31312 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

1Public Law 116–260, div. FF, tit. XVII, sec. 

1705, 134 Stat. 1182, 3293–3294, amending Public 

Law 114–113, div. O, tit. IV, sec. 404, 129 Stat 2242, 

3010–3011 (classified as amended at 34 U.S.C. 

20144(d)(4)(C)). 

2See 34 U.S.C. 20144(j)(10)–(14) (defining the 

terms ‘‘9/11 victim,’’ ‘‘9/11 spouse,’’ and ‘‘9/11 

dependent,’’ among others); see also 28 CFR 104.2, 

104.3. 

3See 34 U.S.C. 20144(b)(1). 

4Public Law 114–113, div. O, tit. IV, sec. 404, 129 

Stat. 2242, 3007–3017 (classified as amended at 34 

U.S.C. 20144). 

5 ‘‘Claimants’’ hold final judgments issued by a 

United States district court under State or Federal 

Law against a foreign state that has been designated 

a state sponsor of terrorism and arising from acts 

of international terrorism. 34 U.S.C. 20144(c)(2). For 

purposes of the Fund, the term ‘‘claim’’ generally 

refers to a claim based on compensatory damages 

awarded to a United States person in a final 

judgment issued by a United States district court 

under State or Federal law against a foreign state 

that has been designated a state sponsor of terrorism 

and arising from acts of international terrorism. In 

general, a claim is determined eligible for payment 

from the Fund if the Special Master determines that 

the judgment holder (referred to as a ‘‘claimant’’) is 

a United States person, that the claim at issue meets 

the definition of claim above, and that the claim 

was submitted timely. 

6Public Law 116–69, div. B, tit. VII, sec. 1701, 

133 Stat. 1134, 1140–1141. The VCF provides 

compensation to those present at the World Trade 

Center on September 11, 2001, at other crash sites, 

or in the New York City Exposure Zone, or their 

personal representative. 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than July 12, 2021. 

A. Federal Reserve Bank of St. Louis 

(Holly A. Rieser, Manager) P.O. Box 442, 

St. Louis, Missouri 63166–2034. 

Comments can also be sent 

electronically to 

Comments.applications@stls.frb.org: 

1. The M&P Community Bancshares, 

Inc. 401(k) Employee Stock Ownership 

Plan, Newport, Arkansas; to acquire 

additional voting shares of up to 39 

percent of M&P Community Bancshares, 

Inc., and thereby indirectly acquire 

additional voting shares of Merchants 

and Planters Bank, both of Newport, 

Arkansas. 

Board of Governors of the Federal Reserve 

System, June 8, 2021. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2021–12322 Filed 6–10–21; 8:45 am] 

BILLING CODE P 

GENERAL SERVICES 

ADMINISTRATION 

[Notice-WWICC–2021–01; Docket No. 2021– 

0003; Sequence No. 1] 

World War One Centennial 

Commission; Notification of Upcoming 

Public Advisory Meeting; Correction 

AGENCY: World War One Centennial 

Commission; General Services 

Administration. 

ACTION: Notice; correction. 

SUMMARY: GSA published a notice in the 

Federal Register of Friday, May 28, 

2021, announcing a meeting of an 

upcoming public advisory meeting. The 

notice contained an incorrect date. This 

notice corrects that date. 

FOR FURTHER INFORMATION CONTACT: 

Daniel S. Dayton, Designated Federal 

Officer, World War 1 Centennial 

Commission, 701 Pennsylvania Avenue 

NW, 123, Washington, DC 20004–2608, 

at 202–380–0725 (Note: This is not a 

toll-free number). 

Correction 

In the Federal Register of Friday, May 

28, 2021, in FR Doc. 2021–11312, on 

page 28833, second column, correct the 

DATES section by removing Wednesday, 

June 23, 2021 and adding Wednesday, 

July 14, 2021 in its place. 

David Coscia, 

Agency Liaison Officer, Office of Presidential 

& Congressional Agency Liaison Services, 

General Services Administration. 

