E-LEARNING FOR HAZMAT AND EMERGENCY RESPONSE (SBIR/STTR INITIATIVE) 

RELEASE DATE:  April 14, 2003

RFA:  ES-03-008

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.115 and 95.143

LETTER OF INTENT RECEIPT DATE: July 19, 2003

APPLICATION RECEIPT DATE: August 19, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Project Period and Amount of Award
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria 
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

NOTICE: This Request for Application (RFA) must be read in conjunction with 
the current 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) GRANT APPLICATIONS. The solicitation (see  
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)contains information 
about the SBIR and STTR programs, regulations governing the programs, and 
instructional information for submission. All of the instructions within the 
SBIR/STTR Omnibus Solicitation apply. 

PURPOSE OF THIS RFA

The purpose of this RFA is to further the development of Advanced Technology 
Training (ATT) Products for the health and safety training of hazardous 
materials (HAZMAT) workers, emergency responders, and skilled support 
personnel.

The mission of the National Institute of Environmental Health Sciences 
(NIEHS) is to promote research and training that will ultimately reduce the 
burden of human disease and illness occurring as a consequence of exposure to 
hazardous environmental substances.  

The major objective of the NIEHS Worker Education and Training Program is to 
prevent work related harm by assisting in the training of workers in how best 
to protect themselves and their communities from exposure to hazardous 
materials encountered during hazardous waste operations, hazardous materials 
transportation, environmental restoration of contaminated facilities or 
chemical/biological/radiological emergency response and clean-up. The 
creation of prevention partnerships between employers, employees, 
universities and community members has been a hallmark of the program. A 
major goal of the NIEHS program is to assist organizations efficiently and 
effectively with the development of institutional competency to provide 
appropriate model training and education programs to hazardous materials 
handlers, chemical emergency responders, and waste cleanup workers, as 
specified in Section 126 (g) of the Superfund Amendments and Reauthorization 
Act of 1986 (SARA), and skilled support personnel as defined in CFR 1910.120.

The NIEHS program has been funded primarily on the basis of the worker 
protection statutes of the Superfund Amendments and Reauthorization Act of 
1986 (Section 126 of SARA). Since its authorization by Congress in 1986, the 
NIEHS Worker Education and Training Program (WETP) has been funding the 
development, deployment, and utilization of state-of-the–art safety and 
health training for hazardous waste operations workers and chemical emergency 
responders. In addition, the WETP began administering additional grant awards 
for such training that has been funded by the Department of Energy to meet 
that Department's expanding high hazard operations training needs associated 
with the massive environmental restoration program being undertaken by the 
DOE Office of Environmental Management (EM). More recently, additional 
training grant awards have been executed and managed by WETP targeting 
minority HAZWOPER workers and the EPA Brownfields program. Since September 
11, 2001, WETP has awarded supplemental training grants in response to 
weapons of mass destruction incidents.

Through the encouragement of multi-state, university-based consortia and the 
development of national non-profit organizations which have focused on 
specific workforce sectors, the program has established technically-
proficient curriculum materials and quality-controlled course presentations. 
These courses have been delivered to hazardous materials workers, emergency 
responders, and skilled support personnel in every region of the country and 
have established new national benchmarks for quality worker safety and health 
training.  

The immediate goal of worker health and safety training is educational in 
nature, designed to provide students with relevant information, program-
solving skills, and the confidence needed to use these tools.  Long-term 
goals of the model training programs should be to assure that workers become 
and remain active participants in determining and improving the health and 
safety conditions under which they work and that avenues for collaborative 
employer-employee relationships in creating safe workplaces are established.

In recent years there have been enormous technological advancements in 
computer-based technologies and applications. These Advanced Training 
Technologies (ATT) include a wide variety of electronic learning (e-learning) 
components. Distance learning, electronic classrooms, interactive TV, 
multimedia, computer-based training, computer-assisted training, virtual 
reality training simulations, CD, CD-R, DVD and video teleconferencing, among 
others, have and are being developed and advanced to support expanding 
training needs and requirements. 

