Document ID: FDA-2010-N-0002-0071
Agency: fda
Document Type: Rule
Title: Certain Other Dosage Form New Animal Drugs: Progesterone Intravaginal Inserts
Posted Date: 2010-10-14T04:00Z

[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Rules and Regulations]               
[Page 63085-63086]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc10-16]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2010-N-0002]

 
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 a supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA provides for use of progesterone 
intravaginal inserts and dinoprost tromethamine by injection for 
synchronization of estrus in lactating dairy cows.

DATES: This rule is effective October 14, 2010.

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 filed a supplement 
to NADA 141-200 that provides for use of EAZI-BREED CIDR Progesterone 
Intravaginal Inserts and dinoprost tromethamine by injection for 
synchronization of estrus in lactating dairy cows. The NADA is approved 
as of July 22, 2010, 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 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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. In Sec.  529.1940, revise paragraphs (d)(2) and (e)(1) and remove 
the last sentence in paragraph (e)(2)(iii) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (d) * * *
    (2) Cows. This product is approved with the concurrent use of 
dinoprost solution when used for indications listed in paragraphs 
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this section. See Sec.  522.690(c) 
of this chapter.
    (e) * * *
    (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 1 day prior to insert removal (Day 6). 
When used for indications listed in paragraph (e)(1)(ii)(B) of this 
section, administer 25 mg dinoprost as a single intramuscular injection 
on the day of insert removal (Day 7).
    (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 estrus in lactating dairy cows.
    (C) For synchronization of the return to estrus in lactating dairy 
cows

[[Page 63086]]

inseminated at the immediately preceding estrus.
    (iii) Limitations. Do not use in beef or dairy heifers of 
insufficient size or age for breeding or in animals with abnormal, 
immature, or infected genital tracts. Do not use in beef cows that are 
fewer than 20 days postpartum. 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.
* * * * *

    Dated: October 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-25893 Filed 10-13-10; 8:45 am]
BILLING CODE 4160-01-P