Submission for OMB Review; 30-Day Comment Request, National Institutes of Health Electronic Application System for Certificates of Confidentiality, 76370-76371 [2016-26445]
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Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hours
PHS Assignment Request Form ..............................................................
PHS Inclusion Enrollment Report .............................................................
Biosketch (Fellowship) ..............................................................................
416–1 ........................................................................................................
PHS 416–5 ...............................................................................................
PHS 6031 .................................................................................................
VCOC Certification ...................................................................................
SBIR/STTR Funding Agreement Certification ..........................................
3,354
3,354
6,707
29
6,707
6,217
6
1,500
1
1
1
1
1
1
1
1
30/60
1
2
10
5/60
5/60
5/60
15/60
1,677
3,354
13,414
290
559
518
1
375
Total Annual Burden Hours ...............................................................
........................
420,101
........................
850,756
Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–26448 Filed 11–1–16; 8:45 am]
BILLING CODE 4140–01–P
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 27, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–26386 Filed 11–1–16; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 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 Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: December 8, 2016.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817,
(Virtual Meeting).
Contact Person: Priscah Mujuru, DRPH,
COHNS, Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Boulevard, Suite 5B01, Bethesda, MD 20892–
7510, 301–435–6908, mujurup@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
VerDate Sep<11>2014
17:18 Nov 01, 2016
Jkt 241001
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request, National Institutes
of Health Electronic Application
System for Certificates of
Confidentiality
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 18, 2016 (81 FR 55207–55208)
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 item(s)
contained in this notice, especially
regarding the estimated public burden
SUMMARY:
PO 00000
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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: Dr. Ann Hardy,
NIH Extramural Human Research
Protections Officer and NIH
Coordinator, Certificates of
Confidentiality, 3701 Rockledge Dr. Rm.
3002, Bethesda, MD 20892, or call nontoll-free number (301) 435–2690 or
Email your request, including your
address to: hardyan@od.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Office of
Extramural Research (OER), NIH, 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 NIH has
submitted to the OMB a request for
review and approval of the information
collection listed below.
Proposed Collection: Certificate of
Confidentiality Electronic Application
System, 0925–0689, expiration date 01/
31/2017, OER, NIH.
Need and Use of Information
Collection: This application system
provides one electronic form to be used
by all research organizations that wish
to request a Certificate of Confidentiality
(CoC) from the NIH. As described in the
authorizing legislation (Section 301(d)
of the Public Health Service Act, 42
U.S.C. 241(d)), CoCs are issued by the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02NON1.SGM
02NON1
76371
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
agencies of Department of Health and
Human Services (HHS), including the
NIH, to authorize researchers
conducting sensitive research to protect
the privacy of human research subjects
by enabling them to refuse to release
names and identifying characteristics of
subjects to anyone not connected with
the research. At the NIH, the issuance of
CoCs has been delegated to the
individual NIH Institutes and Centers
(ICs). To make the application process
consistent across the entire agency, OER
launched an electronic application
system in 2015 that is used by research
organizations that wish to request a CoC
from any NIH IC. Having one system for
all CoC applications to the NIH is more
efficient for both applicants and NIH
staff who process these requests. The
NIH uses the information in the
application to determine eligibility for a
CoC and to issue the CoC to the
requesting organization. It is anticipated
that the NIH ICs will issue
approximately 1300 new CoCs each year
for eligible research projects.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
annualized burden hours estimate is
1,951.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
CoC
CoC
CoC
CoC
Applicants—Private .................................................................................
Applicants—State/local ............................................................................
Applicants—Small business ....................................................................
Applicants—Federal ................................................................................
Dated: October 25, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–26445 Filed 11–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Post-Award Reporting
Requirements Including Research
Performance Progress Report
Collection (Office of the Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 Institutes of Health (NIH) will
publish periodic summaries of proposed
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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Mikia P. Currie, Program
Analyst, Office of Policy for Extramural
Research Administration, 6705
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:18 Nov 01, 2016
Jkt 241001
455
650
130
65
Rockledge Drive, Suite 350, Bethesda,
Maryland 20892, or call a non-toll-free
number 301–435–0941 or Email your
request, including your address to
trialsinfo@od.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: 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 minimizes
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: Public
Health Service (PHS) Post-award
Reporting Requirements, Revision, OMB
0925–0002, Expiration Date 10/31/2018.
