[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hereby withdrawn, effective January 9, 1998.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
