, and 4 at the end of the section. § 27.50 Power and antenna height limits.
(b)* * *
(1)Fixed and base stations transmitting a signal in the 757-758 and 775-776 MHz bands must not exceed an effective radiated power
(ERP)of 1000 watts and an antenna height of 305 m height above average terrain (HAAT), except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section.
(2)Fixed and base stations transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands with an emission bandwidth of 1 MHz or less must not exceed an ERP of 1000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section.
(3)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands with an emission bandwidth of 1 MHz or less must not exceed an ERP of 2000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts ERP in accordance with Table 2 of this section.
(4)Fixed and base stations transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands with an emission bandwidth greater than 1 MHz must not exceed an ERP of 1000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts/MHz ERP accordance with Table 3 of this section.
(5)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands with an emission bandwidth greater than 1 MHz must not exceed an ERP of 2000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts/MHz ERP in accordance with Table 4 of this section.
(6)Licensees of fixed or base stations transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands at an ERP greater than 1000 watts must comply with the provisions set forth in paragraph (b)(8) of this section and § 27.55(c).
(7)Licensees seeking to operate a fixed or base station located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands at an ERP greater than 1000 watts must:
(i)coordinate in advance with all licensees authorized to operate in the 698-763 MHz, 775-793, and 805-806 MHz bands within 120 kilometers (75 miles) of the base or fixed station;
(ii)coordinate in advance with all regional planning committees, as identified in § 90.527 of this chapter, with jurisdiction within 120 kilometers (75 miles) of the base or fixed station.
(8)Licensees authorized to transmit in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands and intending to operate a base or fixed station at a power level permitted under the provisions of paragraph (b)(6) of this section must provide advanced notice of such operation to the Commission and to licensees authorized in their area of operation. Licensees who must be notified are all licensees authorized to operate in the 763-775 MHz and 793-805 MHz bands under part 90 of this chapter within 75 km of the base or fixed station and all regional planning committees, as identified in § 90.527 of this chapter, with jurisdiction within 75 km of the base or fixed station. Notifications must provide the location and operating parameters of the base or fixed station, including the station's ERP, antenna coordinates, antenna height above ground, and vertical antenna pattern, and such notifications must be provided at least 90 days prior to the commencement of station operation.
(9)Control stations and mobile stations transmitting in the 746-757 MHz, 758-763 MHz, 776-793 MHz, and 805-806 MHz bands and fixed stations transmitting in the 787-788 MHz and 805-806 MHz bands are limited to 30 watts ERP.
(10)Portable stations (hand-held devices) transmitting in the 746-757 MHz, 758-763 MHz, 776-793 MHz, and 805-806 MHz bands are limited to 3 watts ERP.
(11)For transmissions in the 757-758, 775-776, 787-788, and 805-806 MHz bands, maximum composite transmit power shall be measured over any interval of continuous transmission using instrumentation calibrated in terms of RMS-equivalent voltage. The measurement results shall be properly adjusted for any instrument limitations, such as detector response times, limited resolution bandwidth capability when compared to the emission bandwidth, etc., so as to obtain a true maximum composite measurement for the emission in question over the full bandwidth of the channel.
(12)For transmissions in the 746-757, 758-763, 776-787, and 788-793 MHz bands, licensees may employ equipment operating in compliance with either the measurement techniques described in paragraph (b)(11) of this section or a Commission-approved average power technique. In both instances, equipment employed must be authorized in accordance with the provisions of § 27.51.
(c)* * *
(5)Licensees seeking to operate a fixed or base station located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal at an ERP greater than 1000 watts must:
(i)coordinate in advance with all licensees authorized to operate in the 698-763 MHz, 775-793, and 805-806 MHz bands within 120 kilometers (75 miles) of the base or fixed station;
(ii)coordinate in advance with all regional planning committees, as identified in §§ 90.527 of this chapter, with jurisdiction within 120 kilometers (75 miles) of the base or fixed station.
(7)A licensee authorized to operate in the 710-716, 716-722, or 740-746 MHz bands, or in any unpaired spectrum blocks within the 698-746 MHz band, may operate a fixed or base station at an ERP up to a total of 50 kW within its authorized, 6 MHz spectrum block if the licensee complies with the provisions of § 27.55(b). The antenna height for such stations is limited only to the extent required to satisfy the requirements of § 27.55(b).
(8)Licensees intending to operate a base or fixed station at a power level permitted under the provisions of paragraph (c)(6) of this section must provide advanced notice of such operation to the Commission and to licensees authorized in their area of operation. Licensees who must be notified are all licensees authorized under this part to operate on an adjacent spectrum block within 75 km of the base or fixed station. Notifications must provide the location and operating parameters of the base or fixed station, including the station's ERP, antenna coordinates, antenna height above ground, and vertical antenna pattern, and such notifications must be provided at least 90 days prior to the commencement of station operation.
(11)Licensees may employ equipment operating in compliance with either the measurement techniques described in paragraph (b)(11) of this section or a Commission-approved average power technique. In both instances, equipment employed must be authorized in accordance with the provisions of § 27.51. Table 1 to § 27.50.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 757-758 and 775-776 MHz Bands and for Base and Fixed Stations in the 698-757 MHz, 758-763 MHz, 776-787 MHz and 788-793 MHz Bands Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 2 to § 27.50.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-757 MHz, 758-763 MHz, 776-787 MHz and 788-793 MHz Bands Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000 Table 3 to § 27.50.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-757 MHz, 758-763 MHz, 776-787 MHz and 788-793 MHz Bands Transmitting a Signal With an Emission Bandwidth Greater than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 4 to § 27.50.—Permissible Power and Antenna Heights for Base and Fixed Stations in the 698-757 MHz, 758-763 MHz, 776-787 MHz and 788-793 MHz Bands Transmitting a Signal With an Emission Bandwidth Greater than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz ) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000 22. Amend § 27.53 as follows: a. Revise paragraph
(c)introductory text and paragraphs (c)(1) through (c)(4). b. Redesignate paragraphs
(d)through
(m)as paragraphs
(e)through (n). c. Add new paragraph (d). d. Revise newly redesignated paragraph
(e)introductory text. e. Redesignate newly redesignated paragraphs (e)(1) through (e)(4) as paragraphs (e)(6) through (e)(9). f. Add new paragraphs (e)(1) through (e)(5). g. Revise newly redesignated paragraph (f). § 27.53 Emission limits.
(c)For operations in the 746-758 MHz band and the 776-788 MHz band, the power of any emission outside the licensee's frequency band(s) of operation shall be attenuated below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, in accordance with the following:
(1)On any frequency outside the 746-758 MHz band, the power of any emission shall be attenuated outside the band below the transmitter power
(P)by at least 43 + 10 log
(P)dB;
(2)On any frequency outside the 776-788 MHz band, the power of any emission shall be attenuated outside the band below the transmitter power
(P)by at least 43 + 10 log
(P)dB;
(3)On all frequencies between 763-775 MHz and 793-805 MHz, by a factor not less than 76 + 10 log
(P)dB in a 6.25 kHz band segment, for base and fixed stations;
(4)On all frequencies between 763-775 MHz and 793-805 MHz, by a factor not less than 65 + 10 log
(P)dB in a 6.25 kHz band segment, for mobile and portable stations;
(d)For operations in the 758-763 MHz and 788-793 MHz bands, the power of any emission outside the licensee's frequency bands of operation shall be attenuated below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, in accordance with the following:
(1)On all frequencies between 769-775 MHz and 799-805 MHz, by a factor not less than 76 + 10 log
(P)dB in a 6.25 kHz band segment, for base and fixed stations;
(2)On all frequencies between 769-775 MHz and 799-805 MHz, by a factor not less than 65 + 10 log
(P)dB in a 6.25 kHz band segment, for mobile and portable stations;
(3)On any frequency between 775-788 MHz, above 805 MHz, and below 758 MHz, by at least 43 + 10 log
(P)dB;
(4)Compliance with the provisions of paragraphs (d)(1) and (d)(2) of this section is based on the use of measurement instrumentation such that the reading taken with any resolution bandwidth setting should be adjusted to indicate spectral energy in a 6.25 kHz segment;
(5)Compliance with the provisions of paragraph (d)(3) of this section is based on the use of measurement instrumentation employing a resolution bandwidth of 100 kHz or greater. However, in the 100 kHz bands immediately outside and adjacent to the frequency block, a resolution bandwidth of at least 30 kHz may be employed.
(e)For operations in the 775-776 MHz and 805-806 MHz bands, transmitters must comply with either paragraphs (e)(1) to (e)(5) of this section or the ACP emission limitations set forth in paragraphs (e)(6) to (e)(9) of this section.
(1)On all frequencies between 763-775 MHz and 793-805 MHz, the power of any emission outside the licensee's frequency bands of operation shall be attenuated below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, by a factor not less than 76 + 10 log
(P)dB in a 6.25 kHz band segment, for base and fixed stations;
(2)On all frequencies between 763-775 MHz and 793-805 MHz, the power of any emission outside the licensee's frequency bands of operation shall be attenuated below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, by a factor not less than 65 + 10 log
(P)dB in a 6.25 kHz band segment, for mobile and portable stations;
(3)On any frequency outside the 775-776 MHz and 805-806 MHz bands, the power of any emission shall be attenuated outside the band below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, by at least 43 + 10 log
(P)dB;
(4)Compliance with the provisions of paragraphs (e)(1) and (e)(2) of this section is based on the use of measurement instrumentation such that the reading taken with any resolution bandwidth setting should be adjusted to indicate spectral energy in a 6.25 kHz segment;
(5)Compliance with the provisions of paragraph (e)(3) of this section is based on the use of measurement instrumentation employing a resolution bandwidth of 100 kHz or greater. However, in the 100 kHz bands immediately outside and adjacent to the frequency block, a resolution bandwidth of at least 30 kHz may be employed.
(f)For operations in the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands, emissions in the band 1559-1610 MHz shall be limited to −70 dBW/MHz equivalent isotropically radiated power
(EIRP)for wideband signals, and −80 dBW EIRP for discrete emissions of less than 700 Hz bandwidth. For the purpose of equipment authorization, a transmitter shall be tested with an antenna that is representative of the type that will be used with the equipment in normal operation. 23. Section 27.55 is amended by revising the section heading and paragraphs (a)(2) and
(c)to read as follows: § 27.55 Power strength limits.
(a)* * *
(2)698-758 and 775-787 MHz bands: 40 dBμV/m.
(c)*Power flux density limit for stations operating in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands.* For base and fixed stations operating in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands in accordance with the provisions of § 27.50(b)(6), the power flux density that would be produced by such stations through a combination of antenna height and vertical gain pattern must not exceed 3000 microwatts per square meter on the ground over the area extending to 1 km from the base of the antenna mounting structure. 24. Section 27.57 is amended by revising paragraph
(b)to read as follows: § 27.57 International coordination.
(b)Operation in the 698-763 MHz, 775-793 MHz, and 805-806 MHz bands is subject to international agreements between Mexico and Canada. Unless otherwise modified by international treaty, licenses must not cause interference to, and must accept harmful interference from, television broadcast operations in Mexico and Canada. 25. Section 27.60 is revised to read as follows: § 27.60 TV/DTV interference protection criteria. Base, fixed, control, and mobile transmitters in the 698-763 MHz, 775-793 MHz, and 805-806 MHz frequency bands must be operated only in accordance with the rules in this section to reduce the potential for interference to public reception of the signals of existing TV and DTV broadcast stations transmitting on TV Channels 51 through 68.
(a)*D/U ratios.* Licensees must choose site locations that are a sufficient distance from co-channel and adjacent channel TV and DTV stations, and/or must use reduced transmitting power or transmitting antenna height such that the following minimum desired signal-to-undesired signal ratios (D/U ratios) are met.
(1)The minimum D/U ratio for co-channel stations is:
(i)40 dB at the hypothetical Grade B contour (64 dBμV/m) (88.5 kilometers (55 miles)) of the TV station;
(ii)For transmitters operating in the 698-746 MHz frequency band, 23 dB at the equivalent Grade B contour (41 dBμV/m) (88.5 kilometers (55 miles)) of the DTV station; or
(iii)For transmitters operating in the 746-763 MHz, 775-793 MHz, and 805-806 MHz frequency bands, 17 dB at the equivalent Grade B contour (41 dBμV/m) (88.5 kilometers (55 miles)) of the DTV station.
