[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