Proposed Collection; 60-Day Comment Request; Rapid Throughput Standardized Evaluation of Transmissible Risk for Substance Use Disorder in Youth, 72682-72683 [2013-28985]
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Federal Register / Vol. 78, No. 232 / Tuesday, December 3, 2013 / Notices
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[FR Doc. 2013–28889 Filed 12–2–13; 8:45 am]
BILLING CODE 4165–15–P
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Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Rapid Throughput
Standardized Evaluation of
Transmissible Risk for Substance Use
Disorder in Youth
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 Institute on Drug Abuse
(NIDA), 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 on 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; (2)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to 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 instructions,
contact Dr. Augie Diana, Health
Scientist Administrator, Prevention
Research Branch, Division of
Epidemiology, Services, and Prevention
Research, NIDA, NIH, 6001 Executive
Boulevard, Room 5163, Bethesda, MD
20892, or call non-toll-free number (301)
443–1942 or Email your request,
including your address to: dianaa@
nida.nih.gov. Formal request for
additional plans and instruments must
be requested in writing.
DATES: Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the data of
this publication.
Proposed Collection: Rapid
Throughput Standardized Evaluation of
Transmissible Risk for Substance Use
Disorder in Youth, 0925-New, National
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Institute on Drug Abuse (NIDA),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This study will finalize the
development of the Transmissible
Liability Index (TLI), thereby advancing
the TLI from a research tool to a
practical instrument. The TLI is a
psychometric tool for detecting youth at
elevated risk for substance use disorder
(SUD). The TLI, a web-based platform
for assessing risk of SUD, is a highly
efficient tool both in terms of the
limited time commitment required as
well as its low cost. The inexpensive
and high efficiency of the TLI for
identifying youths in need of
prevention, and the strong cost-benefits
to society for SUD prevention, portend
strong demand for use in a variety of
populations including family and social
services, schools, mental health
facilities, and youth protection agencies.
To transform the TLI prototype into a
practical instrument, three core tasks
remain: (1) Standardization on a sample
(N = 5,000) that is representative of the
general population to generate norms
that are specific to age, gender and
ethnicity; (2) Construct validity analysis
using standard parametric modeling
techniques to show that heritability
accounts for the major portion of
variance on TLI scores; the sample (150
identical and 150 fraternal twins) will
be representative of the same general
population characteristics identified
above; and (3) Psychometric analysis of
validity and reliability based on the
above data. Validating the TLI furthers
NIDA’s mission by legitimating the tool
for exploring the attitudes and social
predictors of addictive behaviors with
the intention of reducing or eliminating
drug-taking behavior. This research is
squarely within NIDA’s mission of
research on drug abuse and addiction,
as well as its focus on ensuring the
rapid and effective dissemination and
use of the results to significantly
improve efforts to stem substance use
disorder. To move the TLI from the
research domain to practical use
through commercial dissemination, the
research and development team (‘‘the
R&D team’’) needs to satisfy professional
quality standards consistent with
American Psychological Association
regulations. To satisfy those standards,
the R&D team must demonstrate the
reliability and internal validity of the
TLI against existing standardized
psychometric studies for youth
populations, ages 14 to 18. The 14-to-18
year old age range was selected because
it encompasses the years typically spent
in high school, which are known to be
the timeframe when substance use is
E:\FR\FM\03DEN1.SGM
03DEN1
72683
Federal Register / Vol. 78, No. 232 / Tuesday, December 3, 2013 / Notices
likely to begin and accelerates, often
leading to substance abuse disorder.
Notably, the peak period for the
manifestation of cannabis-use disorder
is age 18–19, and the past-yearprevalence for alcohol-use disorder is
age 20–22. The TLI is designed to
identify the propensity for these and
other substance abuse prior to
manifestation; as such, collecting data
from the high school age group (14–18
years old) is critical to identifying atrisk youths for the purposes of early
intervention. Thus, the TLI must be
tested with data collected from youth
populations, ages 14 to 18, comparable
to those in existing studies. Moreover,
the R&D team must provide
psychometric external validation for the
TLI through data collection from sets of
identical and fraternal twins.
Psychometric analyses are required to
show that the TLI performs according to
expectations. Accordingly, studies will
be performed on the collected
information to demonstrate i) construct,
ii) discriminative, iii) concurrent, and
iv) predictive validity.
OMB approval is requested for 2
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
3,083.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent: individuals and households
Number of
respondents
Parent of 14–17 year-old students: Consent Form .........................................
14–18 year-old students: School Survey (TLI) ................................................
14–18 year-old youths or their parents: Consent Form ..................................
14–18 year-old youths: Twins Survey (Demo/D&A) ........................................
14–18 year-old youths: Twins Survey (Dysregulation) ....................................
14–18 year-old youths: Twins Survey (TLI) ....................................................
5,000
........................
600
........................
........................
........................
Dated: November 20, 2013.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA, NIH.
[FR Doc. 2013–28985 Filed 12–2–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
emcdonald on DSK67QTVN1PROD 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 materials,
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
Neurological Disorders and Stroke, Special
Emphasis Panel, Stroke Trials NetworkNDMC.
Date: December 18, 2013.
Time: 9:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
VerDate Mar<15>2010
18:56 Dec 02, 2013
Jkt 232001
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS, NIH, NSC, 6001 Executive
Blvd., Suite 3208, MSC 9529, Bethesda, MD
20892–9529, 301–402–0288,
Natalia.Strunnikova@nih.gov.
