Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 74999 

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. 

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 

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. 

Categories of Records 

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. 

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: 

A. System of Records Maintained by 

CMS 

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: 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 


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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 

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 

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. 

SUMMARY: 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. 


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