[Federal Register Volume 59, Number 166 (Monday, August 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21157]
[[Page Unknown]]
[Federal Register: August 29, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0288]
Purina Mills, Inc.; Withdrawal of Approval of NADA's
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADA's) held by Purina Mills, Inc.
The NADA's provide for use of oxytetracycline concentrate in the feed
of dairy and nondairy cattle, sheep, hogs, poultry, and minks. The
sponsor requested the withdrawal of approval of the NADA's because the
products are no longer being manufactured.
EFFECTIVE DATE: September 8, 1994.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St.
Louis, MO 63166-6812, is the sponsor of NADA 94-959 that provides for
the use of Purina Dairy Plus Medicated (oxytetracycline 1.5 grams per
pound (g/lb)) for mixing in dairy cattle rations. Purina Mills, Inc.,
is also the sponsor of NADA 94-960 that provides for the use of Purina
Mix-R-Mycin Concentrate Medicated (oxytetracycline 20 g/lb) for mixing
in cattle, sheep, hog, poultry, and mink rations. By letter dated
December 1, 1993, Purina Mills, Inc., stated that the products are no
longer marketed and requested a voluntary withdrawal of approval of the
NADA's.
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 5.84), and in accordance with Sec. 514.115 Withdrawal
of approval of applications (21 CFR 514.115), notice is given that
approval of NADA's 94-959 and 94-960 and all supplements and amendments
thereto is hereby withdrawn, effective September 8, 1994.
Dated: August 19, 1994.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 94-21157 Filed 8-26-94; 8:45 am]
BILLING CODE 4160-01-F
