97-22622. Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin Injection; Technical Amendment

[Federal Register Volume 62, Number 165 (Tuesday, August 26, 1997)]
[Rules and Regulations]
[Page 45157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Gentamicin Injection; 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 for gentamicin injection. A document which published 
in the Federal Register of May 15, 1996 (61 FR 24440), inadvertently 
resulted in the 1997 edition of the Code of Federal Regulations not 
containing reference to two gentamicin injection approvals. This 
document amends the gentamicin injection regulations to reflect the 
approvals.

EFFECTIVE DATE: August 26, 1997.
FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary 
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1739.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 15, 1996 (61 
FR 24440), FDA published a document to reflect approval of Schering-
Plough's supplemental NADA 101-862. In amending the regulations to 
reflect the supplemental approval, FDA provided amendatory instructions 
which resulted in two paragraphs inadvertently being removed. This 
document reestablishes those paragraphs in 21 CFR 522.1044(b)(3) and 
(b)(4).

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).
    2. Section 522.1044 is amended by adding paragraphs (b)(3) and 
(b)(4) to read as follows:

Sec. 522.1044   Gentamicin sulfate injection.

*    *    *    *    *
    (b) *  *  *
    (3) See No. 054273 for use of 50 milligrams-per-milliliter solution 
in dogs as in paragraph (d)(5) of this section.
    (4) See No. 050604 for use of 100 milligrams-per-milliliter 
solution in chickens as in paragraph (d)(3) of this section.
*    *    *    *    *

    Dated: August 18, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-22622 Filed 8-25-97; 8:45 am]
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