
[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Notices]
[Pages 74999-75000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov. 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 [email protected].

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


