FR DATE:11/24/2008

[Federal Register: November 24, 2008 (Volume 73, Number 227)]

[Notices]               
[Page 71007-71008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no08-109]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0474] (formerly Docket No. 2007N-0292)

 
George Kindness; 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) permanently 
debarring Mr. George Kindness from

[[Page 71008]]

providing services in any capacity to a person that has an approved or 
pending drug product application including, but not limited to, a 
biologics license application. FDA bases this order on a finding that 
Mr. Kindness was convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of a drug product under the act. After being 
given notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation, Mr. 
Kindness failed to request a hearing. Mr. Kindness's failure to request 
a hearing constitutes a waiver of his right to a hearing concerning 
this action.

DATES: This order is effective November 24, 2008.

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: Jennifer J. Ross, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0372.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 28, 2006, the U.S. District Court for the Western 
District of Tennessee accepted George Kindness's guilty plea to one 
count of being aided and abetted in the introduction and delivery for 
introduction into interstate commerce of a misbranded drug with intent 
to defraud and mislead, a Federal felony offense under sections 301(a) 
and 303(a)(2) of the act (21 U.S.C. 331(a) and 333(a)(2)) and 18 U.S.C. 
2. This offense was committed when Mr. Kindness, president, part-owner 
and laboratory director of Amscot Medical Labs, Inc., manufactured and 
shipped a new drug for use in human beings for the treatment of cancer, 
without an investigational new drug application in effect.
    As a result of this conviction, FDA sent Mr. Kindness by certified 
mail on September 7, 2007, a notice proposing to permanently debar Mr. 
Kindness from providing services in any capacity to a person that has 
an approved or pending drug product application including, but not 
limited to, a biologics license application. The proposal also offered 
Mr. Kindness an opportunity for a hearing on the proposal. The proposal 
was based on a finding, under section 306(a)(2)(A) and (c)(2)(A)(ii) of 
the act (21 U.S.C. 335a(a)(2)(A) and (c)(2)(A)(ii)), that Mr. Kindness 
was convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of a drug product. Mr. Kindness was provided 30 days to file 
objections and request a hearing. Mr. Kindness did not request a 
hearing. Mr. Kindness's failure to request a hearing constitutes a 
waiver of his opportunity for a hearing and a waiver of any contentions 
concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director of the Center for Biologics Evaluation and 
Research, under section 306(a)(2)(A) of the act, and under authority 
delegated to the Director (FDA Staff Manual Guide 1410.35), finds that 
Mr. Kindness has been convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
for development or approval, of a drug product.
    As a result of the foregoing finding, Mr. Kindness is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application (section 306(c)(1)(B) of 
the act). A drug product means a drug, including a biological product, 
subject to regulation under sections 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). Any person with an approved or pending 
drug product application including, but not limited to, a biologics 
license application, who knowingly employs or retains as a consultant 
or contractor, or otherwise uses the services of Mr. Kindness, in any 
capacity, during Mr. Kindness's permanent debarment, will be subject to 
civil money penalties (section 307(a)(6) of the act (21 U.S.C. 
335b(a)(6))). If Mr. Kindness, during his permanent debarment, provides 
services in any capacity to a person with an approved or pending drug 
product application including, but not limited to, a biologics license 
application, Mr. Kindness will be subject to civil money penalties 
(section 307(a)(7) of the act). In addition, FDA will not accept or 
review any abbreviated drug applications submitted by or with the 
assistance of Mr. Kindness during Mr. Kindness's permanent debarment 
(section 306(c)(1)(B) of the act).
    Any application by Mr. Kindness for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. FDA-
2007-N-0474 (formerly Docket No. 2007N-0292) and sent to the Division 
of Dockets Management (see ADDRESSES). All such submissions are to be 
filed in four copies (Sec.  10.20(a) (21 CFR 10.20(a))). The public 
availability of information in these submissions is governed by Sec.  
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 
(Sec.  10.20(j)(1)).

    Dated: November 12, 2008.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. E8-27802 Filed 11-21-08; 8:45 am]

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