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EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH 
DISPARITIES AND TRAINING (PROJECT EXPORT - ESTABLISHING EXPLORATORY CENTERS)

RELEASE DATE:  February 21, 2003

RFA:  MD-03-002 (This RFA has been modified, see RFA-MD-05-003)

National Center on Minority Health and Health Disparities (NCMHD)
 (http://www.ncmhd.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.307

LETTER OF INTENT RECEIPT DATE: March 28, 2003

APPLICATION RECEIPT DATE: April 22, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE

The National Center on Minority Health and Health Disparities (NCMHD) 
invites applications for establishing exploratory centers (P20) under a 
continuing program for Project EXPORT: Centers of Excellence, 
Excellence in Partnerships for Community Outreach and Research on 
Disparities in Health and Training. This Centers of Excellence Program 
was authorized by the Minority Health and Health Disparities Research 
and Education Act of 2000 and is in support of the Department of Health 
and Human Services initiatives to address and ultimately eliminate 
health disparities.  These P20 grant applications will focus on health 
disparities research, community outreach, and training.

Two other announcements inviting applications for Project EXPORT using 
the (P60) Comprehensive Centers (RFA MD-03-003) and the (R24) Resource-
Related Research Project (RFA MD-03-001) award mechanisms are presently 
available. A comparison of the requirements for submitting, and the 
unique characteristics for R24, P20 and P60 applications, can be found 
at http://www.ncmhd.nih.gov.

The P20 center grant awards will provide a mechanism by which 
institutions can strengthen their research and training. For further 
information, refer to the section on eligibility.

These exploratory grants will assist the institution in their 
development of infrastructure for minority health and other health 
disparities research and training, can provide resources for successful 
applicants to assist them in the development of innovative partnership 
models. In addition, the P-20 is intended to help facilitate single or 
multi-site research projects in areas of research relevant to specific 
populations of interest.  Research that explores a broad array of 
determinants of disparities in minority health and health disparities 
is encouraged, as well as that which addresses a full range of health 
promotion approaches with the prevention or reduction of health 
disparities.  

The purpose of this request for applications (RFA) is to solicit 
applications for EXPORT Center programs that would establish centers of 
excellence with a focus on community outreach, research on health 
disparities, and training.  These P20 centers may be established 
independently by eligible institutions, through partnerships between 
minority serving and other designated institutions, or between 
designated and non-designated institutions with substantial existing 
federal research support and/or research infrastructure as reflected in 
a 2002 report on research institutions: 
(http://thecenter.ufl.edu/research_data.html).  

NON-DESIGNATED INSTITUTIONS MUST BE INVOLVED, HOWEVER, IN PARTNERSHIPS 
WITH DESIGNATED INSTITUTIONS TO PARTICIPATE IN PROJECT EXPORT. 
Definitions for designated and non-designated institutions are provided 
in a later section of this RFA.

A predominantly minority serving institution is an academic, health 
care or research institution with an enrollment and/or faculty that 
consists predominantly of racial and ethnic minorities.  Designated 
institutions are eligible based on the requirements as described in the 
section SPECIAL REQUIREMENTS.  

Non-designated institutions are those that do not meet the criteria as 
outlined.  All partnerships must demonstrate a clear mutual benefit 
with respect to developing research programs and/or research training 
and career development programs.  While partnerships among institutions 
are strongly encouraged, involvement in a partnership is not an 
absolute requirement for participation in Project EXPORT.

The objectives of Project EXPORT include but are not limited to: 1) 
promotion of the conduct of minority health and/or other health 
disparities research aimed at reducing disparities in health status, 2) 
building research capacity for health disparities research in minority 
serving and other institutions, and 3) promotion of the participation 
of health disparity groups in biomedical and behavioral research, and 
prevention and intervention activities.  

TECHNICAL ASSISTANCE WORKSHOPS

The NCMHD will conduct one technical assistance and information-sharing 
workshop, in Washington, DC (March 27, 2003). This workshop will allow 
applicants and NIH staff to discuss and clarify any issues or questions 
related to this application. 

Please inform NCMHD staff of the anticipated numbers of attendees by 
contacting Dr. Teresa Chapa via email ([email protected]), or by 
telephone (301-402-0050). To accommodate individuals who cannot attend, 
a summary workshop will be posted on the NCMHD home page at: 
http://www.ncmhd.nih.gov.

RESEARCH OBJECTIVES

Background

The mission of the National Center on Minority Health and Health 
Disparities (NCMHD) is to promote minority health and to lead, 
coordinate, support, and assess the NIH effort to reduce and ultimately 
eliminate health disparities.  In this effort, the NCMHD supports 
basic, clinical, social, and behavioral research; promotes research 
infrastructure and training; fosters emerging programs; disseminates 
information; and, reaches out to minority and other health disparity 
communities.

Although the diversity of the population in contemporary America is one 
of its greatest assets, the richness of this feature is overshadowed by 
the reality of the disproportionate burden of disease and illness that 
is borne by racial and ethnic minority populations and the rural and 
urban poor.  Compelling evidence of the disparate health status of 
America's racial and ethnic minority populations and the economically 
disadvantaged is documented in the form of shorter life expectancies 
and higher rates of cancer, birth defects, infant mortality, asthma, 
diabetes, cardiovascular disease, and stroke.  Other areas in which 
racial and ethnic minorities and the medically underserved suffer a 
disproportionate burden of morbidity and mortality include: HIV 
Infection/AIDS, autoimmune diseases such as lupus and scleroderma, oral 
health, sexually transmitted diseases, disease burden associated with 
mental disorders, drug use associated mortality, and viral borne 
diseases such as hepatitis C.  While studies cannot delineate with 
certainty why health disparities exist, data suggests that differential 
incidences of disease and health outcomes result from the interaction 
of a plethora of factors in complex and unsuspecting ways.

