[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Rules and Regulations]
[Pages 30132-30133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15202]
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[[Page 30133]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use In Animal Feeds; Virginiamycin
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 Pfizer Inc. The supplement provides for use
of a 30% virginiamycin formulation of a Type A medicated article to be
used for the manufacture of Type C medicated feeds for cattle fed in
confinement for slaughter.
EFFECTIVE DATE: June 14, 1996.
FOR FURTHER INFORMATION CONTACT: Russell G. Arnold, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1674.
SUPPLEMENTARY INFORMATION: Pfizer Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 140-998 which provided for use of a
30% virginiamycin Type A medicated article formulation to be used in a
micro-ingredient production process for the preparation of Type C
medicated feeds for cattle fed in confinement for slaughter. The Type C
medicated feed is fed at 11 to 16 grams per ton (g/t) for improved feed
efficiency, 13.5 to 16 g/t for reduction of incidence of liver
abscesses, and 16 to 22.5 g/t for increased rate of weight gain. The
feed is not for animals intended for breeding. The supplement is
approved as of May 3, 1996, and the regulations are amended in 21 CFR
558.635(b) to reflect the approval.
Approval of this supplement does not require submission of new
safety or effectiveness data. The supplement provides for use of an
additional level of Type A medicated article to make a Type C medicated
feed fed at previously approved levels and for previously approved
conditions of use.
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.
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 reports of new clinical or
field investigations (other than bioequivalence or residue studies)
and, in the case of food producing animals, human food safety studies
(other than bioequivalence or residue studies) essential to the
approval and conducted or sponsored by the applicant were not 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. 558.635 [Amended]
2. Section 558.635 Virginiamycin is amended in paragraph (b)(1) by
removing ``to 000069'' and by adding in its place ``used as in
paragraph (f) of this section; and 30 percent activity (136.2 grams per
pound) for the manufacture of Type C medicated feed for cattle used as
in paragraph (f)(3); to 000069''.
Dated: June 7, 1996.
Andrew J. Beaulieau,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 96-15202 Filed 6-13-96; 8:45 am]
BILLING CODE 4160-01-F
