[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Notices]
[Pages 24500-24501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12155]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0013]
Benton County Ag Center, Inc.; Withdrawal of a Notice of
Opportunity for Hearing Proposing To Withdraw Approval of Medicated
Feed Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Center for Veterinary Medicine (CVM), Food and Drug
Administration (FDA), is withdrawing a notice of opportunity for
hearing (NOOH) on a proposal to withdraw approval of 11 medicated feed
applications (MFA's) held by Benton County Ag Center, Inc. CVM has
determined that the firm is in compliance with current good
manufacturing practice (CGMP) regulations for medicated animal feeds
and has instituted a system to maintain its compliance status.
EFFECTIVE DATE: May 15, 1996.
[[Page 24501]]
FOR FURTHER INFORMATION CONTACT: Karen A. Kandra, Center for Veterinary
Medicine (HFV-246), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1765.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of April 26, 1995 (60 FR 20497), CVM provided an opportunity
for hearing on a proposal to withdraw approval of 11 MFA's held by
Benton County Ag Center, Inc., for the manufacture of animal feeds
bearing or containing new animal drugs. CVM took this action based on
the firm's apparent failure to comply with agency CGMP requirements for
medicated animal feeds as evidenced by inspections conducted on
December 22, 1992, and May 3, 4, 10, and 11, 1994.
In a letter that FDA received on May 23, 1995, in response to the
notice, Benton County Ag Center, Inc., stated it had made the necessary
corrections to bring its operations into compliance with CGMP
requirements since the last inspection. The letter requested that FDA
reinspect the feed mill to verify its compliance status, and to
withdraw the NOOH.
On July 17 through 19, 1995, the Iowa Department of Agriculture,
under contract with FDA pursuant to section 702(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 372(a)), reinspected the
feed mill and found that the firm had corrected the previously noted
CGMP deficiencies that had formed the basis for the NOOH. Additionally,
FDA believes that the firm has taken measures to ensure that it will
remain in compliance with CGMP's. Accordingly, CVM is withdrawing the
April 26, 1995, NOOH on the proposal to withdraw approval of the firm's
MFA's.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sec. 512 (21 U.S.C. 360b)) and under authority delegated to the
Director, Center for Veterinary Medicine (21 CFR 5.84).
Dated: April 2, 1996.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 96-12155 Filed 5-14-96; 8:45 am]
BILLING CODE 4160-01-F
