30 Day FRN Notice

9572

Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

National Institutes of Health

National Institute of Mental Health;
Amended Notice of Meeting

Submission for OMB Review; 30-Day
Comment Request Post-Award
Reporting Requirements Including
Research Performance Progress
Report Collection (OD/OPERA)

Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
February 03, 2017, 10:00 a.m. to
February 03, 2017, 03:00 p.m., National
Institutes of Health, Neuroscience
Center, 6001 Executive Boulevard,
Rockville, MD, 20852 which was
published in the Federal Register on
January 18, 2017, 82 FR 5588.
This meeting notice is amended to
change the meeting time to 10:30 a.m.–
1:00 p.m. The meeting is closed to the
public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–02429 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, March
02, 2017, 12:00 p.m. to March 02, 2017,
04:00 p.m., National Cancer Institute
Shady Grove, 9609 Medical Center
Drive, 7W538, Rockville, MD, 20850
which was published in the Federal
Register on January 27, 2017, 82 FR
8620.
The meeting notice is amended to
change the date of the meeting to March
8, 2017 from 12:00 p.m. to 4:00 p.m. The
meeting is closed to the public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.

Lhorne on DSK30JT082PROD with NOTICES

BILLING CODE 4140–01–P

VerDate Sep<11>2014

14:31 Feb 06, 2017

Jkt 241001

ACTION:

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 76371–76372 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.
SUMMARY:

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
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, Room 3505, 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, National Institutes of
Health (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
ADDRESSES:

National Institutes of Health

[FR Doc. 2017–02431 Filed 2–6–17; 8:45 am]

National Institutes of Health.
Notice.

AGENCY:

PO 00000

Frm 00014

Fmt 4703

Sfmt 4703

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) Post-award Reporting
Requirements.
Revision, OMB 0925–0002, Expiration
Date 10/31/2018. Form numbers: PHS
2590, PHS 416–7, PHS 2271, PHS 3734,
PHS 6031–1, and HHS 568. This
collection represents a consolidation of
post-award reporting requirements
under the PRA, including the Research
Performance Progress Report (RPPR).
This collection includes the proposed
additional reporting requirements for
clinical trials.
Need and Use of Information
Collection: The RPPR is now required to
be used by all NIH, Food and Drug
Administration, Centers for Disease
Control and Prevention, and Agency for
Healthcare Research and Quality
grantees. Interim progress reports are
required to continue support of a PHS
grant for each budget year within a
competitive segment. The phased
transition to the RPPR required the
maintenance of dual reporting processes
for a period of time. Continued use of
the PHS Non-competing Continuation
Progress Report (PHS 2590) exists for a
small group of grantees. This collection
also includes other PHS post-award
reporting requirements: PHS 416–7
NRSA Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, Final
Progress Report instructions, iEdison,
and PHS 3734 Statement Relinquishing
Interests and Rights in a PHS Research
Grant. The PHS 416–7, 2271, and 6031–
1 are used by NRSA recipients to
activate, terminate, and provide for
payback of a NRSA. Closeout of an
award requires a Final Invention
Statement (HHS 568) and Final Progress
Report. Using iEdison allows grantees
and federal agencies to meet statutory
requirements for reporting inventions
and patents. The PHS 3734 serves as the
official record of grantee relinquishment
of a PHS award when an award is
transferred from one grantee institution
to another. The Small Business
Innovation Research and Small Business
Technology Transfer (SBIR/STTR) Life
Cycle Certifications are completed by
small business grantees once certain
milestones are reached during the
project period. Pre-award reporting
requirements are simultaneously
consolidated under 0925–0001 and the
changes to the collection here are
related. Clinical trials are complex and

E:\FR\FM\07FEN1.SGM

07FEN1

9573

Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
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 in the PHS
applications and pre-award reporting
requirements as well as continued
monitoring and update during the postaward reporting requirements will
facilitate the NIH’s oversight of clinical
trials. In addition, some of the data
reported in the RPPR will ultimately be
accessible to investigators to update

certain sections of forms when
registering or reporting 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
519,408.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Information collection forms

Reporting:
PHS 416–7 ...............................................................................................
PHS 6031–1 .............................................................................................
PHS 568 ...................................................................................................
iEdison ......................................................................................................
PHS 2271 .................................................................................................
PHS 2590 .................................................................................................
RPPR—Core Data ....................................................................................
Biosketch (Part of RPPR) .........................................................................
Data Tables (Part of RPPR) .....................................................................
Trainee Diversity Report (Part of RPPR) .................................................
PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) .......................................................
Publication Reporting ...............................................................................
Final RPPR—Core Data ...........................................................................
Data Tables (Part of Final RPPR) ............................................................
Trainee Diversity Report (Part of Final RPPR) ........................................
PHS Human Subjects and Clinical Trial Information (Part of Final
RPPR, includes inclusion/enrollment) ...................................................
PHS 3734 .................................................................................................
Final Progress Report ..............................................................................
SBIR/STTR Phase II Final Progress Report ............................................

Average
burden per
response
(in hours)

Total annual
burden hours

12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
480

1
1
1
1
1
1
1
1
1
1

30/60
20/60
5/60
15/60
15/60
18
8
2
4
15/60

6,290
593
932
1,424
5,509
4,374
256,784
5,088
3,032
120

6,420
97,023
18,000
758
480

1
3
1
1
1

4
5/60
10
4
15/60

25,680
8,085
180,000
3,032
120

3,600
479
2,000
1,330

1
1
1
1

4
30/60
1
1

14,400
240
2,000
1,330

Reporting Burden Total .....................................................................
Recordkeeping:
SBIR/STTR Life Cycle Certification ..........................................................

........................

........................

........................

499,033

1,500

1

15/60

375

Grand Total ................................................................................

........................

........................

........................

519,408

Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–02471 Filed 2–6–17; 8:45 am]

This meeting notice is amended to
change the meeting time to 1:00 p.m.–
5:00 p.m. The meeting is closed to the
public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2017–02430 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P

National Institutes of Health

Lhorne on DSK30JT082PROD with NOTICES

Number of
responses per
respondent

National Institute of Mental Health;
Amended Notice of Meeting

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
February 03, 2017, 10:00 a.m. to
February 03, 2017, 03:00 p.m., National
Institutes of Health, Neuroscience
Center, 6001 Executive Boulevard,
Rockville, MD, 20852 which was
published in the Federal Register on
January 18, 2017, 82FR5588.

National Institutes of Health

VerDate Sep<11>2014

14:31 Feb 06, 2017

Jkt 241001

National Institutes of Health,

HHS.
ACTION:

PO 00000

Notice.

Frm 00015

Fmt 4703

Sfmt 4703

Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.

DATES:

Submission for OMB Review; 30-Day
Comment Request PHS Applications
and Pre-Award Reporting
Requirements (OD/OPERA)
AGENCY:

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.

SUMMARY:

Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden

ADDRESSES:

E:\FR\FM\07FEN1.SGM

07FEN1