The Federal Register

Renovations in the Division of Dockets Management

Wed, Sep 8 2004 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the partial closing of the Division of Dockets Management (DDM) on September 9, 2004, to September 14, 2004. During the renovations in DDM, it is necessary to partially close the office to allow the staff and others to store and dismantle furniture and other items. The purpose of this document is to inform the public in advance to avoid confusion in carrying out DDM's functions.

Opportunities for Cooperative Research and Development Agreements (CRADAs) To Undertake Research and Development of

Wed, Sep 8 2004 11:00:00 GMT

The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, is seeking proposals from potential collaborators for one or more Cooperative Research and Development Agreements (CRADAs) to test, by scientific means meeting U.S. Food and Drug Administration (FDA) standards, the hypothesis that compounds representative of the following classes (numbered 18 below) may be useful in the treatment of drug dependence:

1. CRF1 antagonists.

2. Cannabinoid1 antagonists.

3. MGluR5 antagonists.

4. AMPA antagonists.

5. Selective, high affinity dopamine D3 agonists and antagonists.

6. Selective, high affinity dopamine D1 full or partial agonists.

7. Kappa opioid antagonists.

8. Compounds from classes not named in 17 above, but for which compelling rationales are provided by potential collaborators.

National Cancer Institute: Cooperative Research and Development Agreement (``CRADA'') Opportunity and Licensing

Wed, Sep 8 2004 11:00:00 GMT

The National Cancer Institute (NCI) is currently seeking Cooperative Research and Development Agreement (CRADA) collaborator(s) to work with investigators in the Center for Cancer Research (CCR) to explore, for drug development and clinical testing, novel
antiangiogenic agents that target adrenomedullin gene products. Research and development may include development of blocking reagents (humanized antibodies, peptide antagonists, small molecules), formulation for systemic and topical application, preclinical animal studies, and clinical trials. Licensing is available for background inventions related to this technology.

Government-Owned Inventions; Availability for Licensing

Wed, Sep 8 2004 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

Wed, Sep 8 2004 11:00:00 GMT

Government-Owned Inventions; Availability for Licensing

Wed, Sep 8 2004 11:00:00 GMT

National Institutes of Health

Wed, Sep 8 2004 11:00:00 GMT

National Institute of Environmental Health Sciences; Notice of a Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) on October 20, 2004, at the U.S. Environmental Protection Agency (EPA), 109 TW Alexander Drive, Durham, NC (Building C, Room C111, Auditorium sections A. and B). The SACATM provides advice on the statutorily mandated duties of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the activities of the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).

The meeting is being held on October 20, 2004, from 8:30 a.m. until adjournment and is open to the public with attendance limited only by the space available. Individuals wh