(2)The minimum D/U ratio for adjacent channel stations is 0 dB at the hypothetical Grade B contour (64 dBμV/m) (88.5 kilometers (55 miles)) of the TV station or −23 dB at the equivalent Grade B contour (41 dBμV/m) (88.5 kilometers (55 miles)) of the DTV station.
(b)*TV stations and calculation of contours.* The methods used to calculate TV contours and antenna heights above average terrain are given in §§ 73.683 and 73.684 of this chapter. Tables to determine the necessary minimum distance from the 698-763 MHz, 775-793 MHz, and 805-806 MHz station to the TV/DTV station, assuming that the TV/DTV station has a hypothetical or equivalent Grade B contour of 88.5 kilometers (55 miles), are located in § 90.309 of this chapter and labeled as Tables B, D, and E. Values between those given in the tables may be determined by linear interpolation. Distances for station parameters greater than those indicated in the tables should be calculated in accordance with the required D/U ratios, as provided in paragraph
(a)of this section. The locations of existing and proposed TV/DTV stations during the period of transition from analog to digital TV service are given in part 73 of this chapter and in the final proceedings of MM Docket No. 87-268.
(1)Licensees of stations operating within the ERP and HAAT limits of § 27.50 must select one of four methods to meet the TV/DTV protection requirements, subject to Commission approval:
(i)Utilize the geographic separation specified in Tables B, D, and E of § 90.309 of this chapter, as appropriate;
(ii)When station parameters are greater than those indicated in the tables, calculate geographic separation in accordance with the required D/U ratios, as provided in paragraph
(a)of this section;
(iii)Submit an engineering study justifying the proposed separations based on the parameters of the land mobile station and the parameters, including authorized and/or applied for facilities, of the TV/DTV station(s) it is trying to protect; or,
(iv)Obtain written concurrence from the applicable TV/DTV station(s). If this method is chosen, a copy of the agreement must be submitted with the application.
(2)The following is the method for geographic separations.
(i)Base and fixed stations that operate in the 746-763 MHz, 775-787 MHz, and 788-793 MHz bands having an antenna height
(HAAT)less than 152 m. (500 ft.) shall afford protection to co-channel and adjacent channel TV/DTV stations in accordance with the values specified in Table B (co-channel frequencies based on 40 dB protection) and Table E (adjacent channel frequencies based on 0 dB protection) in § 90.309 of this chapter. Base and fixed stations that operate in the 698-746 MHz band having an antenna height
(HAAT)less than 152 m. (500 ft.) shall afford protection to adjacent channel DTV stations in accordance with the values specified in Table E in § 90.309 of this chapter, shall afford protection to co-channel DTV stations by providing 23 dB protection to such stations' equivalent Grade B contour (41 dBμV/m), and shall afford protection to co-channel and adjacent channel TV stations in accordance with the values specified in Table B (co-channel frequencies based on 40 dB protection) and Table E (adjacent channel frequencies based on 0 dB protection) in § 90.309 of this chapter. For base and fixed stations having an antenna height
(HAAT)between 152-914 meters (500-3,000 ft.) the effective radiated power must be reduced below 1 kilowatt in accordance with the values shown in the power reduction graph in Figure B in § 90.309 of this chapter. For heights of more than 152 m. (500 ft.) above average terrain, the distance to the radio path horizon will be calculated assuming smooth earth. If the distance so determined equals or exceeds the distance to the hypothetical or equivalent Grade B contour of a co-channel TV/DTV station ( *i.e.* , it exceeds the distance from the appropriate Table in § 90.309 of this chapter to the relevant TV/DTV station), an authorization will not be granted unless it can be shown in an engineering study ( *see* paragraph (b)(1)(iii) of this section) that actual terrain considerations are such as to provide the desired protection at the actual Grade B contour (64 dBμV/m for TV and 41 dBμV/m for DTV stations) or unless the effective radiated power will be further reduced so that, assuming free space attenuation, the desired protection at the actual Grade B contour (64 dBμV/m for TV and 41 dBμV/m coverage contour for DTV stations) will be achieved. Directions for calculating powers, heights, and reduction curves are listed in § 90.309 of this chapter for land mobile stations. Directions for calculating coverage contours are listed in § 73.683 through 73.685 of this chapter for TV stations and in § 73.625 of this chapter for DTV stations.
(ii)Control, fixed, and mobile stations (including portables) that operate in the 787-788 MHz and 805-806 MHz bands and control and mobile stations (including portables) that operate in the 698-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands are limited in height and power and therefore shall afford protection to co-channel and adjacent channel TV/DTV stations in the following manner:
(A)For control, fixed, and mobile stations (including portables) that operate in the 787-788 MHz and 805-806 MHz bands and control and mobile stations (including portables) that operate in the 746-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands, co-channel protection shall be afforded in accordance with the values specified in Table D (co-channel frequencies based on 40 dB protection for TV stations and 17 dB for DTV stations) in § 90.309 of this chapter.
(B)For control and mobile stations (including portables) that operate in the 698-746 MHz band, co-channel protection shall be afforded to TV stations in accordance with the values specified in Table D (co-channel frequencies based on 40 dB protection) and to DTV stations by providing 23 dB protection to such stations' equivalent Grade B contour (41 dBμV/m).
(C)For control, fixed, and mobile stations (including portables) that operate in the 787-788 MHz and 805-806 MHz bands and control and mobile stations (including portables) that operate in the 698-757 MHz, 758-763 MHz, 776-787 MHz, and 788-793 MHz bands, adjacent channel protection shall be afforded by providing a minimum distance of 8 kilometers (5 miles) from all adjacent channel TV/DTV station hypothetical or equivalent Grade B contours (adjacent channel frequencies based on 0 dB protection for TV stations and −23 dB for DTV stations).
(D)Since control, fixed, and mobile stations may affect different TV/DTV stations than the associated base or fixed station, particular care must be taken by applicants/licensees to ensure that all appropriate TV/DTV stations are considered ( *e.g.* , a base station may be operating within TV Channel 62 and the mobiles within TV Channel 67, in which case TV Channels 61, 62, 63, 66, 67 and 68 must be protected). Control, fixed, and mobile stations shall keep a minimum distance of 96.5 kilometers (60 miles) from all adjacent channel TV/DTV stations. Since mobiles and portables are able to move and communicate with each other, licensees must determine the areas where the mobiles can and cannot roam in order to protect the TV/DTV stations. Note to § 27.60: The 88.5 km
(55mi)Grade B service contour (64 dBμV/m) is based on a hypothetical TV station operating at an effective radiated power of one megawatt, a transmitting antenna height above average terrain of 610 meters (2000 feet) and the Commission's R-6602 F(50,50) curves. *See* § 73.699 of this chapter. Maximum facilities for TV stations operating in the UHF band are 5 megawatts effective radiated power at an antenna HAAT of 610 meters (2,000 feet). *See* § 73.614 of this chapter. The equivalent contour for DTV stations is based on a 41 dBμV/m signal strength and the distance to the F(50,90) curve. *See* § 73.625 of this chapter. 26. Section 27.70 is amended by revising paragraph
(a)introductory text and paragraphs (b)(1) and (b)(2) to read as follows: § 27.70 Information exchange.
(a)*Prior notification.* Public safety licensees authorized to operate in the 763-775 MHz and 793-805 MHz bands may notify any licensee authorized to operate in the 746-757, 758-763, 776-787, or 788-793 MHz bands that they wish to receive prior notification of the activation or modification of the licensee's base or fixed stations in their area. Thereafter, the 746-757, 758-763, 776-787, or 788-793 MHz band licensee must provide the following information to the public safety licensee at least 10 business days before a new base or fixed station is activated or an existing base or fixed station is modified:
(b)* * *
(1)Allow a public safety licensee to advise the 746-757, 758-763, 776-787, or 788-793 MHz band licensee whether it believes a proposed base or fixed station will generate unacceptable interference;
(2)Permit 746-757, 758-763, 776-787, and 788-793 MHz band licensees to make voluntary changes in base or fixed station parameters when a public safety licensee alerts them to possible interference; and, 27. Section 27.303
(a)is amended by revising paragraph
(a)introductory text to read as follows: § 27.303 Upper 700 MHz commercial and public safety coordination zone.
(a)*General.* CMRS operators are required, prior to commencing operations on fixed or base station transmitters on the 776-787 MHz and 788-793 MHz bands that are located within 500 meters of existing or planned public safety base station receivers, to submit a description of their proposed facility to a Commission-approved public safety coordinator. 28. Section 27.501 is revised to read as follows: § 27.501 746-763 MHz, 775-793 MHz, and 805-806 MHz bands subject to competitive bidding. Mutually exclusive initial applications for licenses in the 746-763 MHz, 775-793 MHz, and 805-806 MHz bands are subject to competitive bidding. The general competitive bidding procedures set forth in part 1, subpart Q of this chapter will apply unless otherwise provided in this subpart. 29. Section 27.601 is amended by revising paragraph (c)(1) introductory text to read as follows: § 27.601 Authority and coordination requirements.
(c)* * *
(1)A Guard Band licensee, or a spectrum lessee operating at 775-776 MHz and 805-806 MHz pursuant to a spectrum lease arrangement under §§ 1.9030 and 1.9035 of this chapter, must notify Commission-recognized public safety frequency coordinators for the 700 MHz Public Safety band and adjacent-area Guard Band licensees within one business day after the licensee or the spectrum lessee has: 30. Add subpart N to part 27 as follows: Subpart N—700 MHz Public/Private Partnership Sec. 27.1301 Purpose and scope. 27.1303 Upper 700 MHz D Block license conditions. 27.1305 Shared wireless broadband network. 27.1307 Spectrum use in the network. 27.1308 Organization and structure of the 700 MHz public/private partnership. 27.1310 Network sharing agreement. 27.1315 Establishment, execution, and application of the network sharing agreement. 27.1320 Failure to comply with the NSA or the Commission's rules. 27.1325 Resolution of disputes after grant of the upper 700 MHz D block license. 27.1327 Construction requirements; criteria for renewal. 27.1330 Local public safety build-out and operation. 27.1333 Geographic partitioning, spectrum disaggregation, license assignment, and transfer. 27.1335 Prohibition on discontinuance of public safety operations. 27.1340 Reporting obligations. § 27.1301 Purpose and scope. The purpose of this subpart, in conjunction with subpart AA of part 90, is to establish rules and procedures relating to the 700 MHz Public/Private Partnership entered between the winning bidder for the Upper 700 MHz D Block license, the Upper 700 MHz D Block licensee, the Network Assets Holder, the Operating Company, the Public Safety Broadband Licensee, and other related entities as the Commission may require or allow. Pursuant to this partnership, the Upper 700 MHz D Block licensee and the Operating Company will be responsible for constructing and operating a nationwide, shared interoperable wireless broadband network used to provide a commercial service and a broadband network service for public safety entities. The shared network assets will be held by the Network Assets Holder and the Shared Wireless Broadband Network will operate on both the commercial spectrum licensed to the Upper 700 MHz D Block licensee and the public safety broadband spectrum licensed to the Public Safety Broadband Licensee. This subpart of the part 27 rules sets forth specific provisions relating to the Upper 700 MHz D Block license, the Upper 700 MHz D Block licensee, and other related entities as the Commission may require or allow with respect to the 700 MHz Public/Private Partnership. Subpart AA of the part 90 rules sets forth related provisions applicable to the Public Safety Broadband License and the Public Safety Broadband Licensee with respect to the 700 MHz Public/Private Partnership. § 27.1303 Upper 700 MHz D Block license conditions.
(a)The winning bidder at auction of the license for Block D in the 758-763 MHz and 788-793 MHz bands will be granted the Upper 700 MHz D Block license only after this winning bidder has entered, with the Public Safety Broadband Licensee and other related entities as the Commission may require or allow, into the Network Sharing Agreement
(NSA)that has been approved by the Commission, has executed such other agreements as the Commission may require or allow, and has met all other necessary conditions pertaining to the award of this license.
(b)The Upper 700 MHz D Block licensee shall comply with all of the applicable requirements set forth in this part and subpart, including the construction requirements set forth in § 27.14, and shall comply with the terms of the NSA and such other agreements as the Commission may require or allow.
(c)The Upper 700 MHz D Block licensee shall have the exclusive right to build and operate the shared wireless broadband network, except as set forth in §§ 20.1330 and 90.1430 of this chapter.
(d)The Upper 700 MHz D Block licensee must not discontinue, reduce, or impair service to public safety users unless and until, pursuant to Commission procedures, it has obtained prior authorization from the Commission.
(e)The Upper 700 MHz D Block licensee must provide the Public Safety Broadband Licensee with priority access during emergencies, as specified in the NSA.