[FR Doc. 2021–12308 Filed 6–10–21; 8:45 am] 

BILLING CODE 6820–95–P 

GOVERNMENT ACCOUNTABILITY 

OFFICE 

Notice of Estimated Lump Sum CatchUp Payments to Eligible 9/11 Victims, 

9/11 Spouses, and 9/11 Dependents; 

Request for Comment 

AGENCY: U.S. Government 

Accountability Office (GAO). 

ACTION: Notice of estimated lump sum 

catch-up payments; request for 

comment. 

SUMMARY: GAO is now accepting 

comments on estimated potential lump 

sum catch-up payments to certain 9/11 

victims, 9/11 spouses, and 9/11 

dependents who have submitted eligible 

claims for payment from the United 

States Victims of State Sponsored 

Terrorism Fund. GAO is conducting a 

review and publishing this notice 

pursuant to the requirements of the 

Sudan Claims Resolution Act. 

Comments should be sent to the email 

address below. 

DATES: Interested persons are invited to 

submit comments on or before July 12, 

2021. 

ADDRESSES: Submit comments to 

FundPaymentComments@gao.gov or in 

writing to Mr. Charles Michael Johnson, 

Jr. at 441 G Street NW, Washington, DC 

20548. 

FOR FURTHER INFORMATION CONTACT: 

Charles Michael Johnson, Jr. at (202) 

512–7500 or JohnsonCM@gao.gov if you 

need additional information. For general 

information, contact GAO’s Office of 

Public Affairs, 202–512–4800. 

SUPPLEMENTARY INFORMATION: 

Background 

On March 26, 2021, GAO published a 

notice (86 FR 16211) of our 

methodology for estimating certain 

lump sum catch-up payments. The 

supplementary information included 

with the notice explained that, pursuant 

to Section 1705 of the Sudan Claims 

Resolution Act,1 GAO is conducting a 

review and publishing notices for 

estimating potential lump sum catch-up 

payments to 9/11 victims, 9/11 spouses, 

and 9/11 dependents 2 who have eligible 

claims for payment from the United 

States Victims of State Sponsored 

Terrorism Fund (Fund). The Fund, 

which is administered by a Special 

Master and supported by Department of 

Justice (DOJ) personnel,3 was 

established in 2015 by the Justice for 

United States Victims of State 

Sponsored Terrorism Act (Terrorism 

Act).4 In 2019, the United States Victims 

of State Sponsored Terrorism Fund 

Clarification Act (Clarification Act) 

removed language from the Terrorism 

Act precluding 9/11-related claimants 5

who received awards from the Victim 

Compensation Fund (VCF) from 

receiving payments from the Fund.6

However, because 9/11 family members 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31313 

7The Fund allocated $1.1 billion for initial-round 

payments and $1.095 billion for second-round 

payments. See U.S. Victims of State Sponsored 

Terrorism Fund, ‘‘Special Master Report Regarding 

the Third Distribution,’’ at 2 (June 2020). 

8See id.; U.S. Victims of State Sponsored 

Terrorism Fund, http://www.usvsst.com (last 

accessed June 1, 2021). 

9A summary of these comments are captured 

below; however, some comments fell into multiple 

categories and are included in all applicable 

categories. 

10 GAO counted comments received multiple 

times with the same content and sender as one 

comment. 

11According to the Fund’s June 2020 

congressional report, the applications of eligible 

claimants who applied in rounds one or two are 

carried forward into subsequent payment rounds. 

U.S. Victims of State Sponsored Terrorism Fund, 

‘‘Special Master Report Regarding the Third 

Distribution,’’ at 2 (June 2020). 

12As discussed in footnote 5, in general the Fund 

determines the eligibility of a claim for payment in 

each round by determining that the claimant holds 

a final judgment issued by a United States district 

court under State or Federal Law against a foreign 

state that has been designated a state sponsor of 

terrorism and arising from acts of international 

terrorism and that the claim was submitted timely. 

