[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