30-day notice

Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
Place: Sheraton Chapel Hill Hotel, One
Europa Drive, Chapel Hill, NC 27517.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 919/541–0670, worth@niehs.nih.gov.
Name of Committee:
National Institute of Environmental Health
Sciences Special Emphasis Panel;
Environmental Health Science Cores.
Date: November 6, 2015
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Imperial Center, One
Europa Drive, Chapel Hill, NC 27517.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 6, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–25903 Filed 10–9–15; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

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National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
This meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

21:23 Oct 09, 2015

(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: October 6, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–25906 Filed 10–9–15; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: National Institute
of Mental Health (NIMH) Recruitment
Milestone Reporting System
Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Mental Health (NIMH),
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
June 1, 2015, page 31053, and allowed
60-days for public comment. Four (4)
public comments were received.
Comments include concerns about the
clarity of the announcement, the utility
of the information collected, and the
frequency of tri-annual and monthly
reporting. NIMH carefully considered
all comments received and has changed
the language in the supporting
statement to confirm that reporting of
recruitment milestones in the RMR
applies to participants in all extramural
NIMH-sponsored clinical trials,
regardless of size, as well as other
clinical research studies that plan to
enroll 150 or more human subjects in a

SUMMARY:

BILLING CODE 4140–01–P

VerDate Sep<11>2014

Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Review of Career
Development Applications.
Date: October 28, 2015.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Raul A. Saavedra, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Boulevard, Suite 3208, MSC
9529, Bethesda, MD 20892–9529, 301–496–
9223, saavedrr@ninds.nih.gov.

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single study. Investigators who fail to
meet their milestones may be requested
to submit interim monthly reports.
NIMH has determined tri-annual
reporting to be the minimum necessary
to provide effective recruitment
monitoring. When studies fall
significantly behind their recruitment
goals, monthly reporting is necessary in
order to ensure the study can be
completed within the proposed budget
and timeframe. Based on current study
performance, NIMH expects less than
5% of respondents will require monthly
reporting. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institute of
Mental Health, National Institutes of
Health, 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.
Direct Comments to OMB: 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, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: NIMH Project Clearance
Liaison, Science Policy and Evaluation
Branch, OSPPC, NIMH, NIH,
Neuroscience Center, 6001 Executive
Boulevard, MSC 9667, Rockville Pike,
Bethesda, MD 20892, or call 301–443–
4335, or Email your request, including
your address to:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection
National Institute of Mental Health
(NIMH) Recruitment Milestone
Reporting System (OMB control number
0925–0697)—REVISION—National
Institute of Mental Health (NIMH),
National Institute of Health (NIH).
Need and Use of Information Collection
The Recruitment Milestone Reporting
(RMR) System allows NIMH staff to
monitor more effectively the

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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices

recruitment of participants in all NIMHsponsored clinical trials, regardless of
size, and other clinical research studies
that plan to enroll 150 or more human
subjects in a single study. Clinical
studies can have difficulty recruiting,
and accurate and timely reporting is the
best way to ensure recruitment goals are
met within the expected timeframe.
Investigators develop a recruitment plan
that includes tri-yearly milestones for
recruitment of the total study
population, and for recruitment of racial
and ethnic minority participants. Once

recruitment is scheduled to begin,
investigators report actual progress on
recruitment milestones three times per
year, by April 1, August 1, and
December 1. Investigators who fail to
meet their milestones may be requested
to submit interim monthly reports. The
primary use of this information is to
ensure that realistic recruitment
milestones are established from the
onset of a project, and that these
milestones are met throughout the
course of the research. By ensuring
timely recruitment into clinical research

studies, NIMH can reduce the need to
extend timelines or supplement funds
in order to complete the research
project, potentially increasing efficiency
in the funding process and expediting
the availability of treatments for mental
illness.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,295.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Tri-yearly NIMH Recruitment Milestone Reporting
(RMR).
Monthly NIMH Recruitment Milestone Reporting
(RMR).
Total ...............................................................

Dated: October 6, 2015.
Melba Rojas,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015–25941 Filed 10–9–15; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: International HIV/
AIDS Research Fellowship Award
Program (NIDA)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on October 8, 2014, page
60895, and allowed 60 days for public
comment. No comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institute on Drug Abuse
(NIDA), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented

mstockstill on DSK4VPTVN1PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

21:23 Oct 09, 2015

Number of
respondents

Type of respondent

Jkt 238001

Average
burden per
response
(in hours)

Total annual
burden hours

NIMH Principal Investigators.
NIMH Principal Investigators.

900

3

45/60

2,025

40

9

45/60

270

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

940

3,060

45/60

2,295

on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: 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,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Steve W. Gust, Ph.D., Director,
NIDA International Program, NIDA,
NIH, 6001 Executive Blvd., Bethesda,
Maryland 20892–0234; or call non-tollfree number (301) 443–6480; or Email:
your request, including your address to:
sgust@nida.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: International
HIV/AIDS Research Fellowship Award
Program, 0925–New, National Institute

FOR FURTHER INFORMATION CONTACT:

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Number of
responses per
respondent

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on Drug Abuse (NIDA), National
Institutes of Health (NIH).
Need and Use of Information
Collection: Initially this collection was
part of a clearance request for the
application forms for two programs, and
due to protracted delays in the readiness
of one of the programs it became
necessary to create a stand-alone request
for this program. This request is for the
Application Form for this international
training program. The program will
recruit post-doctoral researchers into a
new fellowship research training
program for HIV and drug use. The
program will train new researchers in
research to advance the science of HIV
and drug use and foster multinational
research in this disease area. The
program is open to all foreign nationals.
The Application Form will collect
necessary information for determining
the most meritorious applicants. NIDA
is requesting approval from OMB for
this application form to be used by the
Institute’s fellowship program to train
new researchers and fund experienced
scientists, of other nations, in research
to advance the science of HIV and drug
use while fostering multinational
research in this disease area. The
application form will be web-based.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total annual
estimated burden hours are 83.

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