EXCELLENCE IN PARTNERSHIPS FOR COMMUNITY OUTREACH, RESEARCH ON HEALTH 
DISPARITIES AND TRAINING (CENTERS OF EXCELLENCE – RESOURCE-RELATED 
RESEARCH GRANTS)

RELEASE DATE:  February 6, 2004

RFA Number:  RFA-MD-04-002  

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH)  
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION:  
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 19, 2004
APPLICATION RECEIPT DATE: April 19, 2004

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 Resource-Related Research Grants 
(R24) 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 R24 grant applications 
will focus on the development of resources and infrastructure at some 
institutions as a prelude to initiating full-scale health disparities 
research, community outreach, and training. 

The purpose of a resource-related research grant (R24) under Project 
EXPORT is to augment and strengthen the institutional infrastructure 
and capacity to conduct research (basic, clinical, behavioral, and/or 
social sciences) aimed at addressing and ultimately eliminating health 
disparities.

The expectation is that following the 3 years of support for the 
developmental/planning phase the recipients of R24 awards will be 
positioned to compete for a P20 or P60 application.  Thus, an 
application for an R24 must describe a 3-year plan that will allow the 
applicant institution to compete successfully for a P20. Partnering 
with an institution with on-going Health Disparities research is 
encouraged during this developmental/planning phase.

Accordingly, the objectives of an R24 application initiative are to 1) 
build research capacity for health disparities research in minority-
serving and other designated institutions; 2) promote the participation 
of health disparity groups in biomedical and behavioral research and 
prevention and intervention activities; and, 3) promote planning for 
the conduct of minority health and/or other health disparities 
research. 

The range of activities that may be supported by this Project EXPORT 
activity includes: the acquisition of data and analyses necessary to 
clarify/refine research questions; the identification and development 
of collaborative resources; recruiting research expertise; development 
of testable hypotheses and theories and/or the framework to which the 
research will contribute.

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, 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 six Resource-Related Research 
Projects, (R-24), ten Exploratory Center Grants, (P-20), and  
11 Comprehensive Center Grants, (P-60).  In the second year of Project 
EXPORT Centers of Excellence Program, NCMHD supported the establishment 
of ten Resource-Related Research Projects, (R-24), 11 Exploratory 
Center Grants, (P-20), and 12 Comprehensive Center Grants, (P-60).

This announcement is intended to expand the Centers of Excellence 
Program, in order to ultimately 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., socio-
economically disadvantaged individuals in rural and urban areas).

Research Topics for Consideration

In developing the research question(s) to be considered, possible 
topics responsive to this RFA include, but are not limited to:

o   Interdisciplinary minority health and other health disparities 
research, including basic, clinical, behavioral and social sciences 
research to advance 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, environmental 
exposures, genetic variations and/or other underlying biological 
factors, ethnic and familial factors.

o   Developmental influences across the life span, specific health 
behaviors, and discrimination in health processes, psychosocial and 
socio-cultural influences, 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.

The research topics listed above are neither comprehensive, 
restrictive, nor in priority order.

Project EXPORT Developmental/Planning Activities. 

Note that the planning phase for this R24 application requires detailed 
information on the functioning and proposed activities of the 
Administrative Core and the Advisory Committee. In order that external 
reviewers and NCMHD staff understand the proposed future research 
areas, be sure to provide substantial detail(s) in the following 
components: 

o   Administrative Core

o   Research questions, feasibility studies, pilot research directions

o   Community Outreach and Information Dissemination Core 

o   Training / Mentoring activities
 
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 Questions/Feasibility Studies/Pilot Research Component -- 
Mandatory -- 10-page maximum

The research questions/feasibility studies/pilot research component may 
include several proposed investigations under the direction of a 
component director. And overall, the projects within the component must 
be interrelated so that they collectively contribute to the goals of 
Project EXPORT to a greater extent than if the projects were undertaken 
separately.  

The component should be thematic, highly focused, and interrelated 
areas of investigation. The descriptions of all proposed feasibility 
studies or pilot projects must be limited to 1 page each. This is in 
addition to the recommended 10-page maximum.

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).

Project EXPORT developmental grant applicants may create programs for 
disseminating evidence based minority health and health disparities 
research information as well as sponsor activities that encourage 
community participation in research either as study participants or 
equipping 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. Information transfer refers specifically to 
activities that involve interactive exchanges between Project EXPORT 
staff and the community.

With respect to equipping health disparity communities to develop and 
manage 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.

