[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Rules and Regulations]
[Pages 57928-57930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28599]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Lasalocid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 use of a 20-percent lasalocid Type A medicated
article in making a Type C medicated feed for rabbits used as a
coccidiostat.
EFFECTIVE DATE: November 24, 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.
[[Page 57929]]
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland Rd.,
Nutley, NJ 07110-1199, 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 (g) per pound) 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 growing turkeys, and a 113-g/t Type C medicated
feed for chukar partridges, for prevention of coccidiosis. The firm has
filed a supplemental NADA that expands the use of the Type A medicated
article for use in making a 113-g/t Type C medicated feed for rabbits
for the prevention of coccidiosis caused by Eimeria stiedae. Approval
is based in part on data and information in Public Master File (PMF)
5042 established under the National Research Support Project (NRSP) 7
(formerly the Interregional Research Project No. 4 (IR-4)), Southern
Region, University of Florida, Gainesville, FL 32610.
The supplemental NADA is approved as of October 20, 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 does not
qualify for marketing exclusivity because no new clinical or field
investigations (other than bioequivalence or residue studies) and no
new human food safety studies (other than bioequivalence or residue
studies) essential to approval of the supplement were conducted or
sponsored by the applicant.
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 by revising paragraph (b)(7) and in
the table in paragraph (e)(1) by adding new entry ``(xv)'' to read as
follows:
Sec. 558.311 Lasalocid.
* * * * *
(b) * * *
(7) 20 percent activity to No. 000004 for use as follows:
(i) Chukar partridges as in paragraph (e)(1)(xiii).
(ii) Turkeys as in paragraph (e)(1)(xiv).
(iii) Rabbits as in paragraph (e)(1)(xv).
* * * * *
(e) * * *
(1) * * *-
----------------------------------------------------------------------------------------------------------------
Lasalocid sodium activity in Combination in
grams per ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
(xv) 113 (0.0125 pct). ................... Rabbits; for prevention Feed continuously as 000004
of coccidiosis caused sole ration up to 6 1/
by Eimeria stiedae. 2 weeks of age.
----------------------------------------------------------------------------------------------------------------
[[Page 57930]]
* * * * *
Dated: November 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-28599 Filed 11-22-95; 8:45 am]
BILLING CODE 4160-01-F
