Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD), 14958-14959 [2019-07354]
Download as PDF
<![CDATA[
14958
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
Average
burden
per response
(in hours)
Total annual
burden hours
VCOC Certification ...................................................................................
SBIR/STTR Funding Agreement Certification ..........................................
6
1,500
1
1
5/60
15/60
1
375
Total Annual Burden Hours ...............................................................
421,777
421,777
........................
2,150,389
Dated: April 5, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2019–07324 Filed 4–11–19; 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 (OD)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for 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.
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: 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
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
jbell on DSK30RV082PROD with NOTICES
Number of
responses per
respondent
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
comments and/or suggestions from the
public and affected agencies are invited
on 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: Public
Health Service (PHS) Post-award
Reporting Requirements Revision, OMB
0925–0002, Expiration Date 3/31/2020,
Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: Starting in January 2020,
NIH will require applicants and
recipients to address Human Fetal
Tissue requirements within the SF–424
R&R and the Research Performance
Progress Report (RPPR) due to
Congressional ((Sections 498A and 498B
of the PHS Act (42 U.S.C. 289g–1 and
289g–2)) and Department of Health and
Human Services (45 CFR 46.204 and
46.206) mandates regarding human fetal
tissue research. Applicants and
recipients will be required to comply
with Federal and state laws concerning
the acquisition of human fetal tissue
(including cell lines) as well as include
a concise description of the proposed
characteristics of the human fetal cells/
tissue outlining the procurement budget
details, and how the applicants/
recipients will document the processes
for how they will use the human fetal
tissues and cells. Additionally, this
revision will clarify information
regarding an institutional commitment
to ensuring that proper policies,
procedures, and oversight are in place to
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
prevent discriminatory harassment and
other discriminatory practices. The
RPPR is 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, 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
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 NIH to ensure participant safety,
data integrity, and accountability of the
use of public funds. 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
E:\FR\FM\12APN1.SGM
12APN1
14959
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
requirements as well as continued
monitoring and update during the postaward reporting requirements will
facilitate 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
519,408.
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) .....................................................................
Trainee Diversity Report (Part of RPPR) .................................................
PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) .......................................................
Publication Reporting ...............................................................................
Final RPPR—Core Data ...........................................................................
Data Tables (Part of Final RPPR) ............................................................
Trainee Diversity Report (Part of Final RPPR) ........................................
PHS Human Subjects and Clinical Trial Information (Part of Final
RPPR, includes inclusion/enrollment) ...................................................
PHS 374 ...................................................................................................
Final Progress Report ..............................................................................
SBIR/STTR Phase II Final Progress Report ............................................
Average
burden per
response
(in hours)
Total annual
burden hours
12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
480
1
1
1
1
1
1
1
1
1
1
30/60
20/60
5/60
15/60
15/60
18
8
2
4
15/60
6,290
593
932
1,424
5,509
4,374
256,784
5,088
3,032
120
6,420
97,023
18,000
758
480
1
1
1
1
1
4
5/60
10
4
15/60
25,680
8,085
180,000
3,032
120
3,600
479
2,000
1,330
1
1
1
1
4
30/60
1
1
14,400
240
2,000
1,330
Reporting Burden Total .....................................................................
........................
........................
........................
519,033
Recordkeeping:
SBIR/STTR Life Cycle Certification ..........................................................
1,500
1
15/60
375
Grand Total ................................................................................
220,983
220,983
........................
519,408
Dated: April 5, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–07354 Filed 4–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2019–0002; Internal
Agency Docket No. FEMA–B–1910]
Proposed Flood Hazard
Determinations; Correction
jbell on DSK30RV082PROD with NOTICES
Number of
responses per
respondent
Federal Emergency
Management Agency, DHS.
ACTION: Notice; correction.
AGENCY:
On March 18, 2019, FEMA
published in the Federal Register a
proposed flood hazard determination
SUMMARY:
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
notice that contained an erroneous
table. This notice provides corrections
to that table, to be used in lieu of the
information published at 84 FR 9805.
The table provided here represents the
proposed flood hazard determinations
and communities affected for Yakima
County, Washington and Incorporated
Areas.
Comments are to be submitted
on or before July 11, 2019.
DATES:
The Preliminary Flood
Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study
(FIS) report for each community are
available for inspection at both the
online location and the respective
Community Map Repository address
listed in the table below. Additionally,
the current effective FIRM and FIS
report for each community are
accessible online through the FEMA
Map Service Center at https://
msc.fema.gov for comparison.
ADDRESSES:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
You may submit comments, identified
by Docket No. FEMA–B–1910, to Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov.
Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at https://
www.floodmaps.fema.gov/fhm/
fmx_main.html.
FOR FURTHER INFORMATION CONTACT:
FEMA
proposes to make flood hazard
determinations for each community
listed in the table below, in accordance
with Section 110 of the Flood Disaster
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14958-14959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07354]
-----------------------------------------------------------------------
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
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for 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 [email protected].
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 on 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: Public Health Service (PHS) Post-award
Reporting Requirements Revision, OMB 0925-0002, Expiration Date 3/31/
2020, Office of the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: Starting in January 2020,
NIH will require applicants and recipients to address Human Fetal
Tissue requirements within the SF-424 R&R and the Research Performance
Progress Report (RPPR) due to Congressional ((Sections 498A and 498B of
the PHS Act (42 U.S.C. 289g-1 and 289g-2)) and Department of Health and
Human Services (45 CFR 46.204 and 46.206) mandates regarding human
fetal tissue research. Applicants and recipients will be required to
comply with Federal and state laws concerning the acquisition of human
fetal tissue (including cell lines) as well as include a concise
description of the proposed characteristics of the human fetal cells/
tissue outlining the procurement budget details, and how the
applicants/recipients will document the processes for how they will use
the human fetal tissues and cells. Additionally, this revision will
clarify information regarding an institutional commitment to ensuring
that proper policies, procedures, and oversight are in place to prevent
discriminatory harassment and other discriminatory practices. The RPPR
is 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, 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 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 NIH to ensure participant safety, data
integrity, and accountability of the use of public funds. 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
[[Page 14959]]
requirements as well as continued monitoring and update during the
post-award reporting requirements will facilitate 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 519,408.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden 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 18 4,374
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
Trainee Diversity Report (Part of RPPR)..... 480 1 15/60 120
PHS Human Subjects and Clinical Trial 6,420 1 4 25,680
Information (Part of RPPR, includes
inclusion enrollment report)...............
Publication Reporting....................... 97,023 1 5/60 8,085
Final RPPR--Core Data....................... 18,000 1 10 180,000
Data Tables (Part of Final RPPR)............ 758 1 4 3,032
Trainee Diversity Report (Part of Final 480 1 15/60 120
RPPR)......................................
PHS Human Subjects and Clinical Trial 3,600 1 4 14,400
Information (Part of Final RPPR, includes
inclusion/enrollment)......................
PHS 374..................................... 479 1 30/60 240
Final Progress Report....................... 2,000 1 1 2,000
SBIR/STTR Phase II Final Progress Report.... 1,330 1 1 1,330
---------------------------------------------------------------
Reporting Burden Total.................. .............. .............. .............. 519,033
----------------------------------------------------------------------------------------------------------------
Recordkeeping:
SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total......................... 220,983 220,983 .............. 519,408
----------------------------------------------------------------------------------------------------------------
Dated: April 5, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-07354 Filed 4-11-19; 8:45 am]
BILLING CODE 4140-01-P
