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Extra-Label
Use of Medicated
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.
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draft guidance consistent with FDA's good guidance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
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 guidancewill 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
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