Observations and anecdotes provide clues about the etiology of the 
disproportionate burden of disease and illness, but it has only been 
through rigorous population and epidemiologic research that the medical 
community has been able to reasonably discern the extent of the 
healthcare crisis.  We are now poised to more completely define the 
scope of the problem and begin the process of identifying and 
evaluating new approaches to mitigating disparities in health.  
Clearly, the soundest investment that can be made for the present and 
immediate future is a strengthened commitment to research, research 
training, and enhanced community involvement aimed at elucidating the 
etiology of health disparities, developing new diagnostics and 
treatment and prevention strategies, and the full implementation of 
such.

Project EXPORT is central to NCMHD's investment strategy for addressing 
disparities in health status.  Consistent with the goals of the trans-
NIH Strategic Plan, EXPORT Centers will focus on research aimed at 
reducing and eliminating health disparities, improving research 
capacity, and providing outreach and education.

In the first year of Project EXPORT Centers of Excellence Program, 
NCMHD supported the establishment of 6 Resource-Related Research 
Projects, (R-24), 9 Exploratory Center Grants (P-20), and 11 (P-60) 
Comprehensive Center Grants.  This announcement is intended to expand 
the Centers of Excellence Program to include all geographic regions of 
the US and its territories and to ensure the establishment of centers 
that focus on disparities in health status for all health disparity 
populations, including African Americans, American Indians and Alaska 
Natives, Asian Americans, Hispanic Americans, Native Hawaiians, Pacific 
Islanders and other medically underserved populations (i.e., 
socioeconomically disadvantaged individuals in rural and urban areas).

Research Topics for Consideration

The following sections provide examples of potential research 
directions and endeavors.  The examples are not exhaustive and do not 
define areas of mandated research.

Research Themes

Project EXPORT Centers of Excellence Programs should reflect the 
following research themes:
o   Discoveries of the biological underpinnings of disparities 
in health status.
o   Creating healthy communities with a focus on identifying 
environmental determinants of health disparities.
o   Empowering community based organizations for participatory 
research.
o   Prevention First! In addressing and eliminating acute and 
chronic diseases and conditions.
o   Exploring health promotion and disease prevention across 
the life span and in all settings: the home, school, 
community, workplace, and faith-based settings, all from a 
multidisciplinary perspective.

Research Areas of Emphasis and Scope

The DHHS special emphasis areas are a priority, and investigators are 
encouraged to design studies using the following research 
methodologies/ strategies:
o   Population-based studies with a focus on the DHHS special 
emphasis areas:  cardiovascular disease, stroke, cancer, 
diabetes, HIV/AIDS, infant mortality, and mental health.
o   Within and between-group comparative studies designed to 
identify similarities and differences in physiological 
processes at the sub-population level.
o   Studies that use ethnographic methods to articulate the 
interacting effects between the economy, the community, the 
household, and the individual with the goal of 
operationalizing psychosocial and societal experiences in a 
quantitative manner such that their impact on 
physiological/psychological processes can be assessed.

Health Promotion/Prevention Research Objectives/Priority Areas:
o   Communications research   how to reach racial/ethnic 
minority and other medically underserved populations with 
messages that will lead to positive behavioral and health 
changes.
o   Translational research   successfully incorporating 
research into health promotion/prevention programs or 
policies in communities, schools, businesses, families, 
prisons, etc.
o   Epidemiologic studies   focusing on assessing and advancing 
understanding of health disparities in local communities
o   Prevention/Interventions research within health disparity 
populations (African Americans, American Indians and Alaska 
Natives, Asian Americans, Hispanic Americans, Native 
Hawaiians, Pacific Islanders, and other medically 
underserved populations (including the rural and urban 
poor), and geographical regions (Appalachia, U.S.-Mexico 
Border region, Mississippi Delta region, and Tribal 
Communities).
o   Cultural sensitivity/competency, and its role in health 
promotion/disease prevention.
o   Interaction of culture and other variables on issues such 
as recruitment into research studies and clinical trials, 
utilization of services, adherence to lifestyle and 
behavioral changes; and understanding individual cultural 
belief and expression within a multicultural setting.
o   Development of measures, instruments, and research designs 
to facilitate health disparities research.

Capacity Building and Infrastructure Objectives:
o   Development of a cadre of culturally competent researchers 
with expertise in minority health promoting and supporting 
research capacity-building activities at designated 
institutions.
o   Increase the number of underrepresented racial/ethnic 
minorities with careers in the biomedical, bio-behavioral, 
and social sciences research.

Community Outreach Objectives:
o   Engaging communities and their community-based organizations
in research and related activities that address disparities in
health status
o   Facilitating the dissemination of culturally sensitive health
o   Engaging institutions in K-12 Science Education activities

Other topics:  

o   Interdisciplinary minority health and other health 
disparities research, including basic, clinical, behavioral 
and social sciences research to advance the understanding 
of disease/disability development and progression.

o   Research that improves approaches for diagnosis, 
prevention, and treatment.

o   Potential pathways to disparities in health outcomes, 
including but not limited to environmental exposures, 
genetic variations and/or other underlying biological, 
ethnic and familial factors.  In particular studies 
identifying the biological underpinnings of differential 
responses to therapies (i.e., hypertension, diabetes, renal 
transplantation, depression) and/or the differential 
prevalence of disease.  Also included are studies of the 
specific mode of transmission and/or natural history of 
diseases such as hepatitis C in minority groups and 
potential differences related to virologic infection, 
particularly in terms of viral genotype, host differences, 
and/or differential responses to antiviral therapies.

