[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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