2015-05930. Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for 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.

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.

To Submit Comments and for Further Information: 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 [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.

Proposed Collection: Public Health Service (PHS) Applications and Pre-Award Reporting Requirements.

Revision, OMB 0925-0001, Expiration Date 8/31/2015. Form numbers: PHS 398, PHS 416-1, PHS 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 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 8/31/2015. 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. 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 professionals. 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.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,051,794.

Estimates of Hour Burden

Information collection number or form	Number of respondents	Frequency of response	Average time (hrs) per response	Annual burden hours
PHS 398 [paper]	8,389	1	35	293,615
PHS 398 [electronic]	76,312	1	22	1,678,864
PHS Fellowship Supplemental Form [electronic]	4,915	1	16	78,640
PHS 416-1	30	1	10	300
PHS 416-5	3,121	1	0.08	250
PHS 6031	1,559	1	0.08	125
Totals	94,326	1	21.75	2,051,794

Dated: March 9, 2015.

Lawrence A. Tabak,

Deputy Director, National Institutes of Health.