Notices. Notice

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-05BS] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Human Behavior in Fire Study—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description This project will characterize the behaviors of individuals who were involved in a residential fire and determine which behaviors are associated with injuries sustained in the fire incident. Behaviors related to fire escape planning and practice, smoke alarm installation and maintenance, physical and visual access to escape routes, etc. will be studied. In the United States each year, there are approximately 400,000 residential fires, with 14,000 non-fatal and 3,000 fatal civilian injuries. In line with “ *Healthy People 2010* ” objectives, NCIPC works to reduce and eliminate non-fatal and fatal injuries from residential fires. In order to develop effective fire-related injury prevention programs, a better understanding of human behavior in fires is needed. The design of this study will be a matched-pair, case-control study. Cases will be defined as individuals who were injured in a residential fire and controls will be individuals who were involved in a residential fire, but were not injured. Fire incidents involving a fatality will be excluded from this study. Local fire departments throughout the United States will submit fire incident reports to contract personnel, who will select incidents based on geographical location and then screen further for eligibility using a brief telephone interview. For those selected, interviewers will conduct in-depth, computer-assisted face-to-face interviews with participants. The sequence of events surrounding the fire and the behaviors of interviewees will be ascertained using the Behavioral Sequence Interview Technique (BSIT); (Keating & Loftus, 1984). In addition, information on the nature of injuries sustained; characteristics of the fire and home structure; other occupants present; previous fire experiences; safety training; and demographics on the persons interviewed will be collected. The only cost to the respondents is their time. The total annual burden hours are 552. Estimate of Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response Adults—screened and eligible 434 1 15/60 Adults—screened but are ineligible or refused 109 1 5/60 Adult—cases and controls 434 1 1 Dated: September 20, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-15703 Filed 9-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention

(CDC)Announcement Opportunity for Businesses To Partner With National Institute for Occupational Safety and Health (NIOSH) on a Research Project To Evaluate the Reusability of Disposable Filtering Facepiece Respirators

(FFR)Used for Protection Against Infectious Aerosols Authority: 29 U.S.C. Sections 651 *et seq.* AGENCY: The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). ACTION: Notice. SUMMARY: The National Personal Protective Technology Laboratory (NPPTL), NIOSH, is conducting research to determine the reusability of filtering facepiece respirators

(FFR)exposed to infectious aerosols. One aim of this research is to address whether NIOSH-certified FFR are suitable for reuse after decontamination. NIOSH proposes to study the effects of decontaminating a diverse array of FFR including NIOSH-certified N95, P100, and N95 filtering facepiece respirator/surgical mask. This project will also study the survivability of a simulant influenza virus on FFR. NIOSH plans to include in the research study some of the respirator models that have been stockpiled by the U.S government to be used in the event of an influenza pandemic. NIOSH also plans to include models that have head straps versus those that do not have head straps, as well as models with and without exhalation valves. Through this announcement, NIOSH is seeking to identify FFR products or prototypes that possess anti-viral or other novel technologies that disinfect or sterilize infectious aerosols ( *e.g.* , viruses) as part of their materials of construction. Program funding constraints may limit the number of candidate respirators that may be included in the research program. NIOSH will give consideration to the incorporation of novel anti-viral technologies into this research study using the following hierarchy for selection of candidate FFR products and prototypes:

(1)The FFR proposed for consideration in this study are commercially available and are currently certified to meeting 42 CFR part 84 requirements,

(2)the FFR proposed for consideration is in the process of being certified by NIOSH to meet 42 CFR part 84 requirements,

(3)the FFR proposed for consideration are either a prototype or a commercially available product that has not been submitted to NIOSH for certification and the manufacturer submitting the letter of interest has received NIOSH certification for other respiratory protection products, and

(4)the FFR prototype contains a unique technology for disinfecting or sterilizing infectious aerosol particles trapped on the exterior surface of the FFR and complements the diversity of technologies already considered in the research design. Candidate companies will be evaluated based on their capability to achieve the identified criteria in sufficient quantities for testing. Candidates selected could be requested to enter into a Cooperative Research and Development Agreement (CRADA). This announcement does not obligate NIOSH to enter into a contractual agreement with any respondents. NIOSH reserves the right to establish a partnership based on scientific analysis and capabilities found by way of this announcement or other searches, if determined to be in the best interest of the government. DATES: Submit letters of interest within 30 days after the date of publication of this notice in the **Federal Register** . ADDRESSES: Interested manufacturers should submit a letter of interest with information about their capabilities to: NIOSH, National Personal Protection Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill Road, *Attn:* Jonathan Szalajda, Pittsburgh, PA 15236, *E-mail address: zfx1@cdc.gov* . SUPPLEMENTARY INFORMATION: CDC recommends the use of disposable N95, N99, or N100 filtering facepiece particulate respirators

(FFR)as the minimum level of respiratory protection against transmission of influenza virus. During a respirator shortage, it is important to consider whether a previously worn FFR can be used again. Reuse guidelines in the NIOSH Guide to the Selection and Use of Particulate Respirators Certified under 42 CFR 84 recommend reuse based on loading of the filter and functioning of the respirator. Hospital settings tend to have relatively low concentrations of particulates, but the potential for infectious agents exists. Thus, reuse is more dependent upon infection control procedures than on respirator loading considerations. Respirators exposed to viruses are considered to be potentially harmful because of the possibility for the respirator to act as a fomite and the potential for the viral particle to become dislodged during a sneeze/cough or from rough handling. Thus, respirators worn in the presence of a potentially infected patient or co-worker should be disposed of as infectious waste, and touching of the outside of the respirator should be avoided. In January, 2006, the Department of Health and Human Services asked the Institute of Medicine

(IOM)to convene a committee to conduct an assessment of measures that can be taken that would permit the reuse of disposable N95 particulate filtering respirators in healthcare settings and to report the status of current knowledge about the need and development of reusable N95 respirators for healthcare providers and the general public. Some of the key recommendations from that study were that research studies should be conducted to

(1)understand the efficacy of simple decontamination methods that could be used without negative effects on respirator integrity; and

(2)understand the risks associated with handling a respirator that has been used for protection against a viral threat ( *e.g.* , study the likelihood that the exterior surface of the respirator might harbor pathogenic microorganisms and thus serve as a fomite). This research project addresses the major research gaps related to the reusability of filtering facepiece respirators

(FFR)during an influenza pandemic. NIOSH/NPPTL plans to conduct a variety of tasks in this research project, including:

(1)Determining the effect of decontamination on FFR filtration performance;

(2)Development of a standardized test protocol for measuring the efficacy of a decontamination procedure for FFR;

(3)Measure the survivability of a virus simulant trapped on FFR;

(4)Measurement of the reaerosolization of a trapped virus simulant on FFR;

(5)Assess the efficacy of various decontamination methods suitable for FFR;

(6)Determine the effects of decontamination on the FFR fit; and

(7)produce a final report that could be used to issue guidance documents on FFR reuse. FOR FURTHER INFORMATION CONTACT: Jonathan Szalajda, telephone 412-386-6627, or e-mail *zfx1@cdc.gov* . Dated: September 19, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6-15706 Filed 9-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Portfolio on the Disability and Health Team of the Division of Human Development and Disability In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Portfolio on the Disability and Health Team of the Division of Human Development and Disability. *Times and Dates:* 6 p.m.-8 p.m., October 22, 2006 (Closed). 8 a.m.-5 p.m., October 23, 2006 (Closed). 8 a.m.-3 p.m., October 24, 2006 (Closed). *Place:* National Center on Birth Defects and Developmental Disabilities, CDC, 12 Executive Park Drive, Atlanta, Georgia 30329, Telephone Number 404.498.3013. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include expert review of science and programs of the Disability and Health Team. *Contact Person for More Information:* Esther Sumartojo, Associate Director for Science, National Center on Birth Defects and Developmental Disabilities, CDC, 1600 Clifton Road, NE., Mailstop E-87, Atlanta, GA 30333, Telephone Number 404.498.3072. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: September 18, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-15719 Filed 9-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Diseases Transmitted Through the Food Supply AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of annual update of list of infectious and communicable diseases that are transmitted through handling the food supply and the methods by which such diseases are transmitted. SUMMARY: Section 103(d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention

(CDC)published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109). The final list has been reviewed in light of new information and has been revised as set forth below. Effective Date: September 26, 2006. FOR FURTHER INFORMATION CONTACT: Dr. Donald Sharp, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop G-24, Atlanta, Georgia 30333 Telephone:

