[Federal Register Volume 68, Number 8 (Monday, January 13, 2003)]
[Notices]
[Pages 1619-1620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0565]


Harry W. Snyder, Jr.; 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 Harry W. Snyder, Jr., 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. Snyder 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. Snyder failed to request a hearing and, therefore, has 
waived his opportunity for a hearing concerning this action.

DATES: This order is effective January 13, 2003.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole K. Mueller, 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 August 31, 2000, the U.S. District Court for the Northern 
District of Alabama entered judgment against Mr. Snyder for two counts 
of making false statements to an agency of the United States, two 
counts of mail fraud, and one count of conspiracy to commit

[[Page 1620]]

offenses against the United States, Federal felony offenses under 18 
U.S.C. 2, 1001, 1341, and 371, respectively. These offenses were 
committed as part of the development of a new drug for which Mr. Snyder 
was conducting efficacy trials.
    As a result of this conviction, FDA served Mr. Snyder by certified 
mail on May 8, 2002, a notice proposing to permanently debar Mr. Snyder 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal also offered 
Mr. Snyder an opportunity for a hearing on the proposal. The proposal 
was based on a finding, under section 306(a)(2)(A) of the act (21 
U.S.C. 335a(a)(2)(A)), that Mr. Snyder 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. Snyder was provided 30 days to file objections and request a 
hearing. Mr. Snyder 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(a)(2)(A) of the act, and under authority delegated to 
her (21 CFR 5.34), finds that Mr. Harry W. Snyder, Jr., 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. Harry W. Snyder, Jr., is 
permanently debarred 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), 
(see sections 306(c)(1)(B) and (c)(2)(A)(ii) 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. Snyder, 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. Snyder, 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. Snyder during his period of debarment.
    Any application by Mr. Snyder for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 01N-
0565 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.

    Dated: December 23, 2002.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-661 Filed 1-10-03; 8:45 am]
BILLING CODE 4160-01-S