[Federal Register Volume 67, Number 178 (Friday, September 13, 2002)]
[Rules and Regulations]
[Pages 57943-57944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-23339]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Moxidectin
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 Fort Dodge Animal Health. The supplemental
NADA provides for veterinary prescription use of a sustained-release
injectable moxidectin formulation for treatment of existing hookworm
(Uncinaria stenocephala) infections in dogs.
DATES: This rule is effective September 13, 2002.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
mberson@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Div. of American
Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed a
supplement to NADA 141-189 that provides for veterinary prescription
use of PROHEART 6 (moxidectin) Sustained Release Injectable for Dogs
for treatment of existing larval and adult hookworm (U. stenocephala)
infections. The supplemental NADA is approved as of June 13, 2002, and
the regulations are amended in Sec. 522.1451 (21 CFR 522.1451) 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 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)(iii) of the Federal Food, Drug, and
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental
approval qualifies for 3 years of marketing exclusivity beginning June
13, 2002.
The agency has determined under 21 CFR 25.33(d)(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 522
Animal drugs.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
[[Page 57944]]
Sec. 522.1451 [Amended]
2. Section 522.1451 Moxidectin is amended in paragraph (d)(2) by
adding ``and Uncinaria stenocephala'' following ``caninum''.
Dated: August 22, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 02-23339 Filed 9-12-02; 8:45 am]
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