Agency Information Collection Activities: Proposed Collection; Comment Request, 37596-37598 [2016-13841]
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37596
Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
III. How does the comparative
effectiveness of treatment vary by
patient characteristics, including age,
sex, risk factors, comorbidities,
characteristics of disease, anatomic
segment affected, and characteristics of
the therapy (e.g., exercise intensity, type
of mechanical compression)?
IV. What are the comparative safety
concerns associated with each treatment
strategy (e.g., adverse drug reactions,
bleeding)? Do the safety concerns vary
by patient subgroup (age, sex, race, risk
factors, comorbidities, anatomic
segment, or disease severity)?
PICOTS (Population, Intervention,
Comparator, Outcome, Timing, Setting)
asabaliauskas on DSK3SPTVN1PROD with NOTICES
KQ 1: Diagnosis
I. Population(s):
A. Adults (over age 18) with the
diagnosis of LE varicose veins, LE
chronic venous insufficiency/
incompetence/reflux, and/or LE
chronic venous thrombosis/
obstruction (including postthrombotic syndrome)
II. Diagnostic Measures:
A. Air plethysmography, LE venous
duplex ultrasonography (with and
without compression), invasive
venography, magnetic resonance
venography, computed tomographic
venography, serum D-dimer testing,
Villalta score
III. Comparators:
A. Diagnostic modalities listed above
(air plethysmography, LE duplex
venous ultrasonography [with and
without compression], invasive
venography, magnetic resonance
venography, computed tomographic
venography, serum D-dimer testing,
Villalta score) will be compared to
one another
IV. Outcomes:
A. Sensitivity, specificity, positive
predictive value, negative
predictive value, inter -rater
reliability, internal consistency, test
-retest reliability, false positives,
false negatives, and positive and
negative likelihood ratios for each
diagnostic measure listed above
will be compared
V. Timing:
A. Not applicable
VI. Settings:
A. All clinical settings, including
inpatient and outpatient
KQs 2–3: Treatment
I. Population(s):
A. KQ 2: A symptomatic or
symptomatic adults (over age 18)
with the diagnosis of LE varicose
veins and/or LE chronic venous
insufficiency/incompetence/reflux:
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19:02 Jun 09, 2016
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i. Subgroup analysis: age, race/
ethnicity, sex, body weight, CEAP
classification, VCSS classification,
severity of disease, anatomic
segment affected (e.g., iliofemoral,
infrainguinal), known malignancy,
presence of LE ulcer
A. KQ 3: A symptomatic or
symptomatic adults(over age 18)
with the diagnosis of LE chronic
venous thrombosis/obstruction
(including post-thrombotic
syndrome):
i. Subgroup analysis: age, race/
ethnicity, sex, body weight, CEAP
classification, VCSS classification,
Villalta score, severity of disease,
anatomic segment affected (e.g.,
iliofemoral, infrainguinal), known
malignancy, presence of LE ulcer
II. Interventions:
A. KQ 2: lifestyle interventions (e.g .,
smoking cessation, leg elevation,
weight reduction, exercise), medical
therapy, local skin care/wound
care, mechanical compression
therapy, and invasive procedures
(i.e., surgical and endovascular
procedures)
i. Medical therapies: diuretics,
aspirin, pentoxifylline,
prostacyclins, zinc sulfate
ii. Invasive surgical/endovascular
procedures: sclerotherapy (liquid,
foam, glue), radiofrequency
ablation, thermal ablation, chemical
ablation, ambulatory phlebectomy,
transilluminated powered
phlebectomy, venous ligation,
venous excision
B. KQ 3: lifestyle interventions (e.g.,
smoking cessation, leg elevation,
weight reduction, exercise), medical
therapy, local skin care/wound
care, mechanical compression
therapy, and invasive procedures
(i.e., surgical and endovascular
procedures)
i. Medical therapies: anticoagulants
including warfarin, apixaban,
rivaroxaban, edoxaban, and
dabigatran; diuretics
ii. Invasive surgical/endovascular
procedures: endovenous
angioplasty/stenting, ultrasound
accelerated thrombolysis for
chronic DVT (EkoSonic®
endovascular system), surgical
thromboembolectomy
III. Comparators:
A. Specific treatments will be
compared to other included
treatments as described above or to
no treatment (placebo or usual care)
IV. Outcomes:
A. Changes on standardized symptom
scores (Villalta score, CEAP
classification, AVVQ score, and
VCSS score); qualitative reduction
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Frm 00031
Fmt 4703
Sfmt 4703
in Ledema; qualitative reduction in
LE pain; improvement in LE venous
hemodynamics/reflux severity as
measured by air plethysmography,
duplex ultrasonography, or invasive
venography; venous wound healing,
recurrent ulceration, patientreported quality of life (including
AVVQ), repeat intervention, LE
amputation E
B. Adverse effects of treatment,
including: adverse drug reactions;
bleeding (including intracranial
bleeding); venous wound infection;
contrast nephropathy; radiationrelated injuries; exercise-related
harms; periprocedural
complications (vessel dissection,
vessel perforation, and AV fistula),
thrombophlebitis, venous
thrombosis (including stent
thrombosis), venous
thromboembolic events (including
PE), and death
V. Timing:
A. Studies with all durations of
followup will be included in the
review; for symptomatic patients,
we will attempt to categorize
studies into those that evaluate
short-term (≤30 days), intermediateter m (31 days to 6 months), and
long-term (≤ 6 months) events.
