Submission for OMB Review; 30-Day Comment Request; Materials To Support NIH Serving as an IRB of Record or a Single IRB for Outside Institutions (Office of the Director), 83855-83856 [2016-28140]
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Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Submission for OMB Review; 30-Day
Comment Request; Materials To
Support NIH Serving as an IRB of
Record or a Single IRB for Outside
Institutions (Office of the Director)
sradovich on DSK3GMQ082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in section
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: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Heart, Lung, Blood and Sleep Conference
Support Applications.
Date: December 12–13, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7196, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
R25 Diversity: Short-Term Research
Education to Increase Diversity.
Date: December 12, 2016.
Time: 10:00 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7189, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 16, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–27997 Filed 11–21–16; 8:45 am]
BILLING CODE 4140–01–P
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
August 22, 2016, page 56667 (81 FR
56667) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
Written comments and/or
suggestions regarding the items(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Julia Slutsman,
Health Science Policy Analyst, Office of
Human Subjects Research Protections
(OHSRP), IRP, OD, NIH, Building 10,
Room 1C154, 10 Center Drive, Bethesda,
MD 20892, or call non-toll-free number
301–402–3444 or email your request,
including your address to: PHERRB@
mail.nih.gov. Formal requests for
additional materials must be requested
in writing.
SUPPLEMENTARY INFORMATION: The Office
of Human Subjects Research Protections
(OHSRP), Office of the Director (OD),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
ADDRESSES:
PO 00000
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83855
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Materials to
Support NIH Serving As an IRB of
Record or a Single IRB for Outside
Institutions, 0925-New, Office of Human
Subjects Research Protections (OHSRP),
Office of the Director, National
Institutes of Health (NIH).
Need and Use of Information
Collection: The NIH Human Research
Protections Program (HRPP) is preparing
to implement the recent ‘‘NIH Policy on
the Use of a Single Institutional Review
Board (sIRB) of Record for Multi-Site
Research,’’ which requires the use of a
single IRB of record for human subject
protections review of certain multisite
studies. Additionally, the NIH and HHS
have recently established the Public
Health Emergency Research Review
Board (PHERRB) mechanism, for human
subject protections review of certain—
typically multisite—public health
emergency research studies. Any of the
12 NIH intramural IRBs can be
designated to serve as the PHERRB for
review of a public health emergency
research protocol. Finally, proposed
changes to federal human subject
protections regulations, if finalized, will
require the use of single IRB review for
the majority of HHS funded, multi-site
studies.
To meet all of these needs, and
support efficient single IRB review,
researchers at outside institutions will
need to provide information to the NIH
HRPP, which includes the NIH
intramural IRBs, using materials
developed by the NIH Office of Human
Subject Protections. The required
materials include: The Application for
PHERRB Review (APR); the Initial
Review Local Context Worksheet
(IRLCW); and the Continuing Review
Local Context Worksheet (CRLCW). This
information collection is intended to
provide the NIH HRPP and the NIH IRBs
with information necessary for NIH to
maintain regulatory compliance in its
conduct of human subject protections
review when an NIH IRB serves an IRB
of record for multisite research and to
provide high quality and timely human
subject protections reviews.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annual burden hours are 790.
E:\FR\FM\22NON1.SGM
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83856
Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
number of
respondents
Estimated
number of
responses per
respondent
Average
time per
response
(in hours)
Estimated
total annual
burden hours
Data collection activity
Type of respondents
APR ...............................
IRLCW ...........................
Principal Investigator (MD or PhD) .....................
Principal Investigator (MD or PhD degree) or
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
Principal Investigator (MD or PhD degree) or
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
20
250
1
1
2
2
40
500
250
1
1
250
..............................................................................
520
520
........................
790
CRLCW ..........................
Total ........................
Dated: November 16, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Need and Use of Information
Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes
and supports programs to facilitate the
participation of qualified investigators
on CTEP-supported studies, and to
institute programs that minimize
redundancy among grant and contract
holders, thereby reducing overall cost of
maintaining a robust treatment trials
program. Currently guided by the efforts
of the Clinical Trials Working Group
(CTWG) and the Institute of Medicine
(IOM) recommendations to revitalize the
Cooperative Group program, CTEP has
funded the Cancer Trials Support Unit
(CTSU). The CTSU collects
standardized forms to process site
regulatory information, changes to
membership, patient enrollment data,
and routing information for case report
forms. In addition, CTSU collects
annual surveys of customer satisfaction
for clinical site staff using the CTSU
Help Desk, the CTSU Web site, and the
Protocol and Information Office (PIO).
An ongoing user satisfaction survey is in
place for the Oncology Patient
Enrollment Network (OPEN). User
satisfaction surveys are compiled as part
of the project quality assurance
activities and are used to direct
improvements to processes and
technology.