o   Development of methodological tools for disentangling the 
impact of biologic factors and socioeconomic status on health.

o   Epidemiological studies of the incidence and prevalence of 
disparities in health status among individuals living in 
different geographical regions of the US, in particular, 
Appalachia, U.S.  Mexico Border region, Mississippi Delta 
region, and Tribal Communities. And studies designed to 
investigate factors contributing to the excess morbidity 
and mortality associated with living in such regions.

o   Developmental influences across the life span, specific 
health behaviors, discrimination in health processes, 
psychosocial, socio-cultural, and socioeconomic (SES) 
related factors, such as differential access to health 
care.  Health processes include the technical and 
interpersonal activities pertaining to disease prevention, 
diagnosis, and treatment that go on between patient and 
practitioner.

Project EXPORT Research Infrastructure

EXPORT Center applications should be organized into discrete components 
that comprise a proposed overall program of research.  Take note of 
those cores and components that are mandatory.

o   Administrative Core  - Mandatory -- 15-page maximum

The administrative core component plays a key role in the coordination 
and operation of the proposed EXPORT Center.  Through this core, the 
Center director provides substantive leadership as well as manages the 
administration of the budget.  This core should be described in 
sufficient detail to assure that all proposed components and related 
activities would function optimally and in an interactive, synergistic 
manner.  

o   Research Component -  Mandatory -- 15-page maximum for each full 
research project proposed

Each full research project must be a highly focused area of 
investigation and may include several investigators under the direction 
of a project director.  Each proposed research project will be reviewed 
on its own merit. Thus, each project must be described separately and 
include an individual budget.  Individual research projects must be 
thematic, highly focused, and interrelated so that they collectively 
contribute to the goals of the Center program to a greater extent than 
if the research undertaken under individual components were pursued 
separately.  Provide a clear description of each proposed project, 
including major goals and objectives as well as how it integrates with 
the other Center components in relation to the overall EXPORT Center 
program.

Pilot projects may be included in this section, but are not mandatory. 
The purpose of pilot projects is to provide the Center with a flexible 
means of developing and exploring new research activities or directions 
and unique scientific opportunities that could evolve into 
independently funded research projects.  Such projects must be in a 
separate pilot project component that incorporates all of the pilot 
studies of the proposed Center grant.  While the specific number of 
pilot projects to be proposed is at the discretion of the applicant, 
all proposed pilot projects need not be ongoing at any one time, but 
may be phased in at different points during the life of the proposed 
Center grant.  It is recognized that the relative priority or need for 
specific pilot projects may change over the course of time.

While the Center's framework for the management of pilot funds and the 
mechanism for operating the program are left to the discretion of the 
Center, the application must provide specific information to enable 
adequate scientific evaluation by a peer review committee. (The 
descriptions of all proposed pilot research projects must be limited to 
5 pages each.  This is in addition to the 15-page limit for describing 
each research core component.)

o   Community Outreach and Information Dissemination component --
Mandatory -- 15-page maximum

The mission of the Community Outreach and Information Dissemination 
Component is to integrate the EXPORT Centers into the local communities 
as a disease prevention and health and science education resource.  
Accordingly, there is a three-fold focus:  1) development and 
dissemination of culturally sensitive health information   directly 
related to the research of the Center or general health information 
presented in a culturally sensitive manner; 2) encouraging and 
equipping the community for potential participation in clinical studies 
and for partnering in the conduct of evidence based disease prevention 
and intervention activities; and 3) sponsorship of science education 
outreach activities (e.g., K-12 science programs with area middle 
schools and/or high schools).
   
EXPORT Centers may develop exploratory programs for disseminating 
minority health and health disparities research information, as well as 
sponsor activities that encourage community participation in research 
either as study participants or that equip community based 
organizations for partnering in and/or conducting disease prevention 
and/or intervention activities.  In particular for information 
dissemination purposes, the audiences should include health care 
students and professionals, community based organizations and 
researchers at the host institution as well as investigators at other 
institutions.  Information transfer activities may include, but are not 
limited to activities such as training programs, short courses, 
telemedicine, presentations at professional meetings and publications.  

With respect to equipping health disparity communities to develop and 
manage their own culturally sensitive programs for educating their 
populations and/or participating in prevention and intervention 
activities, the focus could be on addressing risk factors for disease, 
chronic disease management, screening, prevention, and decision making 
with respect to available therapeutics.  Such activities may require a 
substantial portion of the first year for planning and development with 
actual implementation beginning near the second year and continuing in 
subsequent years.

Plans to evaluate the success and/or effectiveness of the proposed 
community outreach/information dissemination should be described, with 
emphasis on the impact of the proposed activities on knowledge, 
attitudes, and/or behaviors.  Note that it is expected that 
considerable development of the Community Outreach Component may be 
ongoing in year one of the project period with full implementation 
targeted for year two.

o   Training Component -- Mandatory -- 15-page maximum

Training activities may be provided at the undergraduate, graduate, 
post-doctoral, and junior faculty level or a combination of two or more 
of the aforementioned levels.

Undergraduate/Graduate Students.  Training components for students may 
include establishing academic term and/or summer training 
opportunities.  For consortia arrangements, in particular, new research 
training programs might provide graduate students the opportunity to 
fulfill their research requirements in research laboratories at the 
partner institution.

