The Federal Register

Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride

Thu, Jul 11 2002 11:00:00 GMT

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 Pharmacia and Upjohn Co. The supplemental NADA provides for injection of ceftiofur hydrochloride suspension in cattle for the treatment of acute metritis.

New Animal Drugs; Change of Sponsor's Address

Thu, Jul 11 2002 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for BioScience Division of Milk Specialties Co.

Advisory Committee: Change of Name and Function; Technical Amendment

Thu, Jul 11 2002 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Drug Abuse Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.

Request for Nominations for Members on Public Advisory Committees; Drug Safety and Risk Management Advisory Committee

Thu, Jul 11 2002 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for four members to serve on the Drug Safety and Risk Management Advisory Committee in the Center for Drug Evaluation and Research.

FDA has a special interest in ensuring that women, minority groups, and the physically challenged are adequately represented on advisory committees and, therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or physically challenged candidates. Final selection from each vacancy will be determined by the expertise required to meet specific agency needs and in a manner to ensure appropriate balance on membership.

Advisory Committee; Renewals

Thu, Jul 11 2002 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the renewal of certain FDA advisory committees by the Deputy Commissioner of Food and Drugs (the Deputy Commissioner). The Deputy Commissioner has determined that it is in the public interest to renew the charters of the committees listed in the following table for an additional 2 years beyond charter expiration date. The new charters will be in effect until the dates of expiration listed in the following table. This notice is issued under the Federal Advisory Committee Act of October 6, 1972 (Public Law 92463 (5 U.S.C. app. 2)).

Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Thu, Jul 11 2002 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 Committee: Drug Safety and Risk Management Advisory Committee (formerly Drug Abuse Advisory Committee).

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

Date and Time: The meeting will be held on July 17, 2002, from 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Kimberly L. Topper, Center for Drug Evaluation and Research (HFD021), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 (for Express delivery: 5630 Fishers Lane, Room 1093, Rockville MD 20857), 3018277001, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 12535. Please call the Information Line for uptodate information on this meeting.

Agenda: T

Draft Revised Guidance for Industry on Bioavailability and Bioequivalence Studies for Orally Administered Drug

Thu, Jul 11 2002 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry entitled ``Bioavailability and Bioequivalence for Orally Administered Drug ProductsGeneral Considerations.'' FDA's Biopharmaceutics Coordinating Committee determined that a revision of the guidance was necessary as a result of experience with implementation of the guidance, input from the Advisory Committee for Pharmaceutical Science at a meeting held on November 28 and 29, 2001, and changes in agency thinking based on new data. This revision should provide better guidance to sponsors conducting bioavailability (BA) and bioequivalence (BE) studies for orally administered drug products.