13The Fund’s ‘‘payment percentage’’ is the 

amount of funds available to pay all eligible 

claimants in a given round divided by 

compensatory damages after accounting for the 

individual and family caps, compensation from 

other sources, and prior payments from the Fund. 

The payment percentage for the initial round of 

payments was 13.6561 percent (generally rounded 

to 13.66 percent in USVSST Fund 

communications). The payment percentage for the 

second round of payments is 4.1955 percent 

(rounded to 4.2 percent in USVSST Fund 

communications). The payment percentage total for 

both rounds is 17.8516 percent, rounded here to 

17.85 percent. See U.S. Victims of State Sponsored 

Terrorism Fund, ‘‘Payment Calculation 

Explanation,’’ at 4 (December 2018). 

14 34 U.S.C. 20144(d)(4)(C)(i). Further, section 

1705 provides for GAO to conduct this audit in 

accordance with 34 U.S.C. 20144(d)(3)(A), which 

generally places limits on the amount of eligible 

claims (referred to as ‘‘statutory caps’’). For 

example, for individuals, the cap is generally 

Continued 

(i.e., immediate family members of 9/11 

victims who are not spouses or 

dependents, such as non-dependent 

parents and siblings) had not received 

awards from the VCF, they were not 

precluded from receiving payments 

from the Fund if their claims were 

determined eligible. The first round of 

payments was distributed in early 2017 

and the second round in early 2019.7 As 

of June 2021, the Fund had allocated 

$1.075 billion for third-round payments 

and was in the process of distributing 

payments on a rolling basis.8 According 

to comments received on our first 

notice, certain 9/11 victims, spouses, 

and dependents have worked with 

members of Congress related to these 

catch-up payments. While the Terrorism 

Act, as amended, contains a provision 

for us to estimate catch-up payments, it 

does not currently authorize such catchup payments to be made. The Fund 

would be responsible for making actual 

payments if authorized. 

Summary of Comments 

GAO received a total of 1,925 

comments by the closing date of April 

26, 2021.9 GAO received 1,910 

comments from individuals or 

anonymous commenters and 15 

comments from organizations.10 GAO 

received about 94 percent of comments 

by email; the remaining comments were 

received in voicemails or letters. GAO 

has carefully considered all comments 

received. Below is a summary of the 

types of comments GAO received and 

GAO’s response. 

Opposition to Use of Second Round 

Judgment Date 

The great majority of comments 

received expressed disagreement with 

the proposed use of September 14, 2018, 

the close of the application period for 

the second round of payments, as the 

date by which claimants must have had 

a final judgment to be eligible for catchup payments. Commentators opposing 

this date raised two consistent 

arguments for why the date should not 

be used. First, commentators explained 

that, because of the statutory bar that 

was in place at the time of the first and 

second rounds of payments from the 

Fund, the majority of otherwise eligible 

victims, spouses, and dependents did 

not seek final damages judgments before 

September 14, 2018, on the advice of 

counsel. They explained that such 

claims for damages would have been 

frivolous and administratively 

burdensome given the bar to recovery 

from the Fund. Second, commentators 

opposing this date also argued that 

Congress’ intent in passing the Sudan 

Claims Resolution Act was to provide 

for the estimation of catch-up payments 

for 9/11 victims, spouses, and 

dependents who had received payments 

from the VCF and had not received 

payments from the Fund in rounds one 

or two. Commentators said that by using 

September 14, 2018 as the cut-off date, 

GAO would exclude most of this 

population and underestimate the 

number of individuals eligible for catchup payments. 

