Document ID: FDA-2008-N-0039-0011
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Altrenogest
Posted Date: 2008-02-21T05:00Z

[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Rules and Regulations]               
[Page 9455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-13]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral Dosage Form New Animal Drugs; Altrenogest

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 Intervet, Inc. The supplemental NADA 
provides for revised food safety labeling for altrenogest oral solution 
used in horses.

DATES: This rule is effective February 21, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed a supplement to NADA 131-310 for REGU-
MATE (altrenogest), an oral solution administered to mares for 
suppression of estrus. The supplemental application provides for a 
revised warning statement on product labeling. The supplemental NADA is 
approved as of January 18, 2008, and 21 CFR 520.48 is amended 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.
    The agency 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 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.  520.48, revise the section heading and paragraph 
(d)(1)(iii) to read as follows:

Sec.  520.48  Altrenogest.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
* * * * *

    Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-3265 Filed 2-20-08; 8:45 am]

BILLING CODE 4160-01-S