Unknown. Notice of waiver termination
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/register/2007/12/04/07-5905A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2007-12-04.xml --- 72 232 Tuesday, December 4, 2007 Contents Agriculture Agriculture Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 68122 E7-23418 Antitrust Antitrust Division NOTICES Competitive impact statements and proposed consent judgments: Vulcan Materials Co. et al., 68180-68193 07-5902 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Medicare & Medicaid Services RULES Medicaid:
Optional State plan case management services, 68077-68093 07-5903 Medicare: Physicians’ referrals to health care entities with which they have financial relationships (Phase III) Correction, 68075-68077 07-5905 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68166 07-5916 Coast Guard Coast Guard PROPOSED RULES Drawrdige operations: Florida, 68116-68118 E7-23412 NOTICES Agency information collection activities; proposals, submissions, and approvals, 68171-68174 E7-23401 Commerce Commerce Department See Economic Analysis Bureau See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration Copyright Copyright Office, Library of Congress NOTICES Copyright office and procedures:
Satellite carrier compulsory license; rate adjustment, 68198-68199 E7-23520 Defense Defense Department NOTICES Civilian health and medical program of uniformed services (CHAMPUS): TRICARE program— Autism Services Enhanced Access Demonstration Project, 68130-68132 E7-23477 Drug Drug Enforcement Administration NOTICES Registration revocations, restrictions, denials, reinstatements: Sabbagh, Ammar, 68196-68197 E7-23476 *Applications, hearings, determinations, etc.:* Boehringer Ingelheim Chemicals Inc., 68193 E7-23480 Cerilliant Corp., 68193-68195 E7-23508 Chattem Chemicals, Inc., E7-23510 68195-68196 E7-23512 Chemic Laboratories, Inc., 68196 E7-23511 Economic Economic Analysis Bureau NOTICES Reports and guidance documents; availability, etc.:
Data sharing activity; data provided to Bureau of Labor Statistics for statistical purposes, 68122-68123 E7-23506 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 68132 07-5938 07-5939 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: Missouri, 68072-68075 E7-23484 Superfund program: National oil and hazardous substances contingency plan priorities list Correction, 68075 E7-23499 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States:
Missouri, 68118-68119 E7-23483 Wisconsin, 68119-68121 E7-23482 NOTICES Air programs: State implementation plans; adequacy status for transportation conformity purposes— Wisconsin, 68160-68161 E7-23493 State operating permit programs— Wisconsin, 68161-68162 E7-23479 E7-23481 Meetings: Scientific Counselors Board, 68162-68163 E7-23485 Executive Executive Office of the President See Presidential Documents Farm Farm Credit Administration RULES Farm credit system: Disclosure to shareholders— Annual report; preparation and distribution, 68060-68062 E7-23502 FAA Federal Aviation Administration RULES Standard instrument approach procedures, 68062-68064 E7-23047 PROPOSED RULES Airworthiness directives:
Boeing, 68106-68107 E7-23460 Cirrus Design Corp., 68108-68111 E7-23456 NOTICES Advisory circulars; availability, etc.: Aircraft Certification Service, advisory circulars, policy documents, and technical standard orders, 68229-68230 07-5915 Federal Energy Federal Energy Regulatory Commission NOTICES Environmental statements; availability, etc.: Rockies Express Pipeline, LLC, 68138-68139 E7-23445 Hydroelectric applications, 68139-68160 E7-23425 E7-23428 E7-23429 E7-23430 E7-23454 Natural gas pipeline rate and refund report filing, 68160 E7-23446 *Applications, hearings, determinations, etc.:* CenterPoint Energy Gas Transmission Co., E7-23449 68133-68134 E7-23452 Columbia Gulf Transmission Co., 68134 E7-23426 Enogex Inc., 68135 E7-23447 Florida Gas Transmission Co., LLC, 68135 E7-23450 McClendon, Stan, 68135-68136 E7-23453 Pypha Energy LLC, 68136 E7-23427 Questar Overthrust Pipeline Co., 68136 E7-23448 Rockies Express Pipeline LLC, 68137 E7-23455 Tennessee Gas Pipeline Co., 68137-68138 E7-23451 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Formations, acquisitions, and mergers, 68163 E7-23464 Meetings; Sunshine Act, 68163-68164 07-5944 FTC Federal Trade Commission NOTICES Prohibited trade practices: Great Atlantic and Pacific Tea Company Inc. et al., 68164-68166 E7-23419 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.: Charles M. Russell and UL Bend National Wildlife Refuges, MT, 68174-68176 E7-23467 Endangered and threatened species and marine mammal permit applications, determinations, etc., E7-23494 68176-68177 E7-23495 Wild Bird Conservation Act:
Green-winged king-parrot, etc.; cooperative breeding program, 68177 E7-23500 Food Food and Drug Administration RULES Human drugs: Current good manufacturing practices— Finished pharmaceuticals, 68064-68070 E7-23294 PROPOSED RULES Human drugs: Current good manufacturing practices— Finished pharmaceuticals, 68113-68116 E7-23292 Finished pharmaceuticals; manufacturing, quality control, and documentation requirements; withdrawn, 68111-68113 E7-23271 NOTICES Food additive petitions:
DSM Nutritional Products, Inc., 68166-68167 E7-23473 Health Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Homeland Homeland Security Department See Coast Guard See Transportation Security Administration Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See National Park Service International International Trade Administration NOTICES Antidumping:
Stainless steel wire rods from— India, 68123-68124 E7-23491 Uranium from— Russian Federation, 68124-68127 E7-23490 Countervailing duties: Pasta from— Italy, 68128 E7-23488 Export trade certificates of review, 68128 E7-23501 Justice Justice Department See Antitrust Division See Drug Enforcement Administration Labor Labor Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 68197-68198 E7-23461 Land Land Management Bureau NOTICES Public land orders:
Montana; public meeting, 68177-68178 E7-23463 Library Library of Congress See Copyright Office, Library of Congress Maritime Maritime Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68230 E7-23474 Coastwise trade laws; administrative waivers: ASPIRE, 68231 E7-23472 NASA National Aeronautics and Space Administration NOTICES Meetings: NASA International Space Station Advisory Committee, 68199 E7-23409 National Foundation National Foundation on the Arts and the Humanities NOTICES Agency information collection activities; proposals, submissions, and approvals, 68199-68200 E7-23424 National Highway National Highway Traffic Safety Administration RULES Motor vehicle safety standards:
Lamps, reflective devices and associated equipment, 68234-68439 07-5644 Motor homes and recreation vehicle trailers over 10,000 pounds; cargo carrying capacity; tire selection and rims, 68442-68466 E7-22962 NOTICES Meetings: Emergency Medical Services Federal Interagency Committee, 68231-68232 E7-23471 National Institute National Institute of Standards and Technology NOTICES Meetings: National Construction Safety Team Advisory Committee, 68128-68129 E7-23492 NIH National Institutes of Health NOTICES Meetings:
National Institute of Allergy and Infectious Diseases, 68167 07-5909 National Institute of Child Health and Human Development, 68169 07-5914 National Institute of General Medical Sciences, 68167 07-5910 National Institute of Mental Health, 68167-68168 07-5911 National Institute of Neurological Disorders and Stroke, 68168-68169 07-5913 National Institute on Aging, 68168 07-5912 Reports and guidance documents; availability, etc.: National Institute of Mental Health strategic plan, 68169 E7-23420 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:
Northeastern United States fisheries— Atlantic hagfish, 68096-68097 E7-23513 Summer flounder, 68095-68096 E7-23509 West Coast States and Western Pacific fisheries— Pacific Coast groundfish, 68097-68105 07-5925 International fisheries regulations: Northwest Atlantic Fisheries Organization Regulatory Area; fish quotas and effort allocation, 68093-68095 E7-23518 NOTICES Endangered and threatened species: Johnson's seagrass; 5-year review, 68129-68130 E7-23503 National Park National Park Service NOTICES Concession contracts and permits:
Expiring contracts; extension, 07-5923 68178-68179 07-5924 National Register of Historic Places; pending nominations, 68179-68180 E7-23423 Nuclear Nuclear Regulatory Commission RULES Energy Policy Act of 2005; implementation: Byproduct material; expanded definition; waiver termination, 68043 E7-23470 Radiation protection standards: Occupational dose records, labeling containers, and total effective dose equivalent, 68043-68059 E7-23469 NOTICES Environmental statements; availability, etc.:
Army Department; Armament Research, Development, and Engineering Center, Picatinny Arsenal, NJ, 68203-68205 E7-23475 Meetings: Nuclear Waste and Materials Advisory Committee, 68205 E7-23466 Meetings; Sunshine Act, 68205-68206 07-5936 Operating licenses, amendments; no significant hazards considerations; biweekly notices, 68206-68224 E7-23225 *Applications, hearings, determinations, etc.:* Davis, Keith, 68200-68202 E7-23478 Dominion Nuclear North Anna, LLC, 68202-68203 E7-23468 Postal Postal Service NOTICES Meetings;
Sunshine Act, 68224-68225 07-5945 Presidential Presidential Documents PROCLAMATIONS *Special observances:* National Drunk and Drugged Driving Prevention Month (Proc. 8208), 68467-68470 07-5951 World AIDS Day (Proc. 8207), 68041-68042 07-5934 SEC Securities and Exchange Commission NOTICES Self-regulatory organizations; proposed rule changes: American Stock Exchange, LLC, 68225-68226 E7-23396 Chicago Board Options Exchange, Inc., 68226-68227 E7-23399 NASDAQ Stock Market LLC, 68228-68229 E7-23397 SBA Small Business Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 68229 E7-23404 Disaster loan areas:
California, 68229 E7-23486 Substance Substance Abuse and Mental Health Services Administration NOTICES Federal agency urine drug testing; certified laboratories meeting minimum standards; list, 68169-68171 E7-23363 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.: BNSF Railway Co., 68232 E7-23465 Transportation Transportation Department See Federal Aviation Administration See Maritime Administration See National Highway Traffic Safety Administration See Surface Transportation Board Transportation Transportation Security Administration NOTICES Transportation Worker Identification Credential Program:
Enrollment dates for the Ports of Tulsa, OK and Albany, NY, 68174 E7-23522 Treasury Treasury Department See United States Mint U.S. Mint United States Mint NOTICES American eagle silver proof coin; price increase, 68232 E7-23487 Veterans Veterans Affairs Department RULES Medical benefits: Medical care or services; reasonable charges, 68070-68072 E7-23505 Separate Parts In This Issue Part II Transportation Department, National Highway Traffic Safety Administration, 68234-68439 07-5644 Part III Transportation Department, National Highway Traffic Safety Administration, 68442-68466 E7-22962 Part IV Executive Office of the President, Presidential Documents, 68467-68470 07-5951 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 232 Tuesday, December 4, 2007 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Chapter I RIN 3150-AH84 Expanded Definition of Byproduct Material; Notification of Waiver Termination AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of waiver termination. SUMMARY: This document announces that on November 30, 2007, in accordance with Section 651(e) of the Energy Policy Act of 2005 and the provisions of the “Plan for the Transition of Regulatory Authority Resulting from the Expanded Definition of Byproduct Material” (transition plan) issued by the U.S. Nuclear Regulatory Commission (Commission or NRC) on October 19, 2007 (72 FR 59157), the Commission determined that the States listed below have a program to license byproduct material, as defined in Sections 11e.(3) and
(4)of the Atomic Energy Act of 1954, as amended, that is adequate to protect the public health and safety. This determination is based on certifications provided to the Commission by Governors of these States. Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, and Wisconsin. In accordance with Section 651(e)(4)(C)(iii) of the Energy Policy Act of 2005, the Agreements entered into between the Commission and each of these States under Section 274b. of the Atomic Energy Act of 1954, as amended, are considered to include byproduct material as defined in Sections 11e.(3) and
(4)as of October 19, 2007. Accordingly, on November 30, 2007, the Commission terminated the time-limited waivers of the Energy Policy Act of 2005 requirements granted by the Commission (70 FR 51581; August 31, 2005) to the each of these States. Users of the newly added byproduct material currently licensed or registered by these States will continue to be subject to the State regulatory authority. FOR FURTHER INFORMATION CONTACT: Kim K. Lukes, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone
(301)415-6701 or e-mail *kxk2@nrc.gov* . SUPPLEMENTARY INFORMATION: Copies of the Governors' certifications and the Commission's decision may be reviewed at the NRC Web site *http://www.nrc.gov* . Dated at Rockville, Maryland, this 28th day of November 2007. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. E7-23470 Filed 12-3-07; 8:45 am] BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION 10 CFR Parts 19, 20, and 50 RIN 3150-AH40 Occupational Dose Records, Labeling Containers, and the Total Effective Dose Equivalent AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The Nuclear Regulatory Commission (NRC or Commission) is amending its regulations related to the reporting of annual dose to workers, the definition of *Total Effective Dose Equivalent* (TEDE), the labeling of certain containers holding licensed material, and the determination of cumulative occupational radiation dose. This final rule limits the routine reporting of annual doses to those workers whose annual dose exceeds a specific dose threshold or who request a report. This final rule also modifies the labeling requirements for certain containers holding licensed material within posted areas in nuclear power facilities. This final rule also amends the definition of TEDE to be consistent with current Commission policy. Finally, this rule removes the requirement that licensees attempt to obtain cumulative exposure records for workers unless these individuals are being authorized to receive a planned special exposure. These revisions reduce the administrative and information collection burdens on NRC and Agreement State licensees without affecting the level of protection for either the health and safety of workers and the public, or for the environment. DATES: *Effective Date:* This final rule is effective on January 3, 2008. ADDRESSES: Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), Room O1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Publicly available documents created or received at the NRC are available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/NRC/reading-rm/adams.html.* From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR Reference staff at
(800)397-4209,
(301)415-4737, or by e-mail to *pdr@nrc.gov.* FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone
(301)415-4123; e-mail *sxs4@nrc.gov.* SUPPLEMENTARY INFORMATION: I. Background II. Discussion III. Summary and Analysis of Public Comments on the Proposed Rule IV. Section-by-Section Analysis of Final Revisions V. Agreement State Compatibility VI. Availability of Documents VII. Voluntary Consensus Standards VIII. Environmental Impact: Categorical Exclusion IX. Paperwork Reduction Act Statement X. Regulatory Analysis XI. Regulatory Flexibility Certification XII. Backfit Analysis XIII. Congressional Review Act I. Background The NRC Strategic Plan, Fiscal Year 2000-Fiscal Year 2005, included among NRC performance goals for nuclear reactor safety, a performance goal for reducing unnecessary regulatory burden on stakeholders. Similarly, the NRC Strategic Plan Fiscal Year 2004-Fiscal Year 2009 includes as an Effectiveness Strategy improving NRC regulations by adding needed requirements and eliminating unnecessary requirements. The Strategic Plan defines unnecessary regulatory burden as requirements that go beyond what is necessary and sufficient to provide reasonable assurance that the public health and safety, environment, and common defense and security will be protected. To reduce unnecessary regulatory burden, the NRC issued a proposed rule on September 22, 2006 (71 FR 55382), to revise 10 CFR 19.13, “Notifications and Reports to Individuals,” 10 CFR 20.1905, “Exemptions to Labeling Requirements,” and 10 CFR 20.2104, “Determination of Prior Occupational Dose.” The NRC also proposed to revise the definition of TEDE in 10 CFR 20.1003, “Definitions,” and 10 CFR 50.2, “Definitions,” to be consistent with current Commission policy. The NRC received 16 comment letters in response to the proposed rule. The commenters included a number of individuals; industry organizations; and power reactor, uranium recovery, and fuel facility licensees. A discussion of the issues raised by the commenters and the Commission's response is covered below in Section III. II. Discussion This final rule includes four principal amendments. These revisions are intended to reduce unnecessary regulatory burden on NRC and Agreement State licensees without affecting the level of protection for either the health and safety of workers and the public, or for the environment. In finalizing this rule, no revisions were made to the regulatory language that was published in the proposed rule (71 FR 55382; September 22, 2006). A. Annual Dose Report to Workers The first amendment revises paragraphs
(b)and
(d)of 10 CFR 19.13 and 10 CFR 20.2205, “Reports to Individuals of Exceeding Dose Limits.” Under 10 CFR 19.13(b), licensees must make dose information available to workers as shown in records maintained by the licensees. The final rule revises 10 CFR 19.13(b) so that licensees must provide an annual report to each individual monitored of the dose received in that monitoring year if
(1)the individual's occupational dose exceeds 1 millisievert
(mSv)(100 millirem (mrem)) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(2)the individual requests his or her annual dose report. However, the NRC will not require licensees to provide unsolicited annual dose reports to those individuals whose annual dose does not exceed these limits. The criterion of 1 mSv (100 mrem) applies to the whole body, to any individual organ or tissue, to the lens of the eye, to the skin of the whole body, and to the skin of the extremities. If the dose to any one of these exceeds the criterion during a monitoring year, then the licensee must provide a dose report to the individual for that year. The criterion of 1 mSv (100 mrem) was selected because it meets the Commission's regulatory objective to provide a significant reduction in administrative and reporting burdens on licensees. In addition, it is consistent with the occupational dose threshold for requiring instruction to workers under 10 CFR 19.12, “Instruction to Workers.” As discussed in the Supplementary Information to the proposed rule, recent occupational radiation exposure data submitted to the NRC under 10 CFR 20.2206, “Reports of Individual Monitoring,” indicates that about 80 percent of the individuals monitored annually received a TEDE that did not exceed 1 mSv (100 mrem). Based upon this information, the final rule will result in a significant reduction in administrative and reporting burdens on licensees. The final rule does not change the Commission's requirements in 10 CFR Part 20, “Standards for Protection Against Radiation,” for monitoring, recordkeeping, or reporting to the Commission. Therefore, the final rule will not affect the level of protection for either the health and safety of workers and the public or for the environment. Under the existing regulatory framework, the requirement to inform individuals of their routine annual doses, when determined through the results of individual monitoring and when such a report is provided to the Commission, appears multiple times in the regulations. This requirement appears in 10 CFR 19.13(d) through the reference to 10 CFR 20.2206, “Reports of Individual Monitoring.” It also appears in 10 CFR 20.2205 through the reference to 10 CFR 20.2206. To improve regulatory efficiency, this final rule removes the reference to 10 CFR 20.2206 in 10 CFR 19.13(d) and 10 CFR 20.2205, and consolidates the requirement to report annual dose to the individual into a single requirement in 10 CFR 19.13(b). The NRC will also revise NRC Form 3, “Notice to Employees,” to instruct workers on how the licensee is to provide dose annually to workers consistent with the final rule. B. Definition of Total Effective Dose Equivalent
(TEDE)The second amendment revises the definition of TEDE in 10 CFR 20.1003 and 10 CFR 50.2. Under the final rule, TEDE means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). The revised definition of TEDE will allow licensees to substitute “effective dose equivalent (EDE)” for “deep-dose equivalent (DDE)” for external exposures. Conforming changes are also made to 10 CFR 1201, “Occupational Dose Limits for Adults.” This revision will clarify and make the definition of TEDE consistent with Commission policy, as discussed in Regulatory Issue Summary
(RIS)2002-06, “Evaluating Occupational Dose for Individuals Exposed to NRC-Licensed Material and Medical X-Rays,” dated April 16, 2002, and subsequently clarified in RIS 2003-04, “Use of the Effective Dose Equivalent in Place of the Deep Dose Equivalent in Dose Assessments,” dated February 13, 2003, and RIS 2004-01, “Method for Estimating Effective Dose Equivalent From External Radiation Sources Using Two Dosimeters,” dated February 17, 2004. This policy explains that the EDE is the primary quantity in the definition of TEDE for external exposures but that licensees are required to use the DDE in place of the EDE when measuring dose from external exposure, unless the EDE is determined by a dosimetry method approved by the NRC. In addition, 10 CFR 20.1201, paragraph
(c)will be revised to add the requirement that when the external exposure is determined by measurement with an external personal monitoring device, the DDE must be used in place of the EDE, unless the EDE is determined by a dosimetry method approved by the NRC. In many external exposure monitoring situations, determining EDE from external exposures may not be practicable. The added administrative burden associated with determining EDE may not be warranted, or an applicable dosimetry method for determining EDE may not exist. The revised wording to 10 CFR 20.1201(c) clarifies that licensees can still use DDE in place of EDE for the external exposure in demonstrating compliance with the TEDE dose limit, consistent with the existing regulatory framework; however, the DDE must be for the part of the whole body receiving the highest exposure. The final rule will not affect the level of protection for either the health and safety of workers and the public or for the environment because the revised definition of TEDE does not decrease the ability to determine dose. The NRC will also revise NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a Monitoring Period,” so that the licensee can enter either the DDE or EDE in Field 11 which currently is labeled “Deep Dose Equivalent (DDE).” In addition, the instruction sheets for completing both forms will be revised to clarify the method to be used to fill in Field 11, “Deep Dose Equivalent (DDE).” Until these forms are revised, licensees should enter in Field 11 the EDE from external exposure if this dose is assessed by means other than a single dosimeter worn by the exposed individual. Otherwise, the DDE is to be entered. C. Labeling Containers The third amendment revises 10 CFR 20.1905 by adding an exemption for containers holding licensed material (other than sealed sources that are either specifically or generally licensed) within nuclear power facilities licensed under 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” or 10 CFR Part 52, “Early Site Permits; Standard Design Certifications; and Combined Licenses for Nuclear Power Plants,” providing certain conditions are met. Licensees of these facilities need not label containers holding licensed material that are within an area posted under 10 CFR 20.1902, “Posting Requirements,” if the containers are conspicuously marked (to indicate that they may contain licensed material) commensurate with the radiological hazard and are accessible only to individuals who have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of the containers. However, the final rule does require the containers to be appropriately labeled under the requirements of 10 CFR 20.1904, “Labeling Containers,” before being removed from the posted area. Under the existing regulatory framework, some nuclear power reactor licensees interpreted 10 CFR 20.1904 to mean that they had to label all containers in a posted area, whether they contained licensed material or not, because every container has the potential for internal contamination. This conservative interpretation of the current regulations put an undue burden on these licensees. Thus, the final revision to 10 CFR 20.1905 requires containers to be conspicuously marked commensurate with the radiological hazard. The final rule exempts the licensee from providing detailed labeling information such as the radionuclide or radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, types of materials, and mass enrichment as required under 10 CFR 20.1905. One purpose of adding conspicuous markings on the containers is to indicate the potential for generating airborne contamination or high radiation dose rates if the containers were opened or mishandled. For example, these containers could be conspicuously marked by using a color-coding system to indicate high, medium, or low levels of activity or hazard. Containers such as 55-gallon steel drums holding contaminated gloves and booties could be marked with a color that represents low levels of activity or low potential for airborne contamination. At nuclear power facilities, containers located within a posted area are accessible only to individuals who have had instruction under 10 CFR 19.12 and who have been assigned a radiation work permit to control their activities. Consequently, workers will be instructed on the handling of marked containers before workers are given access to these containers. The container marking system under this rule will reduce licensee administrative and information collection burdens, but serve the same health and safety functions as the current labeling requirements. Therefore, the final rule will not affect the level of protection for either the health and safety of workers and the public or for the environment. D. Cumulative Occupational Radiation Dose The fourth amendment removes the provision in 10 CFR 20.2104(a)(2) that requires licensees to attempt to obtain the records of cumulative occupational radiation dose for each worker requiring monitoring under 10 CFR 20.1502, “Conditions Requiring Individual Monitoring of External and Internal Occupational Dose.” Since the revision to 10 CFR part 20 (56 FR 23391; May 21, 1991), cumulative lifetime dose is no longer used in Part 20, except for cases involving planned special exposures. That revision made it unnecessary for licensees to attempt to obtain lifetime exposures for workers who are not participating in a planned special exposure program. This issue was discussed further in the Supplementary Information to the proposed rule (71 FR 55382; September 22, 2006). The final rule does not change the criterion under 10 CFR 20.1206, “Planned Special Exposures,” that requires licensees to ascertain the exposure history of an individual's prior lifetime doses as required by 10 CFR 20.2104(b) before permitting an individual to participate in a planned special exposure. The Commission believes that the final amendment to 10 CFR 20.2104(a)(2) will result in a significant reduction in administrative and information collection burdens on licensees. The final rule will not affect the level of protection for either the health and safety of workers and the public or for the environment, because the requirements to determine an individual's occupational radiation dose received during the current year or cumulative radiation dose prior to permitting a planned special exposure have not been amended. In 10 CFR 20.2104, paragraphs
