[Federal Register Volume 67, Number 234 (Thursday, December 5, 2002)]
[Rules and Regulations]
[Pages 72368-72369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30783]


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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 new animal drug application 
(NADA) filed by Purina Mills, Inc. The NADA provides for the use of a 
lasalocid Type A medicated article 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 December 5, 2002.

FOR FURTHER INFORMATION CONTACT: Amey L. Adams, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7560, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St. 
Louis, MO 63166-6812, filed NADA 141-171 that provides for use of 
BOVATEC 68 (lasalocid) Type A medicated article to make Purina Sugar 
Mag Block 1440 BVT Medicated Mineral Block, a free-choice Type C 
medicated feed. The free-choice mineral block is used for increased 
rate of weight gain in pasture cattle (slaughter, stocker, feeder 
cattle, and dairy and beef replacement heifers). The NADA is approved 
as of August 20, 2002, and the regulations are amended in Sec.  558.311 
(21 CFR 558.311) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, Sec.  558.311 is being amended to collocate the entry 
for another free-choice mineral Type C medicated feed, approved under 
NADA 138-993, to the new entry created for NADA 141-171. This is being 
done to improve the readability and clarity of the regulations.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning August 20, 2002.
    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.

    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 (b)(8); in 
paragraph (d)(7) by adding ``and (e)(1)(xviii)'' after ``(e)(1)(xii)''; 
by revising (e)(1)(xii); and by adding paragraph (e)(1)(xviii) to read 
as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (b) * * *
    (8) 15 percent activity to No. 017800 for use as in paragraph 
(e)(1)(xviii) of this section.
* * * * *
    (e) * * *
    (1) * * *

[[Page 72369]]



----------------------------------------------------------------------------------------------------------------
   Lasalocid
sodium activity
  in grams per      Combination in grams per ton       Indications for use         Limitations         Sponsor
      ton
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                                                  * * * * * * *
(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.
                                                  * * * * * * *
(xviii) 1440     ..................................  Pasture cattle          Feed continuously on a  021930
                                                      (slaughter, stocker,    free-choice basis at   017800
                                                      feeder cattle, and      a rate of not less
                                                      dairy and beef          than 60 mg nor more
                                                      replacement heifers):   than 200 mg of
                                                      For increased rate of   lasalocid per head
                                                      weight gain.            per day.
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* * * * *

    Dated: November 8, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30783 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S