Full Text ES-96-004
NIH GUIDE, Volume 25, Number 3, February 9, 1996
RFA:  ES-96-004
P.T. 34

  Environmental Biology 

National Institute of Environmental Health Sciences
Letter of Intent Receipt Date:  April 5, 1996
Application Receipt Date:  May 8, 1996
The National Institute of Environmental Health Sciences (NIEHS)
supports research to identify the role of environmental agents in
perturbations of normal physiologic processes leading to human
disease.  Although direct links between environmental agents and
health outcomes have been established for some diseases, there are
numerous chronic dysfunctions and diseases where there are minimal
scientific data to substantiate a role for the environment in their
etiology or progression, despite the plausibility of these
hypotheses.  Therefore, the goal of this Small Grants Program (R03),
Request for Applications (RFA) is to encourage research that will
establish whether there is sufficient evidence either mechanistically
or from epidemiologic studies to justify further investigations into
the role of environmental agents in the initiation or exacerbation of
human diseases.  Research is specifically encouraged to determine the
sound scientific connection between environmental agent and the
initiation or progression of disease.
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,
Linking of Environmental Agents and Disease, 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 Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone: (202) 512-1800).
Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State or local governments and
eligible agencies of the Federal government.  Foreign institutions
and organizations are not eligible.  Applications from minority
individuals and women are encouraged.  Submission of an application
precludes concurrent submission of a regular research projfect grant
application (R01 or R29) containing the same research proposal.  In
addition, small grant research support may not be used to supplement
research projects currently supported by Federal or non-Federal funds
or to provide interim support for projects under review by the Public
Health Service.
This RFA will use the NIH Small Grants Program (R03) awards.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The requested
costs and project period will be $50,000 (direct cost) for a maximum
of one year.  Small grants are not renewable but may be extended at
the discretion of the applicant organization.
The total estimated funds available for this small grants program is
$750,000 which will support approximately 10
to 12 awards.  This level of support is dependent on the receipt of
sufficient number of applications of high scientific merit.  Although
this program is provided for within the financial plans of the NIEHS,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.
Objectives and Scope
A major goal of the NIEHS is to improve our understanding of the
contribution of environmental factors to the development of disease.
In order for NIEHS to successfully carry out this mission, it is
imperative to have information on the role of the environment in a
wide variety of disease states.  Preliminary data are needed to
foster the development of  mechanistically-based research on the
relationship between environmental agents and diseases.  This RFA is
designed specifically to develop preliminary data on the possible
role of the environment in diseases in which links to exposure are
suggested but remain unproven.  It is anticipated that these
preliminary data will support development of hypothesis-based
research to establish the cause and effect relationship between
environmental exposures and disease etiology.
Research Goals
The goals and scope of the RFA are two-fold. The first is to
encourage and support mechanistically-based research designed to
establish the linkage between exposure to an environmental agent,
tested at environmentally relevant concentrations, and the initiation
or exacerbation of diseases.  The second area of emphasis is to
utilize human populations studies to develop hypotheses relating
environmental exposure to the initiation or exacerbation of diseases.
In either situation, emphasis should be placed on developing the
preliminary data that would lead to the development of an R01 or R29
The role of environmental agents in disease may be approached using
animal models, human tissue/cell-lines or human epidemiologic
studies.  In any case, environmentally relevant concentrations using
dose-response data is encouraged.  The effect of age and the timing
of exposure relative to the toxicity or effect should also be
included as part of the experimental design.
The purpose of this RFA is to expand data on non-cancer diseases.
Therefore, research on the role of environmental agents in the
initiation or exacerbation of cancers of any type will be considered
Animal Welfare Considerations
Investigators are encouraged to consider alternative methods and
approaches in their research applications that do not require the use
of whole animals, that use alternative species such as nonmammals or
invertebrates, that reduce the number of animals required, and that
incorporate refinements to procedures that will result in the
elimination or further minimization of pain and distress to animals.
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 28, 1994 (FR 58 14508-14513) 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.
Prospective applicants are asked to submit, by April 5, 1996, 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 consultants,
the 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 application, the information that it
contains is helpful in planning for the review of applications.  It
allows NIEHS staff to estimate the potential review work load and to
avoid conflict of interest in the review.
The letter of intent is to be sent to:
Ethel B. Jackson, D.D.S.
