[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Rules and Regulations]
[Pages 54193-54194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25972]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of two supplemental new animal
drug applications (NADA's) filed by Hoffmann-La Roche, Inc. One
supplemental NADA provides for the addition of certain lasalocid-
containing Type A medicated articles to dry, powdered milk replacer
before reconstitution. The reconstituted Type C medicated feed is used
to control coccidiosis in nonveal calves. Additionally, FDA is amending
the regulations to reflect approval of another supplemental NADA which
modifies the lasalocid feeding directions for control of coccidiosis in
cattle.
EFFECTIVE DATE: October 20, 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
several concentrations of lasalocid sodium-containing Type A medicated
articles in making Type C medicated cattle feeds (68 to 113 grams of
activity per ton) for the control of coccidiosis caused by Eimeria
bovis and E. zuernii. The firm has filed a supplemental NADA that
expands this use of the drug to nonveal calves using milk replacer
powder.
Additionally, FDA concurred with another supplemental NADA which
was filed to modify the feeding directions for lasalocid medicated feed
when used to
[[Page 54194]]
control coccidiosis in cattle. The supplemental NADA modifies the
feeding directions in the table in Sec. 558.311(e)(1) by changing
``feed continuously'' to ``hand feed''.
The supplemental NADA's are approved as of August 7, 1995, and the
regulations are amended in Sec. 558.311 (21 CFR 558.311) to reflect the
approvals.
Under 21 CFR 514.106(b)(2), these are Category II changes. Approval
of these changes is not expected to have any adverse effect on the
safety or effectiveness of this new animal drug. Accordingly, these
approvals did not require a reevaluation of the safety and
effectiveness data in the parent application.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals for food-
producing animals do not qualify for marketing exclusivity because the
supplemental applications do not contain new clinical or field
investigations (other than bioequivalence or residue studies) and new
human food safety studies (other than bioequivalence or residue
studies) essential to the approvals and conducted or sponsored by the
applicant.
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)(3) by removing
``(xiii)'' and adding in its place ``(xv)'' and in the table in
paragraph (e)(1), in the ``Limitations'' column, in the entry for
``(xii)'' by removing ``feed continuously'' and adding in its place
``hand feed'', and by adding new entry ``(xv)'' to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e)(1) * * *
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Lasalocid sodium activity in Combination in
grams per ton grams per ton Indications for use Limitations Sponsor
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* * * * * *
*
(xv)........................ .................. Replacement calves; In milk replacer 000004
............ for control of powder; hand feed at
coccidiosis caused by a rate of 1 mg of
E. bovis and E. lasalocid per 2.2 lb
zuernii. body weight per day;
include on labeling
warning: ``A
withdrawal period has
not been established
for lasalocid in pre-
ruminating calves. Do
not use in calves to
be processed for
veal.''.
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* * * * *
Dated: October 5, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-25972 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F