82 FR 34952 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 143 (July 27, 2017)

Page Range		34952-34954
FR Document		2017-15796

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.'' This proposed information collection was previously published in the Federal Register on May 5, 2017, 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.

Federal Register, Volume 82 Issue 143 (Thursday, July 27, 2017)

[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 34952-34954]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15796]


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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: ``The AHRQ Safety Program for Improving Antibiotic Use.''
    This proposed information collection was previously published in 
the Federal Register on May 5, 2017, 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 August 28, 2017.

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

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. Antibiotics can have serious adverse effects including 
Clostridium difficile infections, organ dysfunction, allergic 
reactions, and the development of antibiotic resistance on both a 
patient level and population level. This project will assist acute 
care, long-term care and ambulatory care settings across the United 
States in adopting and implementing antibiotic stewardship

[[Page 34953]]

programs, which are coordinated efforts to improve the use of 
antibiotics by promoting the selection of the optimal antibiotic 
regimen, dose, route of administration, and duration of therapy.
    More specifically, 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 Comprehensive Unit-Based Safety Program (CUSP) 
model to enhance antibiotic stewardship efforts in the health care 
settings.
     Assess the adoption of CUSP for antibiotic stewardship and 
evaluate the effectiveness of the intervention in the participating 
health care systems.
     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/families surrounding antibiotic decision-making.
    This study is being conducted by AHRQ through its contractor Johns 
Hopkins University, with subcontracted partner NORC. The AHRQ Safety 
Program for Improving Antibiotic Use 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 this project the following data collections 
will be implemented:
    (1) Structural Assessments: A brief (five to seven questions), 
online Structural Assessment Tool will be administered in all settings 
at baseline (pre-intervention) and at the end of the intervention 
period to obtain general information about facilities and existing 
stewardship infrastructure and changes in stewardship infrastructure 
and interventions as a result of the AHRQ Safety Program.
    (2) Team Antibiotic Review Form: The Stewardship Team 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 are (1) Is an infection 
present requiring antibiotics? (2) Were appropriate cultures ordered 
and best initial choice of antibiotics made? (3) (after at least 24 
hours) Are changes in antibiotic orders appropriate? (4) What duration 
of therapy is appropriate?
    (3) The AHRQ Surveys on Patient Safety Culture 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.
    a. The Hospital Survey on Patient Safety Culture will be utilized 
to evaluate safety culture for acute care hospitals.
    b. The Nursing Home Survey on Patient Safety Culture will be 
administered in long term care.
    c. The Medical Office Survey on Patient Safety Culture will be 
administered in ambulatory care centers.
    (4) Semi-Structured Qualitative Interviews: 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 
usage and clinical outcomes will be extracted from the EHRs of 
participating health care facilities and used to assess the impact of 
the AHRQ Safety Program for Improving Antibiotic Use.

Estimated Annual Respondent Burden

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of    responses  per     Hours per     Total burden
                                                    respondents      respondent      response          hours
----------------------------------------------------------------------------------------------------------------
1. Structural Assessment........................             500               2             0.2             200
2. Team Antibiotic Review Form..................             333              90             0.2           5,994
3. Surveys on Patient Safety Culture (SOPS)
    a. HSOPS....................................           4,167               2              .5           4,167
    b. NHSOPS...................................           4,167               2              .5           4,167
    c. MOSOPS...................................           4,167               2              .5           4,167
4. Semi-structured qualitative interviews                     30               2               1              60
 (Physicians--line 1; Other Health                            60               2               1             120
 Practitioners--line 2..........................
5. EHR data.....................................             500              12              .5           3,000
                                                 ---------------------------------------------------------------
    Total.......................................          13,924             N/A             N/A          21,875
----------------------------------------------------------------------------------------------------------------


[[Page 34954]]


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden    hourly  wage     Total cost
                                                    respondents        hours        rate*  ($)      burden  ($)
----------------------------------------------------------------------------------------------------------------
1. Structural Assessment........................             500             200       \a\ 98.83          19,766
2. Team Antibiotic Review Form..................             333           5,994       \a\ 98.83         592,387
3. SOPS
    a. HSOPS....................................           4,167           4,167       \b\ 27.87         116,134
    b. NHSOPS...................................           4,167           4,167       \b\ 27.87         116,134
    c. MOSOPS...................................           4,167           4,167       \b\ 27.87         116,134
4. Semi-structured qualitative interviews                     30              60       \a\ 98.83           5,930
 (Physicians--line 1; Other Health                            60             120       \b\ 27.87           3,344
 Practitioners--line 2..........................
5. EHR data.....................................             500           3,000       \b\ 27.87          83,610
                                                 ---------------------------------------------------------------
    Total.......................................          13,924          21,875             N/A       1,053,439
----------------------------------------------------------------------------------------------------------------
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 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.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-15796 Filed 7-26-17; 8:45 am]
 BILLING CODE 4160-90-P

