[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Rules and Regulations]
[Pages 50912-50913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; 2-
Mercaptobenzothiazole Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 50913]]

animal drug regulations to reflect approval of a supplemental new 
animal drug application (NADA) filed by Combe, Inc. The supplemental 
NADA provides for the topical use of 2-mercaptobenzothiazole solution 
as an aid in the treatment of certain common skin inflammations in 
dogs.

DATES: This rule is effective August 22, 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: Combe, Inc., 1101 Westchester Ave., White 
Plains, NY 10604, filed a supplement to NADA 5-236 that provides for 
the use of Sulfodene (2-mercaptobenzothiazole) skin 
medication for dogs as an aid in the treatment of hot spots (moist 
dermatitis) and as first aid for scrapes and abrasions. The 
supplemental NADA provides for revisions to labeling. The NADA is 
approved as of July 3, 2000, and the regulations in 21 CFR 524.1376 are 
amended to reflect the approval.
    Approval of this supplemental NADA did not require review of any 
safety or effectiveness data. Therefore, a freedom of information 
summary is not required.
    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 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 part 524 is 
amended as follows:

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

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

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


Sec. 524.1376  [Amended]

    2. Section 524.1376 2-Mercaptobenzothiazole solution is amended in 
paragraph (c)(2) by removing the phrase ``treating moist dermatitis and 
hot spots'' and by adding in its place the phrase ``the treatment of 
hot spots (moist dermatitis)''.

    Dated: July 21, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-21414 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F