[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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superseded by enactment of the Generic Animal Drug and Patent Term 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