Document ID: FDA-2010-N-0002-0022
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Tetracycline Powder; Technical Amendment
Posted Date: 2010-03-18T04:00Z

[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Rules and Regulations]               
[Page 12981]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr10-13]                         

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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: 
cindy.burnsteel@fda.hhs.gov.

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.

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 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