GAO Response: GAO’s calculation 

will now include all eligible claimants 

who are 9/11 victims, spouses, and 

dependents who submitted applications 

by February 19, 2020, the deadline for 

the third round distribution of the 

Fund.11 We previously limited the 

population to those 9/11 victims, 

spouses and dependents who would 

have been eligible to receive a payment 

from the Fund in the first or second 

round but for the language in the 

Terrorism Act precluding claimants 

who received awards from the VCF from 

receiving payments from the Fund. For 

that reason, we had planned to limit the 

population to 9/11 victims, spouses and 

dependents who had eligible final 

judgments prior to the close of the 

application period for the second round 

of payments, September 14, 2018, and 

therefore would have been eligible for 

payment by that time.12 We based this 

approach on our understanding of the 

specific procedures for obtaining 

payments as set forth in the Terrorism 

Act and described by DOJ officials 

supporting the Fund. 

GAO revised the population for the 

purposes of this estimation partially in 

response to the arguments raised by 

commentators opposed to the 

September 14, 2018 cut-off date 

explaining the reasons why eligible 

claimants generally would not have 

pursued final judgments by this date. In 

addition, according to GAO’s analysis, 

the Fund’s summary data on the dates 

of certain claimants’ final judgments 

included only the most recent judgment 

date. According to the DOJ officials that 

support the Fund, the summary data on 

these judgments were compiled for 

internal purposes and not for the 

purpose of calculating payments to 

individual claimants. Instead, the Fund 

reviews each individual claimant’s 

application and documentation when 

determining eligibility and payment 

amounts. The limitations of the Fund’s 

summary data on the date of the 

claimants’ final judgments are discussed 

further in the data limitations section of 

this notice. 

Request To Use the Fund’s Payment 

Percentage in the First and Second 

Round 

GAO received comments about the 

use of the Fund’s payment percentage 

for our estimation lump sum catch-up 

payment.13 For example, commentators 

suggested that GAO add the payment 

percentages calculated by the Fund in 

the first and second rounds to determine 

the percentage needed for catch-up 

payments. 

GAO Response: The mandate calls for 

GAO to estimate potential lump sum 

catch-up payments in ‘‘amounts that, 

after receiving the lump sum catch-up 

payments, would result in the 

percentage of the claims of 9/11 victims, 

9/11 spouses, and 9/11 dependents 

received from the Fund being equal to 

the percentage of the claims of 9/11 

family members received from the fund, 

[as of the date of enactment].’’ 14 Thus, 


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31314 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 

$20,000,000 and for claims of family members 

when aggregated, the cap is generally $35,000,000. 

As such, we used data from the Fund on the claim 

amounts after the application of statutory caps. 

15For the purposes of our analysis, ‘‘net eligible 

claims’’ refers to the monetary amount of all eligible 

claims after the application of relevant statutory 

caps by the Fund, if applicable. 34 U.S.C. 

20144(d)(3)(A). For example, for individuals, the 

cap is generally $20,000,000 and for claims of 

family members when aggregated, the cap is 

generally $35,000,000. To calculate the amount of 

9/11 family members’ net eligible claims, we used 

rounds one and two data, the rounds in which the 

family members’ payments were received, from the 

Fund on the claim amounts after the application of 

statutory caps. To calculate the amount of 9/11 

victims, spouses and dependents’ net eligible 

claims, we used round three data from the Fund on 

the claim amounts after the application of statutory 

caps. 

16The population for which we are estimating 

‘‘catch-up payments’’ are 9/11 victims, spouses, and 

dependents who applied for payments in the first, 

second, or third round of payments from the Fund 

and who did not receive payments from the Fund 

in rounds one or two. See 34 U.S.C. 20144(c), 

(d)(4)(C); U.S. Victims of State Sponsored Terrorism 

Fund, ‘‘Special Master Report Regarding the Third 

Distribution,’’ at 2 (June 2020). According to the 

Fund’s June 2020 congressional report, the 

applications of eligible claimants who applied in 

rounds one or two are carried forward into 

subsequent payment rounds. GAO used the amount 

of net eligible claims calculated in the third round 

for 9/11 victims, spouses, and dependents. 

17As noted above, while the Terrorism Act, as 

amended, contains a provision for us to estimate 

catch-up payments, it does not currently authorize 

such catch-up payments to be made. 

