[Federal Register Volume 75, Number 42 (Thursday, March 4, 2010)]
[Notices]
[Pages 9904-9905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0205]


James A. Holland; 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 James A. 
Holland's request for a hearing and is issuing an order under the 
Federal Food, Drug, and Cosmetic Act (the act) debarring Holland for 5 
years from providing services in any capacity to a person who has an 
approved or pending drug product application. FDA bases this order on a 
finding that Holland was convicted of a misdemeanor under Federal law 
for conduct relating to the development or approval of a drug product 
or otherwise relating to the regulation of a drug product under the act 
and that the type of conduct underlying the conviction undermines the 
process for the regulation of drugs. In determining the appropriateness 
and length of Holland's debarment period, FDA has considered the 
relevant factors listed in the act. Holland has failed to file with the 
agency information and analysis sufficient to create a basis for a 
hearing concerning this action.

DATES: The order is effective March 4, 2010.

ADDRESSES:  Submit applications 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:  G. Matthew Warren, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4613.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 24, 2007, Holland, formerly the head of the oncology 
program at the Stratton Veterans Affairs Medical Center, pled guilty to 
failing to establish and maintain a required record under section 
505(i) of the act (21 U.S.C. 355(i)) in violation of sections 301(e) of 
the act (21 U.S.C. 331(e)). On March 31, 2009, the United States 
District Court for the Northern District of New York sentenced Holland 
to 5 years of probation for his resulting Federal misdemeanor 
conviction under section 303(a)(1) of the act (21 U.S.C. 333(a)(1)). 
The basis for this conviction was Holland's failure to establish and 
maintain adequate and accurate case histories for the subjects of 
clinical trials he oversaw.
    Holland is subject to debarment based on a finding, under section 
306(b) of the act, (1) that he was convicted of a misdemeanor under 
Federal law for conduct relating to the development or approval of a 
drug product or otherwise relating to the regulation of a drug product 
under the act and (2) that the type of conduct underlying the 
conviction undermines the process for the regulation of drugs. 
Holland's conduct related to the development or approval of a drug 
product in that it involved clinical trials designed to study the 
effectiveness of drug products for possible approval by FDA.
    By letter dated June 1, 2009, FDA served Holland a notice proposing 
to debar him for 5 years from providing services in any capacity to a 
person having an approved or pending drug product application. By 
letter dated July 1, 2009, Holland, through counsel, requested a 
hearing on the proposal. In his request for a hearing, Holland does not 
dispute his misdemeanor conviction under Federal law, as alleged by 
FDA. However, he asserts that he has appealed the conviction to the 
United States Court of Appeals for the Second Circuit.
    We reviewed Holland's request for a hearing and find that Holland 
has not created a basis for a hearing because hearings will be granted 
only if there is a genuine and substantial issue of fact. Hearings will 
not be granted on issues of policy or law, on mere allegations, 
denials, or general descriptions of positions and contentions, or on 
data and information insufficient to justify the factual determination 
urged or the action requested (see 21 CFR 12.24(b)).
    The Acting Chief Scientist and Deputy Commissionerhas considered 
Holland's arguments and concludes that they are unpersuasive and fail 
to raise a genuine and substantial issue of fact requiring a hearing.

II. Arguments

    In support of his hearing request, Holland argues that the 
conviction on which FDA bases his proposed debarment is currently on 
appeal. However, under 306(b)(2)(B)(i), Holland

[[Page 9905]]

is subject to debarment if FDA finds that he ``has been convicted of--* 
* * a misdemeanor under Federal law'' and that ``the type of conduct 
which served as the basis for such conviction undermines the process 
for the regulation of drugs.'' FDA has made both findings, and Holland 
does not dispute either finding. Section 306 contains no requirement 
that a conviction be finalized on appeal before it subjects an 
individual to debarment. In fact, under 306(l)(1)(A), ``a person is 
considered to have been convicted of a criminal offense--* * * when a 
judgment of conviction has been entered against the person * * * 
regardless of whether there is an appeal pending.'' Moreover, under 
306(d)(3), Holland may apply to FDA to have the debarment order 
withdrawn if his conviction is reversed. It is therefore clear from 
section 306 that a pending appeal for a conviction does not preclude 
FDA's reliance on that conviction for debarment.

III. Findings and Order

    Therefore, the Acting Chief Scientist and Deputy Commissioner, 
under section 306(b)(2)(B)(i)(I) of the act and under authority 
delegated to him, finds (1) that Holland has been convicted of a 
misdemeanor under Federal law for conduct relating to the development 
or approval of a drug product or otherwise relating to the regulation 
of a drug product under the act and (2) that the type of conduct which 
served as the basis for that conviction undermines the process for the 
regulation of drugs. FDA has considered the relevant factors listed in 
section 306(c)(3) of the act and determined that a debarment of 5 years 
is appropriate.
    As a result of the foregoing findings, Holland is debarred for 5 
years from providing services in any capacity to a person with 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), effective (see DATES) 
(see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 
Any person with an approved or pending drug product application who 
knowingly uses the services of Holland, in any capacity during his 
period of debarment, will be subject to civil money penalties. If 
Holland, 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 Holland during his period of 
debarment.
    Any application by Holland for termination of debarment under 
section 306(d) of the act should be identified with Docket No. FDA-
2009-N-0205 and sent to the Dockets Management Branch (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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Publicly available submissions may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 22, 2010.
Jesse L. Goodman,
Acting Chief Scientist and Deputy Commissioner for Science and Public 
Health.
[FR Doc. 2010-4449 Filed 3-3-10; 8:45 am]
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