Notice2022-13517
Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards
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Published
June 24, 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 statutory and regulatory provisions governing human subject protection and institutional review boards.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37867-37869]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0403]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Protection of Human Subjects and Institutional Review
Boards
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 statutory and regulatory provisions governing human
subject protection and institutional review boards.
DATES: Submit either electronic or written comments on the collection
of information by August 23, 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 August 23, 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 August 23, 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 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-2013-N-0403 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Protection of Human Subjects and
Institutional Review Boards.'' 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#0a5a584b597e6b6c6c4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="520200130126333434123436337c3a3a217c353d24">[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.
[[Page 37868]]
``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.
Protection of Human Subjects; Informed Consent; and Institutional
Review Boards--21 CFR Parts 50 and 56
OMB Control Number 0910-0130--Extension
This information collection supports Agency regulations pertaining
to the protection of human subjects, informed consent, and
responsibilities of institutional review boards (IRBs) as set forth in
parts 50 and 56 (21 CFR parts 50 and 56). Parts 50 and 56 apply to all
clinical investigations regulated by FDA under sections 505(i) and
520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)
and 360j(g), respectively), as well as clinical investigations that
support applications for research or marketing permits for products
regulated by FDA. The regulations in parts 50 and 56 are intended to
protect the rights and safety of subjects involved in such
investigations. The regulations also contain the standards for
composition, operation, and responsibilities of IRBs that review
clinical investigations regulated by FDA.
21 CFR Part 50--Protection of Human Subjects
Provisions in part 50 provide for the protection of human subjects
involved in FDA-regulated clinical investigations. With few exceptions,
no investigator may involve a human being as a subject in FDA-regulated
research unless the investigator has obtained the legally effective
informed consent of the subject or the subject's legally authorized
representative. Basic elements of informed consent are set forth in
Sec. 50.25 (21 CFR 50.25) and include, among other things: (1) a
statement of the purpose and duration of a subject's participation in
the research; (2) a description of the procedures to be followed; (3)
identification of any experimental procedures; (4) a description of
risks, benefits, and appropriate alternative procedures or treatments;
(5) a description of extent to which confidentiality of records
identifying the subject will be maintained; (6) certain contact
information; and (7) a statement that participation is voluntary and
may be discontinued at any time. Additional elements set forth in Sec.
50.25 are required in the informed consent as appropriate. Exceptions
to these requirements are governed by 21 CFR 50.23, which requires both
investigator and physician to certify in writing that necessary
elements for exception from general requirements have been satisfied;
and Sec. 50.24 (21 CFR 50.24), which covers exception from informed
consent requirements for emergency research. In accordance with Sec.
50.27 (21 CFR 50.27) informed consent must be documented, except as
provided in Sec. 56.109(c) (21 CFR 56.109(c)), which provides for an
IRB to waive documentation of informed consent in certain
circumstances.
Informed consent must be documented using a written consent form
approved by the IRB and signed and dated by the subject or the
subject's legally authorized representative at the time of consent. For
each clinical investigation reviewed by an IRB, we believe there will
typically be one associated written consent form developed by an
investigator. In some cases, investigators will seek IRB approval of
changes in the research and/or consent form after initial IRB approval.
For some multi-institutional clinical investigations, the IRB of each
institution involved may separately conduct initial and continuing
review of the research, including review of the written consent form to
determine whether it is in accordance with Sec. 50.25. However, in
cases where a multi-institutional clinical investigation uses a single
IRB review process, there may only be one IRB conducting such reviews.
Additional safeguards are required for children, as prescribed in
subpart D (21 CFR 50.50 through 50.56) of the regulations.
21 CFR Part 56--Institutional Review Boards
The general standards for the composition, operation, and
responsibilities of an IRB are set forth in part 56. IRBs serve in an
oversight capacity by reviewing, among other things, informed consent
documents and protocols for FDA-regulated studies, to make findings
required to approve research, and document IRB actions. Part 56 also
regulates the administrative activities of IRBs reviewing FDA-regulated
research including, among other things, identification of types of IRB
records that must be prepared and maintained. Required recordkeeping
includes documentation pertaining to written procedures, proposals
reviewed, committee membership, meeting minutes, actions taken by the
IRB, correspondence, as well as other functional and operational
aspects of the IRB. Finally, the regulations describe administrative
actions for non-compliance, including both disqualification of IRBs or
IRB parent institutions, as well as reinstatement and alternative and
additional actions.
Description of Respondents: Respondents to the information
collection are IRBs that review and approve clinical investigations
regulated by FDA and clinical investigators of such research who obtain
informed consent of human subjects prior to research participation.
We estimate the annual burden for the collection of information as
follows:
[[Page 37869]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of disclosures Total annual Average burden
21 CFR section respondents per disclosures per disclosure Total hours
respondent
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Sec. 56.113; suspension or 2,520 1 2,520 * 0.5 1,260
termination of research........
Sec. 56.120(a); IRB response 7 1 7 10 70
to lesser administration
actions for noncompliance......
Sec. 56.123; reinstatement of 1 1 1 5 5
an IRB or an institution.......
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Total....................... .............. .............. .............. .............. 1,335
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* 30 minutes.
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on available data, there are approximately 2,520 IRBs
overseeing FDA-regulated clinical research. We have organized the table
summarizing estimated annual reporting burden to list only one
requirement per row recognizing that some provisions may also include
recordkeeping or third-party disclosure tasks. We believe we have
accounted for all burden cumulatively across the information collection
activity tables and invite comments on our estimates.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. 50.24; exceptions from 8 3 24 1 24
informed consent for emergency
research.......................
Sec. 50.27; documentation of 2,520 40 100,800 * 0.5 50,400
informed consent...............
Sec. 56.115; IRB records 2,520 14.6 36,792 40 1,471,680
(documentation of IRB
activities)....................
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Total....................... .............. .............. .............. .............. 1,522,104
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* 30 minutes.
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We characterize activities associated with Sec. Sec. 50.24 and
50.27 as recordkeeping burden. We assume each of the 2,520 IRBs meets
an average of 14.6 times annually and assume 40 hours of person-time
per meeting are required to meet the IRB recordkeeping requirements of
Sec. 56.115. We also assume most recordkeeping is completed
electronically.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average burden
21 CFR section respondents per disclosures per disclosure Total hours
respondent
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Sec. 50.25; elements of 2,520 40 100,800 * 0.5 50,400
informed consent...............
Sec. 56.109(d); written 2,520 2 5,040 * 0.5 2,520
statement about minimal risk
research when documentation of
informed consent is waived.....
Sec. 56.109(e); written 2,520 40 100,800 * 0.5 50,400
notification to approve or
disapprove research............
Sec. 56.109(g); IRB written 8 2 16 1 16
statement about public
disclosures to sponsor of
emergency research under 50.24.
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Total....................... .............. .............. .............. .............. 103,336
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* 30 minutes
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We characterize activities associated with Sec. Sec. 50.25,
56.109(d) and 56.109(e) as disclosure burden. We estimate that eight
IRBs per year will receive a request to review emergency research under
Sec. 50.24, thus requiring written notification under Sec. 56.109(g)
from the IRB to the sponsor. We estimate that it will take an IRB
approximately 1 hour to prepare each written statement, for a total of
2 hours per study. The total annual third-party disclosure burden for
IRBs to fulfill this requirement is estimated at 16 hours.
Dated: June 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13517 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P
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