Document ID: FDA-2011-N-0003-0025
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor; Moxidectin
Posted Date: 2011-08-09T04:00Z

[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Rules and Regulations]
[Pages 48714-48715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 524

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Change of Sponsor; 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 a change of sponsor for three approved new 
animal drug applications (NADAs) for dosage form products containing 
moxidectin from Fort Dodge Animal Health, Division of Wyeth, a wholly 
owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, 
Inc.

DATES: This rule is effective August 9, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, 
NY 10017 has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following three approved NADAs for dosage 
form products containing moxidectin to Boehringer Ingelheim Vetmedica, 
Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002: NADA 141-099, 
NADA 141-220, and NADA 141-247. Accordingly, the Agency is amending the 
regulations in 21 CFR parts 520, 522, and 524 to reflect the transfer 
of ownership.
    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 Parts 520, 522, and 524

    Animal drugs.

    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 parts 520, 
522, and 524 are 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.

0
2. In Sec.  520.1454, revise paragraphs (b) and (d) to read as follows:

Sec.  520.1454  Moxidectin solution.

* * * * *
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Special considerations. See Sec.  500.25 of this chapter.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
4. In Sec.  522.1450, redesignate paragraph (d) as paragraph (e); add 
new paragraph (d); and revise paragraph (b)

[[Page 48715]]

and newly redesignated paragraphs (e)(1) and (e)(3) to read as follows:

Sec.  522.1450  Moxidectin solution.

* * * * *
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) * * *
    (1) Amount. Administer 0.2 mg/kg of body weight (0.2 mg/2.2 pound) 
as a single, subcutaneous injection.
* * * * *
    (3) Limitations. Do not slaughter cattle within 21 days of 
treatment. Because a withholding time for milk has not been 
established, do not use in female dairy cattle 20 months of age and 
older. A withdrawal period has not been established for pre-ruminating 
calves. Do not use in calves to be processed for veal.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1451  [Redesignated as Sec.  524.1450 and Amended]

0
6. Redesignate Sec.  524.1451 as Sec.  524.1450 and revise paragraphs 
(a), (b), and (e)(1) to read as follows:

Sec.  524.1450  Moxidectin.

    (a) Specifications. Each milliliter contains 5 milligrams (mg) 
moxidectin (0.5 percent solution).
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) Amount. Administer topically 0.5 mg per kilogram of body 
weight.
* * * * *

    Dated: August 3, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-20182 Filed 8-8-11; 8:45 am]
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