[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
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