[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
PRAStaff@fda.hhs.gov.

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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..
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         155,079
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
      21 CFR part; activity          Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
56.115; IRB records.............           2,520            14.6          36,792              40       1,471,680
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
56.109(g) IRB written statement                8               2              16               1              16
 about public disclosures to
 sponsor of emergency research
 under 50.24....................
----------------------------------------------------------------------------------------------------------------
\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]
 BILLING CODE 4164-01-P


