Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety Institute, 40146-40147 [2013-15732]
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40146
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices
However, the total annual reporting
hour burden on filers themselves is zero
and not the 563 hours estimated above
because OGE’s estimating methodology
reflects the fact that all respondents hire
private trust administrators or other
private representatives to set up and
maintain the qualified blind and
diversified trusts. Respondents
themselves, typically incoming private
citizen Presidential nominees, therefore
incur no hour burden. The estimated
total annual cost burden to respondents
resulting from the collection of
information is $1,000,000. Those who
use the model documents for guidance
are private trust administrators or other
private representatives hired to set up
and maintain the qualified blind and
diversified trusts of executive branch
officials who seek to establish such
qualified trusts. The cost burden figure
is based primarily on OGE’s knowledge
of the typical trust administrator fee
structure (an average of 1 percent of
total assets) and OGE’s experience with
administration of the qualified trust
program. The $1,000,000 annual cost
figure is based on OGE’s estimate of an
average of five possible active trusts
anticipated to be under administration
for each of the next three years with
combined total assets of $100,000,000.
However, OGE notes that the $1,000,000
figure is a cost estimate for the overall
administration of the trusts, only a
portion of which relates to information
collection and reporting. For want of a
precise way to break out the costs
directly associated with information
collection, OGE is continuing to report
to OMB the full $1,000,000 estimate for
paperwork clearance purposes.
On December 27, 2012, OGE
published a first round notice of its
intent to request paperwork clearance
for the proposed unmodified qualified
trust certificates and modified model
trust documents. See 77 FR 76293–
76294. OGE did not receive any
responses to that notice.
In this second notice, public comment
is again invited on each aspect of the
model qualified trust certificates and
model trust documents, and underlying
regulatory provisions, as set forth in this
notice, including specific views on the
need for and practical utility of this set
of collections of information, the
accuracy of OGE’s burden estimate, the
potential for enhancement of quality,
utility and clarity of the information
collected, and the minimization of
burden (including the use of
information technology).
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Approved: June 27, 2013.
Walter M. Shaub, Jr.,
Director, Office of Government Ethics.
[FR Doc. 2013–15888 Filed 7–2–13; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of one AHRQ
Subcommittee Meetings by Virtual
Review.
AGENCY:
The subcommittee listed
below is part of AHRQ’s Health Services
Research Initial Review Group
Committee. Grant applications are to be
reviewed and discussed at this meeting.
This meeting will be closed to the
public in accordance with 5 U.S.C. App.
2 section 10(d), 5 U.S.C. section
552b(c)(4), and 5 U.S.C. section
552b(c)(6).
Name of Subcommittee: Health Care
Research Training Virtual Review.
Date: July 11, 2013 (Open from 9:00
a.m. to 9:30 a.m. on July 11 and closed
for remainder of the meeting).
Place: Agency for Healthcare Research
and Quality, John Eisenberg Building,
540 Gaither Road, OEREP Conference
Room, Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: (To
obtain a roster of members, agenda or
minutes of the non-confidential portions
of this meeting.)
Mrs. Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research Education and
Priority Populations, AHRQ, 540
Gaither Road, Suite 2000, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
SUPPLEMENTARY INFORMATION: In
accordance with section 10 (a)(2) of the
Federal Advisory Committee Act (5
U.S.C. App. 2), AHRQ announces
meetings of the scientific peer review
groups listed above, which are
subcommittees of AHRQ’s Health
Services Research Initial Review Group
Committee. The subcommittee meetings
will be closed to the public in
accordance with the provisions set forth
in 5 U.S.C. App. 2 section 10(d), 5
U.S.C. 552b(c)(4), and 5 U.S.C.
552b(c)(6). The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
SUMMARY:
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy. Agenda
items for these meeting are subject to
change as priorities dictate.
Dated: June 20, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–15733 Filed 7–2–13; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment From
Northern Metropolitan Patient Safety
Institute
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of Delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005
(Patient Safety Act), Pubic Law 109–41,
42 U.S.C. 299b–21—b–26, provides for
the formation of Patient Safety
Organizations (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 no longer to
meet the requirements of the Patient
Safety Act and Patient Safety Rule, or
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason. AHRQ has accepted a
notification of voluntary relinquishment
from the Northern Metropolitan Patient
Safety Institute of its status as a PSO,
and has delisted the PSO accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on May 29, 2013.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
SUMMARY:
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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email:
pso@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with 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. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found no longer to meet the
requirements of the Patient Safety Act
and Patient Safety Rule, or when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason. 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 the Northern Metropolitan Patient
Safety Institute, PSO number P0021,
which is a component entity of
Northern Metropolitan Hospital
Association, to voluntarily relinquish its
status as a PSO. Accordingly, the
Northern Metropolitan Patient Safety
Institute was delisted effective at 12:00
Midnight ET (2400) on May 29, 2013.
Northern Metropolitan Patient Safety
Institute has patient safety work product
(PSWP) in its possession. The PSO will
meet the requirements of section
3.108(c)(2)(i) of the Patient Safety Rule
regarding notification of providers that
have reported to the PSO. In addition,
according to section 3.108(c)(2)(ii) of the
Patient Safety Rule regarding
disposition of PSWP, the PSO has 90
days from the effective date of delisting
and revocation to complete the
disposition of PSWP that is currently in
the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
Dated: June 21, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–15732 Filed 7–2–13; 8:45 am]
BILLING CODE 4160–90–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Vitamin D and Calcium
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
the public on Vitamin D and Calcium.
Scientific information is being solicited
to inform the Vitamin D and Calcium:
A Systematic Review of Health
Outcomes project, which is currently
being conducted by the Evidence-based
Practice Centers for the AHRQ Effective
Health Care Program. Access to
published and unpublished pertinent
scientific information on vitamin D and
calcium will improve the quality of this
systematic review. AHRQ is conducting
this systematic review pursuant to
Section 1013 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003, Public Law
108–173, and Section 902(a) of the
Public Health Service Act, 42 U.S.C.
299a(a).
SUMMARY:
Submission Deadline on or
before August 2, 2013.
ADDRESSES:
Online submissions: https://
effectivehealthcare.AHRO.gov/
index.cfm/submitscientific-informationpackets/. Please select the study for
which you are submitting information
from the list to upload your documents.
Email submissions: SIPS@epc-src.org.
Print submissions:
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, PO Box
69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
HospitaL Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Robin Paynter, Research Librarian,
Telephone: 503–220–8262 ext. 58652 or
Email: SIPS@epc-src.org.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the Effective
Health Care (EHC) Program Evidencebased Practice Centers to complete a
DATES:
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40147
review of the evidence for Vitamin D
and Calcium: A Systematic Review of
Health Outcomes.
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 requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on vitamin D and calcium,
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://
effectivehealthcare.AHRQ.gov/searchforquides-reviews-and-reports/
?pageaction=displayproduct&
productID=1529
This notice is to notify the public that
the EHC program would find the
following information on Vitamin D and
Calcium helpful:
• A list of completed studies your
company has sponsored for this
indication. In the list, indicate whether
results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
• For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including 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 follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
• A list of ongoing studies your
company has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
• A description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
company for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. The contents of all
submissions will be made available to
the public upon request. Materials
submitted must be publicly available or
can be made public. Materials that are
considered confidential; marketing
materials; pharmacoeconomic,
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]]>Agencies
[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40146-40147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15732]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From
Northern Metropolitan Patient Safety Institute
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of Delisting.
-----------------------------------------------------------------------
SUMMARY: The Patient Safety and Quality Improvement Act of 2005
(Patient Safety Act), Pubic Law 109-41, 42 U.S.C. 299b-21--b-26,
provides for the formation of Patient Safety Organizations (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 no longer to meet the requirements of the Patient Safety
Act and Patient Safety Rule, or when a PSO chooses to voluntarily
relinquish its status as a PSO for any reason. AHRQ has accepted a
notification of voluntary relinquishment from the Northern Metropolitan
Patient Safety Institute of its status as a PSO, and has delisted the
PSO accordingly.
DATES: The directories for both listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. The delisting was effective at 12:00
Midnight ET (2400) on May 29, 2013.
ADDRESSES: Both directories can be accessed electronically at the
following HHS Web site: https://www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD
20850; Telephone (toll free): (866) 403-3697;
[[Page 40147]]
Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY
(local): (301) 427-1130; Email: pso@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
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. The Patient Safety Rule authorizes AHRQ
to list as a PSO an entity that attests that it meets the statutory and
regulatory requirements for listing. A PSO can be ``delisted'' if it is
found no longer to meet the requirements of the Patient Safety Act and
Patient Safety Rule, or when a PSO chooses to voluntarily relinquish
its status as a PSO for any reason. 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 the Northern Metropolitan
Patient Safety Institute, PSO number P0021, which is a component entity
of Northern Metropolitan Hospital Association, to voluntarily
relinquish its status as a PSO. Accordingly, the Northern Metropolitan
Patient Safety Institute was delisted effective at 12:00 Midnight ET
(2400) on May 29, 2013. Northern Metropolitan Patient Safety Institute
has patient safety work product (PSWP) in its possession. The PSO will
meet the requirements of section 3.108(c)(2)(i) of the Patient Safety
Rule regarding notification of providers that have reported to the PSO.
In addition, according to section 3.108(c)(2)(ii) of the Patient Safety
Rule regarding disposition of PSWP, the PSO has 90 days from the
effective date of delisting and revocation to complete the disposition
of PSWP that is currently in the PSO's possession.
More information on PSOs can be obtained through AHRQ's PSO Web
site at https://www.pso.AHRQ.gov/.
Dated: June 21, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-15732 Filed 7-2-13; 8:45 am]
BILLING CODE 4160-90-M
