Submission for OMB Review; 30-Day Comment Request Rapid Throughput Standardized Evaluation of Transmissible Risk for Substance Use Disorder in Youth, 13317-13318 [2014-05142]

Download as PDF 13317 Federal Register / Vol. 79, No. 46 / Monday, March 10, 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. 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, 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. emcdonald on DSK67QTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent: individuals and households 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) .................................. VerDate Mar<15>2010 18:00 Mar 07, 2014 Jkt 232001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Responses per respondent 5,000 600 E:\FR\FM\10MRN1.SGM 1 1 1 1 1 10MRN1 Average burden per response (in hours) 1/60 30/60 1/60 10/60 10/60 Annual hour burden 83 2,500 10 100 100 13318 Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Type of respondent: individuals and households Responses per respondent 14–18 year-old youths: Twins Survey (TLI) .................................................. 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2013–1064] Information Collection Request to Office of Management and Budget Coast Guard, DHS. Sixty-day notice requesting comments. AGENCY: ACTION: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICRs) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of the following collection of information: 1625—NEW, District Five, Coast Guard Auxiliary Safety Survey. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below. DATES: Comments must reach the Coast Guard on or before May 9, 2014. ADDRESSES: You may submit comments identified by Coast Guard docket number [USCG–2013–1064] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT). To avoid duplicate submissions, please use only one of the following means: (1) Online: https:// www.regulations.gov. (2) Mail: DMF (M–30), DOT, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590–0001. (3) Hand delivery: Same as mail address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366–9329. (4) Fax: 202–493–2251. To ensure your comments are received in a timely emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:00 Mar 07, 2014 Jkt 232001 1 manner, mark the fax, to attention Desk Officer for the Coast Guard. The DMF maintains the public docket for this Notice. Comments and material received from the public, as well as documents mentioned in this Notice as being available in the docket, will become part of the docket and will be available for inspection or copying at room W12–140 on the West Building Ground Floor, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find the docket on the Internet at https:// www.regulations.gov. Copies of the ICRs are available through the docket on the Internet at https://www.regulations.gov. Additionally, copies are available from: Commandant (CG–612), Attn Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr Ave. SE., STOP 7710, Washington, DC 20593–7710. FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of Information Management, telephone 202–475–3532, or fax 202–372–8405, for questions on these documents. Contact Ms. Cheryl Collins, Program Manager, Docket Operations, 202–366–9826, for questions on the docket. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection’s purpose, the Collection’s likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection. The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Average burden per response (in hours) 29/60 Annual hour burden 290 accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise these ICRs or decide not to seek approval of revisions of the Collections. We will consider all comments and material received during the comment period. We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG–2013–1064], and must be received by May 9, 2014. We will post all comments received, without change, to https://www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the ‘‘Privacy Act’’ paragraph below. Submitting Comments If you submit a comment, please include the docket number [USCG– 2013–1064], indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online (via https://www.regulations.gov), by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the DMF. We recommend you include your name, mailing address, an email address, or other contact information in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the DMF at the address under ADDRESSES; but please submit them by only one means. To submit E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13317-13318]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05142]



[[Page 13317]]

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

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, 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
14-18 year-old youths: Twins Survey              ..............                1           10/60             100
 (Dysregulation)...............................

[[Page 13318]]

 
14-18 year-old youths: Twins Survey (TLI)......  ..............                1           29/60             290
----------------------------------------------------------------------------------------------------------------


    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
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