Document ID: FDA-2017-N-0002-0003
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of a New Animal Drug
Application
Posted Date: 2017-05-10T04:00Z

[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Page 21694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09365]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Withdrawal of Approval of a New Animal Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA). This action is being taken at 
the sponsors' request because these products are no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective May 22, 2017.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Sioux Biochemical, Inc., 204 Third St. NW., 
Sioux Center, IA 51250 has requested that FDA withdraw approval of NADA 
009-505 for F.S.H.-P (follicle stimulating hormone) Powder for 
Injection because the product is no longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, and in 
accordance with Sec.  514.116 Notice of withdrawal of approval of 
application (21 CFR 514.116), notice is given that approval of NADA 
009-505, and all supplements and amendments thereto, is hereby 
withdrawn, effective May 22, 2017.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of this application.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09365 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P