[Federal Register Volume 64, Number 11 (Tuesday, January 19, 1999)]
[Notices]
[Page 2905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1034]



[[Page 2905]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0371]


Rami Elsharaiha; 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. Rami Elsharaiha 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. Elsharaiha 
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. 
Elsharaiha 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. Elsharaiha have 
proven ineffective.

DATES: Written request for a hearing by February 18, 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 22, 1993, Mr. Elsharaiha entered into a plea agreement 
to plead guilty to one count of making false declarations before a 
grand jury. Based on this plea, the United States District Court for 
the District of Maryland entered judgment against Mr. Elsharaiha on 
March 4, 1994, for one count of making false declarations before a 
grand jury, a Federal felony offense under 18 U.S.C. 1623.
     The underlying facts supporting this felony conviction, and to 
which Mr. Elsharaiha stipulated in his plea agreement, are as follows:
     Mr. Elsharaiha was employed by Quad Pharmaceuticals Co., Inc. 
(Quad), from June 1986 to September 1991 as an inspector in Quad's 
quality control laboratory. On January 13, 1993, Mr. Elsharaiha 
testified before a grand jury empaneled by the United States District 
Court for the District of Maryland. In his testimony, Mr. Elsharaiha 
falsely denied that he was aware that anyone had tried to make changes 
to the raw materials log book while he was an inspector at Quad. Mr. 
Elsharaiha also falsely denied that he was aware that anyone had poured 
a substance such as acid onto the pages of the raw material log book in 
order to expunge information that they did not want seen.

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. Elsharaiha's felony conviction 
under 18 U.S.C. 1623 was for illegal conduct relating to the regulation 
of Quad's drug product. His false statements to the grand jury 
concerned matters that affect FDA's regulatory decisions about drug 
products. Under section 306(1)(2) of the act, mandatory debarment 
applies when an individual is convicted within the 5 years preceding 
this notice. Section 306(c)(2)(A)(ii) of the act requires that Mr. 
Elsharaiha's debarment be permanent.

III. Proposed Action and Notice of Opportunity for a Hearing

     Based on the findings discussed in section II of this document, 
FDA proposes to issue an order under section 306(a)(2) of the act 
permanently debarring Mr. Elsharaiha 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. Elsharaiha is hereby given an opportunity for a hearing to 
show why he should not be debarred. If Mr. Elsharaiha decides to seek a 
hearing, he must file on or before February 18, 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. Elsharaiha'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. Elsharaiha 
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. 
Elsharaiha, making findings and conclusions and denying a hearing.
     The facts underlying Mr. Elsharaiha's conviction are not at issue 
in this proceeding. The only material issue is whether Mr. Elsharaiha 
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-0371 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. 99-1034 Filed 1-15-99; 8:45 am]
BILLING CODE 4160-01-F