Document ID: FDA-2010-N-0002-0013
Agency: fda
Document Type: Notice
Title: New Animal Drugs for Use in Animal Feeds; Chlortetracycline
Posted Date: 2010-03-02T05:00Z

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Page 9334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4205]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0002]

New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 supplemental new animal drug 
application (NADA) filed by ADM Alliance Nutrition, Inc. The 
supplemental NADA provides for use of a higher concentration 
chlortetracycline Type A medicated article for the manufacture of 
medicated feeds for livestock and poultry.

DATES:  This rule is effective March 2, 2010.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: ADM Alliance Nutrition, Inc., 1000 North 
30th St., Quincy, IL 62305-3115, filed a supplement to NADA 48-480 that 
provides for the use of CHLORATET 50 (chlortetracycline), a Type A 
medicated article containing 50 grams of chlortetracycline per pound, 
for the manufacture of medicated feeds for livestock and poultry. The 
supplement provides for use of Type A medicated articles containing 90 
or 100 grams of chlortetracycline per pound. The supplemental NADA is 
approved as of January 7, 2010, and the regulations are amended in 21 
CFR 558.128 to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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 Subject in 21 CFR Part 558

    Animal drugs, animal feeds.

0
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

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.128, revise paragraph (b)(2) to read as follows:

Sec.  558.128   Chlortetracycline.

* * * * *
    (b) * * *
    (2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated 
article.
* * * * *

    Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-4205 Filed 3-1-10; 8:45 am]
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