[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Notices]
[Pages 31789-31790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15482]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0131]
Scott Feuer; Final 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
Scott Feuer, 25 Glenwood Rd., Tenafly, NJ 07670, for a period of 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
finding that Mr. Feuer was convicted of conspiracy to commit an offense
against the United States and that Mr. Feuer's conduct undermined the
process for the regulation of drugs. Mr. Feuer has failed to request a
hearing and, therefore, has waived his opportunity for a hearing
concerning this action.
EFFECTIVE DATE: June 2, 1998.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Leanne Cusumano, 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 March 24, 1993, the United States District Court for the
District of Maryland accepted Mr. Feuer's plea of guilty to one count
of conspiracy to commit an offense against the United States under 18
U.S.C. 371 and 18 U.S.C. 2. This conspiracy conviction was based on Mr.
Feuer's directing others to change manufacturing procedures for the
generic drug Fenoprophen, falsifying records in order to conceal from
the FDA the manufacturing changes, and distributing the Fenoprophen
without FDA approval of the formula actually distributed.
As a result of this conviction, FDA served Mr. Feuer by certified
mail on March 2, 1998, a notice proposing to debar him for a period of
5 years from providing services in any capacity to a person that has an
approved or pending drug product application, and offered him 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. Feuer was convicted of a conspiracy to commit
a felony under Federal law for conduct relating to the regulation of a
drug product and that Mr. Feuer's conduct undermined the process for
the regulation of drugs. Mr. Feuer 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 of the Center for Drug Evaluation and
Research, under section 306(b) of the act, and under authority
delegated to her (21 CFR 5.99(b)), finds that Scott Feuer has been
convicted of conspiracy to commit a felony under Federal law for
conduct relating to the regulation of a drug product and that Mr.
Feur's conduct undermined the process for the regulation of drugs.
As a result of the foregoing finding, Scott Feuer is debarred from
providing services in any capacity to a person with an approved or
pending drug product application under section 505, 507, 512, or 802 of
the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the
Public Health Service Act (42 U.S.C. 262), effective June 2, 1998
(sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21
U.S.C. 321(dd))), for a
[[Page 31790]]
period of 5 years. Any person with an approved or pending drug product
application who knowingly uses the services of Mr. Feuer in any 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.
Feuer, 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 or abbreviated antibiotic drug
applications submitted by or with the assistance of Mr. Feuer during
his period of debarment.
Any application by Mr. Feuer for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. 98N-
0131 and sent to the Dockets Management Branch (address above). 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: May 18, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-15482 Filed 6-9-98; 8:45 am]
BILLING CODE 4160-01-F