[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Notices]
[Page 14433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97N-0007]


Land O'Lakes, Inc., et al.; Withdrawal of Approval of NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADA's) held by Land O' Lakes, 
Inc., and three NADA's held by ADM Animal Health & Nutrition Div. The 
sponsors requested voluntary withdrawal of approval of the NADA's. In a 
final rule published elsewhere in this issue of the Federal Register, 
FDA is amending the regulations by removing those portions which 
reflect approval of these NADA's.

EFFECTIVE DATE: April 4, 1997.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: Land O'Lakes, Inc., Agricultural Services, 
2827 Eighth Avenue South, Fort Dodge, IA 50501, has requested 
withdrawal of approval of NADA 42-489 tylosin Type A medicated articles 
and NADA 98-156 tylosin/sulfamethazine Type A medicated articles.
    ADM Animal Health & Nutrition Div., P.O. Box 2508, Fort Wayne, IN 
46801-2508, has requested withdrawal of approval of NADA 118-874 
pyrantel tartrate Type A medicated articles (the NADA originally held 
by Henwood Feed Additives, Inc.), NADA 127-825 hygromycin B Type A 
medicated articles and NADA 127-826 tylosin/sulfamethazine Type A 
medicated articles (the NADA's originally held by Music City Supplement 
Co.).
    The sponsors requested 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 21 CFR 514.115 
Withdrawal of approval of applications (21 CFR 514.115), notice is 
given that approval of NADA's 42-489, 98-156, 118-874, 127-825, and 
127-826 and all supplements and amendments thereto is hereby withdrawn, 
effective April 4, 1997.

    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending 21 CFR 510.600, 558.274, 558.485, 558.625, 
and 558.630 to reflect withdrawal of approval of these NADA's.

    Dated: March 13, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-7540 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F