NIEHS intends to build on its program experience in environmental safety and 
health training by stimulating creative Small Business Innovative Research 
proposals to create ATT products that will support high quality health and 
safety training for hazardous materials workers, emergency responders, and 
skilled support personnel. To further enhance our ability to move toward 
commercialization of ATT products relevant to model safety and health 
training for hazardous materials workers, emergency responders, and skilled 
support personnel, this initiative focuses on the development of technology 
driven commercial products using the Small Business Innovative Research 
(SBIR)/Small Business Technology Transfer Research (STTR) program.  

In December 2001 NIEHS WETP released RFA-ES-02-002: Initial Development Of 
Innovative E-Learning Products For Worker Safety And Health Training In 
Hazardous Waste And Chemical Emergency Response. In September 2002 NIEHS 
WETP, made one one-year and three two-year Phase I awards in response to 
RFA-ES-02-002. This new RFA, while incorporating the goals of the original RFA, 
builds upon it, by recognizing the need for the application of advanced 
training technologies that focus on chemical, biological, and radiological 
training for skilled support personnel.

NIEHS WETP, in considering the development and application of ATT to worker 
safety and health training, has realized that there is a substantial 
challenge of integrating this new technology to our awardee organizations. 
This challenge is associated with the fact that each of the WETP awardee 
organizations is different with regard to its training target audience, the 
computer literacy and access to such technology among its target audience, 
the work its training target population performs, and training delivery 
methods and means among others. In many ways, these challenges reflect the 
current reality of delivering job-related training content to any adult 
population in the United States. The digital divide in its various 
manifestations is a reality for anyone who attempts to use ATT approaches to 
effectively reach target populations with low levels of computer experience 
and knowledge. This concern for hazardous waste workers and chemical 
emergency responders has been particularly acute for a high risk target 
population, which is characterized by ethnic and cultural diversity, low 
levels of formal education, and minimal prior computer fluency.

Given the WETP core values for hands-on learning, instructor-to-learner, and 
learner-to-learner interaction is viewed as a very valuable part of the 
learning experience. Thus, wholesale replacement of an instructor-led course 
with ATT methods is not normally desirable. The virtual unanimity of views 
expressed by participants at the initial WETP ATT workshop in 1999 indicates 
that successful ATT insertion into an NIEHS-type program would require a 
careful understanding of the relationship between individual skill-based 
components and hands-on, instructor and worker-oriented training. The 
consensus of the workshop participants was that these elements need to be 
clearly identified and that any ATT enhancements must be clearly shown to be 
compatible with these skill objectives for an ATT driven training program to 
be successful.

It is clear that there is a growing convergence between both Learning 
Management Systems (LMS) and Knowledge Management Portals, which should merge 
into more learner-centered technology. Moreover, there is a continuing 
synthesis of traditional classroom pedagogy and the purely on-line or 
computer-based method of learning, which have been characterized as a blended 
learning approach. The NIEHS WETP Advanced Training Technology (ATT) 
Initiative has already created a wealth of background materials that have 
explored the application of technology-supported learning to the safety and 
health field.

RESEARCH OBJECTIVES

NIEHS encourages applicants to this SBIR RFA to review the relevant program 
documentation, to pursue partnerships and collaboration with awardees of the 
WETP program, and to design new ATT or e-learning products that can extend 
the existing NIEHS curricula and training programs into the digital world. 
The following five areas describe the type of products that will be supported 
under this SBIR RFA. Examples include but are not limited to:

A. Products to support e-collaboration in safety and health training:
"E-collaboration in safety and health training" involves enabling 
collaborative development of course materials by personnel widely separated 
geographically within the same organization and between collaborators working 
for different organizations. Some of these course materials exist and can be 
transmitted electronically via the Internet to the instructors and/or 
learners across the nation or world.  
 
