[Federal Register Volume 63, Number 73 (Thursday, April 16, 1998)]
[Rules and Regulations]
[Pages 18835-18836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10033]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use In Animal Feeds; Bambermycins
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 Hoechst Roussel Vet. The supplement
provides for using bambermycins Type A medicated articles to make a
bambermycins free-choice Type C medicated feed for pasture cattle
(slaughter, stocker, and feeder) for increased rate of weight gain.
EFFECTIVE DATE: April 16, 1998.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, filed supplemental NADA 141-034 which
provides for using 10-grams per pound Flavomycin
(bambermycins) Type A medicated articles to make free-choice Type C
medicated feeds for pasture cattle (slaughter, stocker, and feeder).
The Type C medicated feeds are fed to provide 10 to 20 milligrams
bambermycins per head per day for increased rate of weight gain. The
supplement is approved as of March 10, 1998, and the regulations are
amended by adding 21 CFR 558.95(d)(4)(iv) to reflect the approval.
As required by 21 CFR 510.455, each use of a Type A medicated
article to make a free-choice medicated Type C feed requires an
approved NADA or supplemental NADA. Under section 512(m) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(m)), as amended
by the Animal Drug Availability Act of 1996 (Pub. L. 104-250), free-
choice medicated Type C feeds must be manufactured in a licensed feed
mill.
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, from
9 a.m. to 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(iii) of the act, this supplemental
approval for food-producing animals qualifies for 3 years of marketing
exclusivity beginning March 10, 1998, because the supplement contains
substantial evidence of the effectiveness of the drug 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 supplement and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to the use
of bambermycins with the proprietary free-choice Type C feeds as
approved in this supplemental NADA.
The agency has determined under 21 CFR 25.33(a)(3) 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: 21 U.S.C. 360b, 371.
2. Section 558.95 is amended by adding paragraph (d)(4)(iv) to read
as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(4) * * *
[[Page 18836]]
(iv) Use free-choice Type C medicated feeds for pasture cattle
(slaughter, stocker, and feeder) as follows:
(a) Amount. Feed continuously to provide 10 to 20 milligrams of
bambermycins per head per day.
(b) Indications for use. For increased rate of weight gain.
(c) Limitations. Not for use in animals intended for breeding. Each
use in a free-choice Type C medicated feed must be the subject of an
approved new animal drug application (NADA) or supplemental NADA as
required by 21 CFR 510.455.
* * * * *
Dated: March 31, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-10033 Filed 4-15-98; 8:45 am]
BILLING CODE 4160-01-F
