[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
[Rules and Regulations]
[Pages 8371-8372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Progesterone and Estradiol Benzoate
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 Ivy Laboratories, Inc. The supplemental
NADA provides for use of a progesterone-estradiol benzoate ear implant
in suckling beef heifer calves for increased rate of weight gain.
EFFECTIVE DATE: February 25, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Inc., 8857 Bond St.,
Overland Park, KS 66214, filed a supplement to NADA 110-315, which
provides for use of a progesterone-estradiol benzoate ear implant in
suckling beef heifer calves for increased rate of weight gain. Studies
have shown no detrimental effects on reproduction after use of the
implants in heifer calves. The supplement is approved as of January 22,
1997, and the regulations are amended in 21 CFR 522.1940(d)(1)(iii) to
reflect the approval by limiting the use to indicate
[[Page 8372]]
that the implant is not for use in bull calves intended for
reproduction. The basis for approval is discussed in the freedom of
information summary.
In addition, due to enactment of the Generic Animal Drug and Patent
Term Restoration Act of 1988, the paragraph concerning National Academy
of Science/National Research Council status is outdated. At this time,
21 CFR 522.1940 is amended by removing paragraph (d)(2)(iv).
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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
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 approval qualifies
for 3 years of marketing exclusivity beginning January 22, 1997,
because the application contains substantial evidence of the
effectiveness of the drug involved, studies of animal safety or, in the
case of food-producing animals, human food safety studies (other than
bioequivalence or residue studies) required for approval and conducted
or sponsored by the applicant.
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 (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 522
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 part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1940 [Amended]
2. Section 522.1940 Progesterone and estradiol benzoate in
combination is amended in paragraph (d)(1)(iii) by removing the phrases
``For 000033:'' and ``For 021641: Do not use in calves intended for
reproduction.'' and by removing paragraph (d)(2)(iv).
Dated: February 10, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-4517 Filed 2-24-97; 8:45 am]
BILLING CODE 4160-01-F
