[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Page 46400]
From the Federal Register Online via the Government Publishing 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
