Agency Information Collection Activities: Proposed Collection; Comment Request, 27123-27126 [2019-12306]

Download as PDF 27123 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents/ POCs Form name Total .......................................................................................................... Total burden hours N/A N/A Average hourly wage rate * Total cost burden N/A 26,572 * Mean hourly wage of $57.89 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2017 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at http://www.bls.gov/oes/current/naics3_ 622000.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. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–12312 Filed 6–10–19; 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. khammond on DSKBBV9HB2PROD with NOTICES 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: ‘‘The AHRQ Safety Program for Improving Antibiotic Use.’’ In accordance with the SUMMARY: VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 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 1, 2019 and allowed 60 days for public comment. AHRQ did not receive 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 on or before 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 OIRA_submission@ omb.eop.gov (attention: AHRQ’s desk 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 The AHRQ Safety Program for Improving Antibiotic Use The Agency for Healthcare Research and Quality (AHRQ) requests to revise and extend the currently approved AHRQ Safety Program for Improving Antibiotic Use. The AHRQ Safety Program for Improving Antibiotic Use (the ‘‘AHRQ Safety Program’’) aims to help facilities implement antibiotic stewardship programs and to reduce unnecessary antibiotic prescribing. The AHRQ Safety Program has already been implemented in a pilot of integrated delivery systems and a national cohort of 400 acute care hospitals, and is currently being implemented in a national cohort of 500 long-term care facilities. The AHRQ Safety Program was last approved by OMB on September 25, 2017 and will expire on September 30, 2020. The request for extension is to allow for completion of activities and data collection in the AHRQ Safety Program, which are scheduled to occur through March 30, 2021. The OMB control number for the AHRQ Safety Program is 0935–0238. All of the supporting documents for the PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 current AHRQ Safety Program can be downloaded from OMB’s website at https://www.reginfo.gov/public/do/ PRAViewICR?ref_nbr=201707-0935-003. The 2017 OMB clearance included one response for the Structural Assessment and the Medical Office Survey on Patient Safety Culture (MOSOPS), but did not include electronic health record (EHR) data or a second response for the Structural Assessment or MOSOPS for the 4th cohort planned for ambulatory settings. This was because the original OMB clearance expiration date fell in the middle of the planned 4th cohort, so the second Structural Assessment and MOSOPS were not within the approved information collection period, and EHR data collection would have been incomplete. In addition, the project team was not certain that the ambulatory care practices would be able to access EHR data. Based on the experience of the pilot cohort, however, it is believed that many ambulatory practices can access these data, and that these practices are more likely to feasibly participate in the AHRQ Safety Program. The revision also updates the estimated annual burden accordingly, and includes changes to the data collection forms which will be used for the ambulatory care cohort based on lessons learned during the pilot cohort. Background for This Collection As part of the Department of Health and Human Services (DHHS) Hospital Acquired Infection (HAI) National Action Plan (NAP), AHRQ has supported the implementation and adoption of the Comprehensive Unitbased Safety Program (CUSP) to reduce Central-Line Associated Bloodstream Infections (CLABSI) and CatheterAssociated Urinary Tract Infections (CAUTI), and subsequently applied CUSP to other clinical challenges, including reducing surgical site infections and improving care for mechanically ventilated patients. As part of the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) to increase antibiotic stewardship (defined as organized efforts to promote the judicious use of E:\FR\FM\11JNN1.SGM 11JNN1 khammond on DSKBBV9HB2PROD with NOTICES 27124 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices antibiotics) across all healthcare settings, AHRQ is applying the principles and concepts that have been learned from these HAI reduction efforts to antibiotic stewardship (AS). Antibiotic therapy has saved countless lives over the past several decades. However, bacterial resistance to antibiotics has followed closely on the heels of each new agent’s introduction. This has led to an epidemic of antibiotic resistance, with drug choices for some bacterial infections becoming increasingly limited, expensive, and in some cases nonexistent. While antibiotics remain a vital and necessary cornerstone to the treatment of infections, it is estimated that 20–50% of all antibiotics prescribed in U.S. acute care hospitals are either unnecessary or inappropriate. When antibiotics are used inappropriately, bacterial development of resistance is supported in the absence of any therapeutic benefit, and patients receiving unnecessary or inappropriate antibiotics are also exposed to the risk of adverse effects such as rash or renal injury as well as the risk of Clostridioides difficile infection which can cause a deadly diarrhea. Unlike misuse of other medications, the misuse of antibiotics can adversely impact the health of patients who are not even exposed to them because of the potential for spread of resistant organisms. The Centers for Disease Control and Prevention (CDC) estimates that each year at least two million illnesses and 23,000 deaths are caused by drug-resistant bacteria in the United States alone. While approaches including development of new antibiotic agents, increased surveillance for antibiotic resistance, prevention of HAIs, and prevention of transmission of resistant infections are important efforts to combat antibiotic resistance, it is critical to curb the inappropriate use of antibiotics to slow the emergence of antibiotic resistance and to preserve efficacy of existing antibiotics and those under development. As