VI. Settings:
A. Any
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–13761 Filed 6–9–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Survey
of Hospital Quality Leaders.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on February 10, 2016 and
SUMMARY:
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Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
allowed 60 days for public comment.
AHRQ received no 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 July 11, 2016.
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
Survey of Hospital Quality Leaders
The Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Hospital Survey (HCAHPS)
was first implemented on a voluntary
basis in 2006 to assess patients’
experiences with care. Today, hospitals
subject to the Inpatient Prospective
Payment System (IPPS) annual payment
update provisions are required to collect
and submit HCAHPS data in order to
receive their full annual payment
update. In addition, HCAHPS
performance was added to the
calculation of the value-based incentive
payment in the Hospital Value-Based
Purchasing (Hospital VBP) program,
beginning with discharges in October
2012. The FY 2015 Hospital VBP
program links 30% of the Inpatient
Prospective Payment System hospitals’
payment from CMS to HCAHPS
performance.
Despite the high stakes associated
with HCAHPS scores, little is known
about the ways in which hospitals are
using HCAHPS data and supplemental
information about patient experience to
understand and improve their patients’
experiences.
This research has the following goals:
(1) To characterize the role of
HCAHPS in hospitals’ efforts to improve
patient experiences
(2) to identify the types of quality
improvement activities that hospitals
implement to improve their HCAHPS
scores
(3) to describe hospitals’ perspectives
on HCAHPS
(4) to determine the types of
information collected by hospitals
beyond those required for Hospital VBP
This study is being conducted by
AHRQ through its contractor, the RAND
Corporation, pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
Survey of Hospital Quality Leaders:
this survey will elicit information from
approximately 500 hospital quality
leaders in a variety of hospital settings,
including high- and low-performing
hospitals, facilities of varying sizes, and
hospitals representing all nine
geographic Census divisions. Hospital
quality leaders will be asked to provide
information about the use of HCAHPS
in their hospital, with questions
addressing all of the substantive areas
identified in the goals section above.
Characterizing hospitals’ use of
HCAHPS data will provide important
insight into the activities hospitals
conduct to improve patient experience
scores. This information may be useful
in supporting hospitals who lag behind
their peers, learning from hospitals with
outstanding records of patient
experience, and providing
recommendations that may be used to
refine HCAHPS survey content.
Estimated Annual Respondent Burden
Table 1 shows the estimated
annualized burden and cost for the
respondents’ time to participate in this
data collection. These burden estimates
are based on tests of data collection
conducted on nine or fewer entities. As
indicated below, the annual total
burden hours are estimated to be 294
hours. The annual total cost associated
with the annual total burden hours is
estimated to be $14,708.
Table 1 shows the estimated
annualized burden for the respondents’
time to participate in this data
collection. The Survey of Hospital
Quality Leaders will be administered to
500 individuals. Prior work suggests
that 3–5 items can typically be
completed per minute, depending on
item complexity and respondent
characteristics, (Hays & Reeve, 2010;
Berry, 2009). We have calculated our
burden estimate using a conservative
estimate of 4.5 items per minute. The
survey contains 159 items and is thus
estimated to require an average
administration time of 35 minutes. As
indicated below, the annual total
burden hours are estimated to be 294
hours.
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS AND COST
Number of
respondents
Collection task
Number of
responses per
respondent
Hours per
response
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Survey of Hospital Quality Leaders .........
500
1
.59
294
$49.96
$14,708
Totals ................................................
........................
........................
........................
294
........................
14,708
asabaliauskas on DSK3SPTVN1PROD with NOTICES
* Based upon mean hourly wages, ‘‘National Compensation Survey: All United States December 2009—January 2011,’’ U.S. Department of
Labor, Bureau of Labor Statistics.
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
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19:02 Jun 09, 2016
Jkt 238001
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
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Sfmt 4703
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
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37598
Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–13841 Filed 6–9–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6069–N]
Medicare Program; Pre-Claim Review
Demonstration for Home Health
Services
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces a 3year Medicare pre-claim review
demonstration for home health services
in the states of Illinois, Florida, Texas,
Michigan, and Massachusetts where
there have been high incidences of fraud
and improper payments for these
services.
