United States
               Environmental Protection
               Agency
Office of Research and
Development
Washington DC 20460
EPA600/F-98/012
June 1998
www. epa .gov/ncerq a
&EPA      ENDOCRINE DISRUPTORS
               Science To Achieve Results Program
                 1999 Interagency Grants Announcement

                    Opening Date: June 19, 1998
                    Closing Date: September 16, 1998
                        1  Environmental Protection Agency
                          National Institute of Environmental Health Services
                          Department of the Interior
                          National Oceanic and Atmospheric Administration
EPA
600/
F-
98/012
                          Office of Science and Technology Policy

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                                           ENDOCRINE  DISRUPTORS:
                                           Interagency Announcement
                                           Science to Achieve Results Program:
                                           1999 Research Grants
                                           Opening Date: June 19,1998    Closing Date: Sept 16,1998
P
     Contents
; Multiple Agency Interests
* Program Description %   ,
^ Eligibility Requiremejnts
 Standard instructions for .
                                       2
                                       2
                                      -"*•
                                       4:
                                       4
         Guidenes, Limitations,
           and Adjditipnall Requirements  7
I Proprietary Information

 Funding Mechanism
    -"*•    '  '*" "-  '•'   ' - -  ~ .-
                                       9

                                       9
                                        "
         Contacts
           U S EPA Headquarters Library
                  Mai! code 3201
           1200 Pennsylvania Avenue NW
              Washington DC 20460
Introduction

    This announcement is a collabora-
tive effort between the Environmental
Protection Agency, Department of the
Interior, Department of Health and
Human Services (National Institute of
Environmental Health Sciences), and
Department of Commerce (National
Oceanic and Atmospheric Administra-
tion), and is endorsed by the Depart-
ment of Agriculture, Department of
Defense, Department of Energy,
Centers for Disease Control and
Prevention,  Food and Drug Administra-
tion, and the Office of Science and
Technology Policy. The purpose of this
announcement is to develop a govern-
ment-wide coordinated effort to
stimulate innovative, multi disciplinary
research to address high priority
scientific uncertainties related to the
potential adverse effects of endocrine
disrupting chemicals (EDC) in humans
and wildlife.

Background

    This research effort is an impor-
tant mechanism for addressing priority
national research needs identified by
the Endocrine Disrupters Working
Group (EDWG) of the Committee on
Environment and Natural Resources,
National Science and Technology
Council.  The Working Group recog-
nized the need to promote collaboration
between the Federal sector and
academia and the private sector to
ensure that scientific advances are
timely and can be used to inform
national policy on endocrine disrupters.
   A number of overarching research
needs were identified by the EDWG in
the areas of human health, ecological
effects, and exposure assessment as
essential to the larger goal of determin-
ing the extent and magnitude of impact
for endocrine disrupters on wildlife and
human populations and to provide a
firm scientific basis fora determination
of the likely risk that EDCs pose to
human health and the environment.
Specifically, this research effort is
designed to advance the following
priority research needs:
•  Establish relationships between
   exposure to EDCs and adverse
   outcomes for human diseases and
   impaired reproduction and
   development in vulnerable
   populations. Exposure during
   early critical life stages (fetal,
   neonatal, and childhood) are of
   special concern. Quantitation of
   EDC body burdens in vulnerable
   groups is needed, especially for
   non-persistent, non-chlorinated
   EDCs and chemical mixtures.

•  Characterize interspecies variabil-
   ity among taxa and sensitive
   wildlife populations under field
   conditions. Increase emphasis on
   non mammalian wildlife (e.g.,
   amphibians, reptiles, birds, and
   invertebrates) that may be sensitive
   to endocrine disruption.

•  Identify adverse outcomes (e.g.,
   tumors and reduced fecundity) to
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    wildlife, to single individuals and
    to populations, as a result of EDC
    exposures.

Multiple Agency Interests

    To address the increased need for
research on Endocrine Disruptors, the
following Federal organizations have
combined their unique interests and
missions into this coordinated research
program. The following outlines
specific agency interest in endocrine
disrupters research:

Department of Agriculture (USDA).
    The USDA seeks to minimize the
    presence of substances that could
    affect human health and safety,
    such as endocrine disrupters, in the
    environment and in the food
    supply.

Department of Commerce.  National
    Oceanic and Atmospheric
    Administration (NOAA).
    Endocrine disruptor research cuts
    across NOAA's strategic objectives
    of building sustainable fisheries,
    recovering protected species and
    promoting healthy coastal ecosys-
    tems. Understanding the impact  of
    endocrine disrupters on the
    developmental and reproductive
    biology of marine and anadromous
    fish, marine mammals, sea turtles,
    and marine invertebrates is
    especially relevant.

Department of Defense (DoD), Tri-
    Service Toxicology Consortium
    [comprised of the Naval Medical
    Research Institute, Detachment
    (Toxicology); U.S. Army Medical
    Research Detachment; and the
    U.S. Air Force Toxicology
    Division] fosters preventive
    strategies for intervening with
    health risks from chemicals of
    military interest, including
    potential toxic insults to the
    endocrine, reproductive, neurologi-
    cal, and immune systems.
Department of Energy (DOE). The
    DOE funds research on endocrine
    disrupting chemicals as part of its
    effort to understand and reduce the
    environmental and public health
    threats from its facilities.

Environmental Protection Agency
    (EPA). The objectives of the
    endocrine disruptor research
    program are to determine whether
    there are health effects occurring in
    human and wildlife populations
    and to improve understanding of
    endocrine disrupters in the
    environment.  Chemicals that are
    known or suspected of being
    endocrine disrupters fall within the
    authorities and responsibilities of
    the EPA as mandated in 12 major
    environmental statutes to protect
    human health and the environment.

Department of Health and Human
    Services
    Centers for Disease Control and
    Prevention.  The human health
    consequences of endocrine
    disrupters are of concern as they
    relate to identification  of human
    health hazards, surveillance of
    human diseases or exposures,
    determination of preventable risk
    factors for disease, and develop-
    ment and evaluation of prevention
    programs.