In addition to traditional face-to-face meetings and phone calls, a number of 
electronic tools and online approaches can be used to facilitate distributed 
teams in their creating or updating instructional products. These 
capabilities include email, list serves, bulletin boards, chat rooms, 
threaded discussion groups, ftp, and web-enabled database-oriented 
development tools. Potential products include but are not limited to: 
 
1. Create a database enabling instructors from all over the country to add 
new case studies in hazardous materials response. As an instructor is 
preparing to teach a course, he or she searches through this database to find 
the four most applicable problems. These problems are then downloaded and 
printed and included in the learner's binders. 

2. Develop a technology application to enable electronic distribution of 
self-study and classroom based curriculum materials to instructors and 
learners who are involved hazardous materials response. This saves 
significant dollars in shipping and allows for an entire community to have 
the latest materials always available to them. 

3. Create an electronic forum with collaboration tools to discuss needs and 
provide feedback regarding new or existing courses via list serve or enable 
hazardous materials instructors to post requests/recommendations to others in 
the training community regarding existing courses, resources, and lessons 
learned that have been deployed.  

B. Products to support e-certification in safety and health training:
"E-certification in safety and health training" involves preparing and 
maintaining instructor competence as a critical issue in creating and 
maintaining the quality of health and safety training delivery and assuring 
adequate worker protection. This ATT option entails the use of online 
resources to improve instructor competence. The role of the instructor is 
highly valued in the WETP. Many grantee programs have systematic approaches 
to train, certify, and maintain instructor competence in both the content 
matter and in teaching skills. Potential products include but are not limited 
to: 
 
1. Developing a system to provide pre-class training as an approach to 
deliver information before a class event to learners. For example, the 
International Union of Operating Engineers (IUOE) has created three ATT 
knowledge-oriented courses to be completed by prospective peer trainers prior 
to attending their live Instructor Certification course. 

2. Creating a web-based product for supporting online discussions among 
instructors as an approach that can stimulate exchange before a formal 
training begins. For example, the International Association of Firefighters 
(IAFF) has created an online bulletin board that instructors can use to ask 
content and teaching methodology questions. 

3. Sharing electronic or printable resources as an approach that can make 
large reference materials and resources open to learners at any time. The 
IAFF has also created an online bulletin board that supports posting and 
sharing of instructor produced electronic resources.   

4. Providing access tools to knowledge-oriented resources through innovative 
technology deployment to extend training effectiveness and continuity. Pre-
assessments (knowledge self-checks) could be posted as an "Am I ready" 
(useful prior to teaching various courses), coupled with learning resources, 
online reviews, or FAQ's (Frequently Asked Questions).  

5. Facilitating learning technology for ATT-augmented classroom teaching as 
an effective feedback and collaboration approach for training in multiple 
locations. Stored streaming video clips of effective live classroom 
techniques including how to use ATT effectively as a tool in the classroom 
can also be a resource to trainers. 

C. Products to support e-teaching in safety and health training:
"E-teaching in safety and health training" encompasses live or virtual 
classroom training as significant part of effective safety and health 
training delivery. A key WETP core value relative to ATT is to preserve the 
role of the trainer/instructor in classroom-like environments in the 
modeling, teaching and verifying of skills and knowledge. This ATT option for 
safety and health training delivery looks directly at ways technology can be 
used appropriately in live instructor-led, face-to-face and virtual 
classrooms. Potential products include but are not limited to:

1. Creating applications for augmenting the face-to-face classroom 
environment as an approach that can foster collaborative learning. Recent 
years have seen a remarkable improvement in the capability and quality of 
what can be presented electronically in the instructor-led classroom. High 
quality fixed or portable projectors can be attached to desktop or portable 
computers to enable the instructor to augment the classroom learning 
experience in very exciting ways.  
  
2. Technology applications for using special computer-equipped classrooms to 
bring technology seamlessly into the learning process. Some classrooms, 
particularly those designed to teach programming or use of the Internet will 
have several networked computers (one for each learner or pair of learners). 
In these classrooms, the instructor can facilitate the hands-on learning of 
the new skills and may be able to show the entire class what one individual 
or team is learning. Group brainstorming and decision-making, if appropriate 
to the class objectives, are also supported in these classrooms. 
 
