FR DATE:09/30/2003

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

[Notices]               
[Page 56298-56299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se03-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000N-1530]

 
Richard L. Borison; 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 Dr. 
Richard L. Borison for 10 years 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 Dr. Borison was convicted of 
felonies under Georgia State law for racketeering, theft, and false 
statements and representations,

[[Page 56299]]

and was a material participant in offenses for which another person is 
being debarred. Dr. Borison has 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 8, 1998, the Superior Court for the County of Richmond, 
State of Georgia, accepted Dr. Borison's plea of guilty and entered 
judgment against him for 36 counts of criminal offenses under Georgia 
State law for racketeering, theft, and false statements and 
representations.
    As a result of this conviction, FDA served Dr. Borison by certified 
mail on December 5, 2002, a notice proposing to debar him for 10 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal also offered 
Dr. Borison an opportunity for a hearing on the proposal. The debarment 
proposal was based on findings: (1) Under section 306(b)(2)(B)(ii) of 
the act (21 U.S.C. 335a(b)(2)(B)(ii) that Dr. Borison was convicted of 
felonies under State law for racketeering, theft, and false statements 
and representations; and (2) under section 306(b)(2)(B)(iii) of the act 
that Dr. Borison was a material participant in offenses leading to the 
conviction and debarment of another individual. Dr. Borison was 
provided 30 days to file objections and to request a hearing. Dr. 
Borison 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(b)(2)(B) of the act, and under authority delegated to 
her (21 CFR 5.34), finds that Dr. Richard L. Borison: (1) Has been 
convicted of a felony under State law for racketeering, theft, and 
false statements and representations; and (2) was a material 
participant in offenses leading to the conviction of another 
individual.
    As a result of the foregoing findings, Dr. Richard L. Borison is 
debarred for 10 years (two periods of 5 years, to run consecutively, 
based on his conviction for State felonies and his role as a material 
participant in the offenses leading to the conviction and debarment of 
another individual) from providing services in any capacity to a person 
that has 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)(iii) 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 Dr. Borison in any 
capacity during his period of debarment will be subject to civil money 
penalties. If Dr. Borison, 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. In 
addition, FDA will not accept or review any abbreviated new drug 
applications submitted by or with the assistance of Dr. Borison during 
his period of debarment.
    Any application by Dr. Borison for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 
2000N-1530 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. 03-24656 Filed 9-29-03; 8:45 am]

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