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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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                               ( print 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