[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