[Federal Register: January 13, 2003 (Volume 68, Number 8)]
[Notices]
[Page 1619-1620]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja03-63]
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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