[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Notices]
[Pages 63438-63439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities 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) 276-0361.

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

[[Page 63439]]

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.
    [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:

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

    Written comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

Alicia Broadus,
Public Health Advisor.
[FR Doc. 2024-17142 Filed 8-2-24; 8:45 am]
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