Post-Doctoral Training.  Training components may also support post-
doctoral training for individuals that have earned the doctorate degree 
or equivalent and who are from racial and ethnic minority groups or 
other health disparity subpopulations. Including opportunities for 
postdoctoral training within Project EXPORT will fulfill an important 
gap.  

Junior Faculty at Minority Serving Institutions (MSIs)- With respect to 
faculty at MSIs, mentored research components may be developed to 
provide assistance in learning new methodologies or to encourage 
faculty participation.  

The applicant institution and its partners must demonstrate or give 
reasonable assurances that it has: the capacity to train predoctoral 
and/or postdoctoral students for careers in biomedical, behavioral, 
epidemiological or health services research; and the capacity to 
conduct continuing education programs on the Center's designated 
research theme in the medical, behavioral, epidemiological, or health 
service fields.  Further, the research training core is expected to:  
develop, implement and evaluate research development activities related 
to conducting health disparities research for participants at all 
partnering institutions; provide training on issues related to 
developing cultural competence; increase the number of potential 
investigators from racial and ethnic minority and other health 
disparity groups; and identify and facilitate interdisciplinary 
collaboration to promote the conduct of health disparities research.

For partnerships and consortia, in particular, training initiatives 
should represent true collaborations that function across institutional 
boundaries.

o   Shared Resource Core(s) -- 15-page maximum

Shared resource cores are intended to enhance opportunities for 
investigators at the Center to take advantage of new technologies that 
could enhance and broaden their research initiatives.  While, research 
is not conducted as part of the shared resource core, quality assurance 
activities that evaluate the operation, resources, quality and 
utilization of the core and are directed at problem identification and 
improvement of core functioning are appropriate.  Some examples of 
support that are typically provided in shared resource cores include:  
a) technology that implements automation of large batch preparations; 
b) tissue and/or cell culture facilities; c) complex instrumentation, 
(e.g., electron microscopy, mass spectrometry, electrophysiology); d) 
animal care and preparation; e) service and training; f) patient 
coordination; and g) information processing, data management, and 
statistical services; and h) telehealth development and use.

In collaborative partnerships and/or consortia arrangements, priority 
must be given to locating newly developed shared resource core 
activities at predominantly minority serving institutions.

o   Minority Health and Health Disparity Education Component -- 15-page 
maximum

An educational component could focus on efforts to augment existing or 
create new curricula among partner institutions that would be 
culturally sensitive and used to educate undergraduates, graduate 
students, or postdoctoral trainees in research, medicine, or public 
health of the need to reduce and eliminate disparities in health status 
among the nation's ethnic and racial minority groups and other 
medically underserved populations.

MECHANISM OF SUPPORT

This RFA will use NIH series P20 Exploratory Grant award mechanism. As 
an applicant, you will be solely responsible for planning, directing, 
and executing the proposed project.  This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation applications 
based on this project will compete with all investigator-initiated 
applications and will be reviewed according to NIH peer review 
procedures.  The anticipated award date is September 29, 2003.

FUNDS AVAILABLE

The NCMHD intends to commit approximately $4.5 million in FY 2003 to 
fund up to three new grants in response to this RFA.  An applicant may 
request a project period of up to five years and a budget for DIRECT 
COSTS of up to $1.1 million per year. In addition, Facilities and 
Administrative (F & A or indirect) costs will be provided at the 
applicant's negotiated rates.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. 
Although the financial plans of the NCMHD provide support for this 
program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.  At this time, it is not known if this RFA 
will be reissued.

ELIGIBLE INSTITUTUIONS

You may submit an application if your institution meets the Special 
Requirements listed below:

o   Public or private institution (i.e. University, College, Hospital 
and/or laboratory).
o   Do not have a comprehensive P-60 or specialized center (P-50) 
grant funded by other NIH Institutes and Centers.

Foreign institutions are not eligible.

For-profit or non-profit state, local and faith-based organizations, 
and Tribal governments must partner with eligible institutions in order 
to participate in this RFA. Additional requirements pursuant to the 
statute that authorized this program can be found in the section 
SPECIAL REQUIREMENTS.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

DEFINITIONS

The definitions below are intended to clarify concepts that are 
expressed in this RFA.

APPLICANT INSTITUTION:  The applicant institution is the entity at 
which the EXPORT Center will be physically and/or integrated into its 
administrative structure.  The Center Director must have his/her 
primary appointment at the applicant institution.

COLLABORATING INSTITUTION:  The collaborating institution is the 
institution with which the applicant institution has partnered.

PREDOMINANTLY MINORITY SERVING INSTITUTION:  A predominantly minority 
serving institution is an academic, health care or research institution 
with an enrollment and/or faculty that consists predominantly of racial 
and ethnic minorities. 
 
DESIGNATED INSTITUTION:  Pursuant to Public Law 106-525, a designated 
institution is an intuition of higher learning that has a history of 
enrolling and graduating racial and ethnic minority and 
socioeconomically disadvantaged students from their degree programs.  
The recruitment of racial and ethnic minority faculty and staff is also 
a priority at such institutions. The recruitment of racial and ethnic 
minority faculty and staff is also a priority at such institutions.  