(f)These conditions and requirements will apply to any related entities that the Commission may require or allow, as provided for in the NSA or otherwise as authorized by the Commission. § 27.1305 Shared wireless broadband network. The Shared Wireless Broadband Network developed by the 700 MHz Public/Private Partnership must be designed to meet requirements associated with a nationwide, public safety broadband network. At a minimum, the network must incorporate the following features:
(a)Design for operation over a broadband technology platform that provides mobile voice, video, and data capability that is seamlessly interoperable across public safety local and state agencies, jurisdictions, and geographic areas, and that includes current and evolving state-of-the-art technologies reasonably made available in the commercial marketplace with features beneficial to the public safety community.
(b)Sufficient signal coverage to ensure reliable operation throughout the service area consistent with typical public safety communications systems.
(c)Sufficient robustness to meet the reliability and performance requirements of public safety.
(d)Sufficient capacity to meet the needs of public safety.
(e)Security and encryption consistent with state-of-the-art technologies.
(f)A mechanism to automatically prioritize public safety communications over commercial uses on a real-time basis consistent with the requirements of § 27.1307.
(g)Operational capabilities consistent with features and requirements that are typical of current and evolving state-of-the-art public safety systems.
(h)Operational control of the network by the Public Safety Broadband Licensee to the extent necessary to ensure that public safety requirements are met. § 27.1307 Spectrum use in the network.
(a)*Spectrum use.* The shared wireless broadband network developed by the 700 MHz Public/Private Partnership will operate using spectrum associated with the Upper 700 MHz D Block license in the 758-763 MHz and 788-793 MHz bands and the Public Safety Broadband License in the adjacent 763-768 MHz and 793-798 MHz bands.
(b)*Access to spectrum in the 758-763 MHz and 788-793 MHz bands.* The Upper 700 MHz D Block licensee shall lease the spectrum rights associated with the Upper 700 MHz D Block license to the Operating Company, pursuant to the Commission's spectrum leasing rules. The spectrum leasing arrangement shall be a long-term *de facto* transfer leasing arrangement for the entire remaining term of the Upper 700 MHz D Block license. If the Upper 700 MHz D Block license is renewed, the parties will be required to renew this spectrum leasing arrangement as well.
(c)*Access to spectrum in the 763-768 MHz and 793-798 MHz bands.* The Public Safety Broadband Licensee, which holds the Public Safety Broadband License pursuant to part 90 rules, must lease the spectrum usage rights associated with this license, pursuant to a spectrum manager leasing arrangement set forth in part 1 subpart X, to the Upper 700 MHz D Block licensee and the Operating Company for the entire remaining term of the Public Safety Broadband License to effectuate the 700 MHz Public/Private Partnership. The Upper 700 MHz D Block licensee and the Operating Company are the only entities that are eligible to lease the spectrum usage rights associated with the Public Safety Broadband License to operate on the 763-768 and 793-798 MHz bands. If the Upper 700 MHz D Block license is cancelled, this spectrum leasing arrangement will automatically terminate.
(d)* Commercial operations in the 763-768 MHz and 793-798 MHz bands.* Commercial operations in the 763-768 MHz and 793-798 MHz bands through the spectrum manager leasing arrangement shall not cause harmful interference to primary users ( *i.e.* , public safety users) and cannot claim protection from harmful interference from the primary public safety operations in the 763-768 MHz and 793-798 MHz bands. The network providing commercial operations in the 763-768 MHz and 793-798 MHz bands through the spectrum manager leasing arrangement must be designed to automatically assign priority to public safety users, to the exclusion and/or immediate preemption of any commercial use on a dynamic, real-time priority basis, and to guarantee that public safety users suffer no harmful interference or interruption or degradation of service due to commercial operations in the 763-768 MHz and 793-798 MHz bands. § 27.1308 Organization and structure of the 700 MHz public/private partnership.
(a)The Upper 700 MHz D Block licensee, the Network Assets Holder and such other related entities as the Commission may require or allow shall be formed by the winning bidder of the Upper 700 MHz D Block license. The Upper 700 MHz D Block licensee, the Network Assets Holder, and related entities as the Commission may require or allow must be Special Purpose Bankruptcy Remote Entities formed to hold the license, to hold the shared network assets, or for such other purpose as the Commission may require or allow. The winning bidder of the Upper 700 MHz D Block license shall also form the Operating Company, which must also be a Special Purpose Bankruptcy Remote Entity. Upon issuance of the Upper 700 MHz D Block license, the winning bidder will assign all of its rights and obligations under the NSA to the Upper 700 MHz D Block licensee, Network Assets Holder, the Operating Company, and any other related entities that the Commission may require or allow.
(b)The Upper 700 MHz D Block licensee and other related entities as the Commission may require or allow shall have the obligation to build out the Shared Wireless Broadband Network, as provided for in the NSA or otherwise as authorized by the Commission. § 27.1310 Network sharing agreement. The relationship between the Upper 700 MHz D Block licensee, the Public Safety Broadband Licensee, and related entities as the Commission may require or allow will be governed by the Network Sharing Agreement
(NSA)and such other separate agreements as the Commission may require or allow that are negotiated and entered into between the parties. The NSA must, at a minimum, include the following terms:
(a)All of the substantive rights and obligations of the parties relating to the NSA, as established by the Commission concerning the 700 MHz Public/Private Partnership.
(b)Network specifications that comply with § 27.1305.
(c)The definition of “emergency” for purposes of emergency priority access.
(d)All service fees to be imposed for services to public safety, including fees for normal network service and fees for priority access to the D Block spectrum in an emergency.
(e)A detailed build-out schedule consistent with § 27.1327, including coverage of major highways and interstates, as well as incorporated communities with a population in excess of 3,000.
(f)The right of the Public Safety Broadband Licensee to determine and approve the specifications of public safety equipment used on the network and the right to purchase its own subscriber equipment from any vendor it chooses, to the extent such specifications and equipment are consistent with reasonable network control requirements established in the NSA.
(g)The Upper 700 MHz D Block licensee must offer at least one handset suitable for public safety use that includes a seamlessly integrated satellite solution pursuant to the terms, conditions, and timeframes set forth in the NSA.
(h)Any major modification of the terms of the NSA, related agreements or documents, or such other agreements as the Commission may require or allow must be submitted to the Commission for prior approval. All other modifications must be submitted to the Chiefs of the Wireless Telecommunications Bureau and the Public Safety and Homeland Security Bureau for prior approval.
(i)The NSA shall require, in a separate agreement, the granting of an irrevocable and assignable right of first refusal to purchase the network assets if and whenever such assets are otherwise to be sold and an irrevocable and assignable option in favor of the Public Safety Broadband Licensee to purchase the network and all network assets if and whenever the Upper 700 MHz D Block license is cancelled or terminated, by reason of default or for any other reason, for a consideration equivalent to the fair market value of the tangible and intangible assets sold. This right and option shall be senior to, and have priority over, any other right, claim, or interest in or to the network or the network assets. The NSA shall also include a fair market valuation methodology to determine the fair market value of the shared wireless broadband network assets.
(j)The NSA must have a term, not to exceed 10 years from February 17, 2009, that coincides with the terms of the Upper 700 MHz D Block license and the Public Safety Broadband License. § 27.1315 Establishment, execution, and application of the network sharing agreement. The following requirements and processes relate to the establishment, execution, and application of the NSA:
(a)*Approval of NSA as pre-condition for granting the Upper 700 MHz D Block License.* The Commission shall not grant the Upper 700 MHz D Block license until the winning bidder for the Upper 700 MHz D Block license has negotiated the NSA and such other agreements as the Commission may require or allow with the Public Safety Broadband Licensee, and the NSA and related agreements or documents have been approved by the Commission and executed by the required parties. Parties to the NSA must also include the Upper 700 MHz D Block licensee, the Network Assets Holder, and the Operating Company, as these entities are defined in § 27.4.
(b)*Requirement of negotiation.* Negotiation of an NSA between the winning bidder for the Upper 700 MHz D Block license and the Public Safety Broadband Licensee must commence by the date the winning bidder files its long form application or the date on which the Commission designates the Public Safety Broadband Licensee, whichever is later, and must conclude within six months of that date. Parties to this negotiation are required to negotiate in good faith. Two members of the Commission staff, one from the Wireless Telecommunications Bureau and one from the Public Safety and Homeland Security Bureau, shall be present at all stages of the negotiation as neutral observers.
(c)*Reporting requirements.* The winning bidder for the Upper 700 MHz D Block license must file a report with the Commission within 10 business days of the commencement of the negotiation period certifying that active and good faith negotiations have begun, providing the date on which they commenced, and providing a schedule of the initial dates on which the parties intend to meet for active negotiations, covering at a minimum the first 30-day period. Beginning three months from the triggering of the six-month negotiation period, the winning bidder for the Upper 700 MHz D Block license and the Public Safety Broadband Licensee must jointly provide detailed reports, on a monthly basis and subject to a request for confidential treatment, on the progress of the negotiations throughout the remainder of the negotiations. These reports must include descriptions of all material issues that the parties have yet to resolve.
(d)*Submission of final agreement.* As soon as the parties have reached an agreement on all the terms of the NSA, related agreements or documents, and such other agreements as the Commission may require or allow, but not later than five business days after the six-month period for negotiation has expired, they must submit the NSA together with all agreements and related documents referenced in the NSA, for review and approval by the full Commission. The Commission will act on the NSA within 60 days of receipt. The Commission may approve the NSA in its entirety, approve with modifications, or require the parties to address additional terms or re-draft existing terms within a specified timeframe. After the NSA is approved, the parties must execute the NSA and such other agreements as the Commission may require or allow, and submit executed copies to the Commission within 10 business days of approval.
(e)*Submission of disputed issues.* If the parties have not reached agreement on all terms of the NSA and related agreements by the end of the six-month period, they must notify the Commission not later than five business days after the expiration of the six-month period of the terms on which they have agreed, the nature of the remaining issues, each party's position on each issue, whether additional negotiation is likely to produce an agreement, and, if so, a proposed deadline for reaching agreement on the NSA. Authority is delegated jointly to the Chiefs of the Wireless Telecommunications Bureau and the Public Safety and Homeland Security Bureau to resolve any remaining disputes.
(f)*Resolution of disputes.* Actions to resolve disputes may include, but are not limited to:
(1)Granting additional time for negotiation;
(2)Issuing a decision on the disputed issues and requiring the submission of a draft agreement consistent with the decision;
(3)Directing the parties to further brief the remaining issues in full for immediate Commission decision; and/or
(4)Immediate denial of the long-form application filed by the winning bidder for the Upper 700 MHz D Block license.
(g)*Default by winning bidder for Upper 700 MHz D Block license.* If the winning bidder for the Upper 700 MHz D Block fails to comply with negotiation or dispute resolution requirements or fails to execute a Commission-approved NSA, its long form application will be denied. If the long form application of the winning bidder of the Upper 700 MHz D Block license is denied for any reason, including as a consequence of an action taken pursuant to paragraphs
(e)and
(f)of this section, it will be deemed to have defaulted under § 1.2109(c) of this chapter, and will be liable for the default payment specified in § 1.2104(g) of this chapter. § 27.1320 Failure to comply with the NSA or the Commission's rules.
(a)Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the Upper 700 MHz D Block license and awarding it to a new licensee. In the event the Upper 700 MHz D Block license is cancelled, the Commission shall issue an order cancelling the license and announcing the process for awarding rights to the spectrum to a new licensee. Pending the award to a new licensee, the Commission shall issue the Operating Company a special temporary authority to prevent interruption of services provided over the Shared Wireless Broadband Network. The Operating Company must continue to provide both commercial service and services to public safety during the transition. Upon grant of a new license, the Commission shall establish the terms and timing under which the special temporary authorization shall be cancelled and the new Upper 700 MHz D Block licensee assumes the construction and operation of the network.
(b)If the Commission cancels or terminates the Upper 700 MHz D Block license, a fair market valuation of the shared wireless broadband network assets shall be performed immediately, pursuant to the fair market valuation methodology set forth in the NSA. In the event that the Upper 700 MHz D Block license is awarded to a new entity, the Public Safety Broadband Licensee's option to purchase the network and all network assets if and whenever the Upper 700 MHz D Block license is cancelled or terminated and its right of first refusal to purchase the network assets if and whenever such assets are otherwise to be sold shall be assigned to the new Upper 700 MHz D Block licensee and the new Network Assets Holder. § 27.1325 Resolution of disputes after grant of the upper 700 MHz D block license.
