[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3415-3417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 February 21, 2023.

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 0910-0130. 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.

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

[[Page 3416]]

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 noncompliance, 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.
    In the Federal Register of June 24, 2022 (87 FR 37867), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. No comments were received.
    We estimate the annual burden for the collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
                21 CFR section                     Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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56.113; suspension or termination of research.           2,520               1           2,520  0.5 (30 minutes)........................           1,260
56.120(a); IRB response to lesser                            7               1               7  10......................................              70
 administration actions for noncompliance.
56.123; reinstatement of an IRB or an                        1               1               1  5.......................................               5
 institution.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................           1,335
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\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      records per    Total annual       Average burden per recordkeeping        Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
50.24; exceptions from informed consent for                  8               3              24  1.......................................              24
 emergency research.
50.27; documentation of informed consent......           2,520              40         100,800  0.5 (30 minutes)........................          50,400
56.115; IRB records (documentation of IRB                2,520            14.6          36,792  40......................................       1,471,680
 activities).
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................       1,522,104
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\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
                21 CFR section                    Number of     disclosures per   Total annual        Average burden per disclosure         Total hours
                                                 respondents      respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
50.25; elements of informed consent..........           2,520                40         100,800  0.5 (30 minutes).......................          50,400

[[Page 3417]]

 
56.109(d); written statement about minimal              2,520                 2           5,040  0.5 (30 minutes).......................           2,520
 risk research when documentation of informed
 consent is waived.
56.109(e); written notification to approve or           2,520                40         100,800  0.5 (30 minutes).......................          50,400
 disapprove research.
56.109(g); IRB written statement about public               8                 2              16  1......................................              16
 disclosures to sponsor of emergency research
 under Sec.   50.24.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ................  ..............  .......................................         103,336
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\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 and 
56.109(d) and (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: January 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00974 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P


