[Federal Register Volume 68, Number 193 (Monday, October 6, 2003)]
[Rules and Regulations]
[Pages 57613-57614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


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. The supplemental 
NADA provides for use of progesterone intravaginal inserts for 
synchronization of the return to estrus in lactating dairy cows 
inseminated at the immediately preceding estrus.

DATES: This rule is effective October 6, 2003.

FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0231, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199 filed a supplement to NADA 141-200 that 
provides for use of EAZI-BREED CIDR Progesterone Intravaginal Inserts 
for synchronization of the return to estrus in lactating dairy cows 
inseminated at the immediately preceding estrus. The NADA is approved 
as of July 29, 2003, and the regulations are amended in 21 CFR 529.1940 
to reflect the approval. The basis of approval is discussed in the 
freedom of information summary.
    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 
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental 
approval qualifies for 3 years of marketing exclusivity beginning July 
29, 2003.
    The agency has determined under 21 CFR 25.33(c) 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.

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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. Section 529.1940 is amended in paragraph (e)(3) in the first 
sentence by removing the phrase ``; or in lactating dairy cows''; and 
by revising paragraphs (d)(1), (d)(2), (e)(1), and (e)(2) to read as 
follows:


Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (d) * * *
    (1) Product labeling shall bear the following warnings: ``Avoid 
contact with skin by wearing latex gloves when handling inserts. Store 
removed inserts in a plastic bag or other sealable container until they 
can be disposed of in accordance with applicable local, State, and 
Federal regulations.''
    (2) 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)(2)(i) of this section. See Sec.  
522.690(c) of this chapter.
* * * * *
    (e) * * *
    (1) Amount. Administer one intravaginal insert per animal for 7 
days. When used for indications listed in paragraph (e)(2)(i) 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.
    (2) Indications for use--(i) For synchronization of estrus in 
suckled beef cows and replacement beef and dairy heifers, for 
advancement of first postpartum estrus in suckled beef cows,

[[Page 57614]]

and for advancement of first pubertal estrus in replacement beef 
heifers.
    (ii) For synchronization of the return to estrus in lactating dairy 
cows inseminated at the immediately preceding estrus.
* * * * *

    Dated: September 24, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-25249 Filed 10-3-03; 8:45 am]
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