    Food and Drug Administration.
    Endocrine disrupters are of
    concern to FDA in its responsibili-
    ties for ensuring that foods are
    safe, wholesome, and honestly
    labeled, that medicines are safe
    and effective, and for regulating
    medical devices, cosmetics,
    veterinary drugs, and animal feed.
    Premarket review of substances,
    final product approval, and post-
    market surveillance establishes an
    additional need for information on
    endocrine disrupters.
    National Institute of Environ-
    mental Health Sciences (NIH).
    NIEHS supports research directed
    at characterizing human health
    impacts from exposure to environ-
    mental agents.  Mechanistic
    research on chemicals which
    mimic or block the actions of
    natural hormones such as estrogens
    or androgens and epidemiologic
    studies of the health effects of
    EDCs in women, men, and
    children are high priorities. This
    research will provide a clearer
    picture of the exposure required for
    adverse health effects.

Department of the Interior (DOI).
    The U.S. Geological Survey
    (USGS) and the U.S. Fish and
    Wildlife Service seek information
    on the ecological effects of
    endocrine disrupters in wild
    animals, including fish, amphib-
    ians, reptiles, birds, and mammals
    as a basis for decisions on the
    management and conservation of
    these biological resources.

Program Description

Research proposals are sought in the
following areas:

1.  Population-level effects of EDCs
    in wildlife

    The goal of this component of the
RFA is to solicit integrated, multi
disciplinary research on the ecological
effects of EDCs. We are interested in
studies that assess the impacts of EDCs
at multiple levels of biological organi-
zation. Many studies have shown
changes in endocrine homeostasis in
terms of biochemical/histological
measurements at the sub-organismal
level, but the significance of these
observations in terms of adverse effects
on reproduction and development at the
population-level is uncertain. Pro-
posed studies may focus on understand-
ing effects observed in the field or on
1999 Grants for Research

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                                                                              United States Environmental Protection Agency
                                                                                      Office of Research and Development
                                                                                      Science To Achieve Results (STAR)
controlled studies in the laboratory or
field; we encourage evaluation of
empirical and/or theoretical linkages
between endpoints at multiple levels of
biological organization. Of continuing
interest are those classes/groups of wild
animals that are potentially at risk due
to unique life history traits as they
relate to reproductive strategies.  There
is no preference as to specific chemical
stressors to study other than that they
exert effects through  mechanisms
associated with endocrine function.

•   Potential research could include
    either assessment of specific
    populations at sites known to be
    contaminated with suspected EDCs
    or evaluation of populations
    known to be adversely affected
    (e.g., animals in decline or those
    with a high percentage of individu-
    als exhibiting abnormal patholo-
    gies) for reasons that may relate to
    EDCs. One approach might be to
    assess biological responses at the
    cellular and subcellular level that
    are suggestive of exposure to
    EDCs and relate  these responses to
    adverse changes  at the individual
    and population levels. This type of
    analysis woutd require a careful
    assessment of temporal consider-
    ations associated with exposure
    and effects. Relationship of
    responses across levels of biologi-
    cal organization could be evaluated
    using either empirical or concep-
    tual models or a combination of
    the two.

•   Research is needed which ad-
    dresses prediction of the potential
    endocrine disrupting effects
    associated with the production and
    use of new chemicals on individu-
    als and populations in terms of
    likely expression of toxicity.  One
    approach might be to link con-
    trolled field or mesocosm studies
    to theoretical modeling that
    involves identification of the
    mechanism of action.
 •    Proposals are requested that focus
     upon relating endpoints suggestive
     of effects on endocrine function to
     adverse outcomes in individuals
     and populations.  Most mechanistic
     endpoints indicative of alterations
     in specific endocrine systems
     cannot be easily linked to adverse
     biological effects. For example,
     there have been reports of the
     induction of vitellogenin in fish
     exposed to certain types of
     effluents, but the practical conse-
     quences of this estrogen-mediated
     response in terms of population
     viability are unclear (note, this is
     used solely as an example, not
     necessarily to solicit proposals on
     this specific topic to the exclusion
     of others).  Because of the critical
     roles  that successful reproduction
     and early development have on
     population dynamics, these
     endpoints are of particular interest.
     Animal models for this research
     are not constrained to any particu-
     lar class/species but, to the extent
     practically possible, should focus
     on species/classes that are ecologi-
     cally  important but that have not
     traditionally been the focus of
     research in this area. Of particular
     interest are species  which might be
     at significant risk due either to
     unique aspects of life history and/
     or potential EDC exposure.  This
     might include oviparous animals,
     long-lived animals with limited
     reproductive capacity, inverte-
     brates, or amphibians.

2.  Effects of exposure to EDCs
     during development on human
     health

     The goal of this component of the
RFA is to encourage integrated, multi
disciplinary epidemiologic, toxicologic,
and basic science research on the
effects of EDCs on human health.
Research is sought to determine the
health consequences from exposures
during in utero, neonatal, and/or
childhood development to agents that
interfere with function of the endocrine
system. Health endpoints of interest
may be manifest before birth, during
the neonatal period, during childhood,
puberty, and in adulthood. New
methods to characterize human
exposure during these critical windows
of development are encouraged.

    Health consequences should be
considered in humans and animal
models in males and females. Condi-
tions of interest in males include birth
defects, including hypospadias and
other urogenital abnormalities; alter-
ations in the normal growth and
development of male sex organs,
including prostate and testes; puberty;
changes in male hormone patterns; and
sperm count and quality.  In females,
health endpoints include birth defects;
onset of menarche and other aspects of
pubertal development; menstrual
disturbances and alterations in hormone
patterns; and female infertility, includ-
ing endometriosis. Studies of potential
EDC impact on physical and mental
growth and development are appropri-
ate in both genders.

•   Proposals are requested that  focus
    on the development of animal
    models of endocrine disrupter-
    induced human diseases, with
    special attention on determining
    modes and mechanisms of action
    for use in low dose extrapolation
    of effects on reproductive develop-
    ment.  Studies that integrate
    physiologically-based pharmacoki-
    netic models of chemical metabo-
    lism and distribution with biologi-
    cally-based quantitative dose-
    response modeling components are
    of special interest. Laboratory
    studies can include whole animal
    effects and tissue and cell culture
    studies of cellular and molecular
    effects of exposure.

