Full Text ES-94-008

DEVELOPMENT GRANT:  ENVIRONMENTAL HEALTH SCIENCES CENTERS

NIH GUIDE, Volume 23, Number 22, June 10, 1994

RFA:  ES-94-008

P.T. 04

Keywords: 
  ENVIRONMENT 
  Biomedical Research, Multidiscipl 


National Institute of Environmental Health Sciences

Letter of Intent Receipt Date:  July 15, 1994
Application Receipt Date:  September 08, 1994

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 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 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.  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.

This RFA has one receipt date.  However, the NIEHS intends to
announce additional receipt dates for developmental grants
periodically.

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 REQUIREMENTS

Applicants must have a minimum of $500,000 in funded research related
to environmental health sciences to be eligible for this
solicitation.  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.  While
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 under-represented 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 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 of them from the Chief, Environmental Health Resources Branch at
the address listed below.

FUNDS AVAILABLE

The funding level for NIEHS developmental rants 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.  The earliest possible award date is
April 1, 1995.  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.

RESEARCH OBJECTIVES

Background

At every stage of life, economically disadvantaged and/or underserved
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 about 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, 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 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.  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 Institute 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 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 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;

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 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 for discussions of progress towards establishing the
interdisciplinary effort needed to apply for an NIEHS center.

STUDY POPULATIONS

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy 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 July 15, 1994, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NIEHS staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Ethel Jackson
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 104 Alexander Drive, MD 17-09
Research Triangle Park, NC  27709
Telephone:  (919) 541-7826

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267.

Applications must be received at the NIH by September 8, 1994.  The
RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application.  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.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:

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

To expedite review, it is requested that two copies be sent to:

Dr. Ethel Jackson
Division of Extramural Research & Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709

Schedule

Letter of Intent Receipt Date:  July 15, 1994
Application Receipt Date:       September 8, 1994
Initial Scientific Review       October/November 1994
Advisory Council Review         January 1995
Anticipated Date of Award:      April 1, 1995

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIEHS.  Incomplete applications will be
returned to the applicant without further consideration.  If NIEHS
staff find that the application is not responsive to the RFA, it will
be returned without further consideration.  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.

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 (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the principal investigator/program director
and the official signing for the applicant organization will be
promptly notified.

AWARD CRITERIA

The anticipated date of award is April 1, 1995.  Scientific merit, as
reflected by the priority score; availability of funds; and
programmatic priorities will be considered in making awards.

INQUIRIES

Written and telephone 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:

Donald I. McRee, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 104 Alexander Drive, MD 3-02
Research Triangle Park, NC  27709
Telephone:  (919) 541-1442 or (919) 541-7634

Direct inquiries regarding fiscal matters to:

Mr. David L. Mineo
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, 104 Alexander Dr., MD 2-01
Research Triangle Park, NC  27709
Telephone:  (919) 541-1373

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.894.  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, 43 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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