[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