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.

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, OIRA_submission@omb.eop.gov 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: projectclearancebranch@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

This proposed information collection was previously published in the Federal Register on April 12, 2019, Volume 84, No.212 pages 14956-14957 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 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 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 3/31/2020. 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: NIH has received approval to require applicants and recipients to address Human Fetal Tissue requirements within the SF-424 R&R and the Research Performance Progress Report due to Congressional ((Sections 498A and 498B of the PHS Act (42 U.S.C. 289g-1 and 289g-2)) and Department of Health and Human Services (45 CFR 46.204 and 46.206) mandates regarding human fetal tissue research. Applicants and recipients will be required to comply with Federal and state laws concerning the acquisition of human fetal tissue (including cell lines) obtained from elective abortions as well as include a description of the proposed characteristics of the human fetal cells/tissue outlining the procurement budget details, and how the applicants/recipients will document the processes for how they will use the human fetal tissues and cells. Additionally, this revision will clarify information regarding an institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

This collection also continues to include 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.