09/29/2000

[Federal Register: September 29, 2000 (Volume 65, Number 190)]

[Notices]              

[Page 58555-58556]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr29se00-101]                         

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

 

[Docket No. 94N-0371]

 

 

Rami Elsharaiha; 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. Rami Elsharaiha from providing services in any capacity

to a person that has an approved or pending drug product application.

FDA bases

 

[[Page 58556]]

 

this order on a finding that Mr. Elsharaiha was convicted of a felony

under Federal law for conduct relating to the regulation of a drug

product under the act. Mr. Elsharaiha 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, 301-594-5640.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

On March 4, 1994, the U.S. District Court for the District of

Maryland entered judgment against Mr. Elsharaiha for one count of

making false declarations before a grand jury, a Federal felony offense

under 18 U.S.C. 1623.

 

As a result of this conviction, FDA published in the Federal

Register of January 19, 1999 (64 FR 2905), a notice proposing to

permanently debar Mr. Elsharaiha 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. Elsharaiha was provided 30 days to

file objections and request a hearing. Mr. Elsharaiha 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 of the 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. Rami Elsharaiha 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. Rami Elsharaiha is

permanently debarred from providing services in any capacity to a

person with an approved or pending drug product application under

sections 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, (21 U.S.C. 335a(c)(1)(B) and

(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with an approved or

pending drug product application who knowingly uses the services of Mr.

Elsharaiha, in any capacity, during his period of debarment, will be

subject to civil money penalties. If Mr. Elsharaiha, 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. Elsharaiha during his period of debarment.

 

Any application by Mr. Elsharaiha for termination of debarment

under section 306(d)(4) of the act should be identified with Docket No.

94N-0371 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. 00-25087 Filed 9-28-00; 8:45 am]

BILLING CODE 4160-01-F