COMMUNITY NETWORKS TO REDUCE CANCER HEALTH DISPARITIES 
 
RELEASE DATE:  April 26, 2004
 
RFA Number:  RFA-CA-05-012 

October 2, 2009 - This RFA has been reissued as (RFA-CA-09-032).
 (RFA-CA-07-501 is affiliated with this RFA.)
(RFA-CA-06-504 is affiliated with this RFA.)
 (see addenda NOT-CA-04-017 and NOT-CA-04-018)

EXPIRATION DATE:  July 14, 2004
 
Department of Health and Human Services (DHHS)

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

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.393, 93.394, 
93.399

LETTER OF INTENT RECEIPT DATE: June 14, 2004
APPLICATION RECEIPT DATE:  July 13, 2004
 
This RFA is a reissue of RFA-CA-99-003, which was published in the NIH 
Guide on March 23, 1999.

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Cancer Institute, through its Center to Reduce Cancer 
Health Disparities (CRCHD), invites cooperative agreement grant 
applications (U01) for Community Networks to Reduce Cancer Health 
Disparities Through Education, Research, and Training (Community 
Networks Program – CNP).  The purpose of the CNP is to reduce cancer 
health disparities by conducting community-based participatory 
education, training, and research among racial/ethnic minorities (e.g., 
African Americans, Hispanics, Asians, Pacific Islanders, and Native 
Americans/Alaska Natives) and underserved populations (e.g., 
Appalachian, rural, low socioeconomic status and other underserved 
populations). The overall goals of this program are to significantly 
improve access to and utilization of beneficial cancer interventions in 
communities with cancer health disparities, thereby reducing these 
disparities.

The CNP will be implemented in three phases. The goal of Phase I is to 
develop and increase capacity building to support community-based 
participatory education, research, and training to reduce cancer health 
disparities. The goal of Phase II is to develop community-based 
participatory research and training programs to reduce cancer health 
disparities.  The goal of Phase III is to establish credibility and 
sustainability of the CNP. 
 
RESEARCH OBJECTIVES

Background

In 1989, the National Black Leadership Initiative was created to 
conduct cancer awareness activities in response to concerns that the 
incidence and mortality rates for many types of cancers were higher in 
black Americans than in whites. In 1992, the Hispanic Leadership and 
the Appalachian Leadership Initiatives were added. The general finding 
of the Leadership Initiatives was that there was a need to conduct more 
research to better understand differences in the cancer rates between 
these populations and other Americans.  In 1999, the National Cancer 
Institute (NCI) decided to replace the National Leadership Initiatives 
on Cancer Awareness with the Special Populations Networks (SPNs) for 
Cancer Awareness, Research, and Training. In April 2000, the NCI funded 
18 SPN Cooperative Agreements. These SPNs have developed community-
based infrastructures that provide expertise in culturally competent 
cancer awareness activities in racial/ethnic minority and underserved 
populations, as well as training researchers from racial/ethnic 
minority and underserved populations to conduct community-based 
participatory research.

As this SPN program draws to an end in 2005, the Center to Reduce 
Cancer Health Disparities (CRCHD) plans to reorient the focus of the 
RFA from special population awareness research to reducing cancer 
health disparities among racial/ethnic minority and underserved 
populations. Since there is a disconnect between the research 
discovery/development systems and the delivery systems for cancer 
prevention and care, there is a need to increase and sustain delivery 
of beneficial interventions to racial/ethnic minorities and underserved 
groups.  The redesign and re-issuance of that RFA will focus on closing 
this gap in the delivery system in those communities with cancer health 
disparities.

Purpose and Objectives

The purpose of the Community Networks Program (CNP) is to reduce cancer 
health disparities by conducting community-based participatory 
education, training, and research (that is, active community 
participation in the activities – that are conducted by, for, and with 
the community) among racial/ethnic minorities (e.g., African Americans, 
Hispanics, Asians, Pacific Islanders, and Native Americans/Alaska 
Natives) and underserved populations (e.g., Appalachian, rural, low 
socioeconomic status and other underserved populations). The overall 
goals of this program are to significantly improve access to and 
utilization of beneficial cancer interventions in communities with 
cancer health disparities and provide a cadre of well-trained 
researchers who will continue to reduce disparities in communities.

