[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Rules and Regulations]
[Page 27727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12721]



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  Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules 
and Regulations  

[[Page 27727]]



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 Intervet, Inc. The supplemental NADA 
provides for use of bambermycins Type A medicated articles to make Type 
B and Type C medicated feeds used to increase rate of weight gain in 
pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef 
replacement heifers) when consumed free-choice or hand-fed at a rate of 
not less than 10 milligrams (mg) nor more than 40 mg bambermycins per 
head per day.

DATES: This rule is effective May 21, 2003.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., PO Box 318, 405 State St., 
Millsboro, DE 19966, filed a supplement to NADA 141-034 that provides 
for use of GAINPRO (bambermycins) Type A medicated articles to make 
Type B and Type C medicated feeds used to increase rate of weight gain 
in pasture cattle (slaughter, stocker, feeder cattle, and dairy and 
beef replacement heifers) when consumed free-choice or hand-fed at a 
rate of not less than 10 mg nor more than 40 mg bambermycins per head 
per day. The supplemental NADA is approved as of February 10, 2003, and 
the regulations are amended in 21 CFR 558.95 to reflect the approval. 
The basis of approval is discussed in the freedom of information 
summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
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

0
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]

0
2. Section 558.95 Bambermycins is amended by:
0
a. In paragraphs (d)(4)(ii)(b) and (d)(4)(iv)(a) by removing ``20'' and 
by adding in its place ``40'';
0
b. In paragraph (d)(4)(iii)(d) by adding ``cattle, and dairy and beef 
replacement heifers'' after ``feeder'', and by removing ``5.33'' and 
``10- to 20-milligrams'' and by adding in their respective places 
``10.66'' and ``10 to 40 milligrams''; and
0
c. In paragraphs (d)(4)(ii)(b), (d)(4)(iii)(d), and (d)(4)(iv)(c) by 
adding ``Daily bambermycins intakes in excess of 20 mg/head/day have 
not been shown to be more effective than 20 mg/head/day.'' at the end 
of the paragraph.

    Dated: May 8, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-12721 Filed 5-20-03; 8:45 am]
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