Department of Health and Human Services April 2008 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Dental and Craniofacial Research (NIDCR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 26, 2008 (Volume 73, Number 38, Page 10262) and allowed 60- days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Brain Power! The NIDA Junior Scientist Program, for grades K-5, and the companion program for Middle School, the Brain Power! Challenge. Type of Information Collection Request: This information collection request is for an extension of a previously approved OMB clearance (OMB Control number 0925-0542 that was obtained in 2005, and is requested until April 30, 2010. Need and Use of Information Collection: This is a request to evaluate the effectiveness of the Brain Power! Program's ability (1) increase children's knowledge about the biology of the brain and the neurobiology of drug addiction, (2) increase positive attitudes toward science, careers in science, science as an enjoyable endeavor, and the use of animals in research; and stimulate interest in scientific careers; and (3) engender more realistic perceptions of scientists as being from many races, ages, and genders. The secondary goals of the evaluation are to determine the Program's impact on attitudes and intentions toward drug use. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. There are 2 critical components to this mission: 1. the strategic support and conduct of research across a broad range of disciplines; 2. ensuring the rapid and effective dissemination and use of the results of that research to significantly improve the prevention of drug abuse and addiction, its treatment, and policy. The Brainpower! Challenge project is one of NIDA's many dissemination projects that is anticipated to improve the prevention of drug abuse and addiction among children and youth. These dissemination and diffusion projects complement NIDA's research projects to identify, develop, and refine effective efficient methods, structures, and strategies that test models to disseminate and implement research- tested health behavior change interventions and evidence-based interventions in prevention and treatment. Secondly, from its research NIDA knows that in order for prevention efforts to be effective educational programs must involve teachers, peers, parents, and the entire community. In 1996 NIDA convened a national prevention research conference on preventing drug use among children and adolescents. From it a research-base guide was prepared to provide prevention principles that a school or community can use to implement a prevention program specifically tailored to meet each community's particular needs. And the public response to the guide is evident from the continued requests for the guidean average of about 20,000 per month, and more than 200,000 copies distributed to date. The Brainpower! Challenge project provides a tool for science education that involves teachers, peers, parents and the entire community, and adds to any prevention programs implemented in the community. Thirdly, while education for the prevention of drug abuse may be a worthy function for the Department of Education to conduct, Executive Order 12862 directs federal agencies to provide significant services directly to the public. To provide services from NIDA's research findings, the 1993 the Science Education Abuse Partnership Award Program was conceptualized to ``* * *encourage the development and evaluation of programs that foster an understanding of neuroscience and the biology of drug abuse and addiction among K-12 students * * *.'' NIDA's current Science Education Program to increase scientific literacy and interest in science careers, continues this purpose. The Brainpower! Challenge project will bring a service to the schools and to parents, for laying the foundation for drug prevention among children and youth, and to educate them in the biology and neurobiology of the brain and addiction. Its anticipated achievement will be three- foldprevention of drug abuse among youth, fostering positive attitudes towards science careers, and service provision that translates research findings into practice among a vital population group. The findings will provide valuable information concerning the goals of NIDA's Science Education Program of increasing scientific literacy and stimulating interest in scientific careers. In order to test the effectiveness of the evaluation, information will be collected from students before and after exposure to the curriculum with pre- and post-test self-report measures. Surveys will also be administered to teachers after the completion of the program to examine ease and fidelity of implementation, as well as impact in knowledge and understanding of the neurobiology of addiction. Surveys will be administered to parents to obtain parental reaction and opinion on the materials and the degree to which parents find the curriculum informative and appropriate. Frequency of Response: On occasion. Affected Public: Elementary and middle school students, teachers, and parents. Type of Respondents: Students, Teachers, and Parents. The reporting burden is as follows: Estimated Number of Respondents: 1,337; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: .25; Estimated Total Annual Burden Hours Requested: 640.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

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.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-073- 1999/0-US-02, patent 6,737,511, issued May 15, 2004, entitled Receptor- Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis and 2. E-073-1999/0-US-05, patent application number 11/ 692,112 filed March 27, 2007, entitled Receptor-Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis, to Protox Therapeutics Incorporated (Protox), having a place of business in Vancouver and Victoria, Canada. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to therapeutics for the treatment of spinal cord injury, traumatic brain injury and leukemia.

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The public workshop entitled ``Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, and Juvenile Diabetes Research Foundation Workshop'' will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas.

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 for public comment in response to the notice. This notice solicits comments on FDA's Pet Food Labeling Survey.

