[Federal Register Volume 67, Number 124 (Thursday, June 27, 2002)]
[Rules and Regulations]
[Pages 43247-43248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16050]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two approved new 
animal drug applications (NADAs) and an approved abbreviated new animal 
drug application (ANADA) from Lambert-Kay, A Division of Carter-
Wallace, Inc., to Church & Dwight Co., Inc. The drug labeler code for 
Church & Dwight Co., Inc., is also being listed.

DATES: This rule is effective June 27, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Lambert-Kay, A Division of Carter-Wallace, 
Inc., P.O. Box 1001, Half Acre Rd., Cranbury, NJ 08512-0181, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, NADA 101-497 for TINY TIGER (dichlorophene/toluene) 
Worming Capsules, NADA 101-498 for LK (dichlorophene/toluene) Worming 
Capsules, and ANADA 200-028 for EVICT (pyrantel pamoate) Liquid Wormer 
to Church & Dwight Co., Inc., 469 North Harrison St., Princeton, NJ 
08543-5297. Accordingly, the agency is amending the regulations in 
Secs. 520.580 and 520.2043 (21 CFR 520.580 and 520.2043) to reflect the 
transfer of ownership.
    Church & Dwight Co., Inc., has not been previously listed in the 
animal drug regulations as a sponsor of an approved application. 
Following these changes of sponsorship, Lambert-Kay is no longer the 
sponsor of any approved applications. Accordingly, 21 CFR 510.600(c)(1) 
and (c)(2) is being amended to add entries for Church & Dwight Co., 
Inc., and to remove the entries for Lambert-Kay. Also, Sec. 520.2043 is 
being revised to reflect a current format.
    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 
removing the entry for ``Lambert-Kay, A Division of Carter-Wallace, 
Inc.'' and by alphabetically adding an entry for ``Church & Dwight Co., 
Inc.'' and in the table in paragraph (c)(2) by removing the entry 
``011615'' and by numerically adding an entry for ``010237'' to read as 
follows:

[[Page 43248]]

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

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

----------------------------------------------------------------------------------------------------------------
                Firm name and address                                      Drug labeler code
----------------------------------------------------------------------------------------------------------------
*                  *                  *                  *                  *                  *
                                                        *
Church & Dwight Co., Inc., 469 North Harrison St.,                                                       010237
 Princeton, NJ 08543-5297
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------

    (2) * * * 

------------------------------------------------------------------------
   Drug labeler code                  Firm name and address
------------------------------------------------------------------------
*                  *                  *                  *
                  *                  *                  *
010237                  Church & Dwight Co., Inc., 469 North Harrison
                         St., Princeton, NJ 08543-5297
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

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.


Sec. 520.580  [Amended]

    4. Section 520.580 Dichlorophene and toluene capsules is amended by 
removing footnote 1 every place it appears in the section and in 
paragraph (b)(1) by removing ``011615'' and by adding in its place 
``010237''.
    5. Section 520.2043 is revised to read as follows:


Sec. 520.2043  Pyrantel pamoate suspension.

    (a) Specifications. (1) Each milliliter (mL) contains pyrantel 
pamoate equivalent to 50 milligrams (mg) pyrantel base.
    (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg 
pyrantel base.
    (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg 
pyrantel base.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) Nos. 000069 and 059130 for use of the product described in 
paragraph (a)(1) as in paragraph (d)(1) of this section.
    (2) Nos. 000069, 010237, and 059130 for use of the products 
described in paragraph (a)(2) as in paragraph (d)(2) of this section.
    (3) No. 023851 for use of the product described in paragraph (a)(3) 
as in paragraph (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses and ponies. It is used as 
follows:
    (i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed 
with the usual grain ration, or by stomach tube or dose syringe.
    (ii) Indications for use. For the removal and control of infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles, pinworms 
(Oxyuris), and large roundworms (Parascaris).
    (iii) Limitations. Not for use in horses and ponies to be 
slaughtered for food purposes. When the drug is for administration by 
stomach tube, it shall be labeled: ``Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.''
    (2) Dogs. It is used as follows:
    (i) Dogs and puppies--(A) Amount. 2.27 mg/lb body weight as a 
single dose in the animal's feed bowl by itself or mixed in a small 
quantity of food.
    (B) Indications for use. For the removal of large roundworms 
(Toxocara canis and Toxascarias leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (C) Limitations. Additional treatment may be required and should be 
confirmed by fecal examination within 2 to 4 weeks.
    (ii) Dogs, puppies, and lactating bitches after whelping--(A) 
Amount. 2.27 mg/lb body weight.
    (B) Indications for use. To prevent reinfections of T. canis.
    (C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 
weeks of age. Administer to lactating bitches 2 to 3 weeks after 
whelping. Adult dogs kept in heavily contaminated quarters may be 
treated at monthly intervals.

    Dated: May 24, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-16050 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S