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

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)

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of 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 March 16, 2015, Volume 80, No. 50, pages 13568-13569 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. The 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.

Direct Comments to OMB:

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,

OIRA_submission@omb.eop.gov

or by fax to 202-395-6974, Attention: Desk Officer for NIH.

Comments Due Date:

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

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 Currie, Division of Grants Policy, 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:

ProjectClearanceBranch@mail.nih.gov.

Proposed Collection:

Public Health Service (PHS) Post-award Reporting Requirements. Revision, OMB 0925-0002, Expiration Date 8/31/2015. Form numbers: PHS 2590, PHS 416-7, PHS 2271, PHS 3734, PHS 6031-1, and HHS 568.

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 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. The 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.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 531,802.

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

32,098

1

15

481,470

Biosketch

2,544

1

2

5,088

Data Tables

758

1

4

3,032

PHS Inclusion Enrollment Report

2,544

1

1

2,544

Trainee Diversity Report

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

531,427

Recordkeeping

SBIR/STTR Life Cycle Certification

1,500

1

15/60

375

Grand Total

531,802

Dated: July 29, 2015.

Lawrence A. Tabak,

Deputy Director, National Institutes of Health.

[FR Doc. 2015-19253 Filed 8-4-15; 8:45 am]

BILLING CODE 4140-01-P