Operationally, a Designated Institution is one that has:

o   Been effective in assisting racial and ethnic minority and 
students from other health disparity groups to complete a 
program of study or training and receive the advanced degree 
involved.

o   Made significant efforts to recruit minority students to 
enroll in and graduate from the institution, which may include 
providing means-tested scholarships and other financial 
assistance as appropriate. AND

o   Made significant recruitment efforts to increase the number of 
minority or other members of health disparity populations 
serving in faculty or administrative positions at the 
institutions.

o   NON-DESIGNATED INSTITUTION:  A non-designated institution is 
considered as any institution of higher learning that does not 
have a record of recruiting racial and ethnic minority students 
nor graduating such students from their degree programs.  

o   HEALTH DISPARITY POPULATIONS:  African Americans, Alaskan Natives, 
American Indians, Asian Americans, Hispanic Americans, Native 
Hawaiians, Pacific Islanders, and other medically underserved 
populations, which includes socioeconomically disadvantaged 
individuals in rural and urban areas (P.L. 106-525).

o   PARTNERSHIP AND CONSORTIUM ARRANGEMENTS. When a grant application 
includes research activities that involve more than one 
institution it is considered a partnership or consortium effort, 
depending on the number of institutions involved.  Such 
activities are encouraged in Project Export, but it is imperative 
that such applications be prepared so that the programmatic, 
fiscal and administrative considerations are explained fully.  In 
addition, the Project EXPORT thematic science focus must be 
evident in the application.  Applicants should exercise care in 
preserving the interactions of the participants and the 
integration of the partnership or consortium project(s) with 
those of the primary applicant institution, because synergism and 
cohesiveness can be diminished when projects are located outside 
of the group where the administration of Project EXPORT is 
carried out.  

Applicants are encouraged to review the NIH policy and procedures   
to consortium agreements, which are published as part of the NIH 
Grants Policy Statement, Part III, available on the NIH homepage 
at: http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. 

Questions may be directed to the fiscal contact identified below 
under Inquiries.

DEMOGRAPHIC GOALS

Project EXPORT has a grass-roots strategy with a focus on matching the 
needs of the community with the strengths of local institutions.  
Therefore, establishing EXPORT Centers within geographic areas with 
specific demographic characteristics is an important emphasis. 
Accordingly, an applicant institution and/or its collaborating partner 
must also have at least ONE of the following demographic characteristics:

o   Be located within a metropolitan statistical area (MSA) where the 
density of racial and ethnic minorities within the general 
population is equal to or exceeds:  19 percent for Hispanic 
Americans or African Americans respectively, 10 percent for Asian 
Americans and Pacific Islanders, or 2 percent for Native 
Americans and Alaskan Natives.  In addition, the overall poverty 
rate within the geographic region to be served by the center must 
equal or exceed the national average of 11.3 percent. (Overview 
of Race and Hispanic Origin, Census 2000 Brief, Elizabeth Grieco 
and Rachel Cassidy. 
http://www.census.gov/hhes/poverty/poverty00/tabled.pdf

OR

o   Be located within or near a Health Professional Shortage Area 
(HSPA) or within an officially designated area of underservice.  
For the purposes of this announcement a United States Department 
of Agriculture (USDA) designated HSPA is a geographical area 
having fewer than the generally accepted minimum number of 
clinicians (physicians, dentists and mental health workers) per 
thousand.  A listing of the USDA fully medically served and 
underserved HSAs can be found at: http://www.hrsa.gov/grants/.  

An underserved area is a geographical region with a calculated 
score of 62 or less on the IMU (Index of Medical Underservice 
Scale).  The IMU index is a weighted score derived from four 
criteria: ration of primary medical care physicians per 1,000 
population, infant mortality rate, percentage of population below 
the federal poverty level, and percentage of the population 65 
years and older: http://www.hrsa.gov/grants/.

OR

o   Be located within a Department of Health and Human Service Region 
where the density of Native Americans and Alaskan Natives in the 
general population equals to or exceed 200,000.  There are ten 
DHHS regions: http://www.hhs.gov/about/regions.  American 
Indians and Alaska Natives generally reside in the greatest 
numbers in DHHS regions IV, VI, VIII, IX and X with the overall 
highest density in regions VI (Arkansas, Louisiana, New Mexico, 
Oklahoma, and Texas) and IX (Arizona, California, Hawaii, Nevada, 
Pacific Basin, and Guam). See: 
http://factfinder.census.gov/servlet/BasicFactsServlet.

Any institution that meets the above criteria may form a consortium 
with Tribal Colleges and Universities (TCUs), Tribal health programs or 
with non-designated institutions.  Non-designated institutions are 
institutions of higher learning that do not meet the criteria outlined 
above but which have substantial federal research support and/or 
research infrastructure as reflected in the report on research 
institutions: http://thecenter.ufl.edu/research_data.html.  For a 
listing of HBCUs and HSIs see the following website address: 
http://www.sciencewise.com/.  A listing of TCUs may be found at: 
http://www.humboldt.edu/~hsuitepp/college.html.

Note that while partnerships among designated institutions are strongly 
encouraged, involvement in a partnership is not an absolute requirement 
for participation in Project EXPORT.  Also note that pursuant to Public 
Law 106-525 designated institutions are intuitions of higher learning 
that have a history of enrolling and graduating racial and ethnic 
minority and other socioeconomically disadvantaged students from their 
degree programs.  The recruitment of racial and ethnic minority faculty 
and staff is also priority at such institutions.

ALLOWABLE COSTS IN EXPLORATORY EXPORT CENTER APPLICATIONS

o   Planning, evaluation, and community analysis activities

o   Costs for travel for key personnel, start-up packages for newly 
recruited investigators in areas for development and 
stabilization as well as costs to merge existing programs to 
identify new areas of opportunity.

o   Emerging partnerships, which includes support for workshops, 
seminars, retreats and other forums to strengthen, stabilize and 
consolidate interactions and cooperation between partnering 
institutions for the purpose of identifying new areas of 
opportunity and high priorities as the partnership evolves.

o   Feasibility studies, development of research questions, pilot   
research projects.

