[Federal Register Volume 75, Number 52 (Thursday, March 18, 2010)]
[Rules and Regulations]
[Page 12981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Tetracycline Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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 Alpharma, Inc. The supplemental NADA
provides for revised labeling for a 25 gram per pound concentration of
tetracycline hydrochloride soluble powder used to make medicated
drinking water for calves, swine, chickens, and turkeys for the
treatment and control of various bacterial diseases.
DATES: This rule is effective March 18, 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: Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ
08807 filed a supplement to NADA 65-140 that provides for revised
labeling for DURAMYCIN-10 (tetracycline hydrochloride), a soluble
powder containing 25 grams of tetracycline hydrochloride per pound used
to make medicated drinking water for calves, swine, chickens, and
turkeys for the treatment and control of various bacterial diseases.
The supplemental application is approved as of January 12, 2010, and
the regulations are amended in 21 CFR 520.2345d to reflect the
approval.
In addition, FDA has noticed that this approved concentration of
tetracycline soluble powder has not been codified for this sponsor. At
this time, the regulations are being amended to reflect approval of
this product. This change is being made to improve the accuracy of the
animal drug regulations.
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.
The agency 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. 520.2345d, revise paragraphs (b)(2) and (b)(3); remove
paragraph (b)(4); and redesignate paragraph (b)(5) as paragraph (b)(4)
to read as follows:
Sec. 520.2345d Tetracycline powder.
* * * * *
(b)* * *
(2) No. 000010: 102.4 and 324 grams per pound as in paragraph (d)
of this section.
(3) No. 046573: 25, 102.4, and 324 grams per pound as in paragraph
(d) of this section.
* * * * *
Dated: March 5, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-5925 Filed 3-17-10; 8:45 am]
BILLING CODE 4160-01-S