Full Text ES-92-02

DEVELOPMENT GRANT:  ENVIRONMENTAL HEALTH SCIENCES CENTERS

NIH GUIDE, Volume 21, Number 24, July 3, 1992

RFA:  ES-92-02

P.T. 04

Keywords: 
  Environmental Health 
  Biomedical Research, Multidiscipl 


National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  August 14, 1992
Application Receipt Date:  September 4, 1992

PURPOSE

The overall intent of this National Institute of Environmental Health
Sciences (NIEHS) program is to establish multidisciplinary research
programs supported by core centers (P30s) that have 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) that requests center development
grant (P20) applications from institutions and 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, both public and private. Applications are welcome from
predominantly minority or majority institutions, individually or as
consortia.  Usually, only one developmental grant will be funded at an
institution.  While a single institution must be the applicant, a
multi-institutional arrangement (consortium) is possible if there is a
compelling reason 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 under-represented minority
scientists participating in biomedical and behavioral research.
Therefore, applications from minority individuals and women are
encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) exploratory
grant (P20).  The maximum requested amount of each application may not
exceed $175,000 direct cost per year.  The total project period may not
exceed three years.  It is estimated that approximately one to three
awards will be made.

It is important to stress that award of P20 Developmental Grants 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 from the
program manager listed below.

FUNDS AVAILABLE

The funding level for NIEHS developmental grants will be $175,000
direct costs per year for a maximum of three years.  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 the effects among minority and underserved populations
have been insufficient.  Not much is known about the types of
environmental agents that socioeconomically disadvantaged groups within
the population are exposed to 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 that 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 that 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 problems during pregnancy are common among groups of
women who do not have access to good prenatal care.  Some of these
conditions and other diseases may have an environmental component in
the 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 the 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, of PCBs in children in rural areas, and of 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 used 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 and occupational
settings.  Comprehensive outcomes to these exposures must be defined
and measured.  Prevention and treatment of these effects must also be
generated.

Predominant 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.  Both of these goals have a clear benefit to the health of
the Nation and provide a means of addressing a potential labor shortage
in the twenty-first century.  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 is to provide
support for a group of investigators to develop interdisciplinary
collaborations and strategies, to obtain preliminary results to
demonstrate feasibility, and to 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:

o  Preliminary or feasibility studies to gather sufficient data to
demonstrate the potential of an idea or the validity of an approach, to
acquire or demonstrate technical competence, or to evaluate other
technical factors involved in the development of a project that
addresses the goals of this announcement in conjunction with the goals
of the NIEHS Centers Program;

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

o  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:

o  Planning grant director:  A senior level person competent in
administration should be assigned the responsibility for directing the
planning and development effort.  This person must 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.

o  Planning and advisory committees:  An internal planning committee
shall assist the planning director.  Committee members are to be
selected from within the institution(s) developing the center.
Additional members from the community may also be selected where
appropriate.  This committee shall evaluate scientific, medical,
institutional, and regional considerations and shall 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.

o  Research program definition and implementation:  The research
programs that are to comprise the center must 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, and availability of patient resources.  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.

o  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 an NIEHS Center.

Allowable Components of NIEHS Development Grant 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.

o  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.

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

o  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 must 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.

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.

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 Grants 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.

Funds from NIEHS developmental grants (P20s) may not be used to provide
salary and support for central institutional administrative personnel
usually paid from institutional overhead charges.

STUDY POPULATIONS

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

NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 is
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.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

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

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, by August 14, 1992, a non-binding
letter of intent to apply.  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.  Letters of intent are to be directed
to:

Christopher O. Schonwalder, Ph.D.
Chief, Scientific Programs 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

APPLICATION PROCEDURES

Applicants are to use the grant application form PHS 398 (rev. 9/91),
that is available from most institutional business offices and from the
Office of Grants Inquiries, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449 Bethesda, MD 20892,
telephone (301) 406-7441

In order to assure proper identification of the application, item 2a of
the application form must be filled in as follows:  Check the box
indicated as "yes," enter the RFA number as ES-92-02 and the title as
"NIEHS Center Development Grant."  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
must 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 an application.  Applicants should 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.

The following is the schedule planned for this initiative.

Letter of Intent Receipt Date:   August 14, 1992
Application Receipt deadline:    September 4, 1992
Initial Scientific Review:       October/November 1992
Advisory Council Review:         January 1993
Funding:                         April 1993

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
Chief, Scientific Review Branch
Division of Extramural Research and 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 and 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 must 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 must be followed closely.

REVIEW CONSIDERATIONS

Review will be carried out by the Scientific Review Branch, Division of
Extramural Research and Training, NIEHS.  Applications will be screened
by NIEHS 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 WRITTEN APPLICATION BE
COMPLETE AND STAND ON ITS OWN MERITS.

If a greater number of applications are received than anticipated, 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 this qualification will not be given
a full review, and an abbreviated summary statement listing the reasons
for this decision will be prepared.

Review Criteria

Awards will be made only to those institutions able to demonstrate to
the review committee a high likelihood of success with a competitive
core center grant application (P30) after the P20 grant period.  The
following is not a complete listing of the core center requirements,
but rather is meant to highlight the major requirements for potential
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:

Overall Program

o  The ability to demonstrate a high likelihood of success with a
competitive core center grant application (P30) after the P20 grant
period.

o  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.

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

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

o  Administration and Planning Core

o  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.

o  The proposed administrative organization to conduct the following:

- Organize and maintain internal communication and cooperation among
the investigators involved in the center.

- Establish a management structure that includes fiscal administration,
procurement, property and personnel management, planning budgets, and
other components as needed.

- Develop a mechanism for selecting or replacing professional and
technical personnel within the center.

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

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

- Appropriateness and adequacy of the multidisciplinary teams
constituting center's members.

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

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

Pilot/Feasibility Studies

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

o  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).

Institutional Commitment

o  The institutional commitment to the program, including lines of
responsibility for the Center and the institution's contribution to the
management capabilities of the center.

o  The degree of institutional contributions towards the expenses for
the Administrative and Planning Core and/or to the proposed pilot
project/feasibility studies.

o  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.

o  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 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.

INQUIRIES

Written and telephone inquiries concerning the objectives, scope,
application procedures, and allowable budget items for this RFA,
inquiries about whether or not specific proposals would be responsive,
and requests for P30 guidelines are encouraged and should be directed
to the Scientific Program Branch officer listed above.  The Branch
staff welcomes the opportunity to clarify any issues or questions from
potential applicants.  Questions of an administrative nature not
directly related to the programmatic aspects of this RFA may be
directed to the Grants Management Branch official listed below:

Mr. David Mineo
Chief, Grants Management Branch
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

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 grants 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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