[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12969-12970]
From the Federal Register Online via the Government Publishing 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: [email protected]; 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:
[email protected].
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]
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