E-LEARNING FOR HAZMAT AND EMERGENCY RESPONSE (SBIR/STTR INITIATIVE) RELEASE DATE: April 14, 2003 RFA: ES-03-008 National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.115 and 95.143 LETTER OF INTENT RECEIPT DATE: July 19, 2003 APPLICATION RECEIPT DATE: August 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Project Period and Amount of Award o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations NOTICE: This Request for Application (RFA) must be read in conjunction with the current OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS. The solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the SBIR/STTR Omnibus Solicitation apply. PURPOSE OF THIS RFA The purpose of this RFA is to further the development of Advanced Technology Training (ATT) Products for the health and safety training of hazardous materials (HAZMAT) workers, emergency responders, and skilled support personnel. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to promote research and training that will ultimately reduce the burden of human disease and illness occurring as a consequence of exposure to hazardous environmental substances. The major objective of the NIEHS Worker Education and Training Program is to prevent work related harm by assisting in the training of workers in how best to protect themselves and their communities from exposure to hazardous materials encountered during hazardous waste operations, hazardous materials transportation, environmental restoration of contaminated facilities or chemical/biological/radiological emergency response and clean-up. The creation of prevention partnerships between employers, employees, universities and community members has been a hallmark of the program. A major goal of the NIEHS program is to assist organizations efficiently and effectively with the development of institutional competency to provide appropriate model training and education programs to hazardous materials handlers, chemical emergency responders, and waste cleanup workers, as specified in Section 126 (g) of the Superfund Amendments and Reauthorization Act of 1986 (SARA), and skilled support personnel as defined in CFR 1910.120. The NIEHS program has been funded primarily on the basis of the worker protection statutes of the Superfund Amendments and Reauthorization Act of 1986 (Section 126 of SARA). Since its authorization by Congress in 1986, the NIEHS Worker Education and Training Program (WETP) has been funding the development, deployment, and utilization of state-of-the‚Äďart safety and health training for hazardous waste operations workers and chemical emergency responders. In addition, the WETP began administering additional grant awards for such training that has been funded by the Department of Energy to meet that Department's expanding high hazard operations training needs associated with the massive environmental restoration program being undertaken by the DOE Office of Environmental Management (EM). More recently, additional training grant awards have been executed and managed by WETP targeting minority HAZWOPER workers and the EPA Brownfields program. Since September 11, 2001, WETP has awarded supplemental training grants in response to weapons of mass destruction incidents. Through the encouragement of multi-state, university-based consortia and the development of national non-profit organizations which have focused on specific workforce sectors, the program has established technically- proficient curriculum materials and quality-controlled course presentations. These courses have been delivered to hazardous materials workers, emergency responders, and skilled support personnel in every region of the country and have established new national benchmarks for quality worker safety and health training. The immediate goal of worker health and safety training is educational in nature, designed to provide students with relevant information, program- solving skills, and the confidence needed to use these tools. Long-term goals of the model training programs should be to assure that workers become and remain active participants in determining and improving the health and safety conditions under which they work and that avenues for collaborative employer-employee relationships in creating safe workplaces are established. In recent years there have been enormous technological advancements in computer-based technologies and applications. These Advanced Training Technologies (ATT) include a wide variety of electronic learning (e-learning) components. Distance learning, electronic classrooms, interactive TV, multimedia, computer-based training, computer-assisted training, virtual reality training simulations, CD, CD-R, DVD and video teleconferencing, among others, have and are being developed and advanced to support expanding training needs and requirements. NIEHS intends to build on its program experience in environmental safety and health training by stimulating creative Small Business Innovative Research proposals to create ATT products that will support high quality health and safety training for hazardous materials workers, emergency responders, and skilled support personnel. To further enhance our ability to move toward commercialization of ATT products relevant to model safety and health training for hazardous materials workers, emergency responders, and skilled support personnel, this initiative focuses on the development of technology driven commercial products using the Small Business Innovative Research (SBIR)/Small Business Technology Transfer Research (STTR) program. In December 2001 NIEHS WETP released RFA-ES-02-002: Initial Development Of Innovative E-Learning Products For Worker Safety And Health Training In Hazardous Waste And Chemical