The Health Resources and Services Administration published a meeting notice for the National Advisory Council on Migrant in the Federal Register of April 2, 2008 (73 FR 17991). The meeting place has changed. Correction

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014-2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign equivalents thereof, entitled ``Self-Assembling Nanoparticles Composed of Transmembrane Peptides and Their Application for Specific Intra- Tumor Delivery of Anti-Cancer Drugs'' [HHS Ref. No: E-256-2006/0]; and U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled ``G Protein-Coupled Receptor Antagonists'' [HHS Ref. No: E-290-1997/0] to Calidris Therapeutics which is registered in Japan. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to peptidomimetic drugs for the treatment of cancer as claimed in the Licensed Patent Rights. These cancers may be limited to multiple myeloma, colon, lung, melanoma, liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With respect to the GPCR technology, the exclusive license field of use may be limited to antagonists of the GPCR CXCR4.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained three errors.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Thursday, May 29 and Friday, May 30, 2008.

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.

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 regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping and Records Access Requirements for Food Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The U.S. Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), Office on Women's Health (OWH) announces the development of a National Lupus Awareness campaign with the Advertising Council and invites public and private sector lupus and women's health related organizations to participate as collaborating partners to provide advice on the development and dissemination of the campaign materials.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance document entitled ``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.'' FDA is withdrawing its guidance in response to the release by the Environmental Protection Agency (EPA) of its final ``White Paper Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the Potential Risks Associated With Such Exposure,'' the availability of which is announced elsewhere in this issue of the Federal Register.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2009 (for discharges occurring on or after October 1, 2008 and on or before September 30, 2009) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are proposing to revise existing policies regarding the PPS within the authority granted under section 1886(j) of the Act.

HRSA is announcing the reissuance of Fiscal Year 2009 Service Area CompetitionNew and Competing Continuation Funding (HRSA Announcement Numbers HRSA-09-095, HRSA-09-096, HRSA-09-097, and HRSA- 09-098). The HRSA Electronic Handbook (EHB) application deadline for project periods beginning in November and December 2008 has been changed and the list of available service areas has been updated. The new EHB application deadline for HRSA-09-095 is May 9, 2008. (The grants.gov application deadline of April 7, 2008 remains the same.) All other requirements of HRSA-09-095 remain the same. Please see the chart on pages 6 and 7 of the guidance for a complete listing of all application deadlines. In addition, corrections to two service areas listed in the Service Area Competition guidance have been made. In Appendix F of the guidance, Bismarck, ND, is incorrectly listed as an available service area in fiscal year (FY) 2009. The correct service area that is currently available in FY 2009 is Beulah, ND. Also, Clay, WV, is incorrectly listed as an available service area in FY 2009. The correct service area that is currently available in FY 2009 is Blacksville, WV. Bismarck, ND and Clay, WV, are not available service areas for the FY 2009 Service Area Competition. For a complete listing of all available service areas for the FY 2009 Service Area Competition funding opportunity, please see Appendix F of the guidance.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Coronary Drug-Eluting Stent (DES) Guidance Document Workshop.'' FDA is cosponsoring the workshop with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to discuss the draft guidance entitled ``Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies'' announced in the Federal Register of March 27, 2008, and its companion document entitled ``Coronary Drug- Eluting Stents-Nonclinical and Clinical Studies (Companion Document)'' (the Companion Document). The workshop intends to solicit additional comments on the issues and questions presented in the draft guidance during the open comment period.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides for use of enrofloxacin injectable solution in swine for the treatment and control of respiratory disease.

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 medical device labeling regulations.

Section 931 of the Public Health Service Act (PHS Act), 42 U.S.C. 299c, established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2008. To fill these positions in accordance with the legislative mandate establishing the Council, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. Individuals are particularly sought with experience and success in activities specified in the summary above.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Feasibility of secure messaging for pediatric patients with chronic disease: Pilot implementation in pediatric respiratory medicine.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 15th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: Technical Assistance for Health IT and Health Information Exchange in Medicaid and SCHIP. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 20th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

On February 29, 2008, HHS published a notice of proposed rulemaking, ``Designation of Medically Underserved Populations and Health Professional Shortage Areas'' (73 FR 11232), to revise and consolidate the criteria and processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs). HHS provided a 60-day public comment period, with written comments to be received on or before April 29, 2008. HHS and the Health Resources and Services Administration (HRSA) have received requests for an extension of the comment period. In consideration of these requests, HHS is extending the comment period an additional 30 days, with a new closing date of May 29, 2008.

