DEVELOPMENT OF TECHNOLOGY-DRIVEN PRODUCTS/DEVICES/BIOMARKERS FOR MEASURING 
EXPOSURE TO ENVIRONMENTAL AGENTS:  SBIR INITIATIVE

Release Date:  September 11, 2000

RFA:  ES-00-009

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

Letter of Intent Receipt Date:  October 1, 2000
Application Receipt Date:       November 16, 2000

PURPOSE

The mission of the National Institute of Environmental Health Sciences (NIEHS) 
is to reduce the burden of human illness and dysfunction from environmental 
exposures to chemical agents by understanding the interaction between 
environmental exposures, individual susceptibility, and time.  Exposure 
assessment, the quantification of human contact with chemicals or other 
exposures, is an essential component of environmental, epidemiologic, and risk 
assessment studies aimed at reducing the burden of environmentally induced 
diseases.  It is often the most criticized part of the research, as it is 
difficult to gather reliable and valid measures of exposures, especially when 
they have occurred in the past.  The exposure-disease relationship is subject 
to misclassification and recall bias when surrogate exposure measures, such as 
self-report of exposures, are used.  Historically, tools available to 
epidemiologists were questionnaire and survey methods, which included asking 
subjects about their exposures on the job or at home.  Improvements in 
exposure assessment have been made in occupational and environmental studies 
over time, but new tools are necessary to include improved biomonitoring 
strategies into such research.  

The current explosion in biotechnology and bioengineering is ripe for 
exploitation by exposure assessment and analysis researchers.  A unique 
opportunity exists to infuse the discipline with new strategies and approaches 
in chemical measurement, bioimaging and sensing, and miniaturization, that are 
currently being utilized in the defense, agriculture, and security industries. 
The application of these methods will improve our ability to measure 
environmental pollutants in the air, soil, water, and in human tissues and 
body fluids.  Refinements in exposure assessment strategies using new 
technology will aid in the quantification of the disposition of these agents, 
including the metabolism and clearance in the body.  The development of more 
sensitive and specific monitoring devices, more sophisticated biomonitoring 
scenarios, and novel imaging techniques will help generate much needed data.  
Information from these new devices and products will provide more valid 
estimates of body burden and more precise pharmacokinetic data needed to 
expand our understanding of the toxic effects of these exposures and aid in 
the improved conduct of epidemiologic studies and risk assessment exercises.
The purpose of this Request for Applications (RFA) is to foster the 
integration of biotechnology with bioengineering, imaging techniques, and 
advances in molecular biology in order to revolutionize the field of exposure 
assessment.  It is anticipated that the improvement in exposure assessment 
methodologies that result from this RFA will have a major impact on 
epidemiology and community-based environmental health studies and thereby on 
the risk assessment process and our ability to protect the public health.

Because this initiative deals with a subset of the exposure assessment area, 
that of the development of technology driven commercial products, this 
initiative will use the Small Business Innovation Research (SBIR) program. 
This RFA provides a flexible system within the SBIR program to cover the 
extensive needs and complex development processes needed to develop and 
validate products and devices that will measure exposure to environmental 
agents.

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, 
"Development of Products/Devices/Biomarkers for Assessment of Exposure to 
Environmental Agents: SBIR Initiative," is related to the priority areas of 
environmental health.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://health.gov/healthypeople/

ELIGIBILITY REQUIREMENTS

Eligibility requirements are described in the Omnibus SBIR Solicitation. Each 
organization submitting an SBIR 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.htm)

MECHANISM OF SUPPORT

This RFA invites grant applications for Small Business Innovation Research 
(SBIR) projects with award duration and amounts greater than those routinely 
allowed under the SBIR program.  This RFA must be read in conjunction with the 
Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for 
Phase I SBIR Grant Applications (PHS 2000-2) and the instructions for Phase II 
Grant Applications revised March 1998.  All instructions and information in 
these documents also apply 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, NIH publication 99-8 October 1998.

A.  FAST-TRACK APPLICATIONS.  Applications may be submitted for the 
FAST-TRACK review option.  Information on the FAST-TRACK process may be found 
at: http://grants.nih.gov/grants/funding/sbir.htm
 
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 exposure assessment 
research 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.

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.

B.  INDIVIDUAL PHASE I APPLICATIONS.  Phase I applications in response to this 
RFA will be funded as Phase I SBIR Grants (R43) with modifications as 
described below.  STTR applications will not be accepted under this 
solicitation.  Applications for Phase I grants should be prepared following 
the directions for Phase I SBIR applications as described in the NIH Omnibus 
Solicitation.  The NIH Omnibus SBIR Solicitation is available on the Internet 
at http://grants.nih.gov/grants/funding/sbirsttr1/index.htm

A limited number of hard copies of the NIH Omnibus SBIR Solicitation 
are available from:

PHS SBIR/STTR Solicitation Office
13685 Baltimore Avenue
Laurel, MD  20707-5096
Telephone:  (301) 206-9385
FAX:  (301) 206-9722
Email:  a2y@cu.nih.gov

Page Limitations.  The requirements for Phase I applications apply 
(see NIH OMNIBUS Solicitation).

