[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
