[Federal Register Volume 74, Number 228 (Monday, November 30, 2009)]
[Rules and Regulations]
[Pages 62490-62491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]


Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

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 Alpharma Inc. The ANADA provides for use 
of generic chlortetracycline soluble powder to make medicated drinking 
water for cattle, swine, chickens, and turkeys for the treatment of 
several bacterial diseases.

DATES: This rule is effective November 30, 2009.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
[email protected].

[[Page 62491]]


SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Route 22, Bridgewater, NJ 
08807, filed ANADA 200-441 that provides for the use of A-MYCIN 
(chlortetracycline) Soluble Powder to make medicated drinking water for 
cattle, swine, chickens, and turkeys for the treatment of several 
bacterial diseases. Alpharma Inc.'s A-MYCIN Soluble Powder is approved 
as a generic copy of Fort Dodge Animal Health, A Division of Wyeth 
Holdings Corp.'s AUREOMYCIN (chlortetracycline) Soluble Powder, 
approved under NADA 65-440. The ANADA is approved as of October 9, 
2009, and the regulations are amended in 21 CFR 520.445b to reflect the 
approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(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.
    FDA has determined under 21 CFR 25.33 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. In Sec.  520.445b, revise paragraph (b)(2) to read as follows:


Sec.  520.445b  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) Nos. 046573 and 053501 for use as in paragraph (d) of this 
section.
* * * * *

    Dated: November 23, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-28468 Filed 11-27-09; 8:45 am]
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