[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)]
[Rules and Regulations]
[Pages 47076-47077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22668]


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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 Alpharma, Inc. The supplemental NADA 
provides for an increased daily dosage of lasalocid in pasture cattle.

DATES: This rule is effective September 11, 2001.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 96-298 that 
provides for the use of BOVATEC (lasalocid sodium) Premix in 
cattle. The supplemental NADA provides for an increased daily dosage of 
lasalocid in pasture cattle. The supplemental NADA is approved as of 
July 25, 2001, 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 accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this supplemental 
application may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    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. Section 558.311 is amended by adding paragraph (d)(7); in the 
table in paragraph (e)(1) by revising paragraphs (e)(1)(ix) and 
(e)(1)(xii); by revising paragraphs (e)(2)(iii) and (e)(3)(iii); and in 
paragraphs (e)(2)(iv) and (e)(3)(iv) by removing ``200'' and adding in 
its place ``300'' to read as follows:


Sec. 558.311  Lasalocid.

* * * * *
    (d) * * * 
    (7) Each use in a free-choice Type C cattle feed as in paragraph 
(e)(1)(xii) of this section must be the subject of an approved NADA or 
supplemental NADA as provided in Sec. 510.455 of this chapter.
    (e)(1) * * * 

----------------------------------------------------------------------------------------------------------------
   Lasalocid sodium activity in     Combination in
          grams per ton              grams per ton     Indications for use         Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
*                  *                  *                  *                  *                  *
                                                        *
(ix).............................                    Pasture cattle          Feed continuously at a  046573
                                                      (slaughter, stocker,    rate of not less than
                                                      feeder cattle, and      60 mg or more than
                                                      dairy and beef          300 mg of lasalocid
                                                      replacement heifers):   per head per day when
                                                      for increased rate of   on pasture; the drug
                                                      weight gain. Intakes    must be contained in
                                                      of lasalocid in         at least 1 pound of
                                                      excess of 200 mg/head/  feed.
                                                      day have not been
                                                      shown to be more
                                                      effective than 200 mg/
                                                      head/day.

[[Page 47077]]

 
*                  *                  *                  *                  *                  *
                                                        *
(xii)............................                    Pasture cattle          Feed continuously on a  046573
                                                      (slaughter, stocker,    free-choice basis at
                                                      feeder cattle, and      a rate of not less
                                                      dairy and beef          than 60 mg or more
                                                      replacement heifers):   than 300 mg of
                                                      for increased rate of   lasalocid per head
                                                      weight gain. Intakes    per day.
                                                      of lasalocid in
                                                      excess of 200 mg/head/
                                                      day have not been
                                                      shown to be more
                                                      effective than 200 mg/
                                                      head/day.
 ................................                    Pasture cattle          Feed continuously on a  021930
                                                      (slaughter, stocker,    free-choice basis at
                                                      feeder cattle, and      a rate of not less
                                                      dairy and beef          than 60 mg or more
                                                      replacement heifers):   than 200 mg of
                                                      for increased rate of   lasalocid per head
                                                      weight gain.            per day.
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------

    (2) * * * 
* * * * *
    (iii) Indications for use. Pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers): for increased 
rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day 
have not been shown to be more effective than 200 mg/head/day.
* * * * *
    (3) * * * 
    (iii) Indications for use. Pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers): for increased 
rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day 
have not been shown to be more effective than 200 mg/head/day.
* * * * *

    Dated: August 24, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-22668 Filed 9-10-01; 8:45 am]
BILLING CODE 4160-01-S