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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