[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40421-40423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17462]
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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; Informed Consent; and
Institutional Review Boards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 the information collection provisions found
in Agency regulations pertaining to the protection of human subjects
and responsibilities of institutional review boards (IRBs).
DATES: Submit either electronic or written comments on the collection
of information by October 15, 2019.
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 October 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 15, 2019. 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 ``Protection of Human Subjects; Informed Consent;
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.
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.gpo.gov/fdsys/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
[[Page 40422]]
and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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. 3501-3520), 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.
Protection of Human Subjects; Informed Consent; and Institutional
Review Boards--21 CFR Parts 50 and 56
OMB Control Numbers 0910-0755 and 0910-0130--Revision
This information collection supports Agency regulations pertaining
to the protection of human subjects, informed consent, and
responsibilities of 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 (FD&C 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 investigations filed under
sections 403, 406, 409, 412, 413, 503, 505, 510, 513-515, 520, 531-539,
541, 542, 701, and 721 of the FD&C Act (21 U.S.C. 343, 346, 348, 350a,
350b, 353, 355, 360, 360c, 360c-1, 360d, 360e, 360j, 360hh-360pp,
360rr, 360ss, 371, and 379e) and section 351 of the Public Health
Service Act (42 U.S.C. 262). The regulations also contain the standards
for composition, operation, and responsibilities of IRBs that review
clinical investigations regulated by FDA.
I. Part 50--Protection of Human Subjects
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 a statement of
the purpose and duration of a subject's participation in the research,
as well as a description of the procedures to be followed, risks,
benefits, experimental nature, contact information, that participation
is voluntary, and additional elements as may be appropriate. Exceptions
to these requirements are governed by Sec. 50.23 (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.
II. Part 56--Institutional Review Boards
The general standards for the composition, operation, and
responsibility of an IRB are set forth in part 56. Administrative
activities are also covered and documentation that must be prepared and
maintained is identified. Required recordkeeping includes documentation
pertaining to written procedures, committee membership, meeting
minutes, 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.
On our own initiative, we are revising the information collection
by consolidating the information collection currently approved under
OMB control number 0910-0130 with the information collection currently
approved under OMB control number 0910-0755 pertaining to human subject
protection and IRB responsibilities. Because of the related nature of
the information collections and the applicable regulations in parts 50
and 56, we believe taking this action will improve our operational
efficiency.
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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50.24; exceptions from informed consent for 8 3 24 1........................................ 24
emergency research.
50.25; elements of informed consent--required 2,520 40 100,800 0.5 (30 minutes)......................... 50,400
statements.
50.27; documentation of informed consent..... 2,520 40 100,800 0.5 (30 minutes)......................... 50,400
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.
[[Page 40423]]
56.113; suspension 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..
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Total.................................... .............. .............. .............. ......................................... 155,079
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of data, there are currently 2,520 IRBs
overseeing FDA-regulated clinical research. We have revised the table
to list only one requirement per row, rather than estimating the
combination of several requirements. The estimated burden resulted in
an increase from 1 hour to 1.5 hours when these combined requirements
were estimated separately. We believe this is a more accurate measure
of the cumulative time necessary for these activities. We invite
comment on this estimate.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR part; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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56.115; IRB records............. 2,520 14.6 36,792 40 1,471,680
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
We assume each of the 2,520 IRBs meets an average of 14.6 times
annually and that approximately 40 hours of person-time per meeting are
required to meet the requirements of the regulation. We have reduced
the average burden per record from 100 hours to 40 hours because we
believe the original estimate of 100 hours has decreased with the use
of electronic recordkeeping and new technologies available to maintain
records. We request comments on this revision.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
21 CFR section Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
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56.109(g) IRB written statement 8 2 16 1 16
about public disclosures to
sponsor of emergency research
under 50.24....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
For the third-party disclosure burden, we estimate that eight IRBs
per year will receive a request to review emergency research under
Sec. 50.24. 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: August 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17462 Filed 8-13-19; 8:45 am]
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