Emergency Response. In September 2002 NIEHS WETP, made one one-year and three two-year Phase I awards in response to RFA-ES-02-002. This new RFA, while incorporating the goals of the original RFA, builds upon it, by recognizing the need for the application of advanced training technologies that focus on chemical, biological, and radiological training for skilled support personnel. NIEHS WETP, in considering the development and application of ATT to worker safety and health training, has realized that there is a substantial challenge of integrating this new technology to our awardee organizations. This challenge is associated with the fact that each of the WETP awardee organizations is different with regard to its training target audience, the computer literacy and access to such technology among its target audience, the work its training target population performs, and training delivery methods and means among others. In many ways, these challenges reflect the current reality of delivering job-related training content to any adult population in the United States. The digital divide in its various manifestations is a reality for anyone who attempts to use ATT approaches to effectively reach target populations with low levels of computer experience and knowledge. This concern for hazardous waste workers and chemical emergency responders has been particularly acute for a high risk target population, which is characterized by ethnic and cultural diversity, low levels of formal education, and minimal prior computer fluency. Given the WETP core values for hands-on learning, instructor-to-learner, and learner-to-learner interaction is viewed as a very valuable part of the learning experience. Thus, wholesale replacement of an instructor-led course with ATT methods is not normally desirable. The virtual unanimity of views expressed by participants at the initial WETP ATT workshop in 1999 indicates that successful ATT insertion into an NIEHS-type program would require a careful understanding of the relationship between individual skill-based components and hands-on, instructor and worker-oriented training. The consensus of the workshop participants was that these elements need to be clearly identified and that any ATT enhancements must be clearly shown to be compatible with these skill objectives for an ATT driven training program to be successful. It is clear that there is a growing convergence between both Learning Management Systems (LMS) and Knowledge Management Portals, which should merge into more learner-centered technology. Moreover, there is a continuing synthesis of traditional classroom pedagogy and the purely on-line or computer-based method of learning, which have been characterized as a blended learning approach. The NIEHS WETP Advanced Training Technology (ATT) Initiative has already created a wealth of background materials that have explored the application of technology-supported learning to the safety and health field. RESEARCH OBJECTIVES NIEHS encourages applicants to this SBIR RFA to review the relevant program documentation, to pursue partnerships and collaboration with awardees of the WETP program, and to design new ATT or e-learning products that can extend the existing NIEHS curricula and training programs into the digital world. The following five areas describe the type of products that will be supported under this SBIR RFA. Examples include but are not limited to: A. Products to support e-collaboration in safety and health training: "E-collaboration in safety and health training" involves enabling collaborative development of course materials by personnel widely separated geographically within the same organization and between collaborators working for different organizations. Some of these course materials exist and can be transmitted electronically via the Internet to the instructors and/or learners across the nation or world. In addition to traditional face-to-face meetings and phone calls, a number of electronic tools and online approaches can be used to facilitate distributed teams in their creating or updating instructional products. These capabilities include email, list serves, bulletin boards, chat rooms, threaded discussion groups, ftp, and web-enabled database-oriented development tools. Potential products include but are not limited to: 1. Create a database enabling instructors from all over the country to add new case studies in hazardous materials response. As an instructor is preparing to teach a course, he or she searches through this database to find the four most applicable problems. These problems are then downloaded and printed and included in the learner's binders. 2. Develop a technology application to enable electronic distribution of self-study and classroom based curriculum materials to instructors and learners who are involved hazardous materials response. This saves significant dollars in shipping and allows for an entire community to have the latest materials always available to them. 3. Create an electronic forum with collaboration tools to discuss needs and provide feedback regarding new or existing courses via list serve or enable hazardous materials instructors to post requests/recommendations to others in the training community regarding existing courses, resources, and lessons learned that have been deployed. B. Products to support e-certification in safety and health training: "E-certification in safety and health training" involves preparing and maintaining instructor competence as a critical issue in creating and maintaining the quality of health and safety training delivery and assuring adequate worker protection. This ATT option entails the use of online resources to improve instructor competence. The role of the instructor is highly valued in the WETP. Many grantee programs have systematic approaches to train, certify, and maintain instructor competence in both the content matter and in teaching skills. Potential products include but are not limited to: 1. Developing a system to provide pre-class training as an approach to deliver information before a class event to learners. For example, the International Union of Operating Engineers (IUOE) has created three ATT knowledge-oriented courses to be completed by prospective peer trainers prior to attending their live Instructor Certification course. 