of January 1st, 2017, The Joint Commission (TJC)’s new Antimicrobial Stewardship Standard requires that all acute care hospitals have robust antibiotic stewardship programs. In addition, starting on November 28, 2017, the Centers for Medicare & Medicaid Services (CMS) required that all long-term care facilities that receive reimbursement from CMS have antibiotic stewardship programs in place. The Comprehensive Unit-Based Safety Program (CUSP), developed at the Armstrong Institute at Johns VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 Hopkins University, combines improvement in patient safety culture, teamwork, and communication together with a technical bundle of interventions to improve patient safety. CUSP is a powerful culture change tool, which has been successfully utilized to reduce CLABSI in ICUs in Michigan and Rhode Island and subsequently to reduce CLABSI by 41% in more than 1,000 ICUs in 44 states, Puerto Rico and the District of Columbia. Although evidence-based recommendations for prevention of CLABSI had existed for years, the combination of safety culture change on units and implementation of technical interventions resulted in significant reductions in CLABSI and introduced the concept that a rate of zero CLABSIs is achievable. CUSP is also being used to reduce other HAIs in multiple settings (http://www.ahrq.gov/ professionals/quality-patient-safety/ hais/index.html). This project will assist hospitals, nursing homes, and ambulatory care sites across the United States in adopting and implementing AS programs and interventions. This project has the following goals: • Identify best practices in the delivery of antibiotic stewardship in the acute care, long-term care and ambulatory care settings • Adapt the CUSP model to enhance antibiotic stewardship efforts in the health care settings • Develop a bundle of technical and adaptive interventions and associated tools and educational materials designed to support enhanced antibiotic stewardship efforts • Provide technical assistance and training to health care organizations nationwide (using a phased approach) to implement effective antibiotic stewardship programs and interventions • Improve communication and teamwork between health care workers surrounding antibiotic decision-making • Improve communication between health care workers and patients and families surrounding antibiotic decision-making • Conduct a comprehensive evaluation to assess the adoption of the CUSP for AS in acute care, long-term care and ambulatory care settings to identify the effectiveness of the program, process outcomes, and lessons learned The project will be implemented in four cohorts; (1) Cohort 1 is a pilot limited to 10 facilities each in three integrated delivery systems spanning acute care, long-term care, and PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 ambulatory settings; (2) Cohort 2 will expand to include 250–500 acute care hospitals; (3) Cohort 3 will include 250– 500 long-term care facilities; and (4) Cohort 4 will include 250–500 ambulatory care facilities. The AHRQ Safety Program is being undertaken pursuant to AHRQ’s mission to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health systems practices, including the prevention of diseases and other health conditions. 42 U.S.C. 299. Method of Collection To achieve the goals of the AHRQ Safety Program, the following data collections will be implemented: (1) Structural Assessments: A brief, eight question, online Structural Assessment Tool will be administered at baseline (pre-intervention) and at the end of the intervention period to obtain general information about facilities and stewardship infrastructure and changes to stewardship infrastructure and interventions that are anticipated to be sustained as a result of the AHRQ Safety Program (one response per facility for the 4th cohort in ambulatory settings was included in the original OMB review, this revision adds an additional response per facility, relevant changes made to line 1.b. in Exhibits A.1. and A.2.). (2) Team Antibiotic Review Form: The Stewardship Team in hospitals and nursing homes will conduct monthly reviews of at least 10 patients who received antibiotics and fill out an assessment tool in conjunction with frontline staff to determine if the ‘‘four moments of antibiotic decision-making’’ are being considered by providers. The four moments can be summarized as: (1) Is an infection present requiring antibiotics? (2) Are appropriate cultures being ordered and is the most optimal initial choice of antibiotics being prescribed? (3) (after at least 24 hours) Is it appropriate to make changes to the antibiotic regimen (e.g., stop therapy, narrow therapy, change from intravenous to oral therapy)? (4) What duration of therapy is appropriate? (3) The AHRQ Surveys on Patient Safety Culture: The appropriate versions of these surveys and the MOSOPS will be administered to all participating staff at the beginning and end of the intervention. Each survey asks questions about patient safety issues, medical errors, and event reporting in the respective settings. The surveys will be administered to all participating staff at E:\FR\FM\11JNN1.SGM 11JNN1 27125 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices the beginning and end of the intervention. (One response per respondent for the 4th cohort in ambulatory settings was included in the original OMB review, this revision adds an additional response per respondent, relevant changes made to line 3.d. in Exhibits A.1. and A.2.). a. The Hospital Survey on Patient Safety Culture (HSOPS) will be utilized to evaluate safety culture for acute care hospitals. b. The Nursing Home Survey on Patient Safety Culture (NHSOPS) will be administered in long-term care. c. The Medical Office Survey on Patient Safety Culture (MOSOPS) will be administered in ambulatory care centers. (4) Semi-structured qualitative interviews: During the project pilot period with Cohort 1, in-person and/or telephone discussions will be held before and after implementation with stewardship champions/organizational leaders, physicians, pharmacists, nurse practitioners, physician assistants, nurses, certified nursing assistants and others deemed relevant, to learn about the facilitators and barriers to a successful antibiotic stewardship program. Specific areas of interest include stakeholder perceptions of implementation process and outcomes, including successes and challenges