[Federal Register Volume 69, Number 129 (Wednesday, July 7, 2004)]
[Notices]
[Pages 40946-40949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support the National Alliance for 
Hispanic Health; Notice of Intent to Accept and Consider a Single 
Source Application; Availability of Funds for Fiscal Year 2004

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) announces its

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intent to accept and consider a single source application (RFA-FDA-OC-
04-01) for the awarding of a Cooperative Agreement to the National 
Alliance for Hispanic Health (the Alliance). The purpose of the 
agreement is to empower consumers to improve their health by providing 
better consumer health information; ensure that health information 
available to consumers is clear, informative, and effective; leverage 
opportunities to eliminate health disparities in subpopulations; 
respond to the health promotion and disease prevention objectives of 
the Department of Health and Human Services (HHS) ``Healthy People 
2010'' document; and improve health literacy for Hispanic Americans. 
FDA anticipates providing $65,000 (direct and indirect costs) in fiscal 
year (FY) 2004 in support of this project. Subject to the availability 
of funds and successful performance, 2 additional years of support up 
to $65,000 per year (direct and indirect) will be available.

DATES:  Submit applications by August 6, 2004.

ADDRESSES:  Submit completed applications to Sheila Gale, Division of 
Contracts and Grants Management (HFA-531), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7109, 
FAX: 301-827-7101, or e-mail: [email protected]. If the application is 
hand-carried or commercially delivered, it should be addressed to 5630 
Fishers Lane, rm. 2129, Rockville, MD 20857. Applications will be 
accepted during normal business hours, 8 a.m. to 4:30 p.m., Monday 
through Friday.
    The application forms are also available either from Sheila Gale 
(see ADDRESSES) or via the Internet at http://grants.nih.gov/grants/funding/phs398/phs398/html. (FDA has verified the Web site address, but 
we are not responsible for subsequent changes to the Web site after 
this document publishes in the Federal Register.) Do not send the 
application to the Center for Scientific Research, National Institutes 
of Health (NIH). An application not received by FDA in time for orderly 
processing will be returned to the applicant without consideration. 
Please note that FDA is unable to receive applications electronically.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the administrative and financial management aspects of 
this notice: Sheila Gale (see ADDRESSES).
    Regarding the programmatic aspects: Mary C. Hitch, Office of 
External Relations (HF-40), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-4406, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing its intention to accept and consider a single 
source application from the Alliance for the support of a cooperative 
agreement to improve the health of the American Hispanic population by 
providing better consumer health information and ensuring the health 
information available to this consumer group is clear, informative, and 
effective. FDA authority to enter into grants and cooperative 
agreements is set out in section 1704 of the Public Health Service Act 
(42 U.S.C. 300u-3). This program is described in the Catalog of Federal 
Domestic Assistance No. 93.245. Before entering into cooperative 
agreements, FDA carefully considers the benefits such agreements will 
provide to the public. This application is not subject to review under 
Executive Order 12372, Intergovernmental Review of Federal Programs (45 
CFR part 100).
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort to 
reduce morbidity and mortality and improve quality of life. Applicants 
may obtain a paper copy of the ``Healthy People 2010'' objectives, 
volumes I and II, for $70 ($87.50 foreign) S/N017-000-00550-9, by 
writing to the Superintendent of Documents, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N/017-001-
00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://www.healthypeople.gov under ``Publications.''

II. Background

    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 deliver quality health and human services to more 
than 12 million Hispanic health consumers every year. 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.
    For 30 years, the Alliance has been an active partner with FDA and 
its efforts to meet the FDA's mission in Hispanic communities. The 
Alliance has been extensively involved in FDA programs by serving on 
FDA advisory committees as consumer and health professional 
representatives. The Alliance partnered with FDA in the development, 
translation, adaptation, and distribution of consumer educational 
campaign materials. These bilingual (Spanish and English) materials 
have included: Video and print materials on nutrition labeling such as 
Para Vivir Bien, video and print materials on medication safety such as 
Las Medicinas y Usted, and development of a bilingual (Spanish and 
English) section for Hispanic consumers on the FDA Web site.
    The Alliance worked with FDA in support of HHS' Hispanic Agenda for 
Action. The Alliance also worked with FDA and other U.S. Public Health 
Service (PHS) agencies to coordinate and manage the largest Hispanic 
health conference--The 1997 Health and Human Services National Hispanic 
Health Symposium. The symposium brought together over 500 Hispanic 
leaders and community-based organizations to develop a framework to 
involve Hispanic Americans in HHS programs. The Alliance also worked 
with FDA to tailor outreach programs in coordination with Hispanic to 
disseminate health information to the Hispanic community.
    The Alliance has shown the unique capacity to work with academic 
institutions and health agencies on common education, service, and 
research endeavors focused on disease prevention and health promotion 
for minority, disadvantaged, and limited English proficient 
populations.

