Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)

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.

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

trialsinfo@od.nih.gov.

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

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

Information collection forms

Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total annual burden

hours

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 RPPR)

2,544

1

1

2,544

PHS Clinical Trial Report/Form (Part of RPPR)

8,264

1

1

8,264

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

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