Document ID: FDA-2013-N-0403-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards
Posted Date: 2022-06-24T04:00Z

[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37867-37869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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 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.

[[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.......
                                 -------------------------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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)....................
                                 -------------------------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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.
                                 -------------------------------------------------------------------------------
    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