(404)639-2213 SUPPLEMENTARY INFORMATION: Section 103(d) of the Americans with Disabilities Act of 1990, 42 U.S.C. 12113(d), requires the Secretary of Health and Human Services to: 1. Review all infectious and communicable diseases which may be transmitted through handling the food supply; 2. Publish a list of infectious and communicable diseases which are transmitted through handling the food supply; 3. Publish the methods by which such diseases are transmitted; and, 4. Widely disseminate such information regarding the list of diseases and their modes of transmissibility to the general public. Additionally, the list is to be updated annually. Since the last publication of the list on October 4, 2004 (67 FR 61109), new information has been reviewed and added. Norwalk and Norwalk-like viruses, previously listed in Part I, are now identified as Noroviruses so as to conform with current scientific nomenclature. Sapoviruses have been added to Part II. I. Pathogens Often Transmitted by Food Contaminated by Infected Persons Who Handle Food, and Modes of Transmission of Such Pathogens The contamination of raw ingredients from infected food-producing animals and cross-contamination during processing are more prevalent causes of foodborne disease than is contamination of foods by persons with infectious or contagious diseases. However, some pathogens are frequently transmitted by food contaminated by infected persons. The presence of any one of the following signs or symptoms in persons who handle food may indicate infection by a pathogen that could be transmitted to others through handling the food supply: Diarrhea, vomiting, open skin sores, boils, fever, dark urine, or jaundice. The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils is responsible for the foodborne transmission of these pathogens. Non-foodborne routes of transmission, such as from one person to another, are also major contributors in the spread of these pathogens. Pathogens that can cause diseases after an infected person handles food are the following: Noroviruses. Hepatitis A virus. *Salmonella Typhi.* * * Kauffmann-White scheme for designation of *Salmonella* serotypes. *Shigella* species. *Staphylococcus aureus.* *Streptococcus pyogenes.* II. Pathogens Occasionally Transmitted by Food Contaminated by Infected Persons Who Handle Food, But Usually Transmitted by Contamination at the Source or in Food Processing or by Non-foodborne Routes Other pathogens are occasionally transmitted by infected persons who handle food, but usually cause disease when food is intrinsically contaminated or cross-contaminated during processing or preparation. Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers. Preventing food contact by persons who have an acute diarrheal illness will decrease the risk of transmitting the following pathogens: *Campylobacter jejuni.* *Cryptosporidium parvum.* *Entamoeba histolytica.* *Enterohemorrhagic Escherichia coli.* *Enterotoxigenic Escherichia coli.* *Giardia lamblia.* *Nontyphoidal Salmonella.* *Sapoviruses.* *Taenia solium.* *Vibrio cholerae.* *Yersinia enterocolitica.* References 1. World Health Organization. Health surveillance and management procedures for food-handling personnel: report of a WHO consultation. World Health Organization technical report series; 785. *Geneva:* World Health Organization, 1989. 2. Frank JF, Barnhart HM. Food and dairy sanitation. *In:* Last JM, ed. Maxcy-Rosenau public health and preventive medicine, 12th edition. New York Appleton-Century-Crofts, 1986:765-806. 3. Bennett JV, Holmberg SD, Rogers MF, Solomon SL. Infectious and parasitic diseases. *In:* Amler RW, Dull HB, eds. *Closing the gap:* the burden of unnecessary illness. New York: Oxford University Press, 1987:102-114. 4. Centers for Disease Control and Prevention. Locally acquired neurocysticercosis—North Carolina, Massachusetts, and South Carolina, 1989-1991. MMWR 1992; 41:1-4. 5. Centers for Disease Control and Prevention. Foodborne Outbreak of Cryptosporidiosis-Spokane, Washington, 1997. MMWR 1998; 47:27. 6. Noel JS, Humphrey CD, Rodriguez EM, et al., Parkville virus: A novel genetic variant of human calicivirus in the sapporo virus clade, associated with an outbreak of gastroenteritis in adults. J. Med. Virol. 52:173-178, 1997. Dated: September 15, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. E6-15712 Filed 9-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D-0044] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 26, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments

(CLIA)of 1988 Waiver Applications; Availability Congress passed the CLIA (Public Law 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services (the Secretary) before accepting materials derived from human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests that are “simple” and that have an “insignificant risk of an erroneous result” may obtain a certificate of waiver (42 U.S.C. 263a (c)(2)). The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are “ simple” and have “an insignificant risk of an erroneous result” under CLIA (69 FR 22849, April 27, 2004). This guidance document describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets CLIA standards (CLIA waiver application). The guidance recommends that CLIA waiver applications include a description of the features of the device that make it “simple”: A report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail-safe and failure alert mechanism and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate accuracy of the test in the hands of intended operators; and statistical analysis of clinical study results. The guidance also make recommendations concerning labeling of “waived tests.” The burden associated with most of these labeling recommendations is approved under OMB control number 0910-0485. Only new information collections not already approved, are included in the estimate in this document. Recommendations for quick reference instructions are written in simple language that can be posted. The guidance also notes that “waived tests” remain subject to applicable reporting and recordkeeping requirements under 21 CFR part 803. The burden associated with this provision is approved under OMB control number 0910-0437. Respondents to this collection of information are manufacturers of in vitro diagnostic devices. In the **Federal Register** of September 7, 2005 (70 FR 53231), FDA solicited comments on the collection of information requirements. No comments were received in response to this notice. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** No of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Operating & Maintenance Costs 40 1 40 780 31,200 $5,500 1 There are no capital costs associated with this collection of information. ** Table 2.—Estimated Annual Recordkeeping Burden 1 ** No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours per Record Total Hours Total Operating & Maintenance Costs 40 1 40 2,800 112,000 $60,700 1 There are no capital costs associated with this collection of information. Based on previous years of experience, with CLIA waiver applications, FDA expects 40 manufacturers to apply for one CLIA waiver per year. The annual reporting burden to respondents is estimated to be 31,200 hours and the recordkeeping burden for respondents is estimated to be 112,00 hours. FDA based the reporting and recordkeeping burden on agency analysis of premarket submissions with clinical trials similar to the waived laboratory tests. The total operating and maintenance costs associated with the implementation of this draft guidance is estimated to be $66,200. The cost consists of specimen collections for the clinical study (estimated at $23,500); laboratory supplies, reference testing, and study oversight (estimated at $26,700); shipping and office supplies (estimated at $6,000); and educational materials, including quick reference instructions (estimated at $10,000). Dated: September 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-15693 Filed 9-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0357] Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on extending OMB approval on the existing reporting and recordkeeping requirements for processors and importers of fish and fishery products. DATES: Submit written or electronic comments on the collection of information by November 27, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products—21 CFR Part 123 (OMB Control Number 0910-0354)—Extension FDA regulations in part 123 (21 CFR part 123) mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and became effective on December 18, 1997. Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor's HACCP plan (e.g., the values for processing times, temperatures, acidity, etc., as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls. Section 123.12 requires that importers of seafood products take affirmative steps and maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. These records are also to be made available for review by FDA as provided in § 123.12(c). The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and on the nature of the equipment or instruments required to monitor critical control points. The burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry. Costs were estimated for the collection of HACCP data for each type of recordkeeping activity using a labor cost of $15.00 per hour. The burden estimate in table 1 of this document includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. The estimate also does not include collections of information that are a usual and customary part of businesses' normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently, the estimates in table 1 account only for information collection and recording requirements attributable to part 123. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section 2 No. of Respondents Annual Frequency per Response 3 Total Annual Responses Hours per Response 4 Total Hours 123.6(a),(b), and

