[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
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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