(c)and
(d)will also be revised to correct the omission of a reference to paragraph
(b)in this section regarding planned special exposures. Paragraph
(b)requires that prior to permitting an individual to participate in a planned special exposure, the licensee must determine the internal and external doses from all previous planned special exposures, and all doses in excess of the limits (including doses received during accidents and emergencies) received during the lifetime of the individual. This revision adds into paragraphs
(c)and
(d)that licensees obtain complete records of the worker's current and previously accumulated occupational dose in complying with the provisions of 10 CFR 20.2104(b). III. Summary and Analysis of Public Comments on the Proposed Rule The NRC received 16 comment letters in response to the proposed rule. The commenters included a number of individuals; industry organizations; and power reactor, uranium recovery, and fuel facility licensees. The majority of commenters supported NRC's approach. The significant comments discussed below are arranged by subject. No changes to the proposed rule language were made as a result of the comment letters. A. Annual Dose Report to Workers Ten commenters specifically addressed this issue. All agreed with the concept that there should be a defined dose threshold above which licensees are required to provide an annual dose report to monitored individuals. However, some took issue with the threshold proposed by the NRC. *Comment.* Two commenters stated that in order to provide comfort or build trust, more employees are given dosimeters than necessary, and that the effort to provide dosimetry to individuals should not be complicated by a need to provide annual dose reports. *Response.* The Commission's requirements on when to provide dosimetry to a worker are separate from the requirements to provide annual dose reports to workers. As explained in the Supplementary Information accompanying the proposed rule, the NRC agrees that many individuals required to be monitored receive very low doses but that, under the current regulations, employers still had to generate and provide reports of doses far below the regulatory limits in 10 CFR 20.1201(a). *Comment.* One commenter said that there should be a reporting requirement at the termination of employment or if the employee develops a medical condition which could affect the employee's ability to receive occupational exposure because individuals seeking new employment need to be notified of their dose so that they can inform their new employer. *Response.* 10 CFR 19.13(e) currently requires that a licensee provide at the request of a worker who is terminating employment with the licensee, a written report of the radiation dose received by that worker from the operations of the licensee during the current year or fraction thereof. Exposures received as part of medical procedures are not reported to the worker as part of the occupational exposure received at a licensed facility. In the case of a medical condition which could affect the worker's ability to receive occupational exposure, it is the worker's responsibility to notify the licensee of any condition that may interfere with the worker's duties. One example is a woman declaring her pregnancy in order to be exposed to a reduced dose level during the pregnancy. Therefore, the commenter's concerns are addressed by the current regulations. *Comment.* One commenter believed that the criteria for reporting annual dose should be based on a percentage of the applicable limits to preserve the graded approach to controlling exposure that the NRC promotes in risk informed regulations, and recommended that licensees should not be required to report occupational doses to workers when their annual dose is less than 10 percent of the applicable dose limits. *Response.* The NRC disagrees with basing the criteria on a percentage of the applicable limits. As explained in the Supplementary Information accompanying the proposed rule, the approach used is simpler because there is one reporting threshold instead of three (i.e., the whole body, lens of the eye, and skin of the whole body or skin of any extremity) and results in the same reduction in burden. *Comment.* One commenter said that it is not clear why the NRC selected 1 mSv (100 mrem) to be identical with the criterion for requiring instruction to workers under 10 CFR 19.12. This commenter saw no advantage in using the same criterion for notification and instruction. This commenter also took issue with the NRC's position in the Supplementary Information to the proposed rule that raising the threshold from the proposed value of 1 mSv (100 mrem) would not significantly reduce administrative and information collection burdens on licensees. Another commenter believed it to be more logical to use 5 mSv (500 mrem) which is the threshold for requiring individual monitoring of external dose. *Response.* The NRC disagrees with these commenters. An analysis of the occupational radiation exposure data in NUREG-0713, Volume 26, (“Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other Facilities 2004” December 2005), indicates that about 80 percent (i.e., 94,534 individuals) of the 122,322 monitored individuals received a TEDE that did not exceed 1 mSv (100 mrem). Furthermore, 61,725 of the monitored individuals received no measurable exposure. Therefore, the threshold of 1 mSv (100 mrem) meets the Commission's regulatory objective of providing a significant reduction in administrative and reporting burden on licensees without adversely impacting public health and safety. The analysis also indicates that raising the threshold from 1 mSv (100 mrem) to 5 mSv (500 mrem) would not further reduce significantly administrative and reporting burdens on licensees. *Comment.* A commenter objected to using a threshold of 1 mSv (100 mrem) for providing annual dose reports to workers because it results in different requirements for a facility where individuals are monitored and for a facility where individuals are not monitored. The commenter believed that the rule provides a strong incentive for a licensee to cease monitoring workers who might exceed 1 mSv (100 mrem) in a year but are unlikely to exceed 5 mSv (500 mrem), the level of exposure for which licensees are required to provide individual monitoring of external occupational dose under 10 CFR 20.1502. *Response.* The NRC disagrees with the commenter's assertion that the threshold for reporting results in different requirements for licensed facilities. The Commission's requirements for recordkeeping and reporting of dose depend only on the licensee's decision to provide or to not provide individual monitoring. The NRC also disagrees with the commenter's assertion that the rule provides incentive for a licensee to cease monitoring workers who might exceed 1 mSv (100 mrem) in a year but are unlikely to exceed 5 mSv (500 mrem). The NRC believes that licensees will choose to continue to provide monitoring to these individuals for operational convenience because this practice helps alleviate worker concerns of a possible significant exposure. *Comment.* One commenter recommended allowing licensees to choose a reporting criteria that is either the proposed requirement of 1 mSv (100 mrem) or some optimal intermediate administrative threshold that best relates to the licensee's conditions and practices. *Response.* The NRC finds it unacceptable to allow licensees to select the threshold value because it will result in a nonuniform approach to providing reports to individuals. *Comment.* One commenter recommended that both the reporting requirements and the monitoring requirements use the same dose criteria so as to not compromise programs for using dosimeters to confirm compliance. This commenter also stated that 1 mSv (100 mrem) per year is below the detection limit for thermoluminescence detectors that are used for dosimeter wear periods that are less than a month. *Response.* The NRC disagrees with using the same dose criteria because the requirements for monitoring, recordkeeping, and reporting address different aspects of the licensee's operations. The Commission's requirements for recordkeeping and reporting of dose depend only on the licensee's decision to provide or to not provide individual monitoring. Regarding the commenter's concern that 1 mSv (100 mrem) per year is below the detection limit for thermoluminescence detectors, the reporting requirements reflect entries on NRC Form 5, which is the form currently used by licensees to obtain the annual dose information that is reported to the workers. Where monitoring was provided but the dose was not measurable, the licensee can enter “ND” for “Not Detectable” on NRC Form 5. *Comment.* Two commenters stated that the final rule language needs to explicitly state that the reporting threshold applies to the whole body, to the lens of the eye, to the skin of the whole body, and the skin of the extremities. *Response.* The NRC believes that the final rule language in 10 CFR 19.13(b) requires no further clarification. Requiring licensees to provide an annual report to each individual when the individual's occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue is inclusive of the dose to any part of the body. If any dose value as reported on NRC Form 5 exceeds 1 mSv (100 mrem), then an annual dose report must be provided to the monitored individual. In addition, the revision to the reporting requirements in 10 CFR 19.13(b) does not change the methods for calculating doses to an individual. *Comment.* One commenter stated that the Commission should consider a two-tiered threshold:
(1)100 mrem for whole body and lens of the eye, and
(2)1,000 mrem for extremities/organ, because there is a 10-fold difference in the dose limits involved. The commenter also believed that this approach would result in major administrative savings for medical and research workers. *Response.* The NRC disagrees with this comment. Several approaches were evaluated for establishing a threshold value above which licensees are required to provide an annual dose report to a monitored individual. The approach selected for the final rule has the merit of simplicity while also achieving the intended aim of reducing unnecessary regulatory burden. The regulatory analysis conducted for the final rule (Section X, below) shows that the 1 mSv (100 mrem) annual reporting threshold by itself results in a significant burden reduction for licensees as a whole. B. Definition of Total Effective Dose Equivalent
(TEDE)Five commenters specifically addressed this issue. Most of these commenters agreed with the proposed revision to the definition of TEDE in 10 CFR 20.1003 and 10 CFR 50.2. *Comment.* One commenter stated that the NRC has no basis to approve dosimetry methods for determining the effective dose equivalent and recommended allowing use of the effective dose equivalent when the methodology is in accordance with a nationally recognized standard or the radiation control agency with jurisdiction. *Response.* The NRC disagrees that there is no basis to approve dosimetry methods, and has published guidance on acceptable dosimetry methods in RIS 2004-01, “Method for Estimating Effective Dose Equivalent From External Radiation Sources Using Two Dosimeters,” RIS 2003-04, “Use of the Effective Dose Equivalent in Place of the Deep Dose Equivalent in Dose Assessments,” and RIS 2002-06, “Evaluating Occupational Dose for Individuals Exposed to NRC-Licensed Material and Medical X-Rays.” Further guidance will be provided, as warranted, when additional methods are determined acceptable by the NRC. *Comment.* One commenter said that the Supplementary Information to the proposed rule did not address how the change to the definition of TEDE is consistent with the recommendations of the International Commission on Radiological Protection
(ICRP)and the National Council on Radiation Protection and Measurements (NCRP). *Response.* Total Effective Dose Equivalent
(TEDE)in 10 CFR Part 20 is defined as the sum of two dosimetrically different quantities: The deep-dose equivalent
(DDE)for external exposure and the effective dose equivalent
(EDE)for internal exposure. This approach is not consistent with the basic radiation protection premise that risk is directly proportional to dose. The DDE is not, in many cases, proportional to risk and is often a poor indicator of the risk arising from radiation exposure. This approach of using mixed quantities to define the TEDE is also not consistent with the recommendations of national and international advisory groups such as the NCRP and the ICRP. These groups quantify the total dose by adding the EDEs for both internal and external exposures. The use of mixed quantities has caused significant difficulties to NRC licensees, and has led the Commission to permit substitution of EDE in place of DDE when calculating the TEDE, provided the dose from external exposure is not based on measurements using personnel dosimetry. This provision allows for the fact that the EDE cannot be measured in the field, and when measurements are necessary as the basis for quantifying the dose from external exposures, the DDE may be used as a surrogate quantity that was defined in such a manner that its magnitude provides a conservative numerical estimate for the EDE. The final redefinition of TEDE implements this policy formally, a policy that is now in effect and is being used by NRC licensees. *Comment.* One commenter stated that NRC Forms 4 and 5 need to be revised because of the change to the definition of TEDE, and that the NRC provide options in guidance for reporting EDE versus DDE and for making appropriate calculations of the total organ dose equivalent and TEDE. *Response.* The NRC agrees with the comment. NRC Forms 4 and 5 will be revised to reflect the changes to the definition of TEDE. In addition, the instruction sheets for completing both forms will be revised to clarify the method to be used to fill in Field 11, “Deep Dose Equivalent (DDE).” Guidance for estimating the EDE and DDE is provided in numerous NRC guidance documents. C. Labeling Containers Four commenters specifically addressed this issue. All of the commenters disagreed with the approach taken by the NRC in the proposed rule to limit the exemption to labeling requirements under 10 CFR 20.1905 to nuclear power reactor licensees, and believed that additional categories of licensees should be granted the exemption to labeling requirements for containers holding licensed material. *Comment.* Two commenters stated that the container labeling exemption should be granted to university and medical licensees. One commenter indicated that power reactors have more types of radioactivity and a great range of activity because of the mixtures of fission and activation products, while university and medical areas have pure and well-defined materials used under controlled conditions, mostly employing low quantities of materials with short half lives. The commenter indicated that therefore a dichotomy in the rules for nuclear power plants and other licensees is unjustified. The other commenter stated that the current exemptions in 10 CFR 20.1905 pertain to labeling of containers with applicability to all licensees, and that limiting this exemption to nuclear power facilities for the reasons stated in the Supplementary Information to the proposed rule demonstrates an incomplete understanding of the safety measures in large medical and research facilities. The commenter stated if an undue burden has been placed on the nuclear power industry because of an overly conservative interpretation of the rules, the NRC should specifically be tasked to broaden that interpretation, not exempt a single licensee category from a rule applicable to all other licensees. *Response.* The NRC disagrees with granting the exemption from labeling requirements to university and medical licensees. The burden imposed on nuclear power plant licensees by the current regulation is due to an overly conservative interpretation because of the existence of a large number of structures in a protected area of a nuclear power plant that may be inappropriately considered to be containers holding licensed material, such as cable trays, and containers holding contaminated tools or protective clothing. This situation does not exist at other types of licensed facilities. In addition, although the NRC agrees with the commenter that university and medical licensees implement stringent radiation control programs, the level of redundancy in protective measures in these programs is not as extensive as that found at nuclear power plants. The NRC believes that removing one such measure at nuclear power plants, i.e., labeling containers holding licensed material, will be compensated for by the redundancy in their radiation protection programs. Such extensive redundancy is not normally found in university and medical radiation protection programs. *Comment.* Two commenters recommended that the container labeling exemption be granted to all licensees under 10 CFR part 70, “Domestic Licensing of Special Nuclear Material.” One of these commenters believed that all Part 70 licensees now have this provision in their licenses. This commenter also noted that a Part 70 licensee's variance in radiological hazards is comparable to that of a Part 50 or Part 52 license. *Response.* The NRC disagrees that there is a need to extend the exemption from labeling requirements to include Part 70 licensees. Currently, only Part 70 licensees subject to Subpart H requirements have a license condition that provides the exemption from the labeling requirements of this rule. The Commission has determined that for the remainder of the Part 70 licensees, this license condition is not required. The existing labeling requirements are not a burden to these licensees because they handle few containers holding radioactive material. *Comment.* One commenter suggested that the exemption be expanded to include containers removed from a posted area as long as the container is under continuous direct or electronic surveillance while in transit between one posted area to another. *Response.* The exemption from labeling requirements suggested by the commenter is already provided in 10 CFR 20.1905(c). That regulation specifies that a licensee is not required to label containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by 10 CFR Part 20. D. Cumulative Occupational Radiation Dose Ten commenters addressed this issue. Most of the commenters agreed with removing the provision in 10 CFR 20.2104(a)(2) that requires licensees to attempt to obtain the records of cumulative occupational radiation dose for each worker requiring monitoring under 10 CFR 20.1502. *Comment.* Two commenters suggested that the cost savings to licensees from the revision to 10 CFR 20.2104 have been underestimated. Specifically, these commenters recommended that the NRC consider the savings to those licensees who will no longer have to provide prior dose records to a requesting licensee, stating that the savings of not having to provide prior dose records is $20 per new employee. This estimate is based on an assumption of a savings of $10 per request and on the fact that two licensees would be requested to provide the records per new employee. *Response.* The NRC agrees with the comments and the regulatory analysis for the final rule found in Section X has been revised to use the suggested values. *Comment.* One commenter expressed a concern that it is essential for the licensee to obtain current year dose records. *Response.* The NRC agrees with the need for a licensee to determine and record the dose for an individual during the current year. The final rule does not revise the requirements in 10 CFR 20.2104(a) that require a licensee to determine the occupational radiation dose received by an individual during the current year. The final rule removes only the requirement that licensees attempt to obtain cumulative exposure records for workers, i.e., exposure records for previous years, unless these individuals are being authorized to receive a planned special exposure. *Comment.* One commenter suggested that an additional revision be made to 10 CFR 19.13 to remove the language in paragraph
(a)regarding using an individual's social security number as an appropriate identifier for reports. This commenter was concerned about the risk of identity theft. *Response.* Based on recent Office of Management and Budget guidance, Federal agencies, including the NRC, are reviewing their uses of Social Security Numbers
(SSNs)with the goal of eliminating unnecessary uses of SSNs. However, revision of 10 CFR 19.13(a) to remove the language specific to using the individual's social security number as an identifier is outside the scope of this rulemaking. *Comment.* One commenter believed that removing the requirement in 10 CFR 20.2104(a)(2) to attempt to obtain the records of cumulative occupational radiation dose would eliminate lifetime dose records and the ability to do any retrospective, low dose occupational risk assessments. *Response.* As explained in the Supplementary Information accompanying the proposed rule, occupational exposures were initially restricted by the cumulative lifetime dose received and, under certain circumstances, an individual could receive as much as 0.12 Sv (12 rems) in a year. However, following revision to 10 CFR Part 20 (56 FR 23391; May 21, 1991), cumulative lifetime dose is no longer used in the Commission's regulations to restrict occupational exposures. The reduced occupational dose limit of 0.05 Sv (5 rems) per year in the current 10 CFR 20.1201(a)(1)(i) essentially accomplishes the same goal as the previous dose limit of 0.03 Sv (3 rems) per calendar quarter constrained by the then age-dependent, cumulative lifetime dose limit. (The goal is an average cumulative dose rate of 0.05 Sv (5 rems) per year to the individual.) Therefore, it is no longer necessary for licensees to obtain records of cumulative occupational dose. However, 10 CFR Part 20 still requires licensees to maintain records of individual monitoring results and to submit to the NRC an annual report of the results of individual monitoring. The ability to do a retrospective dose assessment is not affected by this final rule. The revision to 10 CFR 20.2104(a)(2) does not change the Commission's requirements for monitoring individuals or for maintaining records of doses received by individuals at licensed facilities. Thus, the dose records for individuals whose exposure histories span more than one licensed facility will still be available for risk assessments. *Comment.* One commenter stated that removing the requirement in 10 CFR 20.2104(a)(2) will not reduce future burden on licensees because if the NRC implements the proposed International Commission on Radiological Protection