34952 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices

chloride, trospium chloride, Exclusion Exclusion
darifenacin, solifenacin succinate, Unable to read or translate.
fesoterodine, tolterodine, propiverine); None.
calcium channel blockers (e.g., Sharon B. Arnold,
Settings
nimodipine); botulinum toxin Deputy Director.
injections; TRPV1 antagonists (e.g., Inclusion [FR Doc. 2017–15799 Filed 7–26–17; 8:45 am]
resiniferatoxin); antidepressants (e.g., BILLING CODE 4160–90–P
tricyclics, SSRI, SNRI); beta-3 adeno- Interventions provided in primary
receptor agonists (e.g., mirabegron). care or specialized clinic or equivalent
Combinations of eligible by any healthcare provider; participants
are community-dwelling. DEPARTMENT OF HEALTH AND
nonpharmacological and HUMAN SERVICES
pharmacological interventions. Exclusion
Exclusion Agency for Healthcare Research and
Surgical, institutionalized, or in- Quality
Interventions not available in the hospital settings.
United States and surgical treatments. Agency Information Collection
Country setting.
Comparator Activities: Proposed Collection;
Inclusion Comment Request
Inclusion
Any geographic area. AGENCY: Agency for Healthcare Research
Other eligible nonpharmacological and Quality, HHS.
interventions, other eligible Exclusion ACTION: Notice.
pharmacological interventions, other
eligible combination interventions, no None. SUMMARY: This notice announces the
active treatment or placebo. Study Designs intention of the Agency for Healthcare
Exclusion Research and Quality (AHRQ) to request
Inclusion that the Office of Management and
Noneligible interventions, including Budget (OMB) approve the proposed
surgery. For effectiveness outcomes:
information collection project: ‘‘The
Randomized controlled trials (RCTs),
Outcomes AHRQ Safety Program for Improving
with no minimum sample size,
Antibiotic Use.’’
Inclusion including pooled individual patient This proposed information collection
Measures of UI: Pad tests and other data from RCTs; nonrandomized was previously published in the Federal
measures of leakage volumes; comparative studies that used strategies Register on May 5, 2017, and allowed
incontinence counts/frequency (e.g., by to reduce bias (e.g., adjustment, 60 days for public comment. AHRQ did
diary), including urgency UI counts/ stratification, matching, or propensity not receive any substantive comments.
frequency and stress UI counts/ scores), N≥50 women per group (N≥100 The purpose of this notice is to allow an
frequency; physical examination (e.g., women total). additional 30 days for public comment.
cough stress test); complete remission, For harms outcomes: RCTs, with no DATES: Comments on this notice must be
improvement (partial remission), minimum sample size; nonrandomized received by August 28, 2017.
worsening, no change; subjective longitudinal comparative studies ADDRESSES: Written comments should
bladder control; patient satisfaction (regardless of strategies to reduce bias), be submitted to: AHRQ’s OMB Desk
with intervention; need to use including registries or large databases, Officer by fax at (202) 395–6974
protection. N≥50 women per group (N≥100 women
Quality of life and related (attention: AHRQ’s desk officer) or by
total); single arm longitudinal studies, email at OIRA_submission@
questionnaires: Generic, validated; UI- including registries, large databases, and
specific, validated. omb.eop.gov (attention: AHRQ’s desk
large case series N≥100 women; case- officer).
Other patient-centered outcomes,
based on the findings of the contextual control studies (where cases are selected FOR FURTHER INFORMATION CONTACT:
question (what defines a successful based on presence of harm), N≥50 Doris Lefkowitz, AHRQ Reports
outcome). female cases and ≥50 female controls Clearance Officer, (301) 427–1477, or by
Adverse events. (N≥100 women total). email at doris.lefkowitz@AHRQ.hhs.gov.
All outcomes: Published, peer- SUPPLEMENTARY INFORMATION:
Exclusion
reviewed articles or unpublished data
Bladder and pelvic tests that do not from the Food and Drug Administration Proposed Project
measure UI specifically or are used for (FDA) or from the Web site In accordance with the Paperwork
diagnostic purposes (e.g., urodynamic ClinicalTrials.gov. Reduction Act, 44 U.S.C. 3501–3521,
testing, pelvic muscle strength); AHRQ invites the public to comment on
urination measures that do not measure Exclusion this proposed information collection.
UI specifically (e.g., total voids [that Antibiotics can have serious adverse
include nonincontinence voids], For effectiveness outcomes: Single
group, case-control, and case report/ effects including Clostridium difficile
catheterization, postvoid residuals, infections, organ dysfunction, allergic
mstockstill on DSK30JT082PROD with NOTICES

urinary retention, perceived micturition series studies; nonrandomized
comparative studies with only crude or reactions, and the development of
difficulty). antibiotic resistance on both a patient
unadjusted data.
Timing level and population level. This project
Publication language. will assist acute care, long-term care and
Inclusion ambulatory care settings across the
Inclusion
Minimum 4 weeks follow up (since United States in adopting and
the start of treatment). Any. implementing antibiotic stewardship

