[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13317-13318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05142]
[[Page 13317]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Rapid
Throughput Standardized Evaluation of Transmissible Risk for Substance
Use Disorder in Youth
SUMMARY: 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 for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on December 3, 2013, page 72682-72683 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. The
National Institute 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 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, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
DATES: 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 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: [email protected]. Formal request for additional plans
and instruments must be requested in writing.
Proposed Collection: Rapid Throughput Standardized Evaluation of
Transmissible Risk for Substance Use Disorder in Youth, Reference No
N44DA-12-5562, 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 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
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Average
Number of Responses per burden per Annual hour
Type of respondent: individuals and households respondents respondent response (in burden
hours)
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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)...............................
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14-18 year-old youths: Twins Survey (TLI)...... .............. 1 29/60 290
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Dated: March 4, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA, NIH.
[FR Doc. 2014-05142 Filed 3-7-14; 8:45 am]
BILLING CODE 4140-01-P