III. Delineation of Substantive Involvement

    Inherent in the cooperative agreement award is substantive 
involvement by the awarding agency. Accordingly, FDA will have 
substantive involvement in the programmatic activities of the entire 
project funded by this cooperative agreement. Substantive involvement 
includes, but is not limited, to the following items:
    1. FDA will appoint a project officer or coproject officer, who 
will actively monitor the FDA-supported program under this award.
    2. FDA will provide guidance, direction and technical assistance in 
developing the approach and methods that may be used by the recipient.
    3. FDA will participate with the recipient to determine the scope 
of: (1) Consumer health literacy educational

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electronic media and Web campaigns; (2) the design and development of 
consumer health literacy publications; (3) the methodology, scope, and 
interpretation of focus groups pre- and post-test health literacy 
messages; and (4) the utility of current consumer health literacy 
education materials.
    4. FDA will have final approval of the methodology for behavioral 
research studies on disparities in health for Hispanic Americans, 
including protocol design, data analysis, interpretation of findings, 
and coauthorship of publications.

IV. Goals and Objectives

    Through this cooperative agreement FDA seeks to support initiatives 
that will reach millions of consumers within the targeted population 
with credible health information by conducting culturally and 
linguistically appropriate public education initiatives through print 
and electronic media, help lines, the Internet, libraries, publication 
of bilingual patient and consumer health information materials (English 
and Spanish) and networks of community-based organizations.

V. Availability of Funds

    It is anticipated that FDA will fund this cooperative agreement at 
a level of $65,000 (direct and indirect costs) for the first year 
award.

VI. Length of Support

    The length of support will be 1 year with the possibility of an 
additional 2 years of noncompetitive support. Continuation beyond the 
first year will be based upon satisfactory performance during the 
preceding year, receipt of a noncompeting continuation application, and 
the availability of Federal FY appropriations.

VII. Reason for Single Source Selection

    FDA believes that there is compelling evidence that the Alliance is 
uniquely qualified to fulfill the objectives of the proposed 
cooperative agreement. The Alliance is an established and recognized 
authority on Hispanic American health, health disparities, and health 
literacy needs. The Alliance has shown a unique capacity to enhance 
health literacy. The Alliance has accomplished the following:
     Developed a nationally recognized center for health 
information for health professionals and Hispanic consumers. The center 
includes development and operation of a toll-free national bilingual 
(Spanish and English) telephone help line that provides health 
information to callers, drawing from a regularly updated resource of 
over 16,000 community health providers. The center also reviews 
bilingual health information materials for accuracy and timeliness;
     Provided valuable information and leadership through their 
trademark Provider Information Training and Technical Assistance 
Network program. This program trains health care professionals on how 
to work more effectively with minority, disadvantaged and limited 
English proficient populations;
     Established a capacity to deliver family-focused services 
to Hispanic communities, including the trademarked Strengthening 
Families bilingual family support and health education program;
     Developed a substantial portfolio of health promotion and 
disease prevention programs that deal extensively with Hispanic health 
issues within local communities. Through this initiative, the Alliance 
supports a network of local agencies that: Provide a foundation on 
which to develop, promote, and conduct community-based education; 
support health professional programs aimed at preventing and reducing 
unnecessary morbidity and health disparities among Hispanic 
populations. These initiatives support the HHS ``Healthy People 2010'' 
goals;
     Assessed and evaluated the current education, research, 
and disease prevention and health promotion programs for member 
organizations, affiliated groups and Hispanic subpopulations;
     Developed a critical knowledge base of essential disease 
prevention, health promotion, and research evaluation strategies that 
are necessary for any health intervention dealing with Hispanic 
Americans;
     Developed a national organization whose members have the 
collective capacity to conduct sponsored research;
     Reached millions of consumers within the targeted 
population with credible health information by conducting culturally 
and linguistically appropriate public education initiatives such as: 
(1) A national health information telephone help line; (2) an 
interactive health Web site that features Web broadcasts of Spanish 
language radio shows on Hispanic health topics; (3) an extensive 
bilingual consumer library; (4) publication of bilingual patient and 
consumer health information materials (English and Spanish); and (5) 
outreach through the Alliance Reporter (the official national 
newsletter) and a network of community media (television, radio, and 
print) and organizations;
     Supported health care providers in their efforts to 
deliver quality services by providing guidance on social service needs 
such as translation services, cultural proficiency education, and 
professional development on meeting the unique health needs of 
Hispanics;
     Supported a database of community-based organizations, 
health care providers and researchers with the capacity to reach and 
meet the needs of Hispanics in the United States; and
     Improved and promoted scientific research by collecting 
and upgrading proprietary health data.

VIII. Submission Requirements

    The original and two copies of the completed grant application form 
PHS 398 (rev. 5/01) with copies of the appendices for each of the 
copies should be delivered to Sheila Gale (see ADDRESSES). The outside 
of the mailing package should be labeled ``Response to RFA-FDA-OC-04-
1''. No supplemental or addendum material will be accepted after the 
receipt date. Information collection requirements requested on Form PHS 
398 and the instruction have been submitted by the PHS to the Office of 
Management and Budget (OMB) and were approved and assigned OMB control 
number 0925-001.
    Data and information included in the application, if identified by 
the applicant as trade secret or confidential commercial information 
will be given treatment as such to the extent permitted by the Freedom 
of Information Act (5 U.S.C. 552(b)(4)) and FDA's implementing 
regulations (21 CFR 20.61).

