The Federal Register

60Day-04-03]

Tue, Dec 9 2003 11:00:00 GMT

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 the CDC Reports Clearance Officer on (404) 4981210.

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

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Dec 9 2003 11:00:00 GMT

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) 4981210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project: The National Electronic Injury Surveillance SystemAll Injury Program (NEISSAIP) Special Study on Motor Vehicle SafetyNewNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Motor vehicle injuries are the leading cause of death in the U.S. for people aged 134. In 2000, more than 40,000 people died as a result of motor vehiclerelated injuries. In addition,

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Dec 9 2003 11:00:00 GMT

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 the CDC Reports Clearance Officer at (404) 4981210.

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Dec 9 2003 11:00:00 GMT

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
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collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collect

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Dec 9 2003 11:00:00 GMT

Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment

Tue, Dec 9 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which overthecounter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).

Agency Information Collection Activities; Announcement of the Office of Management and Budget Approval; Inspection by

Tue, Dec 9 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Oncologic Drugs Advisory Committee; Amendment of Notice

Tue, Dec 9 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of November 18, 2003 (68 FR 6507665077). The amendment is being made to reflect a change in the Location portion of the document. There are no other changes.

Additional Action on Findings of Scientific Misconduct

Tue, Dec 9 2003 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final additional action in the following case:

KueiFu (Tom) Lin, D.V.M., Medical University of South Carolina (MUSC): Based on the report of an investigation conducted by MUSC and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found on June 12, 2001, that Dr. Lin, a former graduate student, Department of Biochemistry and Molecular Biology at MUSC, engaged in scientific misconduct in research supported by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL29397, ``Regulation and Function of Renal Kallikrein,'' and R01 HL56686, ``Gene Therapy in Experimental Hypertension and Renal Diseases,'' by falsifying data published in publications in Hypertension 26:847853, 1995, Hypertension Research 20:269277, 1997, and Human Gene Therapy 9:1429 1438, 1998.

Subsequent to the exec

Findings of Scientific Misconduct

Tue, Dec 9 2003 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case:

Jianhua (James) Xu, M.S., University of Alberta: Based on the University of Alberta (UA) Report, the respondent's admissions, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Jianhua (James) Xu, M.S., former technician at UA, engaged in scientific misconduct in research funded by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL6175101.

Mr. Xu performed experiments on the enzyme lipid phosphate phosphatase1 (LPP1) from a family of enzymes that affect signal transduction by glycerolipid and sphingolipid phosphate esters as second messengers. A typical experiment involved the investigation of the effects on various glycerolipids, sphingolipids, and other related effector compounds on the activity of LPP1 either in tiss

Maternal and Child Health Federal Set-Aside Program; Special Projects of Regional and National Significance;

Tue, Dec 9 2003 11:00:00 GMT

The Health Resources and Services Administration (HRSA) announces that approximately $33 million in fiscal year (FY) 2004 funds will be available for making competitive grants to provide abstinence education to adolescents, subject to the availability of
appropriations. There are no cost sharing, matching or cost participation requirements of the program. Eligibility is open to public and private entities, including faithbased and community organizations, which develop and/or provide an abstinence program consistent with the definition of ``abstinence education'' in section 510 of the Social Security Act. In addition, the entity must agree not to provide a participating adolescent any other education regarding sexual conduct in the same setting. All awards will be made under the program authority of
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section 501(a)(2) of the Social Security Act, the Maternal and Child Health (MCH) Federal SetAside Program (42 U.S.C. 701(a)(2)) and will be administered by the Maternal and Child Hea

Proposed Collection; Comment Request; Submission for OMB Review; Comment Request; Request for Generic Clearance To

Tue, Dec 9 2003 11:00:00 GMT

Under the provisions of section 3507(a)(1(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 26, 2003, pages 5127551276 and allowed 60 days for public comment. No public comments were 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: Request for Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists. Type of Infor

Government-Owned Inventions; Availability for Licensing

Tue, Dec 9 2003 11:00:00 GMT

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 federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Government-Owned Inventions; Availability for Licensing

Tue, Dec 9 2003 11:00:00 GMT

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

Government-Owned Inventions; Availability for Licensing

Tue, Dec 9 2003 11:00:00 GMT

National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

Tue, Dec 9 2003 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Steroid Receptor Chaperones in Axonal Elongation.

Date: December 11, 2003.

Time: 8:30 am to 9:30 am.

Agenda: To review and evaluate grant applications.

Place: RitzCarlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202, (Telephone Conference Ca