[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Notices]
[Page 58557]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0424]
Mohammad Uddin; Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) permanently
debarring Mr. Mohammad Uddin from providing services in any capacity to
a person that has an approved or pending drug product application. FDA
bases this order on a finding that Mr. Uddin was convicted of a felony
under Federal law for conduct relating to the regulation of a drug
product under the act. Mr. Uddin failed to request a hearing and,
therefore, has waived his opportunity for a hearing concerning this
action.
EFFECTIVE DATE: September 29, 2000.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On November 19, 1993, the United States District Court for the
District of Maryland entered judgment against Mr. Uddin for one count
of obstruction of an agency proceeding, a Federal felony offense under
18 U.S.C. 1505.
As a result of this conviction, FDA published in the Federal
Register of January 12, 1999 (64 FR 1809), a notice proposing to
permanently debar Mr. Uddin from providing services in any capacity to
a person that has an approved or pending drug product application and
offering him an opportunity for a hearing on the proposal. The proposal
was based on a finding, under section 306(a)(2)(B) of the act (21
U.S.C. 355a(a)(2)(B)), that he was convicted of a felony under Federal
law for conduct relating to the regulation of a drug product. Mr. Uddin
was provided 30 days to file objections and request a hearing. Mr.
Uddin did not request a hearing. His failure to request a hearing
constitutes a waiver of his opportunity for a hearing and a waiver of
any contentions concerning his debarment.
II. Findings and Order
Therefore, the Director, Center for Drug Evaluation and Research,
under section 306(a)(2)(B) of the act, and under authority delegated to
her (21 CFR 5.99), finds that Mr. Mohammad Uddin has been convicted of
a felony under Federal law for conduct relating to the regulation of a
drug product.
As a result of the foregoing finding, Mr. Mohammad Uddin is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
section 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health Service Act (42 U.S.C. 262),
effective September 29, 2000 (sections 306(c)(1)(B) and (c)(2)(A)(ii)
and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an
approved or pending drug product application who knowingly uses the
services of Mr. Uddin, in any capacity, during his period of debarment,
will be subject to civil money penalties. If Mr. Uddin, during his
period of debarment, provides services in any capacity to a person with
an approved or pending drug product application, he will be subject to
civil money penalties. In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Mr. Uddin during his period of debarment.
Any application by Mr. Uddin for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. 94N-
0424 and sent to the Dockets Management Branch (address above). All
such submissions are to be filed in four copies. The public
availability of information in these submissions is governed by 21 CFR
10.20(j). Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 11, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-25088 Filed 9-28-00; 8:45 am]
BILLING CODE 4160-01-F
|
