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New Animal Drugs for Use in Animal Feeds; Lasalocid

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 [Federal Register: February 2, 2007 (Volume 72, Number 22)]
[Rules and Regulations]
[Page 4954-4955]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02fe07-7]

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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: eric.dubbin@fda.hhs.gov.

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.

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

? 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]
BILLING CODE 4160-01-S

 
 

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