(c)5,500 1 5,500 4.00 22,000 123.12(a)(2)(ii) 1,100 80 88,000 0.20 17,600 123.6(c)(7) 5,500 280 1,540,000 0.30 462,000 123.7(d) 2,200 4 8800 0.10 880 123.8(d) 5,500 47 258,500 0.10 25,850 123.11(c) 5,500 280 1,540,000 0.10 154,000 123.12(c) 1,100 80 88,000 0.10 8,800 123.12(a)(2) 55 1 55 4.00 220 123.10 275 1 275 24.00 6,600 Total 708,950 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 These estimates include the information collection requirements in the following sections:§ 123.16Smoked Fish—process controls (see § 123.6(b))§ 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b))§ 123.28(c) and (d)—Records—molluscan shellfish (see § 123.6(c)(7)) 3 Based on an estimated 280 working days per year. 4 Estimated average time per 8-hour work day unless one-time response. Dated: September 19, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-15694 Filed 9-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0427] Determination of Regulatory Review Period for Purposes of Patent Extension; KETEK AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for KETEK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product KETEK (telithromycin). KETEK is indicated for treatment of acute bacterial exacerbation of chronic bronchitis due to *Streptococcus (S.) pneumoniae* , *Haemophilus (H.) influenzae* , or *Moraxella (M.) catarrhalis* , acute bacterial sinusitis due to *S. pneumoniae* , *H. influenzae* , *M. catarrhalis* , or *Staphylococcus aureus* , and community-acquired pneumonia due to *S. pneumoniae* , *H. influenzae* , *M. catarrhalis* , *Chlamydophila pneumoniae* , or *Mycoplasma pneumoniae* , for patients 18 years old and above. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for KETEK (U.S. Patent No. 5,635,485) from Aventis S. A., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 29, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of KETEK represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for KETEK is 2,206 days. Of this time, 713 days occurred during the testing phase of the regulatory review period, while 1,493 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : March 20, 1998. The applicant claims February 19, 1998, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was March 20, 1998, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : March 1, 2000. The applicant claims February 28, 2000, as the date the new drug application

(NDA)for Ketek (NDA 21-144) was initially submitted. However, FDA records indicate that NDA 21-144 was submitted on March 1, 2000. 3. *The date the application was approved* : April 1, 2004. FDA has verified the applicant's claim that NDA 21-144 was approved on April 1, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,076 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by November 27, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 26, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 1, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-15690 Filed 9-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2006E-0023 and 2006E-0345] Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE—New Drug Application 21-506 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted, as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product MYCAMINE (micafungin sodium). MYCAMINE is indicated for treatment of patients with esophageal candidiasis and prophylaxis of *Candida* infections in patients undergoing hematopoietic stem cell transplantation. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for MYCAMINE (U.S. Patent Nos. 6,107,458 and 6,265,536) from Astellas Pharma, Inc., and the Patent and Trademark Office requested FDA's assistance in determining these patents' eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of MYCAMINE represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for MYCAMINE is 2,546 days. Of this time, 1,493 days occurred during the testing phase of the regulatory review period, while 1,053 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : March 29, 1998. The applicant claims February 26, 1998, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was March 29, 1998, which was 30 days after FDA receipt of the original IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : April 29, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)for MYCAMINE (NDA 21-506) was initially submitted on April 29, 2002. 3. *The date the application was approved* : March 16, 2005. FDA has verified the applicant's claim that NDA 21-506 was approved on March 16, 2005. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,192 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by November 27, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 26, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket numbers found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 9, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-15767 Filed 9-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2006M-0161, 2006M-0264, 2006M-0148, 2006M-0200, 2006M-0162, 2006M-0199, 2006M-0193, 2006M-0235] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is publishing a list of premarket approval applications

(PMAs)that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in Table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the **Federal Register** . Instead, the agency now posts this information on the Internet on FDA's home page at *http://www.fda.gov* . FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the **Federal Register** , and FDA believes that the Internet is accessible to more people than the **Federal Register** . In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2006, through June 30, 2006. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. **Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2006, through June 30, 2006** PMA No./Docket No. Applicant Trade Name Approval Date P050021/2006M-0161 QLT, Inc. CERALAS I LASER & CERALINK SLIT LAMP ADAPTER December 20, 2005 P040052/2006M-0264 MonoGen, Inc. MONOPREP PAP TEST

(MPPT)March 3, 2006 P040028/2006M-0148 Medispectra, Inc. LUMA CERVICAL IMAGING SYSTEM March 16, 2006 P050012/2006M-0200 Dexcom, Inc. DEXCOM

(STS)CONTINUOUS GLUCOSE MONITORING SYSTEM March 24, 2006 P050026/2006M-0162 QLT, Inc. QUALTEL ACTIVIS LASER & ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT SLIT LAMP ADAPTERS April 4, 2006 P030008(S4)/2006M-0199 SurgiVision Refractive Consultants WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM April 19, 2006 P040033/2006M-0193 Smith & Nephew Orthopaedics BIRMINGHAM HIP RESURFACING

