[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
                                                 ---------------------------------------------------------------
        Reporting Burden Total..................  ..............  ..............  ..............         519,033
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Recordkeeping:
    SBIR/STTR Life Cycle Certification..........           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
            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