NIH Guide: SBIR/STTR E-LEARNING FOR HAZMAT AND EMERGENCY RESPONSE

SBIR/STTR E-LEARNING FOR HAZMAT AND EMERGENCY RESPONSE

RELEASE DATE: May 12, 2004

RFA NUMBER: RFA-ES-04-004

EXPIRATION DATE: August 20, 2004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.113, 93.115 and 95.143

LETTER OF INTENT RECEIPT DATE: July 26, 2004
APPLICATION RECEIPT DATE: August 19, 2004

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 [PDF] or
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word]) 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
(SBIR) and Small Business Technology Transfer (STTR) applications 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/STTR 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 supported curricula and training programs into the
digital world. Proposals to assist NIEHS with its internal management and
operations are not solicited under this SBIR/STTR RFA. NIEHS urges applicants
to review the descriptions of current NIEHS SBIR/STTR awards found at
http://www.niehs.nih.gov/wetp/program/att.htm#awardees and to avoid
duplicating the curricula and subject matter content of these awards. The
following five areas describe the type of products that will be supported
under this SBIR/STTR 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://www.wetp.org/wetp/docs/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/wetp/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.

NOTE: Studies proposed under this RFA will not support vertebrate animals or
human subjects research.

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, 2005. 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. This
program does not require cost sharing as defined in the current NIH Grants
Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#matching_or_cost_sharing.

Except as otherwise stated in this RFA, awards will be administered under NIH
grants policy as stated in the NIH Grants Policy Statement, December 2003,
available at. http://grants.nih.gov/grants/policy/nihgps_2003/.

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 NIEHS 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
Principal Investigator 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:

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 NIEHS staff to estimate the potential review workload and
plan the review.

The letter of intent is to be sent to:

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.) Effective October
1, 2003, applications must have a DUN and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by
calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line
11 of the face page of the PHS 398 forms. 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

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://grants1.nih.gov/grants/funding/phs398/labels.doc or
http://grants1.nih.gov/grants/funding/phs398/labels.pdf

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 (for USPS EXPRESS OR REGULAR MAIL)
Bethesda, MD 20817 (for EXPRESS/COURIER – NON-USPS SERVICE)

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

RECEIPT OF APPLICATIONS: Applications must be received on or before the
receipt date listed on the first page of this announcement. 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 8 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
initial review unless the applicant withdraws the pending application. The CSR
will not accept any application that is essentially the same as one already
reviewed. 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 from the previous unfunded version of the application.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIEHS. Incomplete and/or nonresponsive applications
will not be reviewed.

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 NIEHS in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:

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 written critique.
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. The scientific review group will address and
consider each of the following criteria in assigning the application’s overall
score:

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.

ADDITIONAL REVIEW 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 APPLICATIONS: 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 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: For Phase I/Phase II
Fast-Track applications, 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 (formerly Product
Development Plan) that adequately addresses the seven 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 report
Hazwoper Training:Utilizing Advanced Training Technologies in 1999
http://www.wetp.org/wetp/docs/workshops/niosh/ATT_report_summary.htm, the
WETP ATT Lessons Learned Report in September 2000
http://www.wetp.org/wetp/att/ATTReport2000-09-18.pdf, and the Development of
an Integrated WETP ATT Program: Final Report 2001
http://www.wetp.org/wetp/att/ATTFINALDRAFT31JAN01a.doc.

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, 2004
Application Receipt Date: August 19, 2004
Peer Review Date: November/December 2004
Council Review: February 2005
Earliest Anticipated Start Date: April 1, 2005

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
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.

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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