(a)The Upper 700 MHz D Block licensee, the Operating Company, the Network Assets Holder and the Public Safety Broadband Licensee may at any time bring a complaint to the Commission based on a claim that another party to the NSA has deviated from the terms of the NSA, or a petition for a declaratory ruling to resolve the proper interpretation of an NSA term or provision. The Commission also may at any time, on its own motion, determine to address any material breach or interpret any NSA term or provision.
(b)The Commission shall have primary responsibility and jurisdiction for adjudicating disputes that arise following execution of the NSA. The Commission may, however, require the parties to first seek a settlement to the dispute or authorize the parties to resolve the dispute through litigation or other means. Breach of license terms, the NSA, or the Commission's rules may result in cancellation of the Upper 700 MHz D Block license, the Public Safety Broadband License, or both.
(c)The Chiefs of the Public Safety and Homeland Security Bureau and the Wireless Telecommunications Bureau are delegated joint responsibility for adjudicating disputes. § 27.1327 Construction requirements; criteria for renewal.
(a)The Upper 700 MHz D Block licensee shall comply with the applicable construction requirements of § 27.14.
(b)The Upper 700 MHz D Block licensee shall comply with the applicable procedures and criteria for license renewal of § 27.14. § 27.1330 Local public safety build-out and operation.
(a)The Upper 700 MHz D Block licensee and the Operating Company through its lease arrangements shall, except in the two limited circumstances set forth herein, have the exclusive right to build and operate the Shared Wireless Broadband Network.
(b)*Rights to early build-out in areas with a build-out commitment.* In an area where the Upper 700 MHz D Block licensee has committed, in the NSA, to build out by a certain date, a public safety entity may, with the pre-approval of the Public Safety Broadband Licensee and subject to the requirements set forth herein, construct a broadband network in that area at its own expense so long as the network is capable of operating on the Shared Wireless Broadband Network and meets all the requirements and specifications of the network required under the NSA.
(1)*Options for early build-out in areas with a build-out commitment.* In order to obtain authorization to construct a broadband network as set forth in paragraph
(b)of this section, the requesting public safety entity must agree to one of the following:
(i)To, on its own, or through the Public Safety Broadband Licensee acting on its behalf, construct the network at its own expense, and upon completion of construction transfer the network to the Upper 700 MHz D Block licensee, which shall then integrate that network into the Shared Wireless Broadband Network constructed pursuant to the NSA; or
(ii)To, in agreement with the Upper 700 MHz D Block licensee, provide all funds necessary for the Upper 700 MHz D Block licensee to complete the early construction of the network, including any and all additional resource and personnel costs, allowing the Upper 700 MHz D Block licensee at all times to own, operate, and manage the network as an integrated part of the Shared Wireless Broadband Network.
(2)*Negotiation of amendment to NSA.* Under either early build out option set forth in paragraph (b)(1) of this section, the Public Safety Broadband Licensee, the Upper 700 MHz D Block licensee, and the public safety entity must, prior to any construction, negotiate an amendment to the NSA regarding this part of the network, specifying ownership rights, fees, and other terms, which may be distinct from the analogous terms governing the Shared Wireless Broadband Network, and such amendment must be approved by the Commission.
(i)Such amendment must provide the terms under which the Upper 700 MHz D Block licensee shall receive full ownership rights and shall compensate the public safety entity (or the Public Safety Broadband Licensee, where appropriate) for the construction of the network; and shall, absent agreement to the contrary, provide for such transfer and compensation to occur prior to the scheduled build out date for such network in the NSA.
(ii)Any right to compensation from the Upper 700 MHz D Block licensee related to such early build-out shall be limited to the cost that would have been incurred had the Upper 700 MHz D Block licensee constructed the network itself in accordance with the original terms and specifications of the NSA, as reasonably determined by the parties and negotiated as part of the NSA amendment required in paragraph (b)(2) of this section. Such costs shall not include costs attributable solely to advancing the date of construction or otherwise expediting the construction process.
(3)*Operations.* The public safety entity may not commence operations on the network until ownership of the network has been transferred to the Upper 700 MHz D Block licensee. Further, no operations shall be allowed except those authorized and conducted pursuant to the authority of the Public Safety Broadband License.
(4)*Attribution of early build-out to national benchmarks.* Upon completion of construction, transfer of ownership to the Upper 700 MHz D Block licensee, and compensation as required herein, if applicable, the Upper 700 MHz D Block licensee may include the network constructed pursuant to the early build-out provisions herein for purposes of determining whether it has met its national build-out benchmarks and the build-out requirements of the NSA.
(5)*Rights to build out and operate in areas without a build-out commitment.* In areas for which the NSA does not require the Upper 700 MHz D Block licensee to build out the Shared Wireless Broadband Network, a public safety entity may build out and operate a separate, exclusive network in the 700 MHz public safety broadband spectrum at any time, provided the public safety entity has received the written approval of the Public Safety Broadband Licensee and operates its independent network pursuant to a spectrum leasing arrangement into which the public safety entity has entered with the Public Safety Broadband Licensee.
(i)Such leasing arrangement shall not require the approval or consent of the Upper 700 MHz D Block licensee; however, the Public Safety Broadband Licensee must provide the Upper 700 MHz D Block licensee with notice of the public safety entity's intent to construct in that area within 30 days of receipt of a request from a public safety entity seeking to exercise this option, and shall inform the Upper 700 MHz D Block licensee of the public safety entity's anticipated build-out date(s).
(ii)Should the Upper 700 MHz D Block licensee, within 30 calendar days from receipt of notice of the public safety entity's intent to construct in that area, certify in writing to the Public Safety Broadband Licensee that it will build out the shared network in the area within a reasonable time of the anticipated build-out date(s), as determined by the Public Safety Broadband Licensee, the Public Safety Broadband Licensee shall not allow the public safety entity to build and operate its own separate exclusive network in that area, provided that the Upper 700 MHz D Block licensee and the Public Safety Broadband Licensee execute an amendment to the NSA indicating the Upper 700 MHz D Block licensee's commitment to build the network in that area. Such commitment shall become enforceable against the Upper 700 MHz D Block licensee as part of its overall build-out requirements.
(iii)If the Upper 700 MHz D Block licensee does not exercise its option to commit to build out the network in the requested area within 30 calendar days of receipt of notice of the public safety entity's intent to construct in such area, the Public Safety Broadband Licensee and the public safety entity may proceed with a spectrum leasing arrangement, which must be filed with the Commission prior to the public safety entity commencing any operations. The spectrum leasing arrangement must take the form of a spectrum manager leasing arrangement under the rules specified in § 1.9020 of this chapter, and incorporate the following conditions:
(A)The network must provide broadband operations;
(B)The network must be fully interoperable with the Shared Wireless Broadband Network;
(C)The network must be available for use by any public safety entity in the area;
(D)The network must satisfy any other terms or conditions required by the Public Safety Broadband Licensee; and
(E)The public safety entity must construct and place into operation its network within one year of the effective date of the spectrum manager leasing arrangement. If the public safety entity fails to place the network into operation within one year, the Public Safety Broadband Licensee shall terminate the spectrum leasing arrangement pursuant to § 1.9020(h)(3) of this chapter. The public safety entity may also seek extended implementation authority from the Commission pursuant to the requirements of § 90.629 of this chapter.
(6)Except as set forth herein, the separate network is not required to meet the other specifications of the Shared Wireless Broadband Network. Absent agreement of the public safety entity, the Public Safety Broadband Licensee, and the Upper 700 MHz D Block licensee, the separate network may not operate using any spectrum associated with the Upper 700 MHz D Block license.
(7)The Public Safety Broadband Licensee must file with the Commission any spectrum manager leasing arrangement as specified in § 1.9020(e) of this chapter; such filing shall identify the public safety entity leasing the spectrum, the particular areas of spectrum leased as part of this build-out option, and the specific network infrastructure and equipment deployed on such leased spectrum. § 27.1333 Geographic partitioning, spectrum disaggregation, license assignment and transfer.
(a)The 700 MHz Upper D Block license may not be partitioned or disaggregated.
(b)The 700 MHz Upper D Block licensee will be permitted to assign or transfer its licensee subject to Commission review and prior approval. The Upper 700 MHz D Block license assignment or transfer applications are precluded from overnight processing. § 27.1335 Prohibition on discontinuance of public safety operations. The Upper 700 MHz D Block licensee, the Operating Company and the Network Assets Holder are prohibited from discontinuing or degrading the broadband network service provided to the Public Safety Broadband Licensee or to public safety entities unless either at the request of the public safety entity or entities in question or with the pre-approval of the Commission. The Upper 700 MHz D Block licensee shall notify the affected public safety entity or entities and the Public Safety Broadband Licensee at least 30 days prior to any unrequested discontinuance or degradation of network service. § 27.1340 Reporting obligations.
(a)The Upper 700 MHz D Block licensee and the Public Safety Broadband Licensee shall jointly file quarterly reports with the Commission. These reports shall include audited financial statements, how the specific requirements of public safety are being met, detailed information on the areas where broadband service has been deployed, which public safety entities are using the broadband network in each area of operation, what types of applications are in use in each area of operation, and the number of declared emergencies in each area of operation.
(b)The Upper 700 MHz D Block licensee and Public Safety Broadband Licensee have joint responsibility to register the base station locations with the Commission, providing basic technical information, including geographic location. PART 90—PRIVATE LAND MOBILE RADIO SERVICES 31. The authority citation for part 90 continues to read as follows: Authority: Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), and 332(c)(7). 32. Section 90.5 is amended by revising paragraphs (k), (l), and (m), and adding paragraph
(n)to read as follows: § 90.5 Other applicable rule parts.
(k)Part 27 contains rules relating to miscellaneous wireless communications services.
(l)Part 51 contains rules relating to interconnection.
(m)Part 68 contains technical standards for connection of private land mobile radio equipment to the public switched telephone network.
(n)Part 101 governs the operation of fixed microwave services. 33. Section 90.7 is amended by adding the following definitions in alphabetical order to read as follows: § 90.7 Definitions. *700 MHz Public/Private Partnership.* The public/private partnership established for the development and operation of a nationwide, shared interoperable wireless broadband network operating on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands in accordance with the Commission's rules. *Network Assets Holder.* The Network Assets Holder is a Special Purpose Bankruptcy Remote Entity that is formed to hold the assets of the shared wireless broadband network associated with the 700 MHz Public/Private Partnership, in accordance with the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Network Sharing Agreement (NSA).* An agreement entered into between the winning bidder, the Upper 700 MHz D Block licensee, the Network Assets Holder, the Operating Company, the Public Safety Broadband Licensee, and any other related entities that the Commission may require or allow regarding the shared wireless broadband network associated with the 700 MHz Public/Private Partnership that will operate on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands. *Operating Company.* The Operating Company is a Special Purpose Bankruptcy Remote Entity that is formed to build and operate the shared wireless broadband network associated with the 700 MHz Public/Private Partnership, in accordance with the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Public Safety Broadband License.* The Public Safety Broadband License authorizes public safety broadband services in the 763-768 MHz and 793-798 MHz bands on a primary basis. *Public Safety Broadband Licensee.* The licensee of the Public Safety Broadband License in the 763-768 MHz and 793-798 MHz bands. *Shared Wireless Broadband Network.* Wireless broadband network associated with the 700 MHz Band Public/Private Partnership that operates on the 758-763 MHz and 788-793 MHz bands and the 763-768 MHz and 793-798 MHz bands pursuant to the terms of the Network Sharing Agreement, such other agreements as the Commission may require or allow, and the Commission's rules. *Special Purpose Bankruptcy Remote Entity.* A “special purpose entity” is a legal entity created for a special limited purpose, in this context primarily to hold the Upper 700 MHz D Block license or the network assets, or to conduct the construction or operation of the Shared Wireless Broadband Network associated with the 700 MHz Public/Private Partnership. A special purpose entity is “bankruptcy remote” if that entity is unlikely to become insolvent as a result of its own activities, is adequately insulated from the consequences of a related party's insolvency, and contains certain characteristics which enhance the likelihood that it will not become the subject of an insolvency proceeding. *Upper 700 MHz D Block license.* The Upper 700 MHz D Block license is the nationwide license associated with the 758-763 MHz and 788-793 MHz bands. *Upper 700 MHz D Block licensee.* The Special Purpose Bankruptcy Remote Entity to which the Upper 700 MHz D Block license must be transferred upon execution of the Network Sharing Agreement. References herein to the rights and obligations of the Upper 700 MHz D Block licensee include the exercise or discharge of such rights or obligations, respectively, by related entities as are provided for in the NSA or otherwise as authorized by the Commission. 34. Section 90.18 is added to read as follows: § 90.18 Public Safety 700 MHz Nationwide Broadband Network. The 763-768/793-798 MHz band is dedicated to a broadband public safety communications system with a nationwide level of interoperability. A nationwide license for this spectrum is held by a single entity, the Public Safety Broadband Licensee, which must enter into the 700 MHz Public/Private Partnership with the licensee of the adjacent Upper 700 MHz D Block license, pursuant to a Network Sharing Agreement and such other agreements as the Commission may require. The specific provisions relating to the 700 MHz Public/Private Partnership are set forth in subpart AA of this part and subpart N of part 27. The Public Safety 700 MHz Nationwide Broadband Network is established in the Second Report and Order in PS Docket No. 06-229. 35. Section 90.20 is amended by revising the entries for “470 to 512” and “763 to 775; “806 to 817” by removing the entry for “764 to 776”; and by adding entries for “763 to 775” and “793 to 805” in the frequency or band table in paragraph (c)(3) and by revising paragraph (d)(77) is to read as follows: § 90.20 Public Safety Pool.
