Patient Safety Organizations: Voluntary Relinquishment From HealthWatch, Inc., 74788-74789 [2011-30798]
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Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name/Deliberative method
Total burden
hours
Average hourly
wage rate
Total cost burden
Educational Materials ......................................................................
Knowledge and Attitudes Pretest Survey ........................................
Knowledge and Attitudes Post-test Survey .....................................
Deliberative Experience Survey ......................................................
1685
1685
1685
1056
1685
843
562
264
21.35
$21.35
21.35
21.35
35,975
$17,998
11,999
5,636
Total ..........................................................................................
8852
N/A
N/A
248,662
* Based upon the mean of the wages for 00–000 All Occupations ($21.35), May 2010 National Occupational Employment and Wage Estimates.
United States, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ https://www.bls.gov/oes/current/oes_nat.htm#00–0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 below breaks down the costs
related to this study. These are the costs
associated with the portion of the
contract awarded to AIR to conduct the
experiment. Since the implementation
and evaluation periods will span 24
months, the costs have been annualized
by taking the total cost and dividing by
2.
EXHIBIT 3—ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT
Cost component
Total cost
Project Management ........................................................................................................................................
Technical Expert Panel ....................................................................................................................................
Technology Tools ............................................................................................................................................
Develop Educational Materials ........................................................................................................................
Evaluation Plan ................................................................................................................................................
Implement Methods .........................................................................................................................................
Conceptual Framework ....................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Reporting .........................................................................................................................................................
Overhead .........................................................................................................................................................
Total ..........................................................................................................................................................
emcdonald on DSK5VPTVN1PROD with NOTICES
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 healthcare
research and healthcare 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.
VerDate Mar<15>2010
17:34 Nov 30, 2011
Jkt 226001
Dated: November 16, 2011.
Carolyn Clancy,
Director.
[FR Doc. 2011–30795 Filed 11–30–11; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Annualized cost
$60,106
117,793
177,580
368,624
214,566
1,624,169
50,195
566,846
135,693
1,281,340
4,596,914
$30,053
58,896
88,790
184,312
107,283
812,085
25,098
283,423
67,847
640,670
2,298,457
Rule), 42 CFR part 3, authorizes AHRQ,
on behalf of the Secretary of HHS, to list
as a PSO an entity that attests that it
meets the statutory and regulatory
requirements for listing. A PSO can be
‘‘delisted’’ by the Secretary if it is found
to no longer meet the requirements of
the Patient Safety Act and patient Safety
Rule, including when a PSO chooses to
voluntarily relinquish its status as a
PSO for any reason.
Patient Safety Organizations:
Voluntary Relinquishment From
HealthWatch, Inc.
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of delisting.
The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12 Midnight
ET (2400) on November 1, 2011.
ADDRESSES:
DATES:
AGENCY:
AHRQ has accepted a
notification of voluntary relinquishment
from HealthWatch, Inc. of its status as
a Patient Safety Organization (PSO). The
Patient Safety and Quality Improvement
Act of 2005 (Patient Safety Act), Public
Law 109–41, 42 U.S.C. 299b–21—b–26,
provides for the formation of PSOs,
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of health care
delivery. The Patient Safety and Quality
Improvement Final Rule (Patient Safety
SUMMARY:
PO 00000
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Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Susan Grinder, Center for Quality
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email:
pso@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices
Background
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity is to
conduct activities to improve patient
safety and the quality of health care
delivery. HHS issued the Patient Safety
Rule to implement the Patient Safety
Act. AHRQ administers the provisions
of the Patient Safety Act and Patient
Safety Rule (PDF file, 450 KB. PDF
Help) relating to the listing and
operation of PSOs. Section 3.108(d) of
the Patient Safety Rule requires AHRQ
to provide public notice when it
removes an organization from the list of
federally approved PSOs. AHRQ has
accepted a notification from
HealthWatch, Inc., PSO number P0010,
which is a component entity of Quality
Health Strategies, Inc., to voluntarily
relinquish its status as a PSO.
Accordingly, HealthWatch, Inc. was
delisted effective at 12 Midnight ET
(2400) on November 1, 2011.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
Dated: November 16, 2011.
Carolyn M. Clancy,
Director.
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Pressure Ulcer Treatment Medical
Devices
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Scientific
Information Submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
manufacturers of pressure ulcer
treatment medical devices, such as (but
not limited to): Ultrasonic wound care
systems, negative pressure therapy
units, turning & positioning systems,
special mattresses, mattress covers,
pillows, cushions, etc. Scientific
information is being solicited to inform
our Pressure Ulcer Treatment Strategies:
A Comparative Effectiveness Review,
which is currently being conducted by
the Evidence-based Practice Centers for
the AHRQ Effective Health Care
Program. Access to published and
emcdonald on DSK5VPTVN1PROD with NOTICES
VerDate Mar<15>2010
17:34 Nov 30, 2011
Jkt 226001
In
accordance with Section 1013 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, the Agency
for Healthcare Research and Quality has
commissioned the Effective Health Care
(EHC) Program Evidence-based Practice
Centers to complete a comparative
effectiveness review of the evidence for
pressure ulcer treatment strategies.
