[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Rules and Regulations]
[Page 16270-16271]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-7]
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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; Melengestrol and
Lasalocid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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[[Page 16271]]
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal
Health, Inc. The ANADA provides for use of single-ingredient Type A
medicated articles containing melengestrol and lasalocid to make two-
way combination drug Type B or Type C medicated feeds for heifers fed
in confinement for slaughter.
DATES: This rule is effective April 4, 2007.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health,
Inc., 8857 Bond St., Overland Park, KS 66214, filed ANADA 200-451 for
use of HEIFERMAX 500 (melengestrol acetate) Liquid Premix and BOVATEC
(lasalocid sodium) single-ingredient Type A medicated articles to make
dry and liquid, two-way combination drug Type B or Type C medicated
feeds for heifers fed in confinement for slaughter. Ivy Laboratories'
ANADA 200-451 is approved as a generic copy of NADA 140-288, sponsored
by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., for combination
use of MGA 500 and BOVATEC. The application is approved as of March 12,
2007, and the regulations are amended in 21 CFR 558.342 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 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.
0
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
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.342 [Amended]
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2. In Sec. 558.342, amend the table in paragraph (e)(1)(iii) in the
``Sponsor'' column by adding in numerical sequence ``021641''.
Dated: March 26, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-6180 Filed 4-3-07; 8:45 am]
BILLING CODE 4160-01-S