•   Epidemiologic studies of the health
    consequences of EDCs are
    encouraged. Improved methods of
    exposure assessment for individual
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    chemicals or environmentally
    relevant mixtures is a critical
    element of all epidemiologic
    studies in this field. Case control,
    cohort, and other novel study
    designs are encouraged. The
    development of new analytical
    techniques and biomarkers to
    measure EDCs currently in
    commercial use but that may not
    be as persistent in the environment
    as the organochlorines is needed.
    Examples of classes of EDCs not
    well studied to date include
    fungicides, herbicides, and
    industrial chemicals such as
    bisphenol A, alkyl phenols, and
    phthalates.

•   Exposure assessment studies to
    describe the levels of EDC
    chemicals currently or recently in
    use and in the environment are
    encouraged. These  studies should
    seek to relate past and current
    environmental levels of exposure
    with human body burden and
    health outcomes.  The develop-
    ment of methods from which to
    extrapolate between environmental
    levels and human exposures is
    encouraged.

    In all cases,  we welcome and
encourage the submission of proposals
from groups of investigators and
institutions that can bring sufficient
multi-disciplinary expertise to address
the outlined areas.

    Background information regarding
the state-of-the-science can be obtained
by consulting Kavlock et al, 1996',
Ankley, et al, 19972, Crisp et al 19983
and the EPA Research Strategy on
Endocrine Disrupters. The latter
document is available on the Internet
(http://www.epa.gov/ORD/resplans/
respians.html). These documents are
meant to provide background informa-
tion, not specific research priorities for
this RFA.
Funds Available
    Approximately $8-10M will be
available to support this program from
the participating Agencies and Depart-
ments during the first year.  The upper
limit for awards is $500,000 per year,
total costs. Awards up to three years
may be requested and are subject to the
availability of funds.
     'Kavlock, R.J., G.P. Daston, C.
DeRosa, P. Fenner-Crisp,L.E. Gray, S.
Kaattari, G. Lucier, M. Luster, M.J. Mac, C.
Maczka, R. Miller, J. Moore, R. Rolland, G.
Scott, D.M. Sheehan, T. Sinks, and H.A.
Tilson (1996). Research needs for the risk
assessment of health and environmental
effects of endocrine disruptors: a report of
the US EPA sponsored workshop. Environ.
Health Perspectives 104 (Supplement
4):715-740.

    2Ankley, G.T., R.D. Johnson, N.E.
Detenbeck, S.P. Bradbury, G. Toth, and L.
Folmar,  1997. Development of a research
strategy for assessing the ecological risk of
endocrine disruptors.  Rev. Toxicol. 1:71-
106.

    'Crisp, T.M., E.D. Clegg, R.L. Cooper,
W.P. Wood, D.G. Anderson, K.P. Baetcke,
J.L. Hoffmann, M.S. Morrow, DJ. Rodier,
I.E. Schaeffer, L.W. Touart, M.G. Zeeman,
Y.M. Patel(1998). Environmental
endocrine disruption:  an effects assessment
and analysis. Environ. Health Perspectives
106 (Supplement l):ll-56.
Healthy People 2000

    The cooperating agencies are
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 on endocrine
disruption is related to the priority area
of environmental health.  Potential
applicants may obtain a copy of
"Healthy People 2000" (full report:
stock number 017-001-00474-0 or
summary report: stock number 017-
001-00473-1) through the Superinten-
dent of Documents, Government
Printing Office, Washington, DC
20402-9325 (telephone: 202-512-
1800).

Eligibility Requirements
    Academic and not-for-profit
organizations located in the U.S., and
state or local governments, are eligible
under all existing authorizations. Profit-
making firms are not eligible to receive
grants under this program. Federal
Laboratories, national laboratories
funded by federal agencies (FFRDCs),
and federal employees are not eligible
to apply to this program.  Federal
employees are encouraged to cooperate
or collaborate with academic and not-
for-profit organizations within the
limits imposed by applicable legislation
and regulations.  Potential applicants
who are uncertain of their eligibility
should contact Dr. Robert E. Menzer
(listed under "Contacts").

Standard Instructions for

Submitting an Application

    This section contains a set of
special instructions related to how
applicants should apply for a research
grant under this solicitation. Proposed
projects must be .for research designed
to advance the state of knowledge in
the research areas described in this
solicitation.
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                                                                            United Stales Environmental Protection Agency
                                                                                    Office of Research and Development
                                                                                    Science To Achieve Results (STAR)
Sorting Codes
The Application
    In order to facilitate proper
assignment and review of applications,
each applicant is asked to identify the
topic area in which the application is to
be considered. At various places within
the application, applicants will be asked
to identify this topic area by using the
Sorting Code. The Sorting Code for
this solicitation is

    99-NCERQA-D1 for Population-
level effects ofEDCs in wildlife

    99-NCERQA-D2 for  Effects of
exposure to EDCs during development
on human health

    The Sorting Code must be placed
at the top of the abstract (as shown in
the abstract format), in Box 10 of
Standard Form 424 (as described in  the
section on SF424), and should also be
included in the address on the package
that is sent to EPA (see the section on
how to apply).
  U.S. EPA Headquarters Library
          Mai! code 3201
  1200 Pennsylvania Avenue NW
      Washington  DC 20460
    The initial application is made
through the submission of the materials
described below. It is essential that
the application contain all  the
information requested and be
submitted in the formats described.
If it is not, the application may be
rejected on administrative grounds.  If
an application is considered  for award,
(i.e., after external peer review and
internal review) additional forms and
other information will be requested by
the Project Officer of the funding
agency. The application should not
be bound or stapled in any way. The
Application contains the following:

A.  Standard Form 424: The appli-
    cant must complete Standard Form
    424 (see attached form and
    instructions).  This form will act as
    a cover sheet for the application
    and should be its first page.
    Instructions for completion of the
    SF424 are included with the form.
    The form must contain the original
    signature of an authorized repre-
    sentative of the applying institu-
    tion. Please note that both the
    Principal Investigator and an
    administrative contact should be
    identified in Section 5 of the
    SF424.

B.  Key Contacts: The applicant
    must complete the Key  Contacts
    Form (attached) as the second page
    of the submitted application.

