[Federal Register Volume 60, Number 124 (Wednesday, June 28, 1995)]
[Rules and Regulations]
[Pages 33342-33343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15768]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Nicarbazin Type A
Medicated Article
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 an abbreviated new animal drug
application (ANADA) filed by Planalquimica Industrial Ltda. The ANADA
provides for the use of a nicarbazin-containing Type A medicated
article in making Type C medicated chicken feeds for the prevention of
coccidiosis.
EFFECTIVE DATE: June 28, 1995.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Planalquimica Industrial Ltda., Rua das
Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao
Paulo, Brazil, has filed ANADA 200-027, which provides for the use of a
nicarbazin-containing Type A medicated article in making Type C
medicated chicken feeds as an aid in preventing outbreaks of cecal and
intestinal coccidiosis.
Planalquimica's ANADA 200-027 for a 113.5-gram-per-pound nicarbazin
Type A medicated article (Nicarmix) is approved as a generic copy of
Merck Research Laboratories' NADA 9-476 for Nicarb. The ANADA
is approved as of June 28, 1995, and the regulations are amended in 21
CFR 510.600(c) and 558.366(a) 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Planalquimica Industrial
Ltda.'' and in the table in paragraph (c)(2) by numerically adding a
new entry for ``060728'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
[[Page 33343]]
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Firm name and address Drug labeler code
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* * * *
* * *
Planalquimica Industrial Ltda., Rua
das Magnolias nr. 2405, Jardim das
Bandeiras, CEP 13053-120, Campinas,
Sao Paulo, Brazil.................. 060728
* * * *
* * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
060728................ Planalquimica Industrial Ltda., Rua das
Magnolias nr. 2405, Jardim das Bandeiras, CEP
13053-120, Campinas, Sao Paulo, Brazil
* * * *
* * *
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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. 558.366 [Amended]
4. Section 558.366 Nicarbazin is amended in paragraph (a) by
removing the phrase ``000006 and 000986'' and adding in its place
``000006, 000986, and 060728''.
Dated: June 21, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-15768 Filed 6-27-95; 8:45 am]
BILLING CODE 4160-01-F
