Document ID: FDA-2009-N-0665-0055
Agency: fda
Document Type: Rule
Title: Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts
Posted Date: 2009-11-17T05:00Z

[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Rules and Regulations]               
[Page 59073-59074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no09-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2009-N-0665]

 
Certain Other Dosage Form New Animal Drugs; Progesterone 
Intravaginal Inserts

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 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

[[Page 59074]]

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

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
2. Section 529.1940 is revised to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

    (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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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.

    Dated: November 3, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-27497 Filed 11-16-09; 8:45 am]

BILLING CODE 4160-01-S