[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
[Rules and Regulations]
[Pages 8372-8373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4514]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Melengestrol Acetate,
Monensin, 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 Pharmacia & Upjohn Co. The supplement
provides for the use of separately approved Type A medicated articles
containing melengestrol acetate (dry form only), monensin, and tylosin
to manufacture certain combination drug, dry, meal Type B medicated
feeds for use in making Type C medicated feeds. The feeds are for
heifers fed in confinement for slaughter for increased rate of weight
gain, improved feed efficiency, suppression of estrus, and reduced
incidence of liver abscesses.
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, 301-594-1638.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn, 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental NADA 138-792, which
provides for combining separately approved melengestrol acetate (MGA)
(dry form only), monensin sodium, and tylosin phosphate Type A
medicated articles to manufacture dry, meal Type B medicated feeds used
to make Type C medicated feeds for heifers fed in confinement for
slaughter for increased rate of weight gain, improved feed efficiency,
suppression of estrus (heat), and reduced incidence of liver abscesses.
The supplement is approved as of December 17, 1996, and 21 CFR 558.342
is amended in paragraph (c)(5)(iii)(C) to reflect the approval.
Approval of this supplement which provides for use of a different
physical
[[Page 8373]]
form of Type B feed did not require reevaluation of the safety or
effectiveness data supporting the NADA or the submission of any new
data. Therefore, a freedom of information summary 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 approval does not
qualify for marketing exclusivity because the supplement does not
contain substantial evidence of the effectiveness of the drug involved,
any 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 of the supplement and conducted or
sponsored by the applicant.
The agency has determined under 21 CFR 25.24(d)(1)(ii) 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)(5)(ii)(C) by removing the word ``pelleted''.
Dated: January 31, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-4514 Filed 2-24-97; 8:45 am]
BILLING CODE 4160-01-F
