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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FR DATE: 09/30/2003

[Federal Register: September 30, 2003 (Volume 68, Number 189)]

[Notices]               
[Page 56300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se03-83]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000N-1427]

 
Edmund J. Striefsky; 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 Edmund J. Striefsky 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 Mr. Striefsky was convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the act. Mr. Striefsky failed to request a hearing 
and, therefore, has waived his opportunity for a hearing concerning 
this action.

DATES: This order is effective September 30, 2003.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (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 28, 1998, the U.S. District Court for the District of 
Maryland accepted Mr. Edmund J. Striefsky's plea of guilty to one count 
of distributing an adulterated drug into interstate commerce, a Federal 
felony offense under section 501(a)(2)(B) of the act (21 U.S.C. 
351(a)(2)(B)).
    As a result of this conviction, FDA hand delivered to Mr. Striefsky 
on February 11, 2003, a notice proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal also offered Mr. 
Striefsky an opportunity for a hearing on the proposal. The proposal 
was based on a finding, under section 306(a)(2)(B) of the act (21 
U.S.C. 335a(a)(2)(B)), that Mr. Striefsky was convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product under the act. Mr. Striefsky was provided 30 days to file 
objections and request a hearing. Mr. Striefsky did not request a 
hearing. His failure to request a hearing constitutes a waiver of his 
opportunity for a hearing and a waiver of any contentions concerning 
his debarment.

II. Findings and Order

    Therefore, the Director, Center for Drug Evaluation and Research, 
under section 306(a)(2)(B) of the act, and under authority delegated to 
her (21 CFR 5.34), finds that Mr. Edmund J. Striefsky has been 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product under the act.
    As a result of the foregoing finding, Mr. Edmund J. Striefsky 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 Mr. Striefsky, in any 
capacity, during his 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 Mr. Striefsky, during his period of debarment, provides services in 
any capacity to a person with an approved or pending drug product 
application, he 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 Mr. Striefsky during his period of debarment.
    Any application by Mr. Striefsky for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 
2000N-1427 and sent to the Division of Dockets Management (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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 4, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-24657 Filed 9-29-03; 8:45 am]

BILLING CODE 4160-01-S