The Federal Register

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Dec 16 2005 11:00:00 GMT

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of the NADAs.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Dec 16 2005 11:00:00 GMT

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.

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is withdrawing approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory

Fri, Dec 16 2005 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on January 23, 2006, from 8 a.m. to 5 p.m.

Location: Holiday Inn Select Bethesda, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301652 2000.

Contact Person: Darrell Lyons, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: lyonsd@cder.fda.gov, or FDA Advisory Committee Information Line, 1800741813

Memorandum of Understanding Between the United States Food and Drug Administration and the C-Path Institute

Fri, Dec 16 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration and the CPath Institute. The specific purpose of this MOU is to establish an overarching framework for collaboration between the parties. This framework will be based on mutually agreed upon programs and activities in the areas of applied scientific research and training/education to foster the development of new evaluation tools to inform medical product development. The parties shall each leverage its own expertise and resources to facilitate programs of shared interests across the diverse disciplines of therapeutics, biological sciences, engineering and medical devices in building applied research and training/education programs. The appropriate formal agreements will be executed as required by law for any activities that result from this collaboration.

Program Exclusions: November 2005

Fri, Dec 16 2005 11:00:00 GMT

During the month of November 2005, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusions is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, e.g., a hospital, that submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive Branch procurement and nonprocurement programs and activities.

Government-Owned Inventions; Availability for Licensing

Fri, Dec 16 2005 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.

National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Fri, Dec 16 2005 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 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 Allergy and Infectious Diseases Special Emphasis Panel, Hyperaccelerated Award/Mechanisms in Immunomodulation Trials (January 2006).

Date: January 3, 2006.

Time: 1 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Con

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Fri, Dec 16 2005 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.

Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group. Biomedical Research Review Subcommittee.

Date: February 2728, 2006.

Time: 8:30 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Sathasiv

National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

Fri, Dec 16 2005 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 552(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 on Deafness and Other Communications Disorders Special Emphasis Panel, NIDCD P30 Research Core Center.

Date: January 11, 2006.

Time: 8 a.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Shigu

National Institute on Deafness and Other Communication Disorders; Notice of Meeting

Fri, Dec 16 2005 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 a meeting of the National Deafness and Other Communication Disorders Advisory Council.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Nam

National Library of Medicine; Amended Notice of Meeting

Fri, Dec 16 2005 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Working Group on Chemical Information Resource Coordination, December 19, 2005, 8 a.m. to 4 p.m., National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894, which was published in the Federal Register on December 8, 2005, 70 FR 73018.

The meeting location has changed to the National Institutes of Health, Building 45, Conference Room A, 8600 Rockville Pike, Bethesda, Maryland 20814. The meeting is open to the public.

Dated: December 8, 2005.
Anna Snouffer,
Acting Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 0524123 Filed 121505; 8:45 am]
BILLING CODE 414001M

National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of

Fri, Dec 16 2005 11:00:00 GMT

The Center for the Evaluation of Risks to Human Reproduction (CERHR) announces availability of the two draft expert panel reports on genistein and soy formula on January 16, 2006, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from CERHR (see ADDRESSES below). CERHR invites public comments on sections 14 of both draft expert panel reports (see SUPPLEMENTARY INFORMATION below). An expert panel will meet on March 1517, 2006, at the Radisson Hotel Old Town in Alexandria, Virginia to review and revise each draft expert panel report and reach conclusions regarding whether exposure to genistein or soy formula is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the a

National Toxicology Program; Hormonally-Induced Reproductive Tumors: Relevance of Rodent Bioassays Workshop

Fri, Dec 16 2005 11:00:00 GMT

For more than a quarter century, the National Toxicology Program (NTP) testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of animal models used in its bioassays to critically analyze their predictive power and determine whether the protocols for these studies should be altered. As part of this effort, the NTP is convening a workshop titled ``HormonallyInduced Reproductive Tumors: Relevance of Rodent Bioassays.'' The 2\1/2\ day workshop will be held on May 2224, 2006, at the Marriott Raleigh Crabtree Valley, 4500 Marriott Drive, Raleigh, NC 27612.

The workshop's overall goal is to determine the adequacy and relevance to human disease outcome of rodent models for four types of hormonallyinduced reproductive tumors (ovary, mammary gland, prostate, and testis). Other topics for discussion include proposed modes of action (for each tumor type and for hormonal tumors in ge

National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods

Fri, Dec 16 2005 11:00:00 GMT

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is considering convening an independent peer review panel (hereafter, ``Panel'') to evaluate the validation status of five in vitro pyrogenicity test methods: (1) Human PBMC/IL6 in vitro pyrogen test (PBMC/IL6), (2) human whole blood/IL1 in vitro pyrogen test (WB/IL 1), (3) human whole blood/IL1 in vitro pyrogen test: application of cryopreserved human whole blood cryo (WB/IL1), (4) the human whole blood/IL6 in vitro pyrogen test (WB/IL6), and (5) an alternative in vitro pyrogen test using the human monocytoid cell line MONO MAC6 (MM6/IL6). NICEATM requests public comments as to the appropriateness and relative priority of this activity. In addition, NICEAM requests the nomination of expert scientists for consideration as potential Panel members in the event a Panel meeting occurs. Finally, NICEATM requests the submission of data from the rabbit pyrogenicity test, the bacteri

National Toxicology Program; Liaison and Scientific Review Office; Meeting of the NTP Board of Scientific Counselors

Fri, Dec 16 2005 11:00:00 GMT

The National Toxicology Program (NTP) established the Nanotechnology Working Group (``the NWG'') to the NTP Board of Scientific Counselors in 2005 to enhance public and stakeholder input into the NTP nanotechnology research program. The second meeting of the NWG is scheduled for March 15, 2006 at the Holiday InnRosslyn at Key Bridge (1900 N Fort Myer Drive, Arlington, VA 22209). This meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any topic discussed at the meeting. A copy of the agenda and any additional information about the meeting will be posted on the NTP website when available (see NTP Web site http://ntp.niehs.nih.gov select ``Meetings and Workshops'').