Full Text ES-93-01

DEVELOPMENT GRANT:  ENVIRONMENTAL HEALTH SCIENCES CENTERS

NIH GUIDE, Volume 22, Number 10, March 12, 1993

RFA:  ES-93-01

P.T. 34

Keywords: 
  Environmental Health 
  Biomedical Research, Multidiscipl 


National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  June 1, 1993
Application Receipt Date:  July 28, 1993

PURPOSE

The overall intent of this National Institute of Environmental Health
Sciences (NIEHS) program is to establish multidisciplinary research
programs that utilize state-of-the-art science and address as a
primary focus environmentally-related health problems of economically
disadvantaged and/or underserved populations. The first step in this
process is the current request for applications (RFA) which requests
Center Development Grant (P20) applications from institutions or
consortia of institutions wishing to develop multi-disciplinary core
center (P30) grants with this theme.

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 RFA,
Developmental Grant:  Environmental Health Sciences Centers, is
related to the priority area of environmental health.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington DC 20402-9325 (telephone
202-783-3238).

ELIGIBILITY

Applications may be submitted by domestic for-profit and non- profit
organizations, public and private including predominantly minority
institutions, individually or as joint efforts of minority
institutions and majority institutions. Usually, only one
developmental grant will be funded at an institution.  Although a
single institution must be the applicant, a multi-institutional
arrangement (consortium) is possible if there is a compelling reason
for it and if there is clear evidence of close interaction among the
participants.

The NIEHS has a significant commitment to the support of programs
designed to increase the number of underrepresented minority
scientists participating in biomedical and behavioral research.
Therefore, applications from minority individuals and women are
encouraged.

MECHANISM OF SUPPORT

It is important to stress that award of Developmental Grants (P20)
will be highly competitive.  These awards will be made to only those
institutions able to demonstrate to the review committee a high
likelihood of success in following the P20 grant period by a
competitive core center grant application. Therefore, the
requirements established by the NIEHS for its Core Center must be
considered attainable by applicants for the P20 award.  The NIEHS has
available upon request the guidelines for these applications (P30)
and potential applicants for the P20 award are encouraged to obtain a
copy of them from the Chief, Environmental Health Resources Branch at
the address listed below.

Approximately $800,000 has been set-aside for this program.  The
funding level for NIEHS developmental grants will be $175,000 direct
costs per year for a maximum of three years.  It is important to note
that to be eligible for a core center (P30) that would follow after
the P20 award period, a minimum of $1,000,000 direct costs of NIH
peer reviewed, investigator initiated research support (or its
equivalent) must be in place.  This research must be directly related
to the theme proposed for the Core Center.

FUNDS AVAILABLE

It is anticipated that one to three developmental grants will be
awarded depending upon the appropriation of funds for this purpose
and the quality of the applications received.  The awards are not
renewable and supplements are not allowed.

RESEARCH OBJECTIVES

Background

The Extent of the Problem

Most Americans want to live long and healthy lives, and the majority
of them achieve that goal.  In general, however, members of
economically disadvantaged and/or underserved populations are less
likely to do so.  At every stage of life, these populations suffer
disproportionate levels of morbidity and mortality.  The
socioeconomically disadvantaged suffer the lowest life expectancy and
highest adverse health consequences of inadequate access to
high-quality health care.  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 exposure to these agents.

Research efforts to identify the sources of hazardous environmental
exposures and their effects among minority and underserved
populations have been insufficient.  Not much is known about the
types of environmental agents to which socioeconomically
disadvantaged groups within our population are exposed at home and on
the job.  There has been little research to see how exposure to these
agents varies with socioeconomic status.  It is reasonable to
hypothesize that factors such as malnutrition, health status,
socioeconomic status, in combination with behaviors such as smoking,
alcohol consumption and drug use play important roles in the dose
response, metabolism and health effects of these hazardous agents
among these populations.

Exposures to harmful environmental agents may be more extensive among
the socioeconomically disadvantaged because of the jobs available to
them and the conditions in which they work.  Occupational exposures
vary greatly with job responsibility.  The lowest paying jobs in
industrial plants are usually the most risky.  A high percentage of
certain jobs may be held by one racial group.

Geographic location also plays an important role in environmental
exposure of socioeconomically disadvantaged populations.  Inner city
poor often live in homes with high lead levels.  These populations
may also be exposed to higher levels of air pollution.  Toxic wastes
sites are more frequent in rural, low socioeconomic counties in the
US.  Nuclear facilities and chemical plants are often located in
rural areas.  Disadvantaged neighborhoods may rely on well water
which may be polluted with toxic chemicals.

Medical care is often inadequate or unavailable to a significant
proportion of the socioeconomically disadvantaged and minority
populations in America today.  This is in conjunction with the fact
that many chronic diseases and other medical problems associated with
exposure to environmental agents are highly prevalent in segments of
the population which are economically disadvantaged.  Lead poisoning
and the cognitive and developmental damage associated with exposure
to lead occur disproportionately among minority populations.  High
blood pressure and prostate cancer are very common among Blacks.  Low
birth weight babies and other problems during pregnancy are common
among groups of women who do not have access to good prenatal care.
Some of these conditions or other disease may have an environmental
component in their etiology.  The lack of resources for early
identification of the effects of toxic agents in these subgroups may
lead to an increased disease burden in a population economically
least able to cope with it.

Recent progress and opportunities

Some work has been done to investigate the effects of pesticides in
agricultural workers, PCBs in children in rural areas, and lead
exposure in socioeconomically disadvantaged urban children, usually
looking at neurological outcomes.  The effect of low versus high air
pollutant exposure on pulmonary function has been extensively
studied.  Evidence from the NHANES study has shown that for
comparable levels of exposure, different racial groups have different
levels of blood lead.  Some evidence is also available that suggests
the toxic effects of some agents such as lead can be mitigated by
good nutrition.

Many of these studies have been of underserved populations, but none
have focused on the problems from the perspective of identifying
issues of highest impact on these populations.  Thus, progress has
been minimal in most areas due to the lack of well-developed studies
targeting socioeconomically disadvantaged populations.  More effort
must be put into defining disadvantaged populations having high
levels of exposure to types of environmental hazards in the home or
occupational settings.  Comprehensive outcomes to these exposures
must be defined and measured.  Prevention and treatment of these
effects must also be generated.

Prominent among the goals of the NIEHS is the achievement of
"environmental equity" for all populations, as well as to bring
minority populations into the mainstream of biomedical research as
scientists.  The achievement of both of these goals will benefit the
health of the nation and provide a means of encouraging the needs of
all populations.  As one new aspect of this effort the NIEHS is
requesting submission of Center Development Grant applications that
focus on the environmentally-related health problems of
socioeconomically disadvantaged populations.

Objectives and Scope

The primary purpose of the NIEHS Center Development Grant (P20) is to
provide support for a group of investigators to develop
interdisciplinary collaborations and strategies, to obtain
preliminary results to demonstrate feasibility and develop a research
program focused on the goals of this announcement.  The resulting
program will then be used as the basis for an application for an
NIEHS core center grant (P30). Thus, the components of an NIEHS
Center Development Grant may include, but are not limited to:

1.  Preliminary or feasibility studies to gather sufficient data to
demonstrate the potential of ideas or the validity of approaches, to
acquire or demonstrate technical competence, or to evaluate other
technical factors involved in the development of projects that
addresses the goals of this announcement in conjunction with the
goals of the NIEHS Centers Program;

2.  Recruitment of new investigators whose expertise would strengthen
the center grant application that will be submitted later;

3.  Inter- or intra-institutional planning to develop research
strategies, including the establishment of a timetable or milestones,
for the subsequent center grant application.

It is important to note that the award of a developmental grant by
the NIEHS does not imply a commitment to future funding of any
programs planned with the support of such a grant.  Separate
applications must be submitted for such programs and such
applications will be evaluated on the basis of their own merits.

SPECIAL REQUIREMENTS

In order to ensure that developmental grants remain focused on
appropriate goals and make sufficient progress towards establishing
the interdisciplinary effort needed to apply for an NIEHS center,
frequent programmatic assessments will be necessary.  In addition to
yearly staff review through progress reports, the directors of
developmental grants will be asked to attend the periodic meetings of
the Environmental Health Sciences Center Directors.

Elements of a Planning and Development Effort

The following elements are essential in the planning and subsequent
development of an NIEHS center:

1.  Planning grant director:  A senior level person competent in
administration should be assigned the responsibility for directing
the planning and development effort.  This person should devote a
significant proportion of his/her time to this endeavor.  The
planning director will be the Principal Investigator of the P20
Center Development Grant application.  It is both customary and
desirable that the planning director be the proposed founding
director of the new center.

2.  Planning and advisory committees:  An internal planning committee
should assist the planning director.  Committee members should be
selected from within the Institution(s) developing the center.
Additional members from the community should also be selected where
appropriate.  This committee should evaluate scientific, medical,
institutional, and regional considerations and should make sure that
all available resources are considered in the planning process.  It
may be advisable for all elements of the institution(s) affected by
the center to be represented on this committee.  In addition, an
external advisory group, consisting of senior individuals who are
familiar with the functions and organization of NIEHS designated
centers, should be convened periodically to give the planning
director knowledgeable advice on the development of a research center
as well as unbiased and independent assessments of the center's
progress to date and its objectives and plans for the future.

3.  Research program definition and implementation:  The research
programs which are to comprise the center should be defined in terms
of relevance to the problem, productiveness, membership in the center
(present and future), peer reviewed grant/contract research base,
space needs and utilization, availability of patient resources, etc.
The research programs should be multidisciplinary in nature and may
focus on basic, clinical or prevention investigations.  They should
build on the current strengths of the institution.  This definition
and its subsequent implementation should also include consideration
of local, regional, and national needs.  Shared resources that will
support the peer reviewed research projects of the center programs
will also need to be defined.

4.  Definition of how research activities will be translated or
linked to the patient care, educational and other outreach activities
of the center:  The relationship between the center's research
activities and the patient care, educational (both professional and
lay), community outreach and other activities of the center must be
defined.  Mechanisms should be developed so that the results of
research performed at the center and elsewhere can impact quickly and
positively on the populations served by the center in its geographic
area.  Such translational activities are a fundamental aspect of a
NIEHS Center.

Allowable Components of NIEHS Development Grant (P20) Applications

Each applicant should consider the strengths and weaknesses of the
planned research group plus the expertise and the preliminary data
that would be required to demonstrate the technical competence
necessary for a successful interdisciplinary center grant
application.

1.  Pilot projects/Feasibility studies.  Research projects of limited
scope to generate data needed to demonstrate technical feasibility
such as access to study populations and to validate an experimental
approach may be proposed.  Costs required for carrying out individual
projects may be requested.

2.  Organizational development.  The goal of the P20 grant is to
bring together the individuals and organizational structure that will
lead to a successful P30 application.  Therefore, partial salary
support as an incentive for the recruitment of faculty who will be
part of the subsequent P30 application is acceptable.

3.  Administrative/Planning core.  Each developmental project must
designate a director who will be the key figure in the scientific
planning and subsequent administration of the proposed NIEHS project.
Planning efforts should be described in terms of the necessary
feasibility studies, recruitment of new investigators, establishment
of new collaborations, development of plans for data release and
outreach to the scientific community, and other components that will
strengthen and broaden any existing programs in the research area of
the proposed project.  An internal steering committee is strongly
recommended.  Funds may be requested for the purpose of obtaining
outside advice and for necessary administrative personnel.

Costs are allowable in accordance with the cost principles outlined
in OMB Circulars A-110, A-21, and A-122, and the provisions in DHHS
Administration of Grants Federal Regulations Title 45 Part 74 and the
PHS Grant Policy Statement, provided they fall into one of the
categories below.  It is important to recognize that, even though a
cost may be allowable, it is the responsibility of the applicant to
adequately justify the inclusion and amounts of all items for which
funding is required.

Non-allowable Costs for NIEHS Developmental Grants

Funds from these grants may not be used to provide salary and support
for central institutional administrative personnel usually paid from
institutional overhead charges.

Generally, funds for renovation of existing facilities or to purchase
substantial amounts of equipment will not be allowed.  If such
requests are made, they must be justified in terms of the critical
nature of the equipment for the success of the overall objectives of
the developmental grant, rather than for the planned program project
or center grant.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy in
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan and summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.  For the purpose of this policy, clinical research
includes human biomedical and behavioral studies of etiology,
epidemiology, prevention (and preventive strategies), diagnosis, or
treatment of diseases, disorders or conditions, including but not
limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned to the applicant.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Although not a prerequisite for applying, potential applicants are
encouraged to submit to NIEHS staff a non-binding letter of intent to
apply by June 1, 1993.  The letter of intent should include 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.  The letter of intent neither influences review nor
funding decisions, but it enables NIEHS staff to plan the review and
to ensure that each potential applicant receives relevant program
information prior to preparation of the application.

The letter of intent is to be sent to:

Chief, Environmental Health Resources Branch
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-7634

INQUIRIES

NIEHS staff welcomes the opportunity to clarify any issues or
questions from potential applicants.  Written and telephone inquiries
concerning the objectives, scope and application procedures for this
RFA, and inquiries about whether or not specific proposals would be
responsive are encouraged and may be directed to:

Thorsten A. Fjellstedt, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-0131

Questions regarding administrative or fiscal matters may be directed
to:

Mr. David Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-7628

METHOD OF APPLYING

Applicants are to use research grant application form PHS 398 (rev.
9/91) which is available from most institutional offices of sponsored
research and from the Office of Grants Inquiries, Division of
Research, Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD  20892, telephone (301) 496-7441.

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
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 2a of the face page of the application form and the YES box must
be marked.  As a guideline, it is suggested that approximately ten
pages will be sufficient to describe the planned mission and
structure of the proposed project and three to five pages to describe
each feasibility study or other activity.  Each project should be
presented in the format used for NIH research grant (R01), but in
greatly abbreviated form.

Although not a prerequisite for applying, applicants are encouraged
to consult with NIEHS staff concerning the technical and substantive
aspects of preparing the applications is recommended.  Applicants may
contact NIEHS staff by phone early in the preparation of the
application.  However, applicants should understand that advice given
by staff is independent from the review process.

Schedule

Letters of Intent Receipt Date:  June 1, 1993
Application Receipt Date:        July 28, 1993
Initial Scientific Review:       Oct/Nov 1993
Advisory Council Review:         January 1994
Anticipated Date of Award:       April 1, 1994

Mail the complete original application and three copies to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

To expedite review, two copies must also be sent to:

Dr. Donald I. McRee
Division of Extramural Research & Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-7508

All human and animal welfare as well as misconduct assurances must be
complete for an application to be reviewed.  All follow-up assurances
and approvals submitted as pending must be received within 60 days of
the application receipt deadline or the application will not be
reviewed.

The written application is the basis for the merit review.
Particular attention should be given to the format of the
application.  The standard instructions provided with form PHS 398
(rev. 9/91) are designed primarily for applications for single
research projects.  Developmental Center Grant applications require
additional information as outlined below.  Page limitations presented
in the form PHS 398 (rev. 9/91) instructions should be followed
closely.

REVIEW CONSIDERATIONS

Review will be carried out by the NIEHS Scientific Review Branch,
Division of Extramural Research and Training.  Applications will be
screened by staff for responsiveness to the RFA.  Those considered
unresponsive will be returned to the applicant without review.
Responsive applications will be reviewed by either the Environmental
Health Sciences Review Committee or a review committee empaneled by
the Scientific Review Branch staff.

Site visits as part of the initial review of applications are not
planned.  Therefore, it is imperative that the application be
complete and stand on its own merits.

If a large number of applications are received, the NIEHS will
utilize a triage process whereby the applications are given a
preliminary scientific review by scientific peers in order to
identify the most meritorious applications.  Those applications
identified as highly meritorious will be given a full scientific
review and a complete and detailed summary statement will be
prepared.  Those applications not achieving these qualification will
not be given a full review and an abbreviated summary statement
listing the reasons for this decision will be prepared.

Review Criteria
A major review criterion is the likelihood of success in following
the P20 grant period by a competitive core center grant application
(P30).  The following is not a complete listing of the Core Center
requirements but, rather, is meant to highlight the major
requirements for applicants for P30 programs.

o  A minimum of $1,000,000 direct costs of NIH peer reviewed,
investigator initiated research support (or its equivalent) that is
directly related to the Core Center and to the mission of the NIEHS.

o  A demonstrated institutional commitment to the core center.

o  A program cohesiveness that clearly indicates that the presence of
the Core Center makes a significant difference to the individual
research projects by providing and fostering a high degree of synergy
among the various research projects.

The major review factors listed below will be used in the evaluation
of the applications for NIEHS Center Development Grants:

I.  Overall Program

A.  The ability to demonstrate a high likelihood of success in
following the P20 grant period by a competitive core center grant
application (P30).

 B.  The scientific merit of the program as a whole and the
development of a well-defined central focus of clear importance and
relevance to the goals and mission of the NIEHS.

C.  The significance of the overall program goals and responsiveness
to the goals of this initiative.

D.  The balance of administrative and planning expenses in comparison
to those for conducting the small-scale studies.

II.  Administration and Planning Core

A.  The scientific and administrative leadership ability and
experience of the Center Director and his/her commitment and ability
to devote adequate time to the effective management of the Center.

B.  The proposed administrative organization to conduct the
following:

1.  Organize and maintain internal communication and cooperation
among the investigators involved in the Center.

2.  Establish a management structure that includes fiscal
administration, procurement, property and personnel management,
planning budgets, etc.

3.  Develop mechanism for selecting or replacing professional or
technical personnel within the Center.

4.  Develop an appropriate and adequate review committee to assess
the scientific merit of the proposed pilot project/feasibility
studies.

5.  Institute a mechanism for reviewing the use of and administration
of funds for the proposed pilot project/feasibility studies.

6.  Appropriateness and adequacy of the multidisciplinary teams
constituting Center's members.

7.  Adequacy of the initial research agenda and of the planning
mechanism for elaborating a long-term research agenda for the
institution.

8.  The appropriateness of the budgets for the various components of
the application.

III.  Pilot/Feasibility Studies

A.  The balance in coverage of the topics identified as the goals and
scope of this initiative.

B.  The scientific and technical quality of the proposed pilot
project/feasibility studies.  (Note:  Reviewers will not vote on the
merit of each study.  The overall quality of the proposed pilot
project/feasibility studies will be taken into account in arriving at
an evaluation of the application).

IV.  Institutional Commitment

A.  The institutional adequacy of the lines of responsibility for the
Center and the institution's contribution to the management
capabilities of the Center.

B.  The academic environment and resources in which the activities
will be conducted, including the availability of space, equipment,
and facilities, and the potential for interaction with scientists
from other departments and schools.

D.  The institutional commitment to any newly recruited individuals
responsible for conducting essential Center functions and activities.

AWARD CRITERIA

The following will be considered in making funding decisions:

o  Quality of the proposed applications as determined by peer review.

o  Responsiveness to the goals of this RFA and the mission of the
NIEHS.

o  Availability of funds.  Although this program is provided for in
the financial plans of the NIEHS, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose.  Funding
beyond the first and subsequent years of the award will be contingent
upon satisfactory progress during the preceding year and upon
availability of funds.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance Number 93.894.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 100-607) and
administered under PHS grant policies and Federal Regulations 42 CFR
Part 52 and 45 CFR Part 74.  The program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

.

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