[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