Form numbers: PHS 2590, PHS 416–7,
PHS 2271, PHS 3734, PHS 6031–1, and
HHS 568. This collection represents a
consolidation of post-award reporting
requirements under the PRA, including
the Research Performance Progress
Report (RPPR). This collection includes
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Frequency of
response
1
1
1
1
Average
time per
response
(in hours)
90/60
90/60
90/60
90/60
Total annual
burden
hours
683
975
195
98
the proposed additional reporting
requirements for clinical trials.
Need and Use of Information
Collection: The RPPR is now required to
be used by all NIH, Food and Drug
Administration, Centers for Disease
Control and Prevention, and Agency for
Healthcare Research and Quality
(AHRQ) grantees. Interim progress
reports are required to continue support
of a PHS grant for each budget year
within a competitive segment. The
phased transition to the RPPR required
the maintenance of dual reporting
processes for a period of time.
Continued use of the PHS Noncompeting Continuation Progress Report
(PHS 2590), exists for a small group of
grantees. This collection also includes
other PHS post-award reporting
requirements: PHS 416–7 National
Research Service Award (NRSA)
Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, Final
Progress Report instructions, iEdison,
and PHS 3734 Statement Relinquishing
Interests and Rights in a PHS Research
Grant. The PHS 416–7, 2271, and 6031–
1 are used by NRSA recipients to
activate, terminate, and provide for
payback of a NRSA. Closeout of an
award requires a Final Invention
Statement (HHS 568) and Final Progress
Report. iEdison allows grantees and
federal agencies to meet statutory
requirements for reporting inventions
and patents. The PHS 3734 serves as the
official record of grantee relinquishment
of a PHS award when an award is
transferred from one grantee institution
to another. Pre-award reporting
E:\FR\FM\02NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76370-76371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request, National
Institutes of Health Electronic Application System for Certificates of
Confidentiality
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
18, 2016 (81 FR 55207-55208) 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 item(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: Dr. Ann Hardy, NIH Extramural Human Research
Protections Officer and NIH Coordinator, Certificates of
Confidentiality, 3701 Rockledge Dr. Rm. 3002, Bethesda, MD 20892, or
call non-toll-free number (301) 435-2690 or Email your request,
including your address to: hardyan@od.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Office of Extramural Research (OER), NIH,
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 NIH has submitted to the OMB a request for review and
approval of the information collection listed below.
Proposed Collection: Certificate of Confidentiality Electronic
Application System, 0925-0689, expiration date 01/31/2017, OER, NIH.
Need and Use of Information Collection: This application system
provides one electronic form to be used by all research organizations
that wish to request a Certificate of Confidentiality (CoC) from the
NIH. As described in the authorizing legislation (Section 301(d) of the
Public Health Service Act, 42 U.S.C. 241(d)), CoCs are issued by the
[[Page 76371]]
agencies of Department of Health and Human Services (HHS), including
the NIH, to authorize researchers conducting sensitive research to
protect the privacy of human research subjects by enabling them to
refuse to release names and identifying characteristics of subjects to
anyone not connected with the research. At the NIH, the issuance of
CoCs has been delegated to the individual NIH Institutes and Centers
(ICs). To make the application process consistent across the entire
agency, OER launched an electronic application system in 2015 that is
used by research organizations that wish to request a CoC from any NIH
IC. Having one system for all CoC applications to the NIH is more
efficient for both applicants and NIH staff who process these requests.
The NIH uses the information in the application to determine
eligibility for a CoC and to issue the CoC to the requesting
organization. It is anticipated that the NIH ICs will issue
approximately 1300 new CoCs each year for eligible research projects.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total annualized burden hours
estimate is 1,951.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of per response Total annual
respondents response (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
CoC Applicants--Private......................... 455 1 90/60 683
CoC Applicants--State/local..................... 650 1 90/60 975
CoC Applicants--Small business.................. 130 1 90/60 195
CoC Applicants--Federal......................... 65 1 90/60 98
----------------------------------------------------------------------------------------------------------------
Dated: October 25, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26445 Filed 11-1-16; 8:45 am]
BILLING CODE 4140-01-P
