[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Page 59714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Animal Drugs, Feeds, and Related Products; Change of Sponsor; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the correct sponsor for an approved new 
animal drug application. The sponsor that is currently specified in the 
regulations is incorrect. This document amends the regulations to 
correct that error.

EFFECTIVE DATE: November 5, 1998.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), 5600 Fishers Lane, Rockville, MD 20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: FDA has discovered that an error has become 
incorporated into the agency's regulations for animal drugs, feeds, and 
related products. An amendment published on June 30, 1997 (62 FR 
35075), amended Sec. 522.1044 (21 CFR 522.1044) in paragraph (b)(3) by 
removing ``054273'' and adding in its place ``000010''. However, 
Sec. 522.1044(b)(3) was not added to the agency's regulations until 
August 26, 1997 (62 FR 45157). Because Sec. 522.1044(b)(3) did not 
exist when the amendment was made, the regulations were not amended and 
therefore the regulations are incorrect. This document corrects that 
error.

List of Subjects in 21 CFR Part 522

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 522 continues to read as 
follows:

     Authority: 21 U.S.C. 360b.

Sec.  522.1044  [Amended]

    2. Section 522.1044 Gentamicin sulfate injection is amended in 
paragraph (b)(3) by removing ``054273'' and adding in its place 
``000010''.

    Dated: October 22, 1998.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 98-29611 Filed 11-4-98; 8:45 am]
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