(ICRP)recommendation on dose limits averaged over several years, then licensees will need to reconstruct a worker's prior dose records. *Response.* A change in this area would not affect the ability of licensees to implement dose averaging if the Commission were to decide to adopt this practice in the future. The revision does not remove the requirement to record and report the doses received by monitored workers, rather, it simply removes the requirements for each licensee to compile the exposure history of each worker as recorded on FORM 5s unless the worker is being authorized to receive a planned special exposure. Should another purpose develop (such as dose averaging) that would justify such data compilation, it would be as easy to do as for a planned special exposure, because the records would still be available. *Comment* . One commenter stated that the rule should be expanded to not require a licensee to obtain a worker's dose records prior to permitting the worker to participate in a planned special exposure, but to require the worker to retrieve this data. The commenter believed that this would alleviate an administrative burden on the licensee. *Response* . This comment is outside the scope of this rulemaking. The final rule does not address the methods used to obtain a worker's dose history when that dose history is required prior to permitting the worker to participate in a planned special exposure. The final rule only removes the requirement for a licensee to obtain the records of cumulative occupational radiation dose except when authorizing a planned special exposure. IV. Section-by-Section Analysis of Final Revisions This final rule amends 10 CFR 19.13, 20.1003, 20.1201, 20.1905, 20.2104, 20.2205, and 50.2. Section 19.13—Notifications and Reports to Individuals. Paragraph
(b)is revised to require a licensee to provide an annual dose report to an individual when the individual's occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue, or when the individual requests a report of the individual's annual dose, and that all dose records shall be made available to workers onsite. In order to consolidate the requirement to report annual dose to the individual into a single requirement in 10 CFR 19.13(b), paragraph
(d)is revised to remove the reference to 10 CFR 20.2206. Section 20.1003—Definitions. In 10 CFR 20.1003, the definition of *Total Effective Dose Equivalent*
(TEDE)is revised to state that TEDE is the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). Section 20.1201—Occupational Dose Limits for Adults. Paragraph
(c)is revised to add the requirement that when the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the NRC. Section 20.1905—Exemptions to Labeling Requirements. A new paragraph
(g)is added to 10 CFR 20.1905 to provide an exemption for containers holding licensed material (other than sealed sources that are either specifically or generally licensed) that are in an area posted under the requirements of 10 CFR 20.1902 at a nuclear power facility. The final rule does not require the licensee to label the container according to 10 CFR 20.1904 if it is conspicuously marked (such as by color coding) commensurate with the radiological hazard and accessible only to individuals who have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of the containers. The final rule also requires that the container must be appropriately labeled as required by 10 CFR 20.1904 before being removed from the posted area. This exemption to the labeling requirements for containers holding licensed material does not apply to non-power reactor and materials licensees, or for sealed sources. Section 20.2104—Determination of Prior Occupational Dose. Paragraph (a)(2) is removed to delete the requirement that licensees attempt to obtain the records of cumulative occupational radiation dose. The introductory text of paragraph
(a)and paragraph (a)(1) are combined and designated as paragraph (a). Paragraphs
(c)and
(d)are also revised to add a reference to paragraph
(b)in this section regarding planned special exposures. Section 20.2205—Reports to Individuals of Exceeding Dose Limits. Section 20.2205 is revised to remove the reference to 10 CFR 20.2206, in order to consolidate the requirement to report annual dose to the individual into a single requirement in 10 CFR 19.13(b). Section 50.2—Definitions. In 10 CFR 20.1003, the definition of *Total Effective Dose Equivalent*
(TEDE)is revised to state that TEDE is the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). V. Agreement State Compatibility Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs,” approved by the Commission on June 30, 1997, and published in the **Federal Register** (62 FR 46517; September 3, 1997), this rule is a matter of compatibility between NRC and the Agreement States, thereby providing consistency among the Agreement States and the NRC's requirements. The NRC analyzed the rule in accordance with the procedure established in Part III, “Categorization Process for NRC Program Elements,” of Handbook 5.9 to Management Directive 5.9, “Adequacy and Compatibility of Agreement State Programs” (which may be viewed at *http://nrc-stp.ornl.gov/* ). The NRC has determined that the compatibility categories for the sections amended in this rule are the same as for the sections in the existing regulations, except for the new exemption
(g)added to 10 CFR 20.1905. The revisions to 10 CFR 19.13 and 20.2205 are classified as Compatibility Category C. A Compatibility Category C designation means the Agreement State should adopt the essential objectives of the requirement to avoid conflicts, duplications, or gaps. The revisions to 10 CFR 20.1003 and 20.1201(c) are classified as Compatibility Category A. A Compatibility Category A designation means the requirement is a basic radiation protection standard or related definition, sign, label, or term necessary for a common understanding of radiation protection principles. Agreement State requirements designated Compatibility Category A should be essentially identical to NRC requirements. The new exemption
(g)added to 10 CFR 20.1905 is classified as Compatibility Category NRC. A Compatibility Category NRC designation means the Agreement State should not adopt the requirement for purposes of compatibility. These are NRC program elements that address regulatory items that cannot be relinquished to Agreement States under the Atomic Energy Act or provisions of the regulations in title 10 of the CFR. The revision to 10 CFR 20.2104(a) is classified as Compatibility Category D. A Compatibility Category D designation means the Agreement State is not required to adopt the requirement for compatibility. VI. Availability of Documents The NRC is making the documents identified below available to interested persons through one or more of the following methods. Public Document Room (PDR). The NRC Public Document Room is located at 11555 Rockville Pike, Rockville, Maryland. NRC's Agency-wide Documents Access and Management System (ADAMS). The NRC's PARS Library is located at *www.nrc.gov/reading-rm/adams.html* . The NRC staff contact (NRC Staff). Stewart Schneider, U.S. Nuclear Regulatory Commission, Mail Stop O-12D3, Washington, DC 20555-0001; telephone
(301)415-4123; *sxs4@nrc.gov* . Document PDR ADAMS NRC staff Final Rulemaking X X X Public Comments on Proposed Rule X X X Proposed Rulemaking (71 FR 55382; September 22, 2006) X X X NRC Form 3 X X X NRC Form 4 X X X NRC Form 5 X X X RIS 2002-06 X X X RIS 2003-04 X X X RIS 2004-01 X X X NUREG-0713, Vol. 26 X X NUREG-1350, Vol. 17 X X NUREG/BR-0184 X X NUREG/BR-0058, Rev. 4 X X Standards for Protection Against Radiation: Final Rule (56 FR 23391; May 21, 1991) X X NRC Strategic Plan, Fiscal Year 2000-Fiscal Year 2005 X X X Copies of NUREGs may be purchased from The Superintendent of Documents, U.S. Government Printing Office, Mail Stop SSOP, Washington, DC 20402-0001; Internet: *bookstore.gpo.gov* ;
(202)512-1800. Copies are also available from the National Technical Information Service, Springfield, VA 22161-0002; *http://www.ntis.gov* ; 1-800-553-6847 or, locally,
(703)605-6000. Some publications in the NUREG series are included in the document collections in the Electronic Reading Room on NRC's Web site at *http://www.nrc.gov/reading-rm.html* . VII. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or is otherwise impractical. In this final rule, the NRC is revising requirements for the reporting of annual dose to workers, the definition of *Total Effective Dose Equivalent* (TEDE), the labeling of certain containers holding licensed material, and the determination of cumulative occupational radiation dose. This regulatory action does not constitute the establishment of a standard that contains generally applicable requirements. VIII. Environmental Impact: Categorical Exclusion The NRC has determined that the amendments to 10 CFR parts 19, 20, and 50 are the types of actions described in categorical exclusion 10 CFR 51.22(c). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulatory action. Specifically, the revision to 10 CFR 19.13(b) to limit the routine reporting of annual doses to workers comes under the categorical exclusion in 10 CFR 51.22(c)(1), which covers all revisions to 10 CFR part 19. The amendments to the definition of TEDE in 10 CFR 20.1003 and 10 CFR 50.2 and to 10 CFR 20.1201(c) to add the requirement that the effective dose equivalent be determined by a dosimetry method approved by the NRC come under the categorical exclusion in 10 CFR 51.22(c)(2) because these revisions are of a minor nature and do not substantially modify existing regulations. For the amendments to 10 CFR 20.1905 to revise the requirements for labeling containers and to 10 CFR 20.2104 to remove the requirement to obtain lifetime exposure records, these revisions involve recordkeeping requirements and thus come under the categorical exclusion in 10 CFR 51.22(c)(3)(ii). Finally, because the amendment to 10 CFR 20.2205 involves a reporting requirement, this revision comes under the categorical exclusion in 10 CFR 51.22(c)(3)(iii). IX. Paperwork Reduction Act Statement This final rule amends information collection requirements contained in 10 CFR Parts 19, 20, and 50, and NRC Form 4 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget, approval numbers 3150-0044, 3150-0014, 3150-0011, and 3150-0005. The changes to 10 CFR Parts 19, 20, and 50, and NRC Form 4 do not contain a new or amended information collection requirements. Existing requirements were approved by the Office of Management and Budget, approval number(s) 3150-0044, 3150-0014, 3150-0011, and 3150-0005. Because the rule will reduce the burden for existing information collection requirements, the public burden for the information collections in 10 CFR parts 19 and NRC Form 4 is expected to be decreased by 235 and 44 hours per licensee, respectively. This reduction includes the time required for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the information collection. Send comments on any aspect of these information collections, including suggestions for further reducing the burden, to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to *INFOCOLLECTS@NRC.GOV* ; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0044, 3150-0014, 3150-0011, and 3150-0005) Office of Management and Budget, Washington, DC 20503. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. X. Regulatory Analysis The Commission has prepared a regulatory analysis on this final rule and has included it in this **Federal Register** notice. The analysis examines the costs and benefits of the alternatives considered by the Commission. The Commission requested public comment on the draft regulatory analysis for the proposed rule (71 FR 55382; September 22, 2006). Two comments were received on the draft regulatory analysis and are discussed above in Section III. These comments were considered and the regulatory analysis revised appropriately. 1. Statement of the Problem and Objective The NRC has determined that the regulations in 10 CFR 19.13, 20.1003, 20.1201, 20.1905, 20.2104, and 50.2 impose an undue regulatory burden on licensees. The final rule makes these regulations consistent with current Commission policy and reduces administrative and information collection burdens on NRC and Agreement State licensees. The final rule amends certain requirements for notification of workers, revises the definition of *Total Effective Dose Equivalent* (TEDE), amends certain container labeling requirements, and removes the requirement that licensees attempt to obtain the records of cumulative occupational radiation dose for certain individuals. These revisions do not affect the level of protection for either the health and safety of workers and the public or for the environment. 2. Identification of Regulatory Alternatives This regulatory analysis evaluates the savings and costs of two regulatory alternatives. The following subsections describe these two alternatives. 2.1 No-Action Alternative The no-action alternative is the status quo had this rule not been promulgated. Under that alternative, licensees would have been required to:
(1)Provide annual dose reports to all monitored individuals,
(2)determine the TEDE by summing the deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for external doses),
(3)use the current exemptions to labeling requirements for containers holding licensed material, and
(4)attempt to obtain the records of lifetime occupational radiation dose for all individuals. The no-action alternative is the baseline for analyzing the rule alternative. The no-action alternative does not accomplish the stated objective. 2.2 Rule Alternative Under the rule alternative, the NRC is revising its regulations in 10 CFR parts 19, 20, and 50 for:
(1)Reporting dose to workers,
(2)the definition of TEDE,
(3)the labeling of certain containers holding licensed material, and
(4)the requirement that licensees attempt to obtain the records of cumulative occupational radiation dose for all individuals. This alternative makes the regulations consistent with current Commission policy and reduces administrative and information collection burdens on NRC and Agreement State licensees. Because this action is being taken to ease burden, the rulemaking process is the only regulatory option appropriate to make the changes effective. 3. Analysis of Values and Impacts 3.1 Identification of Affected Attributes The attributes that the rule could affect were identified by using the list of potential attributes provided in Chapter 5 of NUREG/BR-0184, “Regulatory Analysis Technical Evaluation Handbook” (January 1997). *Industry Implementation* . This attribute is affected by three of the four principal revisions: The revisions to the requirements for the annual dose reports to workers, the labeling of containers holding licensed material, and the attempt to obtain the records of cumulative occupational radiation dose for an individual. In implementing these changes, licensees will incur the costs of revising procedures. *Industry Operation* . This attribute is affected by three of the four principal revisions. Licensees will realize savings by only having to provide annual dose reports to individuals when their dose exceeds 1 mSv (100 mrem), by not having to label containers holding licensed material (except sealed sources that are already labeled) in a posted area in a nuclear power facility, and by not having to ascertain the exposure history of an individual's prior lifetime doses except to permit an individual to participate in a planned special exposure. *NRC Implementation* . The NRC will incur costs to make minor revisions to NRC Form 3, “Notice to Employees,” to account for the revisions to the reporting of annual dose to workers. In addition, the NRC will incur costs to make minor revisions to NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a Monitoring Period,” and their instructions, to account for the revision to the definition of TEDE. *Regulatory Efficiency* . All four of the principal revisions will enhance regulatory efficiency. The revisions are intended to reduce administrative and information collection burdens on NRC and Agreement State licensees without affecting the level of protection for either the health and safety of workers and the public or for the environment. 3.2 Methodology The incremental savings and costs of the regulatory action are analyzed relative to the baseline described in Section 2.1 of this regulatory analysis. The savings come from any desirable changes in the affected attributes, while the costs come from any undesirable changes in the affected attributes. Under Office of Management and Budget guidance and NUREG/BR-0058, “Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission,” Revision 4 (September 2004), the results of the analysis are presented using a discounted flow of funds at a 3 and 7 percent real discount rate. Under 10 CFR 20.2206, seven categories of NRC licensees are required to submit to the NRC annual radiation exposure reports for monitored individuals: Commercial nuclear power reactors; industrial radiographers; fuel processors (including uranium enrichment), fabricators and reprocessors; manufacturers and distributors of byproduct material; independent spent fuel storage installations; facilities for land disposal of low-level waste; and geologic repositories for high-level waste. (No NRC licensees are currently involved in operating low-level waste disposal facilities or geologic repositories for high-level waste.) In addition, 10 CFR 20.2206(b) requires that licensees submit annual reports using NRC Form 5 or electronic media containing all the information required by NRC Form 5. For the above licensees, the value-impact analysis uses the occupational exposure data maintained in the NRC's Radiation Exposure Information and Reporting System (REIRS) database (NUREG-0713, Volume 26, “Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other Facilities 2004” (December 2005)). While more recent data has been issued, the values have not changed significantly from those used in the regulatory analysis for the proposed rule. To simplify the analysis, the seven categories of licensees are consolidated into two groups. The first group contains only commercial nuclear power reactor licensees (nuclear power reactor licensees) and the second group contains all of the other licensee categories listed above (REIRS materials licensees). The seven categories of licensees specified in 10 CFR 20.2206 do not include all NRC licensees. Most NRC licensees (e.g., hospitals, medical facilities, universities, radiological services, disposal) are not required to submit annual radiation exposure reports for monitored individuals. These licensees (non-REIRS materials licensees) constitute the third group of licensees for whom a value-impact analysis was done. This group contains both Agreement State and NRC licensees. For this group of licensees, the NRC has no records of the number of monitored individuals or the annual doses they received (except in the rare case of an overexposure). Based on professional judgment, the NRC assumes that 500,000 individuals are monitored annually by non-REIRS materials licensees. In addition, it is assumed that about 70 percent of them receive an annual dose that does not exceed 1 mSv (100 mrem). This factor is derived from the data in NUREG-0713 for REIRS materials licensees and is assumed to apply to non-REIRS materials licensees. The following assumptions and data were used to assess the incremental values and impacts associated with the regulatory action. • Based on NUREG-0713, the number of nuclear power reactor licensees is 104 (NRC licensees only). • Based on NUREG-0713, the number of REIRS materials licensees is 123 (NRC licensees only). • Based on NUREG-1350, Volume 17, “NRC Information Digest: 2005-2006 Edition” (July 2005), there are approximately 17,298 Agreement State licensees. While more recent data has been issued, the values have not changed significantly from those used in the regulatory analysis for the proposed rule. • The number of non-REIRS materials licensees (Agreement State and NRC licensees) was estimated as follows. A review of the NRC Licensing Tracking System database in October 2005 indicated that a total of 4,517 materials licensees are administered by the NRC. While more recent data has been issued, the values have not changed significantly from those used in the regulatory analysis for the proposed rule. Correcting for the 123 REIRS materials licensees in the database and accounting for Agreement State licensees, the total number of Agreement State and NRC licensees designated as non-REIRS materials licensees is approximately 21,692 licensees (17,298 Agreement State licensees + 4,517 NRC materials licensees−123 REIRS materials licensees). • The number of NRC licensees designated as non-REIRS materials licensees is 4,394 licensees (4,517 NRC materials licensees−123 REIRS materials licensees). • Based on NUREG-0713, the number of individuals working for all nuclear power reactor licensees is 110,290. • The average number of individuals working at each of the 104 nuclear power plants is estimated to be 1,060. • Based on NUREG-0713, the number of individuals working for all REIRS materials licensees is 12,032. • Based on professional judgment, the NRC assumes that 500,000 individuals are monitored annually by non-REIRS materials licensees (Agreement State and NRC licensees). • Based on NUREG-0713, 70 percent of the individuals monitored by nuclear power reactor licensees receive an annual dose that does not exceed 1 mSv (100 mrem). • Based on NUREG-0713, 80 percent of the individuals monitored by REIRS materials licensees receive an annual dose that does not exceed 1 mSv (100 mrem). • Based on NUREG-0713 and professional judgment, the NRC assumes that 80 percent of the individuals monitored by non-REIRS materials licensees receive an annual dose that does not exceed 1 mSv (100 mrem). • The NRC estimates that procedural revisions will require 20 hours for each of the 104 nuclear power plants. • For REIRS and non-REIRS materials licensees, the time needed to revise procedures ranges from 2 to 20 hours, depending on the size of the facility. This analysis uses 10 hours as the average time to revise procedures for these licensees. • For nuclear power reactor licensees, it is assumed that the average life remaining for power reactor facilities is 49 years. For 3 and 7 percent real discount rates, the analysis uses present value multiplication factors of 25.50 and 13.77, respectively, following the guidance in NUREG/BR-0184. • For REIRS and non-REIRS materials licensees, it is assumed that the average life remaining for the facilities is 20 years. For 3 and 7 percent real discount rates, the analysis uses factors of 14.9 and 10.6, respectively, following the guidance in NUREG/BR-0184. 3.3 Analysis 3.3.1 Annual Dose Report to Workers *Nuclear power reactor licensees.* In implementing the regulatory action, nuclear power reactor licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 20 hours to revise the procedures for each of the 104 nuclear power plants. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $2,100 per nuclear power plant (20 hours × $105/hour) and $220,000 for the nuclear power industry (104 licensees × $2,100/licensee). With respect to industry operation, there will be a savings from not having to provide unsolicited annual dose reports (NRC Form 5) to workers when their doses do not exceed 1 mSv (100 mrem). As discussed in the regulatory analysis for the proposed rule (71 FR 55382; September 22, 2006), the NRC estimated the annual savings to be $3,000 per nuclear power plant and $310,000 for the nuclear power industry ($3,000 × 104 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $77,000 ($3,000 × 25.50) and $8 million ($310,000 × 25.50), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $41,000 ($3,000 × 13.77) and $4.3 million ($310,000 × 13.77), respectively. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. The NRC estimates it will take 5 minutes (0.083 hour) for a licensee to prepare an annual dose report for each worker. Using the 2004 data in NUREG-0713, it was determined that about 80 percent of the monitored individuals had an annual dose that did not exceed 1 mSv (100 mrem). It is further assumed that 90 percent of this population will not request an annual dose report. Assuming an average of 1,060 workers per nuclear power plant, the annual burden reduction from implementing the regulatory action is estimated to be 63 hours per nuclear power plant (1,060 workers × 0.083 hour × 0.8 × 0.9) and the total annual industry burden reduction is 6,600 hours (63 hours/licensee × 104 licensees). *REIRS materials licensees* . In implementing the regulatory action, REIRS materials licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 10 hours to revise the procedures for each of the 123 REIRS materials licensees. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $1,050 per licensee (10 hours × $105/hour) and $130,000 for all licensees in this category (123 licensees × $1,050/licensee). With respect to industry operation, using the 2004 data in NUREG-0713, it was determined that 8,254 workers (about 70 percent of the monitored individuals) had an annual dose that did not exceed 1 mSv (100 mrem). Assuming these workers are equally distributed among the 123 licensees in this group, about 67 workers per licensee will not receive an annual dose report. It is further assumed that 90 percent of this population will not request an annual dose report (NRC Form 5). The NRC estimates a savings of $10 per worker not receiving a dose report. Thus, the estimated annual savings is $600 per licensee (67 workers/licensee × $10/worker × 0.9) and $74,000 for all licensees in this category ($600/licensee × 123 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings per licensee and for all licensees in this category are $9,000 ($600 × 14.9) and $1.1 million ($74,000 × 14.9), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings per licensee and for all licensees in this category are $7,000 ($670 × 10.6) and $780,000 ($74,000 × 10.6), respectively. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. The NRC estimates it will take 5 minutes (0.083 hour) for a licensee to prepare an annual dose report for each worker. Assuming that 90 percent of the 67 workers per licensee will not request a dose report, the annual burden reduction from implementing the regulatory action is estimated to be 5 hours per licensee (67 workers × 0.083 hour × 0.9) and 620 hours for all licensees in this category (5 hours/licensee × 123 licensees). *Non-REIRS materials licensees.* In implementing the regulatory action, non-REIRS materials licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 10 hours to revise the procedures for each of the 21,692 non-REIRS materials licensees. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $1,050 per licensee (10 hours × $105/hour) and $23 million for all licensees in this category (21,692 licensees × $1,050/licensee). With respect to industry operation, the NRC assumes 500,000 monitored workers, 21,692 non-REIRS licensees, 23 workers per licensee, and a savings of $10 for each worker who does not receive a dose report. In addition, the previously defined factor of 70 percent for REIRS materials licensees is used to estimate the fraction of workers who will not receive an annual dose report (NRC Form 5). Thus, 16 workers per licensee are assumed to not receive an annual dose report. It is further assumed that 90 percent of this population will not request an annual dose report. The estimated annual savings is $140 per licensee (16 workers/licensee × $10/worker × 0.9) and $3 million for all licensees in this category ($140/licensee × 21,692 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings per licensee and for all licensees in this category are $2,000 ($140 × 14.9) and $45 million ($3 million × 14.9), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings per licensee and for all licensees in this category are $1,500 ($140 × 10.6) and $32 million ($3 million × 10.6), respectively. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. The NRC estimates it will take 5 minutes (0.083 hour) for a licensee to prepare an annual dose report for each worker. Assuming that 90 percent of the 16 workers per licensee will not request a dose report, the annual burden reduction from implementing the regulatory action is estimated to be 1.2 hours per licensee (16 workers × 0.083 hour × 0.9) and 26,000 hours for all licensees in this category (1.2 hours/licensee × 21,692 licensees). For NRC licensees only, the total annual burden reduction is estimated to be 5,300 hours (1.2 hours/licensee × 4,394 NRC licensees). 3.3.2 Definition of Total Effective Dose Equivalent