2. Creating a web-based product for supporting online discussions among instructors as an approach that can stimulate exchange before a formal training begins. For example, the International Association of Firefighters (IAFF) has created an online bulletin board that instructors can use to ask content and teaching methodology questions. 3. Sharing electronic or printable resources as an approach that can make large reference materials and resources open to learners at any time. The IAFF has also created an online bulletin board that supports posting and sharing of instructor produced electronic resources. 4. Providing access tools to knowledge-oriented resources through innovative technology deployment to extend training effectiveness and continuity. Pre- assessments (knowledge self-checks) could be posted as an "Am I ready" (useful prior to teaching various courses), coupled with learning resources, online reviews, or FAQ's (Frequently Asked Questions). 5. Facilitating learning technology for ATT-augmented classroom teaching as an effective feedback and collaboration approach for training in multiple locations. Stored streaming video clips of effective live classroom techniques including how to use ATT effectively as a tool in the classroom can also be a resource to trainers. C. Products to support e-teaching in safety and health training: "E-teaching in safety and health training" encompasses live or virtual classroom training as significant part of effective safety and health training delivery. A key WETP core value relative to ATT is to preserve the role of the trainer/instructor in classroom-like environments in the modeling, teaching and verifying of skills and knowledge. This ATT option for safety and health training delivery looks directly at ways technology can be used appropriately in live instructor-led, face-to-face and virtual classrooms. Potential products include but are not limited to: 1. Creating applications for augmenting the face-to-face classroom environment as an approach that can foster collaborative learning. Recent years have seen a remarkable improvement in the capability and quality of what can be presented electronically in the instructor-led classroom. High quality fixed or portable projectors can be attached to desktop or portable computers to enable the instructor to augment the classroom learning experience in very exciting ways. 2. Technology applications for using special computer-equipped classrooms to bring technology seamlessly into the learning process. Some classrooms, particularly those designed to teach programming or use of the Internet will have several networked computers (one for each learner or pair of learners). In these classrooms, the instructor can facilitate the hands-on learning of the new skills and may be able to show the entire class what one individual or team is learning. Group brainstorming and decision-making, if appropriate to the class objectives, are also supported in these classrooms. 3. Technology applications for broadcasting live classes to remote learners that can reach learners who have no access to technical safety and health resources. Various new web broadcasting technologies are making it possible for an instructor to teach in real time over the Internet (similar to video conferencing which works over phone lines or satellite broadcasts that must be up-linked and then picked up through receivers). The most sophisticated systems digitize and send a video (and audio) stream (live) over the Internet that learners can pickup at their desktops or in learning centers. 4. Creating applications that recognize the needs of populations with low rates of literacy and assist instructors in meeting these needs. This could include products aimed at students with limited computer and Internet skills and access. D. Products to support e-learning in safety and health training: "E-learning in safety and health training" involves technology deployment to provide individualized or small group based training in learning centers, in a technology-enabled "smart classroom" or to learner's desktop is a core part of the technology-supported learning process. As an ATT option, e-learning is used to enable individualized learning, at the learners' convenience and own pace, prior to, as part of, after, or in place of classroom training. E- learning capability is now available to learners at their workplace (desktop, shared computer/kiosk, or learning center) and optionally at home or at the union hall. While multimedia computers connected to the Internet are much more widely available each year, care must be taken to ensure that a targeted set of learners will in fact have the needed access to workstations or learning centers. Potential products include but are not limited to: 1. Creation of applications to provide pre-class assessment and preparatory assignments. Just as instructors within IUOE program have been required to complete certain online courses prior to coming to their onsite instructor certification course, there may be analogous situations where learners who may have not been required to use what they learned previously to do some online pre-assessing and reviewing. This would enable them to catch up to main group and greatly simplify the instructor's job. It may also enable the classroom activities to be more focused on application and doing than on background information and knowledge. 