&EPA
United States
Environmental Protection
Agency
EPA/600/9-91/048
January 1992
Announcement
Request for Applications
HLT-01-92
Biomarkers of Toxic Pollutants in
Human Health
Background
The U.S. Environmental Protection Agency (EPA) is re-
sponsible for protecting public health from the adverse effects
of exposures to environmental agents. In developing regula-
tions to protect public health, EPA currently relies on quanti-
tative assessments of health risks associated with different
pollutants. However, the current lack of understanding about
the underlying biological, chemical, and physical processes
that constitute exposure and its effects also limits EPA's
ability to accurately assess exposure.
The Office of Research and Development (ORD), the re-
search arm of EPA, has published a research strategy docu-
ment entitled "ORD Health Biomarkers Program" (EPA/600/
9-91/009, April 1991). This document contains research plans
that include development of biomarkers, validation of mark-
ers, monitoring of populations, and development of quantita-
tive risk assessment methods. Consistent with this plan, ORD's
Office of Exploratory Research issues this Request for Appli-
cations (RFA) to address only the development of biomarkers
for exposure and effects related to adverse human health
conditions.
Scope
The purpose of this RFA is to implement Phase One of
ORD's research strategy by supporting research on the identi-
fication and development of new and potentially useful bio-
logical markers of exposure and effects applicable to human
health. The primary criteria for human biomarkers are to
provide practical tests, and a higher priority will be given to
markers which are:
• measurable in human breath, fluids, or tissues
• measurable using minimal or non-invasive techniques
• interpretable in terms of human susceptibility to exposure
or effect
• indicative of a significant and adverse health effect rather
than minor or potential conditions.
The areas of consideration for this RFA include only neuro-
toxicology, reproductive and developmental toxicology, im-
munotoxicology, pulmonary toxicology, organ toxicology,
and genetic (non-cancer) toxicology. The biomarkers may
occur as behavioral endpoints, or at the organ, cellular, or
molecular levels. Although the use of whole organisms may
be necessary in some instances, studies involving cellular,
biochemical, and genetic processes are particularly encour-
aged.
Exclusions and Limitations
This RFA particularly excludes cancer research, epidemiol-
ogy, and clinical studies. These topics are likely to be the
subjects of future RFAs. Although priority pollutants (Clean
Water Act) were mentioned in the pre-announcement, pollut-
ants related to the Clean Air Act, Toxic Substances Control
Act, and the Federal Insecticide, Fungicide, and Rodenticide
Act are all acceptable under this RFA announcement.
Mechanisms of Support
Assistance under this RFA will be provided by a research
grant administered through EPA's research grants program.
The applicant will be responsible for planning, directing, and
executing the proposed research. Support under this program
is limited to nonprofit research organizations and educational
institutions.
Approximately $1.6 million will be available from fiscal
1992 funds, and it is estimated that about 10 to 12 projects will
be supported. Each project will be supported for a period of up
to 3 years at approximately $100,000 per year. This RFA is
for a double competition with closing dates of April 15,1992,
and October 15, 1992.
The Application
Each application will consist of the APPLICATION FOR
FEDERAL ASSISTANCE FORM (Standard Forms 424
and 424A) and separate sheets providing the budget break-
down for each year of the project, curriculum vitae for the
principal investigators, abstract of the proposed project, and a
project narrative. All certification (drug-free workplace, etc.)
forms must be signed and included with the application.
Application forms, instructions, and other pertinent informa-
tion are contained in the federal grant application kit obtain-
able from:
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Research Grants Staff (RD-675)
U.S. Environmental Protection Agency
401M Street, SW
Washington, DC 20460
Special Instructions
1. The project narrative section of the application must not
exceed twenty-five 8 1/2 x 11 inch, consecutively num-
bered pages of standard type (10 characters per inch),
including tables, graphs, and figures. Attachments, appen-
dices, and reference lists for the narrative section may be
included but come under the 25-page limitation. The SF-
424 and other forms, itemized budget, resumes, and the
abstract are not included in the 25-page limitation.
2. Biographical sketches or resumes must not exceed two
pages for each principal investigator and should focus on
education, position held, and most recent or related publi-
cation. _*_.._
3. Project periods will be for a maximum of three years.
4. Applications in response to this RFA must be identified by
printing "RFA HLT-01-92" in Item 10 on the face page of
Form 424 or in Item 3 of the old Form 5700-12. The
absence of the above identifier from an application ab-
solves EPA of any responsibility if it is not reviewed along
with the other applications responding to the RFA.
Application Review
All applications will be reviewed at a single meeting, after
the closing date, by a scientific peer review panel that will
evaluate and rank each proposal according to its scientific
merit as a basis for recommending Agency approval. The
panel will consider:
• the quality of research plan including theoretical or experi-
mental design, originality, and creativity
• the qualifications of the research team
• the availability and adequacy of facilities and equipment
• the appropriateness of the proposed budget.
Application Submission
To be considered, the original and eight copies of the
application must be received no later than the close of busi-
ness on the respective closing dates. The applications must be
sent to:
Grants Operations Branch (PM-216F)
Grants Administration_Division
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For overnight express mail, the address is:
Grants Operations Branch (202)260-9266
Grants Administration Division
U.S. Environmental Protection Agency
499 South Capital Street, SW
Washington, DC 20460
Staff Contact
Questions relating to this solicitation may be directed to
Clyde Bishop on (202) 260-7473.
United States
Environmental Protection
Agency
Center for Environmental Research
Information
Cincinnati, OH 45268
BULK RATE
POSTAGE & FEES PAID
EPA PERMIT NO. G-35
Official Business
Penalty for Private Use $300
EPA/600/9-91/048
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