[Federal Register Volume 70, Number 242 (Monday, December 19, 2005)]
[Rules and Regulations]
[Pages 75016-75017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Moxidectin Gel; Moxidectin and 
Praziquantel Gel

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 two supplemental new animal 
drug applications (NADAs) filed by Fort Dodge Animal Health, Division 
of Wyeth. The supplemental NADAs provide for oral use of moxidectin gel 
or moxidectin and praziquantel gel in horses and ponies for the 
treatment and control of two additional species of small strongyles.

DATES: This rule is effective December 19, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-087 for QUEST (moxidectin 2.0%) Gel and to NADA 141-216 for QUEST 
Plus (moxidectin 2.0%/praziquantel 12.5%) Gel. Both products are used 
for the treatment and control of various species of internal parasites 
in horses and ponies. The supplements provide for the addition of two 
new species of adult small strongyles to product labeling. The 
supplemental NADAs are approved as of November 23, 2005, and 21 CFR 
520.1452 and 520.1453 are amended to reflect the approval. The basis of 
approval is discussed in the freedom of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications

[[Page 75017]]

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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals qualify 
for 3 years of marketing exclusivity beginning November 23, 2005. 
Exclusivity applies only to the effectiveness claim for adult 
Cylicocyclus radiatus and Petrovinema poculatus for which new data were 
required.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do 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 520

    Animal drugs.

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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.1452  [Amended]

0
2. Section 520.1452 is amended in paragraph (d)(2) as follows:
    a. By removing ``and C. nassatus;'' and adding in its place ``C. 
nassatus, and C. radiatus;'' and
    b. By removing ``and Gyalocephalus capitatus;'' and adding in its 
place ``Gyalocephalus capitatus; and Petrovinema poculatus;''.


Sec.  520.1453   [Amended]

0
3. Section 520.1453 is amended in paragraph (d)(2) as follows:
    a. By removing ``and C. nassatus;'' and adding in its place ``C. 
nassatus, and C. radiatus;'' and
    b. By removing ``and Gyalocephalus capitatus;'' and adding in its 
place ``Gyalocephalus capitatus; and Petrovinema poculatus;''.

    Dated: December 8, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-24166 Filed 12-16-05; 8:45 am]
BILLING CODE 4160-01-S