[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Pages 18655-18656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer at (240) 276-0361.
    Comments are invited on: (a) whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Drug and Alcohol Warning Network (DAWN) (OMB No. 
0930-0078)--Reinstatement With Change

    Under the Public Health Service Act (42 U.S.C. 290aa-4), SAMHSA is 
authorized to collect data on the number of individuals admitted to the 
emergency rooms of hospitals as a result of the abuse of alcohol or 
other drugs. DAWN is a nationwide public health surveillance system to 
improve hospital emergency department (ED) monitoring of substance use-
related visits. It captures data on ED visits related to recent 
substance use and misuse directly from the electronic health records 
(EHR) of participating hospitals. The new DAWN helps SAMHSA and public 
health professionals, clinicians, and policymakers respond effectively 
to the opioid and substance misuse crisis in the United States.
    SAMHSA is requesting OMB approval of reinstatement with change of 
the DAWN data collections, to include following changes:
     Revise the data collection title to ``Drug and Alcohol 
Warning Network'', replacing existing `abuse' term and including 
``alcohol'' in the title.
     Remove drug-related death investigation records review 
component administered by state medical examiners (MEs) and individual 
medical examiners/coroners (ME/Cs).
     Revise data collection procedures where participating 
hospitals can choose the direct chart review option (at the 
contractor's operation center, home-based abstraction or on site at the 
hospital). Hospitals will also have the opportunity to select the 
machine learning with natural language processing (ML with NLP) option. 
The option for hospitals to use their own staff to abstract DAWN data 
as they did in the legacy DAWN is no longer offered.
     Revise the hospital selection design of the ED component 
to a hybrid system that combines sentinel hospitals and probability-
based selection of hospitals from high priority suburban/rural areas 
and from the remaining areas in the United States.
     Change the reporting and publication schedule to further 
increase the timeliness of the new DAWN data availability and delivery 
to SAMHSA. The new DAWN data are collected on an ongoing basis and 
could be available to SAMHSA on demand. The new DAWN data are delivered 
to SAMHSA and available for analysis at a more frequent intervals than 
the legacy DAWN.
     Propose following changes to the ED Case Report Form:
    [cir] Add ``Center for Behavioral Health Statistics and Quality'' 
to specify the center responsible for DAWN data collection.
    [cir] Revise the data collection title to ``Drug and Alcohol 
Warning Network'' from ``Drug Abuse Warning Network.''
    [cir] Replace prior ``Facility'' data field title with ``Hospital 
Emergency Department ID'' to provide more precise description and ID 
number of the DAWN participating hospitals.
    [cir] Q3 ``Age'': replace prior option of ``less than 1 year'' with 
two detailed options of ``4 weeks (28 days) or younger'' and ``Between 
4 weeks and one year old (>4 weeks, <1 year)'' to enable new 
identification of neonatal substance issues.
    [cir] Q4 ``County of Residence'': revise data field title from 
prior ``patient's home zip code'' and add more accurate description on 
what data to be collected and clarify the purpose of data collection. 
Add new ``Unable to determine county'' option to improve data accuracy 
and account for geographical variation.
    [cir] Q6 ``Gender Identity'' and Q7 ``Sexual Orientation'': added 
to provide inclusive measures and to align with SAMHSA's efforts in 
enhancing behavioral health equities among diverse populations.
    [cir] Q8 ``Ethnicity'' and Q9 ``Race'': revise prior data field 
``Race/Ethnicity'' to align with OMB 1997 Standards for Maintaining, 
Collecting, And Presenting Federal Data on Race and Ethnicity 
(Statistical Policy Directive No. 15) and to improve data accuracy and 
comprehensiveness.
    [cir] Q10 ``Case Description'': replace the word ``drug(s)'' with 
``substance(s)'' to clarify that the DAWN collects data on all 
substances including alcohol. Add new instruction language of ``Do not 
include information that could identify the patient or hospital'' to 
provide clear instruction and specify the importance of patient and 
hospital privacy protection.
    [cir] Q11 ``Substance(s) Involved and Route of Administration'': 
add two new options of ``transdermal'' and ``vaped'' to improve the 
comprehensiveness of the list on how substance is administered by the 
patient. Remove ``Mark if confirmed by toxicology test'' and ``alcohol 
involved?''
    [cir] Q12 ``Diagnosis'': change the question order and move the 
data field after Q11. Revise prior instruction of ``list up to 4 
diagnoses'' to ``list all diagnoses'' to enhances new DAWN's ability to 
identify novel drug, drug trends, and drug outbreaks.
    [cir] Q13 ``Type of Case'': remove instruction language of ``using 
the decision tree.'' Revise the existing option of ``seeking detox'' to 
``seeking detox and/or substance abuse treatment only'' and remove age 
restriction for ``Alcohol only'' option to include cases involving 
alcohol as the only substance of all ages.
    [cir] Q14, Q15, and Q16 ``Was naloxone/buprenorphine/Methadone 
administered to the patient in the ED'': added to capture new data on 
the implementation of medication-assisted treatment for opioid use 
disorder in the emergency department setting and understand why 
buprenorphine and methadone is administered.

[[Page 18656]]

    [cir] Q17 ``Disposition'': add new options and re-categorize 
disposition to improve data accuracy and comprehensiveness and better 
understand where the patient went after their ED visit.
     Proposes a new Activity Report From to be submitted by the 
abstractors to collect information on the date of ED visits the 
abstractor has reviewed, counts of ED visits for that date, number of 
records reviewed, and number of left without being seen (LWBS) visits 
for the ED visit date if participating hospitals choose the direct 
chart review option.
    The estimated annual burden for the DAWN data collection is as 
follows:

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                                                                                                              Hours per    Total    Average
                Information collection activities                   Number of    Responses per      Total      response    burden   hourly      Total
                                                                   respondents     respondent     responses   (in hours)   hours     wage    annual cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Setting Up Activities *
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Initial outreach and recruitment (all hospitals)................           143                1         143        81.50   11,655    $48.72     $567,807
ED record provision setting up (direct chart review)............            58                1          58         5.25      305     26.71        8,133
ED record provision setting up (ML with NLP)....................            85                1          85        36.00    3,060     26.71       81,733
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Ongoing Maintenance Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ongoing Maintenance (direct chart review).......................            58                1          58         1.50       87     26.71        2,324
Ongoing Maintenance (ML with NLP)...............................            85                1          85         6.00      510     26.71       13,622
                                                                 ---------------------------------------------------------------------------------------
    Totals......................................................  ............  ...............  ..........  ...........   15,616  ........      673,619
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Setting up activities will be conducted once.

    Send comments to Carlos Graham, SAMHSA Reports Clearance Officer, 
5600 Fisher Lane, Room 15E57A, Rockville, MD 20852 OR email him a copy 
at [email protected]. Written comments should be received by 
May 13, 2024.

Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024-05446 Filed 3-13-24; 8:45 am]
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