Agency Information Collection Activities: Proposed Collection; Comment Request, 36603-36606 [2019-15986]

Download as PDF Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices khammond on DSKBBV9HB2PROD with NOTICES has been resolved, and notify the Requestor in writing of the notification to the Commission. Informal resolution of a matter does not prevent the Requestor from seeking Commission consideration, in an additional or subsequent determination, subject to the requirements of this program. After the recommendation is circulated for a Commission vote, in the event of an objection, the matter shall be automatically placed on the next meeting agenda consistent with the Sunshine Act, 5 U.S.C. 552b(g), and applicable Commission regulations, 11 CFR part 2. However, if within 60 business days of the filing of a request for consideration, the Commission has not resolved the issue or provided guidance on how to proceed with the matter by the affirmative vote of four or more Commissioners, the OC may proceed with the matter. After the 60 business days has elapsed, any requestor will be provided a copy of OGC’s recommendation memorandum and an accompanying vote certification, or if no such certification exists, a cover page stating the disposition of the memoranda. Confidential information will be redacted as necessary. After the request review process has concluded, or a Final Audit Report has been approved, a copy of the request for consideration, as well as the recommendation memorandum and accompanying vote certification or disposition memorandum, will be placed with the Committee’s filings or audit documents on the Commission’s website within 30 days. These materials will also be placed on the Commission’s web page dedicated to legal questions considered by the Commission under this program. This procedure is not intended to circumvent or supplant the Advisory Opinion process provided under 52 U.S.C. 30108 and 11 CFR part 112. Accordingly, any legal issues that qualify for consideration under the Advisory Opinion process are not appropriate for consideration under this new procedure. Additionally, this policy statement does not supersede the procedures regarding eligibility and entitlement to public funds set forth in Commission Directive 24 and 11 CFR 9005.1, 9033.4, 9033.6 or 9033.10. II. Annual Review No later than July 1 of each year, the OC and OGC shall jointly prepare and distribute to the Commission a written report containing a summary of the requests made under the program over the previous year and a summary of the Commission’s consideration of those VerDate Sep<11>2014 16:54 Jul 26, 2019 Jkt 247001 requests and any action taken thereon. The annual report shall also include the Chief Compliance Officer’s and the General Counsel’s assessment of whether, and to what extent, the program has promoted efficiency and fairness in both the Commission’s report review process and in the audit process, as well as their recommendations, if any, for modifications to the program. The Commission may terminate or modify this program through additional policy statements at any time by an affirmative vote of four of its members. Dated: July 23, 2019. On behalf of the Commission. Ellen Weintraub, Chair, Federal Election Commission. [FR Doc. 2019–15988 Filed 7–26–19; 8:45 am] BILLING CODE 6715–01–P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 22, 2019. A. Federal Reserve Bank of Minneapolis (Mark A. Rauzi, Vice PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 36603 President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. Frandsen Financial Corporation, Arden Hills, Minnesota; to acquire 100 percent of the voting shares of Peoples Bank Midwest, Hayward, Wisconsin. Board of Governors of the Federal Reserve System, July 23, 2019. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2019–15976 Filed 7–26–19; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. AGENCY: ACTION: Notice. 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 ‘‘Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care.’’ In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 12, 2019, and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment. SUMMARY: Comments on this notice must be received by 30 days after date of publication. DATES: Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by email at OIRA_submission@ omb.eop.gov (attention: AHRQ’s desk officer). ADDRESSES: FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\29JYN1.SGM 29JYN1 khammond on DSKBBV9HB2PROD with NOTICES 36604 Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices Proposed Project Method of Collection Evaluating and Implementing the Six Building Blocks Team Approach To Improve Opioid Management in Primary Care To achieve the goals of this project the following data collections will be implemented: (1) Clinical Staff Survey. A brief survey will be administered electronically to all clinical staff, including primary care physicians, nurse practitioners, physician assistants, social workers, medical assistants, registered nurses, pharmacists and behavioral health workers, toward the beginning of 6BBs Toolkit implementation and approximately 12 months later. A quality improvement (QI) point person will provide email addresses for the staff who will be invited to complete the survey from each participating organization. These email addresses will be used to send clinical staff the surveys at both time points. The survey will collect information about staff’s self-reported