Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects; Informed Consent; and Institutional Review Boards, 69747-69749 [2019-27351]
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Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
Description: The data collected by
form OCSE–75 are used to prepare the
OCSE preliminary and annual data
reports. In addition, Tribes
administering CSE programs under Title
IV–D of the Social Security Act are
required to report program status and
accomplishments in an annual narrative
report and submit the OCSE–75 report
annually.
69747
Respondents: Tribal Child Support
Enforcement Organizations or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
tribe.
ANNUAL BURDEN ESTIMATES
Instrument
Annual
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden
hours
OCSE–75 .........................................................................................................
60
1
60
3,600
Estimated Total Annual Burden
Hours: 3,600.
FOR FURTHER INFORMATION CONTACT:
Authority: Title IV–D of the Social Security
ACT as required by CFR 45 Section
309.170(b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
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:
[FR Doc. 2019–27423 Filed 12–18–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Protection of Human Subjects; Informed
Consent; and Institutional Review
Boards—21 CFR Parts 50 and 56
Food and Drug Administration
OMB Control Numbers 0910–0755 and
0910–0130—Revision
[Docket No. FDA–2013–N–0403]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Protection of
Human Subjects; Informed Consent;
and Institutional Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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: Fax written comments on the
collection of information by January 21,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0130. Also
include the FDA docket number found
in brackets in the heading of this
document.
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SUMMARY:
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19:13 Dec 18, 2019
Jkt 250001
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.
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
(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 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 21 CFR 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
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
subject or the subject’s legally
authorized representative.
Basic elements of informed consent
are set forth in § 50.25 and include,
among other things, a statement of the
purpose and duration of a subject’s
participation in the research; a
description of the procedures to be
followed; identification of any
experimental procedures; a description
of risks, benefits, and appropriate
alternative procedures or treatments; a
description of extent to which
confidentiality of records identifying the
subject will be maintained; certain
contact information; and 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 § 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, which covers
exception from informed consent
requirements for emergency research. In
accordance with § 50.27, informed
consent must be documented, except as
provided in § 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
E:\FR\FM\19DEN1.SGM
19DEN1
69748
Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
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.
Finally, additional safeguards are
required for children, as prescribed in
subpart D (21 CFR parts 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
21 CFR part 56. IRBs serve in an
oversight capacity by reviewing, among
other things, informed consent
documents and protocols for FDAregulated 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.
Consolidation of Information Collection
Requests
On our own initiative, we are revising
the information collection under OMB
control number 0910–0130 to include
information collection under OMB
control number 0910–0755 pertaining to
the protection of human subjects,
including informed consent and certain
IRB requirements. 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.
Description of Respondents:
Respondents to the information
collection are IRBs that review and
approve clinical investigations regulated
by the FDA and clinical investigators of
such research who obtain informed
consent of human subjects prior to
research participation.
In the Federal Register of August 14,
2019 (84 FR 40421), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received. Upon our own review,
however, we have reorganized and
added detail to the notice to describe
more clearly the information collection
and associated burden. We continue to
invite comment.
We estimate the annual burden for the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
21 CFR section
Average
burden per
disclosure
Total annual
disclosures
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
1
2,520
* 0.5
1,260
7
1
1
1
7
1
10
5
70
5
Total ........................................................................
........................
..............................
........................
........................
1,335
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* (30 minutes).
Based on a review of data, there are
currently 2,520 IRBs overseeing FDAregulated clinical research. After
reorganizing the table summarizing
estimated annual reporting burden to
list only one requirement per row as
discussed in the 60-day notice (84 FR
40421), we recognized that some of
those regulatory provisions are more
appropriately characterized as having
associated recordkeeping or third-party
disclosure burdens. Therefore, we have
revised Tables 1, 2, and 3 accordingly in
this notice. We request comments on
this estimate.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
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
2,520
2,520
3
40
14.6
24
100,800
36,792
1
* 0.5
40
24
50,400
1,471,680
Total ..............................................................................
........................
........................
........................
........................
1,626,759
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
* (30 minutes).
As discussed above, we have
reorganized the table to characterize our
estimate of burden associated with
50.24 and 50.27 as recordkeeping
burdens. We assume each of the 2,520
IRBs meets an average of 14.6 times
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annually and that approximately 40
hours of person-time per meeting are
required to meet the IRB recordkeeping
requirements of 21 CFR 56.115. We have
reduced the estimate of average burden
per response from 100 hours to 40 hours
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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 estimate burden associated
with recordkeeping responsibilities
E:\FR\FM\19DEN1.SGM
19DEN1
69749
Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
under 21 CFR parts 50 and 56
cumulatively, however we have
itemized burden associated with certain
of the regulatory provisions for purposes
of providing a more detailed estimate.
We invite comment on burden
associated with these information
collection requirements.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
21 CFR section
50.25; elements of informed consent ............................
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 ........................................................................
Total annual
disclosures
Average
burden per
disclosure
Total hours
2,520
40
100,800
* 0.5
50,400
2,520
2
5,040
* 0.5
2,520
2,520
40
100,800
* 0.5
50,400
8
2
16
1
16
........................
..............................
........................
........................
103,336
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* (30 minutes).
