Public Meeting of the Presidential Commission for the Study of Bioethical Issues, 3816-3817 [2014-01344]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
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Network of Patient Safety Databases
(NPSD).
The Software Developer’s meeting
will focus on discussion of the
implementation and use of Common
Formats for Event Reporting—Hospital
1.1 and 1.2; the technical specifications,
which provide direction to software
developers that plan to implement the
Common Formats electronically; and
future development plans for the
Common Formats. The technical
specifications are a critical component
that allow for the aggregation of patient
safety event data.
The technical specifications consist of
the following:
Æ data dictionary—defines data
elements and their attributes (data
element name, answer values, field
length, guide for use, etc.) included in
Common Formats;
Æ clinical document architecture
(CDA) implementation guide—provides
instructions for developing a file to
transmit the Common Formats Patient
Safety data from the PSO to the PSO
PPC using the Common Formats;
Æ validation rules and errors
document—specifies and defines the
validation rules that will be applied to
the Common Formats data elements
submitted to the PSO PPC;
Æ Common Formats flow charts—
diagrams the valid paths to complete
generic and event specific formats (a
complete event report);
Æ local specifications—provides
specifications for processing, linking
and reporting on events and details
specifications for reports; and
Æ metadata registry—includes
descriptive facts about information
contained in the data dictionary to
illustrate how such data corresponds
with similar data elements used by
other Federal agencies and standards
development organizations [e.g., HL—7,
International Standards Organization
(ISO)].
Agenda, Registration and Other
Information About the Meeting
The 2014 meeting will be an
interactive forum designed to allow
meeting participants not only to provide
input, but also to respond to the input
provided by others. The meeting agenda
will include: an overview of Federal
efforts related to the Common Formats;
presentations and discussion of
implementations of Common Formats
Event Reporting—Hospital Version 1.1
and 1.2; discussion of next steps for
upcoming Common Formats releases;
and a review of data submission both by
PSOs and by vendors on behalf of PSOs.
AHRQ requests that interested
persons send an email to the PSO PPC
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at support@psoppc.ORG for registration
information. The meeting space will
accommodate approximately 150
participants. A detailed agenda and
logistical information will be provided
to meeting registrants before the
meeting. Prior to the meeting, AHRQ
invites review of the technical
specifications for Common Formats
which can be accessed through AHRQ’s
PSO Web site at https://www.pso.AHRQ.
GOV/formats/commonfmt.htm.
Dated: January 14, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–01242 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues (the
Commission) will conduct its sixteenth
meeting on February 10–11, 2014. At
this meeting, the Commission will
discuss the BRAIN Initiative and
ongoing work in neuroscience.
DATES: The meeting will take place
Monday, February 10, 2014, from 9 a.m.
to approximately 5 p.m. and Tuesday,
February 11, 2014, from 9 a.m. to
approximately 5 p.m.
ADDRESSES: Washington Marriott, 1221
22nd St. NW., Washington, DC 20037.
Telephone (202) 872–1500.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues, 1425
New York Avenue NW., Suite C–100,
Washington, DC 20005. Telephone:
202–233–3960. Email: Hillary.Viers@
bioethics.gov. Additional information
may be obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given of the
sixteenth meeting of the Commission.
The meeting will be open to the public
with attendance limited to space
available. The meeting will also be
webcast at www.bioethics.gov.
Under authority of Executive Order
13521, dated November 24, 2009, the
SUMMARY:
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President established the Commission.
The Commission is an expert panel of
not more than 13 members who are
drawn from the fields of bioethics,
science, medicine, technology,
engineering, law, philosophy, theology,
or other areas of the humanities or
social sciences. The Commission
advises the President on bioethical
issues arising from advances in
biomedicine and related areas of science
and technology. The Commission seeks
to identify and promote policies and
practices that ensure scientific research,
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda item for the
Commission’s sixteenth meeting is to
discuss the BRAIN Initiative and
ongoing work in neuroscience.
The draft meeting agenda and other
information about the Commission,
including information about access to
the webcast, will be available at
www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
Respectful debate of opposing views
and active participation by citizens in
public exchange of ideas enhances
overall public understanding of the
issues at hand and conclusions reached
by the Commission. The Commission is
particularly interested in receiving
comments and questions during the
meeting that are responsive to specific
sessions. Written comments will be
accepted at the registration desk and
comment forms will be provided to
members of the public in order to write
down questions and comments for the
Commission as they arise. To
accommodate as many individuals as
possible, the time for each question or
comment may be limited. If the number
of individuals wishing to pose a
question or make a comment is greater
than can reasonably be accommodated
during the scheduled meeting, the
Commission may make a random
selection.
Written comments will also be
accepted in advance of the meeting and
are especially welcome. Please address
written comments by email to info@
bioethics.gov, or by mail to the
following address: Public Commentary,
Presidential Commission for the Study
of Bioethical Issues, 1425 New York
Avenue NW., Suite C–100, Washington,
DC 20005. Comments will be made
publicly available, including any
personally identifiable or confidential
business information that they contain.
Trade secrets should not be submitted.
Anyone planning to attend the
meeting who needs special assistance,
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
such as sign language interpretation or
other reasonable accommodations,
should notify Esther Yoo by telephone
at (202) 233–3960, or email at
Esther.Yoo@bioethics.gov in advance of
the meeting. The Commission will make
every effort to accommodate persons
who need special assistance.
