Agency Information Collection Activities; Proposed Collection; Public Comment Request, 7473-7474 [2015-02650]
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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
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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
7474
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Title
Average
burden per
response
(in hours)
Total burden
hours
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ....
6,000
0.5
45/60
2,250
Total ..........................................................................................................
........................
........................
........................
1,138,230
OS specifically requests comments on
(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.
Darius Taylor,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2015–02650 Filed 2–9–15; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0821]
rljohnson on DSK3VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
VerDate Sep<11>2014
15:20 Feb 09, 2015
Jkt 235001
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Quarantine Station Illness Response
Forms: Airline, Maritime, and Land/
Border Crossing (0920–0821, exp. 08/
31/15)—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is requesting a revision to a
currently approved information
collection, Quarantine Station Illness
Response Forms: Airline, Maritime, and
Land/Border Crossing). This revision
seeks to incorporate the changes that
resulted from activities undertaken
during the response to Ebola. These
changes include two major components,
both of which have been given previous
emergency clearance by OMB under
Control Number 0920–1031 and 0920–
1034, with an expiration date of April
30, 2015. As a part of this revision, CDC
is requesting the full three year approval
and 12 months of burden for the
following:
The incorporation of two public
health screening forms that are currently
used to assess risk for Ebola in travelers
coming to the United States from
countries experiencing widespread
transmission of the disease. These forms
are the United States Traveler Health
Declaration and a completely revised
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Frm 00073
Fmt 4703
Sfmt 4703
Ebola Entry Screening Risk Assessment
Form, each given approval from OMB
under OMB Control No 0920–1031. The
additional burden requested for the
English versions of the health
declaration and the risk assessment
form, as well as the French and Arabic
translation guides for the health
declaration and risk assessment forms,
is 13,664 hours.
In this revision, CDC is maintaining
the ability to use the Ebola Entry
Screening Risk Assessment Form in the
event that a traveler is identified as ill
on a U.S.-bound flight prior to arrival.
In the no material or non-substantive
change to a currently approved
collection granted by OMB on 9/18/
2014, CDC requested 100 respondents
and 5 hours of burden. Because the risk
assessment form is more
comprehensive, it requires more time
for a traveler to complete the
assessment. CDC is requesting an
additional 20 hours of burden for the
purpose of assessing ill travelers, for a
total of 25 hours of burden. No
additional respondents are requested.
CDC is also requesting the
incorporation of a telephonic,
automated survey administered through
the Interactive Voice Response (IVR)
phone system, which asks travelers if
they have developed a fever or any other
symptoms potentially indicative of
Ebola exposure (OMB Control No 0920–
1034). The IVR system would be
implemented to assist state and local
public health authorities with active
monitoring of individuals coming to the
United States from countries affected by
the current Ebola outbreak. Use of this
information collection tool would be
voluntary and provides a cost- and timesaving mechanism for supporting states
with their active monitoring
responsibilities. The additional 12month annualized burden requested for
the use of the IVR system is
approximately 71,400 hours.
No revisions are requested to the Air
Travel, Maritime Conveyance or Land
Travel Illness and Death Investigation
forms or burden associated with these
forms. The current burden associated
with these routine information
collections is 314 hours.
E:\FR\FM\10FEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7473-7474]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier HHS-0990-0260-60D]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Assistant Secretary for Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
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 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).
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Title respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d)IRB Actions, .116 and .117 6,000 39.3 1 235,980
Informed Consent............................... 3
.115(a) IRB Recordkeeping....................... 6,000 15 10 900,000
[[Page 7474]]
.103(b)(5) Incident Reporting, .113 Suspension 6,000 0.5 45/60 2,250
or Termination Reporting.......................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,138,230
----------------------------------------------------------------------------------------------------------------
OS specifically requests comments on (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.
Darius Taylor,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2015-02650 Filed 2-9-15; 8:45 am]
BILLING CODE 4150-36-P
