[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
