[Federal Register Volume 64, Number 175 (Friday, September 10, 1999)]
[Rules and Regulations]
[Pages 49082-49083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23467]
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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; Lasalocid and
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 new animal drug application
(NADA) filed by Hoechst Roussel Vet. The NADA provides for combining
approved single ingredient lasalocid and bambermycins Type A medicated
articles to make Type C medicated broiler feeds to be used for
prevention of certain forms of coccidiosis and for increased rate of
weight gain and improved feed efficiency.
EFFECTIVE DATE: September 10, 1999.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-28), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600.
[[Page 49083]]
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, filed NADA 141-129 that provides for
combining approved single ingredient Avatec (lasalocid) and
Flavomycin (bambermycins) Type A medicated articles to make
Type C medicated broiler feeds containing 68 to 113 grams per ton (g/t)
lasalocid and 1 to 2 g/t bambermycins. The Type C medicated broiler
feeds are used for prevention of coccidiosis caused by Eimeria tenella,
E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and
for increased rate of weight gain and improved feed efficiency in
broiler chickens. The NADA is approved as of August 6, 1999, and the
regulations are amended in 21 CFR 558.95 by adding paragraph
(d)(1)(xiv) and in 21 CFR 558.311 by adding paragraph (e)(4)(ii) to
reflect the approval.
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.
The agency has determined under 21 CFR 25.33(a)(2) 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.
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.
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)(1)(xiv) to
read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(1) * * *
(xiv) Amount per ton. Bambermycins 1 to 2 grams, plus lasalocid 68
to 113 grams.
(a) Indications for use. For prevention of coccidiosis caused by E.
tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E.
maxima, and for increased rate of weight gain and improved feed
efficiency in broiler chickens.
(b) Limitations. For broiler chickens only. Feed continuously as
sole ration. Lasalocid as provided by No. 063238 in Sec. 510.600(c) of
this chapter.
* * * * *
3. Section 558.311 is amended by adding paragraph (e)(4)(ii) to
read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(4) * * *
(ii) Bambermycins as in Sec. 558.95 of this chapter.
Dated: August 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-23467 Filed 9-9-99; 8:45 am]
BILLING CODE 4160-01-F