3. Technology applications for broadcasting live classes to remote learners 
that can reach learners who have no access to technical safety and health 
resources. Various new web broadcasting technologies are making it possible 
for an instructor to teach in real time over the Internet (similar to video 
conferencing which works over phone lines or satellite broadcasts that must 
be up-linked and then picked up through receivers). The most sophisticated 
systems digitize and send a video (and audio) stream (live) over the Internet 
that learners can pickup at their desktops or in learning centers.

4. Creating applications that recognize the needs of populations with low 
rates of literacy and assist instructors in meeting these needs.  This could 
include products aimed at students with limited computer and Internet skills 
and access.  

D. Products to support e-learning in safety and health training: "E-learning 
in safety and health training" involves technology deployment to provide 
individualized or small group based training in learning centers, in a 
technology-enabled "smart classroom" or to learner's desktop is a core part 
of the technology-supported learning process.  As an ATT option, e-learning 
is used to enable individualized learning, at the learners' convenience and 
own pace, prior to, as part of, after, or in place of classroom training. E-
learning capability is now available to learners at their workplace (desktop, 
shared computer/kiosk, or learning center) and optionally at home or at the 
union hall. While multimedia computers connected to the Internet are much 
more widely available each year, care must be taken to ensure that a targeted 
set of learners will in fact have the needed access to workstations or 
learning centers. Potential products include but are not limited to: 

1. Creation of applications to provide pre-class assessment and preparatory 
assignments. Just as instructors within IUOE program have been required to 
complete certain online courses prior to coming to their onsite instructor 
certification course, there may be analogous situations where learners who 
may have not been required to use what they learned previously to do some 
online pre-assessing and reviewing. This would enable them to catch up to 
main group and greatly simplify the instructor's job. It may also enable the 
classroom activities to be more focused on application and doing than on 
background information and knowledge. 

2. Building a technology-supported learning medium for separating out 
knowledge-based components of a health and safety course and teaching it via 
a blended approach. Using primarily online methods, Hazardous Materials 
Training and Research Institute's (HMTRI) online HAZWOPER course is an 
excellent example for this application. For courses with objectives beyond 
familiarization, these knowledge-based components (sub-courses) must be 
matched with hands-on components (sub-courses). Familiarization-only courses 
may be appropriate as stand alone online or off-line courses as there is no 
implied capabilities to be demonstrated other than awareness. The following 
are types of content and activities that are commonly taught in this manner: 
facts and concept knowledge acquisition including drill and practice (e.g. 
rail-workers first responder course). Animations and simulations including 
virtual walkthroughs, procedure practice, case studies, problems, assignments 
and quizzes and tests may also be part of this application approach. 

3. Creation of an Electronic Performance Support System (EPSS) as a post-
training resource for workers involved in HAZWOPER activities. Providing 
post-class follow-up, refresher training, review and online reference allows 
learners to re-access the online course and materials for up to a year after 
completing it. The traditional workplace or craft-based EPSS may also be 
blended with knowledge management or web-based portal applications. 

4. Learning technology applications and collaboration tools for augmenting 
live or individualized training with email, discussion groups, and other 
collaborative tools for not-at-the-same-time (asynchronous) communications 
and learning. This can be done between instructor and student(s) via email to 
provide feedback and answer questions or between students working as teams 
and on group assignments (via discussion groups and collaborative tools). 

5. Creating applications that recognize the needs of populations with low 
rates of literacy. This could include products aimed at students with limited 
computer and Internet skills.  

