[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Pages 16802-16803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06728]



[[Page 16802]]

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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. One public comment was 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)
----------------------------------------------------------------------------------------------------------------
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

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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: March 19, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), NIDA, NIH.
[FR Doc. 2014-06728 Filed 3-25-14; 8:45 am]
BILLING CODE 4140-01-P