Notice2023-24094
David Winne: Grant of Special Termination; Final Order Terminating Debarment
Primary source
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Published
November 1, 2023
Effective
November 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of David Winne with an effective date of August 18, 2024. FDA bases this order on a finding that Mr. Winne provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Mr. Winne's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.
Full Text
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<title>Federal Register, Volume 88 Issue 210 (Wednesday, November 1, 2023)</title>
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[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 74999-75000]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24094]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2558]
David Winne: Grant of Special Termination; Final Order
Terminating Debarment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) granting special termination of the debarment of David Winne with
an effective date of August 18, 2024. FDA bases this order on a finding
that Mr. Winne provided substantial assistance in the investigations or
prosecutions of offenses relating to a matter under FDA's jurisdiction,
and that special termination of Mr. Winne's debarment serves the
interest of justice and does not threaten the integrity of the drug
approval process.
DATES: This order is effective November 1, 2023.
ADDRESSES: Submit comments electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Written comments may be submitted to the Dockets
Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
[[Page 75000]]
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#a6c2c3c4c7d4cbc3c8d2d5e6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="80e4e5e2e1f2ede5eef4f3c0e6e4e1aee8e8f3aee7eff6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
In a Federal Register notice dated August 18, 2023 (88 FR 56636),
David Winne was permanently debarred from providing services in any
capacity to a person with an approved or pending drug product
application under section 306(a) of the FD&C Act (21 U.S.C. 335a(a)).
The debarment was based on FDA's finding that Mr. Winne was convicted
of a felony under Federal law for conduct relating to the regulation of
any drug product under the FD&C Act. On September 7, 2023, Mr. Winne
applied for special termination of debarment, under section 306(d)(4)
of the FD&C Act.
Under section 306(d)(4)(C) of the FD&C Act, FDA may limit the
period of debarment of a permanently debarred individual if the Agency
finds that the debarred individual has provided substantial assistance
in the investigation or prosecution of offenses described in section
306(a) or (b) of the FD&C Act or relating to a matter under FDA's
jurisdiction. In addition, pursuant to section 306(d)(4)(D)(ii) of the
FD&C Act, in cases of an individual FDA may limit the period of
debarment to less than permanent but to no less than 1 year, whichever
serves the interest of justice and protects the integrity of the drug
approval process.
Special termination of debarment is discretionary with FDA. FDA
generally considers a determination by the Department of Justice
concerning the substantial assistance of a debarred individual
conclusive in most cases. Mr. Winne cooperated with the United States
Attorney's Office in the investigation of several individuals, as
substantiated by a letter submitted by the United States Attorney's
Office for the Southern District of New York to the sentencing judge in
Mr. Winne's case and which was submitted to the Agency by Mr. Winne.
His cooperation contributed to the successful prosecution of these
individuals. Accordingly, FDA finds that Mr. Winne provided substantial
assistance as required by section 306(d)(4)(C) of the FD&C Act.
The additional requisite showings, i.e., that termination of
debarment serves the interest of justice and poses no threat to the
integrity of the drug approval process, are difficult standards to
satisfy. In determining whether these have been met, the Agency weighs
the significance of all favorable and unfavorable factors in light of
the remedial, public health-related purposes underlying debarment.
Termination of debarment will not be granted unless, weighing all
favorable and unfavorable information, there is a high level of
assurance that the conduct that formed the basis for debarment has not
recurred and will not recur, and that the individual will not otherwise
pose a threat to the integrity of the drug approval process.
The evidence FDA reviewed in support of termination shows that Mr.
Winne was convicted for a first offense; that he has no prior or
subsequent convictions for conduct described under the FD&C Act and has
committed no other wrongful acts affecting the drug approval process.
The evidence presented supports the conclusion that the conduct upon
which Mr. Winne's debarment was based is unlikely to recur. For these
reasons, the Agency finds that termination of Mr. Winne's debarment
serves the interest of justice and will not pose a threat to the
integrity of the drug approval process.
Under section 306(d)(4)(D) of the FD&C Act, the period of debarment
of an individual who qualifies for special termination may be limited
to less than permanent but to no less than 1 year. Mr. Winne's period
of debarment, which commenced on August 18, 2023, has not lasted for at
least 1 year. As such, his period of debarment cannot terminate until
August 17, 2024. Accordingly, the Assistant Commissioner, Office of
Human and Animal Food Operations, under section 306(d)(4) of the FD&C
Act and under authority delegated to the Assistant Commissioner, finds
that David Winne's application for special termination of debarment
should be granted, and that the period of debarment should terminate on
August 18, 2024, thereby allowing him to provide services in any
capacity to a person with an approved or pending drug product
application after that date. As a result of the foregoing findings,
David Winne's debarment is terminated effective August 17, 2024.
Dated: October 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24094 Filed 10-31-23; 8:45 am]
BILLING CODE 4164-01-P
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