Summary of Responses To Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity, 26790-26791 [2013-10968]
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Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
E. Periodic Reporting
FDA is soliciting comments on the
advisability of requiring periodic
reporting for modifications to 510(k)cleared devices that do not require new
510(k) submissions. FDA does not
typically review 510(k) modifications
decisions that do not result in 510(k)
submissions, unless that information is
specifically looked at during an
inspection or submitted in conjunction
with future changes that do require a
510(k). If manufacturers were required
to submit periodic reports identifying
and describing their design changes that
did not result in 510(k) submissions,
FDA would then review these changes
and ensure that decisions were made
appropriately. This process would likely
be similar to annual reporting of device
changes for approved class III devices.
Over time, periodic reporting would
give FDA a more complete picture of the
changes industry is making to 510(k)cleared devices, and may allow FDA to
tailor 510(k) modifications requirements
to ensure that the Agency is reviewing
only the changes it needs to in new
510(k) submissions. Review of periodic
reports, however, would require
additional FDA resources. Comments on
periodic reporting should address the
following questions.
1. How often should FDA require
periodic reports, e.g., annually,
biannually, etc.?
2. Should FDA require periodic
reports for all 510(k) devices or only
certain devices? If not all devices, then
which ones?
3. What information should be
included in a periodic report?
mstockstill on DSK4VPTVN1PROD with NOTICES
F. Other Policy Proposals
FDA acknowledges that any one of the
above options may be insufficient on its
own; if any changes are made to FDA’s
510(k) modification policy, the Agency
may adopt a combination of those
options. FDA also acknowledges that
other options may exist that have not
been identified above. FDA is therefore
soliciting any other proposals for
revising the Agency’s 510(k)
modification policy. Any policy must
ensure:
• Consistent decision-making by both
industry and FDA;
• Adequate control of device
modifications that could significantly
affect safety or effectiveness; and
• Effective FDA oversight of
modifications to 510(k)-cleared devices
to adequately protect the public health
and allow for medical device
innovation.
Proposals should be as detailed and
specific as possible, and should take
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into account the issues discussed above
in the individual options.
G. Examples
In addition to the options discussed
above, FDA is seeking specific examples
of device changes that manufacturers
have made that should not trigger the
requirement for a new 510(k)
submission, with explanations as to
why 510(k) submissions should not be
required. These examples will help FDA
develop an appropriate 510(k)
modifications policy. FDA typically sees
only those device modifications that
result in new 510(k) submissions;
device changes that do not result in new
510(k) submissions generally are not
reviewed by the Agency. Industry
provision of these changes will help
inform FDA’s 510(k) modifications
interpretation.
Examples of device changes may also
be used for discussion during this
public meeting. All examples discussed
publicly will be de-identified. Examples
may be submitted to the Agency in deidentified form through third parties
such as trade associations.
Dated: May 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10888 Filed 5–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Summary of Responses To Request
for Information (RFI): Opportunities To
Apply a Department of Health and
Human Services Message Library To
Advance Understanding About Toddler
and Preschool Nutrition and Physical
Activity
Health Resources and Services
Administration, HHS.
ACTION: Summary of Responses to
Request for Information (RFI).
AGENCY:
On January 29, 2013, the
Health Resources and Services
Administration (HRSA) issued a
Request for Information (RFI) to solicit
ideas and information related to ways in
which the U.S. Department of Health
and Human Services (HHS) can work
with interested partners to disseminate
and apply TXT4Tots, a library of short,
evidence-based messages on nutrition
and physical activity targeted to parents,
caregivers, and health care providers of
children ages 1–5 years. HRSA released
the TXT4Tots library in English and
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Spanish on February 19, 2013; and
followed with an Open Forum on
February 20, 2013, to provide further
opportunity for input on dissemination
and application of the library of
messages. HHS received over 25 written
responses to the RFI, and approximately
100 individuals participated in the
Open Forum.
Comments and Responses: The
written responses to the RFI as well as
the comments received through the
Open Forum indicate that TXT4Tots
aligns with the activities of many
existing organizations and programs.
Several of the respondents expressed an
interest in collaborative opportunities to
incorporate the messages into current
outreach and educational efforts. Some
examples of current programs that could
leverage the TXT4Tots messages include
initiatives at the federal, state, and local
levels. The majority of the suggested
organizations and programs focus on
promoting healthy choices for children
and their families. Recommendations
included integrating the TXT4Tots
messages into their programs and
services or using the internet to
disseminate the information through
Web sites and social media.
Respondents also emphasized that
mobile health, social media, and other
innovative strategies are a valuable
resource to reach a diverse population
and can be effectively leveraged to
support equitable access to health
information. With regard to vehicles for
dissemination of the TXT4Tots
messages, respondents suggested that
they needn’t be complicated, but should
be user friendly. In addition,
respondents noted that the most
effective tools for dissemination are
those that can fully engage the end
users. Specific suggestions for
dissemination of the TXT4Tots
messages included social media,
existing tools and applications, existing
Web sites and web services, and text
messages, as well incorporating
messages into baby product packaging,
curricula, health fairs, emails,
newsletters, and print materials.
