[Federal Register Volume 67, Number 119 (Thursday, June 20, 2002)]
[Rules and Regulations]
[Pages 41823-41825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15633]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 529
Certain Other Dosage Form New Animal Drugs; Progesterone
Intravaginal Inserts
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by DEC International, Inc. The NADA provides for use of
progesterone intravaginal inserts for manipulation of estrus in cattle.
DATES: This rule is effective June 20, 2002.
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: DEC International, Inc., 1919 South
Stoughton Rd., P.O. Box 8050, Madison WI 53708-8050, filed NADA 141-200
that provides for use of EAZI-BREED CIDR Progesterone Intravaginal
Inserts 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. The NADA is approved as of May 2,
2002, and the regulations in 21 CFR part 529 are amended by adding
Sec. 529.1940 to reflect the approval. The regulation in 21 CFR 522.690
is being amended to add a cross-reference for the concurrent use of
dinoprost solution by intramuscular injection and is being revised to
reflect a current format. The basis of approval is discussed in the
freedom of information summary.
In addition, DEC International, Inc., has not been previously
listed in the animal drug regulations as a sponsor of an approved
application. At this time, 21 CFR 510.600(c) is being amended to add
entries for the firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Dockets Management Branch (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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning May 2, 2002.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 522 and 529
Animal drugs.
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 parts 510,
522, and 529 are amended as follows:
[[Page 41824]]
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding an entry for ``DEC International, Inc.'' and in
the table in paragraph (c)(2) by numerically adding an entry for
``067080'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * *
* * *
DEC International, Inc., 1919 South Stoughton 067080
Rd., P.O. Box 8050, Madison, WI 53708-8050
* * * *
* * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * *
* * *
067080 DEC International, Inc., 1919 South
Stoughton Rd., P.O. Box 8050, Madison, WI
53708-8050
* * * *
* * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
4. Section 522.690 is revised to read as follows:
Sec. 522.690 Dinoprost solution.
(a) Specifications. Each milliliter (mL) of solution contains
dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost.
(b) Sponsors. See Nos. 000009 and 059130 in Sec. 510.600(c) of this
chapter.
(c) Special considerations. (1) Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(2) Women of child-bearing age, asthmatics, and persons with
bronchial and other respiratory problems should exercise extreme
caution when handling this product. Dinoprost tromethamine is readily
absorbed through the skin and can cause abortion and bronchiospasms.
Accidental spillage on the skin should be washed off immediately with
soap and water.
(d) Conditions of use--(1) Horses--(i) Amount. 1 mg per 100 pounds
of body weight as a single intramuscular injection.
(ii) Indications. For its luteolytic effect to control timing of
estrus in estrus cycling mares and in clinically anestrous mares that
have a corpus luteum.
(iii) Limitations. Not for use in horses intended for food.
(2) Cattle--(i) Beef cattle and nonlactating dairy heifers--(A)
Amount. 25 mg as an intramuscular injection either once or twice at a
10- to 12-day interval.
(B) Indications. For its luteolytic effect to control timing of
estrus and ovulation in estrous cycling cattle that have a corpus
luteum.
(ii) Beef cattle and nonlactating dairy heifers--(A) Amount. 25 mg
as a single intramuscular injection.
(B) Indications. For treatment of pyometra (chronic endometritis).
(iii) Nonlactating cattle--(A) Amount. 25 mg as a single
intramuscular injection during the first 100 days of gestation.
(B) Indications. For its abortifacient effect in nonlactating
cattle.
(iv) Lactating dairy cattle--(A) Amount. 25 mg as a single
intramuscular injection.
(B) Indications. For treatment of unobserved (silent) estrus in
lactating dairy cattle that have a corpus luteum.
(v) Dinoprost solution as provided by No. 000009 in Sec. 510.600(c)
of this chapter may be used concurrently with progesterone intravaginal
inserts as in Sec. 529.1940 of this chapter.
(3) Swine--(i) Amount. 10 mg as a single intramuscular injection.
(ii) Indications. For parturition induction in swine when injected
within 3 days of normal predicted farrowing.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
5. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
6. Section 529.1940 is added to read as follows:
Sec. 529.1940 Progesterone intravaginal inserts.
(a) Specifications. Each insert contains 1.38 grams of progesterone
in molded silicone over a nylon spine.
(b) Sponsor. See No. 067080 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.540(a) of this chapter.
(d) Special considerations. (1) Wear latex gloves when handling
inserts. Store removed inserts in a plastic bag or other sealable
container until they can be disposed 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. See
Sec. 522.690(c) of this chapter.
(e) Conditions of use--(1) Amount. Administer one intravaginal
insert per animal for 7 days. Administer 25 milligrams (mg) dinoprost
(5 milliliters (mL) of 5 mg/mL solution as in Sec. 522.690(a) of this
chapter) 1 day prior to insert removal.
(2) Indications for use. 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.
(3) 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; or in lactating dairy cows. Do not use an insert more than
once. To prevent the potential transmission of venereal and bloodborne
diseases, the inserts should
[[Page 41825]]
be disposed after a single use. Administration of vaginal inserts for
periods greater than 7 days may result in reduced fertility. Dinoprost
solution as provided by No. 000009 in Sec. 510.600(c) of this chapter.
Dated: June 6, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-15633 Filed 6-19-02; 8:45 am]
BILLING CODE 4160-01-S