Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Environmental Health Sciences (NIEHS)
Funding Opportunity Title	SBIR E-learning for HAZMAT and Emergency Response (SBIR [R43/R44])
Activity Code	R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II and Fast-Track.
Announcement Type	Reissue of RFA-ES-10-003
Related Notices	May 9, 2012 - This RFA has been reissued as RFA-ES-12-005.
Funding Opportunity Announcement (FOA) Number	RFA-ES-11-008
Companion FOA	Not Applicable
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.142
FOA Purpose	This funding opportunity announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose 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. These products would complement the goals and objectives of the Worker Education and Training Program (WETP). The major objective of the NIEHS/WETP 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. There is a need to ensure that learning and training technologies are further developed, field tested and applied to real world situations. It is the intent of this FOA to support the development of emerging technologies to improve worker preparedness through training and education enhancements and methodologies, and to support e-collaboration, e-teaching, and e-learning in safety and health training for workers engaged in hazardous materials response. The financial support for this initiative comes directly from NIEHS Worker Education and Training Branch SBIR funds.

Posted Date	April 8, 2011
Open Date (Earliest Submission Date)	June 28, 2011
Letter of Intent Due Date	June 28, 2011
Application Due Date(s)	July 28, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	November/December 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April 1, 2012
Expiration Date	July 29, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

NIEHS encourages applicants to this SBIR FOA to review the relevant program documentation, to pursue partnerships and collaboration with awardees of the WETP program, and to design new Advanced Technology Training (ATT) or e-learning products that can extend the existing NIEHS supported curricula and training programs into the digital world. Proposals to assist NIEHS with its internal management and operations are not encouraged under this SBIR FOA. To avoid being non-responsive to this SBIR FOA, applicants must review the descriptions of current and prior NIEHS SBIR awards found at http://www.niehs.nih.gov/careers/hazmat/programs/att/index.cfm and avoid duplicating the curricula and subject matter content of these awards. An exemption is allowed for those applications that are highly innovative. These applicants should contact the listed Program Administrators if their application topic is among the listed descriptions. The following four areas describe the type of products that will be supported under this SBIR FOA. Note that all products must be directly related to safety and health training for hazardous materials and emergency response. Examples include but are not limited to:

A. Emerging technology 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 collaborative electronic tools and online approaches can be used to facilitate distributed teams in updating their instructional products. These capabilities may include, but are not limited to email, list serves, bulletin boards, chat rooms, threaded discussion groups, ftp, electronic forums, social networking sites, and web-enabled database-oriented development tools.

B. Products to support e-teaching in safety and health training:

"E-teaching in safety and health training" encompasses live or virtual classroