[Federal Register Volume 69, Number 135 (Thursday, July 15, 2004)]
[Notices]
[Pages 42443-42444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16036]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0160]


Withdrawal of Guidance Document on Use of Unapproved Hormone 
Implants in Veal Calves

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
guidance for industry (172) entitled ``Use of Unapproved 
Hormone Implants in Veal Calves.'' This guidance, which was issued on 
April 2, 2004, is being withdrawn because the policy contained within 
it only applied to veal calves presented for slaughter prior to June 6, 
2004.

[[Page 42444]]


FOR FURTHER INFORMATION CONTACT: Gloria J. Dunnavan, Center for 
Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1166, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register dated April 8, 2004 
(69 FR 18594), FDA announced the availability of a guidance for 
industry (172) entitled ``Use of Unapproved Hormone Implants 
in Veal Calves.'' This guidance outlined special measures to ensure the 
safety of veal in response to the identified illegal use of unapproved 
hormone implants in veal calves. The policy outlined in this guidance 
only applied to veal calves presented for slaughter prior to June 6, 
2004. Therefore, the guidance is no longer relevant and is being 
withdrawn. Because there is no approved animal drug application 
providing for the use of these implants in veal calves, such use is 
illegal. Under section 512 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360b), use of an unapproved new animal drug 
results in the drug being unsafe, and, therefore, the drugs are 
adulterated under section 501(a)(5) of the act (21 U.S.C. 351(a)(5)). 
In addition, food that bears or contains these drugs is adulterated 
under section 402(a)(2)(C)(ii) of the act (21 U.S.C. 342(a)(2)(C)(ii)).

    Dated: July 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16036 Filed 7-14-04; 8:45 am]
BILLING CODE 4160-01-S