[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34109-34110]
From the Federal Register Online via the Government Publishing 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 http://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 http://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