Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 12914-12915 [2016-05425]
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12914
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
received within 60 days of the date of
this publication.
Proposed Collection: Methodological
Studies for the Population Assessment
of Tobacco and Health (PATH) Study
(NIDA), 0925–0675, expiration date 5/
31/2016—EXTENSION—NIDA, NIH, in
partnership with the Food and Drug
Administration (FDA).
Need and Use of Information
Collection: This is a request to continue
the Population Assessment of Tobacco
and Health (PATH) Study’s conduct of
Control Act. The methodological studies
under this extension will continue to
enhance the approaches used by the
PATH Study for data and biospecimen
collections to obtain high quality and
useful data; minimize respondent
burden; and achieve and maintain high
response, retention, and follow-up rates.
methodological studies in support of
improvements in the Study’s
approaches for data and biospecimen
collection. The PATH Study is a
national longitudinal cohort study of
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17; the Study conducts annual or
biannual interviews and collects
biospecimens from adults and youth to
inform FDA’s regulatory actions under
the Family Smoking Prevention and
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
annualized burden hours are 29,750.
ESTIMATED ANNUALIZED BURDEN HOURS
Data collection activity
Number of
respondents
Type of respondent
In-person surveys .........................................
Web surveys .................................................
Focus groups and individual in-depth qualitative interviews.
Biospecimen collection .................................
Adults
Youth
Adults
Youth
Adults
[FR Doc. 2016–05431 Filed 3–10–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; The Clinical Trials Reporting
Program (CTRP) Database (NCI)
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, 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.
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
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
Total annual
burden hours
....................................
....................................
....................................
....................................
....................................
5,000
3,500
5,000
3,500
1,000
1
1
1
1
1
90/60
90/60
90/60
90/60
2
7,500
5,250
7,500
5,250
2,000
Youth ....................................
Adults ....................................
1,000
1,000
1
1
2
15/60
2,000
250
20,000
20,000
........................
29,750
Total .......................................................
Dated: March 7, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison. NIDA, NIH.
Average
burden per
response
(in hours)
Number of
responses per
respondent
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)
The quality, utility, and clarity of the
information to be collected; and (4)
Minimize 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.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Jose Galvez, MD, Office
of the Director, National Cancer
Institute, 9609 Medical Center Drive,
1W468, Rockville, MD 20852 or call
non-toll-free number 240–276–5206 or
Email your request, including your
address to: jose.galvez@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
PO 00000
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best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: The Clinical
Trials Reporting Program (CTRP)
Database, 0925–0600, Expiration Date
05/31/2016—EXTENSION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) Database is an
electronic resource that serves as a
single, definitive source of information
about all NCI-supported clinical
research. This resource allows the NCI
to consolidate reporting, aggregate
information and reduce redundant
submissions. Information is submitted
by clinical research administrators as
designees of clinical investigators who
conduct NCI-supported clinical
research. The designees can
electronically access the CTRP Web site
to complete the initial trial registration.
Subsequent to registration, four
amendments and four study subject
accrual updates occur per trial annually.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The estimated
annualized burden hours are 18,000.
E:\FR\FM\11MRN1.SGM
11MRN1
12915
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Type of respondents
Forms
Clinical Research Administrators ..........................
Initial Registration .........
Amendment ..................
Accrual Updates ...........
3,000
3,000
3,000
1
4
4
1
1
15/60
3,000
12,000
3,000
Totals .............................................................
.......................................
9,000
27,000
........................
18,000
Dated: March 2, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
Dated: March 4, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05425 Filed 3–10–16; 8:45 am]
[FR Doc. 2016–05430 Filed 3–10–16; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
NIH Pathways to Prevention
Workshop: Advancing Research To
Prevent Youth Suicide
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 meeting.
The 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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Nonhuman Primate Reagent
Resource (U24).
Date: April 8, 2016.
Time: 10:30 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Nancy VazquezMaldonado, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, Room 3F52B, National
Institutes of Health/NIAID, 5601 Fishers
Lane, MSC 9834, Bethesda, MD 20892–9834,
(240) 669–5044, nvazquez@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
The National Institutes of
Health (NIH) will host a workshop on
Advancing Research To Prevent Youth
Suicide on March 29–30, 2016. The
workshop is free and open to the public.
DATES: March 29, 2016, from 8:30 a.m.–
4:50 p.m. and March 30, 2016, from 8:30
a.m.–1:00 p.m.
