Notice2022-09751
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 88 (Friday, May 6, 2022)</title>
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[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27168-27170]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#d181839082a5b0b7b791b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="4e1e1c0f1d3a2f28280e282a2f6026263d60292138">[email protected]</span></a>.
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 <a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide">https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide</a>. 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......................
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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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-are-not">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-are-not</a>, 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
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