use of evidence-based opioid prescribing practices; procedures in place around opioid prescribing management; self efficacy regarding safe opioid prescribing; knowledge, beliefs and attitudes regarding opioid prescribing; adaptive reserve; selfreported burnout; and reported implementation experiences. The survey will also collect information about staffs’ background (e.g., clinic role and tenure). The survey will consist largely of closed-ended questions (e.g., scale or Likert response options) with several open-ended questions. (2) Staff Interviews. Interviews will be conducted with 5 staff at each of the 15 participating health care organizations. AHRQ will conduct 2 rounds of interviews, with the first round occurring within several months after the How-To-Guide is distributed to the organization and the second round occurring 12 months later. The evaluation team will conduct in-depth interviews with: a. The quality improvement (QI) lead and b. Four additional staff who are involved in 6BBs implementation at each organization, that might include a clinician, information technology analyst, social worker, behavioral health specialist, and/or care coordinator. Staff interviewees will be selected by the QI lead at each organization, who will be asked to nominate a range of staff from those who embraced changes to those who were less willing to implement changes. Interviews will capture qualitative data regarding the organization’s history with efforts to curb opioid prescribing, experiences using the How-To-Guide, implementation of the 6BB intervention The project ‘‘Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care’’ fully supports AHRQ’s mission. The ultimate aim of this project is to further validate and expand the Six Building Blocks to Safer Opioid Management (6BBs) intervention and its associated resources and guidance to support primary care providers in safer opioid prescribing. Opioid overdose deaths have increased dramatically since 1999, and despite recent decreases in the national opioid prescribing rate, prescribing rates remain high in many U.S. counties. Primary care providers (PCPs) are responsible for about half of all dispensed opioid pain relievers. To address the emerging opioid epidemic, the Six Building Blocks to Safer Opioid Management (6BBs) Toolkit has been developed to support primary care providers in safer opioid prescribing, largely concordant with the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain. The 6BBs is a structured, systems-based approach for improving management of patients on long-term opioid therapy that targets six work areas a primary care practice needs to redesign in order to improve their clinic’s management of patients on longterm opioid therapy. Building upon previous work supported by AHRQ to address the opioid epidemic, this research has the following goals: 1. To improve the guidance for the 6BBs Toolkit, 2. To further implement the 6BBs in primary care practices, and 3. To understand the facilitators and barriers to implementing the Six Building Blocks to Safer Opioid Management. This study is being conducted by AHRQ through its contractor, Abt Associates Inc., pursuant to AHRQ’s statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). VerDate Sep<11>2014 16:54 Jul 26, 2019 Jkt 247001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 and associated opioid management interventions, and lessons learned that can be shared with other health care organizations. (3) Virtual Launch Meeting. A virtual launch meeting will be held for organization liaisons and quality improvement leaders from participating health care organizations to launch 6BBs Toolkit implementation. The meeting will be conducted by webconference, and will last up to 2 hours. (4) Quarterly Check-In Calls. A project team member will hold a quarterly check-in call with organization liaisons and quality improvement leaders to assess the progress of implementation of the 6BBs intervention and improvement initiatives at each organization. Checkin calls will occur quarterly for up to 12 months. Each call will be up to 60 minutes in duration, and notes will be taken by an evaluation team member during each call. (5) QI Measures. Each health care organization will be asked to report quarterly on the number of patients on long-term opioid therapy and the proportion of those who are on greater than 90 morphine milligram equivalents, co-prescribed a benzodiazepine, and had the prescription drug monitoring program checked and a urine drug screen. Organizations may also select other outcome measures aligned to their own goals. (6) Other outcome and output data from administrative records, electronic medical records, and organizational documents (Secondary Data). Health care organizations may also report their progress on implementing the 6BB intervention and associated changes in care processes through completion of worksheets contained in or associated with the How-To-Guide. Since these data collections involve simply submitting worksheets they complete for their own benefit while working through the How-To-Guide, they pose only minimal data collection burden to the health care organization, specifically the person who completes the worksheets (i.e., QI lead). The project team will also obtain relevant organizational documents (e.g., opioid prescribing policies, quality improvement plans, sample patient agreements, relevant practice workflows, screen shots of data dashboards). The purpose of the proposed data