Extramural Division
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 17-09
104 T.W. Alexander Drive, Building 17, Room 1717
Research Triangle Park, NC  27709
Telephone:  (919) 541-7826
FAX:  (919) 541-2503
EMAIL:  jackson4@niehs.nih.gov
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and may be obtained from
the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0715,
email:  girg@drgpo.drg.nih.gov.
The following supplemental instructions are given:
Only one small grant application may be submitted by a principal
Due to the limited size of awards, no specific budget categories and
percent efforts will be required.  This will be a $50,000 award -
direct cost.  Equipment will be limited to $5,000.
The applicant must be explicit in describing the proposed interface
between an environmentally relevant agent and the induction or
exacerbation of a specific disease.  Background information must
suggest, or at least not preclude, a possible interaction between
these parameters.
Since this award is to support pilot studies, preliminary data are
not required except to indicate the expertise of the PI to carry out
the proposed studies.
The Research Plan (Specific Aims, Background and Significance,
Preliminary Studies, Research Design and Methods sections) is not to
exceed 10 pages.  Tables and figures are included in the 10 page
limitation.  Applications that exceed page limitations or PHS 398
requirements for font size (height or letters), type density
(characters per inch), and margins (see PHS 398 directions) will be
returned to the investigator.
Do not submit an appendix.
The RFA Label available in the PHS 398 (rev. 5/95) 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 2 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, clear, and single sided photocopies
in one package to:
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 Dr. Ethel Jackson, at the address listed under LETTER
OF INTENT.  It is important to send these two copies at the same time
as the original and three copies are sent to the Division of Research
Grants.  Otherwise the NIEHS cannot guarantee that the application
will be reviewed in competition for this RFA.
Applications must be received by May 21, 1996.  If an application is
received after that date, it will be returned to the applicant
without review.
Responsiveness of Applications to RFA
Upon receipt, all applications will undergo an administrative review
by senior scientific staff of the NIEHS for their responsiveness to
the RFA.  Only those applications considered to be responsive to the
RFA will be forwarded for peer review.  Applications considered
non-responsive to the RFA will be returned to the applicant without
further consideration.  The following criteria will be considered:
o  Is the application focused on an environmental agent and its
linkage to a disease state that is within the mission of the National
Institute of Environmental Health Sciences?
o  Is the application focused on the linkage of exposure to an
environmental agent and a non-cancer disease endpoint?
o  Is there reasonable evidence or suggestion that there may exist a
linkage between an environmental exposure and a disease state?
o  Is there a plausible biological mechanism suggested linking the
environmental exposure and the disease state?
o  Areas of science in which there are sufficient preliminary data
that would support the submission of a regular research project grant
application do not qualify under this RFA.
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 NIH peer review
procedures.  As part of the initial merit review, all applications
will 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 applications under review, will be
discussed and assigned a priority score.
Review Criteria
o  scientific, technical, or medical significance of the proposed
research as it relates to the connection between an environmental
agent and the initiation or exacerbation of human disease;
o  potential of the proposed research to result in the development of
hypothesis-based research establishing cause and effect
o  appropriateness and adequacy of the experimental design and
methods proposed to carry out the research; innovativeness or promise
of the research idea;
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o  reasonableness/appropriateness of the requested budget in relation
to the proposed research;
o  availability of resources necessary to perform the research; and
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
The anticipated date of award is September, 1996 pending availability
of funds.  The following will be considered in making funding
o  quality of the proposed project as determined by peer review;
o  availability of funds; and
o  program balance among research areas of the announcement.
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:
Jerrold J. Heindel, Ph.D.
Organs and Systems Toxicology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 3-02
104 T.W. Alexander Drive, Building 3, Room 316
Research Triangle Park, NC  27709
Telephone:  (919) 541-0781
FAX:  (919) 541-2843
EMAIL:  heindel_j@niehs.nih.gov
Gwen W. Collman, Ph.D.
Chemical Exposures and Molecular Biology Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 3-04
104 T.W. Alexander Drive, Building 3, Room 306
Research Triangle Park, NC  27709
Telephone:  (919) 541-4500
FAX:  (919) 541-2843
EMAIL:  collman@niehs.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. David L. Mineo
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD 2-01
104 T.W. Alexander Drive, Building 2, Room 203B
Research Triangle Park, NC  27709
Telephone:  (919) 541-7628
FAX:  (919) 541-2860
EMAIL:  mineo@niehs.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance No. 93.113 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, 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 PHS strongly encourages all grant and contract 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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