E. Products to support the training of skilled support personnel (SSP 
involved in responses to weapons of mass destruction (WMD)incidents:  SSP 
played key roles in the Oklahoma City, Pentagon, and World Trade Center 
terrorist incidence responses. SSP include a wide range of job categories 
such as laborers, operating engineers, carpenters, ironworkers, sanitation 
workers, and utility workers. Training for SSP should be based upon a 
foundation of HAZWOPER (Hazardous Waste Operations and Emergency Response 
Standard) training with refresher training used as one vehicle to update and 
get new information out to SSP. While sections A, B, C, and D above may be 
interpreted to include SSP, additional training issues were identified in the 
NIEHS WETP report "Learning From Disasters: Weapons of Mass Destruction 
Preparedness Through Worker Training." This report is available on-line at 
http://wetp.org/oldchfiles/awardee_mtgs/spring02/WMDreport.pdf
Additional training issues were also identified in the NIEHS WETP report 
"Improving the Training of Secondary Responders to Terrorist Actions: A 
Review of the Problem and Feasible Solutions." This report is available on-
line at http://www.wetp.org/newsbriefs/jan03/Jan3_NIEHSFeasibility.pdf

Among the additional training issues identified were:

1. The need for short, incident specific awareness training that can be 
delivered prior to entry into a response action. This e-product would assist 
in a training that must include instruction in the wearing of appropriate 
personal protective equipment, what WMD hazards are involved, and what duties 
are to be performed. 

2. The need for cross training about the roles of other responders.  SSP can 
provide enhanced assistance to the first responder operations (fire, 
emergency medical services, search and rescue, and law enforcement) during 
early phases of an incident response if they better understand the response, 
rescue, and recovery activities. For example, the scene of a terrorist 
incident is also a crime scene; therefore, understanding the role of criminal 
investigators is an important issue for SSP.

3. The need for incident command system training. SSP often do not fully 
understand their own duties and responsibilities within the incident command 
system including their place in the incident chain of command. 

4. The need to incorporate awareness-level training on WMD into the basic 40 
hour Hazardous Waste Operations and Emergency Response Standard (HAZWOPER) 
course.

5. The need to address other, specific training issues. These issues include 
confined spaces, blood borne pathogens, personal protective equipment, 
HAZCOM, hazard assessment, fire watch, first aid/CPR, site safety, working 
around heavy equipment, physical threats such as heat stress, fatigue, shift 
work, fall protection, and psychological stress.  

MECHANISM(S) OF SUPPORT

This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project. Future unsolicited, competing-continuation 
applications based on this project will compete with all SBIR/STTR 
applications and will be reviewed according to the customary peer review 
procedures. The anticipated award date is April 1, 2004. Applications that 
are not funded in the competition described in this RFA may be resubmitted as 
NEW SBIR/STTR applications using the standard receipt dates for NEW 
applications described in the current SBIR/STTR Omnibus Solicitation.

This RFA uses just-in-time concepts. It also uses the modular budgeting 
format. Specifically, if you are submitting an application budget of $100,000 
total costs (direct, F&A and fee) or less, use the modular format and 
instructions as described in the current SBIR/STTR Omnibus Solicitation. 
Otherwise follow the instructions for non-modular research grant 
applications. This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Except as otherwise stated in this RFA, awards will be administered under NIH 
grants policy as stated in the NIH Grants Policy Statement, March 2001, 
available at http://grants.nih.gov/grants/policy/nihgps_2001.  

Applications may be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus 
Solicitation. Phase II applications in response to this RFA will only be 
accepted as competing continuations of previously funded NIH Phase I 
SBIR/STTR awards. The Phase II application must be a logical extension of the 
Phase I research but not necessarily a Phase I project supported in response 
to this RFA. Fast Track applications will benefit from expedited evaluation 
of progress following the Phase I feasibility study for transition to Phase 
II funding for expanded developmental work. 

PROJECT PERIOD AND AMOUNT OF AWARD
 
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards. For this RFA, budgets up to $100,000 total costs per year 
and time periods up to one year for Phase I may be requested. Budgets up to 
$200,000 total costs per year for up to two years may be requested for Phase 
II. Total costs include direct costs, F&A, and fee/profit.  

