[Federal Register: July 15, 2004 (Volume 69, Number 135)]
[Notices]
[Page 42443-42444]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy04-71]
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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April 2, 2004, is being withdrawn because the policy contained within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:
gloria.dunnavan@fda.gov.
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withdrawn.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