The Federal Register

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Submission of

Wed, Dec 3 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Determination of Regulatory Review Period for Purposes of Patent Extension; STRATTERA

Wed, Dec 3 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for STRATTERA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

Memorandum of Understanding Between the Food and Drug Administration and Agricultural Marketing Service, United

Wed, Dec 3 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Agricultural Marketing Service, United States Department of Agriculture. The purpose of the MOU is to ensure that sponsors of new antimicrobial animal drugs have access to an effective means for evaluating the effects of their drugs on current Food Safety and Inspection Service detection tests.

Memorandum of Understanding Between the Food and Drug Administration and Johns Hopkins University

Wed, Dec 3 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a Memorandum of Understanding (MOU) between FDA and Johns Hopkins University. The purpose of the MOU is to develop collaboration in the areas of education, research, and outreach.

Meeting of the International Subcommittee of the Presidential Advisory Council on HIV/AIDS

Wed, Dec 3 2003 11:00:00 GMT

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the International Subcommittee of the Presidential Advisory Council on HIV/AIDS (PACHA) will host a townhall meeting. This townhall meeting is open to the public. A description of PACHA's functions is included with this notice.

Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State

Wed, Dec 3 2003 11:00:00 GMT

The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2005 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2004 through September 30, 2005. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that we will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for Needy Families (TANF) Contingency Funds, the federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IVE Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commo

Agency Information Collection Activities: Proposed Collection: Comment Request

Wed, Dec 3 2003 11:00:00 GMT

In compliance with the requirement for 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, as amended, 44 U.S.C. Chapter 35), 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 on (301) 4431129.

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

Government-Owned Inventions; Availability for Licensing

Wed, Dec 3 2003 11:00:00 GMT

Correction

In notice document 0329492 appearing on page 66466 in the issue of Wednesday, November 26, 2003, make the following corrections:

1. In the second column, under Degradation and Transcriptional Inhibition of HIF2alpha Protein by 17AAG, in the fourth paragraph, in the fifth line, ``factor2a'' should read ``factor2[agr]''.

2. In the same column, under the same heading, in the same paragraph, the sixth line should read ``(HIF2[agr]). HIF2[agr] is thought to play an''.

3. In the same column, under the same heading, in the same paragraph, in the 13th line, ``HIF2a'' should read ``HIF2[agr].''

4. In the same column, under the same heading, in the same paragraph, in the 16th line, ``HIF2a'' should read ``HIF2[agr].''

5. In the same column, under the same heading, in the same paragraph, in the 22nd line, ``HIF2a'' should read ``HIF2[agr].'' [FR Doc. C329492 Filed 12203; 8:45 am]
BILLING CODE 150501D

National Heart, Lung, and Blood Institute; Notice of Closed Meeting

Wed, Dec 3 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 meeting.

The meeting 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Review of Contract Proposal.

Date: December 16, 2003.

Time: 2 p.m. to 4 p.m.

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Anne P. Clark, PhD, Chief

Center for Scientific Review; Notice of Closed Meetings

Wed, Dec 3 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: Center for Scientific Review Special Emphasis Panel, Analgesia.

Date: December 1, 2003.

Time: 4 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Daniel R. Kenshalo, PhD, Scientific Review Administrat

Center for Scientific Review; Notice of Closed Meetings

Wed, Dec 3 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.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Clinical Neurophysiology, Neuroprosthetics, and Monitoring Devices.

Date: December 1, 2003.

Time: 2:30 p.m. to 4:30 p.m.

[[Page 67691]]

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Cal

National Toxicology Program: Announcement of a Public Meeting To Discuss the Review Process and the Listing/Delisting

Wed, Dec 3 2003 11:00:00 GMT

Summary

The National Toxicology Program (NTP) announces a public meeting to receive public comment on the current process for reviewing nominations for listing in or delisting from the Report on Carcinogens (RoC) and on the current listing criteria used for evaluating the nominations. The purpose of this public meeting is to obtain input and provide all interested parties an opportunity to express their views about the review process for nominations to the RoC and/
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or the evaluation criteria and to comment on the views expressed by others.

The meeting will be held on January 2728, 2004, at the Lister Hill Center Auditorium (Building 38A), National Library of Medicine, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland, 20892. The meeting will begin at 9 am on January 27 and will conclude by noon on January 28 or sooner if the public comments and discussion end earlier. Onsite registration will begin at 8:30 am on January 27. Attendance at the meeting is

National Toxicology Program: Announcement of a Public Meeting To Receive Comment on the NTP Vision and Input to a

Wed, Dec 3 2003 11:00:00 GMT

Summary

The National Toxicology Program (NTP) announces a public meeting to provide all interested parties an opportunity to express their views about the NTP Vision, provide input to a roadmap for implementation of the NTP Vision and comment on the views expressed by others. The NTP Vision for the 21st Century is to move toxicology from a predominately observational science at the level of diseasespecific models to a predominately predictive science focused upon a broad inclusion of targetspecific, mechanismbased, biological observations. The stimulus for the NTP Vision is to develop a framework that will promote the further advancement of toxicology and refine its traditional role as a predominately observational science.

The meeting will be held on January 29, 2004, at the Lister Hill Center Auditorium (Building 38A), National Library of Medicine, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland, 20892. The meeting will begin at 9 a.m. on January 29 and will conc

National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee Meeting;

Wed, Dec 3 2003 11:00:00 GMT

Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (``the Subcommittee'') on February 1718, 2004, in the Rodbell Auditorium, Rall Building at the National Institute of Environmental Health Sciences, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. The meeting will begin at 8:30 a.m. Agenda

The primary agenda topic is the peer review of seven draft NTP Technical Reports of rodent toxicology and carcinogenesis studies conducted by the NTP. This includes the rereview of the NTP Draft Technical Report on Anthraquinone (TR 494), which was originally reviewed in May 1999. The reports are listed in the table below in the tentative order of their review.

The agenda and roster of the Subcommittee members will be available prior to the meeting on the NTP homepage at