with carrying out project tasks and perceived utility of the project; staff roles, engagement and support; and antibiotic prescribing etiquette & culture (i.e., social norms and local cultural factors that contribute to prescribing behavior at the facility/unit-level). (5) Electronic Health Record (EHR) data: Unit-level antibiotic therapy prescriptions and antibiotic use for diagnosed respiratory conditions will be extracted from the Electronic Health Records (EHRs) of participating units and used to assess the impact of the AHRQ Safety Program. (4th cohort in ambulatory settings portion is new from original OMB review, noted in line 6 in Exhibits A.1. and A.2.). Estimated Annual Respondent Burden Exhibit A.1 shows the estimated annualized burden hours for the respondents’ time to complete the Structural Assessments, Team Antibiotic Review Forms, AHRQ Patient Safety Culture Surveys, semi-structured qualitative interviews, and EHR data extractions. Data will be collected from 30 acute care, long-term care, and ambulatory care sites during the Cohort 1 one-year pilot period; up to 500 acute care hospitals in Cohort 2; up to 500 long-term care facilities in Cohort 3; and up to 500 ambulatory care sites in Cohort 4. With this revision, the total estimated annualized burden hours for the data collection activities are 27,064. EXHIBIT A.1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name 1. Structural Assessments: a. Structural Assessments—Cohorts 1, 2 and 3 (baseline, post-intervention) ................................................................................................. b. Structural Assessments—Cohort 4 (baseline and endline) ................. 2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) .................................. 3. AHRQ Patient Safety Culture Surveys: a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................ b. HSOPS (Cohort 2) ................................................................................ c. NHSOPS (Cohort 3) ............................................................................. d. MOSOPS (Cohort 4) ............................................................................ 4. Semi-structured qualitative interviews (Cohort 1): a. Physicians ............................................................................................ b. Other Health Practitioners .................................................................... 5. EHR data (Cohorts 1, 2, and 3) .................................................................. 6. EHR data (Cohort 4) ................................................................................... Total .......................................................................................................... Exhibit A.2 shows the estimated annualized cost burden based on the respondents’ time to complete the data Number of responses per respondent Hours per response Total burden hours 343 167 337 2 2 90 0.2 0.2 0.25 137 67 7,583 83 4,167 4,167 4,167 2 2 2 2 0.5 0.5 0.5 0.5 83 4,167 4,167 4,167 30 60 334 167 2 2 12 15 1 1 1 1 60 120 4,008 2,505 14,022 ........................ ........................ 27,030 collection forms. The total cost burden is estimated to be $1,311,096. EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents khammond on DSKBBV9HB2PROD with NOTICES Form name 1. Structural Assessments: a. Structural Assessments—Cohorts 1, 2 and 3 (baseline, post-intervention) ................................................................................................. b. Structural Assessments—Cohort 4 (baseline and endline) ................. 2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) .................................. 3. AHRQ Patient Safety Culture Surveys: a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................ b. HSOPS (Cohort 2) ................................................................................ c. NHSOPS (Cohort 3) ............................................................................. d. MOSOPS (Cohort 4) ............................................................................ 4. Semi-structured qualitative interviews (Cohort 1): a. Physicians ............................................................................................ VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Total burden hours Average hourly wage rate * Total cost burden 343 167 337 137 67 7,583 a $98.83 83 4,167 4,167 4,167 83 4,167 4,167 4,167 b 27.87 b 27.87 2,313 116,134 116,134 116,134 30 60 a 98.83 5,930 E:\FR\FM\11JNN1.SGM 11JNN1 a 98.83 a 98.83 b 27.87 b 27.87 $13,540 6,622 749,428 27126 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden b. Other Health Practitioners .................................................................... 5. EHR data (Cohorts 1, 2, and 3) .................................................................. 6. EHR data (Cohort 4) ................................................................................... 60 334 167 120 4,008 2,505 b 27.87 b 27.87 3,344 111,703 69,814 Total .......................................................................................................... 14,022 27,064 ........................ 1,311,096 b 27.87 * National Compensation Survey: Occupational wages in the United States May 2016 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’ http://www.bls.gov/oes/current/oes_stru.htm. a Based on the mean wages for 29–1069 Physicians and Surgeons, All Other. b Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other. Request for Comments Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–12306 Filed 6–10–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKBBV9HB2PROD with NOTICES [Docket Nos. FDA–2017–E–6741 and FDA– 2018–E–0046] Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION— NDA 208611 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:36 Jun 10, 2019 The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAXDELA IV INJECTION under new drug application (NDA) 208611 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 12, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 9, 2019. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: 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. Jkt 247001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket Nos. FDA– 2017–E–6741 and FDA–2018–E–0046 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27123-27126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12306]


