DEVELOPMENT OF INNOVATIVE E-LEARNING PRODUCTS FOR WORKER SAFETY AND HEALTH TRAINING IN HAZARDOUS WASTE AND CHEMICAL EMERGENCY RESPONSE Release Date: December 12, 2001 RFA: RFA-ES-02-002 National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) Letter of Intent Receipt Date: March 17, 2002 Application Receipt Date: April 17, 2002 PURPOSE 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 emergency response. 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). 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 for over a decade. 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. 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 waste workers and emergency responders 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. NIEHS intends to build on its program experience in environmental safety and health training by stimulating creative Small Business Innovative Research proposals to create products that will support high quality health and safety training for hazardous waste workers and emergency responders. To further enhance our ability to move toward commercialization of on-line learning technologies relevant to model safety and health training for hazardous waste workers and emergency responders, 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. This RFA provides a flexible system within the SBIR program to cover the extensive needs and complex development processes needed to develop products to support and integrate technology-supported training for workers at Superfund sites. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (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/. ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the Omnibus SBIR Solicitation. Each organization submitting an SBIR/STTR grant application must qualify as a small business concern in accordance with the definition given in Section III of the Omnibus SBIR Solicitation (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). MECHANISM OF SUPPORT This RFA invites grant applications for Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) projects with award duration and amounts greater than those routinely allowed under the SBIR/STTR program. This RFA must be read in conjunction with the Omnibus Solicitation of the Public Health Service (Omnibus Solicitation) for Phase I SBIR/STTR Grant Applications and the PHS 398 instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html.) All instructions and information in these documents also apply to applications in response to this RFA. This RFA is a one-time solicitation. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy stated in the NIH Grants Policy Statement, NIH publication 99-8 October 1998. Because the length of time and cost of research involving development and evaluation of learning technologies may exceed that routinely awarded for SBIR/STTR grants, the NIEHS will entertain well-justified Phase I applications for an SBIR/STTR award with a project period up to two years and a budget not to exceed a total cost of $200,000 per year. Consultant and contractual costs associated with Phase I: The total amount of all consultant costs and contractual costs normally may not exceed 33 percent of the total costs requested for Phase I SBIR applications. However, the NIEHS will entertain well-justified Phase I applications for an SBIR award with greater than 33 percent contractual costs when those costs are necessary to support development and evaluation of a remediation or monitoring technology. A. INDIVIDUAL PHASE I APPLICATIONS. Phase I applications in response to this RFA will be funded as Phase I SBIR Grants (R43) and STTR Grants (R41) with modifications as described below. Applications for Phase I grants should be prepared following the directions for Phase I SBIR/STTR applications as described in Chapter VI of the PHS 398 Instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html.) The NIH Omnibus SBIR Solicitation is available on the Internet at http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. FUNDS AVAILABLE The NIEHS intends to commit approximately $670,000 in FY 2002 from the Worker Education and Training Program allocation to fund three to six new awards in response to this RFA. The number of awards will be contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. BACKGROUND NIEHS WETP, in considering the development and application of Advanced Training Technology (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 online (Computer-based Training or Web-based Training) 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 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 e-learning products that can extend the existing NIEHS curricula and training programs into the digital world. The following four areas describe the type of electronic learning 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: 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: 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: 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. 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: 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 standalone online 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 via online learning: 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). INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 (PA) 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Ethel B. Jackson, DDS Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 79 TW Alexander Drive, Building 4401 Research Triangle Park, NC 27709 Phone: (919) 541-7846 Fax: (919) 541-2503 E-mail: jackson4@niehs.nih.gov APPLICATION PROCEDURES Applicants should follow the instructions for SBIR Phase I submission with the modifications as noted in this RFA. This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS. All of the instructions apply with the following exceptions: - Special receipt date - Additional award considerations Applications received in response to this RFA are to be prepared as described in the PHS 398 Instructions, which are available at http://grants.nih.gov/grants/funding/phs398/phs398.html. Applicants should follow the instructions for SBIR Phase I submission with the modifications as noted in this RFA. A sample Phase I SBIR application can be found at http://www.nhlbi.nih.gov/funding/sbir/modelsbi.htm. Projects may be presented for SBIR/STTR support at all stages of learning technology development. Projects will be evaluated on overall innovation and success potential. The future year support will be contingent upon NIEHS programmatic evaluation to ensure that the investigators are accomplishing milestones and time lines presented in the original application. The RFA label available in the PHS 398 (rev. 5/2001) 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. For purposes of identification and processing, the title and number of this RFA must be shown in item 2 on the face page of the SBIR/STTR Phase I applications. 