02-28255. Delfina Hernandez; Debarment Order  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    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.

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    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.

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    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.

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    Dated: October 15, 2002.

    Janet Woodcock,

    Director, Center for Drug Evaluation and Research.

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    [FR Doc. 02-28255 Filed 11-5-02; 8:45 am]

    BILLING CODE 4160-01-S

Document Information

Effective Date:
11/6/2002
Published:
11/06/2002
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
02-28255
Dates:
This order is effective November 6, 2002.
Pages:
67629-67629 (1 pages)
Docket Numbers:
Docket No. 00N-1528
PDF File:
02-28255.pdf