Reports and guidance documents; availability, etc.: Medical devices— label); compliance policy guide,

[Federal Register: August 25, 1999 (Volume 64, Number 164)]

[Notices]

[Page 46400]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25au99-97]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2638]

Use of Medicated Feeds for Minor Species; Draft Compliance Policy Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Use of Medicated Feeds for Minor Species.'' The purpose of the draft CPG is to provide guidance to the field concerning the agency's exercise of regulatory discretion with regard to the extra-label use of medicated feeds for minor species.

DATES: Written comments on the draft CPG may be submitted by November 23, 1999.

ADDRESSES: Submit written requests for single copies of the draft CPG entitled ``Use of Medicated Feed for Minor Species'' to the Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your requests. Submit written comments on the draft CPG to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Judy A. Gushee, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0150, e-mail ``jgushee@bangate.fda.gov''. SUPPLEMENTARY INFORMATION:

1. Background

   Prior to 1994, the Federal Food, Drug, and Cosmetic Act (the act) did not permit extra-label use of animal drugs, but FDA exercised regulatory discretion regarding extra-label use of animal drugs provided certain criteria were met. These criteria were published in CPG 7125.06 and were largely incorporated into the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). AMDUCA amended the act to permit extra-label uses under certain conditions. The AMDUCA regulations are codified in 21 CFR part 530. AMDUCA did not permit extra-label use of medicated feeds. However, there are some minor species that cannot be practically medicated in any other way other than through the use of medicated feeds. Furthermore, minor species such as fish and game birds have very few drugs approved for their use. In such situations, a veterinarian may determine that extra-label use of medicated feeds approved for use in other species can prevent suffering and death in these minor species. Before the implementation of AMDUCA, the agency occasionally exercised regulatory discretion for extra-label use of medicated feeds for minor species based on a medical need as long as the medicated feeds were formulated and labeled in accordance with their approved application. Because AMDUCA did not permit extra-label use of medicated feeds, FDA is providing this guidance to our field personnel when such extra-label use is encountered.

   This level 1 draft guidance document is being issued consistent with FDA's good guidance practices (62 FR 9061, February 27, 1997). This draft CPG represents the agency's current thinking with regard to the extra-label use of medicated feeds for minor species. It does not confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

2. Request for Comments

   Interested persons may, on or before November 23, 1999, submit to the Dockets Management Branch (address above) written comments on the draft CPG entitled ``Use of Medicated Feeds for Minor Species.'' Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft CPG and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. The agency will review all comments, but in issuing a final CPG, need not specifically address every comment. The agency will make changes to the draft CPG in response to comments, as appropriate.

3. Electronic Access

   Copies of the draft CPG may also be downloaded to a personal computer with access to the World Wide Web (www). The Office of Regulatory Affairs (ORA) and CVM home pages include the draft CPG and may be accessed at ``http://www.fda.gov/ora'' or ``http://www.fda.gov/ cvm'', respectively. The draft CPG will be available on the compliance references or compliance information pages for ORA and CVM, respectively.

   Dated: August 18, 1999. Dennis E. Baker, Associate Commissioner for Regulatory Affairs.

   [FR Doc. 99-21961Filed8-24-99; 8:45 am]

   BILLING CODE 4160-01-F