Agency Information Collection Activities: Proposed Collection; Comment Request, 34952-34954 [2017-15796]
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34952
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices
chloride, trospium chloride,
darifenacin, solifenacin succinate,
fesoterodine, tolterodine, propiverine);
calcium channel blockers (e.g.,
nimodipine); botulinum toxin
injections; TRPV1 antagonists (e.g.,
resiniferatoxin); antidepressants (e.g.,
tricyclics, SSRI, SNRI); beta-3 adenoreceptor agonists (e.g., mirabegron).
Combinations of eligible
nonpharmacological and
pharmacological interventions.
Exclusion
Interventions not available in the
United States and surgical treatments.
Comparator
Inclusion
Other eligible nonpharmacological
interventions, other eligible
pharmacological interventions, other
eligible combination interventions, no
active treatment or placebo.
Exclusion
Noneligible interventions, including
surgery.
Outcomes
mstockstill on DSK30JT082PROD with NOTICES
Inclusion
Measures of UI: Pad tests and other
measures of leakage volumes;
incontinence counts/frequency (e.g., by
diary), including urgency UI counts/
frequency and stress UI counts/
frequency; physical examination (e.g.,
cough stress test); complete remission,
improvement (partial remission),
worsening, no change; subjective
bladder control; patient satisfaction
with intervention; need to use
protection.
Quality of life and related
questionnaires: Generic, validated; UIspecific, validated.
Other patient-centered outcomes,
based on the findings of the contextual
question (what defines a successful
outcome).
Adverse events.
Exclusion
Bladder and pelvic tests that do not
measure UI specifically or are used for
diagnostic purposes (e.g., urodynamic
testing, pelvic muscle strength);
urination measures that do not measure
UI specifically (e.g., total voids [that
include nonincontinence voids],
catheterization, postvoid residuals,
urinary retention, perceived micturition
difficulty).
Timing
Inclusion
Minimum 4 weeks follow up (since
the start of treatment).
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Exclusion
Exclusion
Unable to read or translate.
None.
Settings
Sharon B. Arnold,
Deputy Director.
Inclusion
[FR Doc. 2017–15799 Filed 7–26–17; 8:45 am]
Interventions provided in primary
care or specialized clinic or equivalent
by any healthcare provider; participants
are community-dwelling.
Exclusion
Surgical, institutionalized, or inhospital settings.
Country setting.
Inclusion
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
Exclusion
None.
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 OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
SUMMARY:
Study Designs
Inclusion
For effectiveness outcomes:
Randomized controlled trials (RCTs),
with no minimum sample size,
including pooled individual patient
data from RCTs; nonrandomized
comparative studies that used strategies
to reduce bias (e.g., adjustment,
stratification, matching, or propensity
scores), N≥50 women per group (N≥100
women total).
For harms outcomes: RCTs, with no
minimum sample size; nonrandomized
longitudinal comparative studies
(regardless of strategies to reduce bias),
including registries or large databases,
N≥50 women per group (N≥100 women
total); single arm longitudinal studies,
including registries, large databases, and
large case series N≥100 women; casecontrol studies (where cases are selected
based on presence of harm), N≥50
female cases and ≥50 female controls
(N≥100 women total).
All outcomes: Published, peerreviewed articles or unpublished data
from the Food and Drug Administration
(FDA) or from the Web site
ClinicalTrials.gov.
Exclusion
For effectiveness outcomes: Single
group, case-control, and case report/
series studies; nonrandomized
comparative studies with only crude or
unadjusted data.
Publication language.
Inclusion
Any.
Frm 00030
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Any geographic area.
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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
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
E:\FR\FM\27JYN1.SGM
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34953
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices
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 UnitBased 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
respondents
Form name
Hours per
response
Total burden
hours
500
333
2
90
0.2
0.2
200
5,994
4,167
4,167
4,167
2
2
2
.5
.5
.5
4,167
4,167
4,167
5. EHR data .....................................................................................................
mstockstill on DSK30JT082PROD with NOTICES
1. Structural Assessment .................................................................................
2. Team Antibiotic Review Form .....................................................................
3. Surveys on Patient Safety Culture (SOPS)
a. HSOPS .................................................................................................
b. NHSOPS ..............................................................................................
c. MOSOPS ..............................................................................................
4. Semi-structured qualitative interviews (Physicians—line 1; Other Health
Practitioners—line 2 .....................................................................................
Number of
responses
per
respondent
30
60
500
2
2
12
1
1
.5
60
120
3,000
Total ..........................................................................................................
13,924
N/A
N/A
21,875
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34954
Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly
wage rate*
($)
Total cost
burden
($)
500
333
200
5,994
a 98.83
4,167
4,167
4,167
4,167
4,167
4,167
b 27.87
60
120
3,000
a 98.83
5. EHR data .....................................................................................................
30
60
500
b 27.87
5,930
3,344
83,610
Total ..........................................................................................................
13,924
21,875
N/A
1,053,439
1. Structural Assessment .................................................................................
2. Team Antibiotic Review Form .....................................................................
3. SOPS
a. HSOPS .................................................................................................
b. NHSOPS ..............................................................................................
c. MOSOPS ..............................................................................................
4. Semi-structured qualitative interviews (Physicians—line 1; Other Health
Practitioners—line 2 .....................................................................................
a 98.83
b 27.87
b 27.87
b 27.87
19,766
592,387
116,134
116,134
116,134
National Compensation Survey: Occupational wages in the United States May 2016 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’
https://www.bls.gov/oes/current/oes_stru.htm
a Based on the mean wages for 29–1069 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.
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
‘‘Implementation of TeamSTEPPS in
Primary Care Settings (ITS–PC).’’ This
proposed information collection was
previously published in the Federal
Register on May 5, 2017 and allowed 60
days for public comment. No
substantive comments were received.
SUMMARY:
Comments on this notice must be
received by August 28, 2017.
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:
[FR Doc. 2017–15796 Filed 7–26–17; 8:45 am]
BILLING CODE 4160–90–P
mstockstill on DSK30JT082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
19:17 Jul 26, 2017
Jkt 241001
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Proposed Project
‘‘Implementation of TeamSTEPPS in
Primary Care Settings (ITS–PC)’’
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection. As
part of its effort to fulfill its mission,
AHRQ, in collaboration with the
Department of Defense’s (DoD) Tricare
Management Activity, developed
TeamSTEPPS® (Team Strategies and
Tools for Enhancing Performance and
Patient Safety) to provide an evidencebased suite of tools and strategies for
training teamwork-based patient safety
to health care professionals.
TeamSTEPPS includes multiple toolkits
which are all tied to, or are variants of,
the core curriculum. In addition to the
core curriculum, TeamSTEPPS
resources have been developed for
primary care, rapid response systems,
long-term care, and patients with
limited English proficiency.
The main objective of the
TeamSTEPPS program is to improve
patient safety by training health care
staff in various teamwork,
communication, and patient safety
concepts, tools, and techniques and
ultimately helping to build national
capacity for supporting teamwork-based
patient safety efforts in health care
organizations.
Created in 2007, AHRQ’s National
Implementation Program has trained
Master Trainers who have stimulated
the use and adoption of TeamSTEPPS in
health care delivery systems. These
individuals were trained using the
TeamSTEPPS core curriculum at
regional training centers across the U.S.
AHRQ has also provided technical
E:\FR\FM\27JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Notices]
[Pages 34952-34954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15796]
=======================================================================
-----------------------------------------------------------------------
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 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
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:'' https://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