[Federal Register: October 6, 2003 (Volume 68, Number 193)]
[Rules and Regulations]
[Page 57613-57614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc03-4]
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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: hhoward@cvm.fda.gov.
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.
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. 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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