(TEDE)The costs and savings associated with the revised definition of TEDE are minimal. The revision clarifies that the TEDE is defined in terms of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). This revision eliminates the need for licensees to repeatedly request guidance from the NRC and, in some cases, to request a license amendment to clarify the definition. 3.3.3 Labeling Containers The revision to 10 CFR 20.1905, “Exemptions to labeling requirements,” applies only to nuclear power reactor licensees. These licensees will incur one-time implementation costs to revise procedures. The NRC estimates it will take 20 hours to revise the procedures for each of the 104 nuclear power plants. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $2,100 per licensee (20 hours × $105/hour) and $220,000 for the nuclear power industry (104 licensees × $2,100/licensee). With respect to industry operation, as discussed in the regulatory analysis for the proposed rule (71 FR 55382; September 22, 2006), the NRC estimated an annual savings of $30,000 per nuclear power plant from using the exemption to labeling requirements for containers holding licensed material within a posted area. For the entire nuclear power industry, the NRC estimates a savings of $3.1 million (104 licensees × $30,000/licensee). For a flow of funds at a 3 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $770,000 ($30,000 × 25.50) and $79 million ($3.1 million × 25.50), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $410,000 ($30,000 × 13.77) and $43 million ($3.1 million × 13.77), respectively. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. Using an annual savings of $30,000 per nuclear power plant and a staff rate of $105 per hour, the annual burden reduction from implementing the regulatory action is estimated to be 290 hours per plant ($30,000/licensee ÷ $105/hour) and the total annual industry burden reduction is 30,000 hours (290 hours/licensee × 104 licensees). 3.3.4 Cumulative Occupational Radiation Dose *Nuclear power reactor licensees.* In implementing the regulatory action, nuclear power reactor licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 20 hours to revise the procedures for each of the 104 nuclear power plants. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $2,100 per nuclear power plant (20 hours × $105/hour) and $220,000 for the nuclear power industry (104 licensees × $2,100/licensee). With respect to industry operation, there will be a savings from not having to obtain the records of cumulative occupational radiation dose (NRC Form 4) for a worker, unless these individuals are being authorized to receive a planned special exposure. As discussed in the regulatory analysis for the proposed rule (71 FR 55382; September 22, 2006), the NRC estimated the annual savings to be $8,500 per nuclear power plant and $880,000 for the nuclear power industry ($8,500 × 104 licensees). Based on NUREG-0713, each nuclear power plant will annually obtain the dose records for 230 workers. Also, based on public comment, the NRC assumes that each worker has previously worked for two other licensees and that these licensees will incur costs to provide the worker's dose record to the requesting nuclear power plant licensee. The average cost to each licensee to provide a dose record is estimated to be $10. Thus, the estimated savings from not having to obtain the dose records for each worker is $60 (($8,500/nuclear power plant ÷ 230 workers) + (2 × $10/licensee providing the dose record)). 1 The estimated annual savings is $14,000 per nuclear power plant ($60/worker × 230 workers) and $1.5 million for the nuclear power industry ($14,000 × 104 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $360,000 ($14,000 × 25.50) and $38 million ($1.5 million × 25.50), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings per nuclear power plant and for the nuclear power industry are $190,000 ($14,000 × 13.77) and $21 million ($1.5 million × 13.77), respectively. 1 To simplify the expression of annual burden reduction (hours), the hours attributed to the requesting nuclear power plant and responding licensees are combined and attributed solely to the nuclear power plant. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. Using an annual savings of $14,000 per nuclear power plant and a staff rate of $105 per hour, the annual burden reduction from implementing the regulatory action is estimated to be 130 hours per plant ($14,000/licensee ÷ $105/hour) and the total annual industry burden reduction is 14,000 hours (130 hours/licensee × 104 licensees). *REIRS materials licensees.* In implementing the regulatory action, REIRS materials licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 10 hours to revise the procedures for each of the 123 REIRS materials licensees. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $1,050 per licensee (10 hours × $105/hour) and $130,000 for all licensees in this category (123 licensees × $1,050/licensee). With respect to industry operation, using the 2004 data in NUREG-0713, the number of individuals working for REIRS materials licensees is 12,032. Assuming these workers are equally distributed among the 123 licensees in this group, there are about 98 workers per licensee. For this analysis, the NRC assumes that 20 percent of all workers will be affected and that 0.5 hours is required by each REIRS materials licensee (i.e., the requesting licensee) to complete, review, and authorize each NRC Form 4, “Cumulative Occupational Dose History.” Based on public comment, the NRC assumes that each worker has previously worked for two other licensees and that these licensees will incur costs to provide the worker's dose record to the requesting licensee. The average cost to each licensee to provide a dose record is estimated to be $10. Using a staff rate of $105 per hour for the requesting licensee, the estimated savings from not having to request the dose records (including the responses) for each worker is $75 (($105/hour × 0.5 hour/licensee requesting the dose record) + (2 × $10/licensee providing the dose record)). 2 The NRC is not aware of any licensee having authorized a planned special exposure. For this analysis, it is assumed that 99 percent of the NRC Forms 4 will not be needed as the basis for authorizing a planned special exposure. Thus, the estimated annual savings to industry is $180,000 (98 workers/licensee × $75/worker × 0.2 × 0.99 × 123 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings for industry is $2.7 million ($180,000 × 14.9), respectively. For a flow of funds at a 7 percent real discount rate, the estimated savings for industry is $1.9 million ($180,000 × 10.6). 2 To simplify the expression of annual burden reduction (hours), the hours attributed to the requesting REIRS materials licensee and responding licensees are combined and attributed solely to the REIRS materials licensee. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. The annual burden reduction from implementing the regulatory action is estimated to be 10 hours per licensee ((98 workers/licensee × 0.5 hour/worker × 0.2 × 0.99) + (2 × 0.10 hour/licensee providing the dose record)) and 1,200 hours for industry (10 hours/licensee × 123 licensees). *Non-REIRS materials licensees.* In implementing the regulatory action, non-REIRS materials licensees will incur a one-time cost to revise procedures. The NRC estimates it will take 10 hours to revise the procedures for each of the 21,692 non-REIRS materials licensees. Assuming a staff rate of $105 per hour, the one-time cost of implementing the regulatory action will be $1,050 per licensee (10 hours × $105/hour) and $23 million for all licensees in this category (21,692 licensees × $1,050/licensee). With respect to industry operation, the analysis assumes 500,000 individuals working under 21,692 non-REIRS licensees and an even distribution of workers per licensee (23 workers/licensee). The NRC also assumes that 20 percent of all workers will be affected and that 0.5 hours is required to complete, review, and authorize each NRC Form 4. Based on public comment, the NRC assumes that each worker has previously worked for two other licensees and that these licensees will incur costs to provide the worker's dose record to the requesting licensee. The average cost to each licensee to provide a dose record is estimated to be $10. Using a staff rate of $105 per hour for the requesting licensee, the estimated savings from not having to request the dose records (including the responses) for each worker is $75 (($105/hour × 0.5 hour/licensee requesting the dose record) + (2 × $10/licensee providing the dose record)). 3 The NRC is not aware of any licensee having authorized a planned special exposure. For this analysis, it is assumed that 99 percent of the NRC Forms 4 will not be needed as the basis for authorizing a planned special exposure. Thus, the estimated annual savings to industry is $7.4 million (23 workers/licensee × $75/worker × 0.2 × 0.99 × 21,692 licensees). For a flow of funds at a 3 percent real discount rate, the estimated savings for industry is $110 million ($7.4 million × 14.9). For a flow of funds at a 7 percent real discount rate, the estimated savings for industry is $78 million ($7.4 million × 10.6). 3 To simplify the expression of annual burden reduction (hours), the hours attributed to the requesting non-REIRS materials licensee and responding licensees are combined and attributed solely to the non-REIRS materials licensee. In order to provide an estimate of the “hourly” burden reduction, the NRC performed the following analysis. The annual burden reduction from implementing the regulatory action is estimated to be 2.5 hours per licensee ((23 workers/licensee × 0.5 hour/worker × 0.2 × 0.99) + (2 × 0.10 hour/licensee providing the dose record)) and 54,000 hours for industry (2.5 hours/licensee × 21,692 licensees). For NRC licensees only, the total annual burden reduction is estimated to be 11,000 hours (2.5 hours/licensee × 4,394 NRC licensees). 3.3.5 NRC Implementation and Operating Impacts *Annual dose report to workers.* The NRC will incur costs to make minor revisions to NRC Form 3, “Notice to Employees,” to account for the revision to the reporting of annual dose to workers under 10 CFR 19.13(b). The one-time cost for this task is estimated to be $34,000 (320 staff-hours at $105 per hour). This is the only impact to the NRC for this action. *Definition of Total Effective Dose Equivalent (TEDE).* The NRC will incur costs to make minor revisions to NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a Monitoring Period,” and their instructions, to account for the revision to the definition of TEDE. The one-time cost to revise NRC Forms 4 and 5 and their instructions is estimated to be $34,000 (320 staff-hours at $105 per hour). This is the only impact to the NRC for this action. *Labeling Containers.* The NRC will incur no implementation or operating impacts due to the revision to the exemptions to labeling requirements for containers holding licensed material under 10 CFR 20.1905. *Cumulative Occupational Radiation Dose.* The NRC will incur no implementation impacts due to the revision to remove the requirement that licensees attempt to obtain cumulative occupational radiation dose records for workers unless these individuals are being authorized to receive a planned special exposure. With respect to NRC operation, there will be a savings from not having inspectors review the information on NRC Form 4, or its equivalent, and supporting records maintained by licensees. For nuclear power reactor licensees, it is estimated that 1 hour of inspection time is spent reviewing such records at each of the 104 nuclear power plants. Assuming an NRC staff rate of $105 per hour, the estimated annual savings to the NRC is $11,000 (1 hour × 104 licensees × $105/hour). For a flow of funds at 3 and 7 percent real discount rates, the estimated savings to the NRC are $280,000 ($11,000 × 25.50) and $150,000 ($11,000 × 13.77), respectively. The annual burden reduction to the NRC from implementing the regulatory action is estimated to be 104 hours (1 hour × 104 licensees). For each of the 123 REIRS materials licensees, it is estimated that 6 minutes (0.1 hour) of inspection time is spent reviewing NRC Form 4, or its equivalent, and supporting records. The NRC is not aware of any licensee having authorized a planned special exposure. For this analysis, it is assumed that 99 percent of the NRC Forms 4 will not need to be inspected as the basis for authorizing a planned special exposure. Assuming an NRC staff rate of $105 per hour, the estimated annual savings to the NRC is $1,300 (0.1 hour × 123 licensees × $105/hour × 0.99). For a flow of funds at 3 and 7 percent real discount rates, the estimated savings to the NRC are $19,000 ($1,300 × 14.9) and $14,000 ($1,300 × 10.6), respectively. The annual burden reduction to the NRC from implementing the regulatory action is estimated to be 12 hours (0.1 hour × 123 licensees × 0.99). For each of the 4,394 NRC licensees designated as non-REIRS materials licensees, it is estimated that 6 minutes (0.1 hour) of inspection time is spent reviewing NRC Form 4, or its equivalent, and supporting records. As discussed above, it is assumed that 99 percent of the NRC Forms 4 will not need to be inspected as the basis for authorizing a planned special exposure. Assuming an NRC staff rate of $105 per hour, the estimated annual savings to the NRC is $46,000 (0.1 hour × 4,394 licensees × $105/hour × 0.99). For a flow of funds at 3 and 7 percent real discount rates, the estimated savings to the NRC are $685,000 ($46,000 × 14.9) and $490,000 ($46,000 × 10.6), respectively. The annual burden reduction to the NRC from implementing the regulatory action is estimated to be 435 hours (0.1 hour × 4,394 licensees × 0.99). 3.3.6 Other Government Implementation and Operating Impacts The Agreement States will incur no implementation or operating impacts due to the revisions to the reporting of annual dose to workers, the definition of TEDE, or the labeling of containers holding licensed material. For the revisions to the reporting of annual dose to workers and the definition of TEDE, the only impacts are to the NRC to revise NRC Forms 3, 4, and 5. Also, because the revision to the labeling of containers applies only to nuclear power plants licensed by the NRC, there are no impacts to the Agreement States for this action. *Cumulative Occupational Radiation Dose.* For each of the 17,298 Agreement State licensees designated as non-REIRS materials licensees, it is estimated that 6 minutes (0.1 hour) of inspection time is spent reviewing NRC Form 4, or its equivalent, and supporting records. As discussed above, it is assumed that 99 percent of the NRC Forms 4 will not need to be inspected as the basis for authorizing a planned special exposure. Assuming an Agreement State staff rate of $105 per hour, the estimated annual savings to the Agreement States is $180,000 (0.1 hour × 17,298 licensees × $105/hour × 0.99). For a flow of funds at 3 and 7 percent real discount rates, the estimated savings to the Agreement States are $2.7 million ($180,000 × 14.9) and $1.9 million ($180,000 × 10.6), respectively. The annual burden reduction to the Agreement States from implementing the regulatory action is estimated to be 1,700 hours (0.1 hour × 17,298 licensees × 0.99). 4. Presentation of Results Because each revision to the Commission's regulations will reduce burden on licensees, which is the objective of this rulemaking, the costs and benefits have been aggregated for this analysis. The results of the NRC's value-impact assessment for industry implementation and operation are summarized in the following table. Table 1.—Summary of Industry Implementation and Operating Savings [Costs] Final regulatory action Licensee category Implementation savings (costs) ($1,000) Operating savings (costs) Using 7 percent discount rate ($1,000) Using 3 percent discount rate ($1,000) Annual Dose Report to Workers Nuclear power reactor
(220)4,300 8,000 REIRS materials
(130)780 1,100 Non-REIRS materials (23,000) 32,000 45,000 TEDE Nuclear power reactor n/a minimal minimal REIRS materials n/a minimal minimal Non-REIRS materials n/a minimal minimal Labeling Containers Nuclear power reactor
(220)43,000 79,000 REIRS materials n/a n/a n/a Non-REIRS materials n/a n/a n/a Cumulative Occupational Radiation Dose Nuclear power reactor
(220)21,000 38,000 REIRS materials
(130)1,900 2,700 Non-REIRS materials (23,000) 78,000 110,000 Subtotals Nuclear power reactor
(660)68,300 125,000 REIRS materials
(260)2,680 3,800 Non-REIRS materials (46,000) 110,000 155,000 Total (rounded) (47,000) 180,000 280,000 The results of the NRC's value-impact assessment for NRC implementation and operation are summarized in the following table. Table 2.—Summary of NRC Implementation and Operating Savings [Costs] Final regulatory action Licensee category Implementation savings (costs) ($1,000) Operating savings (costs) Using 7 percent discount rate ($1,000) Using 3 percent discount rate ($1,000) Annual Dose Report to Workers Nuclear power reactor REIRS materials
(34)n/a n/a Non-REIRS materials TEDE Nuclear power reactor REIRS materials
(34)n/a n/a Non-REIRS materials Labeling Containers Nuclear power reactor REIRS materials n/a n/a n/a Non-REIRS materials Cumulative Occupational Radiation Dose Nuclear power reactor 150 280 REIRS materials n/a 14 19 Non-REIRS materials 490 685 Total (rounded)
(68)650 980 The results of the NRC's value-impact assessment for Agreement States implementation and operation are summarized in the following table. Table 3.—Summary of Agreement States Implementation and Operating Savings [Costs] Final regulatory action Implementation savings (costs) ($1,000) Operating savings (costs) Using 7 percent discount rate ($1,000) Using 3 percent discount rate ($1,000) Annual Dose Report to Workers n/a n/a n/a TEDE n/a n/a n/a Labeling Containers n/a n/a n/a Cumulative Occupational Radiation Dose n/a 1,900 2,700 Total (rounded) n/a 1,900 2,700 The results of the NRC's assessment of annual burden reduction in hours per licensee and industry are summarized in the following table. Table 4.—Summary of Annual Burden Reduction per Licensee and Industry Final regulatory action Licensee category Annual burden reduction (hours) Licensee Industry Annual Dose Report to Workers Nuclear power reactor 63 6,600 REIRS materials 5 620 Non-REIRS materials 1.2 26,000 TEDE Nuclear power reactor n/a n/a REIRS materials n/a n/a Non-REIRS materials n/a n/a Labeling Containers Nuclear power reactor 290 30,000 REIRS materials n/a n/a Non-REIRS materials n/a n/a Cumulative Occupational Radiation Dose Nuclear power reactor 130 14,000 REIRS materials 10 1,200 Non-REIRS materials 2.5 54,000 Subtotals Nuclear power reactor 483 50,600 REIRS materials 15 1,820 Non-REIRS materials 3.7 80,000 Total (rounded) 500 130,000 The results of the NRC's assessment of annual burden reduction in hours per NRC and Agreement States are summarized in the following table. Table 5.—Summary of Annual Burden Reduction per NRC and Agreement States Final regulatory action Annual burden reduction (hours) NRC Agreement states Annual Dose Report to Workers n/a n/a TEDE n/a n/a Labeling Containers n/a n/a Cumulative Occupational Radiation Dose 550 1,700 Total 550 1,700 The total implementation cost to the NRC for the regulatory action is $68,000. The total operating impact to the NRC for a flow of funds at 3 and 7 percent real discount rates is an estimated savings of $980,000 and $650,000, respectively. There are no implementation impacts to the Agreement States for the regulatory action. The total operating impact to the Agreement States for a flow of funds at 3 and 7 percent real discount rates is an estimated savings of $2.7 million and $1.9 million, respectively. The net present value of the regulatory action is $237 million at a 3 percent real discount rate [industry operation ($280 million) + NRC operation ($980,000) + Agreement State Operation (2.7 million)]—[NRC implementation ($68,000) + industry implementation ($47 million)]. The net present value of the regulatory action is $135 million at a 7 percent real discount rate [industry operation ($180 million) + NRC operation ($650,000) + Agreement State Operation (1.9 million)]—[NRC implementation ($68,000) + industry implementation ($47 million)]. The total reduction in annual burden from implementing the regulatory action is estimated to be 132,000 hours [industry (130,000 hours) + NRC (550 hours) + Agreement States (1,700 hours)]. 5. Decision Rationale The net present value of this regulatory action is $237 million and $135 million for 3 and 7 percent real discount rates, respectively. The total industry reduction in annual burden from implementing the regulatory action is estimated to be 132,000 hours. These savings are obtained by reducing administrative and information collection requirements on licensees. The Commission is implementing this rule because the changes improve the effectiveness of the Commission's regulations and reduce unnecessary regulatory burden without affecting the level of protection for either the health and safety of workers and the public or for the environment. 6. Implementation Schedule The final rule will become effective 30 days after its publication in the **Federal Register** . No impediments to the implementation of the recommended alternative have been identified. XI. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule will not have a significant economic impact upon a substantial number of small entities. Although three of the changes (i.e., the reporting of annual dose to workers, the definition of TEDE, and the determination of cumulative occupational radiation dose) in the final rule pertain to all 21,692 licensees regulated by the NRC and Agreement States, licensees, including the affected small entities, could elect to continue their current practices and remain in compliance with the final regulations. Licensees will incur the costs of changing their procedures only if they determine that the changes will be cost effective; therefore, the NRC has determined that the changes will not have a significant economic impact on licensees defined as small entities. The change related to labeling containers affects only licensees authorized to operate nuclear power reactors. These licensees do not fall within the scope of the definition of “small entities” in the Regulatory Flexibility Act or the scope of the size standards established by the NRC in 10 CFR 2.810. XII. Backfit Analysis The NRC has determined that the backfit rule does not apply to this rule and that a backfit analysis is not required for this rule because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR chapter I. XIII. Congressional Review Act In accordance with the Congressional Review Act of 1996, the NRC has determined that this action is a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB. List of Subjects 10 CFR Part 19 Criminal penalties, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements, Sex discrimination. 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Source material, Special nuclear material, Waste treatment and disposal. 10 CFR Part 50 Antitrust, Classified information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 19, 20, and 50. PART 19—NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTION AND INVESTIGATIONS 1. The authority citation for part 19 continues to read as follows: Authority: Secs. 53, 63, 81, 103, 104, 161, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 955, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2111, 2133, 2134, 2201, 2236, 2282, 2297f); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Section 19.32 is also issued under sec. 401, 88 Stat. 1254 (42 U.S.C. 5891). 2. In § 19.13, paragraphs
(b)and
(d)are revised to read as follows: § 19.13 Notifications and reports to individuals.