GAO estimated the amount needed to 

provide potential lump sum catch-up 

payments so that these payments to 9/ 

11 victims, spouses, and dependents 

would represent an equal percentage of 

their net eligible claims as the amounts 

received by 9/11 family members. GAO 

did not combine the Fund’s payment 

percentages, which were based on 

payments to all eligible claimants in 

each round because the mandate calls 

for GAO to calculate a specific 

percentage for these catch-up payments 

that is based on payments to certain 9/ 

11 claimants only. 

Methodology To Produce Estimates for 

Lump Sum Catch-Up Payments 

To estimate the amount(s) called for 

in the mandate, GAO used data obtained 

from the Fund on the following 

amounts: (1) Payments received by 9/11 

family members in rounds one and two; 

(2) net eligible claims 15 of 9/11 family 

members who received payments in 

rounds one and two; and (3) net eligible 

claims of 9/11 victims, spouses, and 

dependents who have not received 

payments in rounds one or two. To 

calculate the first two amounts, GAO 

identified the population of claimants 

who were 9/11 family members and 

received payments in rounds one and 

two. GAO divided the payments 

received by 9/11 family members in 

rounds one and two by the net eligible 

claims of 9/11 family members who 

received payments in rounds one and 

two to calculate the percentage called 

for in the mandate. To calculate the 

third amount, GAO calculated the total 

net eligible claims of 9/11 victims, 

spouses and dependents who had not 

received payments in rounds one or 

two. GAO multiplied the percentage 

above by the total net eligible claims of 

9/11 victims, spouses, and dependents 

who submitted eligible applications by 

the February 19, 2020 deadline for the 

third round distribution of the Fund.16

This generated an estimate of the total 

amount needed to provide lump sum 

catch-up payments for 9/11 victims, 

spouses, and dependents. 

GAO also calculated the amount 

needed to provide lump sum catch-up 

payments by group (i.e., 9/11 victims, 

spouses, and dependents) utilizing the 

percentage calculated above.17 To 

estimate the average lump sum catch-up 

payments by individual for each group 

in our forthcoming report to Congress, 

GAO will multiply the net eligible claim 

of each claimant by the same percentage 

and then calculate the average catch-up 

payment for individuals within each 

group. 

Data Limitations 

In accordance with GAO standards, 

we assessed the reliability, accuracy, 

and completeness of the readily 

available electronic data DOJ provided 

from the Fund to ensure that it is 

appropriate for our purposes. 

Specifically, we reviewed relevant 

documentation from the Fund, 

including data on net eligible claims, 

judgment dates, and payment 

distributions across three payment 

rounds, conducted interviews with 

agency officials, and checked the data 

for outliers. Our review of the data 

found it to be sufficiently reliable for the 

purposes of estimating potential catchup payments for eligible claimants. 

However, with regard to summary 

data that the Fund provided on the 

dates of claimants’ final judgments, 

GAO found limitations with the 

completeness of this data for the 

purposes of determining which 

claimants had final judgments prior to 

September 14, 2018. According to the 

DOJ officials that support the Fund, the 

summary data provided by the Fund on 

these judgments was compiled for 

internal purposes and not for the 

purposes of calculating individual 

payments to individual claimants. 

Instead, the Fund reviews each 

individual claimant’s application and 

documentation when determining 

eligibility and payment amounts. 

The summary data contained 

information on judgments for each 

claimant in the third distribution, but 

for some claimants who had multiple 

judgments, only the most recent 

judgment was included as it 

incorporated the amounts of any prior 

judgments. For example, a claimant may 

have received one judgment in 2016 for 

pain and suffering damages in the 

amount of $2 million and then received 

a second judgment after September 14, 

2018, which added an additional $15 

million in economic damages to the 

previous pain and suffering damages 

judgment, totaling $17 million. In that 

case, DOJ officials supporting the Fund 

told us that, for their purposes, they 

only needed to record the most recent 

judgment and the total amount (in the 

example about, $17 million), and thus 

use of this summary data to determine 

the population of those eligible for 

catch-up payments could have resulted 

in a potential underestimate of eligible 

claimants. It would not have been 

practicable for us to conduct a case-bycase review of individual judgments to 

determine which claimants had 

multiple judgments, with one prior to 

the September 14, 2018 date used in our 

prior notice and one after that date. 