Emphasis was placed on leveraging
existing platforms that promote healthy
choices for young children and could
readily integrate the TXT4Tots message
content. Respondents also
recommended that the TXT4Tots
messages be linked to additional sources
of information; for example, if utilized
as a text message program, URLs could
be included to link the message
recipients to Web sites with additional
information. In addition, social media
posts could link to Web sites with ideas
for healthy recipes and age-appropriate
activities to compliment the messages.
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
Some respondents indicated that the use
of certain technology-based platforms
may restrict access to the underserved,
who might have limited access to
smartphones or the internet. One
additional concern that was voiced by
numerous respondents was confusion
regarding the purpose of TXT4Tots and
how it is intended to be used.
Specifically, it was unclear that this is
a library of messages that could be used
in a variety of existing platforms and
products and not exclusively a text
messaging service. Guidance regarding
specific details about the use of the
TXT4Tots messages has been added to
the TXT4Tots Web page
(https://www.hrsa.gov/healthit/txt4tots).
HRSA appreciates all of the
thoughtful comments received either via
the RFI or Open Forum. Guidance
regarding specific details about the use
of the TXT4Tots messages has been
added to the TXT4Tots Web page
(https://www.hrsa.gov/healthit/txt4tots).
It is our hope that the thoughtful
recommendations and comments will
spur others to explore innovative ways
for disseminating the TXT4Tots content.
FOR FURTHER INFORMATION CONTACT:
Bethany Applebaum, MPH, Health
Resources and Services Administration,
Office of Women’s Health and Office of
Health Information Technology and
Quality, 5600 Fishers Lane, Room 7–
100, Rockville, Maryland 20857, or
email bapplebaum@hrsa.gov.
Dated: May 2, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–10968 Filed 5–7–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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17:56 May 07, 2013
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FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Induced Pluripotent Stem Cells
Generated Using Lentivirus-Based
Reprogramming
Description of Technology: Five
human induced pluripotent stem cells
(iPSC) lines are generated using
lentivirus-based reprogramming
technology. These lines are pluripotent,
meaning they have the potential to
differentiate into all cells in the body,
and theoretically can proliferate/selfrenew indefinitely. The iPSC lines are:
NC1 (derived from female’s fibroblasts),
NC2 (derived from female’s fibroblasts),
NC3 (derived from male’s HUVECS),
NC4 (derived from male’s fibroblasts)
and NC5 (derived from female’s
fibroblasts). Further details of these cells
are available upon request. NC1 uses a
retrovirus delivery system incorporating
the following vectors: pMIG–hKLF4,
pMIG–hOCT4, pMIG–hSOX2, and
MSCV h c–MYC IRES GFP. NC2–NC5
use the hSTEMCCA–loxP lentivirus
delivery system (a gift from Dr. Gustavo
Mostoslavsky). These cell lines will be
useful for studies related to stem cell
biology, understanding diseases,
potential cell therapies, and small
molecule screening.
Potential Commercial Applications:
The iPSCs of this technology are useful:
(a) To study the biology of stem cell
development,
(b) as controls in studies to screen for
small molecules to change cell fate and/
or to alleviate the phenotypes of various
diseases, and
(c) to test different characterization
and differentiation assays.
Competitive Advantages:
• These cells can serve as control
cells and, thus, significantly reduce the
cost of initiating many research projects.
• These cells can be a good source of
control cells.
Development Stage:
• Prototype
• Pilot
• Early-stage
• In vitro data available
Inventors: Drs. Guibin Chen and
Manfred Boehm (NHLBI)
Intellectual Property: HHS Reference
No. E–274–2012/0—Research Tools.
PO 00000
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26791
Patent protection is not being pursued
for this technology.
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Heart, Lung, and Blood
Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize Induced Pluripotent
Stem Cells. For collaboration
opportunities, please contact Denise
Crooks, OTTAD, at 301–435–0103.
Stapled Peptides for Treatment of
Cardiovascular Diseases and
Inflammation
Description of Technology: The
invention is directed to small molecule
mimetics of apolipoproteins that have
an inter-helical hydrocarbon bond,
which stabilizes helix formation.
Apolipoproteins facilitate the
transport of lipids and cholesterol in the
body. Mimetics of apolipoproteins have
been used to treat cholesterol-related
disorders. However, these mimetics are
susceptible to degradation in biological
fluids and as a result, their ability to
bind cholesterol becomes diminished
over time.
Scientists at NHLBI have devised
methods to stabilize and improve the
performance of apolipoprotein mimetic
peptides, using a modified hydrocarbon
chain (‘‘stapled apolipoproteins’’).
