[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Rules and Regulations]
[Pages 4954-4955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1684]


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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, technical amendment.

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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 ADM Alliance Nutrition, Inc. The 
supplemental NADA provides for the use of a lasalocid Type A medicated 
article containing 20-percent lasalocid activity per pound to make 
free-choice Type C medicated feeds used for increased rate of weight 
gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy 
and beef replacement heifers).

DATES: This rule is effective February 2, 2007.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: ADM Alliance Nutrition, Inc., 1000 North 
30th St., Quincy, IL 62305-3115, filed a

[[Page 4955]]

supplement to NADA 138-993 for use of BOVATEC 91 (lasalocid) Type A 
medicated article to make MoorMan's Cattle Mineral BT, a free-choice 
mineral Type C medicated feed used for increased rate of weight gain in 
pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef 
replacement heifers). The supplement provides for the use of a 
lasalocid Type A medicated article containing 20-percent lasalocid 
activity per pound. The supplemental NADA is approved as of December 
22, 2006, and the regulations are amended in 21 CFR 558.311 to reflect 
the approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, FDA is revising the regulations to correct a cross 
reference for a similar product. This is being done to improve the 
accuracy of the regulations.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.


0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
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2. In Sec.  558.311, remove and reserve paragraph (b)(8), and revise 
paragraph (b)(5) to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (b) * * *
    (5) 15 and 20 percent activity to Nos. 017800 and 021930 for use in 
free-choice mineral feeds for cattle as in paragraph (e)(1)(xviii) of 
this section.
* * * * *

    Dated: January 24, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-1684 Filed 2-1-07; 8:45 am]
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