[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40077-40079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1112.

Project: 2020 National Survey on Drug Use and Health, Clinical 
Validation Study and Redesign Field Test (OMB No. 0930-0110)--Revision 
to 2019 NSDUH Collection

    The National Survey on Drug Use and Health (NSDUH) is a survey of 
the U.S. civilian, non-institutionalized population aged 12 years old 
or older. The data are used to determine the prevalence of use of 
tobacco products, alcohol, illicit substances, and illicit use of 
prescription drugs. The results are used by SAMHSA, the Office of 
National Drug Control Policy (ONDCP), federal government agencies, and 
other organizations and researchers to establish policy, direct program 
activities, and better allocate resources.

2020 NSDUH Main Study

    NSDUH must be updated periodically to reflect changing substance 
use and mental health issues and to continue producing current data. 
For the 2020 NSDUH main study the following changes from 2019 are 
planned: (1) The addition of lifetime and recency questions about 
vaping anything and vaping nicotine or tobacco; the addition of 
lifetime and recency questions on synthetic marijuana and synthetic 
stimulants; (2) the addition of questions in concordance with the 
Diagnostic and Statistical Manual of Mental Disorders (DSM), fifth 
edition criteria (DSM-5) to measure the occurrence of marijuana 
withdrawal symptoms, occurrence of prescription tranquilizer misuse 
withdrawal symptoms and occurrence of craving for all substances; (3) 
minor revisions to the marijuana marketplace module; and (4) other 
minor wording changes to improve the flow of the interview, increase 
respondent comprehension or to be consistent with text in other 
questions.
    By including these new questions in NSDUH, estimates may be 
generated on the use of these substances among the general population 
and allow SAMHSA to provide national-level estimates among adults and 
adolescents on the

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use of vaping, synthetic marijuana, and synthetic stimulants. In 
addition, because NSDUH collects demographic, socioeconomic, and health 
information about each respondent, the inclusion of these questions 
would permit a more detailed understanding of factors associated with 
their use.
    The new questions on craving for all substances and withdrawal for 
marijuana/cannabis were added to the 2020 NSDUH main study to reflect 
the updated DSM-5 diagnostic criteria for substance use disorders. 
Questions measuring withdrawal for tranquilizers have been added to 
ensure SUD for tranquilizers is accurately assessed as well.
    The marijuana marketplace module (originally dropped in the 2015 
redesign questionnaire) was reinserted in the NSDUH main study 
questionnaire starting in 2018 at the request of ONDCP but was 
unchanged from the version previously used in the 2014 NSDUH. (This 
module was not part of the NSDUH questionnaire from 2015-2017.) This 
module consists of a series of questions that seek to gather data such 
as the location, quantity, cost and type of marijuana being purchased 
across the nation. Revisions have been made to this module for 2020 to 
reflect the availability that marijuana can now be purchased from a 
retail store or dispensary.
    As with all NSDUH/NHSDA surveys conducted since 1999, the sample 
size of the NSDUH main study for 2020 will be sufficient to permit 
prevalence estimates for each of the fifty states and the District of 
Columbia. (Prior to 2002, the NSDUH was referred to as the National 
Household Survey on Drug Abuse (NHSDA). The total annual burden 
estimate for the NSDUH main study is shown below in Table 1.

                               Table 1--Annualized Estimated Burden for 2020 NSDUH
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                                     Number of     Responses per   Total number      Hours per     Total burden
           Instrument               respondents     respondent     of responses      response          hours
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Household Screening.............         143,255               1         143,255           0.083          11,890
Interview.......................          69,007               1          69,007           1.000          69,007
Screening Verification..........           4,348               1           4,348           0.067             291
Interview Verification..........          10,351               1          10,351           0.067             694
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    Total.......................         143,255  ..............         226,961  ..............          81,882
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Clinical Validation Study

    In addition, a Clinical Validation Study (CVS) is planned to be 
embedded within the first six months of 2020 NSDUH main study data 
collection to assess revisions to the substance use disorders (SUD) 
module to be consistent with the DSM-5. The CVS will examine the 
validity of this revised NSDUH assessment of SUD by administering 
questions to adults and adolescents who will then be interviewed by 
clinical interviewers (who are blinded to the NSDUH main study 
responses) and classified as having or not having substance use 
disorders based on past year DSM-5 disorders, as assessed by the 
Structured Clinical Interview for DSM-5 (SCID-5)
    During CVS data collection from January through June 2020, 
approximately 1,500 NSDUH main study interview respondents will be 
selected for a follow-up clinical interview at the end of the main 
study interview in order to produce a final sample size of 
approximately 826 CVS respondents. These follow-up clinical interviews 
will be conducted via telephone using the SCID-5 within two to four 
weeks following the NSDUH main study interview.
    Many of the procedures and protocols planned for inclusion in this 
CVS are based upon those previously employed as part of the 2018 
National Mental Health Study (approved under OMB No. 0930-0380) and the 
2008-2012 NSDUH Mental Health Surveillance Study (approved as an add-on 
to NSDUH under OMB No. 0930-0110).
    Also, to complete training prior to CVS data collection, each 
clinical interviewer candidate hired must successfully administer the 
follow-up clinical interview with a volunteer respondent. These 70 
certification interviews will be administered in the same manner as CVS 
follow-up clinical interviews.
    The total annual burden estimate for the CVS is shown below in 
Table 2.