collection effort is to obtain information needed to modify and enhance the 6BB How-To-Guide and to provide information to health care organizations considering using the How-To-Guide to improve their opioid prescribing E:\FR\FM\29JYN1.SGM 29JYN1 36605 Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices practices and relevant outcomes. Since this is only a study conducted in 15 organizations, outcomes or impacts will not be generalizable. The data collected will help the project team: (1) Understand the facilitators and barriers of using the 6BB Toolkit and recommended improvements to processes of care and opioid prescribing practices, and (2) assess the effectiveness of using the 6BB Toolkit to improve processes of care and opioid prescribing practices. The data collection effort may also provide insights that could guide dissemination of the Toolkit. For example, if it was found that a specific type of organization included in this pilot study (e.g., small, stand-alone clinic in a rural area) particularly benefitted from using the Toolkit, then AHRQ could tailor and target its dissemination of the Toolkit to similar organizations. Once revisions are made based on results of this evaluation, the How-To-Guide corresponding to the Toolkit will be published on AHRQ’s website. A manuscript describing the pilot study and its results will also be produced for publication in a peer-reviewed journal. Estimated Annual Respondent Burden Exhibit 1 presents estimates of the reporting burden hours for the data collection efforts. Time estimates are based on prior experiences and what can reasonably be requested of participating health care organizations. The number of respondents listed in column A, Exhibit 1 reflects a projected 75% response rate for data collection efforts 2a and 2b below. 1. Clinical Staff Survey. A brief survey will be emailed to all clinicians both toward the beginning of 6BBs Toolkit implementation and approximately 12 months later. We assumed 20 clinical staff per clinical site, and approximately 50 clinical sites overall (with a range from 1 clinic to 17 per organization), for a total of 1,000 staff across all 15 organizations. We assumed 750 clinical staff will complete the survey based on a 75% response rate. It is expected to take up to 15 minutes to complete. 2. Staff Interviews. In-depth interviews will occur with 5 staff at each health care organization, for a total of up to 75 individuals. The evaluation team will conduct these interviews, each lasting up to 1 hour, at 2 points in time with: a. One QI lead per organization (toward the start of and at the end of the project). b. Four additional staff (e.g., clinician, information technology analyst, social worker) per organization (midway through and at the end of the project). 3. Virtual Launch Meeting. The meeting will occur with the quality improvement (QI) leads at participating health care organizations to launch 6BBs Toolkit implementation. The meeting will be conducted by webconference, and will last up to 2 hours. 4. Quarterly Check-In Calls. Calls will occur with QI leads, clinical champions, and other relevant staff the QI lead identifies, for a total of no more than 5 individuals per organization. These calls will assess progress with the organization’s use of the Toolkit and implementation of associated practice changes, and will occur quarterly over 15 months, for a total of 5 quarterly check-in calls. Each call will take up to 60 minutes. 5. QI Measures. Aggregate reports of the specified quality measures will be provided on a quarterly basis over the course of an 18-month period by a data analyst at each organization, for a total of 15 individuals across all 15 organizations. We assume 40 hours total (10 hours per quarter) for each data analyst to collect and provide these data. 6. Other outcome and output data from administrative records and organizational documents (Secondary Data). These secondary data will be provided by the QI lead at each organization, for a total of 15 individuals across all 15 organizations. We assume 4 hours per month for 12 months for a total of 48 hours for each QI lead to collect and provide these data. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Data collection method or project activity Number of respondents Number of responses per respondent Hours per response Total burden hours A. B. C. D. 1. Clinical Staff Survey * .................................................................................. 2a. Staff Interview—QI Lead ........................................................................... 2b. Staff Interview—Additional Staff ................................................................ 3. Virtual Launch Meeting ................................................................................ 4. Quarterly Check-In Calls ............................................................................. 5. QI Measures ................................................................................................ 6. Secondary data ........................................................................................... 750 15 60 15 75 15 15 2 2 2 1 5 4 12 15/60 1 1 2 1 10 4 375 30 120 30 375 600 720 Total .......................................................................................................... 