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