[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]


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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 
(Office of the Director)

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 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 [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 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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
          Information collection forms              respondents    responses per   response (in    burden  hours
                                                                    respondent        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              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
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    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