[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20729-20731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; (S)-methoprene

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 Wellmark International. The NADA provides for oral use 
of (S)-methoprene for the prevention and control of flea populations.

DATES: This rule is effective April 18, 2000.

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.

SUPPLEMENTARY INFORMATION: Wellmark International, 1000 Tower Rd., 
suite

[[Page 20730]]

245, Bensenville, IL 60106, filed NADA 141-162 that provides for use in 
dogs, 9 weeks of age and older and 4 pounds body weight or greater, for 
the prevention and control of flea populations. (S)-methoprene prevents 
and controls flea populations by preventing the development of flea 
eggs but does not kill adult fleas. Concurrent use of insecticides may 
be necessary for adequate control of adult fleas. NADA 141-162 is 
approved as of January 24, 2000, and the regulations are amended in 21 
CFR part 520 by adding new Sec. 520.1390 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)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning January 24, 
2000, because no active ingredient (including any ester or salt of the 
drug) has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

    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 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Wellmark International'' and in 
the table in paragraph (c)(2) by numerically adding an entry for 
``011536'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

 
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                 Firm name and address                                      Drug labeler code
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
Wellmark International, 1000 Tower Rd., suite 245,       011536
 Bensenville, IL 60106
  *                    *                    *                    *                    *                    *
                                                             *
----------------------------------------------------------------------------------------------------------------

    (2) * * *

 
----------------------------------------------------------------------------------------------------------------
                   Drug labeler code                                      Firm name and address
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
011536                                                   Wellmark International, 1000 Tower Rd., suite 245,
                                                          Bensenville, IL 60106
  *                    *                    *                    *                    *                    *
                                                             *
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


    4. Section 520.1390 is added to read as follows:


Sec. 520.1390  (S)-methoprene.

    (a) Specifications. Each capsule contains 154, 308, or 462 
milligrams (mg) of (S)-methoprene.
    (b) Sponsor. See No. 011536 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. Capsules are given orally, once 
per week at the recommended minimum dosage of 10 mg of (S)-methoprene 
per pound of body weight (22 mg/kilograms).
    (2) Indications for use. For oral use in dogs, 9 weeks of age and 
older and 4 pounds body weight or greater, for the prevention and 
control of flea populations. (S)-methoprene prevents and controls flea 
populations by preventing the development of flea eggs but does not 
kill adult fleas. Concurrent use of insecticides may be necessary for 
adequate control of adult fleas.


[[Page 20731]]


    Dated: March 20, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-9575 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F