FUNDS AVAILABLE 

The NIEHS intends to commit approximately $750,000 to fund four to six Phase 
I and/or Phase II applications under the SBIR/STTR set-aside funding 
mechanism. Although the financial plans of the (IC) provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications. At 
this time, it is not known if competing renewal applications will be accepted 
and/or if this RFA will be reissued.

ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. 
Only small business concerns are eligible to submit SBIR/STTR applications. A 
small business concern is one that, on the date of award for both Phase I and 
Phase II agreements, meets ALL of the criteria as described in the current 
SBIR/STTR Omnibus Solicitation.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs. On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) with the 
small business at the time of award and for the duration of the project. The 
PI on an STTR application may be employed with the small business concern or 
the participating non-profit research institution as long as he or she has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 

SPECIAL REQUIREMENTS  

These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant 
Administration policy statements.

o Awardees will be required to meet at least twice annually to review
progress, share information, and to coordinate training activities.  Since 
awards may be made to applicants that are unfamiliar with NIH grant 
assistance procedures, business officials are expected to meet at least 
annually to review NIH grant management policies.

o Each awardee shall participate annually in two technical workshops, which 
will be sponsored and planned by the NIEHS Program Administrator.  The 
technical workshops will present relevant and topical information to assure 
the continued high quality of worker safety and health training activities 
carried out by the awardees and encourage the exchange of significant 
information regarding effective raining techniques and approaches.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

o Direct questions about scientific/research issues to:

Ted Outwater
Public Health Educator
Worker Education and Training Program 
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
111 T.W. Alexander Drive, EC-25
P.O. Box 12233
Research Triangle Park, NC 27709 
E-mail:  outwater@niehs.nih.gov
Phone:  919-541-2972
Fax: 919-541-0462
http://www.niehs.nih.gov/wetp/home.htm

Direct inquiries about peer review issues to:

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 (EC-30)
Research Triangle Park, NC 27709

Courier Service Address:
Building 4401 - Room 3173
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: (919) 541-1446
Fax:  (919) 541-2503
Email: eckertt1@niehs.nih.gov

Direct inquiries about financial or grants management matters to: fiscal 
matters to:

Ms. Carolyn Mason
Deputy Grants Management Officer
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233 
79 T.W. Alexander Drive, MD EC-22
Research Triangle Park, NC  27709
Telephone: (919) 541-1373
Fax: (919) 541-2860
E-mail: mason6@niehs.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 IC staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent to:

Sally E. Eckert-Tilotta, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 (EC-30)
Research Triangle Park, NC 27709

Courier Service Address:
Building 4401 - Room 3173
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: (919) 541-1446
Fax:  (919) 541-2503
Email: eckertt1@niehs.nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track applications (new and revised.) The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare 
your application in accordance with the SBIR/STTR Omnibus Solicitation and 
the PHS 398. Helpful information for advice and preparation of the 
application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will 
return applications that are not submitted on the 5/2001 version of the PHS 
398. For further assistance contact GrantsInfo, Telephone: (301) 435-0714, 
Email: GrantsInfo@nih.gov

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: This RFA uses the 
modular budgeting format. Specifically, if you are submitting an application 
budget of $100,000 total costs (direct, F&A and fee) or less, use the modular 
format and instructions as described in the SBIR/STTR Omnibus Solicitation. 

USING THE RFA LABEL: The RFA label available in the PHS 398 application form 
must be affixed to the bottom of the face page of the application. Type the 
RFA number on the label.  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 RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf
 
The title and number of this RFA must be typed on line 2 of the face page of 
the application.

SENDING AN APPLICATION TO THE NIH: 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)

To expedite the review process, at the time of submission, send two copies of 
the application to: 

Sally E. Eckert-Tilotta, PhD,
Scientific Review Administrator
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233 (EC-30)
Research Triangle Park, NC 27709

Courier Service Address:
Building 4401 - Room 3173
79 T.W. Alexander Drive
Research Triangle Park, NC 27709
Phone: (919) 541-1446
Fax:  (919) 541-2503
Email: eckertt1@niehs.nih.gov

APPLICATION PROCESSING: 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.

