Agency Information Collection Request. 60-Day Public Comment Request, 19627-19628 [2021-07622]
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19627
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
ANNUALIZED BURDEN HOUR TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Hours per
response
Response
burden hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
14,000
2
0.5
14,000
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 14, 2021.
the document identifier 0990–0260–
60D, and project title for reference, to
Sherrette Funn, email: Sherrette.Funn@
hhs.gov, or call 202–795–7714 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: Extension.
Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
OMB No. 0990–0260 Office of the
Assistant Secretary for Health, Office
for Human Research Protections
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections is requesting a
[FR Doc. 2021–07620 Filed 4–13–21; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0260]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY:
ADDRESSES:
three-year extension of the Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation, OMB
No. 0990–0260.
Information reported to the Federal
departments and agencies under the
Common Rule with respect to a
satisfactory assurance is used to ensure
that an institution engaged in nonexempt research involving human
subjects conducted or supported by a
Common Rule department or agency has
(1) established adequate administrative
policies and procedures for protecting
the rights and welfare of human subjects
in research, and (2) accepts that
responsibility. Other reporting
requirements are used to: Assess
whether the institution is following the
established procedures; ensure that
Federal funds are not expended for
unapproved human subjects research;
and, determine if the approved status of
an awarded grant, contract, or
cooperative agreement should be
reviewed, with the ultimate goal of
maintaining or increasing human
subject protections.
Likely Respondents: Institutions,
institutional review boards and
investigators.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Common rule provision
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113
[2018 Requirements]—Incident Reporting, Suspension
or Termination of IRB approval Reporting .......................
5,200
1
5,200
1
5,200
Total ..............................................................................
........................
........................
5,200
........................
5,200
TABLE 2—ESTIMATED ANNUAL IRB RECORDKEEPING BURDEN
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Common rule provision
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
.115 [Pre-2018 and 2018 Requirement]—Preparation and
documentation of IRB activities ........................................
6,000
16
96,000
12
1,152,000
Total ..............................................................................
........................
........................
96,000
........................
1,152,000
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19628
Federal Register / Vol. 86, No. 70 / Wednesday, April 14, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
disclosures per
respondent
Number of
respondents
.109(d) [Pre-2018 and 2018 Requirements]—Written notification of ........................................................................
IRB approval or disapproval of research ...........................
.46.116(a) and (b) (Pre-2018 Requirements)/.46.116 (b),
(c) and (d) [2018 Requirements]—Elements of informed consent and broad consent ...............................
.46.116(h)—[2018 Requirements]—Posting clinical trial
consent form ...................................................................
.117(a) [Pre-2018 and 2018 Requirements]—Documentation of informed consent .................................................
.117(c)(2) [Pre-2018 and 2018 Requirements]—Written
statement about the research when informed consent
documentation is waived ................................................
Total ............................................................................
Sherrrette A. Funn,
Paperwork Reduction Act Reports Clearance
Office, Office of the Secretary.
[FR Doc. 2021–07622 Filed 4–13–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
jbell on DSKJLSW7X2PROD with NOTICES
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Total hours
25
150,000
0.5
75,000
6,000
25
150,000
0.5
75,000
100
3
300
0.5
150
6,000
25
150,000
0.5
75,000
6,000
10
60,000
1
60,000
........................
..........................
510,300
........................
285,150
(301) 496–0726, prenticekj@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 8, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–07610 Filed 4–13–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Council of Councils.
The meeting will be held as a virtual
meeting and will be open to the public
as indicated below. Individuals who
plan to view the virtual meeting and
need special assistance or other
reasonable accommodations to view the
meeting, should notify the Contact
Person listed below in advance of the
meeting. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
A portion of the meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4), and 552b(c)(6), Title 5
U.S.C., as amended. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
PO 00000
Average
burden per
disclosure
6,000
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Risk, Prevention
and Health Behavior Integrated Review
Group Addiction Risks and Mechanisms
Study Section.
Date: June 14–15, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kristen Prentice,
Ph.D., Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
3112, MSC 7808, Bethesda, MD 20892,
Total annual
disclosures
Frm 00027
Fmt 4703
Sfmt 4703
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Council of Councils.
Open: May 20, 2021.
Time: 11:00 a.m. to 4:15 p.m.
Agenda: Call to Order and Introductions;
Announcements and Updates; Scientific
Talks and Other Business of the Committee.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Virtual Meeting).
Name of Committee: Council of Councils.
Closed: May 21, 2021.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: Review of Grant Applications.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Virtual Meeting).
Open: May 21, 2021.
Time: 11:00 a.m. to 4:05 p.m.
Agenda: NIH Program Updates; Scientific
Talks and Other Business of the Committee.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Franziska Grieder, D.V.M.,
Ph.D., Executive Secretary, Council of
Councils, Director, Office of Research
Infrastructure Programs, Division of Program
Coordination, Planning, and Strategic
Initiatives, Office of the Director, NIH, 6701
Democracy Boulevard, Room 948, Bethesda,
MD 20892, GriederF@mail.nih.gov. 301–435–
0744.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Council of Council’s home page at https://
dpcpsi.nih.gov/council/ where an agenda
will be posted before the meeting date.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
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]]>Agencies
[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19627-19628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07622]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-0260]
Agency Information Collection Request. 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before June 14, 2021.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0260-60D, and
project title for reference, to Sherrette Funn, email:
[email protected], or call 202-795-7714 the Reports Clearance
Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Protection of Human Subjects: Assurance of
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: Extension.
OMB No. 0990-0260 Office of the Assistant Secretary for Health, Office
for Human Research Protections
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting a three-year extension of
the Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation, OMB No. 0990-0260.
Information reported to the Federal departments and agencies under
the Common Rule with respect to a satisfactory assurance is used to
ensure that an institution engaged in non-exempt research involving
human subjects conducted or supported by a Common Rule department or
agency has (1) established adequate administrative policies and
procedures for protecting the rights and welfare of human subjects in
research, and (2) accepts that responsibility. Other reporting
requirements are used to: Assess whether the institution is following
the established procedures; ensure that Federal funds are not expended
for unapproved human subjects research; and, determine if the approved
status of an awarded grant, contract, or cooperative agreement should
be reviewed, with the ultimate goal of maintaining or increasing human
subject protections.
Likely Respondents: Institutions, institutional review boards and
investigators.
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
.103(b)(5), .113 [Pre-2018 5,200 1 5,200 1 5,200
Requirements]/.108(a)(4), .113
[2018 Requirements]--Incident
Reporting, Suspension or
Termination of IRB approval
Reporting......................
-------------------------------------------------------------------------------
Total....................... .............. .............. 5,200 .............. 5,200
----------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual IRB Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
.115 [Pre-2018 and 2018 6,000 16 96,000 12 1,152,000
Requirement]--Preparation and
documentation of IRB activities
-------------------------------------------------------------------------------
Total....................... .............. .............. 96,000 .............. 1,152,000
----------------------------------------------------------------------------------------------------------------
[[Page 19628]]
Table 3--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of disclosures per Total annual burden per Total hours
respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
.109(d) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Written
notification of...............
IRB approval or disapproval of
research......................
.46.116(a) and (b) (Pre-2018 6,000 25 150,000 0.5 75,000
Requirements)/.46.116 (b), (c)
and (d) [2018 Requirements]--
Elements of informed consent
and broad consent.............
.46.116(h)--[2018 100 3 300 0.5 150
Requirements]--Posting
clinical trial consent form...
.117(a) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Documentation
of informed consent...........
.117(c)(2) [Pre-2018 and 2018 6,000 10 60,000 1 60,000
Requirements]--Written
statement about the research
when informed consent
documentation is waived.......
--------------------------------------------------------------------------------
Total...................... .............. ............... 510,300 .............. 285,150
----------------------------------------------------------------------------------------------------------------
Sherrrette A. Funn,
Paperwork Reduction Act Reports Clearance Office, Office of the
Secretary.
[FR Doc. 2021-07622 Filed 4-13-21; 8:45 am]
BILLING CODE P
