2017-02472. Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA)

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

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 76368-76370 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, [e-mail] 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, Suite 350, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number [phone], or Email your request, including your address to: [e-mail].

SUPPLEMENTARY INFORMATION:

The Office of the Director, 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) Applications and Pre-award Reporting Requirements. Revision, OMB 0925-0001, Expiration Date 10/31/2018. Form numbers: PHS 398, PHS416-1, 416-5, and PHS 6031. This collection represents a consolidation of PHS applications and pre-award reporting requirements into a revised data collection under the PRA. This collection includes the proposed use of a new PHS Human Subjects and Clinical Trial Information form.

Need and Use of Information Collection: This collection includes PHS applications and pre-award reporting requirements: PHS 398 (paper) Public Health Service Grant Application forms and instructions; PHS 398 (electronic) PHS Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application (paper); Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic), PHS 416-1, 416-5, and PHS 6031 are currently approved under 0925-0001. All forms expire 10/31/2018. Post-award reporting requirements are simultaneously consolidated under 0925-0002, and include the Research Performance Progress Report (RPPR). The PHS 398 and SF424 applications are used by applicants to request federal assistance funds for traditional investigator-initiated research projects and to request access to databases and other PHS resources. The PHS 416-1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency specific instructions is used in combination with the SF424 (R&R) forms/instructions for Fellowships and is used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416-5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify agreement to fulfill the payback provisions. The Venture Capital Operating Companies (VCOC) Certification and the Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) Funding Agreement Certifications are used by small business applicants. 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 about proposed clinical trials in the PHS applications and pre-award reporting requirements will facilitate the NIH's oversight of clinical trials as well as assist in understanding where needs in the NIH research portfolio may exist. In addition, some of the data collected here will ultimately be accessible to investigators to pre-populate certain sections of forms when registering 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 2,150,389.

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
PHS 398—Paper	4,247	1	35	148,645
PHS 398/424—Electronic:
PHS Assignment Request Form	37,120	1	30/60	18,560
PHS 398 Cover Page Supplement	74,239	1	1	74,239
PHS 398 Modular Budget	56,693	1	1	56,693
PHS 398 Training Budget	1,122	1	2	2,244
PHS 398 Training Subaward Budget Attachment(s) Form	561	1	90/60	842
PHS 398 Research Plan	70,866	1	10	708,660
PHS 398 Research Training Program Plan	1,122	1	10	11,220
Data Tables	1,515	1	4	6,060
PHS 398 Career Development Award Supplemental Form	2,251	1	10	22,510
PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	54,838	1	14	767,732
Biosketch (424 Electronic)	80,946	1	2	161,892
PHS Fellowship—Electronic:
PHS Fellowship Supplemental Form (includes F reference letters)	6,707	1	12.5	83,838
PHS Assignment Request Form	3,354	1	30/60	1,677
PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	5,030	1	14	70,420
Biosketch (Fellowship)	6,707	1	2	13,414
416-1	29	1	10	290
PHS 416-5	6,707	1	5/60	559
PHS 6031	6,217	1	5/60	518
VCOC Certification	6	1	5/60	1
SBIR/STTR Funding Agreement Certification	1,500	1	15/60	375
Total Annual Burden Hours				2,150,389

Dated: February 1, 2017.

Lawrence A. Tabak,

Deputy Director, National Institutes of Health.