(c)* * *
(3)*Frequencies.* Public Safety Pool Frequency Table Frequency or band Class of station(s) Limitations Coordinator * * * * * * * 470 to 512 Base or mobile 68 763 to 775 Base, mobile 77 PX 793 to 805 Mobile 77 PX 806 to 817 ......do 69 * * * * * * *
(d)* * *
(77)Subpart R of this part contains rules for assignment of channels in the 763-775 MHz and 793-805 MHz bands. 36. Section 90.155 is amended by revising paragraph
(a)to read as follows: § 90.155 Time in which station must be placed in operation.
(a)All stations authorized under this part, except as provided in §§ 90.528, 90.529, 90.629, 90.631(f), 90.665, 90.685, and 90.1209, must be placed in operation within twelve
(12)months from the date of grant or the authorization cancels automatically and must be returned to the Commission. 37. Section 90.175 is amended by revising the paragraph heading in paragraph (e), revising paragraphs
(j)(10), through (j)(11) and
(12)and adding paragraph (j)(18) to read as follows: § 90.175 Frequency coordination requirements.
(e)*For frequencies between 470-512 MHz, 769-775/799-805 MHz, 806-824/851-869 MHz and 896-901/935-940 MHz: * * **
(j)* * *
(10)Applications for mobile stations operating in the 470-512 MHz band, 799-805 MHz band, or above 800 MHz if the frequency pair is assigned to a single system on an exclusive basis in the proposed area of operation.
(11)Applications for add-on base stations in multiple licensed systems operating in the 470-512 MHz, 769-775 MHz band, or above 800 MHz if the frequency pair is assigned to a single system on an exclusive basis.
(12)Applications for control stations operating below 470 MHz, 769-775/799-805 MHz, or above 800 MHz and meeting the requirements of § 90.119(b).
(18)Applications for base, mobile, or control stations in the 763-768 MHz and 793-798 MHz bands. 38. Section 90.176 is amended by revising the section heading and revising the heading to paragraph
(c)to read as follows: § 90.176 Coordinator notification requirements on frequencies below 512 MHz or at 769-775/799-805 MHz.
(c)*Frequencies in the 769-775/799-805 MHz band.* * * * 39. Section 90.179 is amended by revising paragraph
(g)to read as follows: § 90.179 Shared use of radio stations.
(g)Notwithstanding paragraph
(a)of this section, licensees authorized to operate radio systems on Public Safety Pool frequencies designated in § 90.20 may share their facilities with Federal Government entities on a non-profit, cost-shared basis. Such a sharing arrangement is subject to the provisions of paragraphs (b), (d), and
(e)of this section, and § 2.103(c) concerning approval of the Public Safety Broadband Licensee for Federal operations in the 763-768 MHz and 793-798 MHz bands. State governments authorized to operate radio systems under § 90.529 may share the use of their systems (for public safety services not made commercially available to the public) with any entity that would be eligible for licensing under § 90.523 and Federal Government entities. 40. Section 90.205 is amended by redesignating paragraphs
(j)through
(r)as paragraphs
(k)through
(s)by adding new paragraph (j), and revising newly redesignated paragraph
(k)to read as follows: § 90.205 Power and antenna height limits.
(j)*763-775 MHz and 793-805 MHz.* Power and height limitations are specified in §§ 90.541 and 90.542.
(k)*806-824 MHz, 851-869 MHz, 896-901 MHz and 935-940 MHz.* Power and height limitations are specified in § 90.635 41. Part 90 is amended by revising the heading to subpart R as follows: Subpart R—Regulations Governing the Licensing and Use of Frequencies in the 763-775 and 793-805 MHz Bands 42. Section 90.521 is amended by revising the first sentence to read as follows: § 90.521 Scope. This subpart sets forth the regulations governing the licensing and operations of all systems operating in the 763-775 MHz and 793-805 MHz frequency bands. * * * 43. Section 90.523 is amended by revising the introductory text and adding paragraph
(e)to read as follows: § 90.523 Eligibility. This section implements the definition of public safety services contained in 47 U.S.C. 337(f)(1). The following are eligible to hold Commission authorizations for systems operating in the 763-775 MHz and 793-805 MHz frequency bands:
(e)The minimum eligibility requirements for the Public Safety Broadband Licensee in the 763-768 MHz and 793-798 MHz bands are as follows:
(1)No commercial interest may be held in the Public Safety Broadband Licensee, and no commercial interest may participate in the management of the Public Safety Broadband Licensee;
(2)The Public Safety Broadband Licensee must be a non-profit organization;
(3)The Public Safety Broadband Licensee must be as broadly representative of the public safety radio user community as possible; and
(4)The Public Safety Broadband Licensee must be in receipt of written certifications from no less than ten geographically diverse state and local governmental entities (the authorizing entities), with at least one certification from a state government entity and one from a local government entity, verifying that—
(i)They have authorized the Public Safety Broadband Licensee to use spectrum at 763-768 MHz and 793-798 MHz to provide the authorizing entities with public safety services; and
(ii)The authorizing entities' primary mission is the provision of public safety services. 44. Revise § 90.525 to read as follows: § 90.525 Administration of interoperability channels.
(a)States are responsible for administration of the Interoperability channels in the 769-775 MHz and 799-805 MHz frequency bands. Base and control stations must be licensed individually. A public safety entity meeting the requirements of § 90.523 may operate mobile or portable units on the Interoperability channels in the 769-775 MHz and 799-805 MHz frequency bands without a specific authorization from the Commission provided it holds a part 90 license. All persons operating mobile or portable units under this authority are responsible for compliance with part 90 of these rules and other applicable federal laws.
(b)License applications for Interoperability channels in the 769-775 MHz and 799-805 MHz frequency bands must be approved by a state-level agency or organization responsible for administering state emergency communications. States may hold the licenses for Interoperability channels or approve other qualified entities to hold such licenses. States may delegate the approval process for interoperability channels to another entity, such as regional planning committees. 45. Add § 90.528 to subpart R to read as follows: § 90.528 Public Safety Broadband License.
(a)The 763-768/793-798 MHz bands are allocated on a nationwide basis for public safety broadband operations and licensed to a single Public Safety Broadband Licensee. The 768-769/798-799 MHz bands also are licensed to the Public Safety Broadband Licensees as guard bands. The license area of the Public Safety Broadband License consists of the contiguous 48 states, Alaska, Hawaii, Gulf of Mexico, and the U.S. territories.
(b)The Public Safety Broadband License authorizes construction and operation of base stations anywhere within the area authorized by the license, except as follows:
(1)A station is required to be individually licensed if:
(i)International agreements require coordination;
(ii)Submission of an environmental assessment is required under § 1.1307 of this chapter; or
(iii)The station would affect areas identified in § 1.924 of this chapter.
(2)Any antenna structure that requires notification to the Federal Aviation Administration
(FAA)must be registered with the Commission prior to construction under § 17.4 of this chapter.
(c)Mobile and portable devices may operate without individual license under the authority of the Public Safety Broadband License.
(d)The term of the Public Safety Broadband License shall not exceed ten years from February 17, 2009. The Public Safety Broadband Licensee is entitled to a renewal expectancy barring violations of law, rules or policy warranting denial of renewal.
(e)The Public Safety Broadband License may not be partitioned or disaggregated.
(f)The Public Safety Broadband Licensee may not voluntarily assign or transfer control of the Public Safety Broadband License.
(g)*Quarterly reporting of financial and operational information.* The Public Safety Broadband Licensee shall submit, on a quarterly basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing Agreement, and as approved by the Commission. Such quarterly financial reports shall be filed with the Commission, with a copy to the Chiefs of the Wireless Telecommunications and the Public Safety and Homeland Security Bureaus. 46. Amend § 90.531 as follows: a. Revise the introductory text to the section. b. Revise paragraph (a),
(b)introductory text, and the table that follows. c. Remove and reserve paragraphs
(c)and (d)(2). d. Revise paragraph (e). e. Add paragraphs
(f)and (g). § 90.531 Band plan. This section sets forth the band plan for the 763-775 MHz and 793-805 MHz public safety bands.
(a)*Base and mobile use.* The 763-775 MHz band may be used for base, mobile or fixed (repeater) transmissions. The 793-805 MHz band may be used only for mobile or fixed (control) transmissions.
(b)*Narrowband segments.* There are two band segments that are designated for use with narrowband emissions. Each of these narrowband segments is divided into 960 channels having a channel size of 6.25 kHz as follows: Frequency range Channel Nos. 769-775 MHz 1-960 799-805 MHz 961-1920
(f)*Internal guard band.* The internal guard band (768-769/798-799 MHz) is reserved.
(g)*Broadband.* The 763-768 MHz and 793-798 MHz bands are allocated for broadband communications pursuant to the Public Safety Broadband License. 47. Section 90.533 is amended by revising the introductory text and paragraphs
(a)and
(c)to read as follows: § 90.533 Transmitting sites near the U.S./Canada or U.S./Mexico border. This section applies to each license to operate one or more public safety transmitters in the 763-775 MHz and 793-805 MHz bands, at a location or locations North of Line A ( *see* § 90.7) or within 120 kilometers (75 miles) of the U.S.-Mexico border, until such time as agreements between the government of the United States and the government of Canada or the government of the United States and the government of Mexico, as applicable, become effective governing border area non-broadcast use of these bands. Public safety licenses are granted subject to the following conditions:
(a)Public safety transmitters operating in the 763-775 MHz and 793-805 MHz bands must conform to the limitations on interference to Canadian television stations contained in agreement(s) between the United States and Canada for use of television channels in the border area.
(c)Conditions may be added during the term of the license, if required by the terms of international agreements between the government of the United States and the government of Canada or the government of the United States and the government of Mexico, as applicable, regarding non-broadcast use of the 763-775 MHz and 793-805 MHz bands. 48. Section 90.535 is amended by revising the introductory text and paragraph
(a)to read as follows: § 90.535 Modulation and spectrum usage efficiency requirements. Transmitters designed to operate in 769-775 MHz and 799-805 MHz frequency bands must meet the following modulation standards:
(a)All transmitters in the 769-775 MHz and 799-805 MHz frequency bands must use digital modulation. Mobile and portable transmitters may have analog modulation capability only as a secondary mode in addition to its primary digital mode. Mobile and portable transmitters that only operate on the low power channels designated in §§ 90.531(b)(3), 90.531(b)(4), are exempt from this digital modulation requirement. 49. Section 90.537 is amended by revising paragraph
(a)to read as follows: § 90.537 Trunking requirement.
(a)*General use channels.* All systems using six or more narrowband channels in the 769-775 MHz and 799-805 MHz frequency bands must be trunked systems, except for those described in paragraph
(b)of this section. 50. Section 90.539 is amended by revising the introductory text to read as follows: § 90.539 Frequency stability. Transmitters designed to operate in 769-775 MHz and 799-805 MHz frequency bands must meet the frequency stability requirements in this section. 51. Section 90.541 is amended by revising the introductory text to read as follows: § 90.541 Transmitting power limits. The transmitting power of base, mobile, portable and control stations operating in the 769-775 MHz and 799-805 MHz frequency bands must not exceed the maximum limits in this section, and must also comply with any applicable effective radiated power limits in § 90.545. 52. Add § 90.542 to subpart R to read as follows: § 90.542 Broadband transmitting power limits.
(a)The following power limits apply to the 763-768/793-798 MHz band:
(1)Fixed and base stations transmitting a signal in the 763-768 MHz band with an emission bandwidth of 1 MHz or less must not exceed an ERP of 1000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts ERP in accordance with Table 1 of this section.
