Notices. Notice

8,375 words·~38 min read·/register/2007/12/17/07-6054

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4150-45-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Pantex Plant, Amarillo, TX, To Be Included in the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Department of Health and Human Services

(HHS)gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Pantex Plant, Amarillo, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: *Facility:* Pantex Plant. *Location:* Amarillo, Texas. *Job Titles and/or Job Duties:* Production workers, technicians, including radiography, guards, physical plant, maintenance, administrative and support staff, contractors, and Atomic Energy Commission staff. *Period of Employment:* January 1, 1950 through December 31, 1991. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 513-533-6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to *OCAS@CDC.GOV.* Dated: December 10, 2007. John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. E7-24427 Filed 12-14-07; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day-08-0338] 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)639-4766 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 Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S.—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The oral use of smokeless tobacco

(SLT)products represents a significant health risk which can cause cancer and a number of non-cancerous oral conditions, and can lead to nicotine addiction and dependence. Furthermore, SLT use is not a safe substitute for cigarette smoking. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq., P. L. 99-252) requires each person who manufactures, packages, or imports smokeless tobacco

(SLT)to provide the Secretary of Health and Human Services

(HHS)with a list of ingredients added to tobacco in the manufacture of smokeless tobacco products. This legislation also authorizes HHS to undertake research, and submit an annual report to Congress (as deemed appropriate) discussing the health effects of these ingredients in smokeless tobacco products. HHS has delegated responsibility for the implementation of this Act to CDC's Office on Smoking and Health (OSH). Respondents report the required information to CDC once per year according to Tobacco Ingredient and Nicotine Reporting instructions posted on the OSH Web site. Changes effective with this reinstatement relate to the redesign of the OSH Web site. There are no costs to respondents other than their time. The total estimated annualized burden hours are 18,843. Estimated Annualized Burden Hours Type of respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Smokeless Tobacco Manufacturers, Packagers, and Importers 11 1 1,713 Dated: December 10, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24316 Filed 12-14-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0210] 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)639-4766 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 List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Cigarette smoking is the leading preventable cause of premature death and disability in the United States. Each year more than 440,000 premature deaths occur as the result of smoking related diseases. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) requires each person who manufactures, packages, or imports cigarettes to provide the Secretary of Health and Human Services

(HHS)with a list of ingredients added to tobacco in the manufacture of cigarettes. This legislation also authorizes HHS to undertake research, and submit an annual report to Congress (as deemed appropriate) discussing the health effects of these ingredients in smokeless tobacco products. HHS has delegated responsibility for the implementation of this Act to CDC's Office on Smoking and Health (OSH). Respondents report the required information to CDC once per year according to Tobacco Ingredient and Nicotine Reporting instructions posted on the OSH web site. Changes effective with this reinstatement relate to the redesign of the OSH web site. There are no costs to respondents other than their time. The total estimated annualized burden hours are 930. Estimated Annualized Burden Hours Type of respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Smokeless Tobacco Manufacturers, Packagers, and Importers 143 1 6.5 Dated: December 10, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24323 Filed 12-14-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-0669] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Evaluation of State Nutrition and Physical Activity Programs to Prevent Obesity and Other Chronic Diseases—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description: The “State Nutrition and Physical Activity Programs to Prevent Obesity and Other Chronic Diseases”

