``Script Your Future'' Medication Adherence Campaign, 34109-34110 [2013-13447]
Download as PDF
Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
II. References
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and is available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site address in this reference
section, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.)
1. ‘‘Further US RB Pharmaceuticals
Announcement,’’ https://www.rb.com/site/
rkbr/templates/mediainvestors
general2.aspx?pageid=1332&cc=GB,
Reckitt Benckiser Group plc, September 25,
2012. Web. May 17, 2013.
Dated: May 31, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–13446 Filed 6–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0012]
‘‘Script Your Future’’ Medication
Adherence Campaign
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
continuing support of a national effort
to promote the importance of
medication adherence to enhance the
health of Americans. Medication
adherence is taking medicine as
directed to treat an illness or disease in
order to get the best health outcome
possible for each patient. Nearly three
out of four Americans report that they
do not take their medication as directed.
One in three people never fill their
prescriptions. The annual price tag for
medication adherence failure is
estimated to be $290 billion, and the
impact on the medical system and
patients from this lack of adherence may
result in relapses or recurrences of
medical symptoms, increases in hospital
visits, or even death. FDA is committed
to addressing this issue, which has
enormous implications for public health
and the U.S. economy, by, in part,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:35 Jun 05, 2013
Jkt 229001
continuing its financial and other
contributions to a carefully planned,
well-executed effective national
campaign begun in 2010 by the National
Consumers League (NCL) called ‘‘Script
Your Future’’.
To continue and enhance this
important public health initiative, the
Division of Health Communications
(DHC)/Office of Communications
(OCOMM)/Center for Drug Evaluation
and Research (CDER) in FDA seeks to
assist the National Consumers League in
the development of new online
resources and tools for patients,
engagement of public and private
partners to build on and complement
existing medication adherence
programs, education of health care
professionals with strategies to share
with patients, continuous evaluation of
the campaign to enhance and improve
it, expansion of public-private
partnerships, strengthening of this
national forum focused on informing
consumers about medication adherence,
and tailoring messaging to
subpopulations of consumers who may
need adaptations or special efforts to
inform and educate them.
DATES: Important dates are as follows:
1. The application due date is July 1,
2013.
2. The anticipated start date is August
2013.
3. The opening date is the date this
announcement is published in the
Federal Register.
4. The expiration date is July 2, 2013.
ADDRESSES: Submit the paper
application to: Gladys Melendez, Grants
Management (HFA–500), Food and Drug
Administration, 5630 Fishers Lane, Rm.
2032, Rockville, MD 20857; and a copy
to Elaine Frost, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 1140, Silver
Spring, MD 20903. For more
information, see section III of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Paula Rausch, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 4110, Silver
Spring, MD 20903, 301–796–3121; or
Gladys Melendez, Grants Management
Branch (HFA–500), Food and Drug
Administration, 5630 Fishers Lane, Rm.
2032, Rockville, MD 20857, 301–827–
7175.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
obtain the full FOA from
gladys.bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
34109
I. Funding Opportunity Description
Request for Application: FDA–RFA–
13–027.
Catalog of Federal Domestic Assistance:
93.103
A. Background
In order to fulfill FDA’s mission to
protect public health by assuring the
safety, efficacy, and security of human
drugs; and helping the public to obtain
the accurate, science-based information
they need to use medications in ways
that maintain and improve their health,
FDA seeks to continue its participation
in a national campaign aimed at
promoting the importance of medication
adherence to enhance the health of
Americans.
FDA recognizes medication adherence
as a formidable health problem that
results in health system and human
costs that adversely impact our nation.
FDA has a responsibility as a public
health agency to educate and inform the
public and health professionals about
the importance of medication
adherence. Since 2010, FDA has been a
key government stakeholder in the
NCL’s initiative, along with other major
government agencies and private and
nonprofit organizations, to address the
issue of poor medication adherence.
FDA is committed to educating and
informing the public about this issue,
including key subpopulations such as
those with low literacy and health
literacy, or that faces health disparities
or is economically disadvantaged.
The NCL is the nation’s oldest
consumer organization. With FDA and
its other government partners, NCL
launched its nationwide ‘‘Script Your
Future’’ campaign in 2010 to address
the issue of poor medication adherence.