C.  INDIVIDUAL PHASE II APPLICATIONS

Phase II applications will not be accepted in response to this RFA unless they 
are part of the FAST-TRACK.  They will only be accepted as competing 
continuations of Phase I SBIR awards funded under this initiative. 

PROJECT PERIOD AND AMOUNT OF AWARD

PHASE I:
Because the length of time and cost of research involving development and 
evaluation of products/devices/biomarkers for the assessment of exposure to 
environmental agents may exceed that routinely awarded for SBIR grants, the 
NIEHS will entertain well-justified Phase I applications for an SBIR award 
with a project period up to two years and a budget not to exceed a total cost 
of $200,000 per year.

PHASE I BUDGET PERIOD REQUESTS THAT EXCEED THE 6-MONTH GUIDELINES
Phase I SBIR Applicants requesting a budget period of more than 1 year should 
follow the following procedures: 

Photocopy Form Page 3 "Budget for Phase I-Direct Costs Only", number it Form 
Page"3a" 

o  Use Form Page 3 for the first year budget and title Form Page 3a "Phase I - 
2nd year budget." This page will not be counted against the "25-page" total.

o  Provide the appropriate/requested information in the narrative 
justification (Form Page 4) for years 1 and 2.

o  Indicate on the Phase I Face page in Field 6, Dates of Project Period, the 
dates for the ENTIRE project period (e.g., Nov, 15, 2000- Nov. 15, 2002) 

o  Indicate on the Phase I Face Page in Field 7, the requested Direct Costs 
for the entire project period and the Total Costs for the entire project 
period (e.g. 2 years). The summary statement will reflect the recommended 
budget for the -01 year and –02 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 
product/device/biomarker for the assessment of exposure to environmental 
agents.

Page Limitations:
The 25-page limitation for Phase I applications applies (see Omnibus 
Solicitation).

PHASE II:

This solicitation is only for Phase I or FAST-TRACK SBIR applications.  Phase 
II applications that result from funded Phase I studies under this RFA, will 
be awarded as Phase II SBIR grants (R44) with modifications as described 
below. In addition, FAST-TRACK Phase I and Phase II applications will be 
accepted as described above.

Project Period and Amount of Award:
Because the length of time and cost of research involving exposure assessment 
products/devices/biomarkers often exceeds that routinely awarded for SBIR 
grants, the NIEHS will entertain well-justified Phase II applications that 
result from Phase I funded projects from this RFA for an SBIR award with a 
project period up to three years and a budget not to exceed $600,000 per year 
total cost.  The increased time and cost are allowed because of the time and 
cost associated with the evaluation and validation on the products/devices/ 
biomarkers developed in Phase II.  It is anticipated that the Phase II 
applications that result from successful Phase I applications funded under 
this RFA will have a significant partnership component with epidemiologists 
and statisticians in order to evaluate and validate the products developed in 
human populations.

Consultant and contractual costs:
The total amount of all consultant costs and contractual costs normally may 
not exceed 50 percent of the total costs requested for Phase II SBIR 
applications.  However, NIEHS will entertain well-justified Phase II 
applications for an SBIR award with greater than 50 percent contractual costs 
when those costs are necessary to support the development, evaluation and 
validation of exposure assessment products/devices/biomarkers.

FUNDS AVAILABLE

It is expected that 10-12 awards will be made in FY 2001, and $3 million from 
the SBIR set-aside of the NIEHS will be designated for this purpose.  The 
number of awards will be dependent upon receipt of a sufficient number and 
diversity of applications with high scientific merit.

RESEARCH OBJECTIVES

Background

The goal of this proposed research initiative is to develop new tools, 
products and devices that will enhance our ability to measure a wider variety 
of chemical contaminants in our environment and in humans.  The integration of 
biotechnology with bioengineering, imaging techniques, and advances in 
molecular biology will revolutionize the field of exposure assessment by 
producing new and innovative commercial products that will aid the detection 
of exposure to environmental agents and improve the detection of the toxicity 
resulting from exposure.  It is anticipated that the improvement in exposure 
assessment methodologies that result from this initiative will have a major 
impact on epidemiology studies and thereby on the risk assessment process and 
our ability to protect the public health.

