Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director), 76371-76372 [2016-26447]
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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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
02NON1
76372
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
requirements are simultaneously
consolidated under 0925–0001 and the
changes to the collection here are
related. Clinical trials are complex and
challenging research activities.
Oversight systems and tools are critical
for the NIH to ensure participant safety,
data integrity, and accountability of the
use of public funds. The NIH has been
engaged in a multi-year effort to
examine how clinical trials are
supported and the level of oversight
needed. The collection of more
structured information in the PHS
applications and pre-award reporting
requirements as well as continued
monitoring and update during the postaward reporting requirements will
facilitate the NIH’s oversight of clinical
trials. In addition, some of the data
reported in the RPPR will ultimately be
accessible to investigators to update
certain sections of forms when
registering or reporting their trials with
ClinicalTrials.gov.
Frequency of response: Applicants
may submit applications for published
receipt dates. For NRSA awards,
fellowships are activated and trainees
appointed.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
307,116.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
Reporting:
PHS 416–7 ...............................................................................................
PHS 6031–1 .............................................................................................
PHS 568 ...................................................................................................
iEdison ......................................................................................................
PHS 2271 .................................................................................................
PHS 2590 .................................................................................................
RPPR—Core Data ....................................................................................
Biosketch (Part of RPPR) .........................................................................
Data Tables (Part of RPPR) .....................................................................
PHS Inclusion Enrollment Report (Part of RPPR) ...................................
PHS Clinical Trial Report/Form (Part of RPPR) .......................................
Trainee Diversity Report (Part of RPPR) .................................................
Publication Reporting ...............................................................................
PHS 3734 .................................................................................................
Final Progress Report ..............................................................................
SBIR/STTR Phase II Final Progress Report ............................................
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden
hours
12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
2,544
8,264
480
32,341
479
11,125
1,330
1
1
1
1
1
1
1
1
1
1
1
1
3
1
1
1
30/60
20/60
5/60
15/60
15/60
15
8
2
4
1
1
15/60
5/60
30/60
1
1
6,290
593
932
1,424
5,509
3,645
256,784
5,088
3,032
2,544
8,264
120
8,085
240
11,125
1,330
Reporting Burden Total .....................................................................
Recordkeeping:
SBIR/STTR Life Cycle Certification ..........................................................
........................
........................
........................
306,741
1,500
1
15/60
375
Grand Total ................................................................................
........................
203,394
........................
307,116
Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–26447 Filed 11–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of federally-funded research and
development. Foreign patent
SUMMARY:
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17:18 Nov 01, 2016
Jkt 241001
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the
National Heart, Lung and Blood
Institute, Office of Technology Transfer
and Development, National Institutes of
Health, 31 Center Drive Room 4A29,
MSC2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Methods for Artificial Oocyte
Activation
Description of Technology
Available for licensing and
commercial development for both
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
human and veterinary uses is a method
of activating mammalian oocytes. These
methods include contacting a
mammalian oocyte of interest arrested at
metaphase II with an effective amount
of a Regulator of G-Protein Signaling
(RGS)2 inhibitor; and contacting the
mammalian oocyte of interest with an
effective amount of a G protein coupled
receptor activator. In general, RGS
proteins stimulate the hydrolysis of GTP
bound to activated Ga subunits, leading
to signal termination. RGS2, which
inhibits both G-aq and G-as signaling
suppresses Ca2+ release in mature
mammalian eggs. Regulators of GProtein Signaling (RGS)2 inhibitor and a
G protein coupled receptor activator can
be used to artificially activate a
mammalian oocyte such that it re-enters
the cell cycle. Examples of RGS2
inhibitors can be nucleic acids like
siRNAs or dsRNAs. G-protein coupled
receptor activators can be acetylcholine,
a neurotransmitter such as serotonin,
hormones, natural or synthetic G
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76371-76372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26447]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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 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 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
Non-competing 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
[[Page 76372]]
requirements are simultaneously consolidated under 0925-0001 and the
changes to the collection here are related. Clinical trials are complex
and challenging research activities. Oversight systems and tools are
critical for the NIH to ensure participant safety, data integrity, and
accountability of the use of public funds. The NIH has been engaged in
a multi-year effort to examine how clinical trials are supported and
the level of oversight needed. The collection of more structured
information in the PHS applications and pre-award reporting
requirements as well as continued monitoring and update during the
post-award reporting requirements will facilitate the NIH's oversight
of clinical trials. In addition, some of the data reported in the RPPR
will ultimately be accessible to investigators to update certain
sections of forms when registering or reporting their trials with
ClinicalTrials.gov.
Frequency of response: Applicants may submit applications for
published receipt dates. For NRSA awards, fellowships are activated and
trainees appointed.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 307,116.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Information collection forms respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Reporting:
PHS 416-7................................... 12,580 1 30/60 6,290
PHS 6031-1.................................. 1,778 1 20/60 593
PHS 568..................................... 11,180 1 5/60 932
iEdison..................................... 5,697 1 15/60 1,424
PHS 2271.................................... 22,035 1 15/60 5,509
PHS 2590.................................... 243 1 15 3,645
RPPR--Core Data............................. 32,098 1 8 256,784
Biosketch (Part of RPPR).................... 2,544 1 2 5,088
Data Tables (Part of RPPR).................. 758 1 4 3,032
PHS Inclusion Enrollment Report (Part of 2,544 1 1 2,544
RPPR)......................................
PHS Clinical Trial Report/Form (Part of 8,264 1 1 8,264
RPPR)......................................
Trainee Diversity Report (Part of RPPR)..... 480 1 15/60 120
Publication Reporting....................... 32,341 3 5/60 8,085
PHS 3734.................................... 479 1 30/60 240
Final Progress Report....................... 11,125 1 1 11,125
SBIR/STTR Phase II Final Progress Report.... 1,330 1 1 1,330
---------------------------------------------------------------
Reporting Burden Total.................. .............. .............. .............. 306,741
Recordkeeping:
SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total......................... .............. 203,394 .............. 307,116
----------------------------------------------------------------------------------------------------------------
Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26447 Filed 11-1-16; 8:45 am]
BILLING CODE 4140-01-P
