[Federal Register Volume 60, Number 107 (Monday, June 5, 1995)]
[Rules and Regulations]
[Pages 29482-29483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13637]
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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
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 Hoffmann-La Roche, Inc. The supplemental
NADA provides for the use of a 20-percent lasalocid Type A medicated
article in making Type C medicated feed used for growing turkeys as a
coccidiostat.
EFFECTIVE DATE: June 5, 1995.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., Nutley, NJ 07110,
is the sponsor of NADA 96-298, which currently provides for the use of
a Type A medicated article containing 20 percent (90.7 grams per pound
(g/lb)) of lasalocid sodium activity in making a 68- to 113-g-per-ton
(g/t) Type C medicated feed for broiler or fryer chickens and chukar
partridges. The firm has filed a supplemental NADA that expands the use
of the article to making a 68- to 113-g/t Type C medicated feed for
growing turkeys for the prevention of coccidiosis caused by Eimeria
meleagrimitis, E. gallopavonis, and E. adenoeides.
The supplemental NADA is approved as of April 28, 1995, and the
regulations are amended in 21 CFR 558.311 to reflect the approval. The
basis for approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, 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 approval qualifies
for 3 years of marketing exclusivity beginning April 28, 1995, because
the supplemental application contains reports of new clinical or field
investigations (other than bioequivalence or residue studies) essential
to the approval of the application and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to the
described use of lasalocid sodium in growing turkeys for which the
supplemental application was approved.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency'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 (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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 558.311 is amended in paragraph (b) by revising
paragraph (b)(7) and in the table in paragraph (e)(1) by adding new
entry ``(xiv)'' to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(b) * * *
(7) 20 percent activity to No. 000004 for use in chukar partridges
as in paragraph (e)(1)(xiii) and for use in turkeys as in paragraph
(e)(1)(xiv) of this section.
* * * * *
(e)(1) * * *
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Lasalocid sodium
activity in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
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* * * * * *
*
(xiv) 68 (0.0075 pct) . . . . . . ........ Growing turkeys; for Feed continuously as 000004
to 113 (0.0125 pct). prevention of sole ration.
coccidiosis caused
by E. meleagrimitis,
E. gallopavonis, and
E. adenoeides.
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[[Page 29483]] * * * * *
Dated: May 24, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13637 Filed 6-2-95; 8:45 am]
BILLING CODE 4160-01-F
