Announcement of Requirements and Registration for “Ensuring Safe Transitions From Hospital to Home”, 57044-57045 [2011-23704]
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57044
Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices
wreier-aviles on DSKGBLS3C1PROD with NOTICES
Analysis of Agreement Containing
Consent Order to Aid Public Comment
the agreement and proposed order or to
modify in any way their terms.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’) has accepted,
subject to final approval, an agreement
containing a consent order from Andrew
N. Finkel (‘‘respondent’’).
The proposed consent order
(‘‘proposed order’’) has been placed on
the public record for thirty (30) days for
receipt of comments by interested
persons. Comments received during this
period will become part of the public
record. After thirty (30) days, the
Commission will again review the
agreement and the comments received,
and will decide whether it should
withdraw from the agreement and take
appropriate action or make final the
agreement’s proposed order.
This matter involves the advertising
of a mobile software application (‘‘app’’)
called Acne Pwner which respondent
developed and sold in Google’s Android
Marketplace. Respondent claimed that
Acne Pwner effectively treats acne. The
instructions for this app directed
consumers to hold the light-emitting
display screen next to the area of skin
to be treated for a few minutes each day.
The Commission’s complaint alleges
that respondent violated Sections 5 and
12 of the FTC Act by claiming, without
substantiation, that the app provided an
effective treatment for acne.
The proposed consent order contains
provisions designed to prevent
respondent from engaging in similar
practices in the future. Part I of the
order prohibits respondent from making
any representation that Acne Pwner, or
any other device as defined by Section
15 of the FTC Act, provides effective
treatment for acne, unless respondent
has competent and reliable scientific
evidence to substantiate that claim.
Part II of the order requires
respondent to have competent and
reliable scientific evidence before
making any safety, performance,
benefits, or efficacy claim about any
device.
Part III of the order requires
respondent, within 15 days of the date
the order becomes final, to pay the
Commission $1,700.
The remaining parts of the proposed
order are standard provisions regarding
recordkeeping, dissemination of the
order to officers and employees, prior
notification to the Commission of
corporate changes, notification of new
employment, filing of compliance
reports, and sunsetting of the order.
The purpose of this analysis is to
facilitate public comment on the
proposed order, and it is not intended
to constitute an official interpretation of
By direction of the Commission.
Donald S. Clark,
Secretary.
Announcement of Requirements and
Registration for ‘‘Ensuring Safe
Transitions From Hospital to Home’’
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[FR Doc. 2011–23595 Filed 9–14–11; 8:45 am]
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Authority: 15 U.S.C. 3719.
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice of a
decision to designate a class of
employees from the General Electric Co.
in Evendale, Ohio, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On August 31, 2011, the Secretary
of HHS designated the following class of
employees as an addition to the SEC:
SUMMARY:
All employees of the Department of
Energy, its predecessor agencies, and their
contractors and subcontractors who worked
at General Electric Co. in Evendale, Ohio,
from January 1, 1961 through June 30, 1970,
for a number of work days aggregating at least
250 work days, occurring either solely under
this employment or in combination with
work days within the parameters established
for one or more other classes of employees
included in the Special Exposure Cohort.
This designation will become
effective on September 30, 2011, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 4676 Columbia Parkway, MS C–
46, Cincinnati, OH 45226, Telephone
877–222–7570. Information requests can
also be submitted by e-mail to
DCAS@CDC.gov.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–23568 Filed 9–14–11; 8:45 am]
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The ‘‘Ensuring Safe
Transitions from Hospital to Home’’
challenge tasks developers with creating
technology solutions that empower
discharged patients to take charge of
their health care during transitions of
places of care. Innovative applications
will help patients and their caregivers
insure that they have all the information
and materials, such as drug
prescriptions, medical equipment,
follow-up appointments, and emergency
contacts, that they need to move safely
to their next care setting.
The statutory authority for this
challenge competition is Section 105 of
the America COMPETES
Reauthorization Act of 2010 (Pub. L.
111–358).
DATES: Effective on September 12, 2011.