As discussed above, we have
reorganized the table to characterize our
estimates of burden associated with 21
CFR 50.25, 56.109(d) and 56.109(e) as
disclosure burdens. We estimate that
eight IRBs per year will receive a
request to review emergency research
under § 50.24, thus requiring written
notification under 21 CFR 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: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27351 Filed 12–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5585]
Bridging for Drug-Device and BiologicDevice Combination Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Bridging
for Drug-Device and Biologic-Device
Combination Products.’’ This draft
guidance, when finalized, will represent
the Agency’s thinking on how to
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SUMMARY:
VerDate Sep<11>2014
19:13 Dec 18, 2019
Jkt 250001
approach bridging in new drug
applications (NDAs) or biologics license
applications (BLAs) for drug-device and
biologic-device single entity or copackaged combination products and
will help to fulfill the performance goals
under the sixth authorization of the
Prescription Drug User Fee Act (PDUFA
VI). For the purposes of this guidance,
the term bridging refers to the process of
establishing the scientific relevance of
information developed in an earlier
phase of the development program or
another development program to
support the combination product for
which an applicant is seeking approval.
Once the applicant has established the
relevance of such information to (i.e.,
bridged to) its product, the applicant
may be able to leverage that information
to streamline the development program.
DATES: Submit either electronic or
written comments on the draft guidance
by February 18, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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,
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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–
2019–D–5585 for ‘‘Bridging for DrugDevice and Biologic-Device
Combination Products.’’ Received
comments 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
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69747-69749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27351]
-----------------------------------------------------------------------
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; Informed Consent; and Institutional Review Boards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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: Fax written comments on the collection of information by January
21, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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 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 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 (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 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 21 CFR 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 and
include, among other things, a statement of the purpose and duration of
a subject's participation in the research; a description of the
procedures to be followed; identification of any experimental
procedures; a description of risks, benefits, and appropriate
alternative procedures or treatments; a description of extent to which
confidentiality of records identifying the subject will be maintained;
certain contact information; and 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 Sec.
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, which covers exception from
informed consent requirements for emergency research. In accordance
with Sec. 50.27, informed consent must be documented, except as
provided in Sec. 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
[[Page 69748]]
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.
Finally, additional safeguards are required for children, as
prescribed in subpart D (21 CFR parts 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 21 CFR 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.
Consolidation of Information Collection Requests
On our own initiative, we are revising the information collection
under OMB control number 0910-0130 to include information collection
under OMB control number 0910-0755 pertaining to the protection of
human subjects, including informed consent and certain IRB
requirements. 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.
Description of Respondents: Respondents to the information
collection are IRBs that review and approve clinical investigations
regulated by the FDA and clinical investigators of such research who
obtain informed consent of human subjects prior to research
participation.
In the Federal Register of August 14, 2019 (84 FR 40421), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. Upon our own
review, however, we have reorganized and added detail to the notice to
describe more clearly the information collection and associated burden.
We continue to invite comment.
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 disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
56.113; suspension or 2,520 1 2,520 * 0.5 1,260
termination of research.....
56.120(a); IRB response to 7 1 7 10 70
lesser administration
actions for noncompliance...
56.123; reinstatement of an 1 1 1 5 5
IRB or an institution.......
----------------------------------------------------------------------------------
Total.................... .............. ................. .............. .............. 1,335
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (30 minutes).
Based on a review of data, there are currently 2,520 IRBs
overseeing FDA-regulated clinical research. After reorganizing the
table summarizing estimated annual reporting burden to list only one
requirement per row as discussed in the 60-day notice (84 FR 40421), we
recognized that some of those regulatory provisions are more
appropriately characterized as having associated recordkeeping or
third-party disclosure burdens. Therefore, we have revised Tables 1, 2,
and 3 accordingly in this notice. We request comments on this estimate.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
50.24; exceptions from informed 8 3 24 1 24
consent for emergency research.
50.27; documentation of informed 2,520 40 100,800 * 0.5 50,400
consent........................
56.115; IRB records 2,520 14.6 36,792 40 1,471,680
(documentation of IRB
activities)....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,626,759
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (30 minutes).
As discussed above, we have reorganized the table to characterize
our estimate of burden associated with 50.24 and 50.27 as recordkeeping
burdens. 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 IRB recordkeeping requirements of 21
CFR 56.115. We have reduced the estimate of average burden per response
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 estimate burden
associated with recordkeeping responsibilities
[[Page 69749]]
under 21 CFR parts 50 and 56 cumulatively, however we have itemized
burden associated with certain of the regulatory provisions for
purposes of providing a more detailed estimate. We invite comment on
burden associated with these information collection requirements.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
50.25; elements of informed 2,520 40 100,800 * 0.5 50,400
consent.....................
56.109(d); written statement 2,520 2 5,040 * 0.5 2,520
about minimal risk research
when documentation of
informed consent is waived..
56.109(e); written 2,520 40 100,800 * 0.5 50,400
notification to approve or
disapprove research.........
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (30 minutes).
As discussed above, we have reorganized the table to characterize
our estimates of burden associated with 21 CFR 50.25, 56.109(d) and
56.109(e) as disclosure burdens. We estimate that eight IRBs per year
will receive a request to review emergency research under Sec. 50.24,
thus requiring written notification under 21 CFR 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: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27351 Filed 12-18-19; 8:45 am]
BILLING CODE 4164-01-P
