[Federal Register Volume 75, Number 198 (Thursday, October 14, 2010)]
[Rules and Regulations]
[Pages 63085-63086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25893]
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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:
[email protected].
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
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1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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]
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