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. However, when 
a previously unfunded application, originally submitted as an investigator-
initiated application, is to be submitted in response to an RFA, it is to be 
prepared as a NEW application. That is the application for the RFA must not 
include an introduction describing the changes and improvements made, and the 
text must not be marked to indicate the changes. While the investigator may 
still benefit from the previous review, the RFA application is not to state 
explicitly how. 

PEER REVIEW PROCESS

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:

o Receive a written critique.
o 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 and assigned a priority score.
o Receive a second level review by the NIEHS National Advisory Council. 

REVIEW CRITERIA

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 the goals within 
the context of the SBIR/STTR Program: 

o Significance
o Approach
o Innovation
o Investigator
o Environment

ALL SBIR/STTR APPLICATIONS

1. SIGNIFICANCE: Does the proposed project have commercial potential to lead 
to a marketable product or process? Does this study address an important 
problem? What may be the anticipated commercial and societal benefits of the 
proposed activity? If the aims of the application are achieved, how will 
scientific knowledge 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?

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 strategies? Are the milestones and evaluation 
procedures appropriate?

3. INNOVATION: Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies? Are the aims original and 
innovative? 

4. INVESTIGATORS: 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 technological 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

Review criteria are described in the Omnibus SBIR Solicitation and available 
on the web at the following URL address: 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf

Additional review criteria are that the proposal must produce a learning 
technology that is relevant to health and safety issues faced by hazardous 
materials workers, chemical emergency responders, or skilled support 
personnel and that the application must address the evaluation and validation 
of the method. The Phase I application should specify clear, measurable goals 
and milestones.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See additional information and 
criteria included in the section for Federal Citations, below.) 

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for all scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated. (See additional information and Inclusion Criteria in the sections 
on Federal Citations, below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the required five items described under Vertebrate 
Animals (section f of the Research Plan instructions) will be assessed.

Human Subjects:

1. Protection of Human Subjects from Research Risks - for all studies 
involving human subjects. See instructions and "Guidance for Preparing the 
Human Subjects Research Section."

If an exemption is claimed, is it appropriate for the work proposed? If no 
exemption is claimed, are the applicant's responses to the six required 
points appropriate? 

Are human subjects placed at risk by the proposed study? If so, are the risks 
reasonable in relation to the anticipated benefits to the subjects and 
others? Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained?

Are the plans proposed for the protection of human subjects adequate?

2. Inclusion of Women Plan - for clinical research only. Does the applicant 
propose a plan for the inclusion of both genders that will provide their 
appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent? 
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants?

3. Inclusion of Minorities Plan - for clinical research only. Does the 
applicant propose a plan for the inclusion of minorities that will provide 
their appropriate representation? Does the applicant provide appropriate 
justification when representation is limited or absent?
Does the applicant propose appropriate and acceptable plans for 
recruitment/outreach and retention of study participants?

4. Inclusion of Children Plan - for all studies involving human subjects. 
Does the applicant describe an acceptable plan in which the representation of 
children of all ages (under the age of 21) is scientifically appropriate and 
recruitment/retention is addressed realistically? If not, does the applicant 
provide an appropriate justification for their exclusion?

5. Data and Safety Monitoring Plan - for clinical trials only. Does the 
applicant describe a Data and Safety Monitoring Plan that defines the general 
structure of the monitoring entity and mechanisms for reporting Adverse 
Events to the NIH and the IRB?

Animal Welfare: If vertebrate animals are involved, are adequate plans 
proposed for their care and use? Are the applicant's responses to the five 
required points appropriate? Will the procedures be limited to those that are 
unavoidable in the conduct of scientifically sound research?

Biohazards: Is the use of materials or procedures that are potentially 
hazardous to research personnel and/or the environment proposed? Is the 
proposed protection adequate?

DATA SHARING: The adequacy of the proposed plan to share data. 

