[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
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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