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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FR DATE:11/13/2002

[Federal Register: November 13, 2002 (Volume 67, Number 219)]

[Notices]               
[Page 68877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-98]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1529]

 
Elaine Yee-Ling Lai; 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) debarring Ms. 
Elaine Yee-Ling Lai for 5 years 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 Ms. Lai was convicted of a 
felony under Federal law for aiding and abetting the making of a false 
document containing a materially fictitious statement in a matter 
within the jurisdiction of a government agency, and that Ms. Lai's 
conduct undermined the process for the regulation of drugs. Ms. Lai 
failed to request a hearing and, therefore, has waived her opportunity 
for a hearing concerning this action.

DATES: This order is effective November 13, 2002.

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: Mary Catchings, 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 June 9, 1998, the U.S. District Court for the Central District 
of California accepted Ms. Lai's plea of guilty to one count of aiding 
and abetting the making of a false document containing a materially 
fictitious statement in a matter within the jurisdiction of a 
government agency, the FDA, in violation of 18 U.S.C. 1001(a)(3) and 2. 
The basis of this conviction was Ms. Lai's act in assisting the 
principal investigator of a clinical study in creating a fraudulent 
document for use by FDA to determine whether a new drug should be 
approved.
    As a result of this conviction, FDA served Ms. Lai by certified 
mail on May 13, 2002, a notice proposing to debar her for 5 years from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal also offered Ms. Lai an 
opportunity for a hearing on the proposal. The debarment proposal was 
based on a finding, under section 306(b)(2)(B)(i)(II) and (a)(2) of the 
act (21 U.S.C. 335a(b)(2)(B)(i)(II) and (a)(2)) that Ms. Lai was 
convicted of a felony under Federal law for aiding and abetting the 
making of a false document containing a materially fictitious statement 
in a matter within the jurisdiction of a government agency and that Ms. 
Lai's conduct undermined the process for the regulation of drugs. Ms. 
Lai was provided 30 days to file objections and to request a hearing. 
Ms. Lai did not request a hearing. Her failure to request a hearing 
constitutes a waiver of her opportunity for a hearing and a waiver of 
any contentions concerning her debarment.

II. Findings and Order

    Therefore, the Director of the Center for Drug Evaluation and 
Research, under section 306(b)(2) of the act, and under authority 
delegated to her (21 CFR 5.99), finds that Ms. Elaine Yee-Ling Lai has 
been convicted of a felony under Federal law for aiding and abetting 
the making of a false document containing a materially fictitious 
statement in a matter within the jurisdiction of a government agency 
and that Ms. Lai's conduct undermined the process for the regulation of 
drugs.
    As a result of the foregoing finding, Ms. Elaine Yee-Ling Lai is 
debarred for 5 years from providing services in any capacity to a 
person that has 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) (see 
sections 306(c)(1)(B) and (c)(2)(A)(iii) 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 Ms. Lai, in any capacity 
during her period of debarment, will be subject to civil money 
penalties. If Ms. Lai, during her period of debarment, provides 
services in any capacity to a person with an approved or pending drug 
product application, she 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 Ms. Lai during her 
period of debarment.
    Any application by Ms. Lai for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 00N-
1529 and sent to the Dockets Management Branch (see ADDRESSES). 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: October 15, 2002.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 02-28715 Filed 11-12-02; 8:45 am]

BILLING CODE 4160-01-S