FOR FURTHER INFORMATION CONTACT:
Adam Wong, 202–720–2866.
Wil Yu, 202–690–5920.
SUPPLEMENTARY INFORMATION:
Subject of Challenge Competition:
ONC, in collaboration with the
Partnership for Patients, seeks to
stimulate innovative approaches to care
transitions and improving patient safety.
Nearly one in five patients discharged
from a hospital will be readmitted
within 30 days. A large proportion of
readmissions can be prevented by
improving communications and
coordinating care before and after
discharge. The Centers for Medicare and
Medicaid Services (CMS) provides a
discharge checklist to help patients and
their caregivers prepare to leave a
hospital, nursing home, or other care
setting. Research has shown that
empowering patients and caregivers
with information and tools to manage
the next steps in their care more
confidently is a very effective way to
reduce errors, decrease complications,
and prevent a return visit to the
hospital. ONC is challenging software
developers to improve care transitions
and build upon these tools by
generating an intuitive and easy-to-use
application to empower patients and
caregivers that leverages NwHIN
standards and services.
SUMMARY:
E:\FR\FM\15SEN1.SGM
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wreier-aviles on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices
Eligibility Rules for Participating in
the Competition:
To be eligible to win a prize under
this challenge, an individual or entity:
(1) Shall have registered to participate
in the competition under the rules
promulgated by Office of the National
Coordinator for Health Information
Technology;
(2) Shall have complied with all the
requirements under this section;
(3) In the case of a private entity, shall
be incorporated in and maintain a
primary place of business in the United
States, and in the case of an individual,
whether participating singly or in a
group, shall be a citizen or permanent
resident of the United States; and
(4) May not be a Federal entity or
Federal employee acting within the
scope of their employment.
An individual or entity shall not be
deemed ineligible because the
individual or entity used Federal
facilities or consulted with Federal
employees during a competition if the
facilities and employees are made
available to all individuals and entities
participating in the competition on an
equitable basis.
Registered participants shall be
required to agree to assume any and all
risks and waive claims against the
Federal Government and its related
entities, except in the case of willful
misconduct, for any injury, death,
damage, or loss of property, revenue, or
profits, whether direct, indirect, or
consequential, arising from their
participation in a competition, whether
the injury, death, damage, or loss arises
through negligence or otherwise.
Participants shall be required to
obtain liability insurance or
demonstrate financial responsibility, in
amounts determined by the head of the
Office of the National Coordinator for
Health Information Technology, for
claims by—
(1) A third party for death, bodily
injury, or property damage, or loss
resulting from an activity carried out in
connection with participation in a
competition, with the Federal
Government named as an additional
insured under the registered
participant’s insurance policy and
registered participants agreeing to
indemnify the Federal Government
against third party claims for damages
arising from or related to competition
activities; and
(2) the Federal Government for
damage or loss to Government property
resulting from such an activity.
Participants must be teams of at least
two people.
VerDate Mar<15>2010
15:07 Sep 14, 2011
Jkt 223001
All participants are required to
provide written consent to the rules
upon or before submitting an entry.
Dates:
• Submission Period Begins: 12:01
a.m., E.D.T., September 12, 2011.
• Submission Period Ends: 11:59
p.m., E.D.T., November 16, 2011.
Registration Process for Participants:
To register for this challenge
participants should:
• Access the https://
www.challenge.gov Web site and search
for the ‘‘Ensuring Safe Transitions from
Hospital to Home’’.
• Access the ONC Investing in
Innovation (i2) Challenge Web site at:
Æ https://www.health2challenge.org/
category/onc/
Æ A registration link for the challenge
can be found on the landing page under
the challenge description.
Amount of the Prize:
• First Prize: $25,000.
• Second Prize: $10,000.
• Third Prize: $5,000.
Awards may be subject to Federal
income taxes and HHS will comply with
IRS withholding and reporting
requirements, where applicable.
Basis Upon Which Winner Will Be
Selected:
The judging panel will make
selections based upon the following
criteria:
1. Innovation.
2. Usability/Design.
3. Potential for impact.
4. Data integration.
5. Use of NwHIN standards and
services.
Additional Information:
Ownership of intellectual property is
determined by the following:
• Each entrant retains title and full
ownership in and to their submission.
Entrants expressly reserve all
intellectual property rights not
expressly granted under the challenge
agreement.
• By participating in the challenge,
each entrant hereby irrevocably grants
to Sponsor and Administrator a limited,
non-exclusive, royalty free, worldwide,
license and right to reproduce,
publically perform, publically display,
and use the Submission to the extent
necessary to administer the challenge,
and to publically perform and
publically display the Submission,
including, without limitation, for
advertising and promotional purposes
relating to the challenge.
Dated: September 8, 2011.
Farzad Mostashari,
National Coordinator for Health Information
Technology.
[FR Doc. 2011–23704 Filed 9–14–11; 8:45 am]
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57045
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Requirements and
Registration for ‘‘Reporting Device
Adverse Events Challenge’’
Authority: 15 U.S.C. 3719.
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
AGENCY:
Medical devices will play an
increasingly large role in the monitoring
and collection of patient data with the
spread of electronic health records. The
United States has a limited system for
the post-market surveillance of medical
devices, specifically as it relates to
monitoring product safety and
effectiveness. The ‘‘Reporting Device
Adverse Events Challenge’’ asks multidisciplinary teams to develop an
application that facilitates the reporting
of adverse events related to medical
devices, whether implanted or used in
the hospital, clinic, or home.
The statutory authority for this
challenge competition is Section 105 of
the America COMPETES
Reauthorization Act of 2010 (Pub. L.
111–358).
DATES: Effective on September 12, 2011.
FOR FURTHER INFORMATION CONTACT:
Adam Wong, 202–720–2866.
Wil Yu, 202–690–5920.
SUPPLEMENTARY INFORMATION:
Subject of Challenge Competition:
The ‘‘Reporting Device Adverse Events
Challenge’’ asks multi-disciplinary
teams to develop an application that
facilitates the reporting of adverse
events related to medical devices,
whether implanted or used in the
hospital, clinic, or home. The
application would make it easy for
patients to report adverse events to their
provider, support the download of
information from EMR or PHR systems
to populate the adverse event report and
provide high quality data, capture
useful information including patient
demographics and device data that is
easily accessible to all stakeholders
(patients, providers, manufacturers, and
researchers) using current technologies
including PC-based browsers, mobile
phones, and tablets, and leverage
NwHIN standards and services
including transport, content, and
vocabularies.
Eligibility Rules for Participating in
the Competition:
To be eligible to win a prize under
this challenge, an individual or entity:
(1) Shall have registered to participate
in the competition under the rules
SUMMARY:
E:\FR\FM\15SEN1.SGM
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Agencies
[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57044-57045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23704]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Requirements and Registration for ``Ensuring Safe
Transitions From Hospital to Home''
Authority: 15 U.S.C. 3719.
AGENCY: Office of the National Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The ``Ensuring Safe Transitions from Hospital to Home''
challenge tasks developers with creating technology solutions that
empower discharged patients to take charge of their health care during
transitions of places of care. Innovative applications will help
patients and their caregivers insure that they have all the information
and materials, such as drug prescriptions, medical equipment, follow-up
appointments, and emergency contacts, that they need to move safely to
their next care setting.
The statutory authority for this challenge competition is Section
105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-
358).
DATES: Effective on September 12, 2011.
FOR FURTHER INFORMATION CONTACT:
Adam Wong, 202-720-2866.
Wil Yu, 202-690-5920.
SUPPLEMENTARY INFORMATION:
Subject of Challenge Competition: ONC, in collaboration with the
Partnership for Patients, seeks to stimulate innovative approaches to
care transitions and improving patient safety. Nearly one in five
patients discharged from a hospital will be readmitted within 30 days.
