[Federal Register Volume 68, Number 131 (Wednesday, July 9, 2003)]
[Notices]
[Pages 40984-40985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Notice of Approval of New Animal Drug Applications; Clindamycin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that it has approved three new animal drug applications (NADAs) or 
abbreviated new animal drug applications (ANADAs) in 2002 for feed 
combinations including a generic bacitracin zinc Type A medicated 
article that were not the subject of final rules. Final rules were not 
published because the applicable sections of the regulation did not 
require amendment.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In accordance with section 512(i) of the 
Federal Food Drug and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 
514.105(a) and 514.106(a), FDA is providing notice that it has approved 
three NADAs or ANADAs in 2002 that were not the subject of final rules. 
Final rules were not published because the applicable sections of part 
558 (21 CFR part 558) did not require amendment.
    On April 29, 2002, FDA approved a supplement filed by Alpharma, 
Inc., to NADA 140-865 for use of single-ingredient MONTEBAN (narasin) 
and BACIFERM (bacitracin zinc) Type A medicated articles to make two-
way combination drug Type B and Type C medicated feeds used for 
prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati, and E. maxima; and for increased 
rate of weight gain and improved feed efficiency in broiler chickens. 
The supplemental NADA provided for use of Alpharma, Inc.'s ALBAC 
(bacitracin zinc) 50 Type A medicated article, approved under ANADA 
200-223 as a generic copy of BACIFERM, in these two-way combination 
chicken feeds. No new data were submitted. The necessary amendment to 
Sec. Sec.  558.78 and 558.363 were made in a final rule (65 FR 55893, 
September 15, 2000) for the 2000 approval of this combination for 
MONTEBAN and BACIFERM Type A medicated articles.
    On May 15, 2002, FDA approved original NADA 141-181 filed by 
Alpharma, Inc., for use of single-ingredient AVATEC (lasalocid) and 
ALBAC (bacitracin zinc) Type A medicated articles to make two-way 
combination drug Type B and Type C medicated feeds for the prevention 
of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. 
adenoeides, and for increased rate of weight gain and improved feed 
efficiency in growing turkeys. No new data were submitted. The 
necessary amendments to Sec. Sec.  558.78 and 558.311 were made in a 
final rule (64 FR 26844, May 18, 1999) for the 1999 approval of 
Alpharma, Inc.'s NADA 141-109 for use of AVATEC and BACIFERM Type A 
medicated articles in two-way combination turkey feeds for identical 
conditions of use.
    On June 24, 2002, FDA approved original ANADA 200-208 filed by 
Alpharma, Inc., for use of single-ingredient AVATEC (lasalocid), 3 
NITRO (roxarsone), and ALBAC (bacitracin zinc) Type A medicated 
articles to make three-way combination drug Type B and Type C medicated 
feeds used for prevention of coccidiosis caused by E. tenella, E. 
necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an 
aid in the reduction of lesions due to E. tenella; and for

[[Page 40985]]

increased rate of weight gain or improved feed efficiency in broiler 
chickens. ANADA 200-208 was approved as a generic copy of Alpharma, 
Inc.'s NADA 126-052, for use of AVATEC, 3 NITRO, and BACIFERM 
(bacitracin zinc) Type A medicated articles for identical conditions of 
combination use. No new data were submitted. The necessary amendments 
to Sec. Sec.  558.78, 558.311, and 558.530 were made in a final rule 
(47 FR 46496, October 19, 1982) for the 1982 approval of the pioneer 
combination.
    Freedom of information summaries containing approved product 
labeling may be seen in the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-17262 Filed 7-8-03; 8:45 am]
BILLING CODE 4160-01-S