[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Notices]
[Pages 20469-20470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-10164]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2638]


Extra-Label Use of Medicated Feeds for Minor Species; 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 new compliance policy guide (CPG) section 615.115 
entitled ``Extra-Label Use of Medicated Feeds for Minor Species.'' The 
purpose of this CPG is to provide guidance to FDA personnel concerning 
the agency's exercise of regulatory discretion with regard to the 
extra-label use of medicated feeds for minor species. This CPG has been 
revised in response to comments received on the draft.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the CPG to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Comments should be identified with the full 
title of the CPG and the docket number found in brackets in the heading 
of this document. See the Supplementary Information section for the 
electronic access to the CPG section 615.115 entitled ``Extra-Label Use 
of Medicated Feeds for Minor Species.''

FOR FURTHER INFORMATION CONTACT: Frances M. Pell, Center for Veterinary 
Medicine (HFV-235), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0188, e-mail: fpell@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 25, 1999 (64 FR 46400), FDA 
published a notice of availability of a draft CPG entitled ``Use of 
Medicated Feeds for Minor Species.'' This CPG was issued as a level 1 
draft guidance consistent with FDA's good guidance practices regulation 
(21 CFR 10.115; 65 FR 56468, September, 2000). The purpose of this CPG 
is to provide guidance to FDA staff concerning the agency's exercise of 
regulatory discretion with regard to the extra-label use of medicated 
feeds for minor species. The CPG represents the agency's current 
thinking on this subject. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public.
    The agency received comments regarding this CPG and has revised the 
CPG in response to the comments. Following is a discussion of the 
issues raised by the comments.

II. The Final Guidance

    The agency received 21 comments on the draft CPG. When finalizing 
the CPG, the agency considered the comments and, as appropriate, 
incorporated them into the final guidance. The final version of the CPG 
differs from the draft only in three areas. The first is a change in 
the minor species definition to reflect a corresponding change to the 
new animal drug regulations at 21 CFR 514.1. Sheep are now considered a 
minor species for all data collection purposes (see 65 FR 47668, August 
3, 2000).
    The second change is a minor clarification of existing provisions. 
The medicated feed must be manufactured and labeled in accordance with 
the approved conditions of use. This means that the feed cannot be 
reformulated in dosage, in form, or nutritional content such that it 
would no longer be appropriate as a feed for the species for which it 
is approved. For example, a medicated feed approved for chickens may 
not be pelleted for use in laboratory animals. An approved swine 
medicated feed may not be made to correspond to the nutrient 
requirements of pheasants or deer. All labeling must be truthful and in 
accordance with the approved conditions of use.
    The third change is further clarification of limitations on the 
agency's intent to exercise regulatory discretion with regard to extra-
label use of medicated feeds. If the medicated feed is to be used in a 
food-producing minor species, the product must be approved in a food-
producing major species. The agency intends to exercise regulatory 
discretion only for farmed or confined species not for unconfined 
wildlife. In aquaculture, the agency intends to exercise regulatory 
discretion only for extra-label use of medicated

[[Page 20470]]

feeds already approved for an aquatic use because factors in the 
aquatic environment that may affect the safety and/or effectiveness of 
the medicated feed are so varied.

III. Availability of Medicated Feeds for Minor Species

    FDA plans to continue to address the issue of lack of availability 
of medicated feeds for minor species. There are serious shortcomings in 
the legal availability of medicated feeds for minor species. These 
include the need for specially formulated feeds for laboratory and zoo 
animals and the needs of species raised in aquaculture. Future guidance 
will be directed specifically at these needs.

IV. Electronic Access

    Persons with access to the Internet may obtain the CPG at http://
www.fda.gov/cvm and http://www.fda.gov/ora.

V. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this CPG. FDA will periodically review the comments and, where 
appropriate, the CPG will be amended. The public will be notified of 
any such amendments through a notice in the Federal Register.

    Dated: April 18, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-10164 Filed 4-19-01; 3:10 pm]
BILLING CODE 4160-01-S