ADDRESSES: The workshop will be held
at the NIH, Masur Auditorium, Building
10 (Clinical Center), 9000 Rockville
Pike, Bethesda, Maryland 20892.
Registration and workshop information
are available on the NIH Office of
Disease Prevention (ODP) Web site at
<https://prevention.nih.gov/p2psp>.
FOR FURTHER INFORMATION CONTACT: For
further information concerning this
workshop, contact the ODP at
<NIHP2P@mail.nih.gov>, 6100
Executive Blvd., Room 2B03, MSC 7523,
Bethesda, MD 20892–7523; Telephone:
301–496–1508; FAX: 301–480–7660.
SUPPLEMENTARY INFORMATION: Suicide
was the second leading cause of death
for youth (10- to 24-year-olds) in 2014,
resulting in 5,504 deaths in the United
States. This mortality has not decreased
compared to other external causes of
death, and youth suicide attempts have
remained at consistent rates for decades.
According to the 2011 Youth Risk
Behavior Surveillance System, 2.4% of
high school students received medical
treatment for attempted suicide, and
7.8% attempted suicide one or more
times within the year. Some groups
(e.g., American Indian youth; young
adults with substance use problems;
SUMMARY:
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children of depressed parents; youth
and young adults who identify as a
sexual and gender minority) are at
increased risk for suicidal behaviors.
One of the challenges in suicide
prevention research is that the primary
outcome of interest is multidetermined
and, depending on the target
population, suicide can be a low base
rate occurrence. Many studies
examining risk in important subgroups
(e.g., racial, ethnic, sexual and gender
minorities) often lack sufficient power
to accurately determine the
effectiveness of the intervention.
Because suicidal behavior is often
multidetermined, it may be that
interventions addressing suicide risk
factors have benefits for suicide
reduction, but these benefits are not
obvious in research findings, nor can
the larger community know of these
benefits. Pooling studies and being able
to link data from individual studies to
multiple data surveillance systems
would be important to better understand
the effectiveness of prevention strategies
on outcomes such as suicide, suicide
attempts, and suicide ideation.
Preventing attempts and self-harm
ideation would likely result in a
reduction in deaths, as well as
reductions in health care and social
burden associated with suicidal
behavior.
Closing the research gaps related to
youth suicide could lead to improved
prevention strategies. The NIH is
engaging in a rigorous assessment of the
available scientific evidence to better
understand the importance of
identifying efforts that could be effective
in preventing suicidal thoughts and
behaviors as early as possible. The
National Institute of Mental Health, the
National Institute on Drug Abuse, the
National Center for Complementary and
Integrative Health, and the NIH Office of
Disease Prevention (ODP) are
sponsoring the Pathways to Prevention
Workshop: Advancing Research To
Prevent Youth Suicide on March 29–30,
2016, in Bethesda, Maryland. The
workshop will evaluate the current state
of knowledge on youth suicide and
identify opportunities for future
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12914-12915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; The Clinical Trials
Reporting Program (CTRP) Database (NCI)
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Cancer Institute, 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.
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) The quality, utility, and clarity of the information to be
collected; and (4) Minimize 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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Jose
Galvez, MD, Office of the Director, National Cancer Institute, 9609
Medical Center Drive, 1W468, Rockville, MD 20852 or call non-toll-free
number 240-276-5206 or Email your request, including your address to:
jose.galvez@nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: The Clinical Trials Reporting Program (CTRP)
Database, 0925-0600, Expiration Date 05/31/2016--EXTENSION, National
Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials
Reporting Program (CTRP) Database is an electronic resource that serves
as a single, definitive source of information about all NCI-supported
clinical research. This resource allows the NCI to consolidate
reporting, aggregate information and reduce redundant submissions.
Information is submitted by clinical research administrators as
designees of clinical investigators who conduct NCI-supported clinical
research. The designees can electronically access the CTRP Web site to
complete the initial trial registration. Subsequent to registration,
four amendments and four study subject accrual updates occur per trial
annually.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The estimated annualized burden
hours are 18,000.
[[Page 12915]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Research Initial 3,000 1 1 3,000
Administrators. Registration.
Amendment....... 3,000 4 1 12,000
Accrual Updates. 3,000 4 15/60 3,000
---------------------------------------------------------------
Totals.................... ................ 9,000 27,000 .............. 18,000
----------------------------------------------------------------------------------------------------------------
Dated: March 2, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-05425 Filed 3-10-16; 8:45 am]
BILLING CODE 4140-01-P
