[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: 94-812]


[[Page Unknown]]

[Federal Register: January 13, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0158]

 

Shulcon Industries, Inc.; Withdrawal of Approval of a New Animal 
Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new animal drug application (NADA) held by Shulcon Industries, 
Inc., for use of pregelatinized starch as an antidiarrheal in newborn 
calves. 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 application. In a final rule published elsewhere in this issue of 
the Federal Register, FDA is amending the regulations by removing the 
entry which reflects approval of the NADA.

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 June 17, 1993 (58 
FR 33445), CVM provided a notice of opportunity for a hearing on a 
proposal to withdraw approval of NADA 111-068 held by Shulcon 
Industries, Inc., 4351 East Sarnac Dr., Tucson, AZ 86718, for use of 
Scourx Calf Antidiarrheal (pregelatinized starch) in 
nonmedicated liquid feed or water for the symptomatic treatment (i.e., 
increasing fecal consistency) of nonspecific diarrhea in newborn 
calves. The application was approved December 20, 1983.
    The notice of opportunity for a hearing stated that CVM 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 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 July 19, 1993, to file a written notice of 
appearance and a request for a hearing (58 FR 33445 at 33446). Shulcon 
Industries, Inc., failed to file such an appearance and request for a 
hearing.

    Under Sec. 514.200 Contents of notice of opportunity for a hearing 
(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 CVM 
to summarily enter a final order withdrawing approval of the NADA.
    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 111-068 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) to remove 
references to the firm (the firm is no longer the sponsor of an 
approved NADA) and is removing 21 CFR 520.2155 to reflect the 
withdrawal of approval of the NADA.

    Dated: January 4, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-812 Filed 1-12-94; 8:45 am]
BILLING CODE 4160-01-F