(NPAO)project was established by CDC to prevent and control obesity and other chronic diseases by supporting States in the development and implementation of nutrition and physical activity interventions, particularly through population-based strategies such as policy-level changes, environmental supports and the social marketing process. The goal of the programs in this project is to attain population-based behavior change such as increased physical activity and better dietary habits; this leads to a reduction in the prevalence of obesity, and ultimately to a reduction in the prevalence of chronic diseases. Evaluation questions for “State Nutrition and Physical Activity Programs to Prevent Obesity and Other Chronic Diseases” have been previously approved under OMB control no. 0920-0669, which is scheduled to expire January 31, 2008. CDC seeks OMB approval to reinstate the evaluation in 2008 with changes, in response to feedback from users and stakeholders based on experience with the previously approved questions. The evaluation is designed to focus on the recipient activities as outlined in the original funding announcement: • Capacity building. • Collaboration. • Planning. • Monitoring the burden of obesity. • Intervention. • Evaluation. Within each of these areas, the plan identifies specific evaluation questions that have been chosen for study. The evaluation questions are asked of the funded states via a web-based data collection system supported by an electronic database every 6 months during the funding cycle. The project will continue to be conducted over a 3-year period. There are no costs to respondents except their time to participate in the survey. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) States participating in NPAO 28 2 12 672 Total 672 Dated: December 11, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-24325 Filed 12-14-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0459] International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test for Particulate Contamination: Subvisible Particles General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.” The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the third annex to the core Q4B guidance, which was made available in draft in the **Federal Register** of August 8, 2006 (71 FR 45059). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by February 15, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Submit written comments on the draft guidance 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding the guidance* : Robert H. King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993-0002, 301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681. *Regarding the ICH* : Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In November 2007, the ICH Steering Committee agreed that a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter” should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group. The draft guidance provides the specific evaluation results from the ICH Q4B process for the Test for Particulate Contamination: Subvisible Particles General Chapter harmonization proposal originating from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that 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. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/publications.htm* . Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24431 Filed 12-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0458] International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 2 on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.” The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the second annex to the core Q4B guidance, which was made available in draft in August 2006 (71 FR 45059, August 8, 2006). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by February 15, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Submit written comments on the draft guidance 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding the guidance* : Robert H. King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993-0002, 301-796-1242; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681. *Regarding the ICH* : Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In November 2007, the ICH Steering Committee agreed that a draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter” should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group. The draft guidance provides the specific evaluation results from the ICH Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter harmonization proposal originating from the three-party PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that 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. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/publications.htm* . Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24434 Filed 12-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0330] Guidance for Industry and Food and Drug Administration Review Staff: Collection of Platelets by Automated Methods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,” dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name “Platelets, Pheresis.” The document contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2005, and supersedes the guidance entitled “Revised Guideline for the Collection of Platelets, Pheresis,” dated October 1988. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,” dated December 2007. The guidance provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). In recent years, many improvements have been made in automated blood cell separator technology, platelet storage stability, and blood cell counting methods. Automated blood cell separator devices are now capable of various plateletpheresis collection procedures including, but not limited to, collection of double and triple platelet components obtained during a single procedure; use of in-process leukocyte reduction; collection of concurrent plasma components; and collection of concurrent Red Blood Cell components. This guidance replaces the draft guidance of the same title, and supersedes the guidance entitled “Revised Guideline for the Collection of Platelets, Pheresis,” dated October 1988. In the **Federal Register** of October 3, 2005 (70 FR 57609), FDA announced the availability of the draft guidance of the same title dated September 2005. FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes:

(1)Revised recommendations for donor selection and management,

(2)revised recommendations for collection performance qualification criteria, and

(3)revised recommendations on quality control monitoring. The guidance announced in this notice finalizes the draft guidance dated September 2005. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 211 (21 CFR part 211), subpart J (Records and Reports) have been approved under OMB control number 0910-0139; the collections of information in part 606 (21 CFR part 606), subpart I (Records and Reports) have been approved under OMB control numbers 0910-0116 and 0910-0458; the collections of information in §§ 606.100(b) and (c), 606.110(a), 606.121, 606.122, 21 CFR 640.25, and 21 CFR 640.27 have been approved under OMB control number 0910-0116; the collections of information in §§ 211.22, 211.80, 211.100(b), and 211.160 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR 610.2 have been approved under OMB control number 0910-0206; and the collections of information in 21 CFR 601.12 and 610.60 have been approved under OMB control number 0910-0338. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: December 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24385 Filed 12-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for the opportunity for public comment on proposed data collection projects [Section 3506 (c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13], the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at

(301)443-1129. Comments are invited on

(a)whether the agency needs to collect the proposed information to properly perform its functions and whether the information has any practical utility;

(b)whether the agency's estimate of the burden of the proposed collection of information is accurate;

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

(d)ways to minimize the burden of the collection of information for respondents ( *e.g.* , by using automated collection techniques or other forms of information technology). Proposed Project: Ryan White HIV/AIDS Program Part F Dental Services Report (OMB No. 0915-0151)—Extension The Dental Reimbursement Program