Dated: January 9, 2014.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2014–01344 Filed 1–22–14; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Scientific Information Request on
Diagnostic Tests of Right Lower
Quadrant Pain (Suspected Acute
Appendicitis)
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 medical devices used for
the diagnosis of right lower quadrant
pain (suspected acute appendicitis), for
example: Magnetic resonance imaging
(MRI), computed tomography (CT),
ultrasound (US), laparoscopic
equipment, or assays. Scientific
information is being solicited to inform
our review of Diagnosis of Right Lower
Quadrant Pain (Suspected Acute
Appendicitis), 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 medical
devices used for the diagnosis of
suspected acute appendicitis will
improve the quality of this review.
AHRQ is conducting this comparative
effectiveness 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).
DATES: Submission Deadline on or
before February 24, 2014.
ADDRESSES: Online submissions: https://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets. Please select the
study for which you are submitting
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SUMMARY:
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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
review of the evidence for Diagnosis of
Right Lower Quadrant Pain (Suspected
Acute Appendicitis).
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 the Diagnosis of Right
Lower Quadrant Pain (Suspected Acute
Appendicitis), including those that
describe adverse events. The entire
research protocol, including the key
questions, is also available online at:
https://effectivehealthcare.AHRQ.gov/
search-for-guides-reviews-and-reports/
?pageaction=displayproduct&productID
=1827.
This notice is to notify the public that
the EHC program would find the
following information on devices for the
Diagnosis of Right Lower Quadrant Pain
(Suspected Acute Appendicitis) helpful:
D 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.
D 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
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to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D 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.
D 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; study types not included in
the review; or information on
indications not included in the review
cannot be used by the Effective Health
Care Program. This is a voluntary
request for information, and all costs for
complying with this request must be
borne by the submitter.
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 systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions. The entire
research protocol, is also available
online at: https://effective
healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?pageaction=
displayproduct&productID=1827.
Key Questions (KQ)
KQ 1
What is the performance of alternative
diagnostic tests, alone or in
combination, for patients with right
lower quadrant (RLQ) pain and
suspected acute appendicitis?
I. What is the performance and
comparative performance of alternative
diagnostic tests in the following patient
populations:
A. Children
B. Adults
C. Non pregnant women of
reproductive age
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]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3816-3817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Meeting of the Presidential Commission for the Study of
Bioethical Issues
AGENCY: Presidential Commission for the Study of Bioethical Issues,
Office of the Assistant Secretary for Health, Office of the Secretary,
Department of Health and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Presidential Commission for the Study of Bioethical Issues
(the Commission) will conduct its sixteenth meeting on February 10-11,
2014. At this meeting, the Commission will discuss the BRAIN Initiative
and ongoing work in neuroscience.
DATES: The meeting will take place Monday, February 10, 2014, from 9
a.m. to approximately 5 p.m. and Tuesday, February 11, 2014, from 9
a.m. to approximately 5 p.m.
ADDRESSES: Washington Marriott, 1221 22nd St. NW., Washington, DC
20037. Telephone (202) 872-1500.
FOR FURTHER INFORMATION CONTACT: Hillary Wicai Viers, Communications
Director, Presidential Commission for the Study of Bioethical Issues,
1425 New York Avenue NW., Suite C-100, Washington, DC 20005. Telephone:
202-233-3960. Email: Hillary.Viers@bioethics.gov. Additional
information may be obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee
Act of 1972, Public Law 92-463, 5 U.S.C. app. 2, notice is hereby given
of the sixteenth meeting of the Commission. The meeting will be open to
the public with attendance limited to space available. The meeting will
also be webcast at www.bioethics.gov.
Under authority of Executive Order 13521, dated November 24, 2009,
the President established the Commission. The Commission is an expert
panel of not more than 13 members who are drawn from the fields of
bioethics, science, medicine, technology, engineering, law, philosophy,
theology, or other areas of the humanities or social sciences. The
Commission advises the President on bioethical issues arising from
advances in biomedicine and related areas of science and technology.
The Commission seeks to identify and promote policies and practices
that ensure scientific research, health care delivery, and
technological innovation are conducted in a socially and ethically
responsible manner.
The main agenda item for the Commission's sixteenth meeting is to
discuss the BRAIN Initiative and ongoing work in neuroscience.
The draft meeting agenda and other information about the
Commission, including information about access to the webcast, will be
available at www.bioethics.gov.
The Commission welcomes input from anyone wishing to provide public
comment on any issue before it. Respectful debate of opposing views and
active participation by citizens in public exchange of ideas enhances
overall public understanding of the issues at hand and conclusions
reached by the Commission. The Commission is particularly interested in
receiving comments and questions during the meeting that are responsive
to specific sessions. Written comments will be accepted at the
registration desk and comment forms will be provided to members of the
public in order to write down questions and comments for the Commission
as they arise. To accommodate as many individuals as possible, the time
for each question or comment may be limited. If the number of
individuals wishing to pose a question or make a comment is greater
than can reasonably be accommodated during the scheduled meeting, the
Commission may make a random selection.
Written comments will also be accepted in advance of the meeting
and are especially welcome. Please address written comments by email to
info@bioethics.gov, or by mail to the following address: Public
Commentary, Presidential Commission for the Study of Bioethical Issues,
1425 New York Avenue NW., Suite C-100, Washington, DC 20005. Comments
will be made publicly available, including any personally identifiable
or confidential business information that they contain. Trade secrets
should not be submitted.
Anyone planning to attend the meeting who needs special assistance,
[[Page 3817]]
such as sign language interpretation or other reasonable
accommodations, should notify Esther Yoo by telephone at (202) 233-
3960, or email at Esther.Yoo@bioethics.gov in advance of the meeting.
The Commission will make every effort to accommodate persons who need
special assistance.
Dated: January 9, 2014.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical
Issues.
[FR Doc. 2014-01344 Filed 1-22-14; 8:45 am]
BILLING CODE 4154-06-P
