INNOVATIVE TECHNOLOGIES FOR HAZARDOUS WASTE SITE REMEDIATION AND 
MONITORING (SBIR/STTR)

Release Date:  August 29, 2001

RFA:  RFA-ES-02-001

National Institute of Environmental Health Sciences
 (http://www.niehs.nih.gov)

Letter of Intent Receipt Date:  October 15, 2001
Application Receipt Date:       November 20, 2001

PURPOSE

The mission of the National Institute of Environmental Health Sciences (NIEHS) 
is to promote research that will ultimately reduce the burden of human illness 
and dysfunction from environmental causes.  Complementary to this mission are 
the goals of the national Superfund Program, established by Congress in 1980 
to: identify, uncontrolled hazardous wastes; characterize the impacts of 
hazardous waste sites and emergency releases on the surrounding environment 
(i.e. communities, ecological systems, and ambient air, soil, water); and, 
institute control or remediation approaches to minimize risk from exposure to 
these contaminants.  With the 1980 passage of the Comprehensive Environmental 
Response, Compensation and Liability Act (CERCLA), better known as Superfund, 
it soon became clear that the strategies for the cleanup of Superfund sites 
and the technologies available to implement these cleanups, were inadequate to 
address the magnitude and complexity of the problem.   

In 1986, six years after the CERCLA was enacted, Congress authorized NIEHS to 
implement a university-based program of basic research and training grants.  
The intent was to improve the ability to identify, assess, and evaluate the 
potential health effects of exposure to hazardous waste and to develop 
innovative chemical, physical and biological technologies for remediating 
sites contaminated by hazardous substances.  The assignment of this Program, 
the Hazardous Substances Research and Training program [Superfund Basic 
Research Program (SBRP)], to the NIEHS underscored an emphasis on human health 
effects assessment, evaluation and prevention.  However, NIEHS was provided 
latitude to support non-traditional NIH research areas such as fate and 
transport and remediation strategies for environmental contaminants.  NIEHS 
has implemented this program by supporting coordinated multiproject, 
multidisciplinary university-based programs that link biomedical research with 
related engineering, hydrogeologic and ecologic research.  A component of this 
multidisciplinary approach has been the development of innovative remediation 
technologies that limit and/or prevent exposure. 

The Superfund Basic Research Program has been very successful in developing 
innovative remediation technologies through support of basic science 
(http://www-apps.niehs.nih.gov/sbrp/).  For example innovative approaches being 
developed in biotechnology and bioengineering provide exciting opportunities 
for the development of novel remediation strategies.  However, there is a need 
to ensure that these processes and others are further developed, field tested 
and applied to real world situations. 

This initiative is designed to foster the commercialization of technologies, 
products and devices developed by the SBRP and others.  An intent of this 
solicitation is to develop products emanating from the science supported by 
the SBRP that is relevant to the clean-up and monitoring of hazardous 
substances.  The Small Business Innovative Research /Small Business Technology 
Transfer Research (SBIR/STTR) program is ideally suited to support these 
demonstration commercialization opportunities.  This RFA provides a flexible 
system within the SBIR/STTR program that allows for the development of 
products and devices for remediation and monitoring of hazardous waste sites.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA), 
“Innovative Technologies for Hazardous Waste Site Remediation and Monitoring,” 
is related to one or more of the priority areas.  Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Eligibility requirements are described in the Omnibus SBIR Solicitation.  Each 
organization submitting an SBIR/STTR grant application must qualify as a small 
business concern in accordance with the definition given in Section III of the 
Omnibus SBIR Solicitation
(http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). 

MECHANISM OF SUPPORT

This RFA invites grant applications for SBIR/STTR projects with award duration 
and amounts greater than those routinely allowed under the SBIR/STTR program.  
This RFA must be read in conjunction with the Omnibus Solicitation of the 
Public Health Service (Omnibus Solicitation) for Phase I SBIR/STTR Grant 
Applications (PHS 2001-2).  The information in these documents also applies to 
applications in response to this RFA.  The NIH has announced that applicants 
may request a larger budget and period of support if necessary for completion 
of the project.  See NIH Guide for Grants and Contracts, February 13, 1998 at: 
http://grants.nih.gov/grants/guide/notice-files/not98-014.html

This RFA is a one-time solicitation. Responsibility for the planning, 
direction and execution of the proposed project will be solely that of the 
applicant.  Awards will be administered under NIH grants policy stated in the 
NIH Grants Policy Statement of March 2001 
(http://grants.nih.gov/grants/policy/nihgps_2001/).

A. INDIVIDUAL PHASE I APPLICATIONS.  Phase I applications in response to this 
RFA will be funded as Phase I SBIR Grants (R43) and STTR Grants (R41) with 
modifications as described below.  Applications for Phase I grants should be 
prepared using the revised PHS 398 Instructions and fillable Forms (rev 05/01) 
which are available on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Specific SBIR 
instructions are located in Chapter VI of the PHS 398.
 
Because the length of time and cost of research involving development and 
evaluation of remediation technologies may exceed that routinely awarded for 
SBIR/STTR grants, the NIEHS will entertain well-justified Phase I applications 
for an SBIR/STTR award with a project period up to two years and a budget not 
to exceed a total cost of $200,000 per year.

Consultant and contractual costs associated with Phase I: The total amount of 
all consultant costs and contractual costs normally may not exceed 33 percent 
of the total costs requested for Phase I SBIR applications.  However, the 
NIEHS will entertain well-justified Phase I applications for an SBIR award 
with greater than 33 percent contractual costs when those costs are necessary 
to support development and evaluation of a remediation or monitoring 
technology.

Specific page limitations for Phase I applications apply (see PHS 398).

B.  INDIVIDUAL PHASE II APPLICATIONS.  Phase II applications will not be 
accepted in response to this RFA unless they are part of the FAST-TRACK.  This 
solicitation is only for Phase I or FAST-TRACK SBIR/STTR applications.  A 
separate announcement for Phase II applications that result from funded Phase 
I studies under this RFA will be developed at a later time. 

C. FAST-TRACK APPLICATIONS.  Applications may be submitted for the FAST-TRACK 
review option.  Information on the FAST-TRACK process may be found in Section 
VI-B of the PHS 398 at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

To be eligible for the FAST-TRACK option, the Phase I SBIR application must 
include well defined quantifiable milestones that will be used to judge the 
success of the proposed research, as well as a credible plan to apply the 
selected technology in a pilot study of interest to test the feasibility for 
site remediation or monitoring technology for the Phase II R44 application.  
The FAST-TRACK must have a section labeled Milestones at the end of the 
Research Plan Phase I.  This section must include well-defined quantifiable 
milestones for completion of Phase I, a discussion of the suitability of the 
proposed milestones for assessing the success in Phase I, and a discussion of 
the implications of successful completion of these milestones on the proposed 
Phase II. In addition, Fast-Track applications must include a concise Product 
Development Plan (limited to ten pages).  Label this section clearly and 
include it in Section J of the Phase II Research Plan. 

Applications submitted through the FAST-TRACK option are subject to the same 
total cost limits per year as when submitted outside of the FAST-TRACK option: 
Phase I R43, not to exceed $200,000 per year total direct costs excluding 
subcontractor indirect costs; Phase II normally not to exceed $500,000 total 
costs per year.  The total duration (Phase I plus Phase II applications) 
cannot exceed four years.  In any case, the Phase I application cannot exceed 
two years duration.
FUNDS AVAILABLE 

The NIEHS intends to commit up to $1.5 million in FY 2002 from the Superfund 
Basic Research Program allocation to fund four to eight new awards in response 
to this RFA.  The number of awards will be contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.

BACKGROUND

The goal of this proposed research initiative is to stimulate the development 
of innovative remediation products to clean-up hazardous substances commonly 
found at Superfund sites.  From a regulatory perspective, protection of human 
health, ecological health and the environment depends upon both limiting 
exposure and preventing exposures, where possible.  Prevention strategies to 
minimize the exposure to a population, human or wildlife, require the 
development and application of appropriate remediation technologies.  Many 
Superfund hazardous waste sites contain a large number of diverse toxic 
chemicals.  Many contain synthetic chemicals having novel structures that are 
rarely found in nature; hence they are degraded slowly by naturally occurring 
organisms.  Through the multidisciplinary nature of the SBRP, both basic and 
applied research has been supported leading to the development of innovative 
remediation strategies and technologies that are tackling these difficult 
contamination scenarios.  Research supported through this program has focused 
on bioremediation, including phytoremediation and physical and chemical 
methods to remediate contaminants from environmental media.  For example, 
bioremediation strategies have included the use of microbes and engineered 
microbes, to reduce or eliminate the toxicity of hazardous substances.  
Phytoremediation strategies are being developed to remove volatile organics 
and metals from aquifers and sediments.  Physical/chemical methods such as 
novel sorbents, supercritical fluid technologies, and electrochemical methods 
are being developed to reduce the burden of exposure to hazardous substances.

Although the SBRP has provided long-term investments in basic research, it is 
critical that the research findings be translated into useful applications 
directed toward attenuation and prevention of exposure.  There is a continued 
need for the development and validation of newer and cheaper approaches to 
remove hazardous substances from environmental media such as soil, sediment 
and aquifers.  In addition, there is a need to develop monitoring strategies 
to assess the amount and extent of contaminants at a site or monitor the 
effectiveness of a remediation technology in both the short and long term.  
This solicitation provides a mechanism for the potential commercialization of 
effective remediation technologies.

RESEARCH OBJECTIVES

This solicitation is in support of:
- Product development of innovative treatment technologies
- Novel monitoring and measurement devices
- Refinement of treatment technologies that are currently under development 

Approaches may take advantage of state-of-the-art molecular, chemical or 
physical treatment, biotechnology, engineering or bioengineering methods.  
Research may include any or all of the phases involved in taking an innovative 
technology to commercialization.  For example, bench scale studies, field-
testing, pilot-scale demonstration, and demonstration research are all 
appropriate for this solicitation.  The research plan should also allow for 
feasibility studies, evaluation of the performance of the technology or 
product and a cost assessment.  Applicants are encouraged to partner with 
existing grantees that have developed innovative methods that are ready for 
scale-up research.  (The SBRP maintains a complete website describing all 
projects being supported by the program: 
http://www-apps.niehs.nih.gov/sbrp/Program2000/programs00.cfm)

For the purposes of this RFA, the appropriate environmental media for clean up 
are soil, sediments and aquifers.  The appropriate chemicals for remediation 
are:

- Hazardous substances found with some frequency at Superfund sites.
- Hazardous breakdown products of such substances formed in environmental 
media.
- Mixtures of substances or breakdown products of such substances found with 
some frequency at Superfund sites.

Note also that the applicant may refer to the Web site: 
http://www-apps.niehs.nih.gov/sbrp/descrip/respri.cfm to obtain information on 
hazardous substances that are relevant to Superfund and to the Environmental 
Protection Agency (EPA) and the Agency for Toxic Substances and Disease 
Registry (ATSDR).

Approaches appropriate for this initiative include but are not limited to the 
following:

o Bioremediation approaches.  This could include the development and use of 
genetically engineered microbes, biosurfactants, and bioreactors.

o Biodegradation approaches.  Specifically there is interest in recalcitrant 
chemicals, simple and complex mixtures, and metals.

o Sequestration approaches.  This could include methods that change the 
valence state of metals rendering then less toxic.

o Phytoremediation strategies.  This could include development of plant 
strains or use of genetically engineered higher plant species to remediate 
toxic waste sites.

o Physical/chemical methods.  Some examples of approaches that may be 
considered include development of functional nano-structures, electrochemical 
methods, supercritical fluid extraction, photocatalytic processes, thermal 
treatment and filtration-based methods.

o Mixed technology approaches that combine biological, chemical and physical 
treatments. 

o Remediation methods for metals and metal-organic mixtures (e.g., Arsenic, 
Mercury, Cadmiun, Manganese).  There is specific interest in innovative 
biological or biophysical approaches for remediating metals found in high 
concentrations or widely dispersed in soils and sediments. 

o Real-time monitors.  For example, the development of an in-line detector to 
monitor the performance of a remediation technology for the long-term 
assessment of the effectiveness of remedial actions. 

o Tools for assessing the long-term reliability of remediation technologies

o Instruments to characterize hazardous waste sites.  This could include 
biosensors, immuno-based assays or other field-ready instruments that measure 
chemical contaminants.  

o Devices to detect and measure hazardous substances.  For example, there is 
interest in the detection of organics in non-aqueous phase liquids and dense 
non-aqueous phase liquids in the subsurface.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the Inclusion of Children as Participants in 
Research Involving Human Subjects that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in a NIH solicitation, 
internet addresses (URLs) should not be used to provide information necessary 
to the review because reviewers are under no obligation to view the Internet 
sites.  Reviewers are cautioned that their anonymity may be compromised when 
they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA.  
It is important for applicants to understand the basic scope of this 
amendment. NIH has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application.  
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted.  Although a letter of 
intent is not required, is not binding, and does not enter into the review of 
a subsequent application, the information that it contains allows NIEHS staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the letter of intent receipt date listed 
to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-30
79 TW Alexander Drive, Building 4401
Research Triangle Park, NC  27709
Phone:  (919) 541-1307
Fax:  (919) 541-2503
E-mail:  bass@niehs.nih.gov

APPLICATION PROCEDURES

Applications in response to this RFA should be submitted using the 5/2001 
revised PHS 398 Application Instructions and new interactive, fillable PDF 
Forms.  See http://grants.nih.gov/grants/forms.htm  for links to these forms.  
Specific instructions for preparing SBIR applications may be found in Section 
VI of the PHS 398. For further assistance contact GrantsInfo, telephone 
301/435-0714, Email: GrantsInfo@nih.gov

Applicants should follow the instructions for SBIR Phase I submission with the 
modifications as noted in this RFA.  

This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE 
PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) 
APPLICATIONS (PHS 2001-2).  All of the instructions within the Omnibus 
Solicitations apply with the following exceptions:

- Special receipt date
- Additional award considerations
- Increased award and amount of duration
- Use of the PHS 398 Instructions and Forms

Applications received in response to this RFA are to be prepared as described 
in the PHS 398.  Eligibility requirements to participate in the SBIR Program 
are described in the Omnibus Solicitation, available electronically through 
the NIH, Office of Extramural Research “Small Business Funding Opportunities” 
at http://grants.nih.gov/grants/funding/sbir.htm. Helpful information in 
preparation of the application can be obtained at 
http://grants.nih.gov/grants/funding/sbir_policy.htm


SBIR/STTR projects submitted in response to this RFA must contain a Phase I 
feasibility segment that must be successful prior to a Phase II award.  
Applications can be submitted for Phase I support, or as a combined Phase I 
and II (FAST-TRACK).  

Projects may be presented for SBIR/STTR support at all stages of remediation 
technology development or development of instruments and tools for monitoring.  
Projects will be evaluated on overall innovation and success potential.  
Larger budgets could be considered for Phase I if required for conduct of the 
research and appropriately justified in the application.  The second year of 
support will be contingent upon NIEHS programmatic evaluation to ensure that 
the investigators are accomplishing milestones and time lines presented in the 
original application.

FAST-TRACK:
Due to the complex nature of the development and validation of innovative 
remediation technologies, it is recommended that only well-defined and more 
advanced projects be proposed for support through this mechanism.  FAST-TRACK 
applications must specify clear, measurable goals for Phase I that should be 
achieved prior to Phase II funding.  In addition, Fast-Track applications must 
include a concise Product Development Plan (limited to ten pages).  Label this 
section clearly and include it in Section J of the Phase II Research Plan.  
Failure to provide measurable goals in the Phase I application and/or 
sufficient detail in the Phase II application may be sufficient reason for the 
peer review committee to exclude the Phase II from consideration.  Special 
provisions described in this RFA pertaining to Phase I and Phase II also apply 
to FAST-TRACK applications.

The RFA label available in the PHS 398 (rev. 5/01) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label included below “For application in response to SBIR/STTR.”  
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.  In addition, the RFA title and number must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

For purposes of identification and processing, the title and number of this 
RFA must be shown in item 2 on the face page of the SBIR/STTR Phase I 
applications.  Follow the mailing instructions in the Omnibus Solicitation for 
Phase I or FAST-TRACK applications.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the applications must be 
sent to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive, Building 4401, Room 116
Research Triangle Park, NC  27709
Phone:  (91) 541-1307
Fax:  (919) 541-2503
E-mail:  bass@niehs.nih.gov

Applications must be RECEIVED BY the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
review, unless the applicant withdraws the pending application.  The CSR will 
not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such applications must include an 
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIEHS.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIEHS in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score and receive a second level review 
by the National Advisory Environmental Health Sciences Council.

REVIEW CRITERIA

Review criteria are described in the PHS 398 and available on the web at the 
following URL address: http://grants.nih.gov/grants/funding/phs398/phs398.html

Additional review criteria are that the proposal must produce a remediation or 
monitoring technology that is relevant to clean-up issues faced by Superfund 
sites and that the application must address the evaluation and validation of 
the method.  The Phase I application should specify clear, measurable goals 
(milestones) that should be achieved prior to initiating Phase II.