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

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: ``The AHRQ Safety Program for Improving Antibiotic Use.'' 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 1, 2019 and allowed 60 days for public 
comment. AHRQ did not receive 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 on or before 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:

Proposed Project

The AHRQ Safety Program for Improving Antibiotic Use

    The Agency for Healthcare Research and Quality (AHRQ) requests to 
revise and extend the currently approved AHRQ Safety Program for 
Improving Antibiotic Use. The AHRQ Safety Program for Improving 
Antibiotic Use (the ``AHRQ Safety Program'') aims to help facilities 
implement antibiotic stewardship programs and to reduce unnecessary 
antibiotic prescribing. The AHRQ Safety Program has already been 
implemented in a pilot of integrated delivery systems and a national 
cohort of 400 acute care hospitals, and is currently being implemented 
in a national cohort of 500 long-term care facilities. The AHRQ Safety 
Program was last approved by OMB on September 25, 2017 and will expire 
on September 30, 2020. The request for extension is to allow for 
completion of activities and data collection in the AHRQ Safety 
Program, which are scheduled to occur through March 30, 2021. The OMB 
control number for the AHRQ Safety Program is 0935-0238. All of the 
supporting documents for the current AHRQ Safety Program can be 
downloaded from OMB's website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201707-0935-003.
    The 2017 OMB clearance included one response for the Structural 
Assessment and the Medical Office Survey on Patient Safety Culture 
(MOSOPS), but did not include electronic health record (EHR) data or a 
second response for the Structural Assessment or MOSOPS for the 4th 
cohort planned for ambulatory settings. This was because the original 
OMB clearance expiration date fell in the middle of the planned 4th 
cohort, so the second Structural Assessment and MOSOPS were not within 
the approved information collection period, and EHR data collection 
would have been incomplete. In addition, the project team was not 
certain that the ambulatory care practices would be able to access EHR 
data. Based on the experience of the pilot cohort, however, it is 
believed that many ambulatory practices can access these data, and that 
these practices are more likely to feasibly participate in the AHRQ 
Safety Program. The revision also updates the estimated annual burden 
accordingly, and includes changes to the data collection forms which 
will be used for the ambulatory care cohort based on lessons learned 
during the pilot cohort.

Background for This Collection

    As part of the Department of Health and Human Services (DHHS) 
Hospital Acquired Infection (HAI) National Action Plan (NAP), AHRQ has 
supported the implementation and adoption of the Comprehensive Unit-
based Safety Program (CUSP) to reduce Central-Line Associated 
Bloodstream Infections (CLABSI) and Catheter-Associated Urinary Tract 
Infections (CAUTI), and subsequently applied CUSP to other clinical 
challenges, including reducing surgical site infections and improving 
care for mechanically ventilated patients. As part of the National 
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) to 
increase antibiotic stewardship (defined as organized efforts to 
promote the judicious use of

[[Page 27124]]

antibiotics) across all healthcare settings, AHRQ is applying the 
principles and concepts that have been learned from these HAI reduction 
efforts to antibiotic stewardship (AS).
    Antibiotic therapy has saved countless lives over the past several 
decades. However, bacterial resistance to antibiotics has followed 
closely on the heels of each new agent's introduction. This has led to 
an epidemic of antibiotic resistance, with drug choices for some 
bacterial infections becoming increasingly limited, expensive, and in 
some cases nonexistent. While antibiotics remain a vital and necessary 
cornerstone to the treatment of infections, it is estimated that 20-50% 
of all antibiotics prescribed in U.S. acute care hospitals are either 
unnecessary or inappropriate. When antibiotics are used 
inappropriately, bacterial development of resistance is supported in 
the absence of any therapeutic benefit, and patients receiving 
unnecessary or inappropriate antibiotics are also exposed to the risk 
of adverse effects such as rash or renal injury as well as the risk of 
Clostridioides difficile infection which can cause a deadly diarrhea. 
Unlike misuse of other medications, the misuse of antibiotics can 
adversely impact the health of patients who are not even exposed to 
them because of the potential for spread of resistant organisms. The 
Centers for Disease Control and Prevention (CDC) estimates that each 
year at least two million illnesses and 23,000 deaths are caused by 
drug-resistant bacteria in the United States alone.
    While approaches including development of new antibiotic agents, 
increased surveillance for antibiotic resistance, prevention of HAIs, 
and prevention of transmission of resistant infections are important 
efforts to combat antibiotic resistance, it is critical to curb the 
inappropriate use of antibiotics to slow the emergence of antibiotic 
resistance and to preserve efficacy of existing antibiotics and those 
under development.
    As of January 1st, 2017, The Joint Commission (TJC)'s new 
Antimicrobial Stewardship Standard requires that all acute care 
hospitals have robust antibiotic stewardship programs. In addition, 
starting on November 28, 2017, the Centers for Medicare & Medicaid 
Services (CMS) required that all long-term care facilities that receive 
reimbursement from CMS have antibiotic stewardship programs in place.
    The Comprehensive Unit-Based Safety Program (CUSP), developed at 
the Armstrong Institute at Johns Hopkins University, combines 
improvement in patient safety culture, teamwork, and communication 
together with a technical bundle of interventions to improve patient 
safety. CUSP is a powerful culture change tool, which has been 
successfully utilized to reduce CLABSI in ICUs in Michigan and Rhode 
Island and subsequently to reduce CLABSI by 41% in more than 1,000 ICUs 
in 44 states, Puerto Rico and the District of Columbia. Although 
evidence-based recommendations for prevention of CLABSI had existed for 
years, the combination of safety culture change on units and 
implementation of technical interventions resulted in significant 
reductions in CLABSI and introduced the concept that a rate of zero 
CLABSIs is achievable. CUSP is also being used to reduce other HAIs in 
multiple settings (http://www.ahrq.gov/professionals/quality-patient-safety/hais/index.html).
    This project will assist hospitals, nursing homes, and ambulatory 
care sites across the United States in adopting and implementing AS 
programs and interventions.
    This project has the following goals:

 Identify best practices in the delivery of antibiotic 
stewardship in the acute care, long-term care and ambulatory care 
settings
 Adapt the CUSP model to enhance antibiotic stewardship efforts 
in the health care settings
 Develop a bundle of technical and adaptive interventions and 
associated tools and educational materials designed to support enhanced 
antibiotic stewardship efforts
 Provide technical assistance and training to health care 
organizations nationwide (using a phased approach) to implement 
effective antibiotic stewardship programs and interventions
 Improve communication and teamwork between health care workers 
surrounding antibiotic decision-making
 Improve communication between health care workers and patients 
and families surrounding antibiotic decision-making
 Conduct a comprehensive evaluation to assess the adoption of 
the CUSP for AS in acute care, long-term care and ambulatory care 
settings to identify the effectiveness of the program, process 
outcomes, and lessons learned

    The project will be implemented in four cohorts; (1) Cohort 1 is a 
pilot limited to 10 facilities each in three integrated delivery 
systems spanning acute care, long-term care, and ambulatory settings; 
(2) Cohort 2 will expand to include 250-500 acute care hospitals; (3) 
Cohort 3 will include 250-500 long-term care facilities; and (4) Cohort 
4 will include 250-500 ambulatory care facilities.
    The AHRQ Safety Program is being undertaken pursuant to AHRQ's 
mission to enhance the quality, appropriateness, and effectiveness of 
health services, and access to such services, through the establishment 
of a broad base of scientific research and through the promotion of 
improvements in clinical and health systems practices, including the 
prevention of diseases and other health conditions. 42 U.S.C. 299.

Method of Collection

    To achieve the goals of the AHRQ Safety Program, the following data 
collections will be implemented:
    (1) Structural Assessments: A brief, eight question, online 
Structural Assessment Tool will be administered at baseline (pre-
intervention) and at the end of the intervention period to obtain 
general information about facilities and stewardship infrastructure and 
changes to stewardship infrastructure and interventions that are 
anticipated to be sustained as a result of the AHRQ Safety Program (one 
response per facility for the 4th cohort in ambulatory settings was 
included in the original OMB review, this revision adds an additional 
response per facility, relevant changes made to line 1.b. in Exhibits 
A.1. and A.2.).
    (2) Team Antibiotic Review Form: The Stewardship Team in hospitals 
and nursing homes will conduct monthly reviews of at least 10 patients 
who received antibiotics and fill out an assessment tool in conjunction 
with frontline staff to determine if the ``four moments of antibiotic 
decision-making'' are being considered by providers. The four moments 
can be summarized as: (1) Is an infection present requiring 
antibiotics? (2) Are appropriate cultures being ordered and is the most 
optimal initial choice of antibiotics being prescribed? (3) (after at 
least 24 hours) Is it appropriate to make changes to the antibiotic 
regimen (e.g., stop therapy, narrow therapy, change from intravenous to 
oral therapy)? (4) What duration of therapy is appropriate?
    (3) The AHRQ Surveys on Patient Safety Culture: The appropriate 
versions of these surveys and the MOSOPS will be administered to all 
participating staff at the beginning and end of the intervention. Each 
survey asks questions about patient safety issues, medical errors, and 
event reporting in the respective settings. The surveys will be 
administered to all participating staff at

[[Page 27125]]

the beginning and end of the intervention. (One response per respondent 
for the 4th cohort in ambulatory settings was included in the original 
OMB review, this revision adds an additional response per respondent, 
relevant changes made to line 3.d. in Exhibits A.1. and A.2.).
    a. The Hospital Survey on Patient Safety Culture (HSOPS) will be 
utilized to evaluate safety culture for acute care hospitals.
    b. The Nursing Home Survey on Patient Safety Culture (NHSOPS) will 
be administered in long-term care.
    c. The Medical Office Survey on Patient Safety Culture (MOSOPS) 
will be administered in ambulatory care centers.
    (4) Semi-structured qualitative interviews: During the project 
pilot period with Cohort 1, in-person and/or telephone discussions will 
be held before and after implementation with stewardship champions/
organizational leaders, physicians, pharmacists, nurse practitioners, 
physician assistants, nurses, certified nursing assistants and others 
deemed relevant, to learn about the facilitators and barriers to a 
successful antibiotic stewardship program. Specific areas of interest 
include stakeholder perceptions of implementation process and outcomes, 
including successes and challenges with carrying out project tasks and 
perceived utility of the project; staff roles, engagement and support; 
and antibiotic prescribing etiquette & culture (i.e., social norms and 
local cultural factors that contribute to prescribing behavior at the 
facility/unit-level).
    (5) Electronic Health Record (EHR) data: Unit-level antibiotic 
therapy prescriptions and antibiotic use for diagnosed respiratory 
conditions will be extracted from the Electronic Health Records (EHRs) 
of participating units and used to assess the impact of the AHRQ Safety 
Program. (4th cohort in ambulatory settings portion is new from 
original OMB review, noted in line 6 in Exhibits A.1. and A.2.).

