[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14304-14305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Melengestrol Acetate

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 two supplemental new animal 
drug applications (NADA's) filed by Pharmacia & Upjohn Co. The 
supplemental NADA's provide for the use of dry and liquid melengestrol 
acetate (MGA) Type A medicated articles to manufacture certain Type B 
and Type C medicated feeds for heifers intended for breeding for 
suppression of estrus (heat).

EFFECTIVE DATE: March 26, 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 Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed supplemental NADA's 34-254 and 39-402 
providing for use of dry and liquid MGA Type A medicated articles to 
manufacture certain Type B and Type C medicated feeds for heifers 
intended for breeding for suppression of estrus (heat). The supplements 
are approved as of February 18, 1997, and the regulations are amended 
in Sec. 558.342 (21 CFR 558.342) by adding new paragraph (d)(7) to 
reflect the approvals.
    In addition, certain mixing directions for liquid feeds are 
required for use of MGA liquid Type A articles to manufacture Type B 
medicated feeds. Those directions had not been codified previously in 
the MGA regulations. At this time, the regulations are amended to 
include those directions in new Sec. 558.342(c) Special considerations 
and existing paragraph (c) is redesignated as paragraph (d).
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 12420 Parklawn Dr., rm. 1-23, 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 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals qualify 
for 3 years of marketing exclusivity beginning February 18, 1997, 
because the supplements contain substantial evidence of effectiveness 
of the drugs involved, 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 
supplements and conducted or sponsored by the applicant. Exclusivity 
only applies to use in heifers intended for breeding for suppression of 
estrus.
    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 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).

    2. Section 558.342 is amended by redesignating paragraph (c) as 
paragraph (d) and by adding new paragraphs (c) and (d)(7) to read as 
follows:


Sec. 558.342  Melengestrol acetate.

* * * * *
    (c) Special considerations. (1) Type B medicated feeds may be 
manufactured from melengestrol acetate liquid Type A articles or Type B 
medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate 
mixing directions as follows:
    (i) For liquid Type B feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no less than

[[Page 14305]]

10 minutes, moving not less than 1 percent of the tank contents per 
minute from the bottom of the tank to the top. Recirculate daily as 
described even when not used.
    (ii) For liquid Type B feeds stored in mechanical, air, or other 
agitation type tank systems: Agitate immediately prior to use for not 
less than 10 minutes, creating a turbulence at the bottom of the tank 
that is visible at the top. Agitate daily as described even when not 
used.
    (2) A positionally stable melengestrol acetate liquid Type B feed 
will not be subject to the requirements for mixing directions 
prescribed in paragraphs (c)(1) of this section provided it has a pH of 
4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a 
viscosity of not less than 300 centipoises per second for 3 months.
    (d) *  *  *
    (7) Amount. 0.5 milligram per head per day.
    (i) Indications for use. For suppression of estrus (heat).
    (ii) Limitation. Heifers intended for breeding. Do not exceed 24 
days of feeding. Administer 0.5 to 2.0 pounds per head per day of Type 
C feed containing 0.25 to 1.0 milligram of melengestrol acetate per 
pound to provide 0.5 milligram of melengestrol acetate per head per 
day. Melengestrol acetate as provided by No. 000009 in Sec. 510.600(c) 
of this chapter.

    Dated: March 13, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-7545 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F