[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