(2)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 763-768 MHz band with an emission bandwidth of 1 MHz or less must not exceed an ERP of 2000 watts and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts ERP in accordance with Table 2 of this section.
(3)Fixed and base stations transmitting a signal in the 763-768 MHz band with an emission bandwidth greater than 1 MHz must not exceed an ERP of 1000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 1000 watts/MHz ERP accordance with Table 3 of this section.
(4)Fixed and base stations located in a county with population density of 100 or fewer persons per square mile, based upon the most recently available population statistics from the Bureau of the Census, and transmitting a signal in the 763-768 MHz band with an emission bandwidth greater than 1 MHz must not exceed an ERP of 2000 watts/MHz and an antenna height of 305 m HAAT, except that antenna heights greater than 305 m HAAT are permitted if power levels are reduced below 2000 watts/MHz ERP in accordance with Table 4 of this section.
(5)Licensees of fixed or base stations transmitting a signal in the 763-768 MHz band at an ERP greater than 1000 watts must comply with the provisions set forth in paragraph
(b)of this section.
(6)Control stations and mobile stations transmitting in the 763-768 MHz band and the 793-798 MHz band are limited to 30 watts ERP.
(7)Portable stations (hand-held devices) transmitting in the 763-768 MHz band and the 793-798 MHz band are limited to 3 watts ERP.
(8)For transmissions in the 763-768 MHz and 793-798 MHz bands, licensees may employ equipment operating in compliance with either of the following measurement techniques:
(i)The maximum composite transmit power shall be measured over any interval of continuous transmission using instrumentation calibrated in terms of RMS-equivalent voltage. The measurement results shall be properly adjusted for any instrument limitations, such as detector response times, limited resolution bandwidth capability when compared to the emission bandwidth, etc., so as to obtain a true maximum composite measurement for the emission in question over the full bandwidth of the channel.
(ii)A Commission-approved average power technique. Table 1 to § 90.542(a).—Permissible Power and Antenna Heights for Base and Fixed Stations in the 763-768 MHz Band Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 2 to § 90.542(a).—Permissible Power and Antenna Heights for Base and Fixed Stations in the 763-768 MHz Band Transmitting a Signal With an Emission Bandwidth of 1 MHz or Less Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)(watts) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000 Table 3 to § 90.542(a).—Permissible Power and Antenna Heights for Base and Fixed Stations in the 763-768 MHz Band Transmitting a Signal With an Emission Bandwidth Greater Than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz) Above 1372
(4500)65 Above 1220
(4000)To 1372
(4500)70 Above 1067
(3500)To 1220
(4000)75 Above 915
(3000)To 1067
(3500)100 Above 763
(2500)To 915
(3000)140 Above 610
(2000)To 763
(2500)200 Above 458
(1500)To 610
(2000)350 Above 305
(1000)To 458
(1500)600 Up to 305
(1000)1000 Table 4 to § 90.542(a).—Permissible Power and Antenna Heights for Base and Fixed Stations in the 763-768 MHz Band Transmitting a Signal With an Emission Bandwidth Greater Than 1 MHz Antenna height
(AAT)in meters
(feet)Effective radiated power
(ERP)per MHz (watts/MHz) Above 1372
(4500)130 Above 1220
(4000)To 1372
(4500)140 Above 1067
(3500)To 1220
(4000)150 Above 915
(3000)To 1067
(3500)200 Above 763
(2500)To 915
(3000)280 Above 610
(2000)To 763
(2500)400 Above 458
(1500)To 610
(2000)700 Above 305
(1000)To 458
(1500)1200 Up to 305
(1000)2000
(b)For base and fixed stations operating in the 763-768 MHz band in accordance with the provisions of paragraph (a)(5) of this section, the power flux density that would be produced by such stations through a combination of antenna height and vertical gain pattern must not exceed 3000 microwatts per square meter on the ground over the area extending to 1 km from the base of the antenna mounting structure. 53. Amended § 90.543 as follows: a. Revise the introductory text. b. Amend paragraph
(a)by removing the tables titled “150 kHz Mobile Transmitter ACP Requirements” and “150 kHz Base Transmitter ACP Requirements”. c. Revise paragraph (b)(1). d. Redesignate paragraphs
(e)and
(f)as paragraphs
(f)and (g). e. Add a new paragraph (e). f. Revise newly redesignated paragraphs
(f)and (g). § 90.543 Emission limitations. Transmitters designed to operate in 769-775 MHz and 799-805 MHz frequency bands must meet the emission limitations in paragraphs
(a)through
(d)of this section. Transmitters operating in 763-768 MHz and 793-798 MHz bands must meet the emission limitations in
(e)of this section.
(b)* * *
(1)*Setting reference level.* Set transmitter to maximum output power. Using a spectrum analyzer capable of ACP measurements, set the measurement bandwidth to the channel size. For example, for a 6.25 kHz transmitter set the measurement bandwidth to 6.25 kHz. Set the frequency offset of the measurement bandwidth to zero and adjust the center frequency of the instrument to the assigned center frequency to measure the average power level of the transmitter. Record this power level in dBm as the “reference power level.”
(e)For operations in the 763-768 MHz and the 793-798 MHz bands, the power of any emission outside the licensee's frequency band(s) of operation shall be attenuated below the transmitter power
(P)within the licensed band(s) of operation, measured in watts, in accordance with the following:
(1)On all frequencies between 769-775 MHz and 799-805 MHz, by a factor not less than 76 + 10 log
(P)dB in a 6.25 kHz band segment, for base and fixed stations.
(2)On all frequencies between 769-775 MHz and 799-805 MHz, by a factor not less than 65 + 10 log
(P)dB in a 6.25 kHz band segment, for mobile and portable stations.
(3)Compliance with the provisions of paragraphs (e)(1) and
(2)of this section is based on the use of measurement instrumentation such that the reading taken with any resolution bandwidth setting should be adjusted to indicate spectral energy in a 6.25 kHz segment.
(f)For operations in the 763-775 MHz and 793-805 MHz bands, all emissions including harmonics in the band 1559-1610 MHz shall be limited to -70 dBW/MHz equivalent isotropically radiated power
(EIRP)for wideband signals, and -80 dBW EIRP for discrete emissions of less than 700 Hz bandwidth. For the purpose of equipment authorization, a transmitter shall be tested with an antenna that is representative of the type that will be used with the equipment in normal operation.
(g)When an emission outside of the authorized bandwidth causes harmful interference, the Commission may, at its discretion, require greater attenuation than specified in this section. 54. Section 90.547 is amended by revising paragraph
(a)introductory text to read as follows: § 90.547 Narrowband interoperability channel capability requirement.
(a)Except as noted in this section, mobile and portable transmitters operating on narrowband channels in the 769-775 MHz and 799-805 MHz frequency bands must be capable of operating on all of the designated nationwide narrowband Interoperability channels pursuant to the standards specified in this part. 55. Section 90.548 is amended by revising paragraph
(a)introductory text to read as follows: § 90.548 Interoperability technical standards.
(a)Transmitters operating on those narrowband channels in the 769-775 and 799-805 MHz band designated for interoperability ( *see* § 90.531) shall conform to the following technical standards: 56. Section 90.551 is revised to read as follows: § 90.551 Construction requirements. Each station authorized under this subpart to operate in the 769-775 MHz and 799-805 MHz frequency bands must be constructed and placed into operation within 12 months from the date of grant of the authorization, except for State channels. However, licensees may request a longer construction period, up to but not exceeding 5 years, pursuant to § 90.155(b). State channels are subject to the build-out requirements in § 90.529. 57. Add subpart AA to part 90 as follows: Subpart AA—700 MHz Public/Private Partnership Sec. 90.1401 Purpose and scope. 90.1403 Public safety broadband license conditions. 90.1405 Shared wireless broadband network. 90.1407 Spectrum use in the network. 90.1408 Organization and structure of the 700 MHz public/private partnership. 90.1410 Network sharing agreement. 90.1415 Establishment, execution, and application of the network sharing agreement. 90.1420 Failure to comply with the NSA or the Commission's rules. 90.1425 Resolution of disputes after grant of the upper 700 MHz D block license. 90.1430 Local public safety build-out and operation. 90.1432 Conditions for waiver to allow limited and temporary wideband operation in the 700 MHz public safety spectrum. 90.1435 Prohibition on discontinuance of public safety operations. 90.1440 Reporting obligations. § 90.1401 Purpose and scope. The purpose of this subpart, in conjunction with subpart N of part 27, is to establish rules and procedures relating to the 700 MHz Public/Private Partnership entered between the winning bidder for the Upper 700 MHz D Block license, the Upper 700 MHz D Block licensee, the Network Assets Holder, the Operating Company, the Public Safety Broadband Licensee, and other related entities as the Commission may require or allow. Pursuant to this partnership, the Upper 700 MHz D Block licensee and the Operating Company will be responsible for constructing and operating a nationwide, shared interoperable wireless broadband network used to provide a commercial service and a broadband network service for public safety entities. The shared network assets will be held by the Network Assets Holder, and the Shared Wireless Broadband Network will operate on both the commercial spectrum licensed to the Upper 700 MHz D Block licensee and the public safety broadband spectrum licensed to the Public Safety Broadband Licensee. This subpart of the part 90 rules sets forth specific provisions relating to the Public Safety Broadband License and the Public Safety Broadband Licensee with respect to the 700 MHz Public/Private Partnership. Subpart N of the part 27 rules sets forth related provisions applicable to the Upper 700 MHz D Block license, the Upper 700 MHz D Block licensee and other related entities as the Commission may require or allow, with respect to the 700 MHz Public/Private Partnership. § 90.1403 Public safety broadband license conditions.
(a)The Public Safety Broadband Licensee shall comply with all of the applicable requirements set forth in this subpart and shall comply with the terms of the Network Sharing Agreement and such other agreements as the Commission may require or allow.
(b)The responsibilities of the Public Safety Broadband Licensee shall include the following:
(1)Negotiation of the NSA and such other agreements as the Commission may require or allow with the winning bidder at auction for the Upper 700 MHz D Block license, pursuant to the requirements set forth in § 90.1410.
(2)General administration of access to the 763-768 MHz and 793-798 MHz bands by individual public safety entities, including assessment of usage fees and related frequency coordination duties.
(3)Regular interaction with and promotion of the needs of the public safety entities with respect to access and use of the 763-768 MHz and 793-798 MHz bands, within the technical and operational confines of the NSA.
(4)Dealings with equipment vendors on its own or in partnership with the Upper 700 MHz D Block licensee, as appropriate, to achieve and pass on the benefits of economies of scale concerning network and subscriber equipment and applications.
(5)Sole authority, which cannot be waived in the NSA, to approve, in consultation with the Upper 700 MHz D Block licensee, equipment and applications for use by public safety entities on the public safety broadband network. State or local entities may seek review of a decision by the Public Safety Broadband Licensee not to permit certain equipment or applications, or particular specifications for equipment or applications, from the Chief, Public Safety and Homeland Security Bureau.
(6)Coordination of stations operating on 700 MHz public safety broadband spectrum with 700 MHz public safety narrowband stations, including management of the internal public safety guard band.
(7)Oversight and implementation of the relocation of narrowband public safety operations in television channels 63 and 68, and the upper one megahertz of channels 64 and 69.
(8)Exercise of sole discretion, pursuant to § 2.103 of this chapter, whether to permit Federal public safety agency use of the public safety broadband spectrum, with any such use subject to the terms and conditions of the NSA.
(9)Review of requests for waiver submitted by public safety entities to conduct wideband operations pursuant to the procedures and restrictions in connection with such waivers as described in § 90.1432. § 90.1405 Shared wireless broadband network. The Shared Wireless Broadband Network developed by the 700 MHz Public/Private Partnership must be designed to meet requirements associated with a nationwide, public safety broadband network. At a minimum, the network must incorporate the following features:
(a)Design for operation over a broadband technology platform that provides mobile voice, video, and data capability that is seamlessly interoperable across public safety local and state agencies, jurisdictions, and geographic areas, and which includes current and evolving state-of-the-art technologies reasonably made available in the commercial marketplace with features beneficial to the public safety community.
(b)Sufficient signal coverage to ensure reliable operation throughout the service area consistent with typical public safety communications systems.
(c)Sufficient robustness to meet the reliability and performance requirements of public safety.
(d)Sufficient capacity to meet the needs of public safety.
(e)Security and encryption consistent with state-of-the-art technologies.
