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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

 Food and Drug Administration, HHS.

# ACTION:

 Notice.

# 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                           ( print 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]

BILLING CODE 4160-01-S