C.  Abstract: The abstract is a very
    important document.  Prior to
    attending the peer review panel
    meetings, some of the panelists
    may read only the abstract.
    Therefore, it is critical that the
    abstract accurately describe the
    research being proposed and
    convey all the essential  elements of
    the research. Also, in the event of
    an award, the abstracts will form
    the basis  for an Annual  Report of
    awards made under this program.
    The abstract should include the
    following information, as indicated
    in the example format provided:
    1.  Sorting Code: Use the code
    99-NCERQA-D1 or99-NCERQA-
    D2.
    2.  Title: Use the exact title as it
    appears in the rest of the applica-
    tion.
    3.  Investigators: List the names
    and affiliations of each investigator
    who will significantly contribute to
    the project. Start with the Princi-
    pal Investigator.
    4.  Project Summary: This
    should summarize: (a) the objec-
    tives of the study (including any
    hypotheses that will be tested), (b)
    the experimental approach to be
    used (which should give an
    accurate description of the project
    as described in the proposal), (c)
    the expected results of the project
    and how it addresses the research
    needs identified in the solicitation,
    and (d) the estimated improve-
    ment in risk assessment or risk
    management that will result from
    successful completion of the work
    proposed.
    5.  Supplemental Keywords: A
    list of suggested keywords  is
    provided for your use. Do  not
    duplicate terms already used in the
    text of the abstract.

D.  Project Description: This
    description must not exceed fifteen
    (15) consecutively numbered
    (center bottom), 8.5x11-inch pages
    of single-spaced standard 12-point
    type with 1-inch margins. The
    description must provide the
    following information:

    1.  Objectives: List the objec-
    tives of the proposed research and
    the hypotheses being tested during
    the project and briefly state why
    the intended research is important.
    This section can also include any
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    background or introductory
    information that would help
    explain the objectives of the study
    (one to two pages recommended).

    2.  Approach: Outline the
    methods, approaches, and lecn-
    niques that you intend to employ in
    meeting the objective stateH above
    (five to 1U pages recommended).

    3.  Expected Results or Ben-
    efits: Describe the results you
    expect to achieve during the
    project, the benefits of success as
    they relate to the topic under which
    the proposal was submitted, and
    the potential recipients of these
    benefits.  This section should also
    discuss the utility of the research
    project proposed for addressing the
    environmental problems described
    in the solicitation (one to two
    pages recommended).

    4.  General Project Informa-
    tion: Discuss other information
    relevant to the potential success of
    the project. This should  include
    facilities, personnel, project
    schedules, proposed management,
    interactions with other institutions,
    etc. (one to two pages recom-
    mended).

    5.  Important Attachments:
    Appendices and/or other informa-
    tion may be included but must
    remain within the 15-page limit.
    References cited are in addition to
    the 15  pages.

E.  Resumes: The resumes of all
    principal investigators and
    important co-workers should be
    presented.  Resumes must not
    exceed two consecutively num-
    bered (bottom center), 8.5x11-inch
    pages of single-spaced standard
    12-point type with 1-inch margins
    for each individual.

F.  Current and Pending Support:
    The applicant must identify any
    current and pending financial
    resources that are intended to
    support research related to that
    included in the proposal or which
    would consume the time of
    principal investigators.  This
    should be done by completing the
    appropriate form (see attachment)
    for each investigator and other
    senior personnel involved in the
    proposal. Failure to provide this
    information may delay consider-
    ation of your proposal.

C.  Budget: The applicant must
    present a detailed, itemized budget
    for the entire project. This budget
    must be in the format provided in
    the example (see attachment) and
    not exceed two consecutively
    numbered (bottom  center), 8.5x 11-
    inch pages with 1-inch margins.
    Please note that institutional cost
    sharing is not required and,
    therefore, does not  have to be
    included in the budget table. If
    desired, a brief statement concern-
    ing cost sharing can be added to
    the budget justification.

H.   Budget Justification: This
    section should describe the basis
    for calculating the personnel,
    fringe benefits, travel, equipment,
    supplies, contractual support,  and
    other costs identified in the
    itemized budget and explain the
    basis for their calculation (special
    attention should be given to
    explaining the travel, equipment,
    and other categories).  This should
    also include an explanation of how
    the indirect costs were calculated.
    This justification should not
    exceed two consecutively num-
    bered (bottom center), 8.5x11-inch
    pages of single-spaced standard
    12-point type with  1-inch margins.

I.   Quality Assurance Narrative
    Statement: For any project
    involving data collection or
    processing, conducting surveys,
    environmental measurements, and/
    or modeling, provide a statement
on how quality processes or
products will be assured. This
statement should not exceed two
consecutively numbered, 8.5x 11-
inch pages of single-spaced
standard 12-point type with 1-inch
margins. This is in addition to the
15 pages permitted for the Project
Description. The Quality Assur-
ance Narrative Statement should,
for each item listed below, either
present the required information or
provide a justification as to why
the item does not apply to the
proposed research. For awards
that involve environmentally
related measurements or data
generation, a quality system that
complies with the requirements of
ANSI/ASQC E4, "Specifications
and Guidelines for Quality
Systems for Environmental Data
Collection and Environmental
Technology Programs," must be in
place.

1.   The activities to be performed
or hypothesis to be tested (refer-
ence may be made to the specific
page and paragraph number in the
application where this information
may be found); criteria for
determining the acceptability of
data quality in terms of precision,
accuracy, representativeness,
completeness, comparability.

2.   The study design including
sample type and location require-
ments and any statistical analyses
that were used to estimate the
types and numbers of samples
required for physical samples or
similar information for studies
using survey and interview
techniques.

3.   The procedures for the
handling and custody of samples,
including sample identification,
preservation, transportation, and
storage.

4.   The methods that will be used
to analyze samples or data col-
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                                                                              United States Environmental Protection Agency
                                                                                      Office of Research and Development
                                                                                       Science To Achieve Results (STAR)
    lected, including a description of
    the sampling and/or analytical
    instruments required.

    5.  The procedures that will be
    used in the calibration and perfor-
    mance evaluation of the sampling
    and analytical methods used during
    the project.

    6.  The procedures for data
    reduction and reporting, including
    a description of statistical analyses
    to be used and of any computer
    models to be designed or utilized
    with associated verification and
    validation techniques.

