Document ID: FDA-2011-N-0003-0007
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Oxytetracycline
Posted Date: 2011-03-28T04:00Z

[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Rules and Regulations]
[Pages 17025-17026]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 529

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Oxytetracycline

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 abbreviated new 
animal drug application (ANADA) filed by Pennfield Oil Co. The 
supplemental ANADA provides for use of oxytetracycline hydrochloride 
soluble powder for control of American and European foulbrood in honey 
bees and for skeletal marking of finfish fry and fingerlings.

DATES: This rule is effective March 28, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, filed a supplement to ANADA 200-026 that provides for 
use of PENNOX 343 (oxytetracycline HCl) Soluble Powder for control of 
American and European foulbrood in honey bees and for skeletal marking 
of finfish fry and fingerlings by immersion. The supplemental ANADA is 
approved as of December 6, 2010, and the regulations in 21 CFR 
520.1660d and 529.1660 are amended 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.
    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 Parts 520 and 529

    Animal drugs.

    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

[[Page 17026]]

CFR parts 520 and 529 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.1660d  [Amended]

0
2. In paragraph (b)(6) of Sec.  520.1660d, remove ``cattle, and sheep'' 
and in its place add ``cattle, sheep, and honey bees.''

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

Sec.  529.1660  [Amended]

0
4. In paragraph (b)(2) of Sec.  529.1660, remove ``Nos. 000069 and 
059130'' and in its place add ``Nos. 000069, 048164, and 059130''.

    Dated: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7216 Filed 3-25-11; 8:45 am]
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