[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Page 67877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0509]


Hoffmann-La Roche, Inc.; Withdrawal of Approval of NADA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) held by Hoffmann-La Roche, Inc. 
The NADA provides for use of chlortetracycline Type A medicated article 
to make Type B or Type C medicated feeds. The sponsor requested the 
withdrawal of approval because the animal drug product is no longer 
manufactured or marketed.

EFFECTIVE DATE: January 9, 1998.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, is the sponsor of NADA 100-903 that provides for 
use of chlortetracycline Type A medicated articles to make Tpye B or 
Type C medicated feeds. The animal drug product had been subject to 
review under the National Academy of Sciences/National Research 
Council, Drug Efficacy Study Implementation Program, and it was 
currently subject to requirements for finalization under that program. 
By letter of August 20, 1997, the sponsor requested withdrawal of 
approval of the NADA because the animal drug product is no longer 
manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.48), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA 100-903 and all supplements and amendments thereto is 
hereby withdrawn, effective January 9, 1998.
    This product had not been the subject of a regulation published 
under section 512 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b). Therefore, an amendment to the animal drug regulations to 
reflect the withdrawal of approval is not required.

    Dated: December 19, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33922 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F