    7.  The intended use of the data as
    they relate  to the study objectives
    or hypotheses.

    8.  The quantitative and or
    qualitative  procedures that will be
    used to evaluate the success of the
    project.

    9.  Any plans for peer or other
    reviews of the study design or
    analytical methods prior to data
    collection.

    ANSI/ASQC  E4, "Specifications and
Guidelines for Quality Systems for Environmen-
tal Data Collection  and Environmental Technol-
ogy Programs" is available for purchase from the
American Society for Quality Control, phone 1-
800-248-1946, item T55. Only in exceptional
circumstances should it be necessary to consult
this document.

J.  Postcard: The Applicant must
    include with the application a self-
    addressed,  stamped 3x5-inch post
    card.  This  will be  used to ac-
    knowledge receipt of the applica-
    tion and to transmit other impor-
    tant information to the  applicant.
How to Apply
    The application and peer review
processes will be managed by EPA for
the cooperating agencies. The original
and ten (10) copies of the fully devel-
oped application and five (5) additional
copies of the abstract (15 in all), must
be received by EPA no later than 4:00
P.M. EDT on the closing date,
September 16,1998.

    The application and abstract must
be prepared in accordance with these
instructions. Informal, incomplete, or
unsigned proposals will not be consid-
ered.  The application should not be
bound or stapled in any way. The
original and copies of the application
should be secured with paper or binder
clips. Completed applications should be
sent via regular mail to:

    U.S. Environmental Protection Agency
    Peer Review Division (8703R)
        Sorting Code: 99-NCERQA-D1
        or 99-NCERQA-D2
    401 M Street, SW
    Washington DC 20460

For express mail or courier-delivered
applications, the following address
must be used:

    U.S. Environmental Protection Agency
    Peer Review Division  (8703R)
        Sorting Code: 99-NCERQA-D1
        or 99-NCERQA-D2
    1300 Pennsylvania Avenue, NW
    Room B-10105
    Washington, DC 20004

Phone: (202) 564-6939 (for express
mail applications)
Guidelines, Limitations, and

Additional Requirements

    If you wish to submit more than
one application, you must ensure that
the research proposed is significantly
different from that in any other that you
have submitted to this solicitation or
from any other grant you are currently
receiving from any federal government
agency.

    Projects that contain subcontracts
constituting more than 40% of the total
direct cost of the grant for each year in
which the subcontract is awarded  will
be subject to special review and may
require additional justification.

    The NIH Revitalization Act of
1993 (Section 492B of Public Law 103-
43) requires that women and members
of minority groups and their subpopula-
tions must be included in all NIH-
supported biomedical and behavioral
research projects involving human
subjects, unless a clear and compelling
rationale and justification is provided
that inclusion is inappropriate with
respect to the health of the subjects or
the purpose of the  research. This
policy supersedes and strengthens the
previous policies (Concerning the
Inclusion of Women in Study Popula-
tions, and Concerning the Inclusion of
Minorities in Study Populations),
which have been in effect since 1990.
The policy contains some provisions
that are substantially different from the
1990 policies.  Grantees, regardless of
funding source, will be expected to
adhere to this policy.

    All investigators proposing
research involving human subjects
should read the "NIH Guidelines for
Inclusion of Women and Minorities as
Subjects in Clinical Research," which
were published in the Federal Register
of March 28, 1994 (FR 59, 14508-
14513) and reprinted in the NIH Guide
for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  Investi-
                                                           National Center for Environmental Research and Quality Assurance

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gators also may obtain copies of the
policy from the NIH program staff
listed under CONTACTS.  Program
staff may also provide further discus-
sion concerning the policy.  Compli-
ance with the above policies will be
evaluated during the review process.

    This program is described in the
Catalog of Federal Domestic Assistance
No. 93.113, 93.114, and 93.115.
NIEHS 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 74. EPA awards
are made under authority of 40 CFR 30
and 40. This program is not subject to
the intergovernmental review require-
ments of executive order 12372 or
Health Systems Agency Review.

    The sponsoring agencies strongly
encourage 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 develop-
ment services are provided to children.

    Researchers will be expected to
budget for and participate in an annual
All-Investigators Meeting with federal
agency scientists and other grantees to
report on research activities and to
discuss issues of mutual interest.
Review and Selection

    All grant applications are initially
reviewed to determine their legal and
administrative acceptability. Accept-
able applications are then reviewed by
an appropriate technical peer review
group. This review is designed to
evaluate each proposal according to its
scientific merit. In general, the review
group will be composed of scientists
and engineers who are experts in their
respective disciplines and are proficient
in the technical areas they  are review-
ing. The reviewers use the following
criteria to help them in their reviews:

    1. The originality and creativity of
    the proposed research, the appro-
    priateness and adequacy of the
    research methods proposed, and
    the appropriateness and adequacy
    of the Quality Assurance Narrative
    Statement. Is the research ap-
    proach practical and technically
    defensible, and can the project be
    performed within the proposed
    time period?  Will the research
    contribute to scientific knowledge
    in the topic area of the solicitation?
    Is the proposal well-prepared with
    supportive information that is self-
    explanatory and understandable?

    2. The qualifications of the
    principal investigator  and other
    key personnel, including research
    training, demonstrated knowledge
    of pertinent literature, experience,
    and publication records. Will all
    key personnel contribute a signifi-
    cant time commitment to the
    project?

    3. The scientific environment,
    including the availability and/or
    adequacy of the facilities and
    equipment proposed for the
    project. Do the proposed experi-
    ments take advantage  of unique
    features of the scientific environ-
    ment or employ usefu! collabora-
    tive arrangements?  Is there
    evidence of institutional support?
    4. The responsiveness of the
    proposal to the research needs
    identified for the topic area. Does
    the proposal adequately address
    the objectives specified for this
    topic area?

    5. Although budget information is
    not used by the reviewers as the
    basis for their evaluation of
    scientific merit, the reviewers are
    asked to provide their view on the
    appropriateness and/or adequacy of
    the proposed budget and its
    implications for the potential
    success of the proposed research.
    Input on requested equipment is of
    particular interest.

    6. For projects involving human
    subjects, the adequacy of plans to
    include both genders and minori-
    ties and their subgroups as
    appropriate for the scientific goals
    of the research. Plans for recruit-
    ment and retention of subjects will
    also  be evaluated.