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem in the 
remediation or monitoring of hazardous substances? Does the proposed project 
have commercial potential to lead to a marketable product or process? What may 
be the anticipated commercial and societal benefits of the proposed activity?  
If the aims of the application are achieved, how will environmental clean up 
or monitoring be advanced? Does the proposal lead to enabling technologies 
(e.g., instrumentation, software) for further discoveries? Will the technology 
have a competitive advantage over existing/alternate technologies that can 
meet the market needs? To what degree does the product rely on state-of-the-
art technology? 

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Is the proposed plan a sound approach for establishing technical and 
commercial feasibility?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?  What is the time frame for developing 
the proposed technologies and the suitability of this time frame for meeting 
research needs? How easy will it be to use the proposed technology?  Are the 
plans for the proposed technology, its integration as an effective solution 
for implementation and dissemination adequate?  If partnerships are proposed, 
how will they facilitate the development and integration of the product?  For 
FAST-TRACK applications - How appropriate are the proposed milestones against 
which to evaluate the demonstration of feasibility for transition to the Phase 
II application.

(3) Innovation:  Does the project apply novel concepts, approaches or method?  
Does the project challenge existing paradigms or develop new methodologies or 
technologies? Are the aims original and innovative? What is the throughput and 
cost effectiveness of the proposed technology?  What additional uses can be 
projected for the proposed technology?

(4) Investigator: Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR?  Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors (if any)? Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed?

(5) Environment: Is there sufficient access to resources (e.g., equipment, 
facilities)?  Does the scientific and technical environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements?  Is there evidence of institutional 
support? 

ADDITIONAL CONSIDERATIONS

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project(s) 
proposed in the application.

SCHEDULE

Letter of Intent Receipt Date:    October 15, 2001
Application Receipt Date:         November 20, 2001
Council Review:                   May 2002
Earliest Anticipated Start Date:  July 2002

AWARD CRITERIA

The following will be considered when making funding decisions: quality of the 
proposed project as determined by peer review, program balance among research 
areas of the announcement, the availability of funds, and the 
commercialization status where the small business concern has received more 
than 15 Phase II awards in the prior five fiscal years, if applicable (see 
this application requirement under “Prior SBIR Phase II Awards” found in the 
“Introduction and Application Instructions” potion of the Omnibus 
Solicitation).

INQUIRIES

Inquiries concerning this RFA are encouraged.  Potential applicants are 
strongly encouraged to contact program staff for pre-application guidance 
and/or for more specific information on the research topics described in this 
RFA.  They are also encouraged to read the advice and information on SBIR 
programs located on the Internet at: 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf

Direct inquiries regarding programmatic issues to:

Ms. Beth Anderson
Program Analyst
Office of Program Development
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive, MD EC-27
Research Triangle Park, NC  27709
Telephone:  (919) 541-4481
Fax:  (919) 541-4937
E-mail:  tainer@niehs.nih.gov

or

Claudia Thompson, Ph.D.
Scientific Program Administrator
Office of Program Development
Division of Extramural Research and Training 
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-4638
Fax:  (919) 316-4606
E-mail:  thompso1@niehs.nih.gov
 
Direct inquiries regarding review issues to:

Linda Bass, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Office of Program Operations
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T.W. Alexander Drive, MD EC-02
Research Triangle Park, NC  27709
Telephone:  (919) 541-1307
Fax:  (919) 541-2503
E-mail:  bass@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carolyn Winters
Grants Management Specialist
Grants Management Branch
Office of Program Operations
National Institute of Environmental Health Sciences
PO Box 12233
111 T.W. Alexander Drive, MD EC-22
Research Triangle Park, NC  27709
Telephone:  (919) 541-7823
Fax:  (919) 541-2860
E-mail:  winters@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113, 93.115 and 95.143 (NIEHS Superfund Hazardous Substances Basic Research 
and Education Grant Program).  Awards will be made under authority of the 
Superfund Amendments and Reauthorization Act of 1986, Title 1, Section III, 
and Title II, Section 209 (Public Law 99-499); and are made under 
authorization of sections 301 and 405 of the Public Health Service Act as 
amended (42 USC 241 and 284) and administered under NIH grants policies and 
Federal Regulations 42 CFR Part 52 and 45 Part 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant 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 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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