The EHC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by systematically requesting
information (e.g., details of studies
conducted) from medical device
industry stakeholders through public
information requests, including via the
Federal Register and direct postal and/
or online solicitations. We are looking
for studies that report on pressure ulcer
treatment strategies, including those
that describe adverse events, as
specified in the key questions detailed
below. The entire research protocol,
including the key questions, is also
available online at: https://effective
healthcare.AHRQ.gov/index.cfm/search
-for-guides-reviews-and-reports/
?pageaction=displayproduct&productid
=838#3870.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–30798 Filed 11–30–11; 8:45 a.m.]
SUMMARY:
unpublished pertinent scientific
information on these devices will
improve the quality of this comparative
effectiveness review. AHRQ is
requesting this scientific information
and conducting this comparative
effectiveness review pursuant to Section
1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173.
DATES: Submission Deadline on or
before January 3, 2012.
ADDRESSES: Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submitscientific-informationpackets/. Please select the study for
which you are submitting information
from the list of current studies and
complete the form to upload your
documents. Email submissions: ehcsrc@
ohsu.edu (please do not send zipped
files—they are automatically deleted for
security reasons).
Print submissions: Robin Paynter,
Oregon Health and Science University,
Oregon Evidence-based Practice Center,
3181 SW Sam Jackson Park Road, Mail
Code: BICC, Portland, OR 97239–3098.
FOR FURTHER INFORMATION CONTACT:
Robin Paynter, Research Librarian,
Telephone: (503) 494–0147 or Email:
ehcsrc@ohsu.edu.
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74789
This notice is a request for industry
stakeholders to submit the following:
• A current product label, if
applicable (preferably an electronic PDF
file).
• Information identifying published
randomized controlled trials and
observational studies relevant to the
clinical outcomes. Please provide both a
list of citations and reprints if possible.
• Information identifying
unpublished randomized controlled
trials and observational studies relevant
to the clinical outcomes. If possible,
please provide a summary that includes
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to withdrawn/follow-up/
analyzed, and effectiveness/efficacy and
safety results.
• Registered ClinicalTrials.gov
studies. Please provide a list including
the ClinicalTrials.gov identifier,
condition, and intervention.
Your contribution is very beneficial to
this program. AHRQ is not requesting
and will not consider marketing
material, health economics information,
or information on other indications.
This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter. In addition to your scientific
information please submit an index
document outlining the relevant
information in each file along with a
statement regarding whether or not the
submission comprises all of the
complete information available.
Please Note: The contents of all
submissions, regardless of format, will be
available to the public upon request unless
prohibited by law.
The draft of this review will be posted on
AHRQ’s EHC program Web site and available
for public comment for a period of 4 weeks.
If you would like to be notified when the
draft is posted, please sign up for the email
list at: https://effectivehealthcare.AHRQ.gov/
index.cfm/join-the-email-list1/.
The Key Questions
A preliminary set of KQs was posted
on the Effective Health Care Program
Web site of the Agency for Healthcare
Research and Quality (AHRQ), and
public comments were collected and
evaluated.
A Summary of the Public Comments
Most of the public comments
addressed specific patient or treatment
characteristics and settings.
Commenters suggested that the review
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]]>Agencies
[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74788-74789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30798]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From
HealthWatch, Inc.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of delisting.
-----------------------------------------------------------------------
SUMMARY: AHRQ has accepted a notification of voluntary relinquishment
from HealthWatch, Inc. of its status as a Patient Safety Organization
(PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient
Safety Act), Public Law 109-41, 42 U.S.C. 299b-21--b-26, provides for
the formation of PSOs, which collect, aggregate, and analyze
confidential information regarding the quality and safety of health
care delivery. The Patient Safety and Quality Improvement Final Rule
(Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an entity that attests that it meets
the statutory and regulatory requirements for listing. A PSO can be
``delisted'' by the Secretary if it is found to no longer meet the
requirements of the Patient Safety Act and patient Safety Rule,
including when a PSO chooses to voluntarily relinquish its status as a
PSO for any reason.
DATES: The directories for both listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. The delisting was effective at 12 Midnight
ET (2400) on November 1, 2011.
ADDRESSES: Both directories can be accessed electronically at the
following HHS Web site: https://www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT: Susan Grinder, Center for Quality
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD
20850; Telephone (toll free): (866) 403-3697; Telephone (local): (301)
427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130;
Email: pso@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
[[Page 74789]]
Background
The Patient Safety Act authorizes the listing of PSOs, which are
entities or component organizations whose mission and primary activity
is to conduct activities to improve patient safety and the quality of
health care delivery. HHS issued the Patient Safety Rule to implement
the Patient Safety Act. AHRQ administers the provisions of the Patient
Safety Act and Patient Safety Rule (PDF file, 450 KB. PDF Help)
relating to the listing and operation of PSOs. Section 3.108(d) of the
Patient Safety Rule requires AHRQ to provide public notice when it
removes an organization from the list of federally approved PSOs. AHRQ
has accepted a notification from HealthWatch, Inc., PSO number P0010,
which is a component entity of Quality Health Strategies, Inc., to
voluntarily relinquish its status as a PSO. Accordingly, HealthWatch,
Inc. was delisted effective at 12 Midnight ET (2400) on November 1,
2011.
More information on PSOs can be obtained through AHRQ's PSO Web
site at https://www.pso.AHRQ.gov/.
Dated: November 16, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-30798 Filed 11-30-11; 8:45 a.m.]
BILLING CODE 4160-90-M
