06/10/1998

[Federal Register: June 10, 1998 (Volume 63, Number 111)]

[Notices]               

[Page 31789-31790]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr10jn98-104]

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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]

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