[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Notices]
[Page 67629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28255]



[[Page 67629]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1528]


Delfina Hernandez; 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. 
Delfina Hernandez 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. Hernandez was convicted of a 
felony under Federal law for conspiring to make false statements in 
matters within the jurisdiction of a government agency, and that Ms. 
Hernandez' conduct undermined the process for the regulation of drugs. 
Ms. Hernandez has failed to request a hearing and, therefore, has 
waived her opportunity for a hearing concerning this action.

DATES: This order is effective November 6, 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 October 22, 1997, the U.S. District Court for the Central 
District of California accepted Ms. Hernandez' plea of guilty to one 
count of conspiring to make false statements in matters within the 
jurisdiction of a government agency, FDA, a Federal felony offense 
under 18 U.S.C. sections 371 and 1001. This conviction was based on Ms. 
Hernandez' participation in falsifying data and information on clinical 
studies for use by FDA in determining the safety and effectiveness of 
drug products.
    As a result of this conviction, FDA served Ms. Hernandez 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. Hernandez 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. Hernandez was convicted of a 
felony under Federal law for conspiring to make false statements in 
matters within the jurisdiction of a government agency, FDA, and that 
Ms. Hernandez' conduct undermined the process for the regulation of 
drugs. Ms. Hernandez was provided 30 days to file objections and to 
request a hearing. Ms. Hernandez 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(b)(2) of the act, and under authority delegated to 
her (21 CFR 5.99), finds that Ms. Delfina Hernandez has been convicted 
of conspiracy to commit a felony under Federal law for conduct relating 
to the regulation of drug products and that Ms. Hernandez' conduct 
undermined the process for the regulation of drugs.
    As a result of the foregoing finding, Ms. Delfina Hernandez is 
debarred for 5 years from providing services in any capacity to a 
person that has 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)(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. Hernandez, in any 
capacity during her period of debarment, will be subject to civil money 
penalties. If Ms. Hernandez, 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. Hernandez 
during her period of debarment.
    Any application by Ms. Hernandez for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 00N-
1528 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. 02-28255 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S