Subject: RFA ES-9l-02 from 3/l5/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 14 Mar 91 13:34 EST

Hi Paul,
   This is the last for today's NIH Guide.  Please post this one to the
NIH Listserver as: RFAES-91-02.91-315
   Thanks for all you help.  Have a nice evening.
                                                 Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA ES9102 ES-91-02 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
SUPERFUND HAZARDOUS SUBSTANCES
BASIC RESEARCH PROGRAM
 
RFA:  ES-91-02
 
P.T. 34; K.W. 1007003, 1007009, 1002016, 0760003, 0755020, 0710030
 
National Institute of Environmental Health Sciences
 
Letter of Intent Receipt Date:  May 1, 1991
Application Receipt Date:  June 13, 1991
 
BACKGROUND
 
The National Institute of Environmental Health Sciences
(NIEHS) is proposing the continuation of a special Program of
basic research and training grants directed towards
understanding, assessing, and attenuating the adverse effects
on human health resulting from exposure to hazardous
substances.  Grants made under this Program will be for
coordinated, multicomponent, interdisciplinary programs, and
the objective is to establish and maintain a unique program
linking biomedical research with related engineering,
hydrogeologic, and ecologic components.
 
The Superfund Amendments and Reauthorization Act (SARA) of
1986 established a university-based program of basic research
within the
NIEHS to complement existing activities within the
Environmental Protection Agency (EPA), the principal manager
of the Superfund Program, and the Agency for Toxic Substances
and Disease Registry (ATSDR).  The EPA has specific mandated
research responsibilities in the area of hazardous substances
at hazardous waste sites; hazardous waste containment and
destruction technologies; and environmental transport and fate
of chemicals; as well as for monitoring and testing for
hazardous substances in the environment.  The ATSDR provides
site-specific, public health assessments and advisories to the
EPA and to state and local agencies, citizens, and health care
providers.  Its research mission includes applied research
into the development and evolution of toxicologic profiles of
hazardous substances found at Superfund sites and the
assurance that toxicologic testing of these substances is
conducted when necessary.  The ATSDR also supports research
into improved clinical laboratory methods to assess human
exposure in communities affected by Superfund sites as well as
the establishment of exposure registries, health surveillance
systems, and epidemiologic studies.
 
The Omnibus Budget Reduction Bill of 1990 reauthorized the
Superfund Program for an additional three years, and in so
doing reauthorized the NIEHS university-based research program
for a three-year time frame.  The SARA legislation
specifically mandates that the basic research program
administered by the NIEHS include the following:
 
o  Methods and technologies to detect hazardous substances in
the environment.
 
o  Advanced techniques for the detection, assessment, and
evaluation of the effects on human health of hazardous
substances.
 
o  Methods to assess the risks to human health presented by
hazardous substances.
 
o  Basic biological, chemical, and physical methods to reduce
the amount and toxicity of hazardous substances.
 
The NIEHS interprets this mandate to include funding for
engineering, ecological, and hydrogeological research, and
will support projects in these areas as long as they are to be
performed in conjunction with biomedically related programs.
The NIEHS hopes to encourage true collaborative efforts
among researchers in these various areas.  While emphasizing
the necessity for a strong biomedical core, it intends that
the non-biomedical projects will be an integral part of the overall
effort and not a support or core function.
 
DESCRIPTION OF THE PROGRAM
 
The NIEHS Superfund Basic Research Program (SBRP) is a
relatively new facet of the Superfund Program.  This Program
is intended to support a wide range of research to address the
broad public health concerns arising from the release of
hazardous substances and hazardous wastes into the
environment, particularly from uncontrolled, leaking waste
disposal sites.  While some of the research currently
supported by NIEHS is relevant to these concerns, the SBRP is
distinct in that its primary objective is to expand the base
of scientific knowledge, reduction in the amount and toxicity
of hazardous substances, and, ultimately, prevention of adverse
human health effects.
 
The research sponsored in the fields of ecology, engineering,
and hydrogeology (designated collectively as non-biomedical
research) integrated into a biomedical research program core
is designed to provide a broader and more detailed body of
scientific information to be used by state, local, and Federal
agencies and by private organizations and industry in making
decisions related to the management of hazardous substances.
 
Presently, the Program is funded at a level of $21.9 million (FY91)
and supports 11 programs encompassing 98 individual research
projects that address all four legislative mandates cited
above.  Many or all of these programs will be submitting
applications for the competitive renewal of their grant.
Nonetheless, this is an open competition to all institutions
meeting the criteria under this Request for Applications (RFA).
 