A large proportion of readmissions can be prevented by improving
communications and coordinating care before and after discharge. The
Centers for Medicare and Medicaid Services (CMS) provides a discharge
checklist to help patients and their caregivers prepare to leave a
hospital, nursing home, or other care setting. Research has shown that
empowering patients and caregivers with information and tools to manage
the next steps in their care more confidently is a very effective way
to reduce errors, decrease complications, and prevent a return visit to
the hospital. ONC is challenging software developers to improve care
transitions and build upon these tools by generating an intuitive and
easy-to-use application to empower patients and caregivers that
leverages NwHIN standards and services.
[[Page 57045]]
Eligibility Rules for Participating in the Competition:
To be eligible to win a prize under this challenge, an individual
or entity:
(1) Shall have registered to participate in the competition under
the rules promulgated by Office of the National Coordinator for Health
Information Technology;
(2) Shall have complied with all the requirements under this
section;
(3) In the case of a private entity, shall be incorporated in and
maintain a primary place of business in the United States, and in the
case of an individual, whether participating singly or in a group,
shall be a citizen or permanent resident of the United States; and
(4) May not be a Federal entity or Federal employee acting within
the scope of their employment.
An individual or entity shall not be deemed ineligible because the
individual or entity used Federal facilities or consulted with Federal
employees during a competition if the facilities and employees are made
available to all individuals and entities participating in the
competition on an equitable basis.
Registered participants shall be required to agree to assume any
and all risks and waive claims against the Federal Government and its
related entities, except in the case of willful misconduct, for any
injury, death, damage, or loss of property, revenue, or profits,
whether direct, indirect, or consequential, arising from their
participation in a competition, whether the injury, death, damage, or
loss arises through negligence or otherwise.
Participants shall be required to obtain liability insurance or
demonstrate financial responsibility, in amounts determined by the head
of the Office of the National Coordinator for Health Information
Technology, for claims by--
(1) A third party for death, bodily injury, or property damage, or
loss resulting from an activity carried out in connection with
participation in a competition, with the Federal Government named as an
additional insured under the registered participant's insurance policy
and registered participants agreeing to indemnify the Federal
Government against third party claims for damages arising from or
related to competition activities; and
(2) the Federal Government for damage or loss to Government
property resulting from such an activity.
Participants must be teams of at least two people.
All participants are required to provide written consent to the
rules upon or before submitting an entry.
Dates:
Submission Period Begins: 12:01 a.m., E.D.T., September
12, 2011.
Submission Period Ends: 11:59 p.m., E.D.T., November 16,
2011.
Registration Process for Participants:
To register for this challenge participants should:
Access the https://www.challenge.gov Web site and search
for the ``Ensuring Safe Transitions from Hospital to Home''.
Access the ONC Investing in Innovation (i2) Challenge Web
site at:
[cir] https://www.health2challenge.org/category/onc/
[cir] A registration link for the challenge can be found on the
landing page under the challenge description.
Amount of the Prize:
First Prize: $25,000.
Second Prize: $10,000.
Third Prize: $5,000.
Awards may be subject to Federal income taxes and HHS will comply
with IRS withholding and reporting requirements, where applicable.
Basis Upon Which Winner Will Be Selected:
The judging panel will make selections based upon the following
criteria:
1. Innovation.
2. Usability/Design.
3. Potential for impact.
4. Data integration.
5. Use of NwHIN standards and services.
Additional Information:
Ownership of intellectual property is determined by the following:
Each entrant retains title and full ownership in and to
their submission. Entrants expressly reserve all intellectual property
rights not expressly granted under the challenge agreement.
By participating in the challenge, each entrant hereby
irrevocably grants to Sponsor and Administrator a limited, non-
exclusive, royalty free, worldwide, license and right to reproduce,
publically perform, publically display, and use the Submission to the
extent necessary to administer the challenge, and to publically perform
and publically display the Submission, including, without limitation,
for advertising and promotional purposes relating to the challenge.
Dated: September 8, 2011.
Farzad Mostashari,
National Coordinator for Health Information Technology.
[FR Doc. 2011-23704 Filed 9-14-11; 8:45 am]
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