[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Pages 4269-4270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0105]


James T. Kimball; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying Mr. James T. 
Kimball's request for a hearing and is issuing a final order under the 
Federal Food, Drug, and Cosmetic Act (the act) permanently debarring 
Mr. James T. Kimball 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 Mr. Kimball was convicted of 
felonies under Federal law for conduct relating to the regulation of a 
drug product under the act. In addition, Mr. Kimball has failed to file 
with the agency information and analyses sufficient to create a basis 
for a hearing concerning this action.

DATES: This order is effective January 30, 2007.

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 May 24, 2000, a jury found Mr. Kimball guilty of one count of 
conspiring to commit offenses against the United States and the Florida 
Department of Health, a Federal felony offense under 18 U.S.C. 371; six 
counts of distributing a misbranded drug into interstate commerce, a 
Federal felony offense under 21 U.S.C. 331(a); and one count of making 
a false statement in a matter within the jurisdiction of a Federal 
agency, a Federal felony offense under 18 U.S.C. 1001. On October 19, 
2000, the U.S. District Court for the Middle District of Florida 
entered judgment and sentenced Mr. Kimball for these offenses.
    The bases for these convictions were Mr. Kimball's knowing and 
willful participation, including conspiring, to violate Federal laws in 
connection with the distribution of a misbranded drug, deprenyl, into 
interstate commerce, and false statements he made to the U.S. Customs 
Service about shipments of deprenyl for export. The drug deprenyl was 
misbranded because it contained selegiline, the active ingredient of a 
prescription drug Eldepryl, but was dispensed without a prescription 
issued by a licensed practitioner.
    As a result of these convictions, FDA served Mr. Kimball by 
certified letter on April 25, 2005,\1\ a proposal to permanently debar 
him from providing services in any capacity to a person that has an 
approved or pending drug product application. The notice also offered 
Mr. Kimball an opportunity to request a hearing on the debarment 
proposal. The debarment 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. Kimball was 
convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the act.
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    \1\ The certified letter was mailed to the prison facility where 
records indicated that Mr. Kimball was incarcerated, and the return 
receipt was signed on April 25, 2005, by an employee at the 
facility. In his request for hearing, Mr. Kimball stated that he 
received the letter on May 5, 2005. The delivery dates do not alter 
the nature of Mr. Kimball's request for a hearing or our application 
of summary judgement in this matter.
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    The certified letter also informed Mr. Kimball that his request for 
a hearing could not rest upon mere allegations or denials, but must 
present specific facts showing that there was a genuine and substantial 
issue of fact requiring a hearing. The letter also informed Mr. Kimball 
that the only material issue of fact was whether he was convicted as 
alleged in the letter, and that the facts underlying his conviction are 
not at issue in this proceeding. Finally, the letter informed Mr. 
Kimball that if it conclusively appeared from the face of the 
information and factual analyses in his request for a hearing that 
there was no genuine and substantial issue of fact that precluded the 
order of debarment, FDA would enter summary judgment against him and 
deny his request for a hearing.
    In a letter dated May 16, 2005, Mr. Kimball responded to the 
certified letter by requesting a hearing.

II. Denial of Hearing

    In his May 16, 2005, request for a hearing, Mr. Kimball does not 
present any arguments or information to show why he should not be 
debarred. Mr. Kimball merely states that: (1) He ``was not convicted 
pursuant to the statements set forth in FDA's alleged notice'', (2) the 
allegations of his convictions are incorrect, and (3) his conviction 
does not mandate his debarment. Such statements do not create a basis 
for a hearing because hearings will not be granted on mere allegations, 
denials, or general

[[Page 4270]]

descriptions of positions (see 21 CFR 12.24(b)(2)). Although FDA's 
proposal to debar Mr. Kimball explained that he had the opportunity to 
file a request for a hearing and then submit factual information within 
60 days from receipt of the letter, Mr. Kimball did not submit any 
factual information. Mr. Kimball has failed to present any arguments or 
information to show why he should not be debarred. Therefore, FDA finds 
that Mr. Kimball has failed to identify any genuine and substantial 
issue of fact requiring a hearing. Accordingly, FDA denies Mr. 
Kimball's request for a hearing.

III. Findings and Order

    Therefore, the Associate Commissioner for Regulatory Affairs, under 
section 306(a) of the act and under authority delegated to him, finds 
that Mr. James T. Kimball has been convicted of felonies under Federal 
law for conduct relating to the regulation of a drug product under the 
act (section 306(a)(2)(B) of the act).
    As a result of the foregoing findings, Mr. James T. Kimball is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application 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), 
effective (see DATES) (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 Mr. 
Kimball 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. Kimball, 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 submitted by or 
with the assistance of Mr. Kimball during his period of debarment.
    Any application by Mr. Kimball for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 
2005N-0105 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: January 22, 2007.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. E7-1416 Filed 1-29-07; 8:45 am]
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