[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]
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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.
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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
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Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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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
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Reporting Burden Total.................. .............. .............. .............. 519,033
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Recordkeeping:
SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375
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Grand Total......................... 220,983 220,983 .............. 519,408
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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