DATES: This demonstration will begin in
Illinois no earlier than August 1, 2016,
in Florida no earlier than October 1,
2016, and in Texas no earlier than
December 1, 2016. The demonstration
will begin in Michigan and
Massachusetts no earlier than January 1,
2017.
FOR FURTHER INFORMATION CONTACT:
Jennifer McMullen, (410) 786–7635.
Questions regarding the Medicare PreClaim Review Demonstration for Home
Health Services should be sent to
HHPreClaimDemo@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
I. Background and Legislative
Authority
Section 402(a)(1)(J) of the Social
Security Amendments of 1967 (42
U.S.C. 1395b–1(a)(1)(J)) authorizes the
Secretary to develop demonstration
projects that ‘‘develop or demonstrate
improved methods for the investigation
and prosecution of fraud in the
provision of care or services under the
health programs established by the
Social Security Act’’ (the Act).
According to this authority, we will
implement a Medicare demonstration
that establishes a pre-claim review
process for home health agencies
(HHAs) to assist in developing
improved procedures for the
identification, investigation, and
prosecution of Medicare fraud occurring
among HHAs providing services to
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Medicare beneficiaries. The proposed
demonstration will begin in Illinois not
earlier than August 1, 2016, will begin
in Florida not earlier than October 1,
2016, and will begin in Texas not earlier
than December 1, 2016. The
demonstration will begin in Michigan
and Massachusetts not earlier than
January 1, 2017. Providers in each state
will be notified by the appropriate
Medicare Administrative Contractor
prior to the start of the demonstration in
the state. Additionally, CMS will utilize
other educational efforts to announce
the program to stakeholders.
This demonstration will evaluate an
additional method that may assist with
the investigation and prosecution of
fraud in order to protect the Medicare
Trust Funds from fraudulent actions
and improper payments. We believe this
demonstration will bolster the efforts
that CMS and its partners have taken in
implementing a series of anti-fraud
initiatives in these states and will
provide valuable data that CMS working
with its law enforcement partners, can
use to combat the submission of
fraudulent claims to the Medicare
program. One such anti-fraud initiative
is the use of temporary moratoria on the
enrollment of new home health
providers that were put in place in the
Miami and Chicago that and were
subsequently expanded to the Fort
Lauderdale, Detroit, Dallas, and
Houston metropolitan areas. These
temporary moratoria prohibit the new
enrollment of home health providers to
help CMS prevent and combat fraud,
waste, and abuse in these locations.
We also believe the data collected
from this demonstration will assist with
a second initiative, the Health Care
Fraud Prevention and Enforcement
Action Team (HEAT) Task Force,
created by the Department of Health and
Human Services and the Department of
Justice (DOJ), and the Heat Task Force’s
ongoing fight against Medicare fraud.
The HEAT Task Force uses resources
across the government to help prevent
and stop fraud, waste, and abuse in the
Medicare and Medicaid programs. Since
2007, the HEAT Task Force of the DOJ
has charged more than 2,300 defendants
with defrauding Medicare of more than
$7 billion and convicted approximately
1,800 defendants of felony health care
fraud offenses. In addition, the data
resulting from this demonstration could
provide investigators and law
enforcement with important information
to determine how to focus their
investigation activities to identify and
combat home health fraud, and in so
doing, protect the Medicare Trust Funds
from fraudulent actions and improper
payments.
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This demonstration may also help
prevent improper payments in
geographic areas where HHA providers
are known to have a high incidence of
fraud. The improper payment rate for
HHA claims has been increasing over
the past several years, and fraud is one
factor contributing to the increase. It is
important to note that while all
payments made as a result of fraud are
considered ‘‘improper payments,’’ not
all improper payments constitute fraud.
CMS’ Comprehensive Error Rate Testing
(CERT) program, which measures
Medicare’s improper payment rate,
estimates the payments that did not
meet Medicare coverage, coding, and
billing rules. The fiscal year (FY) 2015
Department of Health and Human
Services Agency Financial Report
reported that the CERT program’s
calculated 2015 improper payment rate
for HHA claims increased to 59.0
percent from the 2014 rate of 51.4
percent and the 2013 rate of 17.3
percent. The increase in the 2015
improper payment rate was primarily
due to ‘‘insufficient documentation’’
errors, specifically, insufficient
documentation to support the medical
necessity of the services. Similar
documentation errors have also
occurred in previous years. For
example, the 2014 CERT report found
that the majority of home health
payment errors occurred when the
narrative portion of the face-to-face
encounter documentation did not
sufficiently describe how the clinical
findings from the encounter supported
the beneficiary’s homebound status and
need for skilled services.
Due to the substantial increase in
improper payments and concerns raised
by the home health industry, relating to
implementation of the face-to-face
encounter documentation requirement,
we made Medicare HHA payment
policy changes in an effort to simplify
the face-to-face encounter regulations.
