[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Rules and Regulations]
[Pages 11027-11028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4912]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for nine new animal
drug applications (NADA's) from Agri-Bio Corp. to Hoffman-LaRoche, Inc.
This document also corrects an inadvertent error in the animal drug
regulations.
EFFECTIVE DATE: March 1, 1995.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: Agri-Bio Corp., 966 Dorsey St., Gainesville,
GA 30501, has informed FDA that it has transferred the ownership of,
and all rights and interests in, the following approved NADA's to
Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199:
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NADA No. Ingredient(s) Trade name(s)
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128-686..................... Salinomycin Bio-Cox
132-447..................... Salinomycin and Roxarsone Bio-Cox and 3-Nitro
134-284..................... Salinomycin and Bambermycins Bio-Cox and Flavomycins
134-185..................... Salinomycin and Roxarsone and Bambermycins Bio-Cox and 3-Nitro Flavomycin
135-321..................... Salinomycin and Roxarsone and Bacitracin-MD Bio-Cox and 3-Nitro and BMD
135-746..................... Salinomycin and Bacitracin-MD Bio-Cox and BMD
137-536..................... Salinomycin and Roxarsone and Bacitracin Zn Bio-Cox and 3-Nitro and Albac
137-537..................... Salinomycin and Lincomycin Bio-Cox and Lincomix
140-581..................... Salinomycin and Roxarsone and Lincomycin Bio-Cox and 3-Nitro and Lincomix
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Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) and 558.95(b)(1)(xi)(b) and (b)(1)(xii)(b) to
reflect the change of sponsor.
In the Federal Register of January 13, 1995 (60 FR 3079 at 3080),
FDA amended Sec. 558.550; this amendment inadvertently failed to
reflect a previous amendment published in the Federal Register of
December 29,1994 (59 FR 67185). The December 29, 1994, document amended
Sec. 558.550(a)(1) and (a)(2) to provide for specific levels of Type A
articles approved for use for the specified sponsors. The January 13,
1995, document amended Sec. 558.550(a)(2) to add approved referenced
uses as stated in Sec. 558.550(b). This document corrects the
inadventent error made in the final rule of January 13, 1995.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 parts 510 and
558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.600 [Amended]
2. Section 510.600 is amended in the table in paragraph (c)(1) by
removing the entry for ``Agri-Bio Corp.'' and in the table in paragraph
(c)(2) by removing the entry for ``042835''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.95 [Amended]
4. Section 558.95 Bambermycins is amended in paragraphs
(b)(1)(xi)(b) and (b)(1)(xii)(b) by removing ``042835'' and adding in
its place ``000004''.
5. Section 558.550 is amended in paragraph (a)(1) by removing the
number ``042835'' and adding in its place ``000004'', and by revising
paragraph (a)(2) to read as follows:
Sec. 558.550 Salinomycin.
(a) * * *
(2) To 012799 for use of 30 and 60 grams per pound as in paragraphs
(b)(1)(i), (b)(1)(iii) through (b)(1)(xvi), [[Page 11028]] and
(b)(3)(i) through (b)(3)(iii) of this section.
* * * * *
Dated: February 9, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-4912 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F