(b)Each licensee shall make dose information available to workers as shown in records maintained by the licensee under the provisions of 10 CFR 20.2106. The licensee shall provide an annual report to each individual monitored under 10 CFR 20.1502 of the dose received in that monitoring year if:
(1)The individual's occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(2)The individual requests his or her annual dose report.
(d)When a licensee is required by §§ 20.2202, 20.2203 or 20.2204 of this chapter to report to the Commission any exposure of an individual to radiation or radioactive material, the licensee shall also provide the individual a report on his or her exposure data included in the report to the Commission. This report must be transmitted no later than the transmittal to the Commission. PART 20—STANDARDS FOR PROTECTION AGAINST RADIATION 3. The authority citation for part 20 continues to read as follows: Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111). 4. In § 20.1003, the definition of *Total Effective Dose Equivalent* is revised to read as follows: § 20.1003 Definitions. *Total Effective Dose Equivalent*
(TEDE)means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). 5. In § 20.1201, paragraph
(c)is revised to read as follows: § 20.1201 Occupational dose limits for adults.
(c)When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the NRC. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable. 6. In § 20.1905, paragraph
(f)is revised and paragraph
(g)is added to read as follows: § 20.1905 Exemptions to labeling requirements.
(f)Installed manufacturing or process equipment, such as reactor components, piping, and tanks; or
(g)Containers holding licensed material (other than sealed sources that are either specifically or generally licensed) at a facility licensed under Parts 50 or 52 of this chapter, not including non-power reactors, that are within an area posted under the requirements in § 20.1902 if the containers are:
(1)Conspicuously marked (such as by providing a system of color coding of containers) commensurate with the radiological hazard;
(2)Accessible only to individuals who have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of the containers; and
(3)Subject to plant procedures to ensure they are appropriately labeled, as specified at § 20.1904 before being removed from the posted area. 7. In § 20.2104, paragraph (a), the introductory text of paragraph (c), and paragraph
(d)are revised to read as follows: § 20.2104 Determination of prior occupational dose.
(a)For each individual who is likely to receive an annual occupational dose requiring monitoring under § 20.1502, the licensee shall determine the occupational radiation dose received during the current year.
(c)In complying with the requirements of paragraphs
(a)or
(b)of this section, a licensee may—
(d)The licensee shall record the exposure history of each individual, as required by paragraphs
(a)or
(b)of this section, on NRC Form 4, or other clear and legible record, including all of the information required by NRC Form 4. 4 The form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the licensee obtains reports, the licensee shall use the dose shown in the report in preparing the NRC Form 4. For any period in which the licensee does not obtain a report, the licensee shall place a notation on the NRC Form 4 indicating the periods of time for which data are not available. 4 Licensees are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on NRC Form 4 before January 1, 1994, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual. 8. Section 20.2205 is revised to read as follows: 440.250 [Amended] § 20.2205 Reports to individuals of exceeding dose limits. When a licensee is required by §§ 20.2203 or 20.2204 to report to the Commission any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide the individual a report on his or her exposure data included in the report to Commission. This report must be transmitted no later than the transmittal to the Commission. PART 50—DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES 9. The authority citation for part 50 continues to read as follows: Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 937, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111). Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5841). Section 50.10 also issued under secs. 101, 185, 68 Stat. 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under sec. 204, 88 Stat. 1245 (42 U.S.C. 5844). Sections 50.58, 50.91, and 50.92 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80-50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237). 10. In § 50.2, the definition of *Total Effective Dose Equivalent* is revised to read as follows: § 50.2 Definitions. *Total Effective Dose Equivalent*
(TEDE)means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures). Dated at Rockville, Maryland, this 28th day of November 2007. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. E7-23469 Filed 12-3-07; 8:45 am] BILLING CODE 7590-01-P FARM CREDIT ADMINISTRATION 12 CFR Part 620 RIN 3052-AC37 Disclosure to Shareholders; Annual Report to Shareholders AGENCY: Farm Credit Administration. ACTION: Final rule. SUMMARY: The Farm Credit Administration (FCA, Agency, we) issues this final rule amending our regulations to allow Farm Credit System (System) institutions 90 calendar days to prepare and distribute annual reports to shareholders, while retaining the 75 calendar day requirement for electronic reporting and distribution to the FCA. DATES: *Effective Date:* This regulation will be effective 30 days after publication in the **Federal Register** during which either or both Houses of Congress are in session. We will publish a notice of the effective date in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Christopher D. Wilson, Policy Analyst, Office of Regulatory Policy, Farm Credit Administration, McLean, VA 22102-5090,
(703)883-4414, TTY
(703)883-4434, or Bob Taylor, Attorney Advisor, Office of General Counsel, Farm Credit Administration, McLean, VA 22102-5090,
(703)883-4020, TTY
(703)883-4020. SUPPLEMENTARY INFORMATION: I. Objectives Our objectives in this final rule are to: • Extend the time for System institutions to prepare and distribute their annual reports to shareholders from 75 calendar days to 90 calendar days; and • Promote high quality and timely reporting and disclosure by System institutions to shareholders and the FCA. II. Background A. Annual Report Distribution Under FCA Regulations Part 620, Disclosure to Shareholders, establishes the requirements for financial reports for Farm Credit banks and associations. In pertinent part, § 620.4 establishes the time requirement for System institutions to prepare and provide to their shareholders an annual report. System institutions have historically distributed or made annual reports available to shareholders in hard copy. In December 2006, the FCA published a final rule amending § 620.4 to require that System institutions provide annual reports to shareholders within 75 calendar days from the close of the fiscal year. Prior to that time, System institutions had a 90-day deadline. The FCA noted that significant technological developments had occurred over the past decade that had increased the market's appetite for timelier disclosures of financial information. Consistent with changing industry practices, the FCA believed that accelerated reporting would improve information flow and facilitate shareholder and investor decisionmaking. The rule became effective on February 16, 2007. Compliance with the final rule would take effect by the start of the fiscal year immediately following the effective date of the rule. Thus, the 2007 annual report was to be the first annual report distributed under the accelerated filing requirements. B. System's Concerns After the rule became final, System institutions raised several concerns regarding the new 75-day filing requirement. Specifically, System institutions stated that they believed the 75-day requirement only applied to the electronic filing of the report with the FCA and not to the report provided to shareholders. They also collectively stated that it would be burdensome for them to comply with the 75 calendar day accelerated distribution requirement for the annual report to shareholders because of the prohibitive costs and time needed for:
(1)The external audit and review process;
(2)the audit committee review; and
(3)the printing and distribution of the annual report. Furthermore, System institutions indicated that the accelerated filing requirement could adversely affect the timeliness, accuracy, and high quality that have been standard with such disclosures. III. Proposed Rule on Annual Report to Shareholders After reviewing the System's concerns, we published a proposed rule in the **Federal Register** on August 14, 2007, with a 30-day comment period that ended on September 13, 2007. *See* 72 FR 45390, Aug. 14, 2007. The proposed rule would allow a System institution up to 90 calendar days from the close of its fiscal year to prepare and provide a copy of the annual report to shareholders, while retaining the 75 calendar day accelerated filing requirement to send an electronic copy of the report to us. To ensure accelerated disclosure, the proposed rule would require that each System institution:
(1)Send the report electronically to the FCA within 75 calendar days from the close of the institution's fiscal year and, at the same time, publish a copy of its annual report on its Web site; and
(2)provide prior written notification to its shareholders that the institution will publish its annual report on the institution's Web site when the report is sent electronically to the FCA. Furthermore, we stated that the copy of the annual report provided to the shareholders must be substantively identical with the annual report sent to the FCA. We believed that the bifurcated approach resolved any ambiguities from the prior rulemaking and appropriately addressed the System's concerns of providing attractive, high quality, annual reports to shareholders, while meeting the goal of accelerated filing and disclosure. IV. Comments on the Proposed Rule We received comments on the proposed rule from four System institutions, the Federal Farm Credit Banks Funding Corporation (Funding Corporation) on behalf of the System's Accounting Standards Workgroup, two System banks, and a System association. Overall, commenters generally supported the proposed rule, but expressed some concerns and suggested several changes to the proposed rule. We address the substantive comments below. A. Publish the Annual Report on an Institution's Web Site The Funding Corporation stated that it believed that not all associations have Web sites and wanted the FCA to clarify what such an institution should do. We discovered that two small associations do not appear to have an online presence. We agree with the commenter that there is a question of how these institutions will comply with the rule. Because there are only two System institutions without a Web site, we do not believe that we need to change the rule as proposed. For these two institutions only, they could:
(1)Develop their own Web sites;
(2)publish their annual report on another Web site that is available to the shareholders without an access cost; or
(3)make it available by other equivalent means. For example, these two institutions could determine whether they could publish their annual reports on the district bank's or the Farm Credit Council's Web site. The institutions would still be required to comply with all other provisions of the rule, including providing a notice to their shareholders where the annual report will be made available and sending a substantively identical copy of the annual report to both the FCA and the shareholders. Also, we note that under § 620.2(b), each institution must make its annual report available for public inspection at the institution and at the FCA office where the report is filed. B. Prior Written Notification to Shareholders We received identical comments from two commenters on § 620.4(a)(3), which requires each System institution to provide prior written notification to its shareholders that the institution will publish its annual report on its Web site when the report is sent electronically to the FCA. Commenters asserted:
(1)That the requirement to provide prior written notification to shareholders would be unreasonably burdensome and not confer any potential benefits to shareholders; and
(2)it was unclear how often written notification must be provided. As to the first comment, we have assessed the potential benefits of enhanced shareholder decisionmaking versus the costs of providing timelier financial and operating disclosures. Although associations may have some added burden from prior written notification, we fully expect that any such added burden to be minimal and far outweighed by the benefits to shareholders. As discussed below, System institutions have many options on how to comply with the requirement of prior written notification. As to the second comment on how often written notice is required, we again state that written notice must occur only once. In the proposed rule, we stated that the prior written notice must be prominent and conspicuous so that there is effective shareholder notice. This means that a System institution must provide each shareholder effective notice only one time. Institutions have the flexibility to determine the most appropriate or cost-effective way(s) to implement this requirement, including written notification in the Annual Meeting Information Statement, in the preceding fiscal year annual report, when a loan is made, sending a postcard to all shareholders, or including the notice with correspondence to shareholders ( *e.g.* , annual tax statements, newsletters, etc.) C. Communicating Notice of Web Site Availability Commenters also questioned the need to require System institutions to notify shareholders of the Web site availability of annual reports. The commenters stated that posting annual reports on an institution's Web site does not fulfill the regulatory obligation to deliver the reports to shareholders. Finally, they further stated that the individuals most likely to use early Web site access to the annual reports are those who would consult the Web site for information anyway. We believe that the accelerated filing and posting on the Web site of the annual report improves information flow and facilitates shareholder and investor decisionmaking. The use of the Internet and electronic reporting have become industry standards. Although requiring a System institution to post annual reports on its Web site does not fulfill all regulatory obligations, it does facilitate achieving the desired objective of timelier disclosures and improved information flow between associations and their shareholders and investors. Accordingly, a System institution should also include the Web site address with the written notification. D. Persons Entitled to Notice Two commenters said that the proposed rule requires that notice be provided to “shareholders and other interested persons,” but does not define the term “other interested persons.” The commenters suggested that we either define or delete this term. We agree with the commenters that, as currently written, the term “other interested persons” may be unclear. Thus, we are eliminating reference to that term. The final rule will require that notice be provided to “shareholders.” V. Description of Final Rule A. Section 620.4—Preparing and Providing the Annual Report Section 620.4 establishes the requirement for each System institution to prepare and provide a copy of its annual reports to its shareholders. Existing paragraph
(a)of this section requires that each System institution prepare and provide to its shareholders an annual report within 75 days of the end of its fiscal year. In the proposed rule, we proposed to revise § 620.4 to require that each institution of the Farm Credit System:
(1)Prepare and send us an electronic copy of its annual report within 75 calendar days of the end of its fiscal year;
(2)publish a copy of its annual report on its Web site when it sends us the electronic copy;
(3)provide prior written notification to its shareholders and other interested persons that the institution will publish its annual report on the institution's Web site when it is sent electronically to us; and,
(4)within 90 calendar days of the end of its fiscal year, prepare and provide to its shareholders an annual report that is substantively identical to the copy of report that it sent to us. After careful consideration of the substantive comments received, we adopt the modified provisions as final. B. Technical Amendment We are not making a technical amendment because there is no need for it. VI. Regulatory Flexibility Act Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), the FCA hereby certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Each of the banks in the System, considered together with its affiliated associations, has assets and annual income in excess of the amounts that would qualify them as small entities. Therefore, System institutions are not “small entities” as defined in the Regulatory Flexibility Act. List of Subjects in 12 CFR Part 620 Accounting, Agriculture, Banks, banking, Reporting and recordkeeping requirements, Rural areas. For the reasons stated in the preamble, we are amending part 620 of chapter VI, title 12 of the Code of Federal Regulations as follows: PART 620—DISCLOSURE TO SHAREHOLDERS 1. The authority citation for part 620 continues to read as follows: Authority: Secs. 4.19, 5.9, 5.17, 5.19, 8.11 of the Farm Credit Act (12 U.S.C. 2207, 2243, 2252, 2254, 2279aa-11); sec. 424 of Pub. L. 100-233, 100 Stat. 1568, 1656. Subpart B—Annual Report to Shareholders 2. Revise § 620.4(a) to read as follows: § 620.4 Preparing and providing the annual report.