NCL possesses an extensive research
and evaluation framework from past
medication outreach efforts that helped
ensure the campaign’s medication
adherence messages and materials are
based on sound communication science.
In addition, NCL assembled a coalition
of more than 130 public-private partners
to mobilize resources that can increase
awareness and outreach to the public far
beyond what FDA would be able to do
alone to promote increased
understanding and positive actions
among the general public and health
professionals related to this critical
issue. Future NCL plans are in sync
with FDA goals for a national
medication adherence campaign and
FDA seeks to enhance this carefully
designed communications intervention.
FDA has been and remains a key partner
with NCL on issues pertaining to the
safe use of medicines.
E:\FR\FM\06JNN1.SGM
06JNN1
34110
Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
B. Research Objectives
The following are the primary
objectives that FDA/CDER/OCOMM/
DHC seeks to achieve through further
support of this national outreach
campaign: (1) To collaborate with a
large group of public-private partners
that can significantly increase
awareness and outreach far beyond
what FDA would be able to do on its
own to promote increased
understanding and positive actions
among the general public and health
professionals related to this critical
issue; (2) to develop new online
resources and tools for patients; (3) to
educate health care professionals with
strategies to share with patients; (4) to
continually evaluate the campaign to
improve and enhance it; (5) to tailor
campaign messaging to subpopulations
of consumers who may need
adaptations to best inform and educate
them; (6) to further targeted market
outreach through community events and
activities; (7) to develop new campaign
materials for patients and health care
providers; (8) to further widespread
dissemination of campaign materials to
consumers and health care professionals
across the country, including at
pharmacies, community centers,
workplaces, clinic offices, health fairs,
and local events; (9) to provide
counseling and education directly to
consumers about adherence in their
communities, including through the
involvement of students studying
pharmacy, medicine, nursing, and other
health professions; (10) to explore new
media opportunities for dissemination
of the program at the local, State and
national levels, in trade press, online
journals, radio, television, and more;
and (11) to extend outreach through
social media, such as Twitter chats, free
text message reminders, online pledges
through Facebook and Twitter and other
channels.
The following are some specific
objectives that FDA believes can further
enhance the ‘‘Script Your Future’’
campaign: (1) Addition of patient and
family caregiver testimonials to the
campaign Web site; (2) creation of a
custom ‘‘I Will’’ tab on the ‘‘Script Your
Future’’ Facebook page; (3) translation
of the radio public service
announcement from English to Spanish;
(4) development of ‘‘Script Your Futurein-A-Box,’’ a turnkey package
incorporating press background
materials and other elements; and (5)
organization of a public event in fall
2013 and a study to measure the reach
of events, media, and partner
engagement.
VerDate Mar<15>2010
17:35 Jun 05, 2013
Jkt 229001
C. Eligibility Information
Competition is limited to the NCL
because it has unique expertise and
capacity found nowhere else.
Specifically, the FDA/CDER/OCOMM,
DHC, seeks to continue and enhance its
public health mission to educate and
inform the public and health
professions about the importance of
medication adherence by awarding a
grant to the NCL to advance its national
campaign, ‘‘Script Your Future.’’ This
campaign represents a comprehensive,
integrated approach to raise awareness
about the problem of poor medication
adherence, and FDA has served as a key
government stakeholder since 2010.
Because FDA has been a partner in the
formative stages of this campaign and
has seen evidence indicating that it has
already had an impact in helping to
resolve the problem of medication
adherence, FDA seeks to continue
funding new dimensions of the
campaign, especially to serve U.S.
subpopulations of people having low
literacy/health literacy, or who face
health disparities and social and
economic disadvantages.
II. Award Information/Funds Available
A. Award Amount
The total amount of funding for this
grant is $200,000 over 2 years.
Applications budgets will be limited to
$100,000 in the first year and $100,000
in the second year depending on the
availability of funds. The number of
awards anticipated is one individual
award.
B. Length of Support
The term for this grant will begin in
August 2013 for a period of 2 years
through August 15, 2015.
III. Paper Application, Registration,
and Submission Information
To submit a paper application in
response to this FOA, applicants should
first review the full announcement.
