[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Rules and Regulations]
[Pages 66583-66584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32035]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Semduramicin with
Bacitracin Methylene Disalicylate
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 a new animal drug application
(NADA) filed by Pfizer, Inc. The NADA provides for using approved
single ingredient Type A medicated articles to make combination drug
Type C medicated broiler chicken feeds containing semduramicin with
bacitracin methylene disalicylate. The Type C medicated feed is used
for prevention of coccidiosis and for improved feed efficiency.
EFFECTIVE DATE: December 18, 1996.
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1607.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed NADA 141-065, which provides for combining approved Type A
medicated articles containing AviaxTM (semduramicin sodium) with
BMD (bacitracin methylene disalicylate) to make combination
drug Type C medicated broiler chicken feed containing 22.7 grams (g) of
semduramicin and 10 to 50 g of bacitracin methylene disalicylate. The
Type C medicated feed is used for the prevention of coccidiosis caused
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E.
necatrix, and E. tenella, and for improved feed efficiency in broiler
chickens. The NADA is approved as of October 18, 1996, and the
regulations are amended by revising 21 CFR 558.76(d)(3)(xiv) and by
adding 21 CFR 558.555(b)(3) to reflect the approval. The basis for
approval is discussed in the freedom of information summary.
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 this application
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.
[[Page 66584]]
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years marketing exclusivity beginning October 18, 1996, because the
application contains reports of new clinical or field investigations
(other than bioequivalence or residue studies) essential to the
approval of the application and conducted or sponsored by the
applicant.
The agency has determined under 21 CFR 25.24(d)(1)(ii) that this
action is of a type that does 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 in 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 part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. 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).
2. Section 558.76 is amended by revising paragraph (d)(3)(xiv) to
read as follows:
Sec. 558.76 Bacitracin methylene disalicylate
* * * * *
(d) * * *
(3) * * *
(xiv) Semduramicin alone or in combination with roxarsone as in
Sec. 558.555.
3. Section 558.555 is amended by adding new paragraph (b)(3) to
read as follows:
Sec. 558.555 Semduramicin.
* * * * *
(b) * * *
(3) Amount. Semduramicin 22.7 grams with bacitracin methylene
disalicylate 10 to 50 grams per ton.
(i) Indications for use. For the prevention of coccidiosis caused
by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E.
necatrix, and E. tenella, and for improved feed efficiency in broiler
chickens.
(ii) Limitations. Feed continuously as sole ration. Use feed within
2 weeks of production. Do not feed to laying hens. Semduramicin as
provided by 000069, bacitracin methylene disalicylate as provided by
046573 in Sec. 510.600(c) of this chapter.
Dated: December 6, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32035 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F
