09/29/2000

[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]                        

 

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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.

 

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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