ADDITIONAL CONSIDERATONS: The following items may also be considered by 
reviewers but will not be included in the determination of scientific merit:

BUDGET: The reasonableness of the proposed budget may be considered. For all 
applications, is the percent effort listed for the Principal Investigator 
appropriate for the work proposed? On applications requesting up to $100,000 
total costs, is the overall budget realistic and justified in terms of the 
aims and methods proposed? On applications requesting over $100,000 in total 
costs, is each budget category realistic and justified in terms of the aims 
and methods?

PERIOD OF SUPPORT: The appropriateness of the requested period of support in 
relation to the proposed research.

Phase II Application Review Criteria: In addition to the above criteria:

1. How well did the applicant demonstrate progress toward meeting the Phase I 
objectives, demonstrating feasibility, and providing a solid foundation for 
the proposed Phase II activity?

2. Did the applicant submit a concise Commercialization Plan (formerly 
Product Development Plan) that adequately addresses the four areas described 
in the Research Plan, item J?

3. Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan?

Amended Applications: In addition to the above criteria, the following 
criteria will be applied to revised applications: 

1. Are the responses to comments from the previous SRG review adequate? 

2. Are the improvements in the revised application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria: The following 
criteria also will be applied:

1. Does the Phase I application specify clear, appropriate, measurable goals 
(milestones) that should be achieved prior to initiating Phase II?

2. Did the applicant submit a concise Commercialization Plan that adequately 
addresses the four areas described in the Research Plan, item J?

3. To what extent was the applicant able to obtain letters of interest, 
additional funding commitments, and/or resources from the private sector or 
non-SBIR/STTR funding sources that would enhance the likelihood for 
commercialization?

4. Does the project carry a high degree of commercial potential, as described 
in the Commercialization Plan?

Phase I and Phase II Fast-Track applications that satisfy all of the review 
criteria will receive a single rating. Failure to provide clear, measurable 
goals may be sufficient reason for the scientific review group to exclude the 
Phase II application from Fast-Track review.

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 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.

o Applicants should adequately address the concerns raised in the NIEHS WETP 
ATT HAZWOPER in April 1999, the WETP ATT Pilots Lessons Learned Report in 
September 2000, and the Development of an Integrated WETP ATT Program: Final 
Report in April 2001. These reports are located at 
http://www.wetp.org/index.cfm?fuseaction=att

o Applications should describe the potential creation of further 
opportunities for testing, evaluating, mentoring and partnership building 
between various NIEHS WETP consortia and other grantee organizations in the 
development and deployment of e-learning products for safety and health 
training.

o Proposed product development research should propose methodologies for the 
development, delivery and evaluation of health and safety content with a 
focus on new, technology-supported approaches that improve learning, reduce 
costs, and can be demonstrated as effective. 

o Each of the proposed product research and development processes should 
include an effectiveness evaluation schema to assess the learning and 
retention process as part of the product deployment, as well as a lessons 
learned format to document and capture the process of product development and 
documentation.

o Proposed learning products should be created for compatibility with the 
federal government's Sharable Content Object Reference Model (SCORM) to 
assure interoperability of technology-supported learning applications.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  July 19, 2003
Application Receipt Date:  August 19, 2003
Peer Review Date:  November/December 2003
Council Review:  February 2004
Earliest Anticipated Start Date:  April 1, 2004

AWARD CRITERIA

Applications submitted in response to an RFA will compete for available funds 
with all other recommended SBIR and STTR applications. The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

For FAST-TRACK applications, the Phase II portion may not be funded until a 
Phase I final report and other documents necessary for continuation have been 
received and assessed by program staff that the Phase I milestones have been 
successfully achieved. 

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures. In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling justification is 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 clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html;)
a complete copy of the updated Guidelines are available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community. The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects. You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html
Only research using hESC lines that are registered in the NIH Human Embryonic 
Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov). It is the responsibility of the applicant to provide 
the official NIH identifier(s)for the hESC line(s)to be used in the proposed 
research. Applications that do not provide this information will be returned 
without review. 

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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. Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

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 
RFA 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. 

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review. Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement. The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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