[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44386-44387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22225]
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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 revised limitations for using bambermycins Type A medicated
articles to make a bambermycins Type B and Type C medicated feeds for
feedlot cattle and for pasture cattle, including dairy and beef
replacement heifers.
EFFECTIVE DATE: August 19, 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 that
provides for revised limitations for using 10-grams-per-pound
Gainpro (bambermycins) Type A medicated articles to make Type
B and Type C medicated feeds for feedlot cattle and for pasture cattle,
including dairy and beef replacement heifers. The Type C medicated
feeds are fed to provide 10 to 20 milligrams bambermycins per head per
day to feedlot cattle for increased rate of weight gain and improved
feed efficiency and to pasture cattle for increased rate of weight
gain. The supplement is approved as of June 29, 1998, and the
regulations are amended in Sec. 558.95(d)(4) to reflect the approval by
deleting the statement ``Not for use in animals intended for
breeding'', and amending the phrase ``slaughter, stocker, and feeder''
to read ``slaughter, stocker, and feeder cattle, and dairy and beef
replacement heifers.''
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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
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)), this supplemental approval
for food-producing animals qualifies for 3 years of marketing
exclusivity beginning June 29, 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 Type C medicated feeds for dairy and beef replacement
heifers.
The agency has determined under 21 CFR 25.33(a)(1) 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.
Sec. 558.95 [Amended]
2. Section 558.95 Bambermycins is amended in paragraphs
(d)(4)(i)(b), (d)(4)(ii)(b), (d)(4)(iii)(d), and (d)(4)(iv)(c) by
removing the statement ``Not for use in animals intended for
breeding.'' and in paragraphs (d)(4)(ii)(b), (d)(4)(iii), and
(d)(4)(iv), by removing the phrase ``(slaughter, stocker, and feeder)''
and by adding in its place the phrase ``(slaughter, stocker, and feeder
cattle, and dairy and beef replacement heifers).''
[[Page 44387]]
Dated: August 1, 1998.
Margaret Ann Miller,
Acting Director, Office of New Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 98-22225 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F
