[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9573-9575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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

[[Page 9574]]

and associated response time, should be directed to the: Office of 
Management and Budget, Office of Regulatory Affairs, 
[email protected] 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 (301) 435-0941, or Email your request, 
including your address to: [email protected].

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
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                                                                     Number of    Average burden
          Information collection forms               Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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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                         561               1           90/60             842
     Attachment(s) Form.........................
    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                       2,251               1              10          22,510
     Supplemental Form..........................
    PHS Human Subjects and Clinical Trial                 54,838               1              14         767,732
     Information (includes inclusion enrollment
     report)....................................
    Biosketch (424 Electronic)..................          80,946               1               2         161,892
PHS Fellowship--Electronic:
    PHS Fellowship Supplemental Form (includes F           6,707               1            12.5          83,838
     reference letters).........................
    PHS Assignment Request Form.................           3,354               1           30/60           1,677

[[Page 9575]]

 
    PHS Human Subjects and Clinical Trial                  5,030               1              14          70,420
     Information (includes inclusion enrollment
     report)....................................
    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
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    Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-02472 Filed 2-6-17; 8:45 am]
 BILLING CODE 4140-01-P