Notice of Availability of Data for Progesterone Controlled Intravaginal Drug Release (CIDR) Insert for induction of estrus in ewes (sheep) during seasonal anestrous

March 20, 2009

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Progesterone Controlled Intravaginal Drug Release (CIDR)
Insert for induction of estrus in ewes (sheep) during seasonal anestrous; Availability of Data

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the availability of effectiveness, target animal safety, human food safety, and environmental safety data that may be used in support of a new animal drug application (NADA) or supplemental NADA for use of the progesterone insert (CIDR) for induction of estrus in ewes (sheep) during seasonal anestrous.

The data, contained in Public Master File (PMF) 5947, were compiled by the National Research Support Project 7 (NRSP–7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for minor uses.

ADDRESSES:  Submit NADAs or supplemental NADAs to the Document Control Unit (HFV–199), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:  Linda Wilmot, Center for Veterinary Medicine (HFV–120), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8101, email: linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:  Progesterone insert (CIDR) for induction of estrus in ewes (sheep) during seasonal anestrous is a new animal drug under section 201(v) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(v)).  As a new animal drug, progesterone is subject to section 512 of the act (21 U.S.C. 360b), requiring that its uses be the subject of an approved NADA or supplemental NADA.  Sheep are a minor species under the act, Sec. 201 (oo) and in (21 CFR 516.3(b)).

The NRSP–7 Project, North Central region, Iowa State University, Ames, IA 50011 in cooperation with the Western Region of California, Davis, CA 95616, has provided target animal safety, effectiveness, human food safety, and environmental safety data for the Progesterone insert (CIDR) for induction of estrus in ewes (sheep) during seasonal anestrous.  These data, contained in PMF 5947, were reviewed by FDA and found satisfactory to support those aspects of an original or supplemental NADA.

Sponsors of NADAs or supplemental NADAs may, without further authorization, reference the PMF 5947 to support approval of an application filed under 512(b)(1) of the act or 21 CFR 514.1.

An NADA or supplemental NADA must include, in addition to reference to the PMF, animal drug labeling and all other information needed for approval, such as:  Data supporting extrapolation from a major species in which the drug is currently approved or authorized reference to such data; and data concerning manufacturing methods, facilities, and controls.

Persons desiring more information concerning PMF 5947 or requirements for approval of an NADA or supplement may contact Linda Wilmot (see FOR FURTHER INFORMATION CONTACT).

Dated: March 20, 2009.
Bernadette Dunham, D.V.M., Ph.D.
Director, Center for Veterinary Medicine.