[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Page 9334]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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.
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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 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.
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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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