(f)A mechanism to automatically prioritize public safety communications over commercial uses on a real-time basis consistent with the requirements of § 90.1407(c).
(g)Operational capabilities consistent with features and requirements that are typical of current and evolving state-of-the-art public safety systems.
(h)Operational control of the network by the Public Safety Broadband Licensee to the extent necessary to ensure that public safety requirements are met. § 90.1407 Spectrum use in the network.
(a)*Spectrum use.* The Shared Wireless Broadband Network will operate using spectrum associated with the Upper 700 MHz D Block license in the 758-763 MHz and 788-793 MHz bands and the Public Safety Broadband License in the adjacent 763-768 MHz and 793-798 MHz bands.
(b)*Access to spectrum in the 763-768 MHz and 793-798 MHz bands.* The Public Safety Broadband Licensee which holds the Public Safety Broadband License, pursuant to part 90 rules, must lease the spectrum rights associated with this license, pursuant to a spectrum manager leasing arrangement set forth in part 1 subpart X, to the Upper 700 MHz D Block licensee and the Operating Company for the entire remaining term of the Public Safety Broadband License to effectuate the 700 MHz Public/Private Partnership. The Upper 700 MHz D Block licensee and the Operating Company, are the only entities that are eligible to lease the spectrum usage rights associated with the Public Safety Broadband License to operate on the 763-768 and 793-798 MHz bands. If the Upper 700 MHz D Block license is cancelled, this spectrum leasing arrangement will automatically terminate.
(c)*Commercial operations in the 763-768 MHz and 793-798 MHz bands.* Commercial operations in the 763-768 MHz and 793-798 MHz bands through the spectrum manager leasing arrangement shall not cause harmful interference to primary users ( *i.e.* , public safety users) and cannot claim protection from harmful interference from the primary public safety operations in the 763-768 MHz and 793-798 MHz bands. The network providing commercial operations in the 763-768 MHz and 793-798 MHz bands through the spectrum manager leasing arrangement must be designed to automatically assign priority to public safety users, to the exclusion and/or immediate preemption of any commercial use on a dynamic, real-time priority basis, and to guarantee that public safety users suffer no harmful interference or interruption or degradation of service due to commercial operations in the 763-768 MHz and 793-798 MHz bands. § 90.1408 Organization and structure of the 700 MHz public/private partnership.
(a)The Upper 700 MHz D Block licensee and the Network Assets Holder and such other related entities as the Commission may require or allow shall be formed by the winning bidder of the Upper 700 MHz D Block license. The Upper 700 MHz D Block licensee, the Network Assets Holder, and related entities as the Commission may require or allow must be Special Purpose Bankruptcy Remote Entities formed to hold the license, to hold the shared network assets, or for such other purpose as the Commission may require or allow. The winning bidder of the Upper 700 MHz D Block license shall also form the Operating Company, which must also be a Special Purpose Bankruptcy Remote Entity. Upon issuance of the Upper 700 MHz D Block license, the winning bidder will assign all of its rights and obligations under the NSA to the Upper 700 MHz D Block licensee, Network Assets Holder, the Operating Company, and any other related entities that the Commission may require or allow.
(b)The Upper 700 MHz D Block licensee and other related entities as the Commission may require or allow shall have the obligation to build out the Shared Wireless Broadband Network, as provided for in the NSA or otherwise as authorized by the Commission. § 90.1410 Network sharing agreement. The relationship between the Upper 700 MHz D Block licensee, the Public Safety Broadband Licensee, and related entities as the Commission may require or allow will be governed by the Network Sharing Agreement
(NSA)and such other separate agreements as the Commission may require or allow that are negotiated and entered into between the parties. The NSA must, at a minimum, include the following terms:
(a)All of the substantive rights and obligations of the parties relating to the NSA, as established by the Commission concerning the 700 MHz Public/Private Partnership.
(b)Network specifications that comply with § 27.1305 of this chapter.
(c)The definition of “emergency” for purposes of emergency priority access.
(d)All service fees to be imposed for services to public safety, including fees for normal network service and fees for priority access to the D Block spectrum in an emergency.
(e)A detailed build-out schedule consistent with § 27.1327 of this chapter, including coverage of major highways and interstates, as well as incorporated communities with a population in excess of 3,000.
(f)The right of the Public Safety Broadband Licensee to determine and approve the specifications of public safety equipment used on the network and the right to purchase its own subscriber equipment from any vendor it chooses, to the extent such specifications and equipment are consistent with reasonable network control requirements established in the NSA.
(g)The Upper 700 MHz D Block licensee must offer at least one handset suitable for public safety use that includes a seamlessly integrated satellite solution pursuant to the terms, conditions, and timeframes set forth in the NSA.
(h)Any major modification of the terms of the NSA, related agreements or documents, or such other agreements as the Commission may require or allow must be submitted to the Commission for prior approval. All other modifications must be submitted to the Chiefs of the Wireless Telecommunications Bureau and the Public Safety and Homeland Security Bureau for prior approval.
(i)The NSA shall require, in a separate agreement, the granting of an irrevocable and assignable right of first refusal to purchase the network assets if and whenever such assets are otherwise to be sold and an irrevocable and assignable option in favor of the Public Safety Broadband Licensee to purchase the network and all network assets if and whenever the Upper 700 MHz D Block license is cancelled or terminated, by reason of default or for any other reason, for a consideration equivalent to the fair market value of the tangible and intangible assets sold. This right and option shall be senior to, and have priority over, any other right, claim, or interest in or to the network or the network assets. The NSA shall also include a fair market valuation methodology to determine the fair market value of the shared wireless broadband network assets.
(j)The NSA must have a term, not to exceed 10 years from February 17, 2009, that coincides with the terms of the Upper 700 MHz D Block license and the Public Safety Broadband License. § 90.1415 Establishment, execution, and application of the network sharing agreement. The following requirements and processes relate to the establishment, execution, and application of the NSA:
(a)*Approval of NSA as pre-condition for granting the Upper 700 MHz D Block License.* The Public Safety Broadband Licensee must negotiate an NSA and such other agreements as the Commission may require or allow with the winning bidder for the Upper 700 MHz D Block license. The NSA and related agreements or documents must be approved by the Commission and then executed by the relevant parties. Parties to the NSA must also include the Upper 700 MHz D Block licensee, the Network Assets Holder, and the Operating Company, as these entities are defined in § 90.7.
(b)*Requirement of negotiation.* Negotiation of an NSA between the winning bidder for the Upper 700 MHz D Block license and the Public Safety Broadband Licensee must commence by the date the winning bidder files its long form application or the date on which the Commission designates the Public Safety Broadband Licensee, whichever is later, and must conclude within six months of that date. Parties to this negotiation are required to negotiate in good faith. Two members of the Commission staff, one from the Wireless Telecommunications Bureau and one from the Public Safety and Homeland Security Bureau, shall be present at all stages of the negotiation as neutral observers.
(c)*Reporting requirements.* Beginning three months from the triggering of the six-month negotiation period, the Public Safety Broadband Licensee and the winning bidder for the Upper 700 MHz D Block license must jointly provide detailed reports, on a monthly basis and subject to a request for confidential treatment, on the progress of the negotiations throughout the remainder of the negotiations. These reports must include descriptions of all material issues that the parties have yet to resolve.
(d)*Submission of final agreement.* As soon as the parties have reached an agreement on all the terms of the NSA, related agreements or documents, and such other agreements as the Commission may require or allow but not later than five business days after the six-month period for negotiation has expired, they must submit the NSA together with all agreements and related documents referenced in the NSA, for review and approval by the full Commission. The Commission will act on the NSA within 60 days of receipt. The Commission may approve the NSA in its entirety, approve with modifications, or require the parties to address additional terms or re-draft existing terms within a specified timeframe. After the NSA is approved, the parties must execute the NSA and such other agreements as the Commission may require or allow and submit executed copies to the Commission within 10 business days of approval.
(e)*Submission of disputed issues.* If the parties have not reached agreement on all terms of the NSA and related agreements by the end of the six-month period, they must notify the Commission not later than five business days after the expiration of the six-month period of the terms on which they have agreed, the nature of the remaining issues, each party's position on each issue, whether additional negotiation is likely to produce an agreement, and, if so, a proposed deadline for reaching agreement on the NSA. Authority is delegated jointly to the Chiefs of the Wireless Telecommunications Bureau and the Public Safety and Homeland Security Bureau to resolve any remaining disputes.
(f)*Resolution of disputes.* Actions to resolve disputes may include, but are not limited to:
(1)Granting additional time for negotiation;
(2)Issuing a decision on the disputed issues and requiring the submission of a draft agreement consistent with the decision;
(3)Directing the parties to further brief the remaining issues in full for immediate Commission decision; and/or
(4)Immediate denial of the long-form application filed by the winning bidder for the Upper 700 MHz D Block license.
(g)*Default by winning bidder for Upper 700 MHz D Block license.* If the winning bidder for the Upper 700 MHz D Block fails to comply with negotiation or dispute resolution requirements or fails to execute a Commission-approved NSA, its long form application will be denied. If the long form application of the winning bidder of the Upper 700 MHz D Block license is denied for any reason, including as a consequence of an action taken pursuant to paragraphs
(e)and
(f)of this section, it will be deemed to have defaulted under § 1.2109(c) of this chapter and will be liable for the default payment specified in § 1.2104(g) of this chapter. § 90.1420 Failure to comply with the NSA or the Commission's rules.
(a)Failure to comply with the Commission's rules or the terms of the NSA may warrant cancelling the Public Safety Broadband License. The potential remedies also include, but are not limited to, assigning the license to another entity, directing the Public Safety Broadband Licensee to transfer the assignable right to purchase the assets at fair market value, ordering specific performance, or ordering removal and replacement of individual officers, directors or member organizations of the Public Safety Broadband Licensee.
(b)If the Commission cancels or terminates the Upper 700 MHz D Block license, a fair market valuation of the shared wireless broadband network assets shall be performed immediately, pursuant to the fair market valuation methodology set forth in the NSA. In the event that the Upper 700 MHz D Block license is awarded to a new entity, the Public Safety Broadband Licensee's option to purchase the network and all network assets if and whenever the Upper 700 MHz D Block license is cancelled or terminated and its right of first refusal to purchase the network assets if and whenever such assets are otherwise to be sold shall be assigned to the new Upper 700 MHz D Block licensee and the new Network Assets Holder. § 90.1425 Resolution of disputes after grant of the upper 700 MHz D block license.
(a)The Public Safety Broadband Licensee, the Operating Company, the Network Assets Holder, and the Upper 700 MHz D Block licensee may at any time bring a complaint to the Commission based on a claim that another party to the NSA has deviated from the terms of the NSA, or a petition for a declaratory ruling to resolve the proper interpretation of an NSA term or provision. The Commission also may at any time, on its own motion, determine to address any material breach or interpret any NSA term or provision.
(b)The Commission shall have primary responsibility and jurisdiction for adjudicating disputes that arise following execution of the NSA. The Commission may, however, require the parties to first seek a settlement to the dispute or authorize the parties to resolve the dispute through litigation or other means. Breach of license terms, the NSA, or the Commission's rules may result in cancellation of the Public Safety Broadband License, the Upper 700 MHz D Block license, or both.
(c)The Chiefs of the Public Safety and Homeland Security Bureau and the Wireless Telecommunications Bureau are delegated joint responsibility for adjudicating disputes. § 90.1430 Local public safety build-out and operation.
(a)The Upper 700 MHz D Block licensee and the Operating Company through its lease arrangements shall, except in the two limited circumstances set forth herein, have the exclusive right to build and operate the Shared Wireless Broadband Network.
(b)*Rights to early build-out in areas with a build-out commitment.* In an area where the Upper 700 MHz D Block licensee has committed, in the NSA, to build out by a certain date, a public safety entity may, with the pre-approval of the Public Safety Broadband Licensee and subject to the requirements set forth herein, construct a broadband network in that area at its own expense so long as the network is capable of operating on the Shared Wireless Broadband Network and meets all the requirements and specifications of the network required under the NSA.
(1)*Options for early build-out in areas with a build-out commitment.* In order to obtain authorization to construct a broadband network as set forth in paragraph
(b)of this section, the requesting public safety entity must agree to one of the following:
(i)To, on its own, or through the Public Safety Broadband Licensee acting on its behalf, construct the network at its own expense, and upon completion of construction, transfer the network to the Upper 700 MHz D Block licensee, which shall then integrate that network into the Shared Wireless Broadband Network constructed pursuant to the NSA; or
(ii)To, in agreement with the Upper 700 MHz D Block licensee, provide all funds necessary for the Upper 700 MHz D Block licensee to complete the early construction of the network, including any and all additional resource and personnel costs, allowing the Upper 700 MHz D Block licensee at all times to own, operate, and manage the network as an integrated part of the Shared Wireless Broadband Network.
