[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: 94-854]


[[Page Unknown]]

[Federal Register: January 13, 1994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0019]

 

TPC Products, Inc.; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of three new animal drug applications (NADA's) held by TPC Products, 
Inc., for use of certain phenothiazine-containing drug products. FDA is 
taking this action because the firm failed to respond to a notice of 
opportunity for a hearing proposing to withdraw approval of the 
applications. In a final rule published elsewhere in this issue of the 
Federal Register, FDA is amending the regulations by removing the 
entries which reflect approval of the only codified drug product, a 
combination of trichlorofon and phenothiazine powder.

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 the Federal Register of April 27, 1993 
(58 FR 25653), FDA provided a notice of opportunity for a hearing on a 
proposal to withdraw approval of three NADA's held by TPC Products, 
Inc., P.O. Box 4308, 2021 North Grove St., Fort Worth, TX 76106. The 
firm held: (1) NADA 3-808 for the use of phenothiazine drench in 
cattle, (2) NADA 5-224 for the use of phenothiazine and lead arsenate 
drench in sheep and goats, and (3) NADA 13-685 for the use of 
trichlorofon and phenothiazine as a parasiticide in horses. The NADA's 
were approved April 24, 1941, June 8, 1945, and November 6, 1963, 
respectively.
    The notice of opportunity for a hearing stated that FDA was 
proposing to issue an order under section 512(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(e)) withdrawing approval of the 
NADA's and all amendments and supplements thereto on the ground that 
the firm has failed to submit the reports required under 21 CFR 
510.300. The firm was given until May 27, 1993, to file a written 
notice of appearance and a request for a hearing (58 FR 25653). TPC 
Products, Inc., failed to file such an appearance and request for a 
hearing.
    Under 21 CFR 514.200, the failure of the sponsor to file a written 
appearance in answer to a notice of opportunity for a hearing 
constitutes a waiver of the right to a hearing and is grounds for FDA 
to summarily enter a final order withdrawing approval of the NADA's.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 3-808, 5-224, and 13-685 and all amendments and 
supplements thereto is hereby withdrawn, effective January 13, 1994.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending 21 CFR 510.600(c)(1) and (c)(2) by removing 
the entries to the firm (no longer the sponsor of an approved NADA) and 
is removing Sec. 520.2520h Trichlorofon and phenothiazine powder (21 
CFR 520.2520h) (the other two drug products are not codified) which 
reflects the approval of the NADA.

    Dated: January 4, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-854 Filed 1-12-94; 8:45 am]
BILLING CODE 4160-01-F