[Federal Register: March 18, 2008 (Volume 73, Number 53)]
[Rules and Regulations]
[Page 14385-14386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr08-8]
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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 Feed; Zilpaterol
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 new animal drug application
(NADA) filed by Intervet, Inc. The NADA provides for use of approved,
single-ingredient zilpaterol hydrochloride and monensin U.S.P. Type A
medicated articles to make two-way combination Type B and Type C
medicated feeds for cattle fed in confinement for slaughter.
DATES: This rule is effective March 18, 2008.
FOR FURTHER INFORMATION CONTACT: Gerald L. Rushin, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8103, e-mail:
gerald.rushin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed NADA 141-278 that provides for use of
ZILMAX (zilpaterol hydrochloride) and RUMENSIN (monensin U.S.P.) Type A
medicated articles to make dry and liquid, two-way combination Type B
and Type C medicated feeds used for increased rate of weight gain,
improved feed efficiency, and increased carcass leanness; and for
prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii in cattle fed in confinement for slaughter during the last 20
to 40 days on feed. The NADA is approved as of February 15, 2008, and
the regulations in 21 CFR 558.665 are amended to reflect the approval.
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 Division of Dockets Management
(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)(2) 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 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 the
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.
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2. In Sec. 558.665, add paragraph (e)(3) to read as follows:
Sec. 558.665 Zilpaterol.
* * * * *
(e) * * *
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Zilpaterol in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
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(3) 6.8 to Monensin 10 to 40 Cattle fed in confinement for As in paragraph (e)(1) of this 057926
provide 60 to slaughter: As in paragraph section; see paragraph Sec.
90 mg/head/day (e)(1) of this section; and 558.355(d) of this chapter.
for prevention and control of Monensin as provided by No.
coccidiosis due to Eimeria 000986 in Sec. 510.600(c)
bovis and E. zuernii. of this chapter.
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[[Page 14386]]
Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5450 Filed 3-17-08; 8:45 am]
BILLING CODE 4160-01-S