Submission for OMB Review; 30-Day Comment Request Rapid Throughput Standardized Evaluation of Transmissible Risk for Substance Use Disorder in Youth, 16802-16803 [2014-06728]

Download as PDF 16802 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Notices 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 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, OIRA_submission@omb.eop.gov 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, SUMMARY: 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. 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-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. sroberts on DSK5SPTVN1PROD with NOTICES 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) ........................................ 5,000 ........................ 600 ........................ VerDate Mar<15>2010 17:43 Mar 25, 2014 Jkt 232001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Average burden per response (in hours) Responses per respondent E:\FR\FM\26MRN1.SGM 1 1 1 1 26MRN1 1/60 30/60 1/60 10/60 Annual hour burden 83 2,500 10 100 16803 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondent: Individuals and households Number of respondents 14–18 year-old youths: Twins Survey (Dysregulation) .................................... 14–18 year-old youths: Twins Survey (TLI) .................................................... Average burden per response (in hours) Responses per respondent ........................ ........................ 1 1 Annual hour burden 10/60 29/60 100 290 Dated: March 19, 2014. Glenda J. Conroy, Executive Officer (OM Director), NIDA, NIH. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2014–06728 Filed 3–25–14; 8:45 am] National Institutes of Health National Institutes of Health BILLING CODE 4140–01–P National Institute of Mental Health; Notice of Closed Meeting National Library of Medicine; Notice of Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting sroberts on DSK5SPTVN1PROD 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel NIAAA Contract Review— Solicitation PHS2014–1, Topic 088. Date: April 22, 2014. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, (Teleconference), Rockville, MD 20852. Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, EPRB, NIAAA, National Institutes of Health 5365 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451–2067, srinivar@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.273, Alcohol Research Programs; National Institutes of Health, HHS) Dated: March 21, 2014. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. 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 Mental Health Special Emphasis Panel; K22 Special Review. Date: April 7, 2014. Time: 12:00 p.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health Neuroscience Center 6001 Executive Boulevard Rockville, MD 20852 (Telephone Conference Call). Contact Person: David M. Armstrong, Ph.D., Scientific Review Officer Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center/ Room 6138/MSC 9608, 6001 Executive Boulevard, Bethesda, MD 20892–9608, 301– 443–3534, armstrda@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: March 20, 2014. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–06645 Filed 3–25–14; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2014–06644 Filed 3–25–14; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 17:43 Mar 25, 2014 Jkt 232001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of meetings of the Board of Regents of the National Library of Medicine. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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 USC, 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: Board of Regents of the National Library of Medicine Extramural Programs Subcommittee. Date: May 12, 2014. Closed: 2:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, Building 38, 2nd Floor, Conference Room B, 8600 Rockville Pike, Bethesda, MD 20892. Contact Person: Donald A.B. Lindberg, MD, Director, National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20892, 301– 496–6221, lindberg@mail.nih.gov. Name of Committee: Board of Regents of the National Library of Medicine Subcommittee on Outreach and Public Information. Date: May 13, 2014. Open: 7:45 a.m. to 8:45 a.m. Agenda: To review and discuss outreach activities. Place: National Library of Medicine, Building 38, 2nd Floor, Conference Room B, 8600 Rockville Pike, Bethesda, MD 20892. E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

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



[[Page 16802]]

-----------------------------------------------------------------------

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, OIRA_submission@omb.eop.gov 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: dianaa@nida.nih.gov. 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
----------------------------------------------------------------------------------------------------------------
                                                                                      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

[[Page 16803]]

 
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: 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
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