The application should provide a clear description of the major goals 
and objectives and the methodology for accomplishing community outreach 
and information dissemination activities, which include health 
information dissemination and prevention and intervention activities.  
Issues of cultural sensitivity with regard to the intended audience 
should be addressed.  The items below reiterate and/or expand the 
issues that must be addressed in the community outreach/information 
dissemination component.

o  The design, plans and procedures for developing the component, 
including time lines and a description of strategies proposed to 
accomplish specific aims of the project(s) should be described.  
Innovative aspects of the approach to be used should be highlighted.

o  The resources, facilities, agencies, and/or institutions with which 
the Center would work to plan, implement and conduct the proposed 
activities should be fully addressed.  Particular attention must be 
devoted to a description of necessary resources, including specialized 
expertise, and the target audience, or participants who will derive 
benefit from the activity.  If core facilities or services are 
utilized, information on their use should be provided.

o   Plans to evaluate the success and/or effectiveness of the proposed 
community outreach/information dissemination activity should be 
described, with emphasis on the impact of the proposed activities on 
knowledge, attitudes, and/or behaviors.

o   Training / Mentoring Activities —- Mandatory —- 15-page maximum

Project EXPORT developmental activities are expected to provide 
mentoring for junior investigators by experienced researchers.  New and 
established mentoring and training initiatives should represent true 
collaborations that function across institutional boundaries. 

o   Minority Health and Health Disparity Education -- Optional -- 15-
page maximum.

An educational component could focus on efforts to augment existing or 
create new curricula among partner institutions that would apprize and 
culturally sensitize undergraduates and post baccalaureate 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 the medically underserved.  It is 
anticipated, however, that such efforts will later lead to 
institutional commitments to make these curricula an inherent component 
of their educational systems.

The educational component must identify a proposed director and 
describe all planned educational and/or developmental minority health 
and health disparity related curriculum activities. The description 
should include strategies and timelines, and innovative aspects of the 
approach to be used should be highlighted.  The direct cost of the 
educational activity must be well justified.  A description of the 
strategies to evaluate the planned curriculum development activities 
should be provided with emphasis on its anticipated impact on knowledge 
and attitudes.

MECHANISM OF SUPPORT

This RFA will use the NIH Resource-Related Research project (R24) 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 30, 2004.

Allowable Costs

Funds may be requested for personnel, such as faculty release time and 
support for a program director and staff; and consultant services, 
including external advisors and collaborators.  Requests for office 
equipment, office supplies, travel, and other expenses should be 
limited to those necessary for program development and should be 
carefully and specifically justified.  Support will be provided for 
pilot research projects, research infrastructure, or students.  All 
requested items must be related to needs for a 36-month planning 
activity.

FUNDS AVAILABLE

The NCMHD intends to commit approximately $1.0 million in FY2004 to 
fund 3 to 4 new grants in response to this RFA.  An applicant may 
request a project period of up to three years and a budget for direct 
costs of up to $275,000 per year.  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 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 INSTITUTIONS

You may submit an application if your institution has any of the 
following characteristics:

o   Public or private degree granting institution (i.e. universities 
and colleges)
o   Do not have a Comprehensive (P-60) or Exploratory Center(P-20) 
grant funded by other NIH Institutes and Centers.
o   Do not have an existing NCMHD Resource-Related Grant (R-24)
o   Foreign institutions are not eligible to apply

This is an institutional award.  Therefore, only one application per 
institution will be accepted for review and only one award will be made 
to an institution based on the merit of its application and the 
availability of funds.

Non-degree granting institutions, 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 SPECIAL REQUIREMENTS section.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Individuals with the skills, knowledge, and resources necessary to 
carry out the proposed research are 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 institution of higher learning that has a history of 
enrolling and graduating racial and ethnic minority and  
socio-economically 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 other 
health disparity student groups to complete a program of study or 
training and receive the advanced degree involved.

o   Made significant efforts to recruit racial and ethnic minority and 
other health disparity student groups to enroll in and graduate from 
the institution, which may include providing means-tested scholarships 
and other financial assistance as appropriate. 

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 its 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 socio-economically 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.

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 institutions of higher learning 
that have a history of enrolling and graduating racial and ethnic 
minority and other socio-economically disadvantaged students from their 
degree programs.  The recruitment of racial and ethnic minority faculty 
and staff is also a priority at such institutions.

Questions may be directed to the fiscal contact below.

Examples of Allowable Costs for Developmental Activities

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.

