Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 7472-7473 [2015-02649]
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7472
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
document identifier HHS–OS–0990–
0390–30D for reference.
Information Collection Request Title:
Challenge and Prize Competition
Solicitations
Abstract: In 2011, Federal agencies
including HHS were given prize
authority for administering challenges
and competitions. Challenges and
competitions enable the Assistant
Secretary for Administration, HHS to
tap into the expertise and creativity of
the public in new ways. In order for
HHS to quickly and effectively launch
competitions on a continual basis, HHS
seeks an extension on currently
approved generic clearance to collect
information for these challenges and
competitions, which will generally
include first name, last name, email,
city, state and when applicable other
demographic information.
The information collected will be
used to understand whether the
participant has met the technical
requirements for the challenge, assist in
the technical review and judging of the
solutions that are provided, and
understand the impact and
consequences of administering the
competition and developing solutions
for submission. Information may be
collected during the competition or after
its completion.
Need and Proposed Use of the
Information
Challenges and competitions enable
HHS to tap into the expertise and
creativity of the public in new ways.
HHS has sponsored challenges and
competitions in a wide variety of areas
such as recruitment efforts, health data
applications and other types of data,
development of novel technologies, and
communications to increase public
participation and solicit new ideas on a
wide array of topics important to the
agencies mission. HHS’s goal is to
engage a broader number of
stakeholders who are inspired to work
on some of our most pressing health
issues, thus supporting a new ecosystem
of scientists, developers, and
entrepreneurs who can continue to
innovate for public health. The generic
clearance is necessary for HHS to
quickly and effectively launch
competitions on a continual basis.
Likely Respondents: Likely
respondents include individuals,
businesses, and state and local
governments who choose to participate
in a challenge or competition hosted by
HHS.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden
hours
Individuals or Households ...............................................................................
Organizations ...................................................................................................
Businesses .......................................................................................................
State, territory, tribal or local governments .....................................................
1000
1000
1000
60
1
1
1
1
1/6
1/6
1/6
1/6
166.6
166.6
166.6
10
Total ..........................................................................................................
........................
........................
........................
510
Darius Taylor,
Information Collection Clearance Officer.
number 0990–0263, scheduled to expire
on March 31, 2015 Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
[FR Doc. 2015–02652 Filed 2–9–15; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Comments on the ICR must be
received on or before March 12, 2015.
DATES:
Office of the Secretary
[Document Identifier HHS–OS–0990–0263–
30–D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
rljohnson on DSK3VPTVN1PROD with NOTICES
VerDate Sep<11>2014
15:20 Feb 09, 2015
Jkt 235001
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
When
submitting comments or requesting
information, please include the OMB
control number 0990–0263 and
document identifier HHS–OS–30D for
reference.
Information Collection Request Title:
Protection of Human Subjects:
Assurance Identification/IRB
Certification/Declaration of Exemption
Form—Extension OMB No. 0990–0263,
Assistant Secretary for Health, Office for
Human Research Protections.
SUPPLEMENTARY INFORMATION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
SUMMARY:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Abstract: The Office for Human
Research Protections is requesting a
three year extension of the Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form. That
form is designed to promote uniformity
among departments and agencies, and to
help ensure common means of
ascertaining institutional review board
certifications and other reporting
requirements relating to the protection
of human subjects in research. The
Federal Policy for the Protection of
Human Subjects, known as the Common
Rule, requires that before engaging in
non-exempt human subjects research
that is conducted or supported by a
Common Rule department or agency,
each institution must: (1) Hold an
applicable assurance of compliance
[Section 103(a)]; and (2) certify to the
awarding department or agency that the
application or proposal for research has
been reviewed and approved by an IRB
designated in the assurance [Sections
103(b) and (f)].
Need and Proposed Use of the
Information: The information collected
through the Protection of Human
Subjects: Assurance Identification/IRB
E:\FR\FM\10FEN1.SGM
10FEN1
7473
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
Certification/Declaration of Exemption
Form is the minimum necessary to
satisfy the assurance and certification
requirements of Section 491 (a) of the
Public Health Service Act and HHS
Regulations for the protection of human
subjects at 45 CFR 46.103.
Likely Respondents: Research
institutions engaged in HHS-conducted
or —supported research involving
human subjects. Institutional use of the
form is also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule).
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden
hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
12,000
2
30/60
12,000
Total ..........................................................................................................
........................
........................
........................
12,000
Darius Taylor,
Information Collection Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–02649 Filed 2–9–15; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier HHS–0990–0260–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Assistant
Secretary for Health, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary, Department of Health and
Human Services (HHS), announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). The ICR is for extending
the use of the approved information
collection assigned OMB control
number 0990–0260, which expires on
April 30, 2015. Prior to submitting that
ICR to OMB, OS seeks comments from
the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on the ICR must be
received on or before April 13, 2015.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
SUMMARY:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier 0990–0260 for
reference.