(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: November 26, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–28854 Filed 12–2–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
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,
PO 00000
Frm 00058
Fmt 4703
Sfmt 9990
Average
burden per
response
(in hours)
Responses
per
respondent
1
1
1
1
1
1
Annual hour
burden
1/60
30/60
1/60
10/60
10/60
29/60
83
2,500
10
100
100
290
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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, PAR13–228:
Biomarkers for Diabetes, Digestive, Kidney
and Urologic Diseases using Repository
Biosamples.
Date: February 20, 2014.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Najma Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 749, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 26, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–28851 Filed 12–2–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 78, Number 232 (Tuesday, December 3, 2013)]
[Notices]
[Pages 72682-72683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Rapid Throughput
Standardized Evaluation of Transmissible Risk for Substance Use
Disorder in Youth
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 Institute on Drug
Abuse (NIDA), 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 on 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; (2) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to 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 instructions, contact Dr. Augie Diana,
Health Scientist Administrator, Prevention Research Branch, Division of
Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001
Executive Boulevard, Room 5163, Bethesda, MD 20892, or call non-toll-
free number (301) 443-1942 or Email your request, including your
address to: dianaa@nida.nih.gov. Formal request for additional plans
and instruments must be requested in writing.
DATES: Comments Due Date: Comments regarding this information
collection are best assured of having their full effect if received
within 60 days of the data of this publication.
Proposed Collection: Rapid Throughput Standardized Evaluation of
Transmissible Risk for Substance Use Disorder in Youth, 0925-New,
National Institute on Drug Abuse (NIDA), National Institutes of Health
(NIH).
Need and Use of Information Collection: This study will finalize
the development of the Transmissible Liability Index (TLI), thereby
advancing the TLI from a research tool to a practical instrument. The
TLI is a psychometric tool for detecting youth at elevated risk for
substance use disorder (SUD). The TLI, a web-based platform for
assessing risk of SUD, is a highly efficient tool both in terms of the
limited time commitment required as well as its low cost. The
inexpensive and high efficiency of the TLI for identifying youths in
need of prevention, and the strong cost-benefits to society for SUD
prevention, portend strong demand for use in a variety of populations
including family and social services, schools, mental health
facilities, and youth protection agencies. To transform the TLI
prototype into a practical instrument, three core tasks remain: (1)
Standardization on a sample (N = 5,000) that is representative of the
general population to generate norms that are specific to age, gender
and ethnicity; (2) Construct validity analysis using standard
parametric modeling techniques to show that heritability accounts for
the major portion of variance on TLI scores; the sample (150 identical
and 150 fraternal twins) will be representative of the same general
population characteristics identified above; and (3) Psychometric
analysis of validity and reliability based on the above data.
Validating the TLI furthers NIDA's mission by legitimating the tool for
exploring the attitudes and social predictors of addictive behaviors
with the intention of reducing or eliminating drug-taking behavior.
This research is squarely within NIDA's mission of research on drug
abuse and addiction, as well as its focus on ensuring the rapid and
effective dissemination and use of the results to significantly improve
efforts to stem substance use disorder. To move the TLI from the
research domain to practical use through commercial dissemination, the
research and development team (``the R&D team'') needs to satisfy
professional quality standards consistent with American Psychological
Association regulations. To satisfy those standards, the R&D team must
demonstrate the reliability and internal validity of the TLI against
existing standardized psychometric studies for youth populations, ages
14 to 18. The 14-to-18 year old age range was selected because it
encompasses the years typically spent in high school, which are known
to be the timeframe when substance use is
[[Page 72683]]
likely to begin and accelerates, often leading to substance abuse
disorder. Notably, the peak period for the manifestation of cannabis-
use disorder is age 18-19, and the past-year-prevalence for alcohol-use
disorder is age 20-22. The TLI is designed to identify the propensity
for these and other substance abuse prior to manifestation; as such,
collecting data from the high school age group (14-18 years old) is
critical to identifying at-risk youths for the purposes of early
intervention. Thus, the TLI must be tested with data collected from
youth populations, ages 14 to 18, comparable to those in existing
studies. Moreover, the R&D team must provide psychometric external
validation for the TLI through data collection from sets of identical
and fraternal twins. Psychometric analyses are required to show that
the TLI performs according to expectations. Accordingly, studies will
be performed on the collected information to demonstrate i) construct,
ii) discriminative, iii) concurrent, and iv) predictive validity.
OMB approval is requested for 2 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 3,083.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average burden
Type of respondent: individuals and households Number of Responses per per response Annual hour
respondents respondent (in hours) burden
----------------------------------------------------------------------------------------------------------------
Parent of 14-17 year-old students: Consent Form. 5,000 1 1/60 83
14-18 year-old students: School Survey (TLI).... .............. 1 30/60 2,500
14-18 year-old youths or their parents: Consent 600 1 1/60 10
Form...........................................
14-18 year-old youths: Twins Survey (Demo/D&A).. .............. 1 10/60 100
14-18 year-old youths: Twins Survey .............. 1 10/60 100
(Dysregulation)................................
14-18 year-old youths: Twins Survey (TLI)....... .............. 1 29/60 290
----------------------------------------------------------------------------------------------------------------
Dated: November 20, 2013.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA, NIH.
[FR Doc. 2013-28985 Filed 12-2-13; 8:45 am]
BILLING CODE 4140-01-P
