[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76368-76370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Public Health 
Service Applications and Pre-Award Reporting Requirements (Office of 
the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide 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.

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

FOR FURTHER INFORMATION CONTACT: 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

[[Page 76369]]

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 [email protected]. Formal requests for additional plans 
and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address 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 minimizes 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.
    Proposed Collection Title: Public Health Service (PHS) Applications 
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001, 
Expiration Date 10/31/2018. 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. This collection includes the proposed use of 
a new PHS clinical trial application 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 
Individual Fellowship Application Instructions and Forms used only for 
a change of sponsoring institution application [paper]; Instructions 
for a Change of Sponsoring Institution for the National Research 
Service Award (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) 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 
National Research Service Award (NRSA) awards. The PHS 6031 Payback 
Agreement is used by individuals at the time of activation to certify 
agreement to fulfill the payback provisions. Clinical trials are 
complex and challenging research activities. 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.
    Frequency of response: Applicants may submit applications for 
published receipt dates. For NRSA awards, fellowships are activated and 
trainees appointed.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 850,756.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
          Information collection forms              respondents    responses per   response  (in   burden hours
                                                                    respondent        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 Inclusion Enrollment Report.............          54,838               1               1          54,838
    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               3         212,598
    PHS 398 Research Training Program Plan......           1,122               1               3           3,366
    Data Tables.................................           1,515               1               4           6,060
    PHS 398 Career Development Award                       2,251               1               3           6,753
     Supplemental Form..........................
    PHS Clinical Trial Protocol Form............           8,264               1               1           8,264
    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).........................

[[Page 76370]]

 
    PHS Assignment Request Form.................           3,354               1           30/60           1,677
    PHS Inclusion Enrollment Report.............           3,354               1               1           3,354
    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...............  ..............         420,101  ..............         850,756
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    Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26448 Filed 11-1-16; 8:45 am]
 BILLING CODE 4140-01-P