[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9572-9573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Post-Award 
Reporting Requirements Including Research Performance Progress Report 
Collection (OD/OPERA)

AGENCY: National Institutes of Health.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on November 
2, 2016, Volume 81, No. 212, pages 76371-76372 and allowed 60 days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Ms. Mikia P. Currie, Project Clearance Branch, 
Office of Policy for Extramural Research Administration, NIH, Rockledge 
1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, 
or call non-toll-free number (301) 435-0941, or Email your request, 
including your address to: [email protected].

SUPPLEMENTARY INFORMATION: The Office of the Director, National 
Institutes of Health (NIH), may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act (PRA) of 1995, the NIH has submitted to the Office of Management 
and Budget (OMB) a request for review and approval of the information 
collection listed below.
    Proposed Collection: 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 
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 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. Using 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. The Small Business Innovation Research and Small Business 
Technology Transfer (SBIR/STTR) Life Cycle Certifications are completed 
by small business grantees once certain milestones are reached during 
the project period. Pre-award reporting requirements are simultaneously 
consolidated under 0925-0001 and the changes to the collection here are 
related. Clinical trials are complex and

[[Page 9573]]

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.
    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               3            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 3734....................................             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..................  ..............  ..............  ..............         499,033
Recordkeeping:
    SBIR/STTR Life Cycle Certification..........           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
            Grand Total.........................  ..............  ..............  ..............         519,408
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    Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-02471 Filed 2-6-17; 8:45 am]
 BILLING CODE 4140-01-P