[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Notices]
[Pages 58555-58556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25087]


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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