[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
[Rules and Regulations]
[Pages 8373-8374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Agri-Vet Co. The supplement
provides for using liquid bambermycins Type B medicated feeds to make
Type C medicated feeds for cattle fed in confinement for slaughter for
increased rate of weight gain and improved feed efficiency.
EFFECTIVE DATE: February 25, 1997.
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: Hoechst-Roussel Agri-Vet Co., Route 202-206,
P.O. Box 2500, Somerville, NJ 08876-1258, filed supplemental NADA 141-
034 that provides for using 10-gram per pound (g/lb)
Flavomycin (bambermycins) Type A medicated articles to make
40 to 800 g/ton liquid Type B medicated feeds, the liquid Type B feeds
used to make dry Type C medicated feeds. The Type C feeds containing 1
to 4 g/ton bambermycins are for cattle fed in confinement for slaughter
to provide 10 to 20 milligrams bambermycins per head per day for
increased rate of weight gain and improved feed efficiency. The
regulations are amended in Sec. 558.95 (21 CFR 558.95) by adding new
paragraph (a)(5), by redesignating paragraph (b) as paragraph (d), and
by revising newly redesignated paragraph (d)(4)(i)(b) to reflect the
approval.
Furthermore, use of liquid Type B feeds to make Type C feeds
requires publication of specifications and expiration information. New
Sec. 558.95(b) is established to reflect the Type B feed specifications
and expiration information. In the interest of issuing uniform
regulations in the future, new Sec. 558.95(c) is also established at
this time and reserved for future use.
Approval of this supplement did not require submission of
additional safety or efficacy data. A freedom of information (FOI)
summary as in 21 CFR part 20 and 514.11(e)(2)(ii) is not required. An
FOI summary submitted to support approval of the original 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 Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food
producing animals does not qualify for marketing exclusivity because
the supplement does not contain substantial evidence of effectiveness
of the drug involved, any studies of animal safety or 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)(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.
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 558.95 is amended by adding new paragraph (a)(5), by
redesignating paragraph (b) as paragraph (d), by adding new paragraph
(b), by adding and reserving paragraph (c), and by adding a new fourth
sentence to newly redesignated paragraph (d)(4)(i)(b), to read as
follows:
Sec. 558.95 Bambermycins.
(a) * * *
(5) 10 grams of activity per pound to 012799 in Sec. 510.600(c) of
this chapter to make 40 to 800 gram/ton Type B feeds for use as in
paragraph (d)(4)(i) of this section.
(b) Special considerations. (1) Bambermycins liquid Type B feeds
may be manufactured from dry bambermycins Type A articles. The liquid
Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45
percent.
(2) The expiration date for the liquid Type B feed is 8 weeks after
date of manufacture. The expiration date for the dry Type C feed made
from the liquid Type B feed is 1 week after date of manufacture.
(c) [Reserved]
(d) * * *
(4) * * *
(i) * * *
[[Page 8374]]
(b) * * * Liquid Type B feeds containing bambermycins may be used
in the preparation of dry complete ration Type C feeds.
* * * * *
Dated: February 10, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-4512 Filed 2-24-97; 8:45 am]
BILLING CODE 4160-01-F
