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.
1999 Grants for Research
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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
-------
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
-------
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
-------
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
-------
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
-------
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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