Other Special Requirements

Each Project EXPORT developmental activity application must include 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.

Projects/Cores/Components

The minimum acceptable combined number of mandatory cores and 
components is four, and the maximum acceptable number of cores and 
projects is five. Each application must include:

o  Administrative core

o  Research questions/feasibility studies/Pilot Research component 

o  Training / Mentoring component

o  Community Outreach and Information Dissemination component

o  Organization/Administration and Administrative Core. A Project 
EXPORT developmental activity 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.

OTHER SPECIAL REQUIREMENTS

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

o  Program Advisory Committee, 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 such as a 
proposed Program Executive Committee is included, 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 with respect 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 
core shared between the partnering institutions.  This core will be 
responsible for planning and implementing internal processes (e.g., 
workshops and other forums to 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.  In cases where a single 
institution is the applicant, such a planning mechanism is also 
required.

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:

Mireille Kanda, M.D., M.P.H.
Deputy Director
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:   301-402-1366
FAX:   301-480-4049
EMAIL: Kandam@mail.nih.gov 

Direct your questions about peer review issues to:

Lorrita Watson, Ph.D.
NCMHD/NIH
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465 
Telephone: (301) 402-1366 
Fax: (301) 480-4049
Email: WatsonL@ncmhd.nih.gov 

Direct your questions about financial or grants management matters to:

Bryan S. Clark, MBA
Chief Grants Management Officer, NCMHD/NIH
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465 
Telephone: (301) 402-1366 
Fax: (301) 480-4049
Email: Clarkb@ncmhd.nih.gov 

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

Project EXPORT
Lorrita Watson, Ph.D.
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:   301-402-1366
FAX:   301-480-4049
EMAIL: WatsonL@ncmhd.nih.gov  

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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 
sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in PDF format.

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 
two copies of any appendix material must be sent to:

Lorrtia Watson, Ph.D.
NCMHD/NIH
6707 Democracy Blvd., Suite 800 MSC 5465
Bethesda, MD 20892-5465
TEL:   301-402-1366
FAX:   301-480-4049
EMAIL: WatsonL@ncmhd.nih.gov  

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 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  Undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score
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.

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?

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?

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? 

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)?

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

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

o   Feasibility and timeliness of the proposed plan, based on the 
mission, recent development history and current biomedical research 
capability of the applicant institution.

o   Adequacy of the planning process, including concept development and 
involvement of advisory resources.

o   Appropriateness of the organizational and administrative structure 
established to accomplish planning grant goals.

o   Qualifications, experience and commitment of the Program Director, 
and his/her ability to provide effective leadership in developing the 
institutional plan.

o   Appropriateness of the Advisory Committee and its role.

o   Adequacy of institutional commitment to the proposed activities and 
the pursuit of biomedical research in terms of P60 or P20 application 
after the development/planning grant ends.

o   Merit of the applicant's institutional plan for developing an 
enhanced biomedical research infrastructure.

o   For non-degree granting institutions or organizations, 
appropriateness and feasibility of plans to establish, enhance and/or 
maintain collaborative agreements with doctoral degree-granting 
institutions.

o   Strength of the evidence that the researchers and faculty of the 
partnering institutions worked closely together in the preparation of 
the application.

o   The degree to which the letters of support from senior faculty 
and/or institutional leaders were supportive of the planning 
activities.

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

Planning 

o   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).

o   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  (Mandatory)

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 and 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 Component  
(Mandatory)

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 a minority health or 
health disparities topic.

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.

Training / Mentoring Activities  (Mandatory)

o   Evidence of a strong commitment to and plans to help foster and 
facilitate the research career development of junior 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 Component  (Mandatory)

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.

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 19, 2004
Application Receipt Date:  April 19, 2004
Peer Review Date:  June – July 2004
Council Review:  September 2004
Earliest Anticipated Start Date:  September 30, 2004

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
o  Demographic goals

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required 
for all types of clinical trials, including physiologic, toxicity, and 
dose-finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

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 "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: (if 
applicable) 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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at http://stemcells.nih.gov/index.asp 
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal 
funding (see http://escr.nih.gov).   It is the responsibility of the 
applicant to provide, in the project description and elsewhere in the 
application as appropriate the official NIH identifier(s) for the hESC 
line(s)to be used in the proposed research.  Applications that do not 
provide this information will be returned without review. 

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 PA 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:   
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information”, the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as “covered entities”) must do so by April 14, 2003 (with the exception 
of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am 
I a covered entity?”  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm 

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.


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.