27168 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 

applications to FDA. FDA confirms 

whether certain information in the 

application is consistent with FDA’s 

existing records. This helps the thirdparty appraiser to determine the 

manufacturers’ eligibility for 

participation in the VIP. We expect each 

application will take approximately 5 

minutes to submit. 

Aggregate Data Reporting 

The third-party appraiser provides 

FDA with aggregated data across all 

participating manufacturer sites 

quarterly. The aggregate data is used to 

identify broad industry trends and 

patterns that FDA may consider in the 

benefit-risk considerations FDA 

routinely uses to inform planning, 

improve FDA resource allocations, 

improve review efficiency, and inform 

risk-based inspection planning. We 

expect that it will take approximately 8 

hours to prepare and submit the 

aggregate data. 

Summary of Site Appraisal 

The third-party appraiser provides 

FDA with a summary of the appraisal 

result for each participating site. FDA 

intends to consider this information in 

the benefit-risk considerations FDA 

routinely uses to inform planning, 

improve FDA resource allocations, 

improve review efficiency, and inform 

risk-based inspection planning for firms 

that demonstrate capability and 

transparency around their 

manufacturing and product 

performance. We expect it will take 

approximately 20 hours to complete 

each summary. 

The VIP and Certain Regulatory 

Submissions 

FDA expects to gain insights into a 

participant’s manufacturing processes 

and control capabilities intended to 

satisfy recommendations for certain 

PMA or HDE submissions (e.g., PMA/ 

HDE 30-Day Change Notices, PMA/HDE 

Manufacturing Site Change 

Supplements, PMA/HDE Manufacturing 

Modules). Thus, participants in the VIP 

may be able to avail themselves of 

efficiencies that would prevent 

duplicate information and/or allow for 

least burdensome submissions to FDA. 

FDA plans to improve stakeholder 

opportunities to use modified templates 

for such submissions. 

The draft guidance also refers to 

previously approved collections of 

information. These collections of 

information are subject to review by the 

OMB under the PRA. The collections of 

information in the following FDA 

regulations have been approved by OMB 

as listed in the following table: 

21 CFR part Topic OMB control No. 

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

814, subpart H ......................................................................... Humanitarian Device Exemption ............................................. 0910–0332 

820 ........................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

7 ............................................................................................... Recalls ..................................................................................... 0910–0432 

803 ........................................................................................... Medical Device Reporting ....................................................... 0910–0437 

807, subparts A through D ...................................................... Establishment Registration and Listing ................................... 0910–0625 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09734 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–2022–N–0576] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Investigational 

Device Exemptions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

investigational device exemptions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before July 5, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 5, 2022. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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 

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 


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Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Notices 27169 

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– 

2022–N–0576 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Investigational Device Exemptions.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Investigational Device Exemptions—21 

CFR Part 812 

OMB Control Number 0910–0078— 

Extension 

This information collection supports 

implementation of section 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360j(g)), which 

governs exemption for devices for 

investigational use. An investigational 

device exemption (IDE) allows a device 

to be used in investigations involving 

human subjects in which the safety and 

effectiveness of the device is being 

studied. For more information regarding 

IDE, please visit our website at https:// 

www.fda.gov/medical-devices/ 

premarket-submissions-selecting-andpreparing-correct-submission/ 

investigational-device-exemption-ide. 

FDA has promulgated regulations in 

part 812 (21 CFR part 812) intended to 

encourage the discovery and 

development of useful devices intended 

for human use. The regulations set forth 

the scope and applicability of 

exemption requirements for devices for 

investigational use, as well as establish 

application procedures, corresponding 

instruction, and provisions for 

emergency research. The regulations 

also provide for requesting waivers from 

the requirements; and explain sponsor 

responsibilities, including requirements 

for Institutional Review Board (IRB) 

review and approval. Finally, the 

regulations in part 812, subpart G 

(§§ 812.140, 812.145, and 812.150) 

provide for required recordkeeping, the 

inspection of records, and the 

preparation and submission of reports to 

FDA and/or IRBs that oversee medical 

device investigations. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 

Total 

hours 

812.10; waivers .......................................................... 1 1 1 1 1 

812.20, 812.25, and 812.27; applications, investigational plans, and supplements ............................... 229 1 229 80 18,320 

812.27(b)(4)(i); prior investigations within the U.S .... 400 1 400 1 400 

812.27(b)(4)(ii); prior investigations outside the U.S 100 1 100 0.25 25 

812.28; acceptance of data from clinical investigations conducted outside the U.S., and supporting 

information .............................................................. 1,500 1 1,500 10.25 15,375 


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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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