Projects/Cores/Components

The minimum acceptable combined number of cores and components is four, 
and the maximum acceptable number of cores and projects is eight. Each 
proposal must include an Administrative core, a Research component 
(full and pilot projects), a Training component, and a Community 
Outreach component.

o   Administrative Core -- Mandatory.  This component may include the 
costs of recruitment packages for key leadership positions in year one 
and education activities for faculty and staff; salaries of personnel 
responsible for management of the Center, supplies, travel, special 
consultation, program enrichment activities for investigators and staff 
such as special lectures, visiting scientists, symposia, seminars, 
workshops, etc., and costs related to dissemination of research 
information to the scientific community and lay public.  Funds also may 
be requested for the allowable indirect costs of the applicant 
organization(s).  In addition, costs of advisory committee and 
consultants may be included in the administrative core.  Consultants 
for specific components should be included in the budgets for those 
components.

o   Research Component(s) -- Mandatory. A combination of full and pilot 
projects can be requested. Partial salary for essential personnel, and 
other costs essential for the improvement of research infrastructure.

Seed money and start-up funds to support new, innovative pilot projects 
can be requested. Like a small grant, these funds should support 
activities that would serve as the basis for the development of a 
larger research grant applications.  The budget should be submitted for 
the pilot project component as a whole for each year in which pilots 
are proposed.  For years 01 and 02, this budget will reflect costs of 
pilots proposed in the application.  For years 03-05, the budget will 
estimate cost based on the number and kind of work to be pursued.  Note 
that the funds for pilot projects are not intended to supplement 
ongoing research projects.

o   Training Component -- Mandatory.  Support for students, including an 
allotment for research supplies, salary support for the core 
director

o   Community Outreach and Information Dissemination component- 
Mandatory.  Salary support, support for prevention/intervention 
activities, as well as educational outreach, etc.

o   Shared Resource Core.  Funds for the development of a shared 
resource core should be requested in its individual budget.  In the 
first year of the grant, substantial funds may be allocated in the 
budget of the administrative core for recruitment packages for core 
directors.

o   Mentoring Component.  Support for students, including an allotment 
for research supplies, salary support for the core director.

o   Minority Health and Health Disparity Education Component.  Costs 
related to the development and implementation of educational 
activities, partial salary support, etc.

OTHER SPECIAL REQUIREMENTS

Each exploratory EXPORT Center application must include and/or address 
the following:

o   Letters of commitment from the leadership of each partnering 
institution. The letters should indicate full support for this activity 
and specify what efforts will be made to ensure the success of these 
planning activities. Such efforts might include protected faculty time, 
provision to recruit new faculty, space and facilities for the proposed 
new projects/programs, capital improvements, etc.

o   Administrative Structure-- A Center must be an identifiable 
organizational unit with an administrative structure and clear lines of 
authority that will facilitate coordination among Center personnel to 
assure maximum accountability and efficiency in Center operations.  An 
applicant must designate an institutional official(s) to serve as 
principal investigator for the Center and/or as Director of the Center.  
The institutional appointment of the Center Director must provide 
sufficient authority to allocate space, personnel, and other resources 
essential to the Center.  This individual must demonstrate the ability 
to organize, administer and direct the Center.  The Director of the 
Center will have responsibility for planning and coordination of the 
Center program, preparation of the budget and oversight of 
expenditures, staff appointments, space allocation, and other aspects 
of management and operation of the Center.

o   Key professional staff such as directors of individual research 
components and shared resource core components of the Center should 
have the necessary training/experience to assure that the objectives 
and goals of the proposed activities will be achieved.  Such persons 
must be independent investigators with productive research programs.

If a director is not in place at the institution at the time of 
scientific review or award, a plan to recruit such an individual must 
be included in the application.  If an institution has not appointed a 
permanent Center Director at the time of award, the making of an award 
pursuant to this RFA will take place at the discretion of the NCMHD 
director, in consultation with the NCMHD Advisory Council.

o   Budget for an annual meeting in Bethesda, Maryland with NCMHD staff.

o   A Program Advisory Committee must be comprised of at least three to 
five scientists with national scientific reputations in their field; 
their expertise must be directly relevant to the scientific theme of 
the Project EXPORT activity.  The advisory committee 
responsibilities include concept development, program planning, 
encouraging faculty development and mentoring, identifying 
resources, and evaluating progress toward stated goals.  The 
committee will also review and approve candidates for 
replacement/substitute projects and investigators as required, 
before such requests are forwarded to NCMHD.  The committee must 
meet at least twice per year and minutes are to be recorded and made 
available for review by NCMHD program staff responsible for Project 
EXPORT.

If a committee other than the Program Advisory Committee is    
included, such as a proposed Program Executive Committee, specific 
plans regarding committee selection and function should be provided in 
the application.  An Executive Committee usually consists of the heads 
of all cores, representatives from the partnering institution (if 
applicable), and appropriate business officials.  The function of such 
a committee would be to assist the Director and Co-director with 
decisions pertaining to the allocation of funds, the identification and 
selection of key personnel, and the planning and execution of the 
center activities.

o   Planning/Evaluation.  There must be a common planning and 
evaluation process described in the application.  This process 
will be responsible for planning and implementing internal 
processes (e.g., workshops that identify areas of new 
opportunity, as well as for strengthening, establishing and 
merging existing projects/programs).  Internal processes must 
also have an evaluation and prioritization process in place for 
reviewing internal proposals for Pilot and full 
projects/programs, recruitment of research associates, new 
investigators and establishment of resources and infrastructure 
on the basis of their merit and potential to contribute 
effectively to achieving high priority goals and objectives.