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) At the time of submission, two additional copies of the applications must be sent to: Ethel B. Jackson, DDS Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences 79 T.W. Alexander Drive Bldg. 4401, Rm. 110 Research Triangle Park, NC 27709 Phone: (919) 541-7846 Fax: (919) 541-2503 E-mail: jackson4@niehs.nih.gov Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NIEHS Scientific Review Branch. 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 standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. REVIEW CRITERIA 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 workers and chemical emergency responders at Superfund sites 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 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SBIR/STTR Review Criteria In considering the scientific and technical merit of each application, the following criteria will be used: All SBIR/STTR Applications o 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? o 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? o Innovation - Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? - Are the aims original and innovative? - 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?" o 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? In accordance with NIH policy, the following criteria will be applied to ALL applications: o 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? o 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? o Budget - For all applications, is the percent effort listed for the PI 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? In accordance with NIH policy, all applications will also be reviewed with respect to the following: o 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? Inclusion of Women Plan - for clinical research only. See instructions. - 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? 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? 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? 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? Phase II Application Review Criteria In addition to the above criteria: - 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? - Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? - Does the project carry a high degree of commercial potential, as described in the Product Development Plan? Amended Applications In addition to the above criteria, the following criteria will be applied to revised applications. - Are the responses to comments from the previous SRG review adequate? - 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: - Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? - Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in the Research Plan, item J? - 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? - Does the project carry a high degree of commercial potential, as described in the Product Development 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. 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. SCHEDULE Letter of Intent Receipt Date: March 17, 2002 Application Receipt Date: April 17, 2002 Review Date: June 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 2002 AWARD CRITERIA The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, program balance among development areas of the announcement, the availability of funds, and the commercialization status where the small business concern has received more than 15 Phase II awards in the prior five fiscal years, if applicable (see this application requirement under "Prior SBIR Phase II Awards" found in the "Introduction and Application Instructions" potion of the Omnibus Solicitation). INQUIRIES Inquiries concerning this RFA are encouraged. Potential applicants are strongly encouraged to contact program staff for pre-application guidance and/or for more specific information on the research topics described in this RFA. They are also encouraged to read the advice and information on SBIR programs located on the Internet at: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. Direct inquiries regarding programmatic issues to: Mr. Joseph T. "Chip" Hughes Jr., MPH, Director Worker Education and Training Program Division of Extramural Research and Training National Institute of Environmental Health Sciences PO Box 12233, MD EC-25 RTP, NC 27709 Phone: 919-541-0217 Email: hughes3@niehs.nih.gov WETP web: http://www.niehs.nih.gov/wetp or Ms. Sharon Beard Program Administrator Worker Education and Training Program Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233 111 T.W. Alexander Drive, MD EC-25 Research Triangle Park, NC 27709 Telephone: (919) 541-1863 Fax: (919) 316-0462 E-mail: beard1@niehs.nih.gov Direct inquiries regarding review issues to: Ethel B. Jackson, DDS Chief, Scientific Review Branch Office of Program Operations National Institute of Environmental Health Sciences PO Box 12233 111 T.W. Alexander Drive, MD EC-02 Research Triangle Park, NC 27709 Telephone: (919) 541-1307 Fax: (919) 541-2503 E-mail: jackson4@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carolyn Mason Deputy Chief Grants Management Branch Office of Program Operations National Institute of Environmental Health Sciences PO Box 12233 111 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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113, 93.115 and 95.143 (NIEHS Superfund Hazardous Substances Basic Research and Education Grant Program). Awards will be made under authority of the Superfund Amendments and Reauthorization Act of 1986, Title 1, Section III, and Title II, Section 209 (Public Law 99-499), and are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 Part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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