Information Collection Request Title:
Protection of Human Subjects:
Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/
Informed Consent/Consent
Documentation-Extension—0990–0260,
Assistant Secretary for Health, Office for
Human Research Protections.
Abstract: Section 491(a) of Public Law
99–158 states that the Secretary of HHS
shall by regulation require that each
entity applying for HHS support (e.g., a
grant, contract, or cooperative
agreement) to conduct research
involving human subjects submit to
HHS assurances satisfactory to the
Secretary that it has established an
institutional review board (IRB) to
review the research in order to ensure
protection of the rights and welfare of
the human research subjects. IRBs are
boards, committees, or groups formally
designated by an entity to review,
approve, and have continuing oversight
of research involving human subjects.
Pursuant to the requirement of the
Public Law 99–158, HHS promulgated
regulations at 45 CFR part 46, subpart A,
the basic HHS Policy for the Protection
of Human Subjects. The June 18, 1991
adoption of the common Federal Policy
(56 FR 28003) by 15 departments and
agencies implements a recommendation
of the President’s Commission for the
Study of Ethical Problems in Medicine
and Biomedical and Behavioral
Research which was established on
November 9, 1974, by Public Law 95–
622. The Common Rule is based on HHS
regulations at 45 CFR part 46, subpart A,
the basic HHS Policy for the Protection
of Human Subjects.
Need and Proposed Use of the
Information: The information collected
through the Protection of Human
Subjects: Assurance Identification/IRB
Certification/Declaration of Exemption
Form Protection of Human Subjects:
Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/
Informed Consent/Consent
Documentation collection requirement
is the minimum necessary to satisfy the
assurance, certification, reporting,
disclosure, documentation and
recordkeeping requirements of Section
491(a) of the Public Health Service Act
and HHS Regulations for the protection
of human subjects at 45 CFR part 46.
Likely Respondents: Research
institutions engaged in HHS-conducted
or —supported research involving
human subjects. Institutional use of the
form is also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule).
rljohnson on DSK3VPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Title
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent ..................
6,000
.115(a) IRB Recordkeeping .............................................................................
Number of
responses per
respondent
6,000
VerDate Sep<11>2014
15:20 Feb 09, 2015
Jkt 235001
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
E:\FR\FM\10FEN1.SGM
39.3
3
15
10FEN1
Average
burden per
response
(in hours)
Total burden
hours
1
235,980
10
900,000
]]>Agencies
[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7472-7473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier HHS-OS-0990-0263-30-D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for renewal of the approved
information collection assigned OMB control number 0990-0263, scheduled
to expire on March 31, 2015 Comments submitted during the first public
review of this ICR will be provided to OMB. OMB will accept further
comments from the public on this ICR during the review and approval
period.
DATES: Comments on the ICR must be received on or before March 12,
2015.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 0990-0263 and
document identifier HHS-OS-30D for reference.
Information Collection Request Title: Protection of Human Subjects:
Assurance Identification/IRB Certification/Declaration of Exemption
Form--Extension OMB No. 0990-0263, Assistant Secretary for Health,
Office for Human Research Protections.
Abstract: The Office for Human Research Protections is requesting a
three year extension of the Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form. That
form is designed to promote uniformity among departments and agencies,
and to help ensure common means of ascertaining institutional review
board certifications and other reporting requirements relating to the
protection of human subjects in research. The Federal Policy for the
Protection of Human Subjects, known as the Common Rule, requires that
before engaging in non-exempt human subjects research that is conducted
or supported by a Common Rule department or agency, each institution
must: (1) Hold an applicable assurance of compliance [Section 103(a)];
and (2) certify to the awarding department or agency that the
application or proposal for research has been reviewed and approved by
an IRB designated in the assurance [Sections 103(b) and (f)].
Need and Proposed Use of the Information: The information collected
through the Protection of Human Subjects: Assurance Identification/IRB
[[Page 7473]]
Certification/Declaration of Exemption Form is the minimum necessary to
satisfy the assurance and certification requirements of Section 491 (a)
of the Public Health Service Act and HHS Regulations for the protection
of human subjects at 45 CFR 46.103.
Likely Respondents: Research institutions engaged in HHS-conducted
or --supported research involving human subjects. Institutional use of
the form is also relied upon by other federal departments and agencies
that have codified or follow the Federal Policy for the Protection of
Human Subjects (Common Rule).
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance 12,000 2 30/60 12,000
Identification/IRB Certification/Declaration of
Exemption......................................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 12,000
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-02649 Filed 2-9-15; 8:45 am]
BILLING CODE 4150-36-P