o   Centers will be required to submit detailed annual progress 
reports including substantive information about research results to 
date, status of ongoing research, research plans for the next year, and 
any modifications in long-term research plans.  Also required are 
reports of inventions, reports of expenditures, final reports, and 
other reports in accordance with NIH policy.

o   Facilities and Environment. Applicants should describe the 
facilities and environment.  A description of the plans for 
accomplishing any needed enhancements should also be provided.  
Although not required, it is desirable for all Centers to have a 
commitment for sufficient contiguous space so that the Center has a 
high degree of cohesion and visibility.  Reference facilities that 
provide access to relevant literature must be readily available.  It is 
expected that such reference facilities will be the primary repository 
of additional reference materials that may be obtained through Center 
funding. Relevant support services, including adequate data processing 
facilities, must also be readily accessible within or through the 
institution.  Assurances of such support must be included with the 
proposal.

o   Program management, coordination, communication, progress 
assessment, and quality control are typically responsibilities of the 
Director and are facilitated through the administrative core.  The 
administrative core should be described in sufficient detail to assure 
that all proposed components and related activities will function 
optimally.  In addition, day-to-day operations involving procurement, 
finances, personnel, planning, and budgeting should be detailed in the 
description of the administrative core.

o   The applicant may also designate a Scientific Director who will 
be responsible to the Center Director and provide direct supervision of 
the scientific and operational aspects of the research program.  Such a 
person should be an individual who has established scientific 
credentials and who is capable of providing the leadership essential to 
the success of the center program.  The Scientific Director will be 
responsible for assuring interaction and collaboration among scientists 
conducting research within the Center to facilitate a concerted 
approach to the research goals of the Center.  The Scientific Director 
also will be responsible for the direct monitoring of ongoing research 
and for identifying with the assistance of colleagues research 
activities and educational activities to be expanded or decreased and 
needs for additional resources or reallocation of resources.  If the 
Center Director also serves as the Scientific Director, his or her 
functions as Scientific Director should also be described.

o   Each EXPORT Center shall develop a 5-year strategic plan to be 
included in the application as an attachment.  The research focus of 
the proposed Center's plan must reflect the health disparity priorities 
of the Department of Health and Human Services:  infant mortality, 
diabetes, cardiovascular disease, stroke, cancer, HIV/AIDS, and mental 
health, as well as the programs and priorities of the NCMHD, and/or the 
overall priorities of the Trans-NIH Plan for Addressing and Ultimately 
Eliminating Health Disparities.  The plan should also address research-
training goals, the institutions' plans to build on their/its strengths 
and capabilities to conduct minority health and health disparities 
research, and where applicable, address the needs of the partnering 
minority-serving institution(s) in furthering its goals.

The Strategic Plan must highlight the role of the Program Advisory 
Committee in providing a written formal evaluation of the Center's 
progress based on a performance plan to be developed during the first 
year of the grant award.  It is expected that the Program Advisory 
Committee would include recommendations for the EXPORT Center in its 
evaluation.

o   Annual Progress Report/Summary Report.  The Program Director of 
the Center will prepare a progress report annually in addition to a 
Summary Report near the conclusion of the first five years of EXPORT 
Center activity.  The Summary Report should contain, but not be limited 
to, the EXPORT Center description, findings regarding the effectiveness 
of the partnership experience, research findings and observations on 
the administration of the program.

OTHER FUNDING SOURCES

o   Research, dissemination of research information and training 
activities associated with the Center may receive additional funding 
from Federal sources as well as from State and local sources.  The 
NCMHD expects and encourages the institution and scientists attracted 
to such Centers to seek and compete actively for such funding.  
Research staff in funded Centers may submit applications for 
independent research project grants for support of research projects 
that do not overlap with their Center projects.

RESTRICTIONS

o   With respect to activities for which an award [Project 
EXPORT] is authorized to be expended, the Director of the 
Center may not make such an award to a designated research 
institution or consortium for any fiscal year unless the 
institution or institutions in the consortium, as the case may 
be, agree to maintain expenditures of non-Federal amounts for 
such activities at a level that is not less than the level of 
such expenditures maintained by the institutions involved for 
the fiscal year preceding the fiscal year for which such institutions
received such an award [P.L. 106-525 (Section 485F] (e)(1)].

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
two areas: scientific/research and financial or grants management 
issues:

Direct inquiries regarding programmatic issues to:

Tommy L. Broadwater, Ph.D.
Acting Director, Division of Research
and Training Activities, National Center on Minority Health and Health 
Disparities, National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:  301-402-1366
FAX:  301-480-4049
EMAIL:  [email protected]

Direct your questions about financial or grants management matters to:

Mr. Bryan Clark 
Grants Management Officer, National Center on Minority Health and 
Health Disparities, National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465 
Telephone:  (301) 402-1366 
Fax:  (301) 480-4049
Email:  [email protected]

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to: 

Tommy L. Broadwater, Ph.D.
Acting Director, Division of Research
and Training Activities, National Center on Minority Health and Health 
Disparities, National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:  301-402-1366
FAX:  301-480-4049
EMAIL:  [email protected] 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grants 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301 710-0267, Email: [email protected].