                             Table 2--Annualized Estimated Burden for 2020 NSDUH CVS
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                                     Number of     Responses per   Total number      Hours per     Total burden
           Instrument               respondents     respondent     of responses      response          hours
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Follow-Up Clinical Interviews...             800               1             800            0.83             664
Follow-Up Clinical                            70               1              70            0.83              58
 Certifications.................
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    Total.......................             870  ..............             870  ..............             722
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Redesign Field Test

    Also, as part of SAMHSA's ongoing effort to ensure NSDUH continues 
producing current and accurate data, a Redesign Field Test (FT) is 
planned from August through November 2020 to assess potential revisions 
to the NSDUH main study questionnaire. These revisions are designed to 
address changing policy and research data needs; in addition, 
modifications to associated survey materials and methods are designed 
to improve the quality of estimates and the efficiency of data 
collection. Planned FT modifications include changes to respondent 
incentives, respondent materials, the household screening 
questionnaire, the interview questionnaire, and other data collection 
methods.
    The FT is essential for providing a thorough examination of these 
planned changes prior to their deployment on the NSDUH main study to 
determine potential impact across operational and

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substantive domains, including effects on data quality (as measured by 
outcomes such as unit nonresponse, item nonresponse, and survey 
responses), questionnaire timing, data collection efficiency, and 
possible differences in reporting of substance use or mental health 
items.
    During FT data collection from August through November 2020, 
conducted separately from ongoing 2020 NSDUH main study data collection 
at that time, screenings will be completed with approximately 8,110 
English-speaking respondents in the contiguous United States. (Alaska 
and Hawaii are excluded from the FT to control study costs.) From those 
screenings, approximately 4,000 respondents, as representatives of the 
civilian, noninstitutional population aged 12 years old or older, are 
expected to complete a FT interview using the revised questionnaire and 
materials.
    For the NSDUH FT screening, revisions may include: (1) A revised 
roster structure; (2) various wording edits to improve respondent 
comprehension and flow; (3) the use of revised materials, such as the 
lead letter, study description and question & answer brochure; (4) a 
conditional test of a $5 screening incentive to assess impact on 
response rates; and (5) the inclusion of two outcome questions on past 
month alcohol and past month cigarette use at the end of the screening 
to assess nonresponse bias from the screening incentive.
    For the NSDUH FT interview, revisions may include: (1) A 
conditional test of a $50 interview incentive to assess impact on 
response rates; (2) revisions to the DSM-5-based SUD module as a result 
of prior testing in the CVS; (3) the inclusion of new modules on 
substance use treatment and mental health service utilization; (4) the 
addition of new and/or revised questions on a variety of items such as 
Electronic Nicotine Delivery Systems (ENDS), synthetic drugs, pain and 
sleep, vaping and needle use, and criminal justice; (5) the addition of 
measures of adolescent psychological distress and/or impairment; (6) 
the expansion of suicide items; and (7) other general questionnaire 
revisions such as clarifying wording and terminology, reordering for 
improved question flow, formatting changes, removal of questions with 
low prevalence rates, and other minor updates and revisions.
    The total annual burden estimate for the FT is shown below in Table 
3.

                          Table 3--Annualized Estimated Burden for Redesign Field Test
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                                     Number of     Responses per   Total number      Hours per     Total burden
           Instrument               respondents     respondent     of responses      response          hours
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Household Screening.............           8,110               1           8,110           0.083             673
Interview.......................           4,000               1           4,000           1.000           4,000
Screening Verification..........             246               1             246           0.067              17
Interview Verification..........             600               1             600           0.067              40
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    Total.......................           8,110  ..............          12,596  ..............           4,730
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    Written comments and recommendations concerning the proposed 
information collection should be sent by September 12, 2019 to the 
SAMHSA Desk Officer at the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB). To ensure timely 
receipt of comments, and to avoid potential delays in OMB's receipt and 
processing of mail sent through the U.S. Postal Service, commenters are 
encouraged to submit their comments to OMB via email to: 
[email protected]. Although commenters are encouraged to send 
their comments via email, commenters may also fax their comments to: 
202-395-7285. Commenters may also mail them to: Office of Management 
and Budget, Office of Information and Regulatory Affairs, New Executive 
Office Building, Room 10102, Washington, DC 20503.

Summer King,
Statistician.
[FR Doc. 2019-17282 Filed 8-12-19; 8:45 am]
 BILLING CODE 4162-20-P