The Food and Drug Administration (FDA) is announcing the following public meeting: ``Meeting to Present Changes to the Animal Feed Safety System (AFSS) Project and the Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example.'' We are holding the public meeting in an effort to gather further information from you, our stakeholders, on changes to AFSS that will help minimize risks to animal and human health associated with animal feed. The following topics will be discussed: The third draft of the AFSS Framework and work-in-progress on a method for ranking animal feed contaminants by their risks to animal and human health. Elsewhere in this issue of the Federal Register, FDA is announcing a related public meeting notice. Date and Time: The public meeting will be held on May 14, 2008, from 9 a.m. to 4:30 p.m. Location: The public meeting will be held at the Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD 20877. There is parking adjacent to the building. The building is also accessible by public transportation. (Take Metro Red Line to Shady Grove Station and board Ride-On bus 124 to Frederick Rd. at Perry Pkwy. Then, cross the roadway and walk approximately 1 [frac1s2] blocks north to building entrance.) Contact Person: For general information: Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6867, FAX 240-453-6882, e- mail: zoe.gill@fda.hhs.gov. Registration: You may register by telephone, fax, or e-mail by contacting Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6840, FAX 240-453-6880, e-mail: nanette.milton@fda.hhs.gov. Send registration information (including name, title, firm name, address, telephone, and fax number) to Nanette Milton. To obtain the registration form via the Web site, go to https://www.fda.gov/cvm/ AFSS.htm#Meetings. Due to limited meeting space, registration will be required. We strongly encourage early registration. Additionally, please notify Nanette Milton if you need any special accommodations (such as wheelchair access or a sign language interpreter) at least 7 days in advance of the meeting. Comments: Regardless of attendance at the public meeting, interested persons may submit written or electronic 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 https://www.regulations.gov. 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. The docket will remain open for written or electronic comments for 30 days following the meeting. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov

The Food and Drug Administration (FDA or agency) is announcing the availability of a draft guidance for industry entitled ``Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act (PHS Act), Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.'' The draft guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for use of florfenicol injectable solution for the treatment of bovine respiratory disease.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``Preventing Occupational Exposures to Lead and Noise at Indoor Firing Ranges.'' The draft document and instructions for submitting comments can be found at https:// www.cdc.gov/niosh/review/public/-128/. Comments should be provided to the NIOSH Docket Number above. Public Comment Period: April 17, 2008 through June 30, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, Mailstop C- 34, Cincinnati, Ohio 45226. All material submitted to the Agency should reference NIOSH Docket number 128 and must be submitted by June 30, 2008, to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. After the comment period has closed, comments may be accessed electronically at https://www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations, and other information, on the Internet. Background: This Alert is intended to address the concerns of Federal, State, and local law enforcement agencies about occupational exposures of their officers to lead and noise during firearms training and qualifications. The Alert describes the health effects that can occur from occupational exposures to lead and noise at indoor firing ranges and recommends steps that firing range operators, employers, and workers should take to minimize the health risk to workers and shooters. This guidance document does not have the force and effect of law. Contact Person for Technical Information: Chucri (Chuck) A. Kardous, Commander, U.S. Public Health Service, Senior Research Engineer, Division of Applied Research and Technology, CDC/NIOSH, 4676 Columbia Parkway, C27, Cincinnati, Ohio 45225, Phone: 513-533-8146, E-mail: ckardous@cdc.gov. Reference: Web address for this document: https://www.cdc.gov/niosh/ review/public/128/.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is updating its study priorities. SACGHS requests suggestions on possible new topics for the Committee to address.

The Office of Global Health Affairs within the U.S. Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties regarding the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law No. 108-25 (May 27, 2003), and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking, as required under Section 301(f) of the Leadership Act. The proposed rule provides additional information on the policy requirement expressed in this law for entities that receive grants, contracts, or cooperative agreements from the U.S. Department of Health and Human Services (``HHS'') to implement programs or projects under the authority of the Leadership Act. Specifically, it describes the legal, financial, and organizational separation that must exist between these recipients of HHS HIV/AIDS funds and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking.

This document corrects mathematical errors that appeared in the impact analysis accompanying the final rule that appeared in the Federal Register on April 3, 2008 entitled, ``Modification to the Weighting Methodology Used to Calculate the Low-Income Benchmark Amount.''

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Impact of the Patient Safety Improvement Corps (PSIC) Training Program.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Office of Public Health and Science (OPHS) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OPHS. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for overlapping four-year terms.

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), the Office of Child Support Enforcement (OCSE) is publishing notice of amendment of its system of records, entitled ``Federal Case Registry of Child Support Orders'' (FCR), 09-80-0202, last published at 69 FR 46550 on August 3, 2004. The amendment adds four routine uses; new categories of records; and clarifying information and technical amendments.