COMMUNITY-BASED PREVENTION AND INTERVENTION RESEARCH

Release Date: September 2, 1999

RFA:  ES-99-012

National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  October 19, 1999
Application Receipt Date:  December 13, 1999

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The purpose of awards in this program is to develop community-based public
health research approaches to diseases and health conditions having an
environmentally related etiology and determine the impact of these methods.
Moreover, awards are intended to stimulate further advances in the design and
implementation of prevention and intervention methods that are appropriately
applied to environmental health.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
Community-based Prevention and Intervention Research, is related to one or
more of the priority areas.  Potential applicants may obtain a copy of
"Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project
grant (R01) award mechanism.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.  The
total project period for an application submitted in response to this RFA may
not exceed 5 years.  Competitive continuation applications from existing
grantees in the NIEHS Community-based Prevention and Intervention Research
Program in their fourth year of support will be accepted for consideration
under this RFA.  Such applications must follow PHS 398 guidelines for
competitive renewal, including a progress report.  Such applicants are
strongly encouraged to contact Program Staff listed under INQUIRIES for
additional guidance.  The anticipated award date is July 1, 2000.

It is anticipated that the maximum award will be $300,000 direct costs per
year for each grant.

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm

FUNDS AVAILABLE

The NIEHS intends to commit approximately $2,500,000 in FY 2000 to fund
approximately five new and/or competitive continuation grants in response to
this RFA. An applicant may request a project period of up to 5 years and a
budget for direct costs of up to $300,000 per year.  Because the nature and
scope of the research proposed may vary, it is anticipated that the size of
each award will also vary.  Although the financial plans of the NIEHS 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 applications
of outstanding scientific and technical merit.

RESEARCH OBJECTIVES

Background

The mission of the NIEHS is to define:  how environmental exposures affect our
health; how individuals differ in their susceptibility to these effects; and
how these susceptibilities change with time.

To help reduce the burden of environmentally associated diseases and health
conditions, the NIEHS must:  (1) provide the scientific basis and foundation
that is necessary for understanding the impact of the environment on human
health; (2) translate this information into prevention and intervention
strategies; and (3) communicate this information to the public.

The current initiative spans all three of these elements within the missions
of the NIEHS.  Environmental health policy is only as good as the scientific
foundation upon which it rests. Recent advances are enabling scientists to
develop more detailed and meaningful insights into the effects of
environmental agents on basic cellular processes.  This knowledge in turn can
be used to cultivate intervention schemes based on an enhanced understanding
of molecular mechanisms.  In 1992 the NIEHS issued an RFA to develop
interventions at the molecular level for diseases with an environmental
etiology.  That RFA focused on generation and use of molecular biomarkers to
assess the effectiveness of intervention strategies. In 1996 the NIEHS
released an RFA to develop novel culturally relevant prevention/intervention
activities in economically disadvantaged and/or underserved populations
adversely impacted by an environmental contaminant. Environmental health
concerns addressed by awards made in response to this RFA included programs
that address: exposure to agents that exacerbate asthma; reducing agricultural
pesticide exposures and reduction of exposure to lead. The challenge remains
to continue to develop community-based prevention/intervention strategies that
address other environmentally influenced health outcomes in medically
underserved communities, e.g., low birth weight in infants, autoimmune
diseases, diabetes and cardiovascular diseases.

An understanding of the environmental components and basic biology of
disorders can lead to prevention and intervention strategies to circumvent
adverse health effects.  Such strategies can be classified as primary,
secondary, or tertiary prevention.  Traditionally, most approaches have
focused on primary prevention techniques aimed at intervening before disease
arises, such as eliminating or reducing environmental exposures.  As our
understanding of the molecular and cellular basis of environmentally
associated diseases increases, secondary prevention and intervention
techniques can be developed to diagnose and treat people exposed to an
environmental contaminant. These molecular intervention techniques, such as
early detection screening, rely on manipulation of underlying biological
mechanisms, e.g., activation/inactivation of particular genes, enzymes, or
receptors.  These methods may be especially useful in dealing with
environmental exposures that are ubiquitous or difficult to eliminate. 
Tertiary prevention measures seek to limit injury and disability in people
already affected by a specific disease process.

Prevention and intervention schemes must also take into account the social and
cultural lifestyle and behavioral factors that contribute to environmentally
associated disorders.  It is part of the responsibility of the NIEHS to
provide the scientific underpinning that can delineate the contribution of
societal and cultural behaviors in development of these disorders. The
cultural diversity inherent within various racial/ethnic groups has generally
been overlooked by investigators conducting prevention research. Thus, there
is a critical need to address diverse, culturally relevant contexts and
disease etiologies in environmental health.

The present RFA seeks to implement culturally relevant prevention/intervention
activities in economically disadvantaged and/or underserved populations
adversely impacted by an environmental contaminant.  Research efforts to
identify the sources and effects of hazardous environmental exposures among
underserved populations have been insufficient.  Little is known about the
types of environmental agents to which members of such groups are exposed,
both at home and at work.  Members of economically disadvantaged and/or
underserved populations suffer disproportionate levels of morbidity and
mortality.  Additionally, they are most often the populations with the highest
degree of exposure to environmental agents and are frequently the populations
with the least information available as to the health consequences of such
exposure.  Factors such as malnutrition, health status, and socioeconomic
status, in combination with behaviors such as smoking, alcohol consumption,
and drug use may significantly influence the dose response, metabolism, and
health effects of hazardous substances.  Geographic location may also play a
role in determining the degree and effect of environmental exposure among
socioeconomically disadvantaged populations.  For example, inner city
residents often live in homes with high lead levels and are exposed to higher
levels of air pollution.  Toxic waste sites, nuclear facilities, and chemical
plants are often located in rural areas.  More effort must be devoted to
identifying disadvantaged populations having high levels of exposure to
environmental hazards and to generating prevention and intervention strategies
to mitigate the health effects of these hazards.

The current RFA is intended not only to foster additional refinement of
intervention methods but also to strengthen the participation of affected
communities in this effort.  Given the complexity and magnitude of
environmental health problems, research endeavors aimed at improving our
knowledge of and ability to resolve these issues can benefit from establishing
collaborative relationships with the communities experiencing these problems. 
Such community research partnerships have benefits for both the researcher and
the community.  These partnerships can, for example, facilitate the definition
of important environmental issues and concerns, the development of measurement
instruments that are culturally appropriate, and the establishment of trust
that will enrich the value of data collected.  This scheme emphasizes the
involvement of community members throughout the research process, from
development of research questions to interpretation, application, and
dissemination of results.  Only through realization of this final leg of the
NIEHS mission, i.e., communication and partnership formation, can we ensure
that research findings reach and are made relevant to affected individuals and
communities.

Objectives and Scope

This RFA will support research activities that develop and implement improved
prevention and intervention strategies related to environmental health that
are designed to include community-based, culturally appropriate approaches
applicable to underserved populations.  Community-based
prevention/intervention research seeks to expand our knowledge and
understanding of  the potential causes and remedies of environmentally related
disorders, while at the same time enhancing the capacity of communities to
participate in the processes that shape research approaches and intervention
strategies. Community-based research is thus more than just a community placed
outreach activity.  These research projects are community driven and
responsive so as to maximize the potential for change in knowledge, attitudes,
and behavior.  They are conducted in a manner that reinforces collaboration
between community members and research institutions.  Relevant results from
these projects are disseminated to the community in clear, useful terms. 
Moreover, these studies are designed to be culturally appropriate, i.e., due
consideration is given to the social, economic, and cultural conditions that
influence health status.  Identifying and incorporating unique cultural
factors into intervention strategies may result in increased acceptability,
use, and adherence.

Each application should develop a comprehensive, strategic plan with time
schedules and milestones to address all key aspects.  This plan should
include:

o  Identification of target community.  Population(s) should be clearly
identified, community boundaries described, and known environmental health
hazards delineated.

o  Community collaboration.  How will communication and regular exchange of
information and ideas between community members and institutional researchers
be initiated and enhanced?  How are productive relationships with local
representatives established and maintained?  How are local organizations and
leaders recruited?  What are the mechanisms for communities to identify their
environmental health needs?  How will activities be designed to meet these
needs? How will findings be disseminated within the community?

o  Research program definition and implementation.  A variety of research
designs may be proposed.  Primary, secondary, or tertiary prevention
strategies may be included.  Interventions should be based on appropriate
behavioral and scientific theories.  They should also be built on the results
of previous methods shown to be efficacious in changing risk factors related
to knowledge, attitudes, and behaviors.  Interventions should use multiple,
culturally sensitive, community-based approaches and be adapted to the special
needs of underserved populations.

o  Evaluation.  Both outcome and process evaluations should take place.  Only
projects having well developed, comprehensive evaluation plans will be
supported.  The application must include detailed descriptions of process and
outcome evaluation, specify the measures and instruments for data collection,
and indicate a time frame for conducting all evaluation activities.

Experimental design is not restricted by this RFA.  Applicants should develop
their own independent design and provide appropriate justification.  Designs
should focus on an integrated approach employing various culturally
appropriate factors that have been previously shown to be effective.  It is
important that the study population be clearly identified and that community
involvement in developing the design be demonstrated.  An experimental design
with a defined hypothesis is the preferred approach.  A randomized design,
comparing specially constructed interventions against usual and customary
conditions, would be one appropriate study design to test intervention models. 
Other designs may also be considered responsive.  Elements that may be
considered in assembling a research design include sampling procedures,
instrumentation and measurement, data collection, quality control,
recruitment, retention, tracking and follow up, and data analysis.  State of
the art econometric techniques for measuring cost effectiveness of prevention
efforts may also be included.  Applicants are encouraged to test and compare
multiple innovative strategies and to assess their relative effectiveness.

Community-based Research

Community-based research seeks to enhance the capacity of communities to
participate in the processes that shape research approaches and intervention
strategies.  Active cooperation and participation of organizations within the
community(ies) that is (are) the focus of the study are essential components
of the research.  Hence, applicants must describe an existing or proposed
involvement with one or more community-based organizations in an area having
an underserved population adversely impacted by an environmental contaminant. 
This connection is essential to the development of community-based approaches
and should also enhance the potential for long term impact of the project. 
Community input is most meaningful and best utilized if it is built into the
research process from the outset.  Community representatives should be given a
voice in choosing research topics, developing the application, collecting
data, and interpreting results.  Thus, projects should be community-driven and
community-responsive.  Research efforts should reinforce the collaborations
between communities, health care providers and scientists.  Results generated
by the research should be disseminated to community members in useful terms.
This will mandate that all facets of the project design be culturally
appropriate.  Involvement of an Historically Black College or University,
Hispanic College, or Tribal College and/or recruitment of staff from the
community may be appropriate.  However, such efforts will not substitute for
direct involvement of a community-based organization.  Applications lacking an
existing or proposed link to a community-based organization will be considered
to be nonresponsive to this RFA.

The NIEHS has been active in developing pioneering efforts with translational
research programs.  Innovative programs linking environmental health
scientists with health care providers, community members, educators and
schools are making tremendous impacts on environmental health awareness in
medically underserved communities across the nation.  The NIEHS has supported
the development of programs that are at the forefront of community input and
participation with regard to environmental health concerns. Benefits of
community-based research include:
o  The formation of bridges between scientists and communities that allow both
to gain in knowledge and experience.
o  Better definition of a particular environmental health concern.
o  Assistance in development of culturally appropriate measurement
instruments, thus making projects more effective and efficient.
o  Establishment of a level of trust that will enhance both the quantity as
well as the quality of data collected.
o The community gains more knowledge about environmental health problems; and
has a role in addressing those problems.
o  Relationships are built that can have a longer term impact or influence on
those problems.

Principles of community-based research include:

o  Community-based research seeks to enhance the capacity of communities to
participate in the processes that shape research approaches and intervention
strategies.
o  Active cooperation and participation.
o  Community members have a voice in choosing research topics, developing
projects, collecting data, and interpreting results.
o  Projects are community-driven and -responsive.
o  Research efforts reinforce collaboration.
o  Results are disseminated to the community in useful terms.
o  Designed to be culturally appropriate.

SPECIAL REQUIREMENTS

Annual meetings, to be held in Research Triangle Park, NC, are planned for the
exchange of information among investigators.  Applicants must budget travel
costs associated with these meetings in their applications.

In addition, since these projects are community-based and embrace both
research demonstration and dissemination, applicants are expected to maximize
opportunities for information exchange between institutional researchers and
community members.  As part of this program, applicants must generate a report
that describes community input, program implementation, and relevant findings. 
This report must be produced at least annually and distributed among community
members in such a way that it can be easily comprehended by the public. 
Applicants must budget for production and dissemination of such reports.  This
requirement is intended to establish a minimal level of communication among
project participants; additional, more frequent dissemination efforts may be
appropriate.

Relationship to Environmental Justice

Activities conducted under this RFA should be consistent with Federal
Executive Order No. 12898 entitled,  Federal Actions to Address Environmental
Justice in Minority Populations and Low Income Populations.  To the extent
practicable and permitted by law, grantees shall make achieving environmental
justice part of their project's mission by identifying and addressing, as
appropriate, disproportionately high and adverse human health effects of
environmental contaminants on minority and low income populations.

The current RFA builds upon the framework established by the separate NIEHS
grant program entitled "Environmental Justice: Partnerships for
Communication."  That program, initiated in 1993, supports outreach, training,
and education efforts that will become the catalyst for reducing exposure to
environmental pollutants in underserved populations.  Its main objective is to
establish methods for linking members of a community, who are directly
affected by adverse environmental conditions, with environmental health
researchers and health care providers.  This endeavor will help to ensure that
the community is aware of basic environmental health concepts and that they
have a role in defining problems and shaping approaches to their solution.

The present RFA differs from the Environmental Justice grant program in that
the former is a scientific research demonstration and dissemination project,
whereas the latter is an education project.  Thus, this RFA is intended to
support specific, rigorous, scientific research projects that develop and
implement community-based, culturally appropriate prevention/intervention
strategies in underserved communities.  The Environmental Justice program
supports education projects that enhance the flow of information and
communication among scientists, health care providers, and community members. 
Although these programs are complementary, it is important to differentiate
the substantial research orientation of this RFA from the educational goal of
the Environmental Justice program.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided 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 research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 19, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of the RFA in response to which the application may be submitted.  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
NIEHS staff to estimate the potential review workload and avoid conflict of
interest in the review.

The letter of intent is to be sent to:

David P. Brown, M.P.H.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-4964
Fax:  (919) 541-2503
Email: brown4@niehs.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email:
GrantsInfo@nih.gov.

The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets.  Only
limited budgetary information is required under this approach.  The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to
a total direct cost request of $250,000 per year. Applications that request
more than $250,000 direct costs in any year must follow the traditional PHS
398 application instructions.  The total direct costs must be requested in
accordance with the program guidelines and the modifications made to the
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year.  This is not a Form page.

o  Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included
in the overall requested modular direct cost amount.  Include the Letter of
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the type
of agreement and the date. All appropriate exclusions must be applied in the
calculation of the F&A costs for the initial budget period and all future
budget years.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  The RFA label and
line 2 of the application should both indicate the RFA number.  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.

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 must be
sent to:

David P. Brown, M.P.H.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Telephone:  (919) 541-4964
Fax:  (919) 541-2503
Email: brown4@niehs.nih.gov

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 addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIEHS staff.  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 NIEHS
in accordance with the review criteria stated below.  As part of the initial
merit review, a process will be used by the initial review group in which
applications receive a written critique and 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, assigned a
priority score, and receive a second level review by the National Advisory
Environmental Health Sciences 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
the application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. Note that 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.

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

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

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

(4) 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)?

(5) 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?

In addition to the above criteria all applications will also be reviewed with
respect to the following:

o  Extent of community sanction/liaison.  Rationale for selection of the
targeted population and documentation of environmental health needs and risk
factors.  Evidence of access to, interaction with, and participation of
community members and community leaders in development and conduct of the
project.  Establishment of collaborative interactions among all project
participants. Extent to which the design demonstrates sensitivity to cultural
and socioeconomic factors in the community.

o  Demonstration of effective communication channels between researchers and
community members.  Plans for useful and practical dissemination of project
activities and findings within the affected community(ies).  Active
involvement of at least one community based organization is a minimal
requirement for responsiveness to this RFA.

o  Appropriateness of proposed budget and duration in relation to the
project's objectives.

o  Adequacy, appropriateness, feasibility, and comprehensiveness of the
evaluation plan, including sufficient allocation of resources.

o  Feasibility of plans for independently continuing the program. Evidence of
continuing commitment on the part of the proposing institution(s).  The
potential long term impact of the proposed project is especially important.

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will also be
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

o  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  The initial review group will also examine the provisions for the
protection of human subjects and the safety of the research environment.

Schedule

Letter of Intent Receipt Date:    October 19, 1999
Application Receipt Date:         December 13, 1999
Peer Review Date:                 March 2000
Council Review:                   May 2000
Earliest Anticipated Start Date:  July 1, 2000

AWARD CRITERIA

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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Frederick L.Tyson, Ph.D.
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-0176
FAX:  (919) 316-4606
Email:  tyson2@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Carolyn B. Winters
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-7823
FAX:  (919) 541-2860
Email:  winters@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.113, 93.114, and 93.115.  Awards are made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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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