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34954 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average Total cost
Number of Total burden hourly
Form name burden
respondents hours wage rate* ($)
($)

1. Structural Assessment ................................................................................. 500 200 a 98.83 19,766
2. Team Antibiotic Review Form ..................................................................... 333 5,994 a 98.83 592,387
3. SOPS
a. HSOPS ................................................................................................. 4,167 4,167 b 27.87 116,134
b. NHSOPS .............................................................................................. 4,167 4,167 b 27.87 116,134
c. MOSOPS .............................................................................................. 4,167 4,167 b 27.87 116,134
4. Semi-structured qualitative interviews (Physicians—line 1; Other Health
Practitioners—line 2 ..................................................................................... 30 60 a 98.83 5,930
60 120 b 27.87 3,344
5. EHR data ..................................................................................................... 500 3,000 b 27.87 83,610

Total .......................................................................................................... 13,924 21,875 N/A 1,053,439
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 DEPARTMENT OF HEALTH AND Proposed Project
HUMAN SERVICES ‘‘Implementation of TeamSTEPPS in
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s Primary Care Settings (ITS–PC)’’
Agency for Healthcare Research and
information collection are requested Quality In accordance with the Paperwork
with regard to any of the following: (a) Reduction Act, 44 U.S.C. 3501–3521,
Whether the proposed collection of Agency Information Collection AHRQ invites the public to comment on
information is necessary for the proper Activities: Proposed Collection; this proposed information collection. As
performance of AHRQ health care Comment Request part of its effort to fulfill its mission,
research and health care information AHRQ, in collaboration with the
dissemination functions, including AGENCY:Agency for Healthcare Research Department of Defense’s (DoD) Tricare
whether the information will have and Quality, HHS. Management Activity, developed
practical utility; (b) the accuracy of TeamSTEPPS® (Team Strategies and
ACTION: Notice. Tools for Enhancing Performance and
AHRQ’s estimate of burden (including
hours and costs) of the proposed Patient Safety) to provide an evidence-
SUMMARY: This notice announces the based suite of tools and strategies for
collection(s) of information; (c) ways to intention of the Agency for Healthcare
enhance the quality, utility, and clarity training teamwork-based patient safety
Research and Quality (AHRQ) to request to health care professionals.
of the information to be collected; and that the Office of Management and TeamSTEPPS includes multiple toolkits
(d) ways to minimize the burden of the Budget (OMB) approve the proposed which are all tied to, or are variants of,
collection of information upon the information collection project the core curriculum. In addition to the
respondents, including the use of ‘‘Implementation of TeamSTEPPS in core curriculum, TeamSTEPPS
automated collection techniques or Primary Care Settings (ITS–PC).’’ This resources have been developed for
other forms of information technology. proposed information collection was primary care, rapid response systems,
Comments submitted in response to this previously published in the Federal long-term care, and patients with
notice will be summarized and included Register on May 5, 2017 and allowed 60 limited English proficiency.
in the Agency’s subsequent request for days for public comment. No The main objective of the
OMB approval of the proposed substantive comments were received. TeamSTEPPS program is to improve
information collection. All comments patient safety by training health care
will become a matter of public record. DATES: Comments on this notice must be staff in various teamwork,
received by August 28, 2017. communication, and patient safety
Sharon B. Arnold,
ADDRESSES: Written comments should concepts, tools, and techniques and
Deputy Director. ultimately helping to build national
[FR Doc. 2017–15796 Filed 7–26–17; 8:45 am]
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974 capacity for supporting teamwork-based
BILLING CODE 4160–90–P patient safety efforts in health care
(attention: AHRQ’s desk officer) or by
organizations.
email at OIRA_submission@
Created in 2007, AHRQ’s National
omb.eop.gov (attention: AHRQ’s desk Implementation Program has trained
mstockstill on DSK30JT082PROD with NOTICES

officer). Master Trainers who have stimulated
FOR FURTHER INFORMATION CONTACT: the use and adoption of TeamSTEPPS in
Doris Lefkowitz, AHRQ Reports health care delivery systems. These
Clearance Officer, (301) 427–1477, or by individuals were trained using the
TeamSTEPPS core curriculum at
email at doris.lefkowitz@AHRQ.hhs.gov.
regional training centers across the U.S.
SUPPLEMENTARY INFORMATION: AHRQ has also provided technical

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Document Created: 2017-07-27 02:07:13
Document Modified: 2017-07-27 02:07:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on this notice must be received by August 28, 2017.
Contact		Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation		82 FR 34952

82 FR 34952 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 143 (July 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality