kristoff@GENBANK.BIO.NET (Dave Kristofferson) (03/15/91)
$$XID RFA OD9102 OD-91-02 P1O1 *****************************************
REQUEST FOR CONSTRUCTION GRANT APPLICATIONS
RFA: OD-91-02
CONSTRUCTION OF MOUSE PRODUCTION FACILITIES
P.T. 34; K.W. 1002002, 1014002, 1014006
National Institutes of Health
Letter of Intent Receipt Date: April 15, 1991
Application Receipt Date: May 24, 1991
I. BACKGROUND INFORMATION
Public Law 101-190
authorized the National Institutes of Health (NIH)
to make an award to "a public or nonprofit, private entity for
constructing facilities for the purpose of the development and
breeding of specialized strains of mice (including inbred and
mutant mice) for use in biomedical research."
The DHHS Appropriations Act for Fiscal Year 1990, Public Law
101-166, authorized the Secretary to transfer $14,800,000 from
"appropriations available to each of the Institutes...for
extramural facilities construction grants if authorized in law
and if awarded competitively including such amount as he may deem
appropriate for research animal production facilities."
In response to
these Congressional activities, the NIH issued a Request for
Applications (RFA) in Fiscal Year 1990 that resulted in
an award for construction of mouse production facilities.
The Department of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations for 1991 provided $14,800,000 to the
Office of the Director, NIH, for "extramural facilities construction
grants if awarded competitively..."; the report language cited mouse
production facilities in particular. Of this amount, $4,800,000 has
been identified for funding two applications that were submitted in
response to a previous solicitation and received high priority scores
but were not funded in Fiscal Year 1990.
Thus, in response to this latest Congressional action, the NIH is
issuing RFA OD-91-02 to solicit construction grant
applications for the construction of large-scale mouse production
and mutant characterization facilities.
II. OBJECTIVES AND SCOPE
Support may be requested for the costs of constructing non-
Federal facilities dedicated to the breeding and production of
specialized strains of mice, including inbred and mutant mice,
necessary to meet the nation's needs in conducting biomedical
research on a broad range of topics. Associated fixed equipment
necessary for operation of these facilities may also be requested
as part of the application. Instrumentation that usually would
be requested as part of a research project, will not be provided
as part of this construction award.
Facility construction that may be supported under this program
includes:
o Construction of new facilities,
o Additions to existing buildings,
o Completion of uninhabitable "shell" space in new or existing
buildings,
o Major alterations and renovations.
III. MECHANISM OF SUPPORT
A. Eligibility.
Any domestic, non-Federal public or non-profit private
institution, organization, or association that conducts or
supports biomedical research is eligible to apply.
NIH staff will verify application and award eligibility. Those
judged to be unresponsive or ineligible will be returned to the
investigator.
B. Award Mechanism.
The award mechanism will be the construction grant award. Awards
will be administered under Federal Regulation 45 CFR Part 74 -
Administration of Grants, and 42 CFR Part 52b for cancer
construction projects.
C. Funding Participation.
This one-time solicitation based on the Fiscal Year 1991
appropriation will make available up to $10,000,000 for this
initiative, the final amount to be determined by peer-
review evaluation and the judgment of the Director, NIH. Up to
75 percent of the allowable costs of a project may be provided,
not to exceed $10,000,000. The matching contributions by the
institution may be in cash or in kind, fairly evaluated,
including plant and equipment or services throughout the required
20-year period of usage of the facility (and including such
specialized strains of mice as the Secretary, HHS, may request for
purposes of biomedical research). Amounts provided by any agency
of the Federal government, other than the Department of Health and
Human Services, and services assisted or subsidized by any such
agency, may be included in the amount of such matching funds.
Prior to the grant award, an applicant must provide an assurance
of required institutional contributions, as described above, and
that other contributions have been secured to meet any projected
costs in excess of the award amount. Requests of less than
$500,000 will not be accepted. No indirect costs will be
awarded. No continuation costs will be awarded.
D. Award Conditions.
Advertisement for construction bids and construction can be
initiated only after receipt of the construction grant award and
subsequent approval of the working drawings and specifications by
NIH staff, but not later than twelve months after the date of
award. Therefore,
consistent with Public Health Service policy,
no requests to initiate construction
will be entertained
prior to receipt of a construction grant award from NIH and
approval of working drawings and specifications by NIH
staff.
The Principal Investigator should be a highly placed
institutional official, at the level of Dean or equivalent, who
has the responsibility for allocation of space for the program(s)
of biomedical research/research support addressed in the
submitted application and can provide the necessary assurance for
the use requirement stated below.
The facility must be utilized for the specific biomedical
research and/or biomedical research support purposes for which it
was constructed for at least twenty (20) years beginning ninety
(90) days following completion of the construction project. NIH
staff will evaluate use of the facility periodically to assure
its continued use for the approved purposes.
If a grant award is made under the current statutory authority,
all of the conditions set forth in Public Law 101-190 will apply,
including the requirement that mice sold to the Department of
Health and Human Services be reasonably priced in relation to the
cost of the production of the mice and that the applicant
contributes one dollar for each three dollars provided under the
grant.
IV. REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed for scientific and technical merit
by appropriate special peer review group(s) convened by the
Division of Research Grants (DRG), NIH. The second level of
review will be conducted by the National Cancer Advisory Board in
September 1990 to assess the relevance of all proposals to the
objectives described above. In addition, each approved
application will be reviewed by NIH staff and consultants for
adherence to Government regulations and sound engineering
practice. Awards will be made on or before September 30, 1991.
Funding decisions will be guided by the
recommendations of the National Cancer Advisory Board.
Applications will be evaluated on the basis of criteria intended
to assess the following overall question: Is the proposed
facility suitable for the development and breeding of specialized
strains of mice in numbers sufficient to assist in meeting the
need for such mice in PHS-conducted and supported biomedical
research? Thus, the reviewers will consider the following
factors:
o Appropriateness and suitability of the proposed facilities for
the development and breeding of specialized strains of mice for
use in biomedical research.
o The overall scope and quality of the ongoing research and
research support programs of the applicant institution, as well
as the expanded or proposed future research and research support
activities.
o Assurance that the applicant has sufficient financial resources
to maintain the facility for the purpose for which it is to be
constructed.
o The applicant's consideration of safety and biohazard issues in
planning the construction and in its administration.
o Demonstration that the proposed facility is large enough to
produce specialized strains of mice in numbers sufficient to
assist in meeting the need for such mice in biomedical research
conducted or supported by the PHS.
o Specific deficiencies in existing facilities that
would be remedied.
o The proposed physical location and layout of the new facility.
o The reasonableness of the proposed time-course and sequence for
the construction.
o Adequacy of the proposed administrative arrangements with
respect to:
Institutional commitment to use the space for biomedical
research and biomedical research support.
Safety and biohazard issues.
Capabilities of the Principal Investigator and staff for
scientific and fiscal administration of the facility.
V. METHOD OF APPLYING
A. Letter of Intent.
Prospective applicants are asked to submit by April 15, 1991, a
letter of intent to the individuals noted below. The
letter, requested for planning purposes only, must identify the
RFA number noted above, the proposed Principal Investigator, and
include a brief description of the proposed facility and the
type(s) of research/research support to be conducted in the new
facility. The letter of intent does not commit the sender to
submit an application, nor is it a prerequisite for submission of an
application. The original of the letter of intent should be
addressed to:
Mr. Kenneth Brow
Chief, Research Facilities Branch
Division of Cancer Biology, and Diagnosis, and Centers
National Cancer Institute
National Institutes of Health
Executive Plaza North, Room 300
Bethesda, MD 20892
A copy of the letter of intent should be addressed to:
Anthony Demsey, Ph.D.
Associate Director for Referral and Review
Division of Research Grants
National Institutes of Health
Room 338, Westwood Building
5333 Westbard Avenue
Bethesda, MD 20892
B. Pre-Application Instructions
o Intergovernmental-Review -- Executive Order 12372
All applicants are required to comply with Executive Order 12372
as supplemented by DHHS 45 CFR Part l00, Intergovernmental Review
of Department of Health and Human Services Programs and
Activities. (The A-95 Clearinghouse System is no longer in
effect.) Revised Standard Form 424 has been issued to meet the
reporting requirements of Executive Order 12372. The purposes of
this review are to:
1. Identify the relationship of any proposed project to State and
area-wide comprehensive plans and evaluate the significance of
these projects for the plans and programs of particular State
agencies and local governments; and
2. Ensure that public agencies responsible for environmental
standards and civil rights have an opportunity to review and
comment upon proposed projects.
Each applicant is encouraged to discuss projects with the Single
Point of Contact (SPOC) at the earliest time possible and to
provide the SPOC with required information in a timely manner.
(The State Single Point of Contact List is included as an
attachment in the special instructions accompanying the
application Standard Form 424 package.)
The SPOC must be given 60 days to review a construction grant
application. Applications submitted to NIH in response to this
solicitation must contain either SPOC comments or documentation
indicating the date on which the application was submitted to the
SPOC for review.
The SPOC comment period ends 60 days after the application
receipt date. Applicants are to provide the SPOC with a copy of
their application NOT LATER THAN the time the application is
submitted to the Division of Research Grants, NIH.
Applicants required to submit applications for review to a Health
Systems Agency (HSA), or Statewide Health Planning and
Development Agency (SHPDA), should contact the SPOC/HSA/SHPDA to
determine what coordination has been agreed to by those agencies.
NIH is required to notify the SPOC whenever they receive an
application without an indication that the application has been
provided to the SPOC for review.
All SPOC comments should be forwarded to both the applicant and
to the NIH Institute to which the application is assigned. If
comments are provided by the SPOC, the applicant may
submit to the NIH a statement of its reaction to the comments and
any appropriate changes to its application. If no response is
received from the SPOC by the end of the 60 days allotted for
review of the application, the applicant should notify the NIH
that no response was received.
o Public Disclosure
Applicants must also make a public disclosure of the project by
publication, and describe its environmental impact at the time
the SPOC is notified. It is suggested that the notice be carried
in a large-circulation newspaper in the geographical area. This public
disclosure is required by Section 102 of the National
Environmental Policy Act (NEPA) of l969 and by Federal Executive
Order 11514.
One example of a suitable disclosure statement follows:
"PUBLIC NOTICE
"Notice is hereby given that the Uptown Medical School
proposes to construct additional space, partially utilizing
Federal funds. The proposed construction project is the
addition of 2,700 square feet connected to the existing
Allen Building, which is located at 5333 Main Street,
Downtown, Ohio."
"The Medical School has evaluated the environmental and
community impact of the proposed construction. There will
be construction noise and increased construction traffic
during the construction period, 1991-1992. No significant
permanent environmental impacts are foreseen. All building
permits and zoning approvals have been obtained."
"In accordance with Federal Executive Order 11514, which
implements the NEPA of 1969, any individual or group may
comment on, and request information concerning, the
environmental implications of the proposed project.
Communications must be addressed to the Office of
Planning, Uptown Medical School, and be received by (date).
The Federal grant application may be reviewed at the Office
of the Dean, School of Medicine, 5333 Main Street, during
working hours."
o Design Standards
Design requirements are imposed to protect the health and safety
of persons using the proposed facility, control the project's
impact on the natural environment, conserve energy resources,
achieve economy in construction costs, and protect against
natural disasters such as earthquake and flood. Therefore, the
documents listed under REFERENCES at the end of the RFA must be
consulted and their design requirements incorporated into the
review and evaluation of all drawings and specifications.
C. Application
Applicants must use Standard Form 424, "Application for Federal
Assistance." Application forms and special instructions for
completing the forms relevant to this RFA must be requested from
the contact official noted below. Those responsible for preparing
the application should consult appropriate officials of
their institution before completing the application forms.
An institution may submit only one application in response to
this specific announcement. An original and two copies of the
application including appendices should be submitted to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications must be received at NIH by May 24, 1991. To insure
against carrier delays, retain a legible proof-of-mailing receipt
from the carrier, dated no later than one week prior to the
receipt date. Applications received after the receipt date will
not be accepted for review in this competition.
The RFA label included in the Standard Form 424 package 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 the application such that it may not reach
the review committee in time for review.
VI. STAFF CONTACT
For additional information and a copy of the complete RFA and
application Standard Form 424 materials, please contact:
Mr. Kenneth Brow
Chief, Research Facilities Branch
Division of Cancer Biology and Diagnosis
National Cancer Institute
National Institutes of Health
Executive Plaza North, Room 300
Bethesda, MD 20892
Telephone: (301) 496-8534
Inquiries regarding fiscal matters should be addressed to:
Mr. William Wells
Grants Administration Branch
Office of Administrative Management
National Cancer Institute
National Institutes of Health
Executive Plaza South, Room 243N
Bethesda, MD 20892
Telephone: (301) 496-7800
VII. REFERENCES
A. Policy
"Public Health Service Grants Policy Statement." Department of
Health and Human Services, DHHS Publication No. (OASH) 90-50,000.
(Rev.) October 1, 1990.
