[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Rules and Regulations]
[Page 28630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13825]
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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 removal of the international feed number (IFN) for an
ingredient in free-choice, lasalocid, liquid Type C feed.
EFFECTIVE DATE: May 27, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St.,
Nutley, NJ 07110-1199, filed supplemental NADA 96-298, which provides
for removing the IFN for the condensed molasses fermentation solubles
ingredient of the free-choice, lasalocid, liquid Type C feed. The
molasses solubles described by the IFN refer to those solubles from
sugar cane molasses. The liquid Type C feed contains beet molasses
solubles that do not have an IFN.
The supplemental NADA is approved as of May 27, 1997, and the
regulations are amended in 21 CFR 558.311(e)(3)(i) to reflect the
approval.
This action does not affect the safety and effectiveness upon which
the application was approved. Therefore, a freedom of information
summary is not required
The agency has determined under 21 CFR 25.24(a)(9) 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.
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).
Sec. 558.311 [Amended]
2. Section 558.311 Lasalocid is amended in the table in paragraph
(e)(3)(i), in the entry for ``Condensed Molasses Fermentation
Solubles'', in the third column by removing ``5-25-399'' and adding in
its place ``N/A''.
Dated: May 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-13825 Filed 5-23-97; 8:45 am]
BILLING CODE 4160-01-F