Persons interested in applying for a
grant may obtain an application at
https://grants.nih.gov/grants/forms.htm.
For all paper application submissions,
the following steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 and 2, in detail, can be found
at https://www07.grants.gov/applicants/
organization_registration.jsp. Step 3, in
detail, can be found at https://
commons.era.nih.gov/commons/
PO 00000
Frm 00080
Fmt 4703
Sfmt 9990
registration/registrationInstructions.jsp.
After you have followed these steps,
submit paper applications to: Gladys
Melendez, Grants Management Branch
(HFA–500), Food and Drug
Administration, Rm. 2031, 5630 Fishers
Lane, Rockville, MD 20857.
Dated: June 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13447 Filed 6–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: June 26, 2013.
Time: 11:30 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Jay R. Radke, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–496–2550,
jay.radke@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: May 31, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13373 Filed 6–5–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34109-34110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13447]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0012]
``Script Your Future'' Medication Adherence Campaign
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the continuing support of a national
effort to promote the importance of medication adherence to enhance the
health of Americans. Medication adherence is taking medicine as
directed to treat an illness or disease in order to get the best health
outcome possible for each patient. Nearly three out of four Americans
report that they do not take their medication as directed. One in three
people never fill their prescriptions. The annual price tag for
medication adherence failure is estimated to be $290 billion, and the
impact on the medical system and patients from this lack of adherence
may result in relapses or recurrences of medical symptoms, increases in
hospital visits, or even death. FDA is committed to addressing this
issue, which has enormous implications for public health and the U.S.
economy, by, in part, continuing its financial and other contributions
to a carefully planned, well-executed effective national campaign begun
in 2010 by the National Consumers League (NCL) called ``Script Your
Future''.
To continue and enhance this important public health initiative,
the Division of Health Communications (DHC)/Office of Communications
(OCOMM)/Center for Drug Evaluation and Research (CDER) in FDA seeks to
assist the National Consumers League in the development of new online
resources and tools for patients, engagement of public and private
partners to build on and complement existing medication adherence
programs, education of health care professionals with strategies to
share with patients, continuous evaluation of the campaign to enhance
and improve it, expansion of public-private partnerships, strengthening
of this national forum focused on informing consumers about medication
adherence, and tailoring messaging to subpopulations of consumers who
may need adaptations or special efforts to inform and educate them.
DATES: Important dates are as follows:
1. The application due date is July 1, 2013.
2. The anticipated start date is August 2013.
3. The opening date is the date this announcement is published in
the Federal Register.
4. The expiration date is July 2, 2013.
ADDRESSES: Submit the paper application to: Gladys Melendez, Grants
Management (HFA-500), Food and Drug Administration, 5630 Fishers Lane,
Rm. 2032, Rockville, MD 20857; and a copy to Elaine Frost, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 1140, Silver Spring, MD 20903. For more
information, see section III of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Paula Rausch, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 4110, Silver Spring, MD 20903, 301-796-3121; or
Gladys Melendez, Grants Management Branch (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, Rm. 2032, Rockville, MD 20857, 301-
827-7175.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please obtain the full FOA from
gladys.bohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Request for Application: FDA-RFA-13-027.
Catalog of Federal Domestic Assistance: 93.103
A. Background
In order to fulfill FDA's mission to protect public health by
assuring the safety, efficacy, and security of human drugs; and helping
the public to obtain the accurate, science-based information they need
to use medications in ways that maintain and improve their health, FDA
seeks to continue its participation in a national campaign aimed at
promoting the importance of medication adherence to enhance the health
of Americans.
FDA recognizes medication adherence as a formidable health problem
that results in health system and human costs that adversely impact our
nation. FDA has a responsibility as a public health agency to educate
and inform the public and health professionals about the importance of
medication adherence. Since 2010, FDA has been a key government
stakeholder in the NCL's initiative, along with other major government
agencies and private and nonprofit organizations, to address the issue
of poor medication adherence. FDA is committed to educating and
informing the public about this issue, including key subpopulations
such as those with low literacy and health literacy, or that faces
health disparities or is economically disadvantaged.