(a)Each institution of the Farm Credit System must:
(1)Prepare and send to the Farm Credit Administration an electronic copy of its annual report within 75 calendar days of the end of its fiscal year;
(2)Publish a copy of its annual report on its Web site when it sends the report electronically to the Farm Credit Administration;
(3)Provide prior written notification to its shareholders that the institution will publish its annual report on the institution's Web site when the report is sent electronically to the Farm Credit Administration; and
(4)Within 90 calendar days of the end of its fiscal year, prepare and provide to its shareholders an annual report substantively identical to the copy of the report sent to the Farm Credit Administration under paragraph (a)(1) of this section. Dated: November 28, 2007. Roland E. Smith, Secretary, Farm Credit Administration Board. [FR Doc. E7-23502 Filed 12-3-07; 8:45 am] BILLING CODE 6705-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30580; Amdt. No. 3245] Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This Rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective December 4, 2007. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 4, 2007. ADDRESSES: Availability of matters incorporated by reference in the amendment is as follows: *For Examination* — 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which the affected airport is located; 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or, 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . *Availability* —All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit *nfdc.faa.gov* to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. FOR FURTHER INFORMATION CONTACT: Harry. J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPs, Takeoff Minimums and/or ODPs. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A. The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the **Federal Register** expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the SIAPs, the associated Takeoff Minimums, and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center
(FDC)Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided. Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure before adopting these SIAPs, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on November 16, 2007. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, under Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: Effective 20 DEC 2007 Phoenix, AZ, Phoenix Sky Harbor Intl, ILS OR LOC RWY 7R, Amdt 1C Oxnard, CA, Oxnard, ILS RWY 25, Amdt 12 Atlanta, GA, Peachtree City-Falcon Field, RNAV
(GPS)RWY 13, Orig Atlanta, GA, Peachtree City-Falcon Field, RNAV
(GPS)RWY 31, Orig Atlanta, GA, Peachtree City-Falcon Field, VOR/DME RNAV OR GPS RWY 31, Orig-D, (CANCELLED) Jefferson, GA, Jackson County, RNAV
(GPS)RWY 16, Orig-A Jefferson, GA, Jackson County, RNAV
(GPS)RWY 34, Orig-A Jefferson City, MO, Jefferson City Memorial, RNAV
(GPS)RWY 12, Orig Jefferson City, MO, Jefferson City Memorial, GPS RWY 12, Orig-A, CANCELLED Mosby, MO, Midwest National Air Center, ILS OR LOC/DME RWY 18, Orig Mosby, MO, Midwest National Air Center, RNAV
(GPS)RWY 18, Amdt 1 Mosby, MO, Midwest National Air Center, RNAV
(GPS)RWY 36, Amdt 1A Mosby, MO, Midwest National Air Center, NDB RWY 18, Amdt 2, CANCELLED Mosby, MO, Midwest National Air Center, Takeoff Minimums and Obstacles DP, Amdt 1 Grand Island, NE, Central Nebraska Regional, VOR/DME RWY 31, Amdt 8 Grand Island, NE, Central Nebraska Regional, Takeoff Minimums and Obstacle DP, Orig Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, ILS OR LOC/DME RWY 12, Orig Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, RNAV
(GPS)RWY 5, Orig Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, RNAV
(GPS)RWY 12, Amdt 1 Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, RNAV
(GPS)RWY 23, Orig Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, RNAV
(GPS)RWY 30, Amdt 1 Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, LOC/DME RWY 12, Orig, CANCELLED Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, VOR/DME RWY 5, Amdt 5 Scottsbluff, NE, Western Neb RGNL/William B Heilig Field, VOR OR TACAN RWY 23, Amdt 12 Manchester, NH, Manchester, RNAV
(GPS)RWY 24, Amdt 1 Manchester, NH, Manchester, Takeoff Minimums and Obstacle DP, Amdt 7 Jackson, OH, James A. Rhodes, Takeoff Minimums and Obstacle Departure, Amdt 4 Bartlesville, OK, Bartlesville Muni, RNAV
(GPS)RWY 17, Orig Bartlesville, OK, Bartlesville Muni, RNAV
(GPS)RWY 35, Orig Bartlesville, OK, Bartlesville Muni, LOC RWY 17, Amdt 3 Bartlesville, OK, Bartlesville Muni, VOR/DME RWY 35, Amdt 6 Bartlesville, OK, Bartlesville Muni, VOR RWY 17, Amdt 11 Bartlesville, OK, Bartlesville Muni, GPS RWY 17, Orig-B, CANCELLED Bartlesville, OK, Bartlesville Muni, GPS RWY 35, Orig-B, CANCELLED Bartlesville, OK, Bartlesville Muni, Takeoff Minimums and Obstacle DP, Orig Myerstown, PA, Deck, RNAV
(GPS)RWY 19, Orig-A Somerset, PA, Somerset County, RNAV
(GPS)RWY 7, Orig Somerset, PA, Somerset County, RNAV
(GPS)RWY 25, Orig Somerset, PA, Somerset County, GPS RWY 7, Orig-B, CANCELLED Somerset, PA, Somerset County, GPS RWY 25, Orig-B, CANCELLED Somerset, PA, Somerset County, Takeoff Minimums and Obstacle DP, Amdt 2 Newport, RI, Newport State, Takeoff Minimums and Obstacle DP, Amdt 3 Arlington, TX, Arlington Muni, ILS OR LOC/DME RWY 34, Orig Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 17C, Amdt 6 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 17R, Amdt 8 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 18L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS Y RWY 18L, Orig-A, CANCELLED Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 18R, Amdt 5 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 35C, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 35L, Amdt 3 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 36L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, Converging ILS RWY 36R, Amdt 2 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 17C, ILS RWY 17C (CAT II), ILS RWY 17C (CAT III), Amdt 9 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 17L, ILS RWY 17L (CAT II), ILS RWY 17L (CAT III), Amdt 5 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 17R, Amdt 22 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 18L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC Y RWY 18L, Orig-A, CANCELLED Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 18R, ILS RWY 18R (CAT II), ILS RWY (CAT III), Amdt 7 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 35C, ILS RWY 35C (CAT II), ILS RWY 35C (CAT III), Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 35L, Amdt 4 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 35R, ILS RWY 35R (CAT II), ILS RWY 35R (CAT III), Amdt 3 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 36L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, ILS OR LOC RWY 36R, Amdt 4 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 17C, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 17L, Amdt 3 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 17R, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 35C, Amdt 2 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 35L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 35R, Amdt 2 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 36L, Amdt 1 Dallas-Fort Worth, TX, Dallas-Fort Worth Intl, RNAV
(GPS)RWY 36R, Amdt 1 Effective 17 JAN 2008 Jamestown, KY, Russell County, Takeoff Minimums and Obstacle DP, Orig Tupelo, MS, Tupelo Regional, Takeoff Minimums and Obstacle DP, Orig The Dalles, OR, Columbia Gorge Rgnl/The Dalles Muni, RNAV (GPS)-A, Orig-A Greenwood, SC, Greenwood County, Takeoff Minimums and Obstacle DP, Orig Evanston, WY, Evanston-Uinta County Burns Field, ILS OR LOC/DME RWY 23, Amdt 1 Evanston, WY, Evanston-Uinta County Burns Field, RNAV
(GPS)RWY 23, Amdt 4 Effective 14 FEB 2008 Fayette, AL, Richard Arthur Field, RNAV
(GPS)RWY 18, Orig Fayette, AL, Richard Arthur Field, RNAV
(GPS)RWY 36, Orig Fayette, AL, Richard Arthur Field, NDB RWY 18, Amdt 1 Fayette, AL, Richard Arthur Field, Takeoff Minimums and Obstacle DP, Amdt 1 Atwater, CA, Castle, VOR/DME RWY 13, Orig-A, CANCELLED Monte Vista, CO, Monte Vista Muni, RNAV (GPS)-B, Orig Monte Vista, CO, Monte Vista Muni, VOR/DME-A, Amdt 3 La Belle, FL, La Belle Muni, RNAV
(GPS)RWY 14, Orig La Belle, FL, La Belle Muni, RNAV
(GPS)RWY 32, Orig La Belle, FL, La Belle Muni, Takeoff Minimums and Obstacle DP, Orig Taunton, MA, Taunton Muni-King Field, Takeoff Minimums and Obstacle DP, Amdt 2 Buffalo, NY, Buffalo Niagara Intl, NDB RWY 23, Orig, CANCELLED Plattsburgh, NY, Clinton Co, VOR/DME OR GPS-A, Amdt 2A, CANCELLED Plattsburgh, NY, Clinton Co, VOR OR GPS RWY 19, Amdt 3A, CANCELLED Plattsburgh, NY, Clinton Co, ILS RWY 1, Amdt 4B, CANCELLED Plattsburgh, NY, Clinton Co, Takeoff Minimums and Obstacle DP, Amdt 3, CANCELLED Barnwell, SC, Barnwell RGNL, NDB RWY 17, Orig, CANCELLED Charleston, WV, Yeager, Takeoff Minimums and Obstacle DP, Amdt 7 The FAA published an Amendment in Docket No. 30578, Amdt No. 3243 to Part 97 of the Federal Aviation Regulations (Vol 72, FR No. 221, Page 64536; dated November 16, 2007) under section 97.29 effective 20 December 2007, which is hereby rescinded as follows: Yakima, WA, Yakima Air Terminal/Mcallister Field, ILS RWY 27, Amdt 26D. [FR Doc. E7-23047 Filed 12-3-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. 2007N-0280] Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice
(CGMP)regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the **Federal Register** , we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. DATES: This rule is effective April 17, 2008. Submit written or electronic comments on or before February 19, 2008. If we receive no significant adverse comments during the specified comment period, we intend to publish a notice in the **Federal Register** no later than March 18, 2008, confirming the effective date of the direct final rule. If we receive any timely significant adverse comments during the comment period, we will publish a notice of significant adverse comment in the **Federal Register** withdrawing this direct final rule before its effective date. ADDRESSES: You may submit comments, identified by Docket No. 2007N-0280, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulation.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mary Malarkey, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, or Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956, or Frederick Blumenschein, Center for Drug Evaluation and Research (HFD-326), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-827-9022. SUPPLEMENTARY INFORMATION: I. Background Since the development of the CGMP regulations in 1962, FDA has balanced the need for easily understood minimum standards with the need to encourage innovation and the development of improved manufacturing technologies. We strive to give manufacturers latitude to determine how to achieve the level of control necessary for CGMP compliance, recognizing that, in some instances, more direction from FDA is necessary to provide a uniform standard for the entire industry or because of the potential for harm, or the narrow range of acceptable means to accomplish a particular CGMP objective. FDA periodically reassesses and revises the CGMP regulations to accommodate advances in technology that further safeguard the drug manufacturing process and the public health. As technology and scientific knowledge related to CGMP evolve, so does understanding of the material, equipment, and process variables, as well as the operational procedures and oversight methods that must be defined and controlled to achieve assurance of drug product quality. In 1996, as part of this reassessment process, FDA proposed a significant revision to the CGMP regulations for finished pharmaceuticals to clarify certain manufacturing, quality control, and documentation requirements, and to ensure that the regulations more accurately encompass current industry practice (61 FR 20103, May 3, 1996) (1996 proposed rule). Subsequently, as a part of the risk-based pharmaceutical CGMPs for the 21st century initiative, FDA created a CGMP Harmonization Analysis Working Group (CGMP Working Group) to analyze related CGMP requirements in effect in the United States and internationally, including those related to quality systems. The CGMP Working Group compared parts 210 and 211 (21 CFR parts 210 and 211) to the GMPs of the European Union (EU), as well as other FDA regulations (e.g., the Quality Systems Regulation, 21 CFR part 820) to identify the differences and consider the value of supplementing or changing the current regulations. Based on the CGMP Working Group's analysis, we decided to take an incremental approach to modifying parts 210 and 211 (see *http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm#_Toc84065744* ). Because of this change in approach, FDA decided not to finalize the 1996 proposed rule. Therefore, elsewhere in this issue of the **Federal Register** , we are publishing a notice withdrawing the 1996 proposed rule. This direct final rule is intended to clarify and modernize the CGMP regulations, as well as harmonize the regulations with international GMP requirements and other FDA regulations. This direct final rule represents the first increment of modifications to parts 210 and 211. We believe that these updating changes are noncontroversial. II. Description of the Direct Final Rule A. Plumbing This rule deletes from § 211.48(a) the current requirement of adherence to a specific U.S. Environmental Protection Agency
(EPA)water standard and instead simply requires that the plumbing system contain water that is “safe for human consumption.” In an effort to improve harmonization with foreign regulations (particularly the European Union and Japan) and to make the U.S. regulation more consistent with that of the United States Pharmacopeia standard, which is satisfied by compliance with the regulations of the European Union
(EU)and Japan, this revision requires that water supplied by the plumbing system and used to prepare water for pharmaceutical purposes be “safe for human consumption,” and continues the requirement that it “be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product.” Compliance with the standards set forth in the regulations currently prescribed by the EPA would be acceptable under this revision, as would compliance with the standards set forth in the current regulations of the EU or Japan for potable water used to prepare water for pharmaceutical purposes. B. Aseptic Processing The current regulations related to aseptic processing have not been updated to reflect current industry standards and practices. In September 2004, we issued “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” (see *http://www.fda.gov/cder/guidance/5882.fnl.htm”* ). The issuance of this document was the culmination of several years of work, including soliciting input from external stakeholders, such as described below. In 2002, we began work on a draft guidance that was intended to replace the 1987 Guideline on Sterile Drug Products Produced by Aseptic Processing. A concept paper was presented to FDA's Advisory Committee on Pharmaceutical Science on October 22, 2002, for comment. Among other things, the Committee recommended that we work with the Pharmaceutical Quality Research Institute
(PQRI)for resolution of major issues. The PQRI Aseptic Processing Working Group (Aseptic Processing Working Group), composed of members from FDA, industry, and academia, was formed to provide scientifically based input targeting specific aseptic processing topics (e.g., media fills). PQRI performed a survey of the industry on these topics, the results of which were presented to the Aseptic Processing Working Group for consideration. The Aseptic Processing Working Group also considered scientific publications and other regulatory documents in preparing recommendations concerning specific aseptic processing topics. These recommendations were discussed by the Aseptic Processing Working Group on February 27 and 28, 2003 ( *www.pqri.org/commworking/minutes/mtc.asp* ) and presented to the Manufacturing Subcommittee of FDA's Advisory Committee on Pharmaceutical Science on May 22, 2003. In its September 2003, “Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach: Second Progress Report and Implementation Plan,” FDA announced the issuance of the draft guidance. See *http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm* . At the time, the agency noted that the guidance was intended to clarify regulatory expectations, including relevant regulatory standards for sterile drug products. FDA believed the guidance would help reduce the incidence of manufacturing problems with sterile drug products and related drug shortages. The guidance was also consistent with agency efforts to harmonize with international regulatory standards and develop more science-based guidance documents. As noted previously, FDA issued the final guidance in September 2004. After the GMP Harmonization Analysis Working Group completed its formal analysis comparing parts 210 and 211 with the GMPs of the EU as well as with other FDA current good manufacturing practice regulations, it recommended that part 211 be modernized by adding more clarification about aseptic processing in an effort to harmonize with current industry standards and practices. Therefore, we are now amending several regulations related to aseptic processing to clarify the regulatory requirements to reflect currently accepted industry practice as well as, in some cases, to harmonize with international regulatory standards. The revision to § 211.113(b) applies specifically to validation of aseptic processes, but the revisions to the other four sections discussed below apply, as appropriate, to both aseptic and other types of processes and operations. These revisions clarify and reflect longstanding agency interpretation of these regulations and industry practices. The agency notes that these clarifications of the regulations with respect to aseptic processing do not affect the applicability of the final guidance issued in September 2004. The guidance's recommendations on the ways in which manufacturers can satisfy certain aseptic processing regulatory requirements still apply. Section 211.67(a) *Equipment cleaning and maintenance* is being revised to add the phrase “and/or sterilized” after the word “sanitized” in the current regulation. This change updates the terminology to reflect the fact that, in the context of sterile drug products, the appropriate form of sanitization would be sterilization. This is consistent with our interpretation of this regulation for more than 20 years and reflects the currently accepted industry practice. Section 211.84(d)(6) *Testing and approval or rejection of components* drug product containers, and closures, is being revised to change the phrase “that is liable to microbiological contamination,” to “with potential for microbiological contamination.” We believe this revision provides additional clarity without changing the meaning or intent of the regulation. Section 211.94(c) *Drug product containers and closures* is being revised to clarify that validation is required for the processes used to remove pyrogenic properties (depyrogenation processes). The revision reflects currently accepted industry practice and the agency's longstanding interpretation of this regulation. To assure that certain drug products are suitable for their intended use, drug product containers and closures are required to be sterilized and depyrogenated to remove microbial contamination and pyrogens or endotoxin. It has been longstanding industry practice to validate the sterilization and depyrogenation processes used for drug product containers and closures to assure consistent removal of microbial contamination and pyrogens or endotoxin. Lack of evidence of such validation and inadequacies in the validation studies have been cited in FDA actions throughout the years based on this regulation. Accordingly, this rule simply clarifies § 211.94(c) by adding a new sentence at the end which states; “Such depyrogenation processes shall be validated.” Paragraph
(a)of § 211.110 *Sampling and testing of in-process materials and drug products* is being revised to include bioburden process control procedures and tests, where appropriate. The existing regulation provides five examples of control procedures and tests that must be addressed, where appropriate, to monitor the output and to validate the performance of manufacturing processes that may be responsible for causing variation in the characteristics of in-process material and drug product. The existing regulation also acknowledges that the examples are not an all inclusive list of necessary process control procedures and tests. For in-process materials and drug products that are produced by aseptic processing, testing for bioburden is a well established industry standard to ensure that the finished dosage form will be sterile and that the process is not shifting from established limits that may affect control. The revised regulation will add bioburden testing as the sixth example of process control procedures. Paragraph
(b)of § 211.113 *Control of microbiological contamination* is being revised to include validation of aseptic processes for drug products that are purported to be sterile. The current regulation mentions only validation of sterilization processes, not aseptic processes. Even before 1987, when the Guideline for Sterile Drug Products Produced by Aseptic Processing was issued, industry routinely conducted validation studies that substituted microbiological media for the actual product to demonstrate that its aseptic processes were validated. These parts of validation studies are often referred to as media fills. We believe that this revision clarifies existing practices and serves to harmonize the CGMP requirements with Annex 1 of the EU GMPs, which requires such validation. C. Asbestos Filters Our current regulations for filters used in processing liquid injectable products need to be updated. The current regulations require manufacturers, before using asbestos-containing filters, to submit proof to FDA that an alternative filter will or is more likely to result in product contamination. However, we are not aware that asbestos filters are currently commercially manufactured for pharmaceutical use or that they are currently used in the production of pharmaceuticals. Indeed, their use would no longer be considered a good manufacturing practice. Therefore, we are revising §§ 210.3(b)(6) and 211.72 to remove an outdated regulation permitting limited use of asbestos-containing filters. This revision also provides consistency with international standards. We removed from the definition of “non-fiber releasing filter,” the statement that “All filters composed of asbestos are deemed to be fiber-releasing filters”; because the revised regulation does not permit any use of asbestos-containing filters. Thus, this sentence is no longer necessary. Because other nonasbestos, fiber-releasing filters may still be used, the revised regulation retains the current requirement that allows the use of fiber-releasing filters only when necessary, and only if another filter is also used specifically to reduce the amount of shed fibers in the finished pharmaceutical. It is noteworthy that the current CGMP regulation at paragraph
(a)of § 211.65 *Equipment construction* , requires equipment, including filters, to be constructed so that “surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.” We are not changing this requirement, which also restricts the amount and type of objectionable particulates in drug products resulting from contact with equipment. D. Verification by Second Individual Under the current CGMP regulations, several regulations include requirements that certain activities be performed by one person and checked as specified by a second person. Section 211.101(c) requires that each container of component dispensed for use in manufacturing be examined by a second person to assure that it was released by the quality control unit, that the weight or measure is correct as stated in the batch production records, and that the containers are properly identified. Section 211.101(d) requires that each component shall be added to the batch by one person and verified by a second person. Section 211.103 requires that specified yield calculations shall be performed by one person and independently verified by a second person. Section 211.182 requires that the persons performing and double-checking the cleaning and maintenance of major equipment shall date and sign or initial equipment logs indicating that the work was performed. Finally, § 211.188(b)(11) requires that batch production and control records shall include identification of the persons performing and directly supervising or checking each significant step in the operation. When the CGMP regulations were amended in 1978, FDA issued § 211.68, which provides that automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product, subject to certain requirements that the controls used are designed to assure proper performance of such equipment, to assure that changes to records are made only by authorized personnel, to check the input and output for accuracy, and to provide for appropriate backup of data. FDA has periodically been asked whether the requirements for verification by a second individual in §§ 211.101(c) and (d), 211.103, 211.182, and 211.188(b)(11) are applicable in situations where operations are performed by various types of automated equipment rather than by an individual. When these regulations were adopted in 1978, the preamble addressed this issue in response to several comments about the second checking requirements of § 211.101 for charge-in of components when automated systems are used. We specifically noted that the use of automated systems is permitted under section 211.68 and that the requirement of 211.101 would be met if the second individual verifies that the automated system is working properly (43 FR 45013 to 45087 at 45051, September 29, 1978). Thus, in this situation, the first individual is replaced by a machine or other automated process, and only one person is necessary to verify that the automated system is functioning as intended. Due to periodic questions received by FDA about the performance and checking requirements required by §§ 211.101(c) and (d), 211.103, 211.182, and 211.188(b)(11) when the operations are performed by automated equipment, such as the widespread and increasing use of computer-controlled operations, we are revising these sections. The revisions will clarify our long-standing interpretation and policy that verification by a second individual may not be necessary when automatic equipment is used under § 211.68. Rather, in these situations, only one person is needed to verify that the automated equipment is functioning adequately. In cases where there is an operator for the automated equipment, the verifying individual may be, but is not required to be, the operator. Thus, we are amending §§ 211.101(c) and (d), 211.103, 211.182, and 211.188(b)(11) to indicate that the use of automated equipment under § 211.68 may eliminate the need for verification by a second individual and that in those situations only one person is needed to verify that the automated equipment is functioning properly. In addition, we are amending section 211.68 to provide a consistent clarification of this point. E. Miscellaneous Minor Changes Based on 1996 Proposal We are revising § 211.82(b) by replacing the phrase “as appropriate” by the phrase “whichever is appropriate” to eliminate any ambiguity in the regulation and to emphasize that it is, in fact, accepted industry practice to conduct some testing or examination before the components, drug product containers, or closures are released from quarantine. We are revising § 211.84(c)(1) by replacing the phrases “where necessary, by appropriate means” with “when necessary in a manner to prevent introduction of contaminants into the component.” This change will clarify that the act of cleaning is done for a particular purpose, to prevent the introduction of contaminants, and must be done unless such cleaning is not necessary to prevent such an introduction of contaminants. In addition, two editorial changes are being made to § 211.84(d)(3) by replacing the word “conformance” with “conformity” and “procedure” with “specifications.” Similarly, two minor editorial changes are being made to the first sentence of § 211.160(b)(1) by replacing the word “conformance” with “conformity” and “appropriate” with “applicable.” We believe that these revisions provide clarity without changing the meaning or intent of the regulations. III. Direct Final Rulemaking In the **Federal Register** of November 21, 1997 (62 FR 62466), FDA published a notice of availability of a guidance document that explains when and how we intend to employ direct final rulemaking. We have determined that this rule is appropriate for direct final rulemaking because we believe that it includes only noncontroversial amendments and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is publishing elsewhere in this issue of the **Federal Register** a companion proposed rule to revise the CGMP regulations for finished pharmaceuticals. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn as a result of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to either of these rules will be considered as comments to the other. We are providing a comment period on the direct final rule of 75 days after the date of the publication in the **Federal Register** . If we receive any significant adverse comments, we intend to withdraw this direct final rule before its effective date by publication of a notice in the **Federal Register** . A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subjects of a significant adverse comment. If any significant adverse comments are received during the comment period, FDA will publish, within 30 days after the close of the comment period, a notice of significant adverse comment and will withdraw the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures. If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date of the direct final rule within 30 days after the comment period ends. IV. Analysis of Impacts A. Review Under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 1995 FDA has examined the impacts of this direct 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 direct final rule is not a significant regulatory action as defined by the Executive order, because the rule generally either clarifies the agency's longstanding interpretation of, or increases latitude for manufacturers in complying with, preexisting CGMP requirements. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this direct final rule does not impose any new regulatory obligations, the agency certifies that it would 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 direct final rule to result in any 1-year expenditure that would meet or exceed this amount. The purpose of this direct final rule is to update the codified language to reflect current practice and to harmonize requirements in the CGMP regulations with international GMP requirements and other FDA regulations. It would not impose any additional requirements; therefore, industry would not incur incremental compliance costs for these changes. B. Environmental Impact Issuing these clarifying amendments to the CGMP regulations will not have a significant impact on the human environment. Therefore, an environmental impact statement is not required. C. Federalism FDA has analyzed this direct 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. V. Paperwork Reduction Act of 1995 The provisions of this direct final rule contain requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by section 3507(d) of the Paperwork Reduction Act of 1995. The requirements were approved and assigned OMB control number 0910-0139. VI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this direct final rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that any individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects 21 CFR Part 210 Drugs, Packaging and containers. 21 CFR Part 211 Drugs, Labeling, Laboratories, Packaging and Containers, Prescription drugs, Reporting and recordkeeping requirements, Warehouses. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 210 and 211 are amended as follows: PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 1. The authority citation for 21 CFR part 210 continues to read as follows; Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. Section 210.3 is amended by revising paragraph (b)(6) to read as follows: § 210.3 Definitions.