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked.  The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten 
original of the application, including the Checklist, and three signed 
photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and 
five copies of any appendix material must be sent to:

Tommy L. Broadwater, Ph.D.
Acting Director, Division of Research
and Training Activities, National Center on Minority Health and Health 
Disparities, National Institutes of Health
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:  301-402-1366
FAX:  301-480-4049
EMAIL:  [email protected] 

APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an introduction section 
that addresses the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCMHD.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further 
consideration.  Applications that are complete and responsive to the 
RFA will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the NCMHD in accordance with 
the review criteria stated below.  As part of the initial merit review, 
all applications will:

o Receive a written critique
o Receive a second level review by the NCMHD Advisory Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals:

o   Significance
o   Approach
o   Innovation
o   Investigator
o   Environment

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE: Does your study address an important problem?  If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) APPROACH: Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3) INNOVATION: Does your project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Are you appropriately trained and well-suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT: Does the scientific environment in which your work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS: The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION: The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated.  (See 
Inclusion Criteria included in the section on Federal Citations, below)

o DATA SHARING: The adequacy of the proposed plan to share data. 

o BUDGET: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

o OTHER REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

Evidence that the researchers and faculty of the partnering 
institutions worked closely together in the preparation of the 
application.

Letters of support from senior faculty and/or institutional leaders 
were supportive of the planning activities.

As applicable, the adequacy of provisions made for day-to-day 
oversight, coordination, support and logistical services needed to make 
the collaboration successful.

Planning -- The adequacy of the different planning methods proposed by 
the institutions to fully explore areas of opportunity and to ensure 
highly interactive and integrated efforts between individual scientists 
(e.g., research project) and/or between faculty and scientists (e.g., 
training program, education program).

The appropriateness and adequacy of the specific faculty and scientists 
identified to contribute effectively to each aspect of this planning 
effort.

Other Considerations

Administrative Core 

o Adequacy of the administrative core to manage the overall planning 
activities.

o Appropriate justification for the core, including the duplication of 
existing resources or services and anticipated future use of the core.

o Qualifications of the Director of the Administrative core (if 
applicable), including the ability of the center director to provide 
the scientific an administrative leadership for the planning 
activities, strategies to promote scientific planning, interaction, 
implementation, and evaluation; and arrangement for the fiscal 
management of the grant.

o Proposed composition and function of the Executive Committee to 
support the proposed activities.

o The proposed composition and function of the external Advisory 
committee to support a proposed EXPORT Center.

Research Questions/Feasibility Studies/Pilot Projects 

o The scientific merit of the concepts for the proposed research and 
the importance of the information sought to the mission of the NCMHD.

o The process for selecting the pilot/feasibility studies to be 
included in the planning activities.

o How well the proposed research areas address minority health and 
health disparities.

o The innovativeness and promise of the proposed methods to be used in 
the conduct of research.

o The novelty or originality of the proposed research concepts. 

o The appropriateness and justification of the requested budget for the 
proposed planning activities.

o The qualifications of the investigator that will lead the initiative 
to develop the research questions and/or plan feasibility studies.  If 
required, areas in which investigators will be recruited.

o Adequacy of plans to identify and address ethical concerns related to 
conducting health disparities research.

Shared Resource Core 

o Need/justification for the core service/resource.
o Scientific and ethnical merit of the service/resource provided.
o Plans for resource allocation.
o Quality control procedures.
o Qualifications, experience, and commitment of the component director.
o Adequacy of component director's time and effort.
o Adequacy of the resources and environment.

Research Training 

o Evidence of a strong commitment to and plans to help foster and 
facilitate the research career development of racial and ethnic 
minority students and other health disparity students and faculty.

o The plans to facilitate and monitor the research career trajectory 
and productivity of participants at both members of the partner 
institution and where applicable at all members of a consortia.

o Qualifications of the investigator that will lead the planning 
activities for research mentoring component.

Community Outreach/Information Dissemination 

o Adequacy of plans for establishing, sustaining, and evaluating 
research-based prevention and intervention studies with targeted 
communities, if applicable.

o Adequacy of plans for K-12 science education outreach, if applicable.

o A plan for disseminating health disparities research findings to 
participants, community groups, and lay and professional audiences, if 
applicable.

o The qualifications of the leadership of the planning activities for 
research outreach and dissemination.

Overall Research Resource Related Developmental Activity 

o Evidence of collaborative and/or interdisciplinary research, and 
interdisciplinary approach of the Project EXPORT activity.

o Adequacy of the available resources and the quality of the research 
or training environment.

o The institutional commitment to the Project EXPORT planning activity 
in terms of space, resources, administrative authority, and other 
necessary support, e.g., donated faculty time, and the extent to which 
a proposed EXPORT Center would be recognized as a major element within 
the organizational structure of the institution.

o The plans for developmental activities, including recruitment and 
expansion, insofar as the proposed research and/or training program 
justifies these.

o The plans for the provision of protection of human subjects and the 
humane care of animals.

o Appropriateness of the requested budget for the work proposed.

o The adequacy of plans to include both genders, and if applicable, 
other health disparity groups, and children as appropriate for the 
scientific goals of the proposed research.  Plans for the recruitment 
and retention of subjects will also be evaluated.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 28, 2003
Application Receipt Date:  April 22, 2003
Peer Review Date:  July-August 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm.  The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories
in compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them.  This policy applies to all 
initial (Type 1) applications submitted for receipt dates after October 
1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application.  In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations.  Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.  Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas.  This RFA is related to one or more of the priority areas.  
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: The authority for the centers of excellence 
program was provided in the statute that established the National 
Center on Minority Health and Health Disparities.  Pursuant to Section 
485F of the Minority Health and Health Disparities Research and 
Education Act of 2000, The Director of the Center shall make awards of 
grants or contracts to designated biomedical and behavioral research 
institutions for the purpose of assisting the institutions in 
supporting programs of excellence in biomedical and behavioral research 
training for individuals who are members of minority health disparity 
populations or other health disparity populations.  It is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under authorization 
of Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants 
policies described at http://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children. This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.



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