David Winne: Grant of Special Termination; Final Order Terminating Debarment, 74999-75000 [2023-24094]
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Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices
retrieved by name or other personal
identifier) are matched with records of
other Federal or non-Federal agencies.
The Privacy Act requires agencies
involved in a matching program to:
1. Enter into a written agreement,
which must be prepared in accordance
with the Privacy Act, approved by the
Data Integrity Board of each source and
recipient Federal agency, provided to
Congress and the Office of Management
and Budget (OMB), and made available
to the public, as required by 5 U.S.C.
552a(o), (u)(3)(A), and (u)(4).
2. Notify the individuals whose
information will be used in the
matching program that the information
they provide is subject to verification
through matching, as required by 5
U.S.C. 552a(o)(1)(D).
3. Verify match findings before
suspending, terminating, reducing, or
making a final denial of an individual’s
benefits or payments or taking other
adverse action against the individual, as
required by 5 U.S.C. 552a(p).
4. Report the matching program to
Congress and the OMB, in advance and
annually, as required by 5 U.S.C.
552a(o) (2)(A)(i), (r), and (u)(3)(D).
5. Publish advance notice of the
matching program in the Federal
Register as required by 5 U.S.C.
552a(e)(12).
This matching program meets these
requirements.
Barbara Demopulos,
Privacy Act Officer, Division of Security,
Privacy Policy and Governance, Office of
Information Technology, Centers for Medicare
& Medicaid Services.
Participating Agencies
The Department of Health and Human
Services (HHS), Centers for Medicare &
Medicaid Services (CMS) is the
recipient agency, and the Department of
Defense (DoD), Defense Manpower Data
Center (DMDC) is the source agency.
ddrumheller on DSK120RN23PROD with NOTICES1
Authority for Conducting the Matching
Program
The principal authority for
conducting the matching program is 42
U.S.C. 18001, et seq.
Purpose(s)
The purpose of the matching program
is to provide CMS with DoD data
verifying individuals’ eligibility for
coverage under a DoD Health Benefit
Plan (i.e., TRICARE), when requested by
CMS and state-based administering
entities (AE) for the purpose of
determining the individuals’ eligibility
for insurance affordability programs
under the Patient Protection and
Affordable Care Act (PPACA). CMS and
the requesting AE will use the DoD data
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to determine whether an enrollee in
private health coverage under a
qualified health plan through a
federally-facilitated or state-based
health insurance exchange is eligible for
coverage under TRICARE, and the dates
the individual was eligible for TRICARE
coverage. DoD health benefit plans
provide minimum essential coverage
(MEC), and eligibility for such plans
precludes eligibility for financial
assistance in paying for private
coverage. CMS and AE will use the DoD
data to authenticate identity, determine
eligibility for financial assistance
(including an advance tax credit and
cost-sharing reduction, which are types
of insurance affordability programs),
and determine the amount of any
financial assistance.
Categories of Individuals
The categories of individuals whose
information is involved in the matching
program are: (1) active duty service
members and their family members and
(2) retirees and their family members
whose TRICARE eligibility records at
DoD match data provided to DoD by
CMS (submitted by AEs) about
individual consumers who are applying
for or are enrolled in private health
insurance coverage under a qualified
health plan through a federallyfacilitated or state-based health
insurance exchange.
System(s) of Records
The records used in the matching
program are disclosed from these
systems of records, as authorized by
routine uses published in the System of
Records Notices (SORNs) cited below:
Fmt 4703
Sfmt 4703
CMS Health Insurance Exchanges
System (HIX), CMS System No. 09–70–
0560, last published in full at 78 FR
63211 (Oct. 23, 2013), and amended at
83 FR 6591 (Feb. 14, 2018). Routine use
3 authorizes CMS’ disclosures of
identifying information about applicants
to DoD for use in this matching
program.
B. System of Records Maintained by
DoD
The DoD system of records and
routine use that support this matching
program are Routine Use h in DMDC 02
DoD, Defense Enrollment Eligibility
Reporting Systems (DEERS), last
published at 87 FR 32384 (May 31,
2022). Routine use H supports DoD’s
disclosures to CMS.
[FR Doc. 2023–24081 Filed 10–31–23; 8:45 am]
BILLING CODE 4120–03–P
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:
ACTION:
The categories of records used in the
matching program are identity records
and minimum essential coverage (MEC)
period records. To request information
from DoD, CMS will submit a request to
DoD that may contain, but is not limited
to, the following specified data elements
in a fixed record format: Social Security
Number (SSN), first name, middle
name, surname (last name), date of
birth, gender, and requested Qualified
Health Plan (QHP) coverage effective
date and end date. When DoD is able to
match the SSN and name provided by
CMS and information is available, DoD
will provide CMS with the following
about each individual, as relevant: SSN,
response code indicating enrollment in
MEC under a TRICARE plan, and, as
applicable, begin date(s) and end date(s)
of enrollment in MEC under a TRICARE
plan.
Frm 00027
A. System of Records Maintained by
CMS
Food and Drug Administration,
HHS.
Categories of Records
PO 00000
74999
Notice.
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
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75000
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, at 240–402–8743, or
debarments@fda.hhs.gov.
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
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19:48 Oct 31, 2023
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Request for Nominations on Public
Advisory Panels of the Medical
Devices Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
requesting that any industry
organizations interested in participating
in the selection of nonvoting industry
representatives to serve on certain
panels of the Medical Devices Advisory
Committee (MDAC or the Committee) in
the Center for Devices and Radiological
Health (CDRH) notify FDA in writing.
FDA is also requesting nominations for
nonvoting industry representatives to
serve on certain device panels of the
MDAC in the CDRH. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current and upcoming vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by December 1, 2023 (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
December 1, 2023.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives
should be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
