Document ID: FDA-2022-N-0576-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
Device Exemptions
Posted Date: 2022-05-06T04:00Z

[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27168-27170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09751]

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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.

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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

[[Page 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, 
[email protected].

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-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 (Sec. Sec.  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\
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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; applications, investigational plans,                 229                1              229               80           18,320
 and supplements...................................................
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              1,500                1            1,500            10.25           15,375
 outside the U.S., and supporting information......................

[[Page 27170]]

 
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
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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 leftover specimens not individually               700                1              700                4            2,800
 identifiable used in certain studies..............................
812.28(d); records for clinical investigations conducted outside               1,500                1            1,500                1            1,500
 U.S...............................................................
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: 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