B. Animal Care
"Guide for the Care and Use of Laboratory Animals." Department of
Health and Human Services. Prepared by the Committee on Care and
Use of the Institute of Laboratory Animal Resources, National
Academy of Sciences. DHHS Publication No. (NIH) 85-23, Revised
1985.*
"Public Health Service Policy on Humane Care and Use of
Laboratory Animals." Revised as of September 1986. Prepared by
the Office for Protection from Research Risks (OPRR), National
Institutes of Health.*
C. Facility Design and Safety
"Uniform Building Code" (for earthquake protection).
International Conference of Building Officials, 5360 South
Workman Mill Road, Whittier, California 9060l. Use current
edition.*
"Life Safety Code, NFPA 101." National Fire Protection
Association, 470 Atlantic Avenue, Boston, Massachusetts 02ll0.
Use current edition.*
"Standard on Fire Protection for Laboratories Using Chemicals,
NFPA 56C." National Fire Protection Association, 1980.*
"Safety Standard for Laboratories in Health-Related Institutions,
NFPA 56C." National Fire Protection Association, 1980.*
"National Electrical Code, NFPA 70." National Fire Protection
Association. Use current edition.
"Minimum Requirements of Construction and Equipment for Hospitals
and Medical Facilities." DHHS Publication No. (HRA) 86-14500.
(This publication is updated annually; therefore use the current
publication.)*
"Safety and Health Standards (29 CFR 1910), Department of Labor
OSHA." Occupational Safety and Health Administration, OSHA. Use
current edition.*
"General Services Administration Accessibility Standards" (41 CFR
101-19).*
"ASHRAE Handbook - 1987 Applications/Systems, Chapter 30 -
Laboratories." American Society of Heating, Refrigerating and
Air Conditioning Engineers, Inc.*
"Industrial Ventilation, A Manual of Recommended Practices."
American Conference of Governmental Industrial Hygienists. Use
current edition.
"Biosafety in Microbiological and Biomedical Laboratories." DHHS
Publication No. (CDC) 84-8395.*
"National Sanitation Foundation Standard No. 49 for Class II
(Laminar Flow) Biohazard Cabinetry." National Sanitation
Foundation, Revised May 1983.*
"NIH Guidelines for the Laboratory Use of Chemical Carcinogens."
Department of Health and Human Services, National Institutes of
Health. DHHS Publication No. (NIH) 81-2385, May 1981.*
"Recombinant DNA Research, Revised Guidelines." National
Institutes of Health. Federal Register, Vol. 48, June 1, 1983;
pp. 24556-24581.*
Uneconomical, hazardous, or unnecessary use of flood plains for
construction - Executive Order ll296, 3l FR l0663 (August l0,
l966). Flood insurance coverage - Section 202 of the Flood
Protection Act of l973.*
Provisions for potable water supply - Safety of Public Water
Systems Act (Title XIV of the Public Health Service Act).*
Preservation of historical and archeological sites - Section l06,
National Historic Preservation Act of l966 and the Historical and
Archeological Preservation Act of l960 as amended.*
Tornadoes - There is no universally accepted national code
requiring protection of life and property against tornadoes, even
though this natural phenomenon results yearly in loss of life and
damage to facilities costing millions of dollars. In geographic
areas subject to periodic occurrence of tornadoes, the design of
facilities should include special structural and other features
to protect life and minimize damage to facilities from tornadoes.
Plumbing - National Standard Plumbing Code: National Association
of Plumbing-Heating-Cooling Contractors, l0l6 20th Street N.W.,
Washington, D.C. 20036.*
Standard for Non-Flammable Medical Gas Systems, l973, NPA
Bulletin No. 56F; National Fire Protection Association.*
Radiation Protection - Handbook Reports No. 33 and 34: National
Council of Radiation Protection (NCRP), P.O. Box 30l75,
Washington, D.C. 20008.*
Whenever State and local codes or requirements exceed the design
requirements described above or standards incorporated in them,
the more stringent requirements will be applied. State or local
codes may be used as a basis for facility design in lieu of the
above design requirements if a prior determination has been made
by DHHS that the specific State or local code is equivalent to,
or exceeds, DHHS requirements.
*Mandatory Design Standard
Grants for research facilities construction programs of the
National Institutes of Health are subject to Executive Order
12372. All awards will be made under the authority of the Public
Health Service Act, Title IV, Section 413(b)(6)(B) as amended by
Public Law 99-158 (42 USC 285a-2) and administered under PHS
grant policies and Federal Regulations 42 CFR Part 52b and 45 CFR
Part 74, and PL 101-190. This program is described in the
Catalog of Federal Domestic Assistance, Number 93.392, Cancer-
Construction.
$$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.