(2)*Negotiation of amendment to NSA.* Under either early build out option set forth in paragraph (b)(1) of this section, the Public Safety Broadband Licensee, the Upper 700 MHz D Block licensee, and the public safety entity must, prior to any construction, negotiate an amendment to the NSA regarding this part of the network, specifying ownership rights, fees, and other terms, which may be distinct from the analogous terms governing the Shared Wireless Broadband Network, and such amendment must be approved by the Commission.
(i)Such amendment must provide the terms under which the Upper 700 MHz D Block licensee shall receive full ownership rights and shall compensate the public safety entity (or the Public Safety Broadband Licensee, where appropriate) for the construction of the network; and shall, absent agreement to the contrary, provide for such transfer and compensation to occur prior to the scheduled build out date for such network in the NSA.
(ii)Any right to compensation from the Upper 700 MHz D Block licensee related to such early build-out shall be limited to the cost that would have been incurred had the Upper 700 MHz D Block licensee constructed the network itself in accordance with the original terms and specifications of the NSA, as reasonably determined by the parties and negotiated as part of the required NSA amendment required in paragraph (b)(2) of this section. Such costs shall not include costs attributable solely to advancing the date of construction or otherwise expediting the construction process.
(3)*Operations.* The public safety entity may not commence operations on the network until ownership of the network has been transferred to the Upper 700 MHz D Block licensee. Further, no operations shall be allowed except those authorized and conducted pursuant to the authority of the Public Safety Broadband Licensee.
(4)*Attribution of early build-out to national benchmarks.* Upon completion of construction, transfer of ownership to the Upper 700 MHz D Block licensee, and compensation as required herein, if applicable, the Upper 700 MHz D Block licensee may include the network constructed pursuant to the early build-out provisions herein for purposes of determining whether it has met its national build-out benchmarks and the build-out requirements of the NSA.
(5)*Rights to build out and operate in areas without a build-out commitment.* In areas for which the NSA does not require the Upper 700 MHz D Block licensee to build out the Shared Wireless Broadband Network, a public safety entity may build out and operate a separate, exclusive network in the 700 MHz public safety broadband spectrum at any time, provided the public safety entity has received the written approval of the Public Safety Broadband Licensee and operates its independent network pursuant to a spectrum leasing arrangement into which the public safety entity has entered with the Public Safety Broadband Licensee.
(i)Such leasing arrangement shall not require the approval or consent of the Upper 700 MHz D Block licensee; however, the Public Safety Broadband Licensee must provide the Upper 700 MHz D Block licensee with notice of the public safety entity's intent to construct in that area within 30 days of receipt of a request from a public safety entity seeking to exercise this option, and shall inform the Upper 700 MHz D Block licensee of the public safety entity's anticipated build-out date(s).
(ii)Should the Upper 700 MHz D Block licensee, within 30 calendar days from receipt of notice of the public safety entity's intent to construct in that area, certify in writing to the Public Safety Broadband Licensee that it will build out the shared network in the area within a reasonable time of the anticipated build-out date(s), as determined by the Public Safety Broadband Licensee, the Public Safety Broadband Licensee shall not allow the public safety entity to build and operate its own separate exclusive network in that area, provided that the Upper 700 MHz D Block licensee and the Public Safety Broadband Licensee execute an amendment to the NSA indicating the Upper 700 MHz D Block licensee's commitment to build the network in that area. Such commitment shall become enforceable against the Upper 700 MHz D Block licensee as part of its overall build-out requirements.
(iii)If the Upper 700 MHz D Block licensee does not exercise its option to commit to build out the network in the requested area within 30 calendar days of receipt of notice of the public safety entity's intent to construct in such area, the Public Safety Broadband Licensee and the public safety entity may proceed with a spectrum leasing arrangement, which must be filed with and approved by the Commission prior to the public safety entity commencing any operations. The spectrum leasing arrangement must take the form of a spectrum manager leasing arrangement under the rules specified in § 1.9020 of this chapter, and incorporate the following conditions:
(A)The network must provide broadband operations;
(B)The network must be fully interoperable with the Shared Wireless Broadband Network;
(C)The network must be available for use by any public safety entity in the area;
(D)The network must satisfy any other terms or conditions required by the Public Safety Broadband Licensee; and
(E)The public safety entity must construct and place into operation its network within one year of the effective date of the spectrum manager leasing arrangement. If the public safety entity fails to place the network into operation within one year, the Public Safety Broadband Licensee shall terminate the spectrum leasing arrangement pursuant to § 1.9020(h)(3) of this chapter. The public safety entity may also seek extended implementation authority from the Commission pursuant to the requirements of § 90.629.
(6)Except as set forth herein, the separate network is not required to meet the other specifications of the Shared Wireless Broadband Network. Absent agreement of the public safety entity, the Public Safety Broadband Licensee, and the Upper 700 MHz D Block licensee, the separate network may not operate using any spectrum associated with the Upper 700 MHz D Block license.
(7)The Public Safety Broadband Licensee must file with the Commission any spectrum manager leasing arrangement as specified in § 1.9020(e) of this chapter; such filing shall identify the public safety entity leasing the spectrum, the particular areas of spectrum leased as part of this build-out option, and the specific network infrastructure and equipment deployed on such leased spectrum. § 90.1432 Conditions for waiver to allow limited and temporary wideband operations in the 700 MHz public safety spectrum.
(a)*Wideband operations in the 700 MHz Public Safety spectrum.* Wideband operations are prohibited in the public safety allocation of the 700 MHz band public safety spectrum except where the Commission has granted a waiver pursuant to §§ 1.3 and 1.925 of this chapter and subject to the additional conditions and requirements specified in this section. Grants of waiver are restricted to the deployment of a wideband system in the consolidated narrowband portion or the internal public safety guard band portion of the public safety broadband spectrum. Where spectrum in the narrowband segment or internal guard band segment is unavailable for wideband operations, public safety entities may request a waiver to operate in the upper 1.25 megahertz of the public safety broadband spectrum.
(b)Any public safety entity seeking to conduct wideband operations within the public safety allocation must file a request for waiver that is accompanied by an application for authorization and includes the following information:
(1)A letter from the Public Safety Broadband Licensee, confirming that the proposed wideband deployment is not inconsistent with the broadband deployment plan for the affected or adjacent service areas; and
(2)A description of the conditions or transition requirements, if any, agreed to between the applicant and the Public Safety Broadband Licensee.
(c)*Additional requirement for wideband operations in the narrowband segment and Internal Guard Band.* If an applicant seeks permission to deploy wideband systems in the narrowband segment, its waiver request must also include a letter from the appropriate regional planning committee or state licensee confirming that the proposed wideband deployment will not disrupt any regional or state planning efforts that are underway.
(d)*Additional requirements and conditions for wideband operations in the broadband segment.* Permission to conduct wideband operations in the broadband segment will be granted only where spectrum in the narrowband segment or the internal guard band is unavailable for wideband operations. In no event will permission be granted to conduct wideband operations in geographic areas scheduled for broadband deployment within the first three years of the build-out plan for the Shared Wireless Broadband Network.
(1)An applicant seeking permission to deploy wideband systems in the broadband segment must have first issued a request for proposal
(RFP)that permitted interested parties to submit broadband proposals that are technically consistent with the Shared Wireless Broadband Network.
(2)A request for waiver that seeks permission to deploy wideband systems in the broadband segment must include the following information:
(i)A substantially supported, detailed technical showing demonstrating that insufficient spectrum in the narrowband segment or the internal guard band is available to support the desired wideband operations;
(ii)A showing that rejected responses to the required broadband network RFP were more costly, provided less coverage as measured by throughput at the network edge, or were otherwise inferior to the accepted wideband proposal; and
(iii)A detailed plan for integration of such wideband system into the Shared Wireless Broadband Network. This plan must specify how and by what date the wideband applicant will integrate its proposed wideband system into Shared Wireless Broadband Network and must include a certification that the public safety entity will not seek reimbursement for any costs involved in converting the wideband system to Shared Wireless Broadband Network upon completion of that network in the applicant's geographic area.
(3)Authority to conduct wideband operations in the broadband segment of the public safety spectrum will be subject to the following conditions:
(i)All devices operating on the wideband system must be designed to interoperate with Shared Wireless Broadband Network;
(ii)All waivers will expire automatically upon the Upper 700 MHz D Block licensee's initiation of service in the service area covered by such waiver.
(e)*Secondary status of wideband operations.* All wideband operations permitted under this section shall be secondary to the authorized narrowband or broadband applications, as applicable.
(f)*License terms for wideband operations.* Any secondary license to conduct wideband operations in the public safety spectrum shall have a term of no more than five years.
(g)*Renewal of wideband authorization.* Any request for renewal of an initial authorization to conduct wideband operations shall be filed not less than 180 days prior to expiration of the license. All renewal requests must include a showing that continued operation of the wideband system is in the public interest and must be accompanied by a letter from the Public Safety Broadband Licensee confirming that continuing wideband operations are not inconsistent with the broadband deployment plan for the affected or adjacent service areas. The license term for any renewal of a license granted under the waiver provisions herein shall not exceed three years. No more than one license renewal will be granted.
(h)*Grandfathered wideband STA operations.* Upon request, the Public Safety and Homeland Security Bureau may grant a public safety entity that has constructed, deployed, and was operating a wideband system as of July 31, 2007 pursuant to STA to extend the STA grant for periods of no more than 180 days until, but not later than, six months following the selection of the Public Safety Broadband Licensee. § 90.1435 Prohibition on discontinuance of public safety operations. The Upper 700 MHz D Block licensee, the Operating Company, and the Network Assets Holder are prohibited from discontinuing or degrading the broadband network service provided to the Public Safety Broadband Licensee or to public safety entities unless either at the request of the entity or entities in question or it has first obtained the approval of the Commission. The Upper 700 MHz D Block licensee shall notify the affected public safety entity or entities and the Public Safety Broadband Licensee at least 30 days prior to any unrequested discontinuance or degradation of network service. § 90.1440 Reporting obligations.
(a)The *Upper 700 MHz* D Block licensee and the Public Safety Broadband Licensee shall jointly file quarterly reports with the Commission. These reports shall include audited financial statements, how the specific requirements of public safety are being met, detailed information on the areas where broadband service has been deployed, which public safety entities are using the broadband network in each area of operation, what types of applications are in use in each area of operation, and the number of declared emergencies in each area of operation.
(b)The Public Safety Broadband Licensee and the Upper 700 MHz D Block licensee have joint responsibility to register the base station locations with the Commission, providing basic technical information, including geographic location. [FR Doc. 07-4123 Filed 8-23-07; 8:45 am]
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43 references not yet in our index
  • Pub. L. 105-277
  • Pub. L. 105-368
  • 112 Stat. 3315
  • Pub. L. 102-4
  • 485 U.S. 568
  • 526 U.S. 434
  • 464 U.S. 16
  • 26 CFR 301
  • T.D. 9344
  • 26 CFR 1
  • T.D. 9349
  • 24 CFR 581
  • 427 F. Supp. 174
  • 217 F. Supp. 705
  • 21 CFR 630.6
  • 21 CFR 610.45
  • 5 USC 601-612
  • Pub. L. 104-4
  • 44 USC 3501-3520
  • 21 CFR 606
  • 21 CFR 610
  • Pub. L. 109-148
  • Pub. L. 109-234
  • 24 CFR 570
  • 49 CFR 24.403(d)
  • 24 CFR 50
  • Pub. L. 109-171
  • 120 Stat. 4
  • Pub. L. 104-121
  • 110 Stat. 857
  • Pub. L. 106-113
  • 113 Stat. 2502
  • 47 CFR 90.1-90
  • Pub. L. 104-13
  • Pub. L. 107-198
  • 47 CFR 1.87
  • 47 CFR 0
  • 47 CFR 1
  • 47 CFR 2
  • 47 CFR 27
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Pub. L.Public Law 118-137
U.S.C.§ 1118
U.S.C.§ 1110
C.F.R.§ 1910.1028
U.S.C.§ 11411
C.F.R.§ 607.3
U.S.C.§ 262
U.S.C.§ 321
C.F.R.§ 601.5
SCOTUS485 U.S. 568
SCOTUS526 U.S. 434
SCOTUS464 U.S. 16
Cites 79 · showing 12Cited by 0 across 0 sources
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