Document ID: FDA-2022-N-0576-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions
Posted Date: 2022-10-07T04:00Z

[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61032-61033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0576]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Investigational 
Device Exemptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 7, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0078. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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-and-preparing-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 (21 CFR 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.
    In the Federal Register of May 6, 2022 (87 FR 27168), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
     Activity/21 CFR Section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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812.10; waivers.................               1               1               1               1               1
812.20, 812.25, and 812.27;                  229               1             229              80          18,320
 applications, investigational
 plans, and supplements.........
812.27(b)(4)(i); prior                       400               1             400               1             400
 investigations within the
 United States..................
812.27(b)(4)(ii); prior                      100               1             100        0.25 (15              25
 investigations outside the                                                             minutes)
 United States..................
812.28; acceptance of data from            1,500               1           1,500           10.25          15,375
 clinical investigations
 conducted outside the United
 States, and supporting
 information....................
812.28(c); waivers..............              10               1              10               1              10
812.35 and 812.150; application              654               5           3,270               6          19,620
 supplements....................
812.36(c); treatment IDE                       1               1               1             120             120
 applications...................

[[Page 61033]]

 
812.36(f); treatment IDE reports               1               1               1              20              20
812.150; non-significant risk                  1               1               1               6               6
 study reports..................
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    Total.......................  ..............  ..............           5,513  ..............          53,897
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1 There 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
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                                                     Number of                    Average burden
     Activity/21 CFR Section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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812.2(c)(3); records regarding               700               1             700               4           2,800
 leftover specimens not
 individually identifiable used
 in certain studies.............
812.28(d); records for clinical            1,500               1           1,500               1           1,500
 investigations conducted
 outside United States..........
812.140; retention of records...           1,249            3.09           3,865          1.9937           7,706
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    Total.......................  ..............  ..............  ..............  ..............          12,006
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1 There 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-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21852 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P