Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The NADA provides for use of a progesterone intravaginal insert for induction of estrus in ewes during seasonal anestrus.

DATES:

This rule is effective November 17, 2009.

FOR FURTHER INFORMATION CONTACT:

Suzanne J. Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, has filed NADA 141-302 for over-the-counter use of EAZI-BREED CIDR (progesterone) Sheep Inserts for induction of estrus in ewes during seasonal anestrus. The NADA is approved as of October 1, 2009, and the regulations are amended in 21 CFR 529.1940 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.

Under section 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2), this supplemental approval qualifies for 7 years of exclusive marketing rights beginning on the date of approval because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act.

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 Part 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 CFR part 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. Section 529.1940 is revised to read as follows:

(a) Specifications. Each insert contains:

(1) 1.38 grams (g) progesterone in molded silicone over a nylon spine.

(2) 0.3 g progesterone in molded silicone over a flexible nylon spine.

(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section; and the product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.

(c) Related tolerances. See § 556.540(a) of this chapter.

(d) Special considerations—(1) Cows and ewes. Product labeling shall bear the following warnings: “Avoid contact with skin by wearing protective gloves when handling inserts. Store removed inserts in a sealable container until they can be disposed of in accordance with applicable local, state, and Federal regulations.”

(2) Cows. This product is approved with the concurrent use of dinoprost solution on day 6 of the 7-day administration period when used for indications listed in paragraph (e)(1)(ii)(A) of this section. See § 522.690(c) of this chapter.

(e) Conditions of use—(1) Cows—(i) Amount. Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(1)(ii)(A) of this section, administer 25 milligrams (mg) dinoprost (5 milliliters (mL) of 5 mg/mL solution as in § 522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal.

(ii) Indications for use—(A) For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, for advancement of first postpartum estrus in suckled beef cows, and for advancement of first pubertal estrus in replacement beef heifers.

(B) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus.

(iii) Limitations. Do not use in animals with abnormal, immature, or infected genital tracts; or in beef cows that are fewer than 20 days postpartum; or in beef or dairy heifers of insufficient size or age for breeding. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. Administration of vaginal inserts for periods greater than 7 days may result in reduced fertility. Dinoprost solution provided by No. 000009 in § 510.600(c) of this chapter.

(2) Ewes—(i) Amount. Administer one intravaginal insert per animal for 5 days.

(ii) Indications for use. For induction of estrus in ewes (sheep) during seasonal anestrus.

(iii) Limitations. Do not use in animals with abnormal, immature, or infected genital tracts; or in ewes that have never lambed. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. A pre-slaughter withdrawal period is not required when this product is used according to directions.