[Federal Register Volume 62, Number 219 (Thursday, November 13, 1997)]
[Rules and Regulations]
[Page 60781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs for Use in Animal Feeds; Salinomycin and 
Bacitracin Zinc

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 approval of two abbreviated new animal drug 
applications (ANADA's) filed by Alpharma Inc. The ANADA's provide for 
using approved salinomycin and bacitracin zinc Type A medicated 
articles to make Type C medicated broiler chicken feeds used for the 
prevention of coccidiosis and for increased rate of weight gain. This 
document is also amending the animal drug regulations to reflect the 
correct sponsor name for Alpharma Inc.

EFFECTIVE DATE: November 13, 1997.

FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1602.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of ANADA's 200-204 and 200-210 
that provide for combining approved salinomycin and bacitracin zinc 
Type A medicated articles to make Type C medicated broiler feeds 
containing salinomycin 40 to 60 grams per ton (g/t) and bacitracin zinc 
10 to 50 g/t. The Type C medicated feed is used for the prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
brunetti, E. mivati, and E. maxima, and for increased rate of weight 
gain.
    ANADA 200-204, filed by Alpharma Inc., provides for using approved 
BIO-COX (Hoffmann-LaRoche Inc.'s salinomycin NADA 128-686) 
and ALBAC (Alpharma Inc.'s bacitracin zinc ANADA 200-223) 
Type A medicated articles to make the combination drug Type C medicated 
feeds. ANADA 200-210, also filed by Alpharma Inc., provides for using 
approved SACOX (Hoechst-Roussel Vet's salinomycin ANADA 200-
075) and ALBAC (Alpharma Inc.'s bacitracin zinc ANADA 200-
223) Type A medicated articles to make the combination drug Type C 
medicated feeds.
    Alpharma Inc.'s ANADA 200-204 is approved as a generic copy of 
Hoffmann-LaRoche, Inc.'s NADA 139-235. Alpharma Inc.'s ANADA 200-210 is 
approved as a generic copy of Hoechst-Roussel Vet's ANADA 200-089. The 
ANADA's are approved as of September 19, 1997, and the regulations are 
amended in 21 CFR 558.550(b)(1)(vii)(c) to reflect the approvals. The 
basis for approval is discussed in the freedom of information 
summaries.
    FDA is also amending the animal drug regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the correct firm name for Alpharma 
Inc.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of these 
applications may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(1) that these actions are 
of a type that do not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

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: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. 510.600   [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) in the entry for ``ALPHARMA INC.'' and in paragraph (c)(2) in 
the entry for ``046573'' by removing the name ``ALPHARMA INC.'' and 
adding in its place ``Alpharma Inc.''

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


Sec. 558.550   [Amended]

    4. Section 558.550 Salinomycin is amended in paragraph 
(b)(1)(vii)(c) by removing ``No. 000004'' and adding in its place 
``Nos. 000004 and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-29905 Filed 11-12-97; 8:45 am]
BILLING CODE 4160-01-F