Given these limitations, and the 

arguments raised by commentators 

opposed to the September 14, 2018 date 

discussed above, GAO developed a 

more inclusive estimate that included 

eligible 9/11 victims, spouses, and 

dependents from all three payment 

rounds who did not receive a payment 

in the first two rounds of the Fund. 

Estimates for Lump Sum Catch-up 

Payments 

GAO calculated 3,288 9/11 family 

members received total payments of 

$1,155,264,392 in rounds one and two. 

The total net eligible claims of these 9/ 

11 family members was 

$19,723,494,745. Using these amounts, 

we calculated the percentage called for 

in the mandate of 5.8573 percent. We 

then estimated the 5,364 9/11 victims, 

spouses, and dependents had total net 

eligible claims of $45,287,995,177 and 

multiplied the 5.8573 percentage to 

generate $2,652,653,742, the total 

amount needed to provide lump sum 

catch-up payments for 9/11 victims, 

spouses, and dependents, so that the 

percentage of net eligible claims 

received by 9/11 family members is 

equal to the percentage of net eligible 

claims received by the 9/11 victims, 

spouses, and dependents in the 

population (see Table 1). 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Notices 31315 

TABLE 1—ESTIMATED AMOUNT NEEDED TO PROVIDE LUMP SUM CATCHUP PAYMENTS BY GROUP TO ELIGIBLE 9/11 VICTIMS, SPOUSES, AND

DEPENDENTS

Group 

Total amount 

needed to provide 

lump sum catch-up 

payments 

9/11 Victims .................. $811,945,396 

9/11 Spouses ................ 859,813,713 

9/11 Dependents .......... 980,894,632 

Total ....................... 2,652,653,742 

Authority: Pub. L. 116–260, div. FF, tit. 

XVII, 1705, 134 Stat. 1182, 3293–3294 (34 

U.S.C. 20144(d)(4)(C)). 

Charles Michael Johnson, Jr., 

Managing Director, Homeland Security and 

Justice, U.S. Government Accountability 

Office. 

[FR Doc. 2021–12109 Filed 6–10–21; 8:45 am] 

BILLING CODE 1610–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Gastroenterology and Urology Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Gastroenterology and 

Urology Devices Panel of the Medical 

Devices Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

DATES: The meeting will take place 

virtually on July 14, 2021, from 9 a.m. 

Eastern Time to 6 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability may 

be accessed at: https://www.fda.gov/ 

advisory-committees/about-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5211, Silver Spring, 

MD 20993–0002, James.Swink@

fda.hhs.gov, 301–796–6313, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On July 14, 

2021, the committee will discuss, make 

recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

Organ Care System (OCS) Liver System, 

by TransMedics, Inc. The proposed 

Indication for Use for the OCS Liver 

System, as stated in the PMA, is as 

follows: 

The TransMedics® Organ Care System 

(OCSTM) Liver is a portable 

extracorporeal liver perfusion and 

monitoring system indicated for the 

resuscitation, preservation, and 

assessment of liver allografts from 

donors after brain death (DBD) or liver 

allografts from donors after circulatory 

death (DCD) ≤55 years old in a nearphysiologic, normothermic and 

functioning state intended for a 

potential transplant recipient. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/medical-devicesadvisory-committee/gastroenterologyurology-devices-panel. Select the link 

for the 2021 Meeting Materials. 

The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before July 7, 2021. Oral 

presentations from the public will be 

scheduled on July 14, 2021 between 

approximately 2 p.m. Eastern Time and 

3 p.m. Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before June 29, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 30, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallet 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: June 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12266 Filed 6–10–21; 8:45 am] 

BILLING CODE 4164–01–P 


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