[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Rules and Regulations]
[Page 14356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Bambermycins; 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 regulation for bambermycins to correct several cross-references in 
that regulation. In approving a new animal drug application (NADA) 
filed by Hoechst Roussel Vet, FDA failed to amend certain cross-
references to conform to amendments in the approval document and to 
provide certain other cross-references. This document provides for 
those conforming amendments and cross-references.

EFFECTIVE DATE: March 25, 1998.

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 amending the bambermycins regulation to 
reflect approval of Hoechst Roussel Vet's NADA 141-034 (use of 
bambermycins Type A medicated articles to make Type C medicated cattle 
feeds), FDA amended Sec. 558.95 (21 CFR 558.95) by redesignating 
paragraph (b) as paragraph (d) (see 62 FR 8373, February 25, 1997), but 
failed to amend the cross-references in paragraph (a). Furthermore, in 
approving NADA 141-034 to establish several added uses in 
Sec. 558.95(b)(4) (currently Sec. 558.95(d)(4)) (see 59 FR 15624, April 
4, 1994 and 61 FR 43654, August 26, 1996), FDA failed to provide 
reference in paragraph (a)(5) to uses in paragraphs (b)(4)(ii) and 
(b)(4)(iii) (current paragraphs (d)(4)(ii) and (d)(4)(iii)). Section 
558.95 is amended by revising paragraph (a), by revising the cross-
references to paragraphs (d)(1), (d)(2), (d)(3), and (d)(4), as 
appropriate, and by expanding those references in paragraph (a)(5) to 
reflect all uses in paragraph (d)(4).

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

    2. Section 558.95 is amended by revising paragraph (a) to read as 
follows:


Sec. 558.95   Bambermycins.

    (a) Approvals. To sponsors identified by drug labeler codes in 
Sec. 510.600(c) of this chapter for use of bambermycins Type A 
medicated articles as bambermycins activity per pound in paragraph (d) 
of this section as follows:

    (1) To 012799: 2, 4, and 10 grams for use as in paragraphs (d)(1), 
(d)(2), (d)(3), and (d)(4) of this section.
    (2) To 012799: 0.4 gram for use as in paragraph (d)(2) of this 
section.
    (3) To 011490: 0.4 and 2 grams for use as in paragraph (d)(2) of 
this section.
     (4) To 012286, 016968, and 017790: 0.4 and 2 grams for use as in 
paragraph (d)(2) and 2 grams for use as in paragraph (d)(3) of this 
section.
    (5) To 012799: 10 grams to make 40 to 800 grams per ton Type B feed 
for use as in paragraph (d)(4) of this section.
* * * * *

    Dated: March 12, 1998.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-7699 Filed 3-24-98; 8:45 am]
BILLING CODE 4160-01-F