27170 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

Total 

hours 

812.28(c); waivers ...................................................... 10 1 10 1 10 

812.35 and 812.150; application supplements .......... 654 5 3,270 6 19,620 

812.36(c); treatment IDE applications ....................... 1 1 1 120 120 

812.36(f); treatment IDE reports ................................ 1 1 1 20 20 

812.150; non-significant risk study reports ................ 1 1 1 6 6 

Total .................................................................... .......................... .......................... 5,513 .......................... 53,897 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimate of the average reporting 

burden is based on our continued 

experience with the information 

collection. We have adjusted the 

currently approved burden to reflect an 

increase we attribute to Agency 

rulemaking that has become effective 

(OMB control number 0910–AG48) 

since our last evaluation. Regulations in 

part 812 were amended to provide for 

reporting associated with the acceptance 

of data from clinical investigations 

conducted outside the United States. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

812.2(c)(3); records regarding leftover specimens 

not individually identifiable used in certain studies 700 1 700 4 2,800 

812.28(d); records for clinical investigations conducted outside U.S ................................................. 1,500 1 1,500 1 1,500 

812.140; retention of records ..................................... 1,249 3.09 3,865 1.9937 7,706 

Total .................................................................... .......................... .......................... .......................... .......................... 12,006 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In the guidance document ‘‘Informed 

Consent For In Vitro Diagnostic Device 

Studies Using Leftover Human 

Specimens That Are Not Individually 

Identifiable’’ (April 2006), available for 

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

regulatory-information/search-fdaguidance-documents/guidanceinformed-consent-vitro-diagnosticdevice-studies-using-leftover-humanspecimens-are-not, FDA communicates 

its enforcement policy with regard to 

the informed consent regulations (as 

required by section 520(g) of the FD&C 

Act and 21 CFR part 50) for in vitro 

diagnostic device studies that are 

conducted using leftover specimens and 

that meet the criteria for exemption 

from IDE regulation at 21 CFR 

812.2(c)(3). We include burden that may 

be attributable to FDA recommendations 

that sponsors of studies document 

certain information, in table 2, row 1. 

We have otherwise adjusted our 

estimate upward of the average 

recordkeeping burden attributable to 

provisions in part 812 to reflect those 

requirements associated with clinical 

investigations conducted outside the 

United States, and in recognition of the 

required retention period for records. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09751 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0131] 

Feasibility and Early Feasibility Clinical 

Studies for Certain Medical Devices 

Intended to Therapeutically Improve 

Glycemic Control in Patients With Type 

2 Diabetes Mellitus; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Feasibility and Early 

Feasibility Clinical Studies for Certain 

Medical Devices Intended to 

Therapeutically Improve Glycemic 

Control in Patients with Type 2 Diabetes 

Mellitus.’’ This guidance provides 

recommendations for feasibility and 

early feasibility clinical studies for 

certain medical devices intended to 

therapeutically improve glycemic 

control in patients with Type 2 Diabetes 

Mellitus. These medical devices are 

intended to therapeutically reduce 

glycated hemoglobin in Type 2 Diabetes 

Mellitus patients independent of 

medication (e.g., insulin) delivery. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 6, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 27171 

1Center for Disease Control, National Diabetes 

Statistics Report 2020: Estimates of Diabetes and its 

Burden in the United States, available at https://

www.cdc.gov/diabetes/pdfs/data/statistics/ 

national-diabetes-statistics-report.pdf. 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–D–0131 for ‘‘Feasibility and Early 

Feasibility Clinical Studies for Certain 

Medical Devices Intended to 

Therapeutically Improve Glycemic 

Control in Patients with Type 2 Diabetes 

Mellitus.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Feasibility and 

Early Feasibility Clinical Studies for 

Certain Medical Devices Intended to 

Therapeutically Improve Glycemic 

Control in Patients with Type 2 Diabetes 

Mellitus’’ to the Office of Policy, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

5431, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

April Marrone, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2604, Silver Spring, 

MD 20993–0002, 240–402–6510. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance provides 

recommendations for the design of 

feasibility and early feasibility clinical 

studies for certain medical devices 

intended to therapeutically improve 

glycemic control in patients with Type 

2 Diabetes Mellitus (T2DM). T2DM is a 

metabolic disorder that is characterized 

by high blood sugar levels, insulin 

resistance, and relative lack of insulin. 

In 2020, it was estimated that 10.5 

percent of the United States population, 

or roughly 34.2 million Americans, have 

diabetes and that T2DM accounts for 90 

percent to 95 percent of all diabetes 

cases.1

Due to the prevalence of T2DM in the 

United States, many medical device 

manufacturers and researchers seek to 

develop therapeutic medical devices 

that are intended to improve glycemic 

control in patients with T2DM. 

Historically, there have been several 

legally marketed devices that help 

patients manage T2DM, including 

medical devices intended to measure or 

monitor blood sugar (e.g., blood glucose 

monitors, continuous glucose monitors) 

or dose and deliver insulin (e.g., insulin 

pens, pumps, syringes). Medical devices 

that are therapeutically intended to 

improve glycemic control in patients 

with T2DM are an increasing area of 

interest. Manufacturers frequently 

request the Agency’s feedback regarding 

feasibility and early feasibility clinical 

studies for these medical devices. This 

guidance represents the Agency’s initial 

thinking on feasibility and early 

feasibility clinical studies for these 

medical devices. FDA’s 

recommendations may change as more 

information becomes available. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of May 20, 2021 (86 FR 27438). 

FDA considered comments received and 

revised the guidance as appropriate in 

response to the comments, including 

revisions to clarify the scope of devices 

included in the guidance and revisions 

to clarify or provide examples of certain 

terminology used in the guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on feasibility and early 

feasibility clinical studies for certain 

medical devices intended to 

therapeutically improve glycemic 

control in patients with T2DM. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 


JSPEARS on DSK121TN23PROD with NOTICES1
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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