[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Rules and Regulations]
[Pages 56007-56008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8261]


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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 Purina Mills, 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 feed mineral blocks 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 September 26, 2006.

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: Purina Mills, Inc., P.O. Box 66812, St. 
Louis, MO 63166-6812, filed a supplement to NADA 141-171 for use of 
BOVATEC 91 (lasalocid) Type A medicated article to make Purina Sugar 
Mag Block 1440 BVT Medicated Mineral Block, a free-choice 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 August 18, 2006, and the 
regulations are amended in Sec.  558.311 (21 CFR 558.311) to reflect 
the approval.

[[Page 56008]]

 The basis of approval is discussed in the freedom of information 
summary.
    In addition, FDA is amending Sec.  558.311 to remove redundant text 
in an entry for combination use of single-ingredient lasalocid and 
chlortetracycline in cattle feed which was published in error in the 
Federal Register of April 27, 2006 (71 FR 24816). This correction is 
being made 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)(6) 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.

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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

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

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.311  [Amended]

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2. In Sec.  558.311, in paragraph (b)(8), after the number ``15'' add 
the words ``and 20''; and in paragraph (e)(1)(xxvii) in the 
``Indications for use'' column, remove ``control of control of'' and in 
its place add ``control of''.

    Dated: September 15, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-8261 Filed 9-25-06; 8:45 am]
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