[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24013]
[[Page Unknown]]
[Federal Register: September 30, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Progesterone and Estradiol Benzoate in Combination
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 Syntex Animal Health. The supplemental NADA
provides for reimplantation of the drug combination progesterone/
estradiol benzoate in steers fed in confinement for slaughter for
additional improvement in rate of weight gain.
EFFECTIVE DATE: September 30, 1994.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Syntex Animal Health, Division of Syntex
Agribusiness, Inc., 3401 Hillview Ave., Palo Alto, CA 94304, filed a
supplemental NADA 9-576, which provides for reimplantation of
Synovex S (200 milligrams (mg) of progesterone and 20 mg of
estradiol benzoate per implant) at approximately day 70 in steers fed
in confinement for slaughter for additional improvement in rate of
weight gain. The supplemental NADA is approved as of August 19, 1994,
and the regulations are amended in Sec. 522.1940 (21 CFR 522.1940) to
reflect the approval. The basis for approval is discussed in the
freedom of information summary.
Section 522.1940(d)(2)(ii)) is revised to read ``For increased rate
of weight gain and improved feed efficiency,'' and paragraph (e) is
redesignated as paragraph (d)(2)(iv), and it is amended by revising the
first sentence and by removing the second paragraph because it has been
superseded by enactment of the Generic Animal Drug and Patent Term
Restoration Act of 1988.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., 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
Cometic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity
beginning on August 19, 1994, because the supplemental NADA contains a
report of new clinical investigations (other than bioequivalence or
residue studies) essential to the approval of the application and
conducted or sponsored by the applicant. The 3 years of marketing
exclusivity applies only to the change in limitations (provides for the
reimplantation of steers fed in confinement for slaughter for
additional improvement in rate of weight gain) for which the
application is being approved.
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).
2. Section 522.1940 is amended by revising paragraphs (b),
(d)(2)(ii), and (d)(2)(iii); and by redesignating paragraph (e) as
paragraph (d)(2)(iv) and revising it to read as follows:
Sec. 522.1940 Progesterone and estradiol benzoate in combination.
* * * * *
(b) Sponsor. See 000033 for use as provided in paragraphs (d)(1)
and (d)(2) of this section; see 021641 for use as provided in
paragraphs (d)(1) and (d)(2)(i) through (d)(2)(iii)(a) of this section.
* * * * *
(d) * * *
(2) * * *
(ii) Indications for use. For increased rate of weight gain and
improved feed efficiency.
(iii) Limitations. (a) For animals weighing 400 pounds or more; for
subcutaneous ear implantation, one dose per animal.
(b) For additional improvement in rate of weight gain in steers fed
in confinement for slaughter, reimplant at approximately day 70.
(iv) NAS/NRC status. The conditions of use specified in paragraphs
(d)(2)(i) through (d)(2)(iii)(a) are NAS/NRC reviewed and found
effective.
Dated: September 20, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-24013 Filed 9-29-94; 8:45 am]
BILLING CODE 4160-01-F