IX. Reporting Requirements

    An annual Standard Form (SF) 269, Financial Status Report (FSR), is 
required. An original and two copies of the Standard Form 269, 
Financial Status Report (FSR), must be submitted within 90 days after 
the end of the budget period. An original and two copies of the 
progress reports must be submitted on a quarterly basis no later than 
30 days after each quarter. An annual progress report is also required. 
The noncompeting continuation application (PHS2590) will be considered 
the annual program progress report. A final program progress report, 
FSR, and invention statement must be submitted within 90 days after 
expiration of the project period of the cooperative agreement.
    In addition, the principal investigator will be required to present 
the progress of the study at an annual FDA extramural research review 
workshop in Washington, DC. The application should specifically request 
travel costs

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for this requirement in the budget section of the application.

X. Review Procedures and Evaluation Criteria

A. Review Procedures

    The application submitted by the Alliance will initially be 
reviewed by grants management and program staff for responsiveness. To 
be considered, an application must meet the following requirements: (1) 
Be received by the specified due date; (2) be submitted in accordance 
with section VIII ``Submission Requirements'' of this document; (3) not 
exceed the $65,000 (direct and indirect) for each year requested; (4) 
address the specific program goals and objectives; and (5) bear the 
original signatures of both the principal investigator and the 
organization's authorized official. The application will be considered 
nonresponsive if it is not in compliance with this document. If the 
application is found to be nonresponsive, the application will be 
returned to the applicant without further consideration.
    The application submitted by the Alliance will undergo a dual peer 
review. The application will be reviewed first for scientific and 
technical merit by an ad hoc panel of experts in areas associated with 
consumer health information and promotion and disease prevention. If 
the application is recommended for approval, it will then be presented 
to the National Advisory Environmental Health Sciences Council for 
their concurrence.

B. Review Criteria

    The application will be reviewed and evaluated according to the 
following criteria:
Factor 1: Background (15 percent)
    Applicant: (1) Demonstrated knowledge of the health literacy 
problem and health care needs in the Hispanic community; (2) documented 
outcomes of past efforts with the target population; and (3) proposed 
geographic locations to be served by the proposed program.
Factor 2: Approach (45 percent)
    Applicant: (1) Describes an acceptable plan of action with details 
on how the proposed work will be performed, including a timeline, 
listing of other involved organizations, consultants and key 
individuals who will work on the project and a short description about 
their efforts or contributions to the proposed program; (2) identifies 
the results and benefits to be gained by the Hispanic community; (3) 
describes the expected program contributions from providing suitable 
health information toward improving health literacy and eliminating 
health disparities in the Hispanic community; and (4) describes how the 
proposed program meets the following proposed objectives:
     To empower consumers to improve their health by providing 
better health information; and
     To ensure that health information is clear, informative, 
effective, and accessible by the Hispanic community.
Factor 3: Management Plan (20 percent)
    Applicant's demonstrated capability to manage the program as 
determined by the following: (1) Qualification and experience of 
proposed staff or requirements for ``to be hired'' staff, proposed 
staff effort, management experience of the organization related to the 
proposed program; (2) support and established network to conduct the 
proposed program; and (3) evaluate the program as determined by the 
thoroughness, feasibility and appropriateness of the proposed program 
evaluation design, and data collection and analysis procedures.
    Factor 4: Budget and Budget Justification (20 Points)
    Applicant: Proposed program costs are reasonable and based on 
activities to be carried out and the expected program outcomes.

XI. Mechanism of Support

    Support for this project will be in the form of a cooperative 
agreement. This agreement will be subject to all policies and 
requirements that govern the research grant programs of the PHS, 
including the provisions of 42 CFR part 52, 45 CFR part 74, and PHS 
Grants Policy Statement. The regulations issued under Executive Order 
12372 do not apply. The length of support will be up to 3 years. Cost 
sharing or matching is not a requirement of this program. The NIH 
modular grant program does not apply to this FDA program.

XII. Dun and Bradstreet Number (DUNS) Requirement

    Beginning October 1, 2003, applicants are required to have a DUNS 
number to apply for a grant or cooperative agreement from the Federal 
Government. The DUNS number is a nine-digit identification number, 
which uniquely identifies business entities. To obtain a DUNS number, 
call 1-866-705-5711. Be certain to identify yourself as a Federal grant 
applicant when you contact Dun and Bradstreet.

XIII. Legend

    Unless disclosure is required under the Freedom of Information Act 
as amended (5 U.S.C. 552) as determined by HHS freedom of information 
officials or by a court, data contained in the portions of this 
application that have been specifically identified by page number, 
paragraph, etc., by the applicant the applicant as containing 
restricted information, shall not be used or disclosed except for 
evaluation purposes.

    Dated: June 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15427 Filed 7-6-04; 8:45 am]
BILLING CODE 4160-01-S