[Federal Register: December 5, 2002 (Volume 67, Number 234)]
[Rules and Regulations]
[Page 72368-72369]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de02-6]
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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: aadams1@cvm.fda.gov.
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]]
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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