Estimated Annual Respondent Burden

    Exhibit A.1 shows the estimated annualized burden hours for the 
respondents' time to complete the Structural Assessments, Team 
Antibiotic Review Forms, AHRQ Patient Safety Culture Surveys, semi-
structured qualitative interviews, and EHR data extractions. Data will 
be collected from 30 acute care, long-term care, and ambulatory care 
sites during the Cohort 1 one-year pilot period; up to 500 acute care 
hospitals in Cohort 2; up to 500 long-term care facilities in Cohort 3; 
and up to 500 ambulatory care sites in Cohort 4. With this revision, 
the total estimated annualized burden hours for the data collection 
activities are 27,064.

                                 Exhibit A.1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments:
    a. Structural Assessments--Cohorts 1, 2 and              343               2             0.2             137
     3 (baseline, post-intervention)............
    b. Structural Assessments--Cohort 4                      167               2             0.2              67
     (baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2,                337              90            0.25           7,583
 and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
    a. HSOPS, NHSOPS, MOSOPS (Cohort 1).........              83               2             0.5              83
    b. HSOPS (Cohort 2).........................           4,167               2             0.5           4,167
    c. NHSOPS (Cohort 3)........................           4,167               2             0.5           4,167
    d. MOSOPS (Cohort 4)........................           4,167               2             0.5           4,167
4. Semi-structured qualitative interviews
 (Cohort 1):
    a. Physicians...............................              30               2               1              60
    b. Other Health Practitioners...............              60               2               1             120
5. EHR data (Cohorts 1, 2, and 3)...............             334              12               1           4,008
6. EHR data (Cohort 4)..........................             167              15               1           2,505
                                                 ---------------------------------------------------------------
    Total.......................................          14,022  ..............  ..............          27,030
----------------------------------------------------------------------------------------------------------------

    Exhibit A.2 shows the estimated annualized cost burden based on the 
respondents' time to complete the data collection forms. The total cost 
burden is estimated to be $1,311,096.

                                  Exhibit A.2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments:
    a. Structural Assessments--Cohorts 1, 2 and              343             137      \a\ $98.83         $13,540
     3 (baseline, post-intervention)............
    b. Structural Assessments--Cohort 4                      167              67       \a\ 98.83           6,622
     (baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2,                337           7,583       \a\ 98.83         749,428
 and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
    a. HSOPS, NHSOPS, MOSOPS (Cohort 1).........              83              83       \b\ 27.87           2,313
    b. HSOPS (Cohort 2).........................           4,167           4,167       \b\ 27.87         116,134
    c. NHSOPS (Cohort 3)........................           4,167           4,167       \b\ 27.87         116,134
    d. MOSOPS (Cohort 4)........................           4,167           4,167       \b\ 27.87         116,134
4. Semi-structured qualitative interviews
 (Cohort 1):
    a. Physicians...............................              30              60       \a\ 98.83           5,930

[[Page 27126]]

 
    b. Other Health Practitioners...............              60             120       \b\ 27.87           3,344
5. EHR data (Cohorts 1, 2, and 3)...............             334           4,008       \b\ 27.87         111,703
6. EHR data (Cohort 4)..........................             167           2,505       \b\ 27.87          69,814
                                                 ---------------------------------------------------------------
    Total.......................................          14,022          27,064  ..............       1,311,096
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2016 ``U.S. Department of Labor,
  Bureau of Labor Statistics:'' http://www.bls.gov/oes/current/oes_stru.htm.
\a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other.
\b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare
  Practitioners and Technical Workers, All Other.

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.

Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-12306 Filed 6-10-19; 8:45 am]
BILLING CODE 4160-90-P