[Federal Register: April 8, 2004 (Volume 69, Number 68)]
[Notices]
[Page 18594]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap04-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0160]
Guidance for Industry: Use of Unapproved Hormone Implants in Veal
Calves; 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 guidance for industry (172) entitled ``Use
of Unapproved Hormone Implants in Veal Calves.'' This guidance outlines
special measures to ensure the safety of veal in response to the
identified illegal use of unapproved hormone implants in veal calves.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified
with the full title of the guidance and the docket number found in
brackets in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for electronic access to the document.
Submit written requests for single copies of the guidance to the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests.
FOR FURTHER INFORMATION CONTACT: Gloria J. Dunnavan, Center for
Veterinary Medicine (HFV-230), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1168, e-mail:
gloria.dunnavan@fda.gov.
SUPPLEMENTARY INFORMATION:
I. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices (GGPs) regulation in Sec. 10.115 (21 CFR 10.115).
It is being implemented immediately without prior public comment, under
Sec. 10.115(g)(2), because of the agency's urgent need to provide
guidance concerning veal that has been implanted with unapproved
hormones. However, under GGPs, FDA requests comments on the guidance
and will revise the document, if appropriate. Comments will be
considered by the agency in the development of future policy.
This guidance represents the agency's current thinking on the
topic. It does not create or 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 applicable statutes and
regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Copies of this guidance document may be obtained from the CVM home
page (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from the Division of Dockets Management Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm).
Dated: April 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8075 Filed 4-6-04; 2:25 pm]
BILLING CODE 4160-01-S