[Federal Register: May 9, 2007 (Volume 72, Number 89)]
[Rules and Regulations]
[Page 26289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my07-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 529
Certain Other Dosage Form 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 an abbreviated new animal drug
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA
provides for use of oxytetracycline hydrochloride soluble powder for
skeletal marking of finfish fry and fingerlings by immersion.
DATES: This rule is effective May 9, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-460 that provides for use
of TETROXY Aquatic (oxytetracycline hydrochloride) Soluble Powder for
skeletal marking of finfish fry and fingerlings by immersion. The
application is approved as of April 20, 2007, and the regulations are
amended in 21 CFR 529.1660 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.
FDA has determined under 21 CFR 25.33(a)(1) 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 529
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 529 is
amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 529.1660, revise paragraph (b)(1) to read as follows:
Sec. 529.1660 Oxytetracycline.
* * * * *
(b) * * *
(1) Nos. 046573 and 061623 for use of product in paragraph (a)(1)
of this section.
* * * * *
Dated: May 1, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8869 Filed 5-8-07; 8:45 am]
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