[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Notices]
[Pages 1809-1810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0424]
Mohammad Uddin; Proposal to Debar; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to issue
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 proposal 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. This notice also offers Mr.
Uddin an opportunity for a hearing on the proposal. The agency is
issuing this notice in the Federal Register because all other
appropriate means of service of the notice upon Mr. Uddin have proven
ineffective.
DATES: Written request for a hearing by February 11, 1999.
ADDRESSES: Submit written requests for a hearing and supporting
information 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. Conduct Related to Conviction
On November 19, 1993, Mr. Uddin entered into a plea agreement to
plead guilty to one count of obstruction of an agency proceeding. Based
on this plea, the United States District Court for the District of
Maryland entered judgment against Mr. Uddin on June 17, 1994, for one
count of obstruction of an agency proceeding, a Federal felony offense
under 18 U.S.C. 1505.
The underlying facts supporting this felony conviction, and to
which Mr. Uddin stipulated in his plea agreement, are as follows:
Mr. Uddin was Assistant Vice President of Research and Development
at Halsey Drug Co., Inc. (Halsey), during the period August 1987
through March 10, 1993. During an FDA inspection of Halsey on October
22, 1990, to determine Halsey's compliance with the act, Mr. Uddin was
interviewed by FDA investigators. Although Mr. Uddin knew that Halsey
had made three research and development (R&D) batches of
sulfamethoxazole/trimethoprim (generic Bactrim), during the interview
he told the investigators that these batches had not been made. He also
told the investigators that he had made filing batches of generic
Bactrim in both single and double strength dosage forms, when, in fact,
he had not made the single strength batch. Mr. Uddin's false statements
to FDA investigators obstructed FDA's inspection and audit of Halsey.
II. FDA's Finding
Section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual if FDA finds that the individual has been
convicted of a felony under Federal law for conduct relating to the
regulation of any drug product. Mr. Uddin's felony conviction under 18
U.S.C. 1505 was for illegal conduct relating to the regulation of
Halsey's drug product. His false statements to FDA investigators
concerned matters that affect FDA's regulatory decisions about drug
products. Under section 306(l)(2) of the act, mandatory debarment
applies when an individual is convicted within the 5
[[Page 1810]]
years preceding this notice. Section 306(c)(2)(A)(ii) of the act
requires that Mr. Uddin's debarment be permanent.
III. Proposed Action and Notice of Opportunity for a Hearing
Based on the findings discussed previously in this document, FDA
proposes to issue an order under section 306(a)(2) of the act
permanently debarring Mr. Uddin from providing services in any capacity
to a person that has an approved or pending drug product application.
In accordance with section 306 of the act and part 12 (21 CFR part
12), Mr. Uddin is hereby given an opportunity for a hearing to show why
he should not be debarred. If Mr. Uddin decides to seek a hearing, he
must file on or before February 11, 1999, a written notice of
appearance and request for a hearing. The procedures and requirements
governing this notice of opportunity for a hearing, a notice of
appearance and request for a hearing, information and analyses to
justify a hearing, and a grant or denial of a hearing are contained in
part 12 and section 306(i) of the act.
Mr. Uddin's failure to file a timely written notice of appearance
and request for a hearing constitutes an election by him not to use the
opportunity for a hearing concerning his debarment, and a waiver of any
contentions concerning this action. If Mr. Uddin does not request a
hearing in the manner prescribed by the regulations, the agency will
not hold a hearing and will issue the debarment order as proposed in
this letter.
A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If it
conclusively appears from the face of the information and factual
analyses in the request for a hearing that there is no genuine and
substantial issue of fact which precludes the order of debarment, the
Commissioner of Food and Drugs will enter summary judgment against Mr.
Uddin, making findings and conclusions and denying a hearing.
The facts underlying Mr. Uddin's conviction are not at issue in
this proceeding. The only material issue is whether Mr. Uddin was
convicted as alleged in this notice and, if so, whether, as a matter of
law, this conviction mandates his debarment.
A request for a hearing, including any information or factual
analyses relied on to justify a hearing, must be identified with Docket
No. 94N-0424 and sent to the Dockets Management Branch (address above).
All submissions pursuant to this notice of opportunity for a hearing
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.
This notice is issued under section 306 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a) and under authority delegated to the
Director, Center for Drug Evaluation and Research (21 CFR 5.99).
Dated: December 23, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-562 Filed 1-11-99; 8:45 am]
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