2012-15930. Submission for OMB Review; Comment Request: PHS Applications and Pre-Award Reporting Requirements; Revision

Summary:

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act (PRA) of 1995, the Office of the Director (OD), Office of Extramural Research (OER), 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 5, 2012, Volume 77, No. 43, page 13132-13133, and allowed 60 days for public comment. One public comment was received, which asked for clarification about new reporting burdens. It was noted in follow-up that NIH has seen a 21-percent increase in competing applications since the last clearance which has resulted in an increase in the burden hours. We are also transitioning to the Research Performance Progress Report as mandated by OMB.

The purpose of this notice is to allow an additional 30 days for public comment.

Proposed Collection: Title: Public Health Service (PHS) Applications and Pre-award Reporting Requirements. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 6/30/2012. Form numbers: PHS 398, PHS 416-1, 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. 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 (NRSA) Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic) is currently approved under 0925-0001; PHS 416-1, 416-5, and PHS 6031 are currently approved under 0925-0002. All forms expire 6/30/2012. Post-award reporting requirements are simultaneously consolidated under 0925-0002, and include the new Research Performance Progress Report (RPPR).

The PHS 398 application is 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. Frequency of response: Applicants may submit applications for published receipt dates. For NRSA awards, Fellowships are activated and trainees appointed. Affected Public: Universities and other research institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal investigators. The annual reporting burden is as follows: Total Estimated Number of Respondents: 94,326; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 21.75; Estimated Total Annual Burden Hours Requested: 2,051,794. The estimated annualized cost to respondents is $71,812,769.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on 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 minimize 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.

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 sent via email to [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Seleda M. Perryman, Chief, Project Clearance Officer, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3509, 6705 Rockledge Drive, Bethesda, MD 20892-7974; or call non-toll-free number 301-594-7949; or email your request, including your address, to [e-mail].

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.

Dated: June 25, 2012.

Lawrence A. Tabak,

Deputy Director, National Institutes of Health.