Animal drugs, feeds, and related products: Sponsor name and address changes Boehringer Ingelheim Animal Health, Inc.,
FR, November 05, 1998 › Rules › Food and Drug Administration
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Federal Register: November 5, 1998 (Volume 63, Number 214)Rules and RegulationsPage 59714From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr05no98-19
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.
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. 98-29611Filed11-4-98; 8:45 amBILLING CODE 4160-01-F
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