(BHR)SYSTEM May 9, 2006 P050047/2006M-0235 Inamed Corp. JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM 30HV GEL IMPLANTS June 2, 2006 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: September 15, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-15755 Filed 9-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0107] Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: This is an update to previous notice that the Food and Drug Administration

(FDA)will hold a public meeting October 10, 2006, on nanotechnology as it relates to FDA-regulated products. The primary purpose of this update is to notify the public that preregistration to attend or speak at the public meeting will close on September 29, 2006. The purpose of the meeting is to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products. FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices, whether there are new or emerging scientific issues that should be brought to FDA's attention, and any other scientific issues about which the regulated industry, academia, and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDA-regulated products. DATES AND TIMES: The public meeting will be held October 10, 2006, from 9 a.m. to 5 p.m. REGISTRATION: You may preregister to attend or make a presentation at *http://www.fda.gov/nanotechnology/* . Preregistration to make a presentation will close on September 29, 2006; however, there will be onsite registration to attend on a first-come, first-served basis until the room capacity is reached. Onsite registration will be open at the meeting site at 8:30 a.m. on October 10. Once room capacity is reached, individuals will be offered the opportunity to observe the meeting from an overflow room located at the meeting site. If time permits, there will be an open public session. Individuals who have not preregistered to make a presentation can register onsite if they wish to present public comments. While every effort will be made to provide an open public session after all preregistered speakers have made presentations, it is recommended that you preregister if you would like to make a presentation. Onsite registration to make a presentation will be taken on a first-come, first-served basis. Individuals who register at the meeting to speak may be allotted less time to speak than preregistered speakers, depending on the number of registrants. We will post the agenda at *http://www.fda.gov/nanotechnology/* prior to the meeting. ADDRESSES: The public meeting will be held at the Natcher Auditorium, National Institutes of Health Campus (NIH), 9000 Rockville Pike, bldg. 45, Bethesda, MD. We will also post the address for the meeting at *http://www.fda.gov/nanotechnology/* . Note that parking is limited on the NIH Campus and that security procedures are in effect. For further information on parking and security see *http://www.nih.gov/about/visitorsecurity.htm* . Written or electronic comments may be submitted by November 10, 2006. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Poppy Kendall, Food and Drug Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail: *poppy.kendall@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Why Are We Holding a Public Meeting? Previous **Federal Register** Notices (71 FR 19523, April 14, 2006; 71 FR 46232, August 11, 2006) contain detailed supplemental information regarding the rationale and background for the meeting. For more information about FDA's role regarding nanotechnology products, see our Web page at *http://www.fda.gov/nanotechnology/* . II. How Can You Participate? You can participate through oral presentation at the meeting or through written or electronic material submitted to the docket. The length of the presentations will be determined by the number of speakers who preregister and the time available. Based on the requests received so far, the presentations are likely to be less than 8 minutes long. In order to maximize the number of people who have the opportunity to present their views at this public meeting, each individual or organization will be limited to one opportunity to present views at the meeting. However, written material of any length can be submitted to the docket. Individuals and organizations with common interests are encouraged to consolidate or coordinate their presentations. FDA will give the registered speakers an estimated timeframe for their presentations by October 4 through email to the address provided during preregistration. Persons should arrive early to make sure that they are present to make their presentation in case we are ahead of schedule. In a previous notice we indicated the possibility of holding concurrent sessions. However, based on the number of requests for presentation received so far it appears that all can be accommodated by one general session. A final decision on whether there will be concurrent sessions will be made following the cutoff date for registration and will be communicated through the posted agenda at *http://www.fda.gov/nanotechnology/* and e-mail to registered speakers. We ask that you preregister by September 29 (see REGISTRATION ) if you intend to provide an oral presentation. If time permits, there will be an open public session at the meeting. However, individuals who register at the meeting to speak may be allotted less time to speak than preregistered speakers, depending on the number of registrants. The information provided during preregistration will help us determine further how to organize the day. III. Will Meeting Transcripts Be Available? Following the meeting, transcripts will be available for review at the Division of Dockets Management (see ADDRESSES ). IV. How Should You Send Comments on the Issues? An open public docket has been established. Individuals may submit their comments either in writing or electronically to the docket. All comments should include the docket number found in brackets in the heading of this document (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals have the option of submitting 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. Dated: September 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-8242 Filed 9-21-06; 1:22 pm]

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