[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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