2. Building a technology-supported learning medium for separating out knowledge-based components of a health and safety course and teaching it via a blended approach. Using primarily online methods, Hazardous Materials Training and Research Institute's (HMTRI) online HAZWOPER course is an excellent example for this application. For courses with objectives beyond familiarization, these knowledge-based components (sub-courses) must be matched with hands-on components (sub-courses). Familiarization-only courses may be appropriate as stand alone online or off-line courses as there is no implied capabilities to be demonstrated other than awareness. The following are types of content and activities that are commonly taught in this manner: facts and concept knowledge acquisition including drill and practice (e.g. rail-workers first responder course). Animations and simulations including virtual walkthroughs, procedure practice, case studies, problems, assignments and quizzes and tests may also be part of this application approach. 3. Creation of an Electronic Performance Support System (EPSS) as a post- training resource for workers involved in HAZWOPER activities. Providing post-class follow-up, refresher training, review and online reference allows learners to re-access the online course and materials for up to a year after completing it. The traditional workplace or craft-based EPSS may also be blended with knowledge management or web-based portal applications. 4. Learning technology applications and collaboration tools for augmenting live or individualized training with email, discussion groups, and other collaborative tools for not-at-the-same-time (asynchronous) communications and learning. This can be done between instructor and student(s) via email to provide feedback and answer questions or between students working as teams and on group assignments (via discussion groups and collaborative tools). 5. Creating applications that recognize the needs of populations with low rates of literacy. This could include products aimed at students with limited computer and Internet skills. E. Products to support the training of skilled support personnel (SSP involved in responses to weapons of mass destruction (WMD)incidents: SSP played key roles in the Oklahoma City, Pentagon, and World Trade Center terrorist incidence responses. SSP include a wide range of job categories such as laborers, operating engineers, carpenters, ironworkers, sanitation workers, and utility workers. Training for SSP should be based upon a foundation of HAZWOPER (Hazardous Waste Operations and Emergency Response Standard) training with refresher training used as one vehicle to update and get new information out to SSP. While sections A, B, C, and D above may be interpreted to include SSP, additional training issues were identified in the NIEHS WETP report "Learning From Disasters: Weapons of Mass Destruction Preparedness Through Worker Training." This report is available on-line at http://wetp.org/oldchfiles/awardee_mtgs/spring02/WMDreport.pdf Additional training issues were also identified in the NIEHS WETP report "Improving the Training of Secondary Responders to Terrorist Actions: A Review of the Problem and Feasible Solutions." This report is available on- line at http://www.wetp.org/newsbriefs/jan03/Jan3_NIEHSFeasibility.pdf Among the additional training issues identified were: 1. The need for short, incident specific awareness training that can be delivered prior to entry into a response action. This e-product would assist in a training that must include instruction in the wearing of appropriate personal protective equipment, what WMD hazards are involved, and what duties are to be performed. 2. The need for cross training about the roles of other responders. SSP can provide enhanced assistance to the first responder operations (fire, emergency medical services, search and rescue, and law enforcement) during early phases of an incident response if they better understand the response, rescue, and recovery activities. For example, the scene of a terrorist incident is also a crime scene; therefore, understanding the role of criminal investigators is an important issue for SSP. 3. The need for incident command system training. SSP often do not fully understand their own duties and responsibilities within the incident command system including their place in the incident chain of command. 4. The need to incorporate awareness-level training on WMD into the basic 40 hour Hazardous Waste Operations and Emergency Response Standard (HAZWOPER) course. 5. The need to address other, specific training issues. These issues include confined spaces, blood borne pathogens, personal protective equipment, HAZCOM, hazard assessment, fire watch, first aid/CPR, site safety, working around heavy equipment, physical threats such as heat stress, fatigue, shift work, fall protection, and psychological stress. MECHANISM(S) OF SUPPORT This RFA uses the SBIR and STTR mechanisms, which are set-aside programs. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing-continuation applications based on this project will compete with all SBIR/STTR applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW SBIR/STTR applications using the standard receipt dates for NEW applications described in the current SBIR/STTR Omnibus Solicitation. This RFA uses just-in-time concepts. It also uses the modular budgeting format. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A and fee) or less, use the modular format and instructions as described in the current SBIR/STTR Omnibus Solicitation. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. Except as otherwise stated in this RFA, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, March 2001, available at http://grants.nih.gov/grants/policy/nihgps_2001. Applications may be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus Solicitation. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II application must be a logical extension of the Phase I research but not necessarily a Phase I project supported in response to this RFA. Fast Track applications will benefit from expedited evaluation of progress following the Phase I feasibility study for transition to Phase II funding for expanded developmental work. PROJECT PERIOD AND AMOUNT OF AWARD The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I and Phase II awards. For this RFA, budgets up to $100,000 total costs per year and time periods up to one year for Phase I may be requested. Budgets up to $200,000 total costs per year for up to two years may be requested for Phase II. Total costs include direct costs, F&A, and fee/profit. FUNDS AVAILABLE The NIEHS intends to commit approximately $750,000 to fund four to six Phase I and/or Phase II applications under the SBIR/STTR set-aside funding mechanism. Although the financial plans of the (IC) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit SBIR/STTR applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the current SBIR/STTR Omnibus Solicitation. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. On an SBIR application, the principal investigator must have his/her primary employment (more than 50%) with the small business at the time of award and for the duration of the project. The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as he or she has a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. SPECIAL REQUIREMENTS These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. o Awardees will be required to meet at least twice annually to review progress, share information, and to coordinate training activities. Since awards may be made to applicants that are unfamiliar with NIH grant assistance procedures, business officials are expected to meet at least annually to review NIH grant management policies. o Each awardee shall participate annually in two technical workshops, which will be sponsored and planned by the NIEHS Program Administrator. The technical workshops will present relevant and topical information to assure the continued high quality of worker safety and health training activities carried out by the awardees and encourage the exchange of significant information regarding effective raining techniques and approaches. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: Ted Outwater Public Health Educator Worker Education and Training Program Division of Extramural Research and Training National Institute of Environmental Health Sciences 111 T.W. Alexander Drive, EC-25 P.O. Box 12233 Research Triangle Park, NC 27709 E-mail: outwater@niehs.nih.gov Phone: 919-541-2972 Fax: 919-541-0462 http://www.niehs.nih.gov/wetp/home.htm Direct inquiries about peer review issues to: Sally E. Eckert-Tilotta, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 (EC-30) Research Triangle Park, NC 27709 Courier Service Address: Building 4401 - Room 3173 79 T.W. Alexander Drive Research Triangle Park, NC 27709 Phone: (919) 541-1446 Fax: (919) 541-2503 Email: eckertt1@niehs.nih.gov Direct inquiries about financial or grants management matters to: fiscal matters to: Ms. Carolyn Mason Deputy Grants Management Officer Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233 79 T.W. Alexander Drive, MD EC-22 Research Triangle Park, NC 27709 Telephone: (919) 541-1373 Fax: (919) 541-2860 E-mail: mason6@niehs.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Sally E. Eckert-Tilotta, Ph.D. Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 (EC-30) Research Triangle Park, NC 27709 Courier Service Address: Building 4401 - Room 3173 79 T.W. Alexander Drive Research Triangle Park, NC 27709 Phone: (919) 541-1446 Fax: (919) 541-2503 Email: eckertt1@niehs.nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR/STTR Phase I, Phase II and Fast-Track applications (new and revised.) The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: This RFA uses the modular budgeting format. Specifically, if you are submitting an application budget of $100,000 total costs (direct, F&A and fee) or less, use the modular format and instructions as described in the SBIR/STTR Omnibus Solicitation. USING THE RFA LABEL: The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf The title and number of this RFA must be typed on line 2 of the face page of the application. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, send two copies of the application to: Sally E. Eckert-Tilotta, PhD, Scientific Review Administrator Scientific Review Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 (EC-30) Research Triangle Park, NC 27709 Courier Service Address: Building 4401 - Room 3173 79 T.W. Alexander Drive Research Triangle Park, NC 27709 Phone: (919) 541-1446 Fax: (919) 541-2503 Email: eckertt1@niehs.nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator- initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIEHS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique. o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a second level review by the NIEHS National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals within the context of the SBIR/STTR Program: o Significance o Approach o Innovation o Investigator o Environment ALL SBIR/STTR APPLICATIONS 1. SIGNIFICANCE: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? 2. APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? 3. INNOVATION: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? 4. INVESTIGATORS: Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? 5. ENVIRONMENT: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: Review criteria are described in the Omnibus SBIR Solicitation and available on the web at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf Additional review criteria are that the proposal must produce a learning technology that is relevant to health and safety issues faced by hazardous materials workers, chemical emergency responders, or skilled support personnel and that the application must address the evaluation and validation of the method. The Phase I application should specify clear, measurable goals and milestones. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See additional information and criteria included in the section for Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for all scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See additional information and Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. Human Subjects: 1. Protection of Human Subjects from Research Risks - for all studies involving human subjects. See instructions and "Guidance for Preparing the Human Subjects Research Section." If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? 2. Inclusion of Women Plan - for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 3. Inclusion of Minorities Plan - for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 4. Inclusion of Children Plan - for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? 5. Data and Safety Monitoring Plan - for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? Animal Welfare: If vertebrate animals are involved, are adequate plans proposed for their care and use? Are the applicant's responses to the five required points appropriate? Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research? Biohazards: Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? DATA SHARING: The adequacy of the proposed plan to share data. ADDITIONAL CONSIDERATONS: The following items may also be considered by reviewers but will not be included in the determination of scientific merit: BUDGET: The reasonableness of the proposed budget may be considered. For all applications, is the percent effort listed for the Principal Investigator appropriate for the work proposed? On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. Phase II Application Review Criteria: In addition to the above criteria: 1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? 2. Did the applicant submit a concise Commercialization Plan (formerly Product Development Plan) that adequately addresses the four areas described in the Research Plan, item J? 3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? Amended Applications: In addition to the above criteria, the following criteria will be applied to revised applications: 1. Are the responses to comments from the previous SRG review adequate? 2. Are the improvements in the revised application appropriate? Phase I/Phase II Fast-Track Application Review Criteria: The following criteria also will be applied: 1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? 2. Did the applicant submit a concise Commercialization Plan that adequately addresses the four areas described in the Research Plan, item J? 3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? 4. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review. ADDITIONAL CONSIDERATIONS In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application. o Applicants should adequately address the concerns raised in the NIEHS WETP ATT HAZWOPER in April 1999, the WETP ATT Pilots Lessons Learned Report in September 2000, and the Development of an Integrated WETP ATT Program: Final Report in April 2001. These reports are located at http://www.wetp.org/index.cfm?fuseaction=att o Applications should describe the potential creation of further opportunities for testing, evaluating, mentoring and partnership building between various NIEHS WETP consortia and other grantee organizations in the development and deployment of e-learning products for safety and health training. o Proposed product development research should propose methodologies for the development, delivery and evaluation of health and safety content with a focus on new, technology-supported approaches that improve learning, reduce costs, and can be demonstrated as effective. o Each of the proposed product research and development processes should include an effectiveness evaluation schema to assess the learning and retention process as part of the product deployment, as well as a lessons learned format to document and capture the process of product development and documentation. o Proposed learning products should be created for compatibility with the federal government's Sharable Content Object Reference Model (SCORM) to assure interoperability of technology-supported learning applications. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 19, 2003 Application Receipt Date: August 19, 2003 Peer Review Date: November/December 2003 Council Review: February 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Applications submitted in response to an RFA will compete for available funds with all other recommended SBIR and STTR applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities For FAST-TRACK applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-02-001.html;) a complete copy of the updated Guidelines are available at http:// grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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