1035 n/a n/a 2,250 *Number of respondents (Column A) reflects a sample size assuming a 75% response rate for this data collection effort. Exhibit 2, below, presents the estimated annualized cost burden associated with the respondents’ time to participate in this research. The total cost burden is estimated to be about $91,623. khammond on DSKBBV9HB2PROD with NOTICES EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Data collection method or project activity 1. Clinical Staff Survey .................................................................................... 2a. Staff Interview—QI Lead ........................................................................... 2b. Staff Interview—Additional Staff ................................................................ 3. Virtual Launch Meeting ................................................................................ 4. Quarterly Check-In Calls ............................................................................. VerDate Sep<11>2014 16:54 Jul 26, 2019 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Total burden hours 750 15 60 15 75 E:\FR\FM\29JYN1.SGM 375 30 120 30 375 29JYN1 Average hourly wage rate * $48.45 53.69 38.83 53.69 38.83 Total cost burden $18,169 1,611 4,660 1,611 14,561 36606 Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Data collection method or project activity Average hourly wage rate * Total cost burden 5. QI Measures ................................................................................................ 6. Secondary data ........................................................................................... 15 15 600 720 20.59 53.69 12,354 38,657 Total .......................................................................................................... ........................ ........................ ........................ 91,623 The average hourly rate of $48.45 for the clinical staff survey was calculated based on the 2017 mean hourly wage rate for health diagnosing and treating practitioners, $48.45 (occupation code 29–1000). The average hourly rate of $53.69 for QI lead interviews was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11–9111). The average hourly rate of $38.83 for staff interviews was calculated based on the 2017 mean hourly wage rate for healthcare practitioners and technical occupations, $38.83 (occupation code 29–0000). The average hourly rate of $53.69 for the virtual launch meeting was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11–9111). The average hourly wage rate of $38.83 for quarterly check-in calls was calculated based on the 2017 mean hourly wage rate for healthcare practitioners and technical occupations, $38.83 (occupation code 29–0000). The average hourly rate of $20.59 for QI measures was calculated based on the 2017 mean hourly wage rate for medical records and health information technicians, $20.59 (occupation code 29–2071). The average hourly rate of $53.69 for secondary data was calculated based on the 2017 mean hourly wage rate for medical and health services managers, $53.69 (occupation code 11–9111). Mean hourly wage rates for these groups of occupations were obtained from the Bureau of Labor & Statistics on ‘‘Occupational Employment and Wages, May 2017’’ found at the following URL: http://www.bls.gov/oes/current/oes_ nat.htm#b29-0000.htm. khammond on DSKBBV9HB2PROD with NOTICES Total burden hours 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 dissemination functions, including VerDate Sep<11>2014 16:54 Jul 26, 2019 Jkt 247001 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: July 23, 2019. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–15986 Filed 7–26–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: 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: ‘‘Embedded Research in Care Delivery Systems.’’ DATES: Comments on this notice must be received by 60 days after date of publication. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov. Copies of the proposed collection plans, data collection instruments, and SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: Proposed Project ‘‘Embedded Research in Care Delivery Systems’’ Embedded researchers contribute to learning health systems by collaborating with delivery system stakeholders to produce innovations and evidence that can be rapidly implemented to improve the outcomes of individuals and populations and health system performance. Research is defined in this proposed project as embedded when it is conducted by an investigator who is employed or closely affiliated with the care delivery system and when the research project at least partially addresses operational concerns of the system (e.g., ways to improve care quality, value, or other aspects of system performance, such as patient and staff satisfaction). AHRQ is developing tools and findings to support learning health systems and embedded research, and is funding training of researchers to conduct embedded research. The proposed project has the following goals: • Select health care delivery systems that currently apply diverse and distinctive strategies for embedded research. • Conduct and report on qualitative case studies documenting how embedded research is prioritized, funded, managed, conducted, and used in these systems. • Specify several promising strategies for organizing and conducting embedded research. • Provide summaries of study findings that will stimulate consideration of current and future strategies for embedded research among funders, trainers, and delivery system leaders. E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Pages 36603-36606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15986]


=======================================================================
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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.

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

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 ``Evaluating and Implementing the Six Building Blocks Team 
Approach to Improve Opioid Management in Primary Care.'' In accordance 
with the Paperwork Reduction Act, AHRQ invites the public to comment on 
this proposed information collection. This proposed information 
collection was previously published in the Federal Register on April 
12, 2019, and allowed 60 days for public comment. AHRQ did not receive 
any substantive comments. 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.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at [email protected] (attention: AHRQ's desk officer).

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

SUPPLEMENTARY INFORMATION: 

[[Page 36604]]

Proposed Project

Evaluating and Implementing the Six Building Blocks Team Approach To 
Improve Opioid Management in Primary Care

    The project ``Evaluating and Implementing the Six Building Blocks 
Team Approach to Improve Opioid Management in Primary Care'' fully 
supports AHRQ's mission. The ultimate aim of this project is to further 
validate and expand the Six Building Blocks to Safer Opioid Management 
(6BBs) intervention and its associated resources and guidance to 
support primary care providers in safer opioid prescribing.
    Opioid overdose deaths have increased dramatically since 1999, and 
despite recent decreases in the national opioid prescribing rate, 
prescribing rates remain high in many U.S. counties. Primary care 
providers (PCPs) are responsible for about half of all dispensed opioid 
pain relievers. To address the emerging opioid epidemic, the Six 
Building Blocks to Safer Opioid Management (6BBs) Toolkit has been 
developed to support primary care providers in safer opioid 
prescribing, largely concordant with the Centers for Disease Control 
and Prevention's Guideline for Prescribing Opioids for Chronic Pain. 
The 6BBs is a structured, systems-based approach for improving 
management of patients on long-term opioid therapy that targets six 
work areas a primary care practice needs to redesign in order to 
improve their clinic's management of patients on long-term opioid 
therapy.
    Building upon previous work supported by AHRQ to address the opioid 
epidemic, this research has the following goals:
    1. To improve the guidance for the 6BBs Toolkit,
    2. To further implement the 6BBs in primary care practices, and
    3. To understand the facilitators and barriers to implementing the 
Six Building Blocks to Safer Opioid Management.
    This study is being conducted by AHRQ through its contractor, Abt 
Associates Inc., pursuant to AHRQ's statutory authority to conduct and 
support research on healthcare and on systems for the delivery of such 
care, including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of healthcare services and with 
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) 
and (2).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
    (1) Clinical Staff Survey. A brief survey will be administered 
electronically to all clinical staff, including primary care 
physicians, nurse practitioners, physician assistants, social workers, 
medical assistants, registered nurses, pharmacists and behavioral 
health workers, toward the beginning of 6BBs Toolkit implementation and 
approximately 12 months later. A quality improvement (QI) point person 
will provide email addresses for the staff who will be invited to 
complete the survey from each participating organization. These email 
addresses will be used to send clinical staff the surveys at both time 
points. The survey will collect information about staff's self-reported 
use of evidence-based opioid prescribing practices; procedures in place 
around opioid prescribing management; self efficacy regarding safe 
opioid prescribing; knowledge, beliefs and attitudes regarding opioid 
prescribing; adaptive reserve; self-reported burnout; and reported 
implementation experiences. The survey will also collect information 
about staffs' background (e.g., clinic role and tenure). The survey 
will consist largely of closed-ended questions (e.g., scale or Likert 
response options) with several open-ended questions.
    (2) Staff Interviews. Interviews will be conducted with 5 staff at 
each of the 15 participating health care organizations. AHRQ will 
conduct 2 rounds of interviews, with the first round occurring within 
several months after the How-To-Guide is distributed to the 
organization and the second round occurring 12 months later. The 
evaluation team will conduct in-depth interviews with:
    a. The quality improvement (QI) lead and
    b. Four additional staff who are involved in 6BBs implementation at 
each organization, that might include a clinician, information 
technology analyst, social worker, behavioral health specialist, and/or 
care coordinator.
    Staff interviewees will be selected by the QI lead at each 
organization, who will be asked to nominate a range of staff from those 
who embraced changes to those who were less willing to implement 
changes. Interviews will capture qualitative data regarding the 
organization's history with efforts to curb opioid prescribing, 
experiences using the How-To-Guide, implementation of the 6BB 
intervention and associated opioid management interventions, and 
lessons learned that can be shared with other health care 
organizations.
    (3) Virtual Launch Meeting. A virtual launch meeting will be held 
for organization liaisons and quality improvement leaders from 
participating health care organizations to launch 6BBs Toolkit 
implementation. The meeting will be conducted by web-conference, and 
will last up to 2 hours.
    (4) Quarterly Check-In Calls. A project team member will hold a 
quarterly check-in call with organization liaisons and quality 
improvement leaders to assess the progress of implementation of the 
6BBs intervention and improvement initiatives at each organization. 
Check-in calls will occur quarterly for up to 12 months. Each call will 
be up to 60 minutes in duration, and notes will be taken by an 
evaluation team member during each call.
    (5) QI Measures. Each health care organization will be asked to 
report quarterly on the number of patients on long-term opioid therapy 
and the proportion of those who are on greater than 90 morphine 
milligram equivalents, co-prescribed a benzodiazepine, and had the 
prescription drug monitoring program checked and a urine drug screen. 
Organizations may also select other outcome measures aligned to their 
own goals.
    (6) Other outcome and output data from administrative records, 
electronic medical records, and organizational documents (Secondary 
Data). Health care organizations may also report their progress on 
implementing the 6BB intervention and associated changes in care 
processes through completion of worksheets contained in or associated 
with the How-To-Guide. Since these data collections involve simply 
submitting worksheets they complete for their own benefit while working 
through the How-To-Guide, they pose only minimal data collection burden 
to the health care organization, specifically the person who completes 
the worksheets (i.e., QI lead). The project team will also obtain 
relevant organizational documents (e.g., opioid prescribing policies, 
quality improvement plans, sample patient agreements, relevant practice 
workflows, screen shots of data dashboards).
    The purpose of the proposed data collection effort is to obtain 
information needed to modify and enhance the 6BB How-To-Guide and to 
provide information to health care organizations considering using the 
How-To-Guide to improve their opioid prescribing