Specifically, as of January 1, 2015, a
separate narrative is no longer required
as part of the face-to-face
documentation. Rather, the certifying
physician’s or the acute/post-acute care
facility’s medical record(s) for the
patient must contain sufficient
documentation to substantiate eligibility
for home health services.
Despite these recent changes, we
continue to see cases in which the
medical record does not support
eligibility for the home health benefit,
which constitute ‘‘insufficient
documentation’’ errors. Moreover, we
note that the recent regulatory changes
do not address HHA errors in home
health billing other than those related to
the face-to-face narrative requirement.
E:\FR\FM\10JNN1.SGM
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Agencies
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37596-37598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13841]
-----------------------------------------------------------------------
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: ``Survey of Hospital Quality Leaders.'' In accordance with the
Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public
to comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on February 10, 2016 and
[[Page 37597]]
allowed 60 days for public comment. AHRQ received no 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 July 11, 2016.
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
Survey of Hospital Quality Leaders
The Consumer Assessment of Healthcare Providers and Systems
(CAHPS[supreg]) Hospital Survey (HCAHPS) was first implemented on a
voluntary basis in 2006 to assess patients' experiences with care.
Today, hospitals subject to the Inpatient Prospective Payment System
(IPPS) annual payment update provisions are required to collect and
submit HCAHPS data in order to receive their full annual payment
update. In addition, HCAHPS performance was added to the calculation of
the value-based incentive payment in the Hospital Value-Based
Purchasing (Hospital VBP) program, beginning with discharges in October
2012. The FY 2015 Hospital VBP program links 30% of the Inpatient
Prospective Payment System hospitals' payment from CMS to HCAHPS
performance.
Despite the high stakes associated with HCAHPS scores, little is
known about the ways in which hospitals are using HCAHPS data and
supplemental information about patient experience to understand and
improve their patients' experiences.
This research has the following goals:
(1) To characterize the role of HCAHPS in hospitals' efforts to
improve patient experiences
(2) to identify the types of quality improvement activities that
hospitals implement to improve their HCAHPS scores
(3) to describe hospitals' perspectives on HCAHPS
(4) to determine the types of information collected by hospitals
beyond those required for Hospital VBP
This study is being conducted by AHRQ through its contractor, the
RAND Corporation, pursuant to AHRQ's statutory authority to conduct and
support research on healthcare and on systems for the delivery of such
care, including activities with respect to the quality, effectiveness,
efficiency, appropriateness and value of healthcare services and with
respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
Survey of Hospital Quality Leaders: this survey will elicit
information from approximately 500 hospital quality leaders in a
variety of hospital settings, including high- and low-performing
hospitals, facilities of varying sizes, and hospitals representing all
nine geographic Census divisions. Hospital quality leaders will be
asked to provide information about the use of HCAHPS in their hospital,
with questions addressing all of the substantive areas identified in
the goals section above.
Characterizing hospitals' use of HCAHPS data will provide important
insight into the activities hospitals conduct to improve patient
experience scores. This information may be useful in supporting
hospitals who lag behind their peers, learning from hospitals with
outstanding records of patient experience, and providing
recommendations that may be used to refine HCAHPS survey content.
Estimated Annual Respondent Burden
Table 1 shows the estimated annualized burden and cost for the
respondents' time to participate in this data collection. These burden
estimates are based on tests of data collection conducted on nine or
fewer entities. As indicated below, the annual total burden hours are
estimated to be 294 hours. The annual total cost associated with the
annual total burden hours is estimated to be $14,708.
Table 1 shows the estimated annualized burden for the respondents'
time to participate in this data collection. The Survey of Hospital
Quality Leaders will be administered to 500 individuals. Prior work
suggests that 3-5 items can typically be completed per minute,
depending on item complexity and respondent characteristics, (Hays &
Reeve, 2010; Berry, 2009). We have calculated our burden estimate using
a conservative estimate of 4.5 items per minute. The survey contains
159 items and is thus estimated to require an average administration
time of 35 minutes. As indicated below, the annual total burden hours
are estimated to be 294 hours.
Table 1--Estimated Annualized Burden Hours and Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Collection task Number of responses per Hours per Total burden hourly wage Total cost
respondents respondent response hours rate * burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survey of Hospital Quality Leaders...................... 500 1 .59 294 $49.96 $14,708
-----------------------------------------------------------------------------------------------
Totals.............................................. .............. .............. .............. 294 .............. 14,708
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Based upon mean hourly wages, ``National Compensation Survey: All United States December 2009--January 2011,'' U.S. Department of Labor, Bureau of
Labor Statistics.
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
[[Page 37598]]
comments will become a matter of public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-13841 Filed 6-9-16; 8:45 am]
BILLING CODE 4160-90-P