    Applications that are of sufficient
scientific quality based on the peer
review are subjected to a programmatic
review within each participating federal
agency, the object being to assure a
balanced research portfolio under this
program. Scientists from the participat-
ing agencies review these applications
in relation to program priorities and
their complementarity to the ongoing
research within each federal agency.
Applications that are within the
program  areas of NIEHS will be
reviewed by the National Advisory
Environmental Health Sciences
Council in accordance with  PHS policy.
Funding recommendations are devel-
oped by each participating federal
agency.

    Funding decisions are coordinated
through the EDWG, with the final
funding decision being the sole
responsibility of the funding agency.
Grants are selected on the basis of
technical merit, relevancy to the
1999 Grants for Research

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                                                                            United States Environmental Protection Agency
                                                                                    Office of Research and Development
                                                                                    Science To Achieve Results (STAR)
research priorities outlined, program
balance, and budget. A summary
statement of the scientific review by the
peer panel will be provided to each
applicant.

    Applications selected for funding
will require additional certifications,
possibly a revised budget, and re-
sponses to any comments or sugges-
tions offered by the peer reviewers.
Project officers from each of the
funding agencies will contact principal
investigators to obtain these materials.

Proprietary Information

    By submitting an application in
response to this solicitation, the
applicant grants EPA and other partici-
pating agencies permission to share  the
application with technical reviewers
both within and outside of their
respective organizations. Applications
containing proprietary or other types of
confidential information will be
returned to the applicant without
review.

Funding Mechanism

    The funding mechanism for all
awards issued under this solicitation
will consist of grants from the federal
agencies involved in this announcement
and depends on the availability  of
funds. In accordance with Public Law
95-224; the primary purpose of a grant
is to accomplish a public purpose of
support or stimulation authorized by
Federal statute rather than acquisition
for the direct benefit of the govern-
ment. Policies that govern grant award
programs of each agency will prevail
for respective sources of support.
Responsibility for the planning,
direction, and execution of the pro-
posed project will be solely that of the
applicant.
Contacts

    Additional general information on
the grants program, forms used for
applications, etc., may be obtained by
exploring the Web at
    .
The participating agencies do not
intend to make mass-mailings of this
announcement.  Information may also
be obtained by contacting:

U.S. Environmental Protection
Agency
National Center for Environmental
Research and Quality Assurance
(8703R)
401 M Street, SW
Washington DC 20460

    Phone: 1-800-490-9194

    In addition, a contact person has
been identified from each participating
Agency or Department for additional
information on this topic. These
individuals will usually be either the
Program Manager or the Project
Officers for the grants funded under
this announcement. They will respond
to inquires regarding the solicitation
and can respond to any technical
questions related to your application

Endocrine Disrupters

    EPA Contacts

    •   David Reese
        202-564-6919
        reese.david@epamail.epa.gov

    •   Robert Menzer
        202-564-6849
        menzer.robert@epamail.epa.gov

    NIEHS Contacts

    •   Owen Collman
        919-541-4980
        collman @ niehs.nih.gov
•   Jerry Heindel
    919-541-0781
    heindel _j @ niehs.nih.gov

*   David Mineo (for fiscal
    matters)
    919-541-1373
    mineoฎ niehs.nih.gov

DOI Contact

•   Michael Mac
    703-648-4073
    michael_mac @ usgs.gov

NOAA Contact

•   Teri Rowles
    301-713-2322
    teri.rowles@noaa.gov
                                                          National Center for Environmental Research and Quality Assurance

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  APPLICATION FOR
  FEDERAL ASSISTANCE
                                                  2. DATE SUBMITTED
                                                                                                           OMB Approval No. 0348-0043
                                                         Applicant Identifier
  1. TYPE OF SUBMISSION
    Application
    Q  Construction

    D  Non-Construction
                                                  3. DATE RECEIVED BY STATE
Preapplication
O Construction

D Non-Construction
                                                         State Applicant Identifier
4. DATE RECEIVED BY FEDERAL AGENCY
                                    Federal Identifier
  5. APPLICANT INFORMATION     IS THIS PROPOSAL BEING SUBMITTED TO ANOTHER FEDERAL AGENCY?  D YES   D NO  IF Y6S, LIST ACRONYM(S)
  Legal Name:
                                       Organizational Unit:
  Address  (give city, county, state, and zip code):
                                       Name and telephone and E-mail number of the person to be contacted on matters
                                       involving this application (give area code;
                                          PI:
                                                                      ADMIN. CONTACT:
  ซ. EMPLOYER IDENTIFICATION NUMBER (EtN):
                                       7. TYPE OF APPLICANT: (enter appropriate totter In box)
  8. TYPE OF APPLICATION:

                       a  New
        Continuation     D  Revision
  If Revision, enter appropriate letters) in box(es): |	|     |  I
   A. Increase Award       8. Decrease Award   C. Increase Duration
   D. Decrease Duration     Other (specify):
                    A.  State
                    B.  County
                    C.  Municipal
                    D.  Township
                    E.  Interstate
                    F.  Intermunicipal
                    G,  Special District
H.  Independent School Dist.
I.   State Controlled Institution of Higher Learning
J.   Private University
K.  Indian Tribe
L.  Individual
M.  Profit Organization
N.  Other (Specify)	
                                       9. NAME OF FEDERAL AGENCY:
                                                                          U.S. Environmental Protection Agency - ORD - NCERQA
  10. CATALOG OF FEDERAL DOMESTIC
     ASSISTANCE NUMBER:

    TITLE: 99-NCERQA-	
          6     6
                                                                    11. DESCRIPTIVE TITLE OF APPLICANTS PROJECT-.
  12. AREAS AFFECTED BY PROJECT fcrt/es, counties, itaftu. etc.):
  13. PROPOSED PROJECT:
                                   14. CONGRESSIONAL DISTRICTS OF:
     Start Date
                    Ending Date
       a. Applicant
                                   b.  Project
  1S. ESTIMATED TOTAL PROJECT FUNDING:
  a. Federal
  b. Applicant
  c. State
  d. Local
  e. Other
                                                 .00
                    .00


                    .00


                    .00


                    .00
                         16. IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER 12372 PROCESS?
                            a.  YES. THIS PREAPPLICATION/APPLICATION WAS MADE AVAILABLE TO THE
                                    STATE EXECUTIVE ORDER 12372 PROCESS FOR REVIEW ON:
                                                                DATE
       b. NO.  D  PROGRAM IS NOT COVERED BY E.0.12372


              D  OR PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW
  f.  Program Income
  g. TOTAL
                    .00

                    .00
    17. IS THE APPLICANT DELINQUENT ON ANY FEDERAL DEBT?


       Q  Yes     If 'Yes,' attach an explanation.
                                                                                                          D  No
  18. TO THE BEST OF MY KNOWLEDGE AND BELIEF, ALL DATA IN THIS APPLICATION/PREAPPUCATION ARE TRUE AND CORRECT. THE DOCUMENT HAS BEEN DULY
 a. Typed Name of Authorized Representative
                                      b. Title
                                                               c. Telephone number
 d. Signature of Authorized Representative
                                                                                    e. Date Signed
^ravious Editions Not Usable
Prescribed by OMB Circular A-102
                                                                                    StandardFor 424  (REV 4-88)
                                                 Authorized for Local Reproduction

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                                   INSTRUCTIONS FOR THE SF 424
This is a standard form used by applicants as a required facesheet for preapplications and applications submitted for Federal
Assistance. It will be used by Federal agencies to obtain applicant certification that States which have established a review
and comment procedure in response to Executive Order 12372 and have selected the program to be included in their process,
have been given an opportunity to review the applicant's submission.
Item:
                         Entry:
Item:
Entry:
1.    Self-explanatory.                                        12.

2.    Date application submitted to Federal agency (or
      State, if applicable) & applicant's control number
      (if applicable).
3.    State use only (if applicable).

4.    If this application  is  to continue or  revise an
      existing  award, enter present Federal  identifier
      number.  If for a new project, leave blank.

5.    Legal  name  of  applicant,   name   of primary
      organizational  unit  which  will  undertake  the
      assistance  activity,  complete  address  of  the
      applicant, and name and telephone number of the
      person  to  contact  on  matters  related to  this
      application.

6.    Enter Employer Identification Number (BIN) as
      assigned by the Internal Revenue Service.
7.

8.
                                                                   List only the largest political entities affected (e.g.,
                                                                   State, counties, cities.)
                                                             13.    Self-explanatory.
                                                             14.
                                                             15.
      Enter the appropriate letter in the space provided.

      Check  appropriate  box  and  enter  appropriate
      letters) in the space(s) provided:                         j 7

      — "New" means a new assistance award.

      — "Continuation"  means  an extension  for an
         additional funding/budget period for a  project
         with a projected completion date.                      j g

      — "Revision" means any change in the Federal
         Government's financial obligation or contingent
         liability from an existing obligation.
9.     Name of Federal agency from which assistance is
       being requested with this application.

10.    Use the Catalog of Federal Domestic Assistance
       number and title  of the  program  under which
       assistance is required.

11.    Enter a brief descriptive title of the project.  If me
       than one program is involved, you should append
       an explanation on a separate sheet.  If appropriate
       (e.g., construction or real property projects), attach
       a  map   showing  project   location.       For
       preapplications,  use a separate sheet to provide a
       summary description of this project.
      List the applicant's Congressional Districts and
      any Districts) affected by the program or project.

      Amount requested or to be contributed during the
      first funding/budget period by each  contributor.
      Value of in-kind contributions should be included
      on appropriate lines as applicable. If the action
      will result in a dollar change to an existing award,
      include only the  amount of the change.   For
      decreases, enclose the amounts in parentheses.  If
      both basic and supplemental amounts are included,
      show breakdown  on  an  attached sheet.   For
      multiple program funding, use totals and  show
      breakdown using same categories as item IS.

      Applicants should contact the State Single Point of
      Contact (SPOC) for Federal Executive Order 12372
      to determine whether the application is subject to
      the State intergovernmental review process.

      This   question   applies   to   the   applicant
      organization, not the person who signs  as the
      authorized representative.   Categories  of  debt
      include delinquent  audit allowances, loans and
      taxes.

      To be signed by the authorized representative  of
      the applicant.  A copy of the  governing body's
      authorization for you to sign this application  as
      official  representative must  be  on  file  in the
      applicant's office. (Certain Federal agencies may
      require that this authorization be submitted as part
      of the application.
                                                                                          SF424  (REV 4-88) Back

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KEY CONTACTS  FORM

     Authorized Representative: Original awards and amendments will be sent
     to this individual for review and acceptance, unless otherwise indicated.
        Name:

        Title:
        Complete Address:
        Phone Number:
     Payee: Individual authorized to accept payments.
        Name: 	
        Title:	
        Complete Address:
        Phone Number:
     Administrative Contact: Individual from Sponsored Programs Office to
     contact concerning administrative matters (i.e., indirect cost rate computation,
     rebudgeting requests etc.)
        Name: ___	
        Title:
        Complete Address:
        Phone Number:
        FAX Number:
        E-Mail Number:
     Principal Investigator: Individual responsible for the technical completion of
     the proposed work.
        Name: 	
        Title:
        Complete Address:
        Phone Number:

        FAX Number:  _
        E-Mail Number:
NCERQA Form 1 (9/96) For use with EPA STAR Grant Applications

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                    EPA STAR Grant Abstract (Example Format)
  Sorting Code:  99-NCERQA-XX (use the correct code that corresponds to the appropriate RFA topic)
  Title: Use the exact title as it appears in the rest of the application.
  Investigators:  List the names and affiliations of each investigator who will significantly contribute to the
                  project. Start with the Principal Investigator.
  Institution:  Name of university or other applicant.
  Project Period:  October 1, 1999-September 30, 2001, for example.
  Research Category:  Enter your research topic name.

  Project Summary:
          Objectives/Hypothesis: include a short statement on the context of the proposed research in
          relation to other environmental research in the particular area of work
          Approach: outline the methods, approaches, and techniques you intend to employ in meeting the
          objectives
          Expected Results:
          including a brief description of the
          Improvements in Risk Assessment or Risk Management
          that will be realized if the expected results are achieved
   Supplemental Keywords: see attached suggestions. Do not duplicate terms used in the text of the abstract.
NCERQA Form 2 (7/97) For use with EPA STAR Gram Applications

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                           SUGGESTED KEYWORDS
     Media: (media, air, ambient air, atmosphere, ozone, water, drinking water, watersheds, groundwater,
land, soil, sediments, acid deposition, global climate, indoor air, mobile sources, CASTNET, strato-
spheric ozone, tropospheric, marine, estuary, precipitation, leachate, adsorption, absorption, chemical
transport)

     Risk Assessment: (exposure, risk, risk assessment, effects, health effects, ecological effects, human
health, bioavailability, metabolism, vulnerability, sensitive populations, dose-response, carcinogen,
teratogen, mutagen, animal, mammalian, organism, cellular, population,  enzymes, infants, children,
elderly, stressor, age, race, diet, metabolism, genetic pre-disposition, genetic polymorphisms, sex, ethnic
groups, susceptibility, cumulative effects)

     Chemicals, toxics, toxic substances: (chemicals, toxics, particulates, ODS, VOC, CFC, PAH, PNA,
PCB, dioxin, metals, heavy metals, solvents, oxidants, nitrogen oxides, sulfates, organics, DNAPL,
NAPL, pathogens, viruses, bacteria, acid rain, effluent, discharge, dissolved solids, intermediates)

     Ecosystem Protection:  (ecosystem, indicators, restoration, regionalization, scaling, terrestrial,
aquatic, habitat, integrated assessment)

     Risk Management: pollution prevention (green chemistry, life-cycle analysis, alternatives, sustain-
able development, clean technologies, innovative technology, renewable, waste reduction, waste minimi-
zation, environmentally conscious manufacturing); treatment (remediation, bioremediation, cleanup,
incineration, disinfection, oxidation, restoration)

     Public Policy: (public policy, decision making, community-based, cost-benefit, conjoint analysis,
observation, non-market valuation, contingent valuation, survey, psychological, preferences, public good,
Bayesian, socio-economic, willingness-to-pay, compensation, conservation, environmental assets, socio-
logical)

     Scientific Disciplines: (environmental chemistry, marine science, biology, physics, engineering,
social science, ecology, hydrology, geology, histology, epidemiology, genetics, pathology, mathematics,
limnology, entomology, zoology)

     Methods/Techniques: (EMAP, modeling, monitoring, analytical, surveys, measurement methods,
general circulation models, climate models, satellite, landsat, remote sensing)

     Geographic Areas: (Northeast, central, Northwest, Chesapeake Bay, Great Lakes, Midwest, Mid-
Atlantic, states: {use both full name and two letter abbreviation},  EPA Regions 1  through 10)

     Sectors: (agriculture, business, transportation, industry {petroleum, electronics, printing,
etc}:{identify 4 digit SIC codes}, service industry, food processing, etc)
NCERQA Form 3 (8/97)  For use with EPA STAR Grant Applications

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                                   Current and Pending Support
         Tha following information should be provided for each investigator and other senior personnel. Failure to provide this information may delay consideration of this proposal.
Investigator:
                                               Other agencies (including NSF) to which this proposal has been/will be submitted.
Support:      D Current
Project/Proposal Title:
D Pending    D Submission Planned in Near Future  D Transfer of Support
Source of Support:
Total Award Amount: $
Location of Project:
Person-Months Per Year Committed to the Project
              Total Award Period Covered:
                            Cal:
Acad:
Sumr:
Support:      D Current     D  Pending    D Submission planned in Near Future   D Transfer of Support
Project/Proposal Title:
Source of Support:
Total Award Amount: $
Location of Project:
Person-Months Per Year Committed to the Project.
              Total Award Period Covered:
                            Cal:
Acad:
Sumr:
Support:      D Current
Project/Proposal Title:
D Pending    D Submission Planned in Near Future  D Transfer of Support
Source of Support:
Total Award Amount: $
Location of Project:
Person-Months Per Year Committed to the Project.
              Total Award Period Covered:
                            Cal:
Acad:
Sumr:
Support:      D Current     D  Pending    D Submission Planned in Near Future  D Transfer of Support
Project/Proposal Title:
Source of Support:
Total Award Amount: $
Location of Project:
Person-Months Per Year Committed to the Project.
              Total Award Period Covered:
                            Cal:
Acad:
Sumr:
Support:      D Current     D Pending    D Submission Planned in Near Future   D Transfer of Support
Project/Proposal Title:
Source of Support:
Total Award Amount: $
Location of Project:
Person-Months Per Year Committed to the Project.
              Total Award Period Covered:
                           Cal:
Acad:
Sumr:
If this project has previously been funded by another agency, please list and furnish information for immediately preceding funding period.
NSF Form 1239 (7/95) For use with EPA STAR Grant Applications
                                           USE ADDITIONAL SHEETS AS NECESSARY

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Itemized Budget for EPA STAR Grant Applications (Example Format)
CATEGORIES
a. Personnel
Principal Investigator
Co-Pi
Research Scientists
Postdoctoral Scientists
Other Personnel
TOTAL PERSONNEL COSTS
b. Fringe Benefits
%of

c. Travel
Tripl
Tripl
Tripl
...etc.
1 TOTAL TRAVEL COSTS
d. Equipment
Item 1
Item 2
Item 3
...etc.
TOTAL EQUIPMENT COSTS
e. Supplies
Item 1
Item 2
Item 3
...etc.
TOTAL SUPPLY COSTS
f. Contracts
i
2
3
...etc.
TOTAL CONTRACTUAL COSTS
g. Other
Item 1
Item 2
Item 3
...etc.
TOTAL OTHER COSTS
• h. TOTAL DIRECT COSTS
1 (sum of a-g)
1 i. Indirect Costs/Charges
• % of (base}

1 j. TOTAL PROJECT COSTS
I (sum of h & i)
• k. TOTAL REQUESTED
• FROM EPA
YEAR ONE



















YEAR TWO



















YEAR THREE



















TOTAL PROJECT



















NCERQA Form 4 (4ป7) For EPA STAR Gram Applications
                        DO NOT USE THIS FORM -- Example Only --

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U.S. EPA Headquarters Library
      Mail code 3201
1200 Pennsylvania Avenue NW
   Washington DC 20460

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-------