[[Page 36605]]

practices and relevant outcomes. Since this is only a study conducted 
in 15 organizations, outcomes or impacts will not be generalizable.
    The data collected will help the project team: (1) Understand the 
facilitators and barriers of using the 6BB Toolkit and recommended 
improvements to processes of care and opioid prescribing practices, and 
(2) assess the effectiveness of using the 6BB Toolkit to improve 
processes of care and opioid prescribing practices. The data collection 
effort may also provide insights that could guide dissemination of the 
Toolkit. For example, if it was found that a specific type of 
organization included in this pilot study (e.g., small, stand-alone 
clinic in a rural area) particularly benefitted from using the Toolkit, 
then AHRQ could tailor and target its dissemination of the Toolkit to 
similar organizations. Once revisions are made based on results of this 
evaluation, the How-To-Guide corresponding to the Toolkit will be 
published on AHRQ's website. A manuscript describing the pilot study 
and its results will also be produced for publication in a peer-
reviewed journal.

Estimated Annual Respondent Burden

    Exhibit 1 presents estimates of the reporting burden hours for the 
data collection efforts. Time estimates are based on prior experiences 
and what can reasonably be requested of participating health care 
organizations. The number of respondents listed in column A, Exhibit 1 
reflects a projected 75% response rate for data collection efforts 2a 
and 2b below. 1. Clinical Staff Survey. A brief survey will be emailed 
to all clinicians both toward the beginning of 6BBs Toolkit 
implementation and approximately 12 months later. We assumed 20 
clinical staff per clinical site, and approximately 50 clinical sites 
overall (with a range from 1 clinic to 17 per organization), for a 
total of 1,000 staff across all 15 organizations. We assumed 750 
clinical staff will complete the survey based on a 75% response rate. 
It is expected to take up to 15 minutes to complete.
    2. Staff Interviews. In-depth interviews will occur with 5 staff at 
each health care organization, for a total of up to 75 individuals. The 
evaluation team will conduct these interviews, each lasting up to 1 
hour, at 2 points in time with:
    a. One QI lead per organization (toward the start of and at the end 
of the project).
    b. Four additional staff (e.g., clinician, information technology 
analyst, social worker) per organization (midway through and at the end 
of the project).
    3. Virtual Launch Meeting. The meeting will occur with the quality 
improvement (QI) leads at participating health care organizations to 
launch 6BBs Toolkit implementation. The meeting will be conducted by 
web-conference, and will last up to 2 hours.
    4. Quarterly Check-In Calls. Calls will occur with QI leads, 
clinical champions, and other relevant staff the QI lead identifies, 
for a total of no more than 5 individuals per organization. These calls 
will assess progress with the organization's use of the Toolkit and 
implementation of associated practice changes, and will occur quarterly 
over 15 months, for a total of 5 quarterly check-in calls. Each call 
will take up to 60 minutes.
    5. QI Measures. Aggregate reports of the specified quality measures 
will be provided on a quarterly basis over the course of an 18-month 
period by a data analyst at each organization, for a total of 15 
individuals across all 15 organizations. We assume 40 hours total (10 
hours per quarter) for each data analyst to collect and provide these 
data.
    6. Other outcome and output data from administrative records and 
organizational documents (Secondary Data). These secondary data will be 
provided by the QI lead at each organization, for a total of 15 
individuals across all 15 organizations. We assume 4 hours per month 
for 12 months for a total of 48 hours for each QI lead to collect and 
provide these data.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
   Data collection method or project activity        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
                                                              A.              B.              C.              D.
----------------------------------------------------------------------------------------------------------------
