[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12969-12970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0012]


Campaign To Improve Poor Medication Adherence (U18)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the Center for Drug 
Evaluation and Research. A goal of the Center for Drug Evaluation and 
Research is to raise consumers' awareness of the

[[Page 12970]]

importance of good medication adherence, a vital first step toward 
improved adherence behavior and better public health outcomes.

DATES: Important dates are as follows:
    1. The application due date is April 15, 2011.
    2. The anticipated start date is April 16, 2011.
    3. The opening date is March 15, 2011.
    4. The expiration date is April 15, 2011.
    For Further Information and Additional Requirements Contact: 
Programmatic Contact: Tamara Ford, Center for Drug Evaluation and 
Research, Food and Drug Administration, Office of Executive Programs, 
10903 New Hampshire Ave., rm. 6114, Silver Spring, MD 20993, 301-796-
5226, FAX: 301-847-8737, e-mail: Tamara.Ford@fda.hhs.gov; Grants 
Management Contact: Oluyemisi Akinneye, Division of Acquisition Support 
and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, 
rm. 2129, Rockville, MD 20857, 301-827-0079, FAX: 301-827-7101, e-mail: 
Oluyemisi.Akinneye@fda.hhs.gov.
    For more information on the funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at http://grants2.nih.gov/grants/guide/ and/or http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

A. Background

    This funding opportunity is a single source application for the 
award of a cooperative agreement to the National Consumers League (NCL) 
to develop and lead a groundbreaking national campaign to raise 
consumers' awareness of the importance of good medication adherence and 
provide tools to prescribers to help their patients use their 
medications in the most safe and efficacious manner. This campaign is a 
vital first step toward improved adherence behavior and better health 
outcomes.
Relevance
    Inadequate medication adherence is a $290 billion dollar problem 
that touches everyone. Nearly three out of four Americans report that 
they do not take their medications as directed. One in three people 
never fill their prescriptions. Americans with chronic conditions 
account for nearly 45 percent of the population, and they are at 
greater risk for health complications and negative health outcomes 
because of medication adherence problems. Understanding the root causes 
for inadequate medication adherence, and effecting changes in knowledge 
and behaviors to increase appropriate medication adherence and thus 
enhance health outcomes is an important goal for all Americans.

B. Research Objectives

    The goal of this broad campaign is to increase consumer awareness 
of the importance of medication adherence; targeting both consumers 
with chronic conditions and health care practitioners as well as to 
provide tools and support for both health care practitioners and 
consumers in managing and adhering to their medications and medication 
regimens. To plan and facilitate the campaign the NCL has brought 
together a public-private coalition of more than 110 stakeholder 
organizations from within and outside the health care arena, including 
businesses, chain drug stores, health care professionals, insurance 
companies, labor, researchers, pharmaceutical companies, health 
information technology companies, and government agencies. The NCL has 
the expertise, background, and motivation necessary to successfully 
lead this campaign. In addition, the campaign complements FDA's 
mission, protecting the public health by assuring the safety, efficacy, 
and security of human drugs and helping the public obtain accurate, 
science-based information that they need to use medicines and foods to 
maintain and improve their health.

C. Eligibility Information

    Competition is limited to the NCL because it has unique expertise 
and capacity found nowhere else. As part of the implementation of their 
campaign, the NCL is building on extensive research and lessons learned 
from earlier adherence promotion efforts, and with the active 
involvement of more than 110 leading nonprofit organizations, 
professional associations, businesses, and Federal Agencies, including 
FDA, the NCL will: (1) Leverage partnerships with public and private 
stakeholders to raise awareness and disseminate campaign messages 
through their networks, (2) reach out to people suffering from common 
chronic conditions and their caregivers, and (3) conduct more intensive 
targeted outreach in six strategic markets.

II. Award Information/Funds Available

A. Award Amount

    The estimated amount of support in fiscal year (FY) 2011 will be up 
to ($40,000) total costs (direct plus indirect cost) with a possibility 
of 2 additional years at $40,000 each for FY 2012 and FY 2013.

B. Length of Support

    The award will provide 1 year of support, with the possibility of 2 
additional years of support, contingent upon satisfactory performance 
in the achievement of project and program report objectives during the 
preceding year and the availability of Federal FY appropriations.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement located at http://grants2.nih.gov/grants/guide/ and/or http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm. (FDA has verified the Web site addresses 
throughout this document, but FDA is not responsible for any subsequent 
changes to the Web sites after this document publishes in the Federal 
Register.) Persons interested in applying for a grant may obtain an 
application from the PHS 398 application instructions available at 
http://grants.nih.gov/grants/forms.htm, or http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm. For all paper application submissions, the 
following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With Central Contractor Registration.
     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: http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm; Tamara Ford, Center for Drug Evaluation and Research, 
Food and Drug Administration, Office of Executive Programs, 10903 New 
Hampshire Ave., rm. 6114, Silver Spring, MD 20993; Oluyemisi Akinneye, 
Division of Acquisition Support and Grants (HFA-500), Food and Drug 
Administration, 5630 Fishers Lane, rm. 2129, Rockville, MD 20857.

    Dated: March 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5287 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P