[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71965-71966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28130]


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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, HHS.

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.

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 803-C, 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: This proposed information collection was 
previously published in the Federal Register on April 12, 2019, Volume 
84, No. 71 pages 14958-14959 and allowed 60 days for public comment. 
One public comment was received. The purpose of this notice is to allow 
an additional 30 days for public comment. The Office of the Director, 
NIH, may not conduct or

[[Page 71966]]

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 3/31/
2020, Office of the Director (OD), National Institutes of Health (NIH). 
This collection represents eliminating the Final Progress Report form 
as the form has been incorporated into the Final RPPR. Competing 
applications in the future may be updated to reflect related Human 
Fetal Tissue (HFT) information.
    Need and Use of Information Collection: 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 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 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 517,408.

                                        Estimated Annualized Burden Hours
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                                                                            Number of     Average       Total
                                                              Number of     responses    burden per     annual
               Information collection forms                  respondents       per        response      burden
                                                                            respondent   (in hours)     hours
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                                                    Reporting
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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 Information (Part             6,420            1            4       25,680
 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 RPPR)............             480            1        15/60          120
PHS Human Subjects and Clinical Trial Information (Part             3,600            1            4       14,400
 of Final RPPR, includes inclusion/enrollment)...........
PHS 374..................................................             479            1        30/60          240
SBIR/STTR Phase II Final Progress Report.................           1,330            1            1        1,330
SBIR/STTR Life Cycle Certification.......................           1,500            1        15/60          375
                                                          ------------------------------------------------------
    Total................................................  ..............      218,983  ...........      517,408
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    Dated: December 20, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-28130 Filed 12-27-19; 8:45 am]
BILLING CODE 4140-01-P