1. Clinical Staff Survey *......................             750               2           15/60             375
2a. Staff Interview--QI Lead....................              15               2               1              30
2b. Staff Interview--Additional Staff...........              60               2               1             120
3. Virtual Launch Meeting.......................              15               1               2              30
4. Quarterly Check-In Calls.....................              75               5               1             375
5. QI Measures..................................              15               4              10             600
6. Secondary data...............................              15              12               4             720
                                                 -----------------
----------------------------------------------------------------------------------------------------------------
*Number of respondents (Column A) reflects a sample size assuming a 75% response rate for this data collection
  effort.

    Exhibit 2, below, presents the estimated annualized cost burden 
associated with the respondents' time to participate in this research. 
The total cost burden is estimated to be about $91,623.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
   Data collection method or project activity       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Clinical Staff Survey........................             750             375          $48.45         $18,169
2a. Staff Interview--QI Lead....................              15              30           53.69           1,611
2b. Staff Interview--Additional Staff...........              60             120           38.83           4,660
3. Virtual Launch Meeting.......................              15              30           53.69           1,611
4. Quarterly Check-In Calls.....................              75             375           38.83          14,561

[[Page 36606]]

 
5. QI Measures..................................              15             600           20.59          12,354
6. Secondary data...............................              15             720           53.69          38,657
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          91,623
----------------------------------------------------------------------------------------------------------------

    The average hourly rate of $48.45 for the clinical staff survey was 
calculated based on the 2017 mean hourly wage rate for health 
diagnosing and treating practitioners, $48.45 (occupation code 29-
1000).
    The average hourly rate of $53.69 for QI lead interviews was 
calculated based on the 2017 mean hourly wage rate for medical and 
health services managers, $53.69 (occupation code 11-9111). The average 
hourly rate of $38.83 for staff interviews was calculated based on the 
2017 mean hourly wage rate for healthcare practitioners and technical 
occupations, $38.83 (occupation code 29-0000).
    The average hourly rate of $53.69 for the virtual launch meeting 
was calculated based on the 2017 mean hourly wage rate for medical and 
health services managers, $53.69 (occupation code 11-9111).
    The average hourly wage rate of $38.83 for quarterly check-in calls 
was calculated based on the 2017 mean hourly wage rate for healthcare 
practitioners and technical occupations, $38.83 (occupation code 29-
0000).
    The average hourly rate of $20.59 for QI measures was calculated 
based on the 2017 mean hourly wage rate for medical records and health 
information technicians, $20.59 (occupation code 29-2071).
    The average hourly rate of $53.69 for secondary data was calculated 
based on the 2017 mean hourly wage rate for medical and health services 
managers, $53.69 (occupation code 11-9111).
    Mean hourly wage rates for these groups of occupations were 
obtained from the Bureau of Labor & Statistics on ``Occupational 
Employment and Wages, May 2017'' found at the following URL: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.htm.

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 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: July 23, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-15986 Filed 7-26-19; 8:45 am]
 BILLING CODE 4160-90-P