[Federal Register Volume 85, Number 115 (Monday, June 15, 2020)]
[Notices]
[Pages 36203-36205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project ``AHRQ Managing Unhealthy Alcohol Use in Primary Care 
Initiative.'' This proposed information collection was previously 
published in the Federal Register on March 30, 2020 and allowed 60 days 
for public comment. AHRQ did not receive any comments during the 
aforementioned public comment period. The purpose of this notice is to 
allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by 30 days after date 
of publication of this notice.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

AHRQ Managing Unhealthy Alcohol Use in Primary Care Initiative

    The Affordable Care Act established the Patient-Centered Outcomes 
Research Trust Fund (PCORTF) and authorized AHRQ to broadly disseminate 
the research findings published by the Patient-Centered Outcomes 
Research Institute (PCORI) and other government-funded research 
relevant to comparative clinical effectiveness research. AHRQ's PCORTF-
funded initiative identifies research findings that could significantly 
improve patient outcomes through broader implementation in clinical 
practice. Under this initiative, in 2019 AHRQ launched a new 
initiative, Managing Unhealthy Alcohol Use in Primary Care, in order to 
promote the uptake of evidence-based practices for unhealthy alcohol 
use (UAU). As part of this initiative, AHRQ selected six grantees and 
funded a contractor to support and evaluate the grantees. The grantees 
will collectively work with more than 700 primary care practices over 
three years to implement and evaluate strategies to increase the use of 
evidence-based interventions such as screening for unhealthy alcohol 
use, brief interventions for adult patients who drink too much, and 
medication-assisted therapy (MAT) for patients with an alcohol use 
disorder. The contractor will develop a resource center, convene a 
technical expert panel, conduct an ongoing environmental scan, support 
a learning community of grantees, and complete a multisite, mixed 
methods evaluation.
    Unhealthy alcohol use, defined as behaviors ranging from risky 
drinking to alcohol use disorders (AUD), is estimated to be the third 
leading cause of preventable death in the United States. Between 2006 
and 2010, nearly one in ten deaths were alcohol-related. In addition to 
early mortality, UAU is associated with a host of adverse outcomes, 
including unintentional injuries and the development or exacerbation of 
a range of physical and behavioral health conditions. The Centers for 
Disease Control and Prevention estimates suggest that excessive alcohol 
consumption costs the United States $249 billion annually.
    Under the UAU initiative, six AHRQ grantees will work to improve 
the management of UAU in primary care by disseminating and implementing 
evidence-based practices for screening and brief intervention, referral 
to treatment (SBI/RT), and MAT in primary care practices. The multi-
site, mixed-methods evaluation will include primary data collection by 
the evaluator,

[[Page 36204]]

NORC at the University of Chicago. The evaluation will also include 
secondary data collected by the six grantee teams working with 750 
primary care practices. Collectively the data will allow the evaluator 
to assess the implementation and impact of the six grants.
    The project goals, as laid out in the AHRQ request for applications 
include:
     Success of recruitment and retention strategies across all 
six grantees to engage primary care practices for implementation of 
SBI/RT and MAT, across the initiative;
     Effectiveness of the grantees' collective dissemination 
and implementation strategies, and the factors associated with the 
success and/or failure of the strategies as it relates to populations, 
settings and the influence of contextual factors;
     Success at the practice level in increasing the number of 
patients screened, identified, and treated; and
     Overall impact on changes in processes or outcomes that 
can be attributed to the initiative.
    This study is being conducted pursuant to AHRQ's statutory 
authority to broadly disseminate research findings published by the 
Patient-Centered Outcomes Research Institute and other government-
funded research relevant to comparative clinical effectiveness research 
to physicians, health care providers, and patients. 42 U.S.C 299b-37.

Method of Collection

    To achieve the goals of the multi-site evaluation (MSE), AHRQ is 
requesting OMB approval for three years for new data collection by the 
evaluator. The evaluator's primary data collection is requested to 
achieve the goals of the MSE and includes the following data collection 
activities:
    Semi-Structured Qualitative Interviews will take place in-person 
and/or by telephone with key staff from each grantee team (i.e., 
principal investigator, co-investigator, evaluation lead, practice 
facilitation/implementation lead, and project manager) and with 
clinicians and staff at one primary care practice working with each 
grantee. Interviews will be conducted annually beginning at the end of 
Year 1, for a total of three time points per grantee. During Years 1 
and 3 the interviews will be conducted by phone, while Year 2 
interviews will be collected in-person. The interviews for both grantee 
teams and primary care practice staff will cover domains such as 
understanding the practice implementation and changes overtime, methods 
of supporting practices, barriers and facilitators to implementation, 
strategies to overcome barriers, and the number and type of staff 
implementing SBI/RT and MAT.
    Secondary data collected by grantees and analyzed by the evaluator 
will include:
    Aggregated process measure data that will be used to assess whether 
the number of patients receiving SBI/RT and/or MAT increased at the 
practice level. Grantees will survey all participating primary care 
practices at the beginning of the initiative to collect data on basic 
practice characteristics (e.g., size, ownership, staff, and patient 
population) that can be used to evaluate relationships between practice 
characteristics and the number of patients receiving SBI/RT and/or MAT. 
Grantees will also collect quantitative information about the number, 
duration, and function of contact between practice facilitators and 
primary care practices to evaluate the relationship between duration, 
frequency, and type of practice facilitator-practice engagement, and 
the number of patients screened, receiving brief intervention, and/or 
treated for UAU. The practice facilitators will collect data to track 
changes in practices over time and facilitate an overall assessment of 
what activities the practice is conducting to identify and manage UAU.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to complete the semi-structured Key Informant 
Interviews. For the three-year clearance period, the estimated 
annualized burden hours for the interviews are 60.

                                                    Exhibit 1
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
            Data collection activity                 Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Semi-Structured Interviews......................              60               1             1.0              60
                                                 ---------------------------------------------------------------
    Total.......................................              60  ..............  ..............              60
----------------------------------------------------------------------------------------------------------------

    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to complete the Key Informant Interviews. The total 
annualized cost burden is estimated to be $6,109.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Semi-Structured Interviews......................              60              60     \a\ $101.82          $6,109
                                                 ---------------------------------------------------------------
    Total.......................................              60              60  ..............           6,109
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2018 ``U.S. Department of Labor,
  Bureau of Labor Statistics'': https://www.bls.gov/oes/current/oes_stru.htm.
\a\ Based on the mean wages for 29-1062 Family and General Practitioners.

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ's health care research and 
health care information

[[Page 36205]]

dissemination functions, including whether the information will have 
practical utility; (b) the accuracy of AHRQ's estimate of burden 
(including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use 
of automated collection techniques or other forms of information 
technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: June 9, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-12804 Filed 6-12-20; 8:45 am]
BILLING CODE 4160-90-P