[Federal Register Volume 59, Number 9 (Thursday, January 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-853]


[[Page Unknown]]

[Federal Register: January 13, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 520

 

Animal Drugs, Feeds, and Related Products; Trichlorofon and 
Phenothiazine Powder

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 remove those portions of the regulations that 
reflect approval of a new animal drug application (NADA) held by TPC 
Products, Inc. The NADA provides for use of the combination drug 
trichlorofon and phenothiazine as a parasiticide in horses. In a notice 
published elsewhere in this issue of the Federal Register, FDA is 
withdrawing approval of this NADA in addition to two others which are 
not codified.

EFFECTIVE DATE: January 13, 1994.

FOR FURTHER INFORMATION CONTACT: William C. Keller, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of NADA 13-
685 (in addition to two uncodified NADA's for other phenothiazine 
drugs) for use of the combination drug trichlorofon and phenothiazine 
as a parasiticide in horses. The NADA is held by TPC Products, Inc., 
P.O. Box 4308, 2021 North Grove St., Fort Worth, TX 76106. The agency 
is taking this action because the firm failed to respond to a notice of 
opportunity for a hearing on a proposal to withdraw approval of the 
NADA due to the firm's failure to submit the reports required by 21 CFR 
510.300. This document removes 21 CFR 520.2520h to reflect the 
withdrawal of approval of the NADA. Additionally, because the firm is 
no longer the sponsor of an approved NADA, this document amends 21 CFR 
510.600(c)(1) and (c)(2) to remove references to the firm.

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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

Sec. 510.600  [Amended]

     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 ``TPC Products, Inc.,'' and in the 
table in paragraph (c)(2) by removing the entry for ``011531''.

 PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

     Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.2520h  [Removed]

     4. Section 520.2520h Trichlorofon and phenothiazine powder is 
removed.

    Dated: January 4, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-853 Filed 1-12-94; 8:45 am]
BILLING CODE 4160-01-F