[Federal Register Volume 78, Number 232 (Tuesday, December 3, 2013)]
[Notices]
[Pages 72682-72683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28985]


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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: [email protected]. 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
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                                                                                  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
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    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