The CNP will be implemented in three phases. Activities initiated 
during each phase continue to the end of the grant.

Phase I.  The goal of Phase I is to develop and increase capacity 
building to support community-based participatory education, research, 
and training to reduce cancer health disparities.  Within this phase, 
the objectives are as follows: 

(I.1) Within the first year, develop a core organizational 
infrastructure to support community-based participatory activities to 
reduce cancer health disparities by establishing a staff of 
multidisciplinary professionals critical to implementing the program. 

(I.2) Create partnerships with communities that suffer cancer health 
disparities and with other organizations with an interest in reducing 
cancer health disparities among members of these communities.  These 
may include local, community-level organizations (e.g., health services 
and education outreach groups, faith-based groups, and coalitions) that 
serve racial/ethnic minority and underserved populations; primary 
prevention programs (such as smoking cessation and hepatitis B 
vaccination programs); secondary prevention programs (that provide 
screening and early detection testing); cancer treatment facilities 
that serve these communities (e.g, community hospitals);  cancer 
research institutions, including NCI Cancer Centers; national cancer 
prevention and control organizations (e.g. the American Cancer 
Society); other Government agencies that can assist in reducing cancer 
health disparities (e.g. the Centers for Disease Control and Prevention 
[CDC]), Health Resources and Services Administration [HRSA], and 
Centers for Medicare & Medicaid Services [CMS]), and other 
organizations that can affect reductions in cancer health disparities.  
These partnerships should be documented with Memorandum of 
Understanding (MOU) outlining specific roles and responsibilities of 
partners in relation to the CNP. 

(I.3)  Form at least four collaborations with other NCI programs (i.e, 
NCI Centers/Divisions/offices other than the NCI CRCHD) for the purpose 
of reducing cancer health disparities with other than NCI CRCHD 
programs.  The CNP will collaborate with NCI Centers/Divisions/Offices 
on at least four projects involving other NCI efforts to reduce cancer 
health disparities during the grant period.  A partnership with the 
Cancer Information Service’s Partnership program is mandatory.  Other 
NCI activities on disparities include, but are not limited to, 
education projects with the Continuing Umbrella of Research Experience 
(CURE) program to promote development of minority researchers; 
participant recruitment to Division of Cancer Treatment and Diagnosis 
(DCTD) treatment clinical trials; participant recruitment to Division 
of Cancer Prevention (DCP) prevention and screening/early detection 
clinical trials; participant recruitment to Division of Cancer 
Epidemiology and Genetics (DCEG) epidemiological studies (such as 
cohort and case/control studies); Division of Cancer Control and 
Population Sciences (DCCPS) efforts to reduce cancer health disparities 
(such as the Centers for Population Health and Health Disparities 
grants); participant recruitment to Center for Cancer Research 
(CCR) intramural trials; the Energy Balance Dissemination Initiative 
with the Center for Strategic Dissemination and similar NCI projects. 
This list will be expanded as additional potential collaboration 
projects are identified.

(I.4) Increase utilization of beneficial interventions to reduce cancer 
health disparities. Perform community-based participatory educational 
activities that reduce cancer health disparities by increasing cancer 
education and community use of beneficial cancer interventions. These 
interventions include use of, but are not limited to: primary cancer 
prevention, such as smoking cessation programs and hepatitis B 
vaccinations; screening and early detection tests, such as mammography, 
Pap smears, colorectal screening tests, and prostate-specific antigen 
(PSA) tests; and other beneficial interventions that reduce cancer 
health disparities, such as recruitment to clinical trials and 
optimizing energy balance to reduce the cancer burden.  Funds for this 
activity will support the education of the community about beneficial 
intervention activities. The CNP will not pay for the primary and 
secondary prevention services, but rather use existing resources that 
provide these services.  Efforts should be directed at reaching the 
hard-to-reach groups.  

(I.5) Leverage CNP activities by obtaining non-CRCHD funding for 
community-based participatory activities directed at reducing cancer 
health disparities. In collaboration with community partnerships, CNP 
will obtain non-CRCHD funding for community-based participatory 
education and training activities. Development of non-CRCHD funding 
sources is important in creating sustainable, community-based 
participatory education and training activities that can reduce cancer 
health disparities.

Phase II. The goal of Phase II is to develop community-based 
participatory research and training programs to reduce cancer health 
disparities. Within Phase II, the objectives are as follows:

(II.1) Perform community-based participatory research to reduce cancer 
health disparities in local communities. The CNP will develop and 
perform community-based participatory research that involves the full 
spectrum of community-based participatory research — from needs 
assessments to intervention research to policy assessments — with an 
emphasis on developing efficacious community-based participatory 
interventions to reduce cancer health disparities. These interventions 
may involve, but are not limited to: development of educational 
interventions that promote utilization of existing screening and early 
detection resources engaging community participants and their health 
care providers; addressing issues of cancer survivorship and quality of 
life; or dealing with assessing the impact of health care policies on 
reducing cancer health disparities. 

(II.2) Develop pilot research projects.  As part of the CNP research 
efforts, the Community Networks will develop and implement 
collaborative developmental pilot research projects involving 
community-based participatory research in cancer health disparities. 
Pilot research projects should address the spectrum of research on 
cancer health disparities from needs assessments to intervention 
research to policy assessments. A principal objective of this research 
is the development of efficacious community-based participatory 
interventions to reduce cancer health disparities that can be used 
nationwide. Competitive or administrative supplements (at the 
discretion of the NCI) will be used to support pilot research projects.

(II.3) Train researchers in community-based participatory research to 
reduce cancer health disparities, particularly researchers from 
racial/ethnic minority and underserved populations. Community Networks 
will provide in-depth training in cancer prevention and control and 
community-based participatory cancer health disparities research, with 
a focus on developing efficacious interventions for reducing cancer 
health disparities. The researchers will develop community-based 
participatory pilot intervention research projects designed to improve 
understanding of and to aid in reducing cancer health disparities.

Phase III. The goal of Phase III is to establish credibility and 
sustainability of CNP activities that reduce cancer health disparities.  
Within this Phase, the objectives are as follows: 

(III.1) Reduce cancer health disparities at the community level. In the 
short term, increases in participation in primary and secondary 
prevention procedures and other procedures that can reduce disparities 
will be evaluated. In the longer term, cancer health disparities at the 
community level will be assessed.

(III.2) Obtain funding for research proposals on reducing cancer health 
disparities (such as R01, R03, and K awards) developed from the 
Community Networks research program. In collaboration with research and 
community partnerships, Community Networks will develop and obtain 
funding for research proposals stemming from the community-based 
participatory research findings developed by Community Networks 
research projects. Development of non-CRCHD partnerships and funding 
sources is important in creating sustainable Community Networks 
research programs. This funding can come from Government and non-
Government organizations.

(III.3) Provide evidence-based information for reducing disparities to 
decision and policy makers at the local, State, and Federal levels. 
Analyses of policy issues in health disparities should lead to 
information about implementing interventions to reduce cancer health 
disparities, particularly in communities with the greatest burden of 
disease. This information may be directed to decision and policy makers 
at the local, State, and Federal levels. These activities must not 
include lobbying. Rather, policy activities should offer evidence-based 
information based on qualitative and quantitative research findings 
that demonstrate reduced cancer health disparities. 

CNP Organization and related activities

Each CNP will have a Principal Investigator (PI), Project Manager, and 
two to three appropriate employees. Each CNP should also consider 
having a Research Coordinator to assist in the conduct of training and 
research activities, a Policy Analyst for health policy evaluation, a 
Program Evaluator for the CNP evaluation and a Clinical Coordinator to 
assist in clinical activities. These latter staff may have partial 
support up to 20 percent each. Each CNP will have a Steering Committee 
to advise it. This committee will be composed of community leaders; 
community-based participatory researchers; clinical personnel serving 
the community; and others needed to carry out objectives of the CNP. At 
least three members of the Steering Committee should be researchers in 
the area of community-based participatory research who can aid with 
development of pilot research projects. If there are regional sites, 
there should be a similar regional advisory committee(s). The 
committees should meet at least once a year; teleconferencing may be 
used. In addition, there should be a community-based, advisory group 
that meets at least twice a year. This group will be composed of 
community leaders and will articulate the voice of the community to 
program staff by advising on projects for and activities conducted in 
the community.  The Advisory committee can also help disseminate 
information to their communities. 

Each partnership should have an MOU outlining specific roles and 
responsibilities in relation to the CNP. There should be partnerships 
with local community-based organizations, screening and early detection 
centers, diagnosis and treatment facilities that serve the community, 
Government agencies, non-Government organizations, and research 
organizations and university programs (as a source of cancer research 
expertise and research students if the applicant is not a cancer 
research organization or university).
Requirements for Transition through the Phases – The CNP awardee may 
apply for transition to the next phase at the time of the non-competing 
continuation application or as specified by the Program Coordinator.
To proceed from Phase I (year 1) to Phase II (years 2–5), a CNP awardee 
must present a document that addresses the following factors.  The 
awardee must have its organizational infrastructure in place and it has 
established a formal partnership with at least one community 
experiencing disparities—and with at least one primary or secondary 
prevention facility. The awardee must also have established a 
partnership with at least one cancer research organization and/or 
university to facilitate recruitment and training of researchers in 
cancer health disparities, if the applicant is not one of these groups. 
In addition, the awardee needs to have performed at least one cancer 
education activity to increase community member participation in a 
primary and/or secondary prevention facility, providing a description 
of the activity. A detailed plan for implementation of Phase II should 
be included in the application.

To proceed to Phase III from Phase II, a CNP awardee must prepare a 
document that addresses the following factors.  The awardee has been 
awarded and completed at least one NCI-funded pilot research project 
addressing cancer health disparities within the targeted community. A 
written description of this pilot research project, as well as its 
findings and impact on the community, must be submitted. A detailed 
plan for implementation of Phase III should be included in the 
application. 

These documents will be reported as an appendix to the non-competing 
continuation application or as specified by the Program Coordinator.  
Approval and progress to the next Phase will be determined by NCI 
staff.
Annual Cancer Health Disparities Summit Conference
There will be an annual meeting of all CNP awardees, their staffs, and 
key persons from their community partnerships. This CRCHD “Cancer 
Health Disparities Summit Conference” will bring CNP staff together to 
share their experiences, challenges, accomplishments, lessons learned, 
research findings, and to identify areas in which improvement is needed 
and additional collaborations are possible. The agenda will be 
developed by NCI staff associated with management of the CNP, in 
collaboration with other NCI Divisions/Centers/Offices. Budget for 
travel to Washington, DC — once per year for up to eight individuals — 
to attend the “Cancer Health Disparities Summit Conference” should be 
included in the budget of the application.
PI Meetings with CRCHD Director
Awardees will meet with the Director of the CRCHD at least once per 
year. This may be at the “Cancer Health Disparities Summit Conference.”  
Other meetings will be scheduled, on an as needed basis. Funds for one 
additional trip to Washington, DC, by the PI should be included in the 
budget section of the application.

Dissemination of Community Networks research findings 

The CNP will disseminate its research findings. There are a number of 
ways to achieve this objective.  Examples include, but are not limited 
to, the following:  publication of research findings in peer reviewed 
journals; posting of research findings on the cancer control PLANET 
website (http://cancercontrolplanet.cancer.gov/); and dissemination of   
findings by demonstrated “transport” of and “uptake” of efficacious 
interventions to other communities, including developing collaborations 
between CNP grantees and the development of resource implementation 
kits.  

MECHANISM OF SUPPORT
 
This RFA will use the NIH cooperative agreement (U01) award mechanism.  
As an applicant you will be primarily 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 the customary peer 
review procedures.  The anticipated award date is April 2005.  
Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications (such 
as R01 applications) using the standard receipt dates for NEW 
applications described in the instructions to the PHS 398 application.

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting as well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.   

The NIH (U01) is a cooperative agreement award mechanism.  In the 
cooperative agreement mechanism, the PI retains the primary 
responsibility and dominant role for planning, directing, and executing 
the proposed project, with NIH staff being substantially involved as a 
partner with the PI, as described under the section "Cooperative 
Agreement Terms and Conditions of Award." 

FUNDS AVAILABLE 
 
NCI intends to commit approximately $24 million in FY 2005 to fund 18 
to 22 grants in response to this RFA. An applicant may request a 
project period of up to 5 years and a budget for total costs (direct 
plus all applicable facilities and administrative costs) of up to $ 
1.75 million per year for a large scale program (headquarters and four 
or more geographic areas), up to $1.0 million per year for a regional 
program (headquarters and 2-3 geographic areas) and up to $0.5 million 
per year for a local program (headquarters and one geographic area).  
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and cost of 
each award will also vary. Although the financial plans of the NCI 
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. NCI may modify awards to 
meet geographic, racial/ethnic minority and/or underserved population 
needs, overlaps, or program priorities or funds. 

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Domestic institutions/organizations
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply.

Applications are invited from groups representing racial/ethnic 
minority populations, such as African American, American Indian and 
Alaska Native, Asian, Hispanic, and Pacific Islanders and underserved 
populations, such as rural and Appalachian areas.  Applicants should 
have a documented history of involvement with the community and have 
qualified staff to direct the program.  Collaborative applications are 
encouraged.  Among collaborators, one must be designated as the lead 
applicant and assume responsibility for the project.  Organizations 
that must rely primarily on consultants to conduct the project are 
ineligible.  Foreign organizations are not eligible and domestic 
organizations may not include international (foreign) components.

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 

Cooperative Agreement Terms and Conditions of Award 

The administrative and funding instrument used for this program is a 
cooperative agreement (U01), an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial National Cancer Institute 
(NCI) scientific and/or programmatic involvement with the awardee(s) is 
anticipated during performance of the activity.  Under the cooperative 
agreement, the NCI purpose is to support and/or stimulate the 
recipient's activity by involvement in and otherwise working jointly 
with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the 
project as a whole, although specific tasks and activities in carrying 
out the studies will be shared among the awardees and the NCI Program 
Coordinator.

1. Awardee Rights and Responsibilities

a. Awardees have primary authority and responsibility to define 
objectives and approaches and to plan, conduct, analyze, and publish 
results, interpretations, and conclusions of their projects.

b. Awardees must establish and maintain a Project Steering Committee. 
The role and responsibilities of the Steering Committee are described 
below under “Collaborative Responsibilities.” If appropriate, awardees 
with large, multi-site projects may, in addition to establishing an 
overall Project Steering Committee, allow their regional sites to 
organize regional advisory committees. Regional PIs will serve as 
chairpersons of their respective committee and as their representatives 
on the Project Steering Committee. The NCI staff does not serve as a 
member of any regional advisory committee. Regional advisory committees 
function in an advisory roles to the Steering Committee and serve as 
liaisons between the Steering Committee and the community. Further, 
regional advisory committees work to ensure that decisions and 
recommendations of the Steering Committee are effectively adapted to 
regional settings and assist in developing and implementing regionally 
initiated activities, identifying and encouraging minority junior 
researchers and students, interfacing with regional NCI Cancer 
Information Service (CIS) partners, and ensuring community support for 
project activities.

c.  Awardees must establish a Community Advisory Group.  This group 
provides the community with a formal link to the Community Network 
activities.  This group will be composed of local community-based 
leaders that represent the communities with disparities.   This group 
will serve as the voice of the community, advising on activities for 
their communities. It will also create a way to disseminate information 
to the community about the Community Network activities.  The Community 
Advisory Group should represent the spectrum of community groups served 
by the CNP.  This committee should meet at least two times per year.  

d. Awardees must request supplemental funding for pilot projects; the 
Steering Committee and the Community Advisory Group may provide advice 
on key cancer awareness activities and these pilot projects. Any 
disagreement that may arise on scientific/programmatic matters (within 
the scope of the award) between award recipients and the NCI may be 
brought to arbitration. (See “Arbitration,” below.)

e. Awardees must establish and maintain collaborative relationships 
with the NCI Cancer Information Service (CIS) and relevant community 
organizations and groups and apprise the NCI Program Coordinator of any 
need for specialized printed materials and/or media messages.

f. Awardees must seek technical assistance from CIS in developing local 
cancer prevention and control messages that are consistent with NCI 
guidelines. Funds awarded as a result of this RFA may not be used for 
print or broadcast materials that have not been approved by the NCI 
Program Coordinator.

g. Awardees will retain custody of and have primary rights to data 
collected under these awards, subject to Government rights of access 
consistent with current Health and Human Services (HHS), such as Health 
Insurance Portability and Accountability Act (HIPAA) regulations, 
Public Health Service (PHS) policies, and National Institutes of Health 
(NIH) policies.

h. Awardees must provide annual progress reports and additional 
information, as requested by the NCI Program Coordinator. In addition 
to descriptions of past activities and their results, the summary 
report due at the end of each (annual) funding period should include a 
complete reporting of core programs evaluation data elements, as 
specified by NCI; and other reports are specified by the Program 
Coordinator.

i. Awardee must seek technical assistance from the NCI Program 
Coordinator if it is determined that the awardee is not meeting program 
goals in a timely manner.
 
2. NCI Staff Responsibilities - The NCI Program Coordinator (and other 
NCI staff) will have substantial scientific/programmatic involvement 
during the conduct of this activity through technical assistance, 
advice, and coordination above and beyond normal program stewardship 
for grants, as described below.  The NCI Program Coordinator shall:

a. Serve as a member of the Steering Committee;

b. Assist awardees with planning and establishing priorities and 
approve awardees’ plans prior to implementation of Phase activities;

c. Determine whether an awardee-planned community activity is 
consistent with NCI guidelines; 

d. Coordinate activities with other Federal agencies (e.g., the Centers 
for Disease Control and Prevention (CDC), Centers for Medicare & 
Medicaid Services (CMS), and DHHS Office of Minority Health [OMH]) and 
broker interactions between NCI and awardees, as necessary, to provide 
technical assistance and guidance in specialty areas, as well as 
arrange short-term training assignments for minority researchers; and  

e. Convene special meetings and ad hoc groups to address NCI priority 
issues. 

An NCI Program Director will be responsible for normal program 
stewardship of this award, including monitoring of progress and other 
required reports. The Program Director may identify other NCI staff to 
provide technical assistance in specific areas as needed. The Program 
Director may also serve as the Program Coordinator. 

The NCI Program Director will confer with awardees regarding staffing 
needs and must concur in hiring or replacing key program personnel. Key 
personnel are defined as, and should be limited to, individuals who 
contribute in a substantive way to the scientific development or 
execution of the project, whether or not salary is requested. (See NIH 
Grants Policy Statement.)

NCI reserves the right to terminate or curtail the program (or an 
individual award) in the event of substantial shortfall in the 
performance of requirements for any single Phase or key activity of the 
program.

3. Collaborative Responsibilities  

a. Awardees will collaborate with the NCI Program Coordinator to 
establish and maintain for their projects a Steering Committee whose 
role is to function as a governing body. The Steering Committee will 
appropriately comprise scientists and community leaders and/or 
facilitators and will set policy, provide overall guidance and 
direction, and provide support for project-sponsored activities. 
Membership will include the Project PI, NCI Program Coordinator, 
Regional PIs, and others with expertise in relevant scientific or other 
cancer-related or disparity-related disciplines. Responsibilities of 
the Steering Committee include: reviewing and ensuring scientific 
soundness of project plans; guiding development and implementation of 
population-specific cancer control and prevention activities; approving 
joint and pilot research project plans and applications; prioritizing 
project needs; promoting collaborations; and facilitating interactions 
among the NCI, partners, and community populations. The PI will serve 
as chairperson of the Steering Committee and be responsible for 
selecting other members. Decisions and recommendations of the Steering 
Committee will be binding and take precedence over those of regional 
advisory committees.

b. Awardees and the NCI Program Coordinator will collaborate to develop 
and implement an Annual “Cancer Health Disparities Summit Conference,” 
at which awardees may discuss progress of their projects and learn more 
about NCI resources/priorities, and researchers, accompanied by their 
mentors, can share their developmental progress and showcase their 
research projects via oral presentations and/or poster sessions.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters 
(within the scope of the award) between an award recipient and the NCI 
may be brought to arbitration. An arbitration panel will be composed of 
three members: one selected by the Steering Committee (or by the 
individual awardee in the event of an individual disagreement); a 
second member selected by the NCI; and a third member selected by the 
two previously selected members. This special arbitration procedure in 
no way affects the awardee’s right to appeal an adverse action if it is 
otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D and HHS regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Kenneth C. Chu, Ph.D.
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd, Room 602
Bethesda, MD 20892-8341
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-8589
FAX:  (301)-435-9225
Email: KC10D@NIH.GOV

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters 
to:

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892-7150
Telephone:  (301) 496-8634
FAX:  (301) 496-8601
Email: Crystal.Wolfrey@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; and
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 NCI 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:

Kenneth C. Chu, Ph.D.
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd, Room 602
Bethesda, MD  20892-8341
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-8589
FAX:  301-435-9225
Email: KC10D@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.
 
SUPPLEMENTARY INSTRUCTIONS: 
 
RESEARCH PLAN

a. Specific Aims – Specific aims should include the goals and 
objectives as specified in the RFA. Applicants may augment those aims 
as they feel necessary. These aims will be the basis for the evaluation 
plan.

b. Background and Significance – In this section, the applicant should 
provide a description of the cancer health disparities of the 
communities to be addressed.  For each disparity, the description 
should include, but is not limited to, the type of the disparity, the 
population to be addressed, and the cancer site affected. 

c. Preliminary Studies/Progress Report – Description of previous work 
relevant to this RFA and the project proposed. 

d. Research Design and Methods - Describe your proposed CNP in detail. 
Specifically, describe the cancer education activities and health 
disparities research and training program, above and beyond the goals 
and objectives stated in the RFA.  Discuss how the aims will be 
achieved, including a discussion of how the disparities in the 
community are to be reduced, the interventions to be used, the metrics 
that will be used to measure reductions in disparities, the 
partnerships and collaborations proposed, etc.

In addition, the applicant will provide three plans.  Each plan should 
be included as an appendix to the application. The plan must include 
details about the following aspects.

1) Cancer education activities (such as outreach, awareness activities) 
in the communities with disparities emphasizing the increased access to 
and utilization of primary and secondary prevention facilities.  
Justify the cancers to be addressed, the primary and secondary 
prevention procedures to be implemented, the proposed facilities to be 
utilized, and the metrics that will be used to evaluate improvements in 
disparities.  Indicate, if possible, the current usage of these 
procedures/facilities by the community with disparities. (This is the 
baseline, against which improvements may be measured.)  

2) Health disparities research program that outlines the areas of 
research to be undertaken, including interventions to be developed for 
policy assessments and other relevant factors associated in developing 
a health disparities research program. Provide sufficient details to 
allow one to evaluate your expertise in this area.

3) Training program that outlines the source of junior investigators, 
the training program to be undertaken, and other relevant factors 
associated with the training program.  

Furthermore, the applicant must describe at least one proposed research 
project that will be undertaken by the applicant as part of their 
health disparities research program.  This proposed research project 
should be an appendix to the application. Format for research project - 
ten page maximum: abstract, background, hypotheses, study design, 
discussion (no additional appendices for the research project).  If the 
applicant is applying for a regional or large scale award ($1 million 
or more) a minimum of two proposed research projects need to be 
submitted.  

Each partnership should have an MOU outlining roles and 
responsibilities in relation to the Community Networks. If the 
applicant is a community-based organization, partnerships with cancer 
research organizations and universities are particularly important to 
be able to meet the research and training aspects of the CNP.   If the 
applicant is a cancer research organization or university, partnerships 
with community-based organizations are important to demonstrate a 
history of working with the community.  All applicants should have 
partnerships with primary or/and secondary prevention facilities that 
offer beneficial interventions.  

All applicants apply for phase I. If the applicant is a previous SPN 
awardee or their experience qualifies them, the applicant should apply 
for Phase II in this application.  To assess that ability, previous SPN 
awardees should provide evidence of readiness to move to Phase II. That 
is, to proceed from Phase I to Phase II, a Community Networks awardee 
must have its organizational infrastructure in place and have 
established a formal partnership with at least one community 
experiencing disparities—and with at least one primary or secondary 
prevention facility. The awardee must also have established a 
partnership with at least one cancer research organization and/or 
university to facilitate recruitment and training of researchers in 
cancer health disparities, if the applicant is not one of these groups. 
In addition, the awardee needs to have performed at least one cancer 
education activity to increase community member participation in a 
primary and/or secondary prevention facility. A detailed plan for 
implementation of Phase II should also be included.  If the review 
group determines that the applicant has not met the criteria to 
transition to Phase II, the applicant will be considered for award 
beginning with Phase I.

TIMETABLE    

Include a timetable of cancer education activities, and milestones for 
the development of research and training programs for the first and 
second years. 

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/labels.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 
all five copies of the appendix material must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD  20852 (for express/courier service)

Appendices should be comprised of unbound materials, with separators 
between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (See 
http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html.)  
This policy is similar to and consistent with the policy for 
applications addressed to Centers for Scientific Review as published in 
the NIH Guide Notice at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

APPLICATION PROCESSING: Applications must be received on or before 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. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
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.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI.  Incomplete and/or nonresponsive 
applications will not be reviewed. 

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 Division of Extramural Activities of the 
NCI 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 National Cancer Advisory Board. 

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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of these 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The 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, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

SIGNIFICANCE: Does this study address an important problem? If the aims 
of the application are achieved, how will the disparities be reduced? 
Are there indications of the potential for applicant’s effectiveness in 
reaching the most difficult-to-access segments of the community? Will 
the results, such as the interventions, education, training and 
partnerships to be developed, be useful to groups in other parts of the 
country. 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 
reducing cancer health disparities? Does the applicant acknowledge 
potential problem areas and consider alternative tactics? 

Have the cancer health disparities of the community and the proposed 
approaches to address them been described adequately?  Are there 
linkages from the cancer research base to community to cancer 
prevention and early detection facilities?  Are the plans for cancer 
education, research and training adequate and appropriate to address 
the problem of reducing cancer health disparities in the community? Has 
the application demonstrated that they have the abilities to reduce 
cancer health disparities through community-based participatory 
education, research and training? 

INNOVATION: Does the project employ novel concepts, approaches or 
methods to reduce cancer health disparities? Are the aims original and 
innovative? Does the project challenge existing paradigms or develop 
new methodologies or technologies? 

INVESTIGATOR: Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Does the investigator/staff have experience with the 
communities to be addressed.  Does the applicant or its partners have a 
history of working with the communities to be addressed?  Does the 
applicant or partners have expertise in cancer prevention and control 
research so that they can develop interventions to reduce disparities.

ENVIRONMENT: Does the scientific environment in which the 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?  Is there evidence of partnerships 
with communities with disparities? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

For large scale awards ($1 million or more), the applicant must have a 
demonstrated history of achievements in working with community-based 
organizations in the areas of community-based participatory awareness, 
research and training to provide evidence of the capacity to handle a 
large scale project.  For Special Population Network (SPN) grantees, 
this may be demonstrated by the quality of cancer awareness activities 
and community partnerships, pilot projects awarded and completed and 
the papers published as a consequence of their SPN activities as well 
as obtained funding from non-CRCHD sources.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the 
sections on Federal Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score. 

Budget:

The appropriateness of proposed budget and duration in relation to 
proposed project; reasonableness of proposed budget relative to 
proposed activities-particularly, the allocation ratio of funds 
retained for administrative costs and those for local programming will 
be reviewed.  We encourage funding on local community programming while 
minimizing administrative costs.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: June 14, 2004
Application Receipt Date: July 13, 2004
Peer Review Date:  October 2004
Council Review: February 16, 2005
Earliest Anticipated Start Date: April 2005

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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on 
Humane Care and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), 
as mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the 
USDA Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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. See 
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 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 participants.  (See NIH Policy for Data and Safety 
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)

Clinical trials supported or performed by NCI require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB).  
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional Review Board (IRB).  For 
details about the Policy for the NCI for Data and Safety Monitoring of 
Clinical trials, see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I 
and II clinical trials, investigators must submit a general description 
of the data and safety monitoring plan as part of the research 
application.  See NIH Guide Notice on “Further Guidance on a Data and 
Safety Monitoring for Phase I and II Trials” for additional information 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring 
plans for clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

SHARING RESEARCH DATA:  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 
(http://grants.nih.gov/grants/policy/data_sharing) or state why this is 
not possible. 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. 

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.  
A continuing education program in the protection of human participants 
in research is available online at: http://cme.nci.nih.gov/.

HUMAN EMBRYONIC STEM CELLS (hESC): (if applicable) 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 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
(if applicable) 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).  

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.health.gov/healthypeople. 

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.


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