[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