27172 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance is also available at https://

www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Feasibility and Early 

Feasibility Clinical Studies for Certain 

Medical Devices Intended to 

Therapeutically Improve Glycemic 

Control in Patients with Type 2 Diabetes 

Mellitus’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 19045 

and complete title to identify the 

guidance you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations and guidances have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control No. 

807, subpart E ......................................................................... Premarket Notification ............................................................. 0910–0120 

814, subparts A through E ...................................................... Premarket Approval ................................................................. 0910–0231 

812 ........................................................................................... Investigational Device Exemption ........................................... 0910–0078 

‘‘Requests for Feedback on Medical Device Submissions: 

The Q-Submission Program’’.

Q-submissions; Pre-submissions ............................................ 0910–0756 

50, 56 ....................................................................................... Protection of Human Subjects and Institutional Review 

Boards.

0910–0130 

Dated: April 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09738 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Global Affairs: Virtual 

Stakeholder Listening Session in 

Preparation for the 75th World Health 

Assembly 

Time and date: The session will be 

held on Friday, May 13, 2022, from 

10:00 a.m.–12:00 p.m. Eastern Time 

(ET). 

Place: The session will be held 

virtually, and registration is required. 

Please RSVP by May 6, 2022 by sending 

your full name, email address, and 

organization to OGA.RSVP@hhs.gov. 

OGA encourages early registration. 

Status: Open, but requiring RSVP to 

OGA.RSVP@hhs.gov to register. 

Purpose: The U.S. Department of 

Health and Human Services (HHS)— 

charged with leading the U.S. delegation 

to the 75th World Health Assembly— 

will hold an informal Stakeholder 

Listening Session on Friday, May 13, 

10:00 a.m.–12:00 p.m. ET. The listening 

session will be held virtually, and the 

meeting link will be shared with 

registered participants prior to the 

session. 

The Stakeholder Listening Session 

will help the HHS Office of Global 

Affairs prepare the U.S. delegation to 

the World Health Assembly by taking 

full advantage of the knowledge, ideas, 

feedback, and suggestions from all 

communities interested in and affected 

by agenda items to be discussed at the 

75th World Health Assembly. The U.S. 

Government will consider contributions 

received from the stakeholders as it 

develops the U.S. positions. 

The listening session will be 

organized by agenda item, and 

participation is welcome from 

stakeholder communities, including: 

• Public health and advocacy groups; 

• State, local, and Tribal groups; 

• Private industry; 

• Minority health organizations; and 

• Academic and scientific 

organizations. 

All agenda items to be discussed at 

the 75th World Health Assembly can be 

found at this website: https://

apps.who.int/gb/e/e_wha75.html. 

RSVP: Registration is required for the 

event. Please send your full name, email 

address, and organization to 

OGA.RSVP@hhs.gov to register. Please 

RSVP no later than Friday, May 6, 2022. 

Written comments are welcome and 

encouraged, even if you are planning on 

attending the virtual session. Please 

send written comments to the email 

address: OGA.RSVP@hhs.gov. 

We look forward to hearing your 

comments related to the 75th World 

Health Assembly agenda items. 

Dated: May 2, 2022. 

Susan C. Kim, 

Chief of Staff, Office of Global Affairs. 

[FR Doc. 2022–09710 Filed 5–5–22; 8:45 am] 

BILLING CODE 4150–38–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; NHLBI 

Mentored Transition to Independence Study 

Section. 

Date: June 9–10, 2022. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge I, 6705 Rockledge Drive, Bethesda, 

MD 20892 (Virtual Meeting). 

Contact Person: Giuseppe Pintucci, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 205-H, 

Bethesda, MD 20892, (301) 827–7969, 

Pintuccig@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 


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