(b)* * *
(6)*Nonfiber releasing filter* means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 3. The authority citation for 21 CFR part 211 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 4. Section 211.48 is amended by revising paragraph
(a)to read as follows: § 211.48 Plumbing.
(a)Water supplied by the plumbing system of the facility must be safe for human consumption. This water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. 5. Section 211.67 is amended by revising paragraph
(a)to read as follows: § 211.67 Equipment cleaning and maintenance.
(a)Equipment and utensils shall be cleaned, maintained, and sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 6. Section 211.68 is amended by adding paragraph
(c)to read as follows: § 211.68 Automatic, mechanical, and electronic equipment.
(c)Such automated equipment used for performance of operations addressed by §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections for the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section and one person verifies that the operations addressed in those sections are performed accurately by such equipment. 7. Section 211.72 is revised to read as follows: § 211.72 Filters. Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products. Fiber-releasing filters may not be used in the manufacture, processing, or packing of these injectable drug products unless it is not possible to manufacture such drug products without the use of such filters. If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. 8. Section 211.82 is amended by revising paragraph
(b)to read as follows: § 211.82 Receipt and storage of untested components, drug product containers, and closures.
(b)Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of § 211.80. 9. Section 211.84 is amended by revising paragraphs (c)(1), (d)(3), and (d)(6) to read as follows: § 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(c)* * *
(1)The containers of components selected shall be cleaned when necessary in a manner to prevent introduction of contaminants into the component.
(d)* * *
(3)Containers and closures shall be tested for conformity with all appropriate written specifications. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals.
(6)Each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. 10. Section 211.94 is amended by revising paragraph
(c)to read as follows: § 211.94 Drug product containers and closures.
(c)Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated. 11. Section 211.101 is amended by revising paragraphs
(c)and
(d)to read as follows: § 211.101 Charge-in of components.
(c)Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:
(1)The component was released by the quality control unit;
(2)The weight or measure is correct as stated in the batch production records;
(3)The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure conditions of paragraphs (c)(1), (c)(2), and (c)(3) of this section have been met.
(d)Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under § 211.68, only verified by one person. 12. Section 211.103 is revised to read as follows: § 211.103 Calculation of yield. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under § 211.68, be independently verified by one person. 13. Section 211.110 is amended by revising paragraph
(a)introductory text and by adding paragraph (a)(6) to read as follows: § 211.110 Sampling and testing of in-process materials and drug products.
(a)To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:
(6)Bioburden testing. 14. Section 211.113 is amended by revising paragraph
(b)to read as follows: § 211.113 Control of microbiological contamination.
(b)Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes. 15. Section 211.160 is amended by revising paragraph (b)(1) to read as follows: 211.160 General requirements.
(b)* * *
(1)Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. 16. Section 211.182 is revised to read as follows: § 211.182 Equipment cleaning and use log. A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, only the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order. 17. Section 211.188 is amended by revising paragraph (b)(11) to read as follows: § 211.188 Batch production and control records.
(b)* * *
(11)Identification of the persons performing and directly supervising or checking each significant step in the operation, or if a significant step in the operation is performed by automated equipment under § 211.68, the identification of the person checking the significant step performed by the automated equipment. Dated: November 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23294 Filed 12-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AM35 Reasonable Charges for Medical Care or Services AGENCY: Department of Veterans Affairs. ACTION: Final rule. SUMMARY: This final rule amends the Department of Veterans Affairs
(VA)medical regulations concerning “reasonable charges” for medical care or services provided or furnished by VA to certain veterans for nonservice-connected disabilities. It changes the process for determining interim billing charges when a new Diagnosis Related Group
(DRG)code or Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) code identifier is assigned to a particular type or item of medical care or service and VA has not yet established a charge for the new identifier. This process is designed to provide interim billing charges that are very close to what the new billing charges would be when the charges for the new identifiers are established in accordance with the regulations. This final rule also changes the regulations by removing all of the provisions for discounts of billed charges. This will eliminate or reduce duplicate discounting and thereby prevent unintended underpayments to the government. DATES: *Effective Date:* January 3, 2008. FOR FURTHER INFORMATION CONTACT: Romona Greene, Manager of Rates and Charges, VHA Chief Business Office (168), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,
(202)254-0361. SUPPLEMENTARY INFORMATION: In a document published in the **Federal Register** on February 13, 2007 (72 FR 6696), VA proposed to amend VA's medical regulations that were established under the authority of 38 U.S.C. 1729 and that are set forth in 38 CFR 17.101 (referred to below as “the regulations”). The regulations establish methodologies for determining reasonable charges for medical care or services provided or furnished by VA to certain veterans. VA proposed to make the changes described in the SUMMARY portion of this document. VA provided a 30-day comment period that ended March 15, 2007. Two comments were received. One comment did not directly express agreement or disagreement with the proposed rule, but provided information about Medicare requirements. We reviewed that information and determined that the proposed rule is consistent with those Medicare provisions. Accordingly, we are making no change from the proposed rule based on that comment. We discuss below the second comment, and include background concerning provisions of the proposed rule related to that comment. Under the provisions of 38 U.S.C. 1729, VA has the right to recover or collect reasonable charges for such medical care and services from a third party to the extent that the veteran or a provider of the care or services would be eligible to receive payment for: 1. A nonservice-connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health plan contract; 2. A nonservice-connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or 3. A nonservice-connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations (no-fault) insurance. However, consistent with the statutory authority in 38 U.S.C. 1729(c)(2)(B), a third-party payer liable for such medical care and services under a health plan contract has the option of paying, to the extent of its coverage, either the billed charges or the amount the third-party payer demonstrates it would pay for care or services furnished by providers other than entities of the United States for the same care or services in the same geographic area. Except for charges for prescription drugs, the regulations were promulgated to describe methodologies for establishing VA charges that replicate, insofar as possible, the 80th percentile of community charges (see the preamble to VA's proposed rule “Reasonable Charges for Medical Care or Services; 2003 Methodology Changes” published in the **Federal Register** at 68 FR 56876 (Oct. 2, 2003)). VA's methodologies for determining reasonable charges for prescription drugs are based on VA costs and are described in 38 CFR 17.102. Prior to the effective date of this final rule, the regulations included provisions for certain discounts to be applied to billed charges. The discounts were intended to reflect industry standards. VA proposed to eliminate discounts for VA billed charges to avoid unintended duplicate discounting. This was necessary because after VA applied discounts to the billed charges, virtually all third party-payers applied the same discounts a second time (discounts are included in industry software), thereby reducing the billed charges below what was intended by the regulations. VA accordingly proposed to make a number of changes to the regulations to eliminate VA discounts, including changing the regulations at § 17.101(f)(5)(ii) to increase the charges for the professional services of the following providers to 100 percent of the amount that would be charged if the care had been provided by a physician: • Nurse practitioner, • Clinical nurse specialist, • Physician Assistant, • Clinical psychologist, • Clinical social worker, • Dietitian, and • Clinical pharmacist. The second comment noted that Public Law 109-461 recently added marriage and family therapists to the groups eligible to provide care under the VA healthcare system and requested that this group be added accordingly to the list in § 17.101(f)(5)(ii). The second comment otherwise fully supported the proposed rule. Section 201 of Public Law 109-461 amended 38 U.S.C. 7401 and 7402 to add provisions under which qualified marriage and family therapists are identified as eligible to provide care under the VA healthcare system. Section 201 also amended 38 U.S.C. 7401 and 7402 to add provisions under which qualified licensed professional mental health counselors are similarly identified as eligible to provide care under the VA healthcare system. VA has concluded that these statutory provisions make it appropriate to make changes from the proposed rule in the final rule to include provisions concerning both categories: Providers that are marriage and family therapists, and providers that are licensed professional mental health counselors. Third party payers apply discounts from the physician rate for marriage and family therapists and for licensed professional mental health counselors, as third party payers similarly do for the other providers included in the lists in current and proposed § 17.101(f)(5)(ii). Accordingly, after considering the second comment, we are making a change from the proposed rule in the final rule by adding marriage and family therapists and licensed professional mental health counselors to the list of providers in § 17.101(f)(5)(ii). Charges for professional services of the providers included in that list will be 100 percent of the amount that would be charged if the care had been provided by a physician. This final rule is making other changes from the proposed rule that are nonsubstantive. In the § 17.101(g) introductory paragraph, VA proposed to amend a sentence by removing “50 percent” and replacing it with “100 percent”. That sentence says in the current regulations that certain charges “will be 50 percent of the charges otherwise determined as set forth in this paragraph.” This final rule further amends the sentence by removing “otherwise” since that term would no longer be needed. This final rule also makes a nonsubstantive change from the proposed rule's provisions for the authority citation for 38 CFR part 17, so that the final rule will, as intended by the proposed rule, reflect the current language in the part 17 authority citation. In addition, the final rule makes nonsubstantive changes from the proposed rule for purposes of clarity or grammar. Other than nonsubstantive changes in capitalization or punctuation, those changes from the proposed rule are in § 17.101(a)(8)(i) to refer to “billing charge” rather than “billable charge”, in § 17.101(a)(8)(iii) to refer to “VA's billing charge” rather than “VA's charge”, in § 17.101(a)(8)(vii) to refer to “the interim charge” to use the same phrase as in the similar context in paragraphs (a)(8)(iv) and (a)(8)(v) of that section, and in § 17.101(a)(8)(vii) to add for clarity “under this section”, which is used in the current regulations in the analogous provisions of § 17.101(a)(8)(v) of the regulations but was not in the proposed rule. Based on the rationale set forth in the proposed rule and in this document, VA is adopting the provisions of the proposed rule as a final rule with the changes discussed above. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no such effect on State, local, and tribal governments, or on the private sector. Paperwork Reduction Act This document contains no collections of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). Executive Order 12866 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 Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this rule and has concluded that it is a significant regulatory action under Executive Order 12866. Regulatory Flexibility Act The Secretary hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rule would affect mainly large insurance companies. The rule might have an insignificant impact on a few small entities that do an inconsequential amount of their business with VA. Accordingly, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; and 64.022, Veterans Home Based Primary Care. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs-health, Grant programs-veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans. Approved: August 27, 2007. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. For the reasons set out in the preamble, VA amends 38 CFR part 17 as set forth below: PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: Authority: 38 U.S.C. 501, 1721, and as stated in specific sections. 2. Amend § 17.101 by: a. In paragraph
(g)introductory text, removing “50 percent of the charges otherwise” and adding, in its place, “100 percent of the charges”. b. Revising paragraphs (a)(8), (e)(5), (f)(4), and (f)(5)(ii). The revisions read as follows: § 17.101 Collection or recovery by VA for medical care or services provided or furnished to a veteran for a nonservice-connected disability.
(a)* * *
(8)*Charges when a new DRG or CPT/HCPCS code identifier does not have an established charge* . When VA does not have an established charge for a new DRG or CPT/HCPCS code to be used in determining a billing charge under the applicable methodology in this section, then VA will establish an interim billing charge or establish an interim charge to be used for determining a billing charge under the applicable methodology in paragraphs (a)(8)(i) through (a)(8)(viii) of this section.
(i)If a new DRG or CPT/HCPCS code identifier replaces a DRG or CPT/HCPCS code identifier, the most recently established charge for the identifier being replaced will continue to be used for determining a billing charge under paragraphs (b), (e), (f), (g), (h), (i), (k), or
(l)of this section until such time as VA establishes a charge for the new identifier.
(ii)If medical care or service is provided or furnished at VA expense by a non-VA provider and a charge cannot be established under paragraph (a)(8)(i) of this section, then VA's billing charge for such care or service will be the amount VA paid to the non-VA provider without additional calculations under this section.
(iii)If a new CPT/HCPCS code has been established for a prosthetic device or durable medical equipment subject to paragraph
(l)of this section and a charge cannot be established under paragraphs (a)(8)(i) or
(ii)of this section, VA's billing charge for such prosthetic device or durable medical equipment will be 1 and 1/2 times VA's average actual cost without additional calculations under this section.
(iv)If a new medical identifier DRG code has been assigned to a particular type of medical care or service and a charge cannot be established under paragraphs (a)(8)(i) through
(iii)of this section, then until such time as VA establishes a charge for the new medical identifier DRG code, the interim charge for use in paragraph
(b)of this section will be the average charge of all medical DRG codes that are within plus or minus 10 of the numerical relative weight assigned to the new medical identifier DRG code.
(v)If a new surgical identifier DRG code has been assigned to a particular type of medical care or service and a charge cannot be established under paragraphs (a)(8)(i) through
(iv)of this section, then until such time as VA establishes a charge for the new surgical identifier DRG code, the interim charge for use in paragraph
(b)of this section will be the average charge of all surgical DRG codes that are within plus or minus 10 of the numerical relative weight assigned to the new surgical identifier DRG code.
(vi)If a new identifier CPT/HCPCS code is assigned to a particular type or item of medical care or service and a charge cannot be established under paragraphs (a)(8)(i) through
(v)of this section, then until such time as VA establishes a charge for the new identifier for use in paragraphs (e), (f), (g), (h), (i), (k), or
(l)of this section, VA's billing charge will be the Medicare allowable charge multiplied by 1 and 1/2 , without additional calculations under this section.
(vii)If a new identifier CPT/HCPCS code is assigned to a particular type or item of medical care or service and a charge cannot be established under paragraphs (a)(8)(i) through
(vi)of this section, then until such time as VA establishes a charge for the new identifier, the interim charge for use in paragraphs (e), (f), (g), (h), (i), (k), or
(l)of this section will be the charge for the CPT/HCPCS code that is closest in characteristics to the new CPT/HCPCS code.
(viii)If a charge cannot be established under paragraphs (a)(8)(i) through (a)(8)(vii) of this section, then VA will not charge under this section for the care or service.
(e)* * *
(5)*Multiple surgical procedures* . When multiple surgical procedures are performed during the same outpatient encounter by a provider or provider team as indicated by multiple surgical CPT/HCPCS procedure codes, then each CPT/HCPCS procedure code will be billed at 100 percent of the charges established under this section.
(f)* * *
(4)*Charge adjustment factors for specified CPT/HCPCS code modifiers* . Surcharges are calculated in the following manner: From the Part B component of the Medicare Standard Analytical File 5 percent Sample, the ratio of weighted average billed charges for CPT/HCPCS codes with the specified modifier to the weighted average billed charge for CPT/HCPCS codes with no charge modifier is calculated, using the frequency of procedure codes with the modifier as weights in both weighted average calculations. The resulting ratios constitute the surcharge factors for specified charge-significant CPT/HCPCS code modifiers.
(5)* * *
(ii)*Charges for professional services* . Charges for the professional services of the following providers will be 100 percent of the amount that would be charged if the care had been provided by a physician:
(A)Nurse practitioner.
(B)Clinical nurse specialist.
(C)Physician Assistant.
(D)Clinical psychologist.
(E)Clinical social worker.
(F)Dietitian.
(G)Clinical pharmacist.
(H)Marriage and family therapist.