This initiative invites technology-driven applications to develop commercially 
viable products in order to improve existing analytic methods to quantify 
chemical exposures.  The technological tools should be integrated with 
biology, chemistry, computer science, engineering, mathematics, and physics to 
achieve a systems science approach for the analysis of biological information 
useful for assessing exposure to environmental agents and the biological 
consequences of that exposure.  The use of this emerging technology could very 
likely change the face of exposure assessment making it increasingly possible 
to noninvasively detect recent and past exposures, diagnose the associated 
toxicity, and guide intervention therapies.  Technology-driven product 
development appropriate for this initiative include but are not limited to the 
following:

IMPROVED ANALYTIC METHODS TO QUANTIFY EXPOSURE

o  Development of sensitive and inexpensive field kits which use 
nanotechniques to detect and quantitatively assay environmental agents and 
their metabolites in small samples of air, tears, tissues, blood, saliva, or 
urine (blood,saliva or urinary dip-sticks for example) that could be used for 
screening large populations for exposure to specific environmental agents.  

o  Development of field-capable methods to determine body burdens or 
environmental chemicals in the population especially children with a focus on 
improved exposures in homes, school, and in motor vehicles.

o  Quantitation of exposures found in food (i.e., mycotoxins in corn) which 
may pose a hazard to children and sensitive populations.

INSTRUMENTS TO MEASURE BIOMARKERS OF EXPOSURE

o  Development of high throughput fingerprinting of genetic polymorphisms for 
use in large-scale human studies.

o  Miniaturization of high throughput technology for gene/protein expression 
for the detection of toxicant exposure in field studies.

o  Development and validation of instruments that can measure biomarkers or 
surrogate markers of tissue function that can be measured either noninvasively 
or in small blood, saliva or urine samples and that can be used to determine 
tissue toxicity after exposure to environmental agents.

o  Development and validation of biomarkers that reflect exposures to specific 
environmental agents or classes of agents (acute exposures and long term 
chronic exposures) and predict disease risk in individuals. 

o Development of instruments that can detect and quantify past exposures 
(months to years) to environmental agents singly or combined by similar 
mechanism, based on changes in metabolism, biochemical endpoints or molecular 
endpoints.  This could include improved gene expression profiling assays that 
detect chemical signatures from exposure to specific toxicants that can be 
standardized to be used in large scale epidemiology studies. 

o  Development of instruments that can measure chemical specific biomarkers 
for identifying stages in the development of the toxic effects of 
environmental agents from initial exposure to early toxicity to disease or 
dysfunction.

o  Development of an instrument that can measure a battery of biomarkers that 
would quantify exposures to mixtures of chemicals with a similar mechanism of 
action. 

IMPROVED BIOMONITORING OF EXPOSURE

o  Development of sensitive miniaturized user-friendly personal exposure 
assessment monitors for use with children as well as adults.

o  Development of novel technology to monitor daily activity patterns and 
exposure of children (i.e., continuous sampling over time).

o  Sensitive and specific personal monitors to detect exposure to various 
environmental agents, especially low dose environmental exposures (for example 
a home collection kit for house dust or mites or biomonitors that could be 
worn to school that can detect metals, solvents, particulates, air toxics, 
water pollutants etc).

o  Use of nanotechnology and integration of complex functionality for a new 
class of biomedical devices that will be useful for real-time biomonitoring 
and imaging of exposure.  This includes the development of improved contrast 
enhancement agents and probes specific for molecular, cellular, and 
physiological processes that can detect exposure by alteration in 
physiological processes.  

o  Development of screens of cord blood or placenta detect in utero exposure 
to environmental agents along with methods to assess the effects of the 
exposure on organ function at birth and throughout life.

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 the policy 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 an 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. 

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:

Dr. Ethel Jackson, D.D.S.
Chief, 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
111 T.W. Alexander Drive
Research Triangle Park, N.C. 27709
Phone: (919) 541-7826
Fax: (919) 541-2503
E-mail: jackson4@niehs.nih.gov

APPLICATION PROCEDURES

Applicants should follow the instructions for SBIR Phase I submission with the 
modifications as noted in this RFA. A sample Phase I SBIR application can be 
found at http://www.nhlbi.nih.gov/nhlbi/sbir/modelsbi.htm

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 2000-2).  All of the instructions within the Omnibus 
Solicitation apply with the following exceptions:

- Special receipt date
- Additional award considerations
- Increased award amount and duration

Applications received in response to this RFA are to be prepared as described 
in the Omnibus Solicitations for the SBIR program.  Omnibus Solicitations are 
available electronically through the NIH, Office of Extramural Research "Small 
Business Funding Opportunities" at 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf

Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR 
Solicitation Office, phone (301) 206-9385; Fax (301) 206-9722; Email: 
a2y@cu.nih.gov.  Helpful information in preparation of the application can be 
obtained at http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf

Applications in response to this RFA are to be submitted on the applicable 
grant application forms as follows: SBIR Phase I - PHS 6246-1 (1/98) 
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm

The application forms are also located in the back pages of the Omnibus SBIR 
Solicitation.  The RFA title and number must be typed in line 2 on the face 
page of the application form.

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.

SBIR 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).  Phase II applications will be accepted April 1, August 
1, and December 1 after completion of the Phase I applications supported by 
this RFA or as part of a FAST-TRACK application.

Projects may be presented for SBIR support at all stages of exposure 
assessment methodology discovery and development process.  Projects will be 
evaluated on overall innovation and success potential of the product/device or 
biomarker of exposure to environmental agents.  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 investigators 
are accomplishing milestones and time lines presented in the original 
application.

FAST-TRACK: 
Due to the complex nature of the development of products/devices and 
biomarkers of exposure, 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.  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.  If so, the applicant may apply later for Phase II  
support.  Special provisions described in this RFA pertaining to Phase I and 
Phase II also apply to FAST-TRACK applications.

Submit a signed, typewritten original of the application, including the 
Checklist, and one signed, photocopy, 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)

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 Phase I applications. 
Follow the mailing instructions in the Omnibus Solicitation for Phase I or 
FAST-TRACK applications. 

At the time of submission, one additional copy of the application must be sent 
to:

Dr. Ethel Jackson, D.D.S.
Chief, Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 T.W. Alexander Drive
Bldg. 4401, Rm 116
Research Triangle Park, NC 27709
Phone: (919) 541-7826
Fax: (919) 541-2503
E-mail: jackson4@niehs.nih.gov

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the NIEHS 
Scientific Review Branch.  Incomplete applications will be returned to the 
applicant without further consideration.

Applications will be reviewed for scientific and technical merit by an initial 
review group convened by the NIEHS, in accordance with the standard NIH peer 
review procedures.  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 will be discussed and 
assigned a priority score.

REVIEW CRITERIA

Review criteria are described in the Omnibus SBIR Solicitation.  Additional 
review criteria are that the proposal must produce a product, device or 
biomarker that will improve the exposure assessment process and that the 
applications must address the evaluation and validation of the product using 
humans.  The Phase I application should specify clear, measurable goals 
(milestones) that should be achieved prior to initiating Phase II.

Review criteria are described in the NIH Omnibus Solicitation and available on 
the web at the following URL address: 
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers 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 a major scientific impact and thus deserve a high priority 
score. 

1.  Significance.  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?  To what degree does the product rely on state-of-the-art 
technology?

2.  Approach.  Are the conceptual framework, design, and methods adequately 
developed, well integrated, and appropriate to the aims of the project?  Does 
the applicant acknowledge potential problem areas and consider alternative 
tactics?  What is the time frame for developing the proposed technologies and 
suitability of this time frame for meeting the 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 system components? 

3.  Milestones.  How appropriate are the proposed milestones against which to 
evaluate the demonstration of feasibility for transition to the Phase II 
application?

4.  Innovation.  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?  What is the 
throughput and cost effectiveness of the proposed technology?  What additional 
uses can be projected for the proposed technology?

5.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

6.  Environment.  Does the scientific 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.

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" portion of the Omnibus 
Solicitation).

ADVICE ON SUBMITTING APPLICATIONS

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/sbirgrantsmanship.pdf

SCHEDULE

Letter of Intent Date:     October 1, 2000
Application Receipt Date:  November 16, 2000
Review by NAEHSC:          June, 2001
Earliest Award Date:       August, 2001

INQUIRIES

Written and telephone inquiries are encouraged.  The opportunity to clarify 
any issues or questions from potential applicants are welcome.  Inquiries 
regarding programmatic issues may be directed to:

Jerrold Heindel, Ph.D.
Scientific Program Administrator
Organ and Systems Toxicology Branch
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-23
Research Triangle Park, NC 27709
Telephone:  (919) 541-0781
Fax:  (919) 541-5064
E-mail: heindelj@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carolyn Winters
Grants Management Branch
Office of Program Operations
National Institute of Environmental Health Sciences
P.O. 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 and 93.115. Awards are made under authorization of the Public Health 
Service Act, Title IV part A (Public Law 78-419 as amended by Public Law 99-
158, 42USC 241 and 285) and  administered under NIH grants 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 review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood 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.

PHS98-2 is not the current SBIR Solicitation. 

Change to:  This RFA must be read in conjunction with the current calendar year 
Omnibus Solicitation of the National Institutes of Health, Centers for Disease 
Control and Prevention, and Food and Drug Administration for Small Business 
Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase 
I Grant Applications (http://grants.nih.gov/grants/funding/sbirsttr1/index.htm).  
Phase II SBIR application forms and instructions may be may be found on the 
Internet at: http://grants.nih.gov/grants/funding/sbir2/index.htm.  Add the 
following text about budget requests greater than 1 year.

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