The SARA legislation establishing the NIEHS Superfund Program
authorized funding levels of $3 million in Fiscal Year 1987,
$10 million in 1988, $20 million in 1989, $30 million in 1990,
and $35 million in 1991.  The appropriated amounts for this
Program have been $3 million in FY87, $5.9 million in FY88,
$11.9 in FY89, $16.9 million in FY90, and $21.9 million in
FY91.  The authorized funding levels for the next three years
are $35 million per year.  These dollar amounts are budget
ceilings and actual amounts will be appropriated each year
according to the Federal budget process.  Because the funding
level of this program may vary from that authorized, actual
award levels for approved and funded applications will be
based on program balance and the availability of funds, in
addition to the scientific merit considerations of the review
process.  Therefore, it may be necessary to make programmatic
reductions in budget consistent with budgetary abatements and
in order to develop a balanced research Program overall.
 
RESEARCH OBJECTIVES AND SCOPE
 
The SBRP is intended to foster the growth of collaborative
multidisciplinary research programs aimed at understanding
health and environmental effects associated with hazardous
waste sites, and at developing improved technologies for
cleaning up these sites.  The focus of this program is the effects
on human health.
 
The Program's approach primarily emphasizes the use of
advanced basic research to improve the sensitivity and
specificity of techniques for detecting adverse effects in
humans or in ecological systems.  Among those areas of
research judged to be of interest to the SBRP are the
following:
 
o  Development of sensitive methods that would be useful for
human dosimetry following environmental exposure; e.g., the
identification of toxic chemicals in human target tissues, the
development of new biomarkers of effects.
 
o  Epidemiological studies and models to assess exposure and
effects in actual, e.g., occupational, and potentially exposed
human populations; more effective identification and
validation of new and existing biomarkers of human exposure;
studies to determine susceptibility in populations; studies to
determine inter- and intra-individual variability.
 
o  Development of better methods to detect very low
concentrations of chemicals that could pose toxic threats to
humans; establishment of dose-response relationships for
pollutants likely to be found in the environment.
 
o  Improvement of better techniques for measuring and modeling
movement and alteration of chemicals through the media
surrounding the waste dump.
 
o  Study of behavioral, neurological, and
neuroendocrinological effects of toxic chemical exposures,
especially to chronic/delayed exposures at low-levels.
 
o  Study of the reproductive effects of toxic chemicals,
especially in population-based studies and in studies on
fecundity.
 
o  Analysis and evaluation of pollutant impact on toxicity
endpoints, especially as effects on the respiratory, renal and
cardiovascular systems, on the integument (skin), and on
hearing and vision.
 
o  Analysis and studies of specific toxic agents, such as
metals, and simple and complex mixtures (sequential and
concomitant).
 
o  Ecological studies, especially those related to ecological
succession within various ecosystems and the impact toxic
substances may have on the natural course of succession;
studies related to sentinel species model development;
development of model systems to look at the effects of
chemicals on the food web; studies designed to examine the
resistance and resilience to the impact of toxics and
leachates on ecosystems; studies in ecogenetics.
 
o  Studies related to groundwater as a major route of human
exposure; development of methods to examine all forms of
contamination of unconfined and confined aquifers; the study
of remediation methods to clean up contaminated aquifers;
research into the complexities of the subsurface flow
patterns, the physical-chemical characteristics of the
chemicals that have contaminated the aquifer, and the
population characteristics of microorganisms at different
locations within the subsurface that are involved in
biochemical transformation.
 
o  Studies of various physical and chemical parameters
involved in different types of thermal processes for treatment
and degradation of wastes; methods to better determine the
health consequences of combustion by-products; the development
of real-time monitors to determine the level of emissions in
the combustion/pyrolysis process; basic methods to increase
the efficiency of combustion and pyrolysis.
 
o  Continued and increased investigation of alternatives to
thermal destruction, including biological conversion, chemical
conversion or neutralization, and new destructive techniques;
development of new and advanced techniques in
biodegradation/treatment, especially of recalcitrant
chemicals, simple and complex mixtures, and metals.
 
THE ABOVE EXAMPLES OF RESEARCH OPPORTUNITIES ARE ONLY
ILLUSTRATIVE OF THE TYPES OF RESEARCH EFFORTS THAT MAY BE
APPROPRIATE TO THIS PROGRAM AND ARE NOT MEANT TO BE
ALL-INCLUSIVE OR RESTRICTIVE.  Nonetheless, it is important
that investigators submitting an application under this
announcement propose multidisciplinary studies that are
integrated and designed to produce results in the toxic waste
area, primarily in assessing, evaluating, and attenuating the
adverse effects on human health resulting from exposure to
hazardous substances.
 
The NIEHS encourages potential applicants to use institutional
strengths and ideas to prepare applications directed towards
the broad goals of the Program as stated above.  The intent is
to create an environment in which various groups of scientists
can interact, exchange ideas, and proceed efficaciously
towards solving the complex problems of understanding,
assessing, and attenuating risks to human health from
hazardous substances.
 
Strong biomedical research is a requisite of this Program.
Therefore, a minimum of three approved biomedical projects is
required for funding.  Further, the Program expects that the
non-biomedical research will be an integral part of the overall
effort.  All applications considered for funding MUST CONTAIN
APPROVED PROJECTS IN BOTH BIOMEDICAL AND NON-BIOMEDICAL AREAS.
 
TRAINING
 
An area of importance to the overall performance of the
Program, and to the future of environmental health research,
in general, is training.  The NIEHS intends to support
graduate and advanced training in environmental and
occupational health and safety and the engineering aspects of
hazardous waste control, and in geosciences (including
hydrogeology, geologic engineering, geophysics, geochemistry,
and related fields) in the setting of the research program.
Therefore, applicants are encouraged to propose specific plans
for interdisciplinary training as part of their overall
program.  The NIEHS encourages potential applicants to develop
a structured, interdisciplinary pre-doctoral training program.
The training core should aid in the integration of the overall
research effort and should not exceed 6 percent of the total budget.
Of special interest are positions in the non-biomedical
projects to train scientists and engineers in the context of
an interdisciplinary program.  Additional training of pre- and
post-doctoral students may also be carried on outside the
structured training program.
 
In keeping with NIH efforts to train members of minority
groups in its ongoing training programs, applicants are
encouraged to consider these candidates in their recruitment
efforts.
 
Individuals in the training positions must be considered
employees of the institution and not trainees receiving
stipends as in National Research Service Award programs.
Salaries and fringe benefits consistent with institutional
policies may be requested.  Funds may also be requested for
tuition, where appropriate, and travel to one scientific
meeting per year.  Up to six percent of the total direct costs
requested may be identified for this purpose.  Additional
information and instructions may be found in the material
references under "Format for Applications."
 
ELIGIBILITY CRITERIA
 
Section 311(a)(3) of SARA limits recipients of awards to
"accredited institutions of higher education," which are
defined in the Higher Education Act, 20 USC (annotated) 3381.
However, grantees are permitted under the law, and encouraged
by the NIEHS, to subcontract as appropriate with an
organization, public or private, necessary to conduct portions
of the research.  These organizations may include generators
of hazardous wastes, persons involved in the detection,
assessment, evaluation, and treatment of hazardous substances,
owners and operators of facilities at which hazardous
substances are located, and state and local governments.
 
MECHANISM OF SUPPORT
 
The mechanism of support will be the P42 multiproject
grant-in-aid for a period not to exceed three years.  Because
the Program has a three-year authorization beginning in Fiscal
Year 1992, no commitment of funds can be made for budget
periods beginning after Fiscal Year 1994.  Administrative
adjustments may be necessary to make the funding periods
coincide with this time frame.
It is expected that approximately 40 awards will be made.
 
Grants funded under this Program must be multiproject,
interdisciplinary efforts bringing together a group of
investigators to direct discrete research projects, each of
which is related to the goals of the Superfund Basic Research
Program as outlined above.  In addition to the research
projects, applicants may request funds to support core
facilities and common support functions such as administrative
support, shared equipment, and analytical services.
 
THIS PROGRAM IS NOT INTENDED TO SUPPORT INDIVIDUAL RESEARCH
PROJECT GRANTS.  Such projects may be appropriate for support
through the existing grant programs of the NIEHS.
 
Applicants are expected to furnish their own estimates of the
time required to achieve specific objectives of the proposed
work, a schedule for completion of the work, and an outline of
the segments into which the proposed program can be logically
divided.  The applicant and co-investigators will plan,
direct, and execute the research program, but any substantial
modifications in the scope or objectives must be mutually
agreed upon by the grantee institution and the NIEHS.  Because
a variety of approaches will be responsive to this
announcement, it is anticipated that there will be a range of
costs among individual grants awarded.  Similarly, budgetary
reductions may necessitate limiting the amount of awards,
making adjustments in budget and/or effecting a modification
in the scope of proposed work, prior to funding.
 
Unless specifically stated otherwise, all policies and
requirements that govern the grants program of the Public
Health Service will prevail.
 
PROGRAM COORDINATION
 
To facilitate administration and coordination of this Program,
the NIEHS has designated a program administrator for the
Superfund Basic Research Program.  The program administrator
will coordinate plans for any special activities of mutual
interest to the NIEHS and grantees, and will make periodic
visits to grantee institutions to evaluate progress and
provide assistance in administrative considerations.
 
In addition, it is anticipated that grantees under this
Program will meet annually in conjunction with a meeting of
the Advisory Council on Hazardous Substances Research and
Training, which is a Council created under the legislation to
review related Superfund research, training, and demonstration
activities and assist in the coordination of these Federal
programs.  Applicants should budget funds for appropriate
staff to attend a three-day annual meeting in Research
Triangle Park, North Carolina, or Washington, D.C.
 
REVIEW PROCEDURES AND CRITERIA
 
Following staff review for responsiveness to the objectives of
this Program, applications will be reviewed and evaluated by a
group of predominantly non-Federal consultants with expertise
in fields relevant to the innovative research the NIEHS is
seeking to encourage.
 
Based on the large number of complex applications expected, it
is unlikely that applicants will be site-visited.  Therefore,
it is essential that all information required for an adequate
and thorough review be included in the application.
Furthermore, it is the intent of the NIEHS to
identify
non-responsive applications and
return them to the applicant.
 
Applications that are complete and responsive may be
subjected to a preliminary evaluation by a peer review group
to determine their scientific merit relative to the other
applications received in response to this RFA.  As a result of
this triage process the NIEHS will withdraw from further
consideration applications judged to be noncompetitive and
promptly notify the Principal Investigator/program director
and the official signing for the applicant organization.
Those applications judged to be competitive will be further
evaluated for scientific/technical merit.
 
The NIEHS intends to conduct an intensive review on only
the group of most promising applications,
approximately twice the number anticipated to be funded.  The
review group(s) will be convened by the NIEHS to review these
applications.  A second level of review will be performed by
the National Advisory Environmental Health Sciences Council.
 
The major factors to be considered in the evaluation of
responsive applications will include:
 
o  the scientific merit of each proposed project, including
the novelty, originality, and feasibility of the approach, and
the adequacy of the experimental design;
 
o  the technical merit and justification of each core unit;
 
o  the competence of the investigators to accomplish the
proposed research goals, their commitments, and the time they
will devote to the program;
 
o  the scope of the overall effort in relation to the
objectives of the Program to create unique interdisciplinary
programs to include not only biomedical components but also
engineering, ecological, and/or hydrogeological components;
 
o  relevance of the proposed research to problems associated
with hazardous waste sites;
 
o  the adequacy of the facilities to perform the proposed
research;
 
o  the integration of the various projects and core units into
an effective program and plans for interactions among
investigators;
 
o  the qualifications, experience, and commitment of the
Principal Investigator, the ability to devote adequate time
and effort to provide effective leadership;
 
o  the scientific and administrative structure of the program
and integration of the projects into an effective overall
effort;
 
o  the adequacy and commitment of institutional resources to
administer an integrated, collaborative program; and
 
o  the appropriateness of the budget for the proposed program.
 
Because the objective of this Program is to create unique,
interdisciplinary institutional programs addressing the
special needs of Superfund, the review process will
concentrate on the strengths and weaknesses of the overall
program proposed.  Individual projects will be reviewed in
light of their contribution to the entire research effort.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of Healthy
People 2000, a PHS-led national activity for setting priority
areas.  This Request for Applications, Superfund Hazardous
Substances Basic Research Program, is related to the priority
area of environmental health.
Potential applicants may obtain a copy of "Healthy People 2000"
(Full Report:  Stock No. 017-001-00474-0) or "Healthy People 2000"
(Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office,
Washington, D.C. 20402-9325 (telephone 202-783-3238).
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDIES
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA
clinical research grants and cooperative agreements will be
required to include minorities and women in study populations
so that research findings can be of benefit to all persons at
risk of the disease, disorder or condition under study;
special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy
is intended to apply to males and females of all ages.  If
women or minorities are excluded or inadequately represented
in clinical research, particularly in proposed
population-based studies, a clear compelling rationale should
be provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group, together
with a rationale for its choice.  In addition, general and
racial/ethnic issues should be addressed in developing a
research design and sample size appropriate for the scientific
objectives of the study.  This information should be included
in the form PHS 398 in Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups.  However, NIH recognizes that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
 
The rationale for studies on single minority population groups
should be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited to
clinical trials.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
 
If the required information is not contained within the
application, the application will be returned.
 
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies.  If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
 
All applications for clinical research submitted to NIH are
required to address these policies.  NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
 
METHOD OF APPLYING
 
Letters of Intent
 
Prospective applicants are asked to submit a brief letter of
intent that includes a descriptive title of the research
and responsible investigators, and identification of any other
participating institutions.  This letter must be received no
later than May 1, 1991, and must be addressed to:
 
William A. Suk, Ph.D., M.P.H.
Program Administrator, Superfund Basic Research Program
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-0797
 
The NIEHS requests such letters to provide an indication
of the number and scope of applications to be received.
A letter of intent
is not binding, it will not enter into the review of any
proposal submitted subsequently, nor is it a necessary
requirement for application.
 
Application Procedure
 
A SIGNED ORIGINAL AND FOUR SIGNED COPIES MUST BE SENT OR
DELIVERED TO:
 
Division of Extramural Research and Training
Grants Processing
National Institute of Environmental Health Sciences
P. O. Box 12233
104 T. W. Alexander Drive
Research Triangle Park, NC  27709
 
In addition, three signed copies of the application should be
sent or delivered to:
 
Grant Application Receipt Office
Division of Research Grants
National Institute of Health
Westwood Building, Room 240
Bethesda, MD  20892-4500**
 
To ensure their review, applications must be RECEIVED at the
DRG, NIH, and NIEHS in North Carolina by JUNE 13, 1991.
 
PLEASE NOTE THE CHANGE IN APPLICATION PROCEDURE FROM THE USUAL
SUBMISSION.  RECEIPT AT NIEHS IS ESSENTIAL FOR THE EXPEDITIOUS
INITIATION OF THE REVIEW PROCESS.  APPLICATIONS NOT RECEIVED
AT NIEHS BY THE RECEIPT DATE WILL NOT BE ACCEPTED.
 
Format for Applications
 
Applications must be submitted on form PHS 398 (revised 10/88), which is
available from an applicant's Office of Sponsored Research and from the
NIH Division of Research Grants.  To identify the application as a
response to this RFA, check "yes" on item two of page one of the
application and enter the title:  NIEHS SUPERFUND BASIC RESEARCH
PROGRAM, ES-91-02.  Since this form is used primarily for the
traditional research grant application, several sections must be
modified and expanded so that this form can be used to provide the
additional information needed for the Superfund Program applications.
Applicants must request a copy of the Information Bulletin on Program
Project Grants and special instructions for Superfund applications from
Dr. Suk at the address listed above.
 
The RFA label (found in the 10/88 revision of application form
PHS 398) must be affixed to the bottom of the face page of the
original copy of the application.  Failure to use this label
could result in delayed processing of your application such that
it will not reach the review committee in time for review.
 
PROPOSED TIMETABLE
 
Letter of Intent:                            May 1, 1991
Application Receipt Date:                    June 13, 1991
Review by National Advisory
  Environmental Health Sciences Council:     January 1992
Anticipated Award Date:                      April 1992
 
INQUIRIES
 
Requests for Program guidelines, special instructions, and
inquiries regarding this announcement must be directed to:
 
William A. Suk, Ph.D., M.P.H.
Program Administrator, Superfund Basic Research Program
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-0797
 
Grants management inquiries must be directed to:
 
David L. Mineo
Chief, Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-1373
 
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.143, NIEHS Superfund Hazardous Substances
Basic Research and Education Grant Program.  Awards will be
made under the authority of the Superfund Amendments and
Reauthorization Act of 1986, Title 1, Section III, and Title
II, Section 209 (Public Law 99-499); and Public Health Service
Act, Section 301 (Public Law 78-410, as amended), and
administered under PHS grant policies and Federal Regulations
42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.