These stapled apolipoproteins are
superior to singular apolipoproteins in
that they are more resistant to enzymatic
degradation and efflux a greater amount
of cellular cholesterol.
Stapled apolipoproteins can be used
in the treatment of cardiovascular
diseases, particularly for treatment of
atherosclerosis.
Potential Commercial Applications:
• Treatment of inflammation and
cardiovascular diseases, including
hyperlipidemia, atherosclerosis,
restenosis, and acute coronary
syndrome.
• Inclusion in oral, intravenous or
transdermal peptide formulations.
Competitive Advantages:
• Stapled apolipoproteins are more
resistant to proteolysis and display
enhanced bioavailability.
• Stapled apolipoproteins are
amenable to oral delivery and have
increased permeability to the blood
brain barrier.
Development Stage:
• Pre-clinical
• In vitro data available
• In vivo data available (animal)
Inventors: Alan T. Remaley (CC),
Marcelo A. Amar (NHLBI), Imoh Z.
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26790-26791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10968]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Summary of Responses To Request for Information (RFI):
Opportunities To Apply a Department of Health and Human Services
Message Library To Advance Understanding About Toddler and Preschool
Nutrition and Physical Activity
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Summary of Responses to Request for Information (RFI).
-----------------------------------------------------------------------
SUMMARY: On January 29, 2013, the Health Resources and Services
Administration (HRSA) issued a Request for Information (RFI) to solicit
ideas and information related to ways in which the U.S. Department of
Health and Human Services (HHS) can work with interested partners to
disseminate and apply TXT4Tots, a library of short, evidence-based
messages on nutrition and physical activity targeted to parents,
caregivers, and health care providers of children ages 1-5 years. HRSA
released the TXT4Tots library in English and Spanish on February 19,
2013; and followed with an Open Forum on February 20, 2013, to provide
further opportunity for input on dissemination and application of the
library of messages. HHS received over 25 written responses to the RFI,
and approximately 100 individuals participated in the Open Forum.
Comments and Responses: The written responses to the RFI as well as
the comments received through the Open Forum indicate that TXT4Tots
aligns with the activities of many existing organizations and programs.
Several of the respondents expressed an interest in collaborative
opportunities to incorporate the messages into current outreach and
educational efforts. Some examples of current programs that could
leverage the TXT4Tots messages include initiatives at the federal,
state, and local levels. The majority of the suggested organizations
and programs focus on promoting healthy choices for children and their
families. Recommendations included integrating the TXT4Tots messages
into their programs and services or using the internet to disseminate
the information through Web sites and social media.
Respondents also emphasized that mobile health, social media, and
other innovative strategies are a valuable resource to reach a diverse
population and can be effectively leveraged to support equitable access
to health information. With regard to vehicles for dissemination of the
TXT4Tots messages, respondents suggested that they needn't be
complicated, but should be user friendly. In addition, respondents
noted that the most effective tools for dissemination are those that
can fully engage the end users. Specific suggestions for dissemination
of the TXT4Tots messages included social media, existing tools and
applications, existing Web sites and web services, and text messages,
as well incorporating messages into baby product packaging, curricula,
health fairs, emails, newsletters, and print materials. Emphasis was
placed on leveraging existing platforms that promote healthy choices
for young children and could readily integrate the TXT4Tots message
content. Respondents also recommended that the TXT4Tots messages be
linked to additional sources of information; for example, if utilized
as a text message program, URLs could be included to link the message
recipients to Web sites with additional information. In addition,
social media posts could link to Web sites with ideas for healthy
recipes and age-appropriate activities to compliment the messages.
[[Page 26791]]
Some respondents indicated that the use of certain technology-based
platforms may restrict access to the underserved, who might have
limited access to smartphones or the internet. One additional concern
that was voiced by numerous respondents was confusion regarding the
purpose of TXT4Tots and how it is intended to be used. Specifically, it
was unclear that this is a library of messages that could be used in a
variety of existing platforms and products and not exclusively a text
messaging service. Guidance regarding specific details about the use of
the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots).
HRSA appreciates all of the thoughtful comments received either via
the RFI or Open Forum. Guidance regarding specific details about the
use of the TXT4Tots messages has been added to the TXT4Tots Web page
(https://www.hrsa.gov/healthit/txt4tots). It is our hope that the
thoughtful recommendations and comments will spur others to explore
innovative ways for disseminating the TXT4Tots content.
FOR FURTHER INFORMATION CONTACT: Bethany Applebaum, MPH, Health
Resources and Services Administration, Office of Women's Health and
Office of Health Information Technology and Quality, 5600 Fishers Lane,
Room 7-100, Rockville, Maryland 20857, or email bapplebaum@hrsa.gov.
Dated: May 2, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-10968 Filed 5-7-13; 8:45 am]
BILLING CODE 4165-15-P