(DRP)and the Community Based Dental Partnership Program under Part F of the Ryan White HIV/AIDS Program offer funding to accredited dental education programs to support the provision of oral health services for HIV-positive individuals. Institutions eligible for these programs are accredited schools of dentistry, post-doctoral dental education programs and dental hygiene programs. The DRP Application is the Dental Services Report that schools and programs use to apply for funding of non-reimbursed costs incurred in providing oral health care to patients with HIV, or to report annual program data. Awards are authorized under section 2692(b) of the Public Health Service Act (42 U.S.C. § 300ff-111(b)). The Dental Services Report collects data in four different areas: program information, patient demographics and services, funding, and training. It also requests applicants to provide narrative descriptions of their services and facilities, as well as their links and collaboration with community-based providers of oral health services. The primary purpose of collecting this information annually is to verify eligibility and determine reimbursement amounts for DRP applicants, as well as to document the program accomplishments of Community-Based Dental Partnership Program grant recipients. This information also allows HRSA to learn about

(1)the extent of the involvement of dental schools and programs in treating patients with HIV,

(2)the number and characteristics of clients who receive HIV/AIDS program-supported oral health services,

(3)the types and frequency of the provision of these services,

(4)the non-reimbursed costs of oral health care provided to patients with HIV, and

(5)the scope of grant recipients' community-based collaborations and training of providers. In addition to meeting the goal of accountability to Congress, clients, advocacy groups, and the general public, information collected in the Dental Services Report is critical for HRSA, State and local grantees, and individual providers, to help assess the status of existing HIV-related health service delivery systems. The reporting burden for reviewing the Dental Services Report Instructions and completing the Report is estimated as: Instrument Number of respondents Responses per respondent Total responses Hours per response Total burden hours Dental Services Report 80 1 80 20 1600 Send comments to Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: December 11, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-24348 Filed 12-14-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Part C HIV Early Intervention Services Grant AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of Noncompetitive Program Expansion Supplemental Award. SUMMARY: HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area. SUPPLEMENTARY INFORMATION: *Intended Recipient of the Award:* Chase Brexton Health Services, Baltimore, Maryland. *Amount of the Award:* $73,125 (initial three month supplement) and $300,000 (anticipated second 12 month supplement) to ensure ongoing clinical services to the target population. Authority: Section 2651 of the Public Health Service Act, 42 U.S.C. 300ff-51. *CFDA Number:* 93.918. *Project Period:* The first period of supplemental support is from September 30, 2007, through December 31, 2007. The anticipated second period of supplemental support will be January 1, 2008, through December 31, 2008. FOR FURTHER INFORMATION CONTACT: Maria Rios, M.D, via e-mail: *mrios@hrsa.gov,* or via telephone: 301-443-0493. Justification for the Exception to Competition Funding critical HIV medical care and treatment services for homeless populations in Baltimore, MD area will be continued through a noncompetitive program expansion supplement to an existing grant award to Chase Brexton Health Services. This is a temporary award made because the previous grant recipient servicing this population is unable to satisfactorily meet legislative and program requirements. Chase Brexton, a currently funded Ryan White HIV/AIDS Program Part C grantee, is the best qualified and geographically positioned grantee able to provide the necessary continuity of HIV care and treatment for the targeted population. The initial supplemental funding will provide support for three months. Based on satisfactory performance, continued need, and availability of funds, a second and final supplemental award for these services will be awarded for twelve months. Further funding beyond December 31, 2008, for this service area will be competitively awarded during the next Part C HIV Early Intervention Services

(EIS)competing application process. The next available Part C EIS open competing cycle will occur in fiscal year 2009. Dated: December 7, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-24437 Filed 12-14-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Office of the Chief Procurement Officer; Submission for Review; Information Collection Request for Various Contract Related Forms and Regulation on Agency Protests AGENCY: Office of the Chief Procurement Officer, DHS. ACTION: Notice; 30-day notice of information collections under review: Various contract related forms and Regulation on Agency Protests, OMB Control Number 1600-0002 and 1600-0004. SUMMARY: The Department of Homeland Security

(DHS)will submit the following proposed information collection request

(ICR)to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995: 1600-0002 and 1600-0004. The information collection was previously published in the **Federal Register** on August 23, 2007, at 72 FR 48289-48291, allowing for OMB review and a 60-day public comment period. No comments were received by DHS. The purpose of this notice is to allow an additional 30 days for public comments. DATES: Comments are encouraged and will be accepted until January 16, 2008. This process is conducted in accordance with 5 CFR 1320.10. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to Nathan Lesser, Desk Officer, Department of Homeland Security [Office of the Chief Procurement Officer], and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. The Office of Management and Budget is particularly interested in comments which:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

