[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Page 46400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-21961]


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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.

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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:

I. 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.

II. 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.

III. 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. 99-21961 Filed 8-24-99; 8:45 am]
BILLING CODE 4160-01-F