83 FR 9746 - Agency Information Collection Request. 60-Day Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 45 (March 7, 2018)

Page Range		9746-9746
FR Document		2018-04618

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.

Federal Register, Volume 83 Issue 45 (Wednesday, March 7, 2018)

[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Page 9746]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-04618]

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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.

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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 Sherette.Funn@hhs.gov 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 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 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

9746 Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices

ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)

Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption ............................................................................. 14,000 2 0.5 14,000

Total .......................................................................................................... ........................ ........................ ........................ 14,000

Terry S. Clark, FOR FURTHER INFORMATION CONTACT: Protections is requesting an extension
Asst Information Collection Clearance When submitting comments or on a currently approved information
Officer. requesting information, please include collection by the Office of Management
[FR Doc. 2018–04617 Filed 3–6–18; 8:45 am] the document identifier 0990–New–60D and Budget, on the Protection of Human
BILLING CODE 4150–36–P and project title for reference., to Subjects: Assurance of Compliance with
Sherrette.funn@hhs.gov, or call the Federal Policy/IRB Review/IRB
Reports Clearance Officer. Recordkeeping/Informed Consent/
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: Interested Consent Documentation. The purpose of
HUMAN SERVICES persons are invited to send comments the Federal Policy for the Protection of
regarding this burden estimate or any Human Subjects (also known as the
[Document Identifier: OS–0990–0260] other aspect of this collection of Common Rule) is to provide a uniform
information, including any of the government-wide standard for
Agency Information Collection following subjects: (1) The necessity and institutions engaged in research
Request. 60-Day Public Comment utility of the proposed information conducted or supported by the
Request collection for the proper performance of Department of Health and Human
the agency’s functions; (2) the accuracy Services (HHS) to apply regarding the
AGENCY: Office of the Secretary, HHS.
of the estimated burden; (3) ways to protection of human subjects involved
ACTION: Notice. enhance the quality, utility, and clarity in research. The HHS codification of the
SUMMARY: In compliance with the of the information to be collected; and Common Rule is at 45 CFR part 46
requirement of the Paperwork (4) the use of automated collection subpart A. The respondents for this
Reduction Act of 1995, the Office of the techniques or other forms of information collection are institutions engaged in
Secretary (OS), Department of Health technology to minimize the information such research. Institutional adherence to
and Human Services, is publishing the collection burden.
the Common Rule also is required by
Information Collection Request Title:
following summary of a proposed other federal departments and agencies
0990–0260—Extension Protection of
collection for public comment. that have codified or follow the
Human Subjects: Assurance of
DATES: Comments on the ICR must be Compliance with Federal Policy/IRB Common Rule which is identical to 45
received on or before May 7, 2018. Review/IRB Recordkeeping/Informed CFR part 46, subpart A.
ADDRESSES: Submit your comments to Consent/Consent Documentation. Likely Respondents: Institutions
Sherette.Funn@hhs.gov or by calling Abstract: Assistant secretary for engaged in nonexempt human subject’s
(202) 795–7714. Health, Office for Human Research research.

ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Average
Number of
Number of burden per Total burden
Title responses per
respondents response hours
respondent (in hours)

.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent .................. 6,000 39.33 1 235,980
.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .... 6,000 0.5 45/60 2,250

Total .......................................................................................................... ........................ ........................ ........................ 1,138,230

Terry S. Clark, DEPARTMENT OF HEALTH AND meeting of the Board of Regents of the
Asst Information Collection Clearance HUMAN SERVICES National Library of Medicine.
Officer. The meeting will be open to the
[FR Doc. 2018–04618 Filed 3–6–18; 8:45 am] National Institutes of Health public as indicated below, with
daltland on DSKBBV9HB2PROD with NOTICES

BILLING CODE 4150–36–P attendance limited to space available.
National Library of Medicine; Notice of
Individuals who plan to attend and
Meetings
need special assistance, such as sign
Pursuant to section 10(d) of the language interpretation or other
Federal Advisory Committee Act, as reasonable accommodations, should
amended, notice is hereby given of a notify the Contact Person listed below
in advance of the meeting.

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Document Created: 2018-03-07 01:27:15
Document Modified: 2018-03-07 01:27:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the ICR must be received on or before May 7, 2018.
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.
FR Citation		83 FR 9746