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

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

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. FOR FURTHER INFORMATION CONTACT: A copy of this ICR, with applicable supporting documentation, may be obtained by calling Kathy Strouss, Office of the Chief Procurement Officer, Department of Homeland Security, Washington, DC 20528; telephone

(202)447-5300 (this is not a toll free number). SUPPLEMENTARY INFORMATION: Analysis *Agency:* Department of Homeland Security, Office of the Chief Procurement Officer, Acquisition Policy and Legislation. *Title:* Various contract related forms (DHS Forms 0700-01 through 0700-04). *OMB No.:* 1600-0002. *Frequency:* On occasion. *Affected Public:* Businesses or other for profits and individuals and households. *Estimated Number of Respondents:* 7,101 respondents. *Estimated Time Per Respondent:* 1 hour per response. *Total Burden Hours:* 7,101. *Total Burden Cost:* (capital/startup): None. *Total Burden Cost:* (operating/maintaining): None. *Description:* The DHS, Office of the Chief Procurement Officer requires a renewal of an existing OMB Control Number 1600-0002 granted in September 2004 on these four acquisition forms. The information collections under the Homeland Security Acquisition Regulation

(HSAR)are necessary in order to implement applicable parts of the Federal Acquisition Regulation

(FAR)for administering public contracts for supplies and services. Analysis *Agency:* Department of Homeland Security, Office of the Chief Procurement Officer, Acquisition Policy and Legislation. *Title:* Regulation on Agency Protests. *OMB No.:* 1600-0004. *Frequency:* On occasion. *Affected Public:* Businesses or other for profits and individuals and households. *Estimated Number of Respondents:* 50 respondents. *Estimated Time Per Respondent:* 2 hours per response. *Total Burden Hours:* 100 hours. *Total Burden Cost:* (capital/startup): None. *Total Burden Cost:* (operating/maintaining): None. *Description:* The DHS, Office of the Chief Procurement Officer requires a renewal of an existing OMB Control Number 1600-0004, granted in September 2004 for the regulation on agency protests. The information is requested from contractors so that the Government will be able to evaluate protests effectively and provide prompt resolution of issues in dispute when contractors file agency level protests. Scott Charbo, Chief Information Officer. [FR Doc. E7-24295 Filed 12-14-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [CBP Dec. 07-94] Re-Accreditation and Re-Approval of Pan Pacific Surveyors, Inc., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of re-approval of Pan Pacific Surveyors, Inc., of Wilmington, California, as a commercial gauger and laboratory. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 151.13, Pan Pacific Surveyors, Inc., 444 Quay Ave., Suite #7, Wilmington, California 90744, has been re-approved to gauge petroleum and petroleum products, organic chemicals and vegetable oils, and to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 151.13. Anyone wishing to employ this entity to conduct laboratory analysis or gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific tests or gauger services this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling

(202)344-1060. The inquiry may also be sent to *http://www.cbp.gov/xp/cgov/import/operations_support/labs_scientific_svcs/org_and_operations.xml* . DATES: The re-approval of Pan Pacific Surveyors, Inc., as a commercial gauger and laboratory became effective on September 13, 2006. The next triennial inspection date will be scheduled for September 2009. FOR FURTHER INFORMATION CONTACT: Eugene J. Bondoc, Ph.D, or Randall Breaux, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202-344-1060. Dated: December 6, 2007. Ira S. Reese, Executive Director, Laboratories and Scientific Services. [FR Doc. E7-24394 Filed 12-14-07; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [CBP Dec. 07-93] Re-Accreditation and Re-Approval of Inspectorate America Corp., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of re-approval of Inspectorate America Corp., of Bellingham, Washington, as a commercial gauger and laboratory. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 151.13, Inspectorate America Corp., 4041 Home Road, Suite A, Bellingham, Washington 98226, has been re-approved to gauge petroleum and petroleum products, organic chemicals and vegetable oils, and to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 151.13. Anyone wishing to employ this entity to conduct laboratory analysis or gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific tests or gauger services this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling

(202)344-1060. The inquiry may also be sent to *http://www.cbp. gov/xp/cgov/import/operations_support/labs_scientific_svcs/org_and_operations.xml* . DATES: The re-approval of Inspectorate America Corp., as a commercial gauger and laboratory became effective on March 14, 2007. The next triennial inspection date will be scheduled for March 2010. FOR FURTHER INFORMATION CONTACT: Eugene J. Bondoc, PhD, or Randall Breaux, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW., Suite 1500N, Washington, DC 20229, 202-344-1060. Dated: December 6, 2007. Ira S. Reese, Executive Director, Laboratories and Scientific Services. [FR Doc. E7-24395 Filed 12-14-07; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [CBP Dec. 07-92] Re-Accreditation and Re-Approval of King Inspection and Testing, Inc., as a Commercial Gauger and Laboratory AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of re-approval of King Inspection and Testing, Inc., of Carson, California, as a commercial gauger and laboratory. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.12 and 151.13, King Inspection and Testing, Inc., 1300 E. 223rd Street, #401, Carson, California 90745, has been re-approved to gauge petroleum and petroleum products, organic chemicals and vegetable oils, and to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 151.13. Anyone wishing to employ this entity to conduct laboratory analysis or gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific tests or gauger services this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling

(CBP)announces this date of payment for 2008 in accordance with the Tax Reform Act of 1986. DATES: Payment of the 2008 Customs Broker User Fee is due February 15, 2008. FOR FURTHER INFORMATION CONTACT: Bruce Raine, Broker Compliance Branch, Trade Policy and Programs,

(202)863-6544. SUPPLEMENTARY INFORMATION: Background CBP Dec. 07-01 amended section 111.96 of title 19 of the Code of Federal Regulations (19 CFR 111.96) pursuant to the amendment of section 13031 of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (19 U.S.C. 58c) by section 892 of the American Jobs Creation Act of 2004, to establish that effective April 1, 2007 an annual user fee of $138 is to be assessed for each customs broker permit and national permit held by an individual, partnership, association, or corporation. The Customs and Border Protection

(CBP)regulations provide that this fee is payable for each calendar year in each broker district where the broker was issued a permit to do business by the due date which is published in the **Federal Register** annually. See 19 CFR 24.22(h) and (i)(9). Broker districts are defined in the General Notice entitled, “Geographical Boundaries of Customs Brokerage, Cartage and Lighterage Districts” published in the **Federal Register** on September 27, 1995 (60 FR 49971). Section 1893 of the Tax Reform Act of 1986 (Pub. L. 99-514) provides that notices of the date on which the payment is due for each broker permit shall be published by the Secretary of the Treasury in the **Federal Register** by no later than 60 days before such due date. Please note that section 403 of the Homeland Security Act of 2002, 6 U.S.C. 101 *et seq.* , (Pub. L. 107-296) and Treasury Department Order No. 100-16 (see Appendix to 19 CFR part 0) delegated general authority vested in the Secretary of the Treasury over customs revenue functions (with certain specified exceptions) to the Secretary of Homeland Security. This document notifies customs brokers that for calendar year 2008, the due date for payment of the user fee is February 15, 2008. It is anticipated that for subsequent years, the annual user fee for customs brokers will be due on or about the twentieth of January of each year. Dated: December 12, 2007. Daniel Baldwin, Assistant Commissioner, Office of International Trade. [FR Doc. E7-24435 Filed 12-14-07; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-105] Compliance Inspection Report—Mortgagee's Assurance of Completion AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The Compliance Inspection Report is used by staff and private inspectors and appraisers. The Mortgagee's assurance of Completion is used by mortgage companies for establishing escrow for incomplete repairs or construction. HUD staff review and approve these forms and use them in monitoring and training. DATES: *Comments Due Date:* January 16, 2008. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Approval Number (2502-0189) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail Lillian Deitzer at *Lillian_L_Deitzer@HUD.gov* or telephone

(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer. SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(4)Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Compliance Inspection Report—Mortgagee's Assurance of Completion. *OMB Approval Number:* 2502-0189. *Form Numbers:* HUD-92051 and HUD-92300. *Description of the Need for the Information and Its Proposed Use:* The Compliance Inspection Report is used by staff and private inspectors and appraisers. The Mortgagee's Assurance of Completion is used by mortgage companies for establishing escrow for incomplete repairs or construction. HUD staff review and approve these forms and use them in monitoring and training. *Frequency of Submission:* On occasion. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 37,440 16.64 0.248 154,667 *Total Estimated Burden Hours:* 154,667. *Status:* Extension of a currently approved collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: December 10, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. 07-6054 Filed 12-14-07; 8:45 am]

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