[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Rules and Regulations]
[Page 11028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
Animal Drugs, Feeds, and Related Products; Melengestrol Acetate
and Tylosin
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 The Upjohn Co. The supplemental NADA
provides for use of single ingredient Type A medicated articles
containing melengestrol acetate (MGA) and tylosin to manufacture
certain combination drug Type B and Type C medicated feeds for heifers
fed in confinement for slaughter. The supplement provides for use of a
dry MGA Type A article to make a dry Type B or Type C medicated feed.
EFFECTIVE DATE: March 1, 1995.
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: The Upjohn Co., Kalamazoo, MI 49001, filed
supplemental NADA 138-995, MGA with Tylan (MGA with tylosin), which
provides for use of approved MGA and tylosin Type A medicated articles
to make Type B and Type C medicated feeds for heifers being fed in
confinement for slaughter. The supplement removes the requirement for
making dry pelleted Type B or C medicated feed. Therefore, dry MGA and
tylosin Type A articles may be used to make a dry Type B or C medicated
feed containing MGA and tylosin.
This supplement is approved as of January 13, 1995. Accordingly, 21
CFR 558.342(c)(4)(ii)(C) is amended by removing the existing reference
to a pelleted medicated feed to reflect this approval.
This is a manufacturing supplement to an approved NADA. Approval of
this supplement does not require added safety or efficacy data or
information. Therefore, a freedom of information summary as provided in
part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR
514.11(e)(2)(ii)) is not required.
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 supplement for food-
producing animals does not qualify for marketing exclusivity because
the supplement does not contain new clinical or field investigations
(other than bioequivalence or residue studies) and new human food
safety studies (other than bioequivalence or residue studies) essential
to the approval and conducted or sponsored by the applicant.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.342 [Amended]
2. Section 558.342 Melengestrol acetate is amended in paragraph
(c)(4)(ii)(C) by removing the word ``pelleted''.
Dated: February 9, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-4913 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F