(I)Licensed professional mental health counselor. [FR Doc. E7-23505 Filed 12-3-07; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2007-1055; FRL-8502-2] Approval and Promulgation of Implementation Plans; State of Missouri; General Conformity AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action to approve a revision to the Missouri State Implementation Plan
(SIP)to amend the General Conformity Rule to include de minimis emission levels for Particulate Matter 2.5 (PM <sup>2.5</sup> ). This update ensures consistency with the Federal General Conformity Rule. DATES: This direct final rule will be effective February 4, 2008, without further notice, unless EPA receives adverse comment by January 3, 2008. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-OAR-2007-1055, by one of the following methods: 1. *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. 2. *E-mail: shepard.barbara@epa.gov.* 3. *Mail:* Barbara Shepard, Environmental Protection Agency, Region 7, Air Planning and Development Branch, 901 North 5th Street, Kansas City, KS 66101. 4. *Hand Delivery or Courier:* Deliver your comments to Barbara Shepard, Environmental Protection Agency, Region 7, Air Planning and Development Branch, 901 North 5th Street, Kansas City, KS 66101. *Instructions:* Direct your comments to Docket ID No. EPA-R07-OAR-2007-1055. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit through *http://www.regulations.gov* or e-mail information that you consider to be CBI or otherwise protected. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the electronic docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Environmental Protection Agency, Region 7, Air Planning and Development Branch, 901 North 5th Street, Kansas City, KS 66101. The Regional Office's official hours of business are Monday through Friday, 8 to 4:30 excluding Federal holidays. The interested persons wanting to examine these documents should make an appointment with the office at least 24 hours in advance. FOR FURTHER INFORMATION CONTACT: Barbara Shepard at
(913)551-7759, or by e-mail at *shepard.barbara@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us” or “our” is used, we mean EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows: I. General Conformity II. Background for This Action III. State Submittal and EPA Evaluation IV. Public Comment and Final Action V. Statutory and Executive Order Reviews I. General Conformity General conformity is required under section 176(c) of the Clean Air Act (CAA or Act) to prevent the air quality impacts of Federal actions from causing or contributing to a violation of the National Ambient Air Quality Standards (NAAQS) or interfering with the purpose of a SIP. Conformity currently applies to areas that are designated nonattainment, and to certain areas that have been redesignated to attainment after 1990 (maintenance areas). The general conformity regulation is found in 40 CFR part 93 and provisions related to conformity SIPs are found in 40 CFR 51.390. II. Background for This Action In the CAA, Congress recognized that actions taken by Federal agencies could affect states', tribes', and local agencies' abilities to attain and maintain the NAAQS. Section 176(c) of the CAA requires Federal agencies ensure that their actions conform to the applicable SIP for attaining and maintaining the NAAQS. EPA published the General Conformity Regulations in 1993 to cover all Federal actions not related to highway and mass transit funding and approval to implement a portion of section 176(c). The General Conformity Regulations define NAAQS as “those standards established pursuant to section 109 of the Act and include standards for carbon monoxide, lead, nitrogen dioxide, ozone, particulate matter, and sulfur dioxide.” Since 1993, EPA has reviewed and revised the NAAQS for particulate matter to include a new PM <sup>2.5</sup> standard (particulate matter with an aerodynamic diameter of up to 2.5 microns). General conformity requirements are applicable to areas designated nonattainment for this standard, and to certain areas redesignated from nonattainment to attainment (maintenance areas). In July 1997, EPA promulgated a new NAAQS established pursuant to section 109 of the CAA for PM <sup>2.5</sup> . On April 5, 2005, the EPA designated areas as nonattainment for PM <sup>2.5</sup> , and subsequently proposed regulations to implement the new particulate matter standard. Section 176(c)(6) states that the conformity requirements of 176(c) do not apply to an area newly designated nonattainment for a new NAAQS until one year after the designation. The EPA made PM <sup>2.5</sup> designations on April 5, 2005; thus, the applicable general conformity requirements were not effective in these areas until April 5, 2006. The proposed rule published on April 5, 2006, solicited comments on establishing 100 tons per year of PM <sup>2.5</sup> direct or precursor emissions as the de minimis threshold for General Conformity applicability. On July 17, 2006, EPA published a final rule (71 FR 40420), PM <sup>2.5</sup> De Minimis Emission Levels for General Conformity Applicability, which amended the regulations relating to the CAA requirement that Federal actions conform to the appropriate state, tribal or Federal implementation plan for attaining clean air (“general conformity”). This action revised the tables in subparagraphs (b)(1) and (b)(2) of 40 CFR 51.853 and 40 CFR 93.153 by adding the de minimis emissions levels for PM <sup>2.5</sup> and established the previously proposed 100 tons per year as the de minimis emission level for direct PM <sup>2.5</sup> and each of its precursors in nonattainment and maintenance areas. III. State Submittal and EPA Evaluation The SIP revision submitted to EPA on September 10, 2007, amends the state rule, Conformity of General Federal Actions to State Implementation Plans (10 Code of State Regulations
(CSR)10-6.300), to be consistent with the Federal conformity requirements described above. This revision added de minimis emissions levels for PM <sup>2.5</sup> to the state's rule and updated the state's tables for de minimis emissions levels for direct PM <sup>2.5</sup> and the relevant precursors in nonattainment and maintenance areas. This Missouri rule implements Section 176(c) of the CAA, as amended (42 U.S.C. 7401-7671q) and regulations under 40 CFR part 51, subpart W, with respect to conformity of general Federal actions to the applicable implementation plan. Missouri rule 10 CSR 10-6.300 at Subsection (2)(B)26.C, was revised to identify precursors of PM <sup>2.5</sup> consistent with the Federal rule. The state rule identifies the following precursors: Sulfur dioxide, nitrogen oxides (unless the state and EPA have determined they are not significant precursors), and volatile organic compounds and ammonia (only where the state or EPA has determined they are significant precursors). Rule 10 CSR 10-6.300, Subsection (3)(B) was revised to add a requirement that a conformity determination must be made for each criteria pollutant or precursor where the total of direct and indirect emissions of the criteria pollutant or precursor in a nonattainment or maintenance area caused by a Federal action would equal or exceed any of the rates in paragraph (3)(B)1. or 2. of the rule. Subsection (3)(B) of 10 CSR 10-6.300 revised tables in subparagraphs (B)1. and (B)2. by incorporating the Federally established 100 tons per year as the de minimis emission level for direct PM <sup>2.5</sup> , and each of its precursors in nonattainment and maintenance areas. The submittal documents public notice and hearing for this SIP revision in compliance with CAA section 110(l) and 40 CFR 51.102. We have reviewed the submittal to assure consistency with the current CAA, and EPA regulations (40 CFR part 93 and 40 CFR 51.390) governing state procedures for general conformity and interagency consultation and have concluded that the submittal is approvable. Details of our review are set forth in a technical support document, which has been included in the docket for this action. IV. Public Comment and Final Action Under section 110(k) of the Act, and for the reasons set forth above, EPA is taking action to approve the revision to the Missouri SIP which adds de minimis emissions levels for PM <sup>2.5</sup> and precursors, for general conformity purposes. We do not expect objection to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this **Federal Register** , we are simultaneously proposing approval of the same submittal. If we receive adverse comments by January 3, 2008, we will publish a timely withdrawal in the **Federal Register** to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on February 4, 2008. This will incorporate these general conformity procedures into the Federally-enforceable SIP and thereby replace the previous version. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. V. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves state law implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA when it reviews a SIP submission to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by *February 4, 2008.* Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: November 26, 2007. William Rice, Acting Regional Administrator, Region 7. Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart AA—Missouri 2. In § 52.1320 the table in paragraph
(c)is amended by revising the entry for 10-6.300 under Chapter 6 to read as follows: § 52.1320 Identification of Plan.
(c)* * * EPA-Approved Missouri Regulations Missouri citation Title State effective date EPA approval date Explanation Missouri Department of Natural Resources * * * * * * * Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of Missouri * * * * * * * 10-6.300 Conformity of General Federal Actions to State Implementation Plans 9/30/07 12/04/07 [ *insert FR page number where the document begins* ]. * * * * * * * [FR Doc. E7-23484 Filed 12-3-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-R04-SFUND-2007-0719; FRL-8501-8] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List AGENCY: Environmental Protection Agency. ACTION: Direct final notice of deletion of the Standard Auto Bumper Site from the National Priorities List; correction. SUMMARY: This document corrects the direct final notice of deletion of the Standard Auto Bumper Site from the National Priorities List, published in the **Federal Register** of August 27, 2007. This correction clarifies that all Institutional Controls
(ICs)are in place and recorded at the site. DATES: Effective December 4, 2007. FOR FURTHER INFORMATION CONTACT: Michael Taylor, Remedial Project Manager, Superfund Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960, Phone:
(404)562-8762, Electronic Mail: *taylor.michael@epa.gov* Correction In the direct final notice of deletion FRL-8458-7, beginning on page 48942 in the issue of August 27, 2007, make the following correction in the Basis for Site Deletion section, under Response Actions. On page 48945 in the second column, the first paragraph is corrected to read as follows: All institutional controls
(ICs)are in place and recorded at the site. All appropriate Fund-financed response under CERCLA has been implemented. No further response action is necessary. Dated: November 13, 2007. J.I. Palmer, Jr., Regional Administrator, Region 4. [FR Doc. E7-23499 Filed 12-3-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 411 and 424 [CMS-1810-CN2] RIN 0938-AK67 Medicare Program, Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III), Correction AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction of final rule. SUMMARY: This document corrects technical and typographical errors that appeared in the final rule published in the **Federal Register** on September 5, 2007 entitled “Medicare Program, Physicians” Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).” DATES: *Effective Date:* December 4, 2007. FOR FURTHER INFORMATION CONTACT: Lisa Ohrin,
(410)786-4565. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 07-4252 of September 5, 2007 (72 FR 51012), there were a number of technical and typographical errors that are identified and corrected in the Correction of Errors section below. The provisions of this correction notice are effective as if they had been included in the final rule published September 5, 2007. Accordingly, the corrections are effective December 4, 2007. II. Correction of Errors In FR Doc. 07-4252 of September 5, 2007 (72 FR 51012), make the following corrections: A. Corrections to the Preamble 1. On page 51016, 3rd column, 2nd full paragraph, lines 18 and 19, the phrase “productivity bonus or profit share consistent with the special rules” is corrected to read “productivity bonus consistent with the special rules”. 2. On page 51018, 1st column, 3rd full paragraph, line 11, the phrase “other entity.” is corrected to read “other entity).”. 3. On page 51019, a. First column, 1st partial paragraph,
(1)Line 6, the phrase “proposed rulemaking, we proposed to” is corrected to read, “proposed rulemaking (72 FR 42628), we proposed to”.
(2)Line 11, the phrase “ services', ” is corrected to read “ services,’ ”. b. Third column, 1st full paragraph, line 12 the phrase “personally refills an implanted pump “is corrected to read “personally refills an implantable pump”. 4. On page 51021, 2nd column, 1st partial paragraph, line 2, the phrase “requirements of a consultation) are not” is corrected to read “requirements of a consultation) is not”. 5. On page 51024, 3rd column, 1st partial paragraph, line 46, the phrase “every 3-years” is corrected to read “every 3 years”. 6. On page 51025, 2nd column, 2nd full paragraph, lines 13 and 14, the phrase “current 90-days” is corrected to read “current 90 days”. 7. On page 51028, 1st column, a. First full paragraph, lines 21 and 22, the phrase “such arrangements would have been analyzed under the as” is corrected to read “such arrangements would have been analyzed as”. b. Second full paragraph, line 24, the phrase “market value arrangement) under” is corrected to read “market value compensation arrangement) under”. 8. On page 51032, 3rd column, a. First full paragraph, line 3, the phrase “at least 8 hour” is corrected to read “at least 8 hours”. b. Fifth paragraph, lines 8 and 9, the phrase “The in-office ancillary exception” is corrected to read “The in-office ancillary services exception”. 9. On page 51033, 2nd column, 1st full paragraph, lines 11 and 12, the phrase “ordering, or by a member of the group practice when furnished,” with “ordering the DHS, or by a member of the group practice when the DHS is furnished,”. 10. On page 51035, 1st column, 4th paragraph, line 14, the phrase “group practice; or by an entity that is” is corrected to read “group practice; or an entity that is”. 11. On page 51037, 1st column, 1st partial paragraph, lines 4 and 5, the phrase “furnished by the academic medical center” is corrected to read “furnished by the academic medical center as the result of a referral from that physician”. 12. On page 51043, 1st column, 3rd full paragraph, lines 4 and 5, the citation “(69 FR 16084-81605)” is corrected to read “(69 FR 16084-16085)”. 13. On page 51050, 3rd column, 2nd full paragraph, lines 4 through 7, the phrase “people reside in the “hole” zip code, the hospital may recruit a physician to establish a practice into the “hole” zip code.” is corrected to read “inpatients reside in the “hole” zip code, the hospital may recruit a physician to establish a practice in the “hole” zip code”. 14. On page 51055, 1st column, 1st partial paragraph, line 23, the phrase “within 6-months” is corrected to read “within 6 months”. 15. On page 51058, a. First column, 4th paragraph,
(1)Line 13, the figure “CY-2005” is corrected to read “CY 2005”
(2)Line 14, the phrase “CY-2006, and $329 for CY-2007.” is corrected to read “CY 2006, and $329 for CY 2007.”. b. Third column, 1st full paragraph, line 2, the figure “CY-2007)” is corrected to read “CY 2007)”. 16. On page 51062, 3rd column, first full paragraph, a. Lines 26 through 32, the phrase “created by virtue of the ownership interest that does not meet an ownership exception (which, thus, creates a compensation arrangement), in the chain of relationships that runs: hospital-radiology venture-physicians.” is corrected to read “created by virtue of the chain of relationships that runs: hospital (contracts with) radiology venture (owned by) physicians.” b. Lines 36 through 38, the phrase “With respect to the second indirect compensation arrangement, the inquiry would be whether the compensation” is corrected to read “The inquiry would be whether the compensation”. 17. On page 51063, second column, third full paragraph, line 16, the citation “§ 411.355(q)” is corrected to read “§ 411.357(q)”. 18. On page 51064, 1st column, fourth full paragraph, lines 2 and 3, the phrase “the entitys *bona fide* medical staff or in the entitys local” is corrected to read “the entity's *bona fide* medical staff or in the entity's local”. 19. On page 51066, 2nd column, 1st full paragraph, lines 23 through 28, the sentence “(We note that the exception for retention payments applies to federally qualified health centers and rural health clinics in the same manner as it applies to hospitals.)” is corrected to read “(We note that the exception for retention payments applies to remuneration provided by federally qualified health centers and rural health clinics in the same manner as it applies to remuneration provided by hospitals.)”. 20. On page 51068, 1st column, the section heading “ *U. Community-Wide Health Information System* ” is corrected to read “ *U. Community-Wide Health Information Systems* ”. B. Corrections to the Regulations Text 1. On page 51087, 3rd column, 3rd full paragraph, lines 8 through 11, the phrase “For purposes of applying the exceptions in § 411.355 and § 411.357 to arrangements described in paragraphs (c)(1)(i) and (c)(2)(i),” is corrected to read “For purposes of applying the exceptions in § 411.355 and § 411.357 to arrangements in which a physician stands in the shoes of his or her physician organization,”. 2. On page 51091, 1st column, 9th full paragraph, line 5, the phrase “claims submission;” is corrected to read “claims submission.” 3. On page 51093, 2nd column, 9th full paragraph, lines 2 through 4, the phrase “paragraph (e)(1) is also signed by the party to whom the payments are directly made.” is corrected to read “paragraph (e)(1) is also signed by the physician practice.” 4. On page 51094, 2nd column, 8th full paragraph, line 5, the phrase “specifically addressed by another” is corrected to read “specifically excepted by another”. 5. On page 51096, 2nd column, a. Eleventh paragraph, 1st line, the phrase “(C) A certification that the future” is corrected to read “(C) A statement that the future”. b. Twelfth paragraph, line 2, the phrase “anticipates relocating his or medical” is corrected to read “anticipates relocating his or her medical”. II. Waiver of Proposed Rulemaking and 30-Day Delay in the Effective Date We ordinarily publish a notice of proposed rulemaking in the **Federal Register** to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act
(APA)(5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice. Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the **Federal Register** . This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued. Therefore, for reasons noted below, we find good cause to waive proposed rulemaking and the 30-day delayed effective date for the corrections in this notice. This notice merely corrects typographical and technical errors in the preamble and regulations text of the September 5, 2007 final rule and does not make substantive changes to the policies that were adopted in the final rule. Therefore, we find that undertaking further notice and comment procedures to incorporate these corrections into the final rule and delaying the effective date of these changes is unnecessary and contrary to the public interest. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 27, 2007. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. 07-5905 Filed 11-30-07; 8:45 am]
Connectionstraces to 59
Traces to 59 documents
CFR
- Notifications and reports to individuals.§ 19.13
- Exemptions to labeling requirements.§ 20.1905
- Determination of prior occupational dose.§ 20.2104
- Definitions.§ 20.1003
- Definitions.§ 50.2
- Reports to individuals of exceeding dose limits.§ 20.2205
- Instruction to workers.§ 19.12
- Reports of individual monitoring.§ 20.2206
- Occupational dose limits for adults.§ 20.1201
- Posting requirements.§ 20.1902
- Labeling containers.§ 20.1904
- Conditions requiring individual monitoring of external and internal occupational dose.§ 20.1502
- Planned special exposures.§ 20.1206
- Criterion for categorical exclusion; identification of licensing and regulatory actions eligible for categorical exclusion or otherwise not requiring environmental review.§ 51.22
- NRC size standards.§ 2.810
- Records of individual monitoring results.§ 20.2106
- General.§ 97.20
- Collection or recovery by VA for medical care or services provided or furnished to a veteran for a non-service connected disability.§ 17.101
- Charges for care or services.§ 17.102
- Implementation plan revision.§ 51.390
- Public hearings.§ 51.102
U.S. Code
- Purposes§ 3501
- Avoidance of duplicative or unnecessary analyses§ 605
- Rule making§ 553
- Domestic distribution of special nuclear material§ 2073
- Establishment and transfers§ 5841
- Employee protection§ 5851
- Authority and functions of Director§ 3504
- Sex discrimination prohibited§ 5891
- Definitions§ 2014
- Utilization and production facilities for industrial or commercial purposes§ 2132
- License required§ 2131
- Cooperation of agencies; reports; availability of information; recommendations; international and national coordination of efforts§ 4332
- Suspension of licenses during war or national emergency§ 2138
- Construction permits and operating licenses§ 2235
- Office of Nuclear Safety and Safeguards§ 5844
- Hearings and judicial review§ 2239
- Policies contained in international arrangements§ 2152
- Inalienability of licenses§ 2234
- Modification of license§ 2237
- Definitions§ 601
- Young, beginning, and small farmers and ranchers§ 2207
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Federal Aviation Administration§ 106
- Definitions; generally§ 321
- Regulations§ 216
- Recovery by the United States of the cost of certain care and services§ 1729
- Appointments in Veterans Health Administration§ 7401
- Statements to accompany significant regulatory actions§ 1532
- Rules and regulations§ 501
- Establishment, functions, and activities§ 272
- SHORT TITLE.§ 801
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Congressional findings and declaration of purpose§ 7401
46 references not yet in our index
- 10 CFR 20
- 10 CFR 1201
- 10 CFR 50
- 10 CFR 52
- 10 CFR 70
- Pub. L. 104-113
- 10 CFR 19
- 68 Stat. 930
- 83 Stat. 444
- 106 Stat. 2951
- 88 Stat. 1242
- Pub. L. 95-601
- 92 Stat. 2951
- 112 Stat. 2750
- 88 Stat. 1254
- Pub. L. 109-58
- 119 Stat. 806
- 68 Stat. 936
- 68 Stat. 955
- Pub. L. 91-190
- 83 Stat. 853
- 68 Stat. 939
- 88 Stat. 1245
- Pub. L. 97-415
- 96 Stat. 2073
- 68 Stat. 954
- 12 CFR 620
- Pub. L. 100-233
- 100 Stat. 1568
- 14 CFR 97
- 1 CFR 51
- 21 CFR 820
- 5 USC 601-612
- Pub. L. 104-4
- 21 CFR 210
- 21 CFR 211
- 38 CFR 17
- Pub. L. 109-461
- 44 USC 3501-3521
- 40 CFR 52
+ 6 more
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