[Federal Register Volume 68, Number 8 (Monday, January 13, 2003)]
[Notices]
[Page 1619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0566]


Renee Peugeot; 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 Renee Peugeot 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. Peugeot was convicted of a 
felony under Federal law for conduct relating to the development or 
approval, including the process for development or approval, of a drug 
product. Ms. Peugeot failed to request a hearing and, therefore, has 
waived her opportunity for a hearing concerning this action.

DATES: This order is effective January 13, 2003.

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: Nicole K. Mueller, 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 August 31, 2000, the U.S. District Court for the Northern 
District of Alabama entered judgment against Ms. Peugeot for two counts 
of making false statements to an agency of the United States, two 
counts of mail fraud, and one count of conspiracy to commit offenses 
against the United States, Federal felony offenses under 18 U.S.C. 2, 
1001, 1341, and 371, respectively. These offenses were committed as 
part of the development of a new drug for which Ms. Peugeot was 
conducting efficacy trials.
    As a result of this conviction, FDA served Ms. Peugeot by certified 
mail on May 8, 2002, a notice proposing to permanently debar Ms. 
Peugeot from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal also offered 
Ms. Peugeot an opportunity for a hearing on the proposal. The proposal 
was based on a finding, under section 306(a)(2)(A) of the act (21 
U.S.C. 335a(a)(2)(A)), that Ms. Peugeot was convicted of a felony under 
Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product. 
Ms. Peugeot was provided 30 days to file objections and request a 
hearing. Ms. Peugeot 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, Center for Drug Evaluation and Research, 
under section 306(a)(2)(A) of the act, and under authority delegated to 
her (21 CFR 5.34), finds that Ms. Renee Peugeot has been convicted of a 
felony under Federal law for conduct relating to the development or 
approval, including the process for development or approval, of a drug 
product.
    As a result of the foregoing finding, Ms. Renee Peugeot is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
section 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)(ii) 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. Peugeot, in any 
capacity, during her period of debarment, will be subject to civil 
money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). 
If Ms. Peugeot, 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 (section 
307(a)(7) of the act). In addition, FDA will not accept or review any 
abbreviated new drug applications submitted by or with the assistance 
of Ms. Peugeot during her period of debarment.
    Any application by Ms. Peugeot for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 01N-
0566 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: December 23, 2002.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-663 Filed 1-10-03; 8:45 am]
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