The NCL is the nation's oldest consumer organization. With FDA and
its other government partners, NCL launched its nationwide ``Script
Your Future'' campaign in 2010 to address the issue of poor medication
adherence. NCL possesses an extensive research and evaluation framework
from past medication outreach efforts that helped ensure the campaign's
medication adherence messages and materials are based on sound
communication science. In addition, NCL assembled a coalition of more
than 130 public-private partners to mobilize resources that can
increase awareness and outreach to the public far beyond what FDA would
be able to do alone to promote increased understanding and positive
actions among the general public and health professionals related to
this critical issue. Future NCL plans are in sync with FDA goals for a
national medication adherence campaign and FDA seeks to enhance this
carefully designed communications intervention. FDA has been and
remains a key partner with NCL on issues pertaining to the safe use of
medicines.
[[Page 34110]]
B. Research Objectives
The following are the primary objectives that FDA/CDER/OCOMM/DHC
seeks to achieve through further support of this national outreach
campaign: (1) To collaborate with a large group of public-private
partners that can significantly increase awareness and outreach far
beyond what FDA would be able to do on its own to promote increased
understanding and positive actions among the general public and health
professionals related to this critical issue; (2) to develop new online
resources and tools for patients; (3) to educate health care
professionals with strategies to share with patients; (4) to
continually evaluate the campaign to improve and enhance it; (5) to
tailor campaign messaging to subpopulations of consumers who may need
adaptations to best inform and educate them; (6) to further targeted
market outreach through community events and activities; (7) to develop
new campaign materials for patients and health care providers; (8) to
further widespread dissemination of campaign materials to consumers and
health care professionals across the country, including at pharmacies,
community centers, workplaces, clinic offices, health fairs, and local
events; (9) to provide counseling and education directly to consumers
about adherence in their communities, including through the involvement
of students studying pharmacy, medicine, nursing, and other health
professions; (10) to explore new media opportunities for dissemination
of the program at the local, State and national levels, in trade press,
online journals, radio, television, and more; and (11) to extend
outreach through social media, such as Twitter chats, free text message
reminders, online pledges through Facebook and Twitter and other
channels.
The following are some specific objectives that FDA believes can
further enhance the ``Script Your Future'' campaign: (1) Addition of
patient and family caregiver testimonials to the campaign Web site; (2)
creation of a custom ``I Will'' tab on the ``Script Your Future''
Facebook page; (3) translation of the radio public service announcement
from English to Spanish; (4) development of ``Script Your Future-in-A-
Box,'' a turnkey package incorporating press background materials and
other elements; and (5) organization of a public event in fall 2013 and
a study to measure the reach of events, media, and partner engagement.
C. Eligibility Information
Competition is limited to the NCL because it has unique expertise
and capacity found nowhere else. Specifically, the FDA/CDER/OCOMM, DHC,
seeks to continue and enhance its public health mission to educate and
inform the public and health professions about the importance of
medication adherence by awarding a grant to the NCL to advance its
national campaign, ``Script Your Future.'' This campaign represents a
comprehensive, integrated approach to raise awareness about the problem
of poor medication adherence, and FDA has served as a key government
stakeholder since 2010. Because FDA has been a partner in the formative
stages of this campaign and has seen evidence indicating that it has
already had an impact in helping to resolve the problem of medication
adherence, FDA seeks to continue funding new dimensions of the
campaign, especially to serve U.S. subpopulations of people having low
literacy/health literacy, or who face health disparities and social and
economic disadvantages.
II. Award Information/Funds Available
A. Award Amount
The total amount of funding for this grant is $200,000 over 2
years. Applications budgets will be limited to $100,000 in the first
year and $100,000 in the second year depending on the availability of
funds. The number of awards anticipated is one individual award.
B. Length of Support
The term for this grant will begin in August 2013 for a period of 2
years through August 15, 2015.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement. Persons interested in
applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm. For all paper application submissions,
the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Register With Electronic Research Administration
(eRA) Commons
Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Gladys Melendez, Grants Management Branch
(HFA-500), Food and Drug Administration, Rm. 2031, 5630 Fishers Lane,
Rockville, MD 20857.
Dated: June 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13447 Filed 6-5-13; 8:45 am]
BILLING CODE 4160-01-P