OMB approval for an extension to the
existing approval is requested for one
year. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
25,204.
Cancer Therapy Evaluation Program
(CTEP), 9609 Medical Center Drive,
MSC 9742, Rockville, MD 20850 or call
non-toll-free number 240–276–6080 or
Email your request, including your
address to: montellom@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–28140 Filed 11–21–16; 8:45 am]
BILLING CODE 4140–01–P
Proposed Collection; 60-Day Comment
Request; Cancer Trials Support Unit
(National Cancer Institute)
National Institutes of Health.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Michael Montello, Pharm. D.,
FOR FURTHER INFORMATION CONTACT:
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Cancer
Trials Support Unit (CTSU) (NCI),
0925–0624, EXTENSION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
sradovich on DSK3GMQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hour
Form name
Type of respondent
CTSU IRB/Regulatory Approval Transmittal
Form.
CTSU IRB Certification Form .........................
CTSU Acknowledgement Form ......................
Withdrawal from Protocol Participation Form
Health Care Practitioner .....
9,000
12
2/60
3,600
Health Care Practitioner .....
Health Care Practitioner .....
Health Care Practitioner .....
8,500
500
50
12
12
12
10/60
5/60
5/60
17,000
500
50
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]]>Agencies
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83855-83856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Materials To
Support NIH Serving as an IRB of Record or a Single IRB for Outside
Institutions (Office of the Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below. This proposed information
collection was previously published in the Federal Register on August
22, 2016, page 56667 (81 FR 56667) and allowed 60 days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30 days of the date of
this publication.
ADDRESSES: Written comments and/or suggestions regarding the items(s)
contained in this notice, especially regarding the estimated public
burden and associated response time, should be directed to the: Office
of Management and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Julia Slutsman, Health Science Policy Analyst,
Office of Human Subjects Research Protections (OHSRP), IRP, OD, NIH,
Building 10, Room 1C154, 10 Center Drive, Bethesda, MD 20892, or call
non-toll-free number 301-402-3444 or email your request, including your
address to: PHERRB@mail.nih.gov. Formal requests for additional
materials must be requested in writing.
SUPPLEMENTARY INFORMATION: The Office of Human Subjects Research
Protections (OHSRP), Office of the Director (OD), National Institutes
of Health, may not conduct or sponsor, and the respondent is not
required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below.
Proposed Collection: Materials to Support NIH Serving As an IRB of
Record or a Single IRB for Outside Institutions, 0925-New, Office of
Human Subjects Research Protections (OHSRP), Office of the Director,
National Institutes of Health (NIH).
Need and Use of Information Collection: The NIH Human Research
Protections Program (HRPP) is preparing to implement the recent ``NIH
Policy on the Use of a Single Institutional Review Board (sIRB) of
Record for Multi-Site Research,'' which requires the use of a single
IRB of record for human subject protections review of certain multisite
studies. Additionally, the NIH and HHS have recently established the
Public Health Emergency Research Review Board (PHERRB) mechanism, for
human subject protections review of certain--typically multisite--
public health emergency research studies. Any of the 12 NIH intramural
IRBs can be designated to serve as the PHERRB for review of a public
health emergency research protocol. Finally, proposed changes to
federal human subject protections regulations, if finalized, will
require the use of single IRB review for the majority of HHS funded,
multi-site studies.
To meet all of these needs, and support efficient single IRB
review, researchers at outside institutions will need to provide
information to the NIH HRPP, which includes the NIH intramural IRBs,
using materials developed by the NIH Office of Human Subject
Protections. The required materials include: The Application for PHERRB
Review (APR); the Initial Review Local Context Worksheet (IRLCW); and
the Continuing Review Local Context Worksheet (CRLCW). This information
collection is intended to provide the NIH HRPP and the NIH IRBs with
information necessary for NIH to maintain regulatory compliance in its
conduct of human subject protections review when an NIH IRB serves an
IRB of record for multisite research and to provide high quality and
timely human subject protections reviews.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annual burden
hours are 790.
[[Page 83856]]
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average time Estimated
Data collection activity Type of respondents number of responses per per response total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
APR............................................ Principal Investigator (MD or PhD)..... 20 1 2 40
IRLCW.......................................... Principal Investigator (MD or PhD 250 1 2 500
degree) or Research Coordinator (RN,
BA, MA degree) or Regulatory Staff (BA
degree).
CRLCW.......................................... Principal Investigator (MD or PhD 250 1 1 250
degree) or Research Coordinator (RN,
BA, MA degree) or Regulatory Staff (BA
degree).
---------------------------------------------------------------
Total...................................... ....................................... 520 520 .............. 790
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: November 16, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-28140 Filed 11-21-16; 8:45 am]
BILLING CODE 4140-01-P
