Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

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

Title: SBIR/STTR E-learning for HAZMAT and Emergency Response

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Request For Applications (RFA) Number: RFA-ES-05-003

Notice: This funding opportunity 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 current SBIR/STTR Omnibus Solicitation apply. Exceptions are noted in the Executive Summary.

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.115, 95.143

Key Dates
Release Date: June 9, 2005
Letters of Intent Receipt Date(s): July 22, 2005
Application Receipt Dates(s): August 18, 2005
Peer Review Date(s): November/December 2005
Council Review Date(s): February 2006
Earliest Anticipated Start Date: April 1, 2006
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: August 19, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

 Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

 Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

 Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Receipt and Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

 Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting

 Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

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.

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.

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the STTR (R41/R42) and SBIR (R43/R44) grant mechanism(s). Applications may be submitted for support as Phase I, Phase II or Fast-Track grants as described in the SBIR/STTR Omnibus Solicitation. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and the SBIR/STTR Omnibus Solicitation.

Phase II applications in response to this funding opportunity will only be accepted as competing continuations of previously funded Phase I SBIR or STTR awards. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity.

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, 2006.

This funding opportunity uses just-in-time concepts. Effective with the release of the PHS 2005-2 SBIR/STTR Omnibus Solicitation, the modular budget format is no longer accepted for SBIR/STTR grant applications. Applicants must complete and submit budget requests using Form Page 4 and Form Page 5.

2. Funds Available

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 funding opportunity, budgets up to $ 100,000 total costs per year and time periods up to 1 year for Phase I may be requested. Budgets up to $ 200,000 total costs per year and up to 2 years may be requested for Phase II. Total costs include direct costs, F&A, and fee/profit.

The participating IC ( NIEHS) intends to commit approximately $ 786,000 dollars in FY 06 to fund 3-7 Phase I and/or Phase II or Fast-Track applications under the SBIR/STTR set-aside funding mechanism. Although the financial plans of the IC(s) 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only U.S. 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.

1.B. Eligible Individuals

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.

For a 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 s/he 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.

2. Cost Sharing or Matching

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.

3. Other-Special Eligibility Criteria

The NIH will accept as many "different" applications as the applicant organization chooses. However, NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and the SBIR/STTR Omnibus Solicitation.

Section IV. Application and Submission Information

1. Address to Request Application Information

Application submission instructions are contained in Part I of the SBIR/STTR Omnibus Solicitation available from the NIH Small Business Funding website http://grants.nih.gov/grants/funding/sbir.htm. For further assistance contact Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all SBIR/STTR applications (new and revised) using the most current PHS 398 research grant application forms in accordance with the instructions provided in the SBIR/STTR Omnibus Solicitation. Applications must have a D&B Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: July 22, 2005
Application Receipt Date(s): August 18, 2005
Peer Review Date: November/December 2005
Council Review Date: February 2006
Earliest Anticipated Start Date: April 1, 2006

3.A.1. Letter of Intent

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

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 by the date listed at the beginning of this document.

The letter of intent should 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

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application forms as described above. 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must 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

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIEHS . Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission 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.

Applicants 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.

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.

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.

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.

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.

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.

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.

Plan for Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year should include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared. If the final data are not amenable to sharing, for example, if they are proprietary, this must be explained in the application. Under the Small Business Act, SBIR/STTR grantees may withhold their data for four years after the end of the award. The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all SBIR/STTR data developed from work performed under an SBIR/STTR funding agreement for a period of 4 years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR/STTR award, or by agreement between the small business concern and NIH. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center staff likely to accept assignment of their application.

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For more information on data sharing see http://grants.nih.gov/grants/policy/data_sharing/.

Sharing Research Resources
Not applicable

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

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:

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

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

All SBIR/STTR Applications

Significance: Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application 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?

Approach: Are the conceptual or clinical 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?

Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigator: Is the principal investigator appropriately trained and capable of coordinating and managing the proposed SBIR/STTR? Are the investigators and well suited to carry out this work? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? 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?

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 studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Phase II Applications
In addition to the above review 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 specific areas described in Item K of the Phase II Research Plan?

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 that adequately addresses the specific areas described in Item K of the Phase II Research Plan?

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.

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.

Type 2 Phase II Competing Continuation Applications
Not applicable

2.A. Additional Review Criteria:
Not applicable

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? 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.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Patricia P. Thompson
Program Analyst
Worker Education and Training Branch
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
Phone: 919-541-0117
Fax: 919-541-0462
E-mail: thompso2@niehs.nih.gov
Web: http://www.niehs.nih.gov/wetp/home.htm

Ted Outwater
Public Health Educator
Worker Education and Training Branch
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
Web: http://www.niehs.nih.gov/wetp/home.htm

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

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

Section VIII. Other Information

Required Federal Citations

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 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 funding opportunity 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 PA 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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