Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects and Institutional Review Boards, 3415-3417 [2023-00974]
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Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA–OH–22–
001, Panel B, Occupational Safety and
Health Education and Research
Centers (ERC); Amended Notice of
Closed Meeting
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Protection of
Human Subjects and Institutional
Review Boards
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA–
OH–22–001, Panel B, Occupational
Safety and Health Education and
Research Centers (ERC); February 23–
24, 2023, 12 p.m.–5 p.m., EST, in the
original FRN. The meeting was
published in the Federal Register on
December 9, 2022, Volume 87, Number
236, page 75632. The meeting is being
amended to change the Notice of
Funding Opportunity (NOFO) number
and should read as follows:
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–OH–23–003, Panel B,
Occupational Safety and Health
Education and Research Centers (ERC).
The meeting is closed to the public.
HHS.
[Docket No. FDA–2013–N–0403]
FOR FURTHER INFORMATION CONTACT:
khammond on DSKJM1Z7X2PROD with NOTICES
Michael Goldcamp, Ph.D., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, CDC,
1095 Willowdale Road, Morgantown,
West Virginia 26505; Telephone: (304)
285–5951; Email: MGoldcamp@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–00901 Filed 1–18–23; 8:45 am]
BILLING CODE 4163–18–P
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17:49 Jan 18, 2023
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AGENCY:
ACTION:
Food and Drug Administration,
Notice.
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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
3415
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 § 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 § 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 § 50.24 (21 CFR 50.24),
which covers exception from informed
consent requirements for emergency
research. In accordance with § 50.27 (21
CFR 50.27) informed consent must be
documented, except as provided in
§ 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
E:\FR\FM\19JAN1.SGM
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3416
Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
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 § 50.25.
However, in cases where a multiinstitutional 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 FDAregulated 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 60day 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
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
56.113; suspension or termination of research ...........
56.120(a); IRB response to lesser administration actions for noncompliance.
56.123; reinstatement of an IRB or an institution ........
2,520
7
1
1
2,520
7
0.5 (30 minutes) ....
10 ..........................
1,260
70
1
1
1
5 ............................
5
Total ......................................................................
........................
........................
........................
...............................
1,335
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 thirdparty 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
Number of
recordkeepers
21 CFR section
Total annual
records
Average burden
per recordkeeping
Total hours
50.24; exceptions from informed consent for emergency research.
50.27; documentation of informed consent ..................
56.115; IRB records (documentation of IRB activities)
8
3
24
1 ............................
24
2,520
2,520
40
14.6
100,800
36,792
0.5 (30 minutes) ....
40 ..........................
50,400
1,471,680
Total ......................................................................
........................
........................
........................
...............................
1,522,104
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
We characterize activities associated
with §§ 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 § 56.115. We also
assume most recordkeeping is
completed electronically.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
50.25; elements of informed consent .......................
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Number of
disclosures per
respondent
2,520
Frm 00041
Fmt 4703
40
Sfmt 4703
Total annual
disclosures
Average burden
per disclosure
100,800
E:\FR\FM\19JAN1.SGM
0.5 (30 minutes) ....
19JAN1
Total hours
50,400
Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
3417
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
56.109(d); written statement about minimal risk research when documentation of informed consent
is waived.
56.109(e); written notification to approve or disapprove research.
56.109(g); IRB written statement about public disclosures to sponsor of emergency research
under § 50.24.
Total ..................................................................
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
Food and Drug Administration,
HHS.
Notice.
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Average burden
per disclosure
Total hours
2,520
2
5,040
0.5 (30 minutes) ....
2,520
2,520
40
100,800
0.5 (30 minutes) ....
50,400
8
2
16
1 ............................
16
........................
............................
........................
...............................
103,336
VerDate Sep<11>2014
17:49 Jan 18, 2023
Jkt 259001
solicits comments on information
collections associated with the Adverse
Event Program for Medical Devices
(Medical Program Safety Network
(MedSun)).
Either electronic or written
comments on the collection of
information must be submitted by
March 20, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 20, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Food and Drug Administration
ACTION:
Total annual
disclosures
are no capital costs or operating and maintenance costs associated with this collection of information.
We characterize activities associated
with §§ 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 § 50.24, thus requiring written
notification under § 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.
AGENCY:
Number of
disclosures per
respondent
Number of
respondents
21 CFR section
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
PO 00000
Frm 00042
Fmt 4703
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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–
2017–N–0084 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Adverse
Event Program for Medical Devices
(Medical Product Safety Network).’’
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
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
