
[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37820-37821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16091]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Proyecto Informar: Food and Drug Administration Hispanic Outreach 
Initiative (U01)

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 a cooperative agreement 
for the National Alliance for Hispanic Health. The goal of the Food and 
Drug Administration, Office of the Commissioner, is to support 
initiatives that will communicate risk and emergency public health 
information to millions of Spanish-speaking consumers within the 
targeted populations (socially disadvantaged, underserved populations, 
ethnic and racial populations, health professionals, patients and 
caregivers, pediatrics, adolescents, and disabled and older Americans).

DATES: Important dates are as follows:
    1. The application due date is July 15, 2011.
    2. The anticipated start date is in September 2011.
    3. The opening date is June 28, 2011.
    4. The expiration date is July 16, 2011.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: 
    For programmatic questions and concerns: Mary Hitch, Office of 
External Relations, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5320, Silver 
Spring, MD 20993-0002, 301-796-8639, e-mail: mary.hitch@fda.hhs.gov.
    For financial and administrative questions or concerns: Gladys M. 
Melendez, Office of Acquisition and Grant Services, Food and Drug 
Administration, 5630 Fishers Lane (HFA-500), Rockville, MD 20857, 301-
827-7175, e-mail: gladys.bohler@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, and a copy of the full FOA, please 
contact the programmatic or grants contact noted in this section.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

A. Background

    FDA announces its intent to accept a single source application for 
awarding of a Cooperative Agreement to the National Alliance for 
Hispanic Health (The Alliance). The purpose of this agreement is to 
support initiatives that will communicate risk and emergency public 
health information to millions of Spanish-speaking consumers within the 
targeted populations (socially disadvantaged, underserved populations, 
ethnic and racial populations, health professionals, patients and 
caregivers, pediatrics, adolescents, and disabled and older Americans). 
FDA authority to enter grants and cooperative agreements is set out in 
section 1704 of the Public Health Service Act (42 U.S.C. 300u-3).
    FDA relies on community partnerships to enhance its efforts in risk 
and emergency communications about the appropriate use of FDA-regulated 
products and to assure targeted communities understand their roles in 
managing the risks of using FDA-regulated products. Through this 
initiative, FDA also seeks to share risk and benefit information to 
enable people to decide how to use FDA-regulated products, to provide 
access to critical risk and benefit information that is adapted to 
their specific needs--when, where, and in the form they need to best 
understand and apply this information, regarding literacy, language, 
culture, race and ethnicity, and disability.
    This program may support a wide range of appropriate innovative 
education and outreach activities and tools in risk communications. FDA 
must work with partners to continuously develop and disseminate 
communications rapidly and to develop and test messages on the 
appropriate use of FDA-regulated products.

B. Research Objectives

    The goal of the program is to assure effective and efficient 
communications to meet the need for adapted risk communications based 
on literacy, Spanish language, culture, race/ethnicity, disability, and 
other factors during emergency events, such as recalls of FDA-regulated 
products such as food, drugs, cosmetics, and medical devices. The 
applicant must identify specific ways in which FDA could have 
substantial involvement in the proposed program. The applicant must 
suggest activities that would contribute directly to the purpose of the 
program. For any additional initiatives suggested, the applicant should 
identify the objective of the activity, the specific tasks required to 
meet the objective, specific timelines for performing the tasks, and 
specific initiatives to achieve the purpose and goal of this program. 
The recipient will be required to perform the following initiatives:
    Develop and finalize a risk communication and public heath alert 
delivery plan that will contain the tasks needed to accomplish the 
purpose of this program, including a description of the various tasks 
for the project that will be completed, the dates by which each task be 
completed, and who will have responsibility for each task. Task 
milestones must be listed to assure that progress can be measured at 
various dates through the life of the project and document all risk 
communications and public health alert activities to be conducted under 
the agreement and the results of such activities, including criteria 
and indicators used to evaluate the success of the program.
    The plan must delineate the substantial involvement of FDA.

C. Eligibility Information

     National Alliance for Hispanic Health.
    Before entering cooperative agreements, FDA carefully considers the 
benefits such agreements will provide to the public. The Alliance, a 
nonprofit entity as described in section 501(c) 3 of the Internal 
Revenue Code of 1968, is the oldest and largest network of Hispanic 
health and human service providers for the target population. The 
Alliance is an umbrella organization that serves more than 400 national 
and community-based organizations and other health professionals who 
provide access and delivery of quality health and human services to 
some 46.9 million Hispanic health consumers.
    The Alliance is a recognized leader within Hispanic communities and 
works with foundations, corporations, Government Agencies, 
universities, and private industry in carrying out its mission, with 
the objective of improving the health status of Hispanic and minority 
populations.

II. Award Information/Funds Available

A. Award Amount

    Only one grant will be awarded. FDA will award $35,000. Partnering 
Federal Agencies may commit up to an estimated total of $500,000 in 
cofunding or supplemental funds for program expansion, pending the 
availability of funds.

B. Length of Support

    The project will be funded for up to 3 years from the starting date 
for

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activities described in this announcement. Continuation of support 
beyond the first year will be based on satisfactory performance during 
the preceding year, receipt of a noncompeting continuation application, 
and available Federal fiscal year funds.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement available through the 
programmatic or grants contact noted earlier in this document. (See For 
Further Information and Additional Requirements Contact). Persons 
interested in applying for a grant may obtain an application at http://grants2.nih.gov/grants/funding/phs398/phs398.html. For all paper 
application submissions, the following steps are required:
     Step 1: Obtain a Dun and Bradstreet Data Universal 
Numbering System (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: Gladys M. Melendez, Grants Management 
Officer/Specialist at the address noted earlier in this document (See 
For Further Information and Additional Requirements Contact).

    Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16091 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P


