[Federal Register: April 8, 2004 (Volume 69, Number 68)]
[Page 18594]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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 

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: 


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 

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]