[Federal Register Volume 68, Number 107 (Wednesday, June 4, 2003)]
[Rules and Regulations]
[Page 33381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14107]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524


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 an approved new 
animal drug application (NADA) from Combe, Inc., to Farnham Companies, 
Inc.

DATES: This rule is effective June 4, 2003.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Combe, Inc., 1101 Westchester Ave., White 
Plains, NY 10604, has informed FDA that it has transferred ownership 
of, and all rights and interest in, NADA 5-236 for SULFODENE Medication 
for Dogs to Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-
3928. Accordingly, the agency is amending the regulations in 21 CFR 
524.1376 to reflect the transfer of ownership.
    Following this change of sponsorship, Combe, Inc., is no longer the 
sponsor of any approved application. Accordingly, Sec.  510.600(c) is 
being amended to remove the entries for Combe, Inc.
    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 524

    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 parts 510 and 
524 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
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.


Sec.  510.600  [Amended].

0
2. Section 510.600 Names, addresses, and drug labeler codes of sponsors 
of approved applications is amended in the table in paragraph (c)(1) by 
removing the entry for ``Combe, Inc.'' and in the table in paragraph 
(c)(2) by removing the entry for ``011509''.

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

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

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


Sec.  524.1580b   [Amended]

0
4. Section 524.1376 2-Mercaptobenzothiazole solution is amended in 
paragraph (b) by removing ``011509'' and by adding in its place ``No. 
017135''.

    Dated: May 19, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-14107 Filed 6-3-03; 8:45 am]
BILLING CODE 4160-01-S