Agency Information Collection Request. 60-Day Public Comment Request, 9746 [2018-04618]
Download as PDF
<![CDATA[
9746
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
14,000
2
0.5
14,000
........................
........................
........................
14,000
Total ..........................................................................................................
Terry S. Clark,
Asst Information Collection Clearance
Officer.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–04617 Filed 3–6–18; 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:
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 May 7, 2018.
ADDRESSES: Submit your comments to
Sherette.Funn@hhs.gov or by calling
(202) 795–7714.
SUMMARY:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference., to
Sherrette.funn@hhs.gov, or call 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.
Information Collection Request Title:
0990–0260—Extension Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Abstract: Assistant secretary for
Health, Office for Human Research
Protections is requesting an extension
on a currently approved information
collection by the Office of Management
and Budget, on the Protection of Human
Subjects: Assurance of Compliance with
Federal Policy/IRB Review/IRB
Recordkeeping/Informed Consent/
Consent Documentation. The purpose of
the Federal Policy for the Protection of
Human Subjects (also known as the
Common Rule) is to provide a uniform
government-wide standard for
institutions engaged in research
conducted or supported by the
Department of Health and Human
Services (HHS) to apply regarding the
protection of human subjects involved
in research. The HHS codification of the
Common Rule is at 45 CFR part 46
subpart A. The respondents for this
collection are institutions engaged in
such research. Institutional adherence to
the Common Rule also is required by
other federal departments and agencies
that have codified or follow the
Common Rule which is identical to 45
CFR part 46, subpart A.
Likely Respondents: Institutions
engaged in nonexempt human subject’s
research.
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Number of
respondents
Title
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
hours
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent ..................
.115(a) IRB Recordkeeping .............................................................................
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ....
6,000
6,000
6,000
39.33
15
0.5
1
10
45/60
235,980
900,000
2,250
Total ..........................................................................................................
........................
........................
........................
1,138,230
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–04618 Filed 3–6–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
Terry S. Clark,
Asst Information Collection Clearance
Officer.
National Institutes of Health
BILLING CODE 4150–36–P
National Library of Medicine; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
VerDate Sep<11>2014
18:46 Mar 06, 2018
Jkt 244001
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
meeting of the Board of Regents of the
National Library of Medicine.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Page 9746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04618]
-----------------------------------------------------------------------
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 May 7, 2018.
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-New-60D and
project title for reference., to [email protected], or call 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.
Information Collection Request Title: 0990-0260--Extension
Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation.
Abstract: Assistant secretary for Health, Office for Human Research
Protections is requesting an extension on a currently approved
information collection by the Office of Management and Budget, on the
Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation. The purpose of the Federal Policy for the Protection of
Human Subjects (also known as the Common Rule) is to provide a uniform
government-wide standard for institutions engaged in research conducted
or supported by the Department of Health and Human Services (HHS) to
apply regarding the protection of human subjects involved in research.
The HHS codification of the Common Rule is at 45 CFR part 46 subpart A.
The respondents for this collection are institutions engaged in such
research. Institutional adherence to the Common Rule also is required
by other federal departments and agencies that have codified or follow
the Common Rule which is identical to 45 CFR part 46, subpart A.
Likely Respondents: Institutions engaged in nonexempt human
subject's research.
Estimate Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Title Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d)IRB Actions, .116 and .117 6,000 39.33 1 235,980
Informed Consent...............................
.115(a) IRB Recordkeeping....................... 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension 6,000 0.5 45/60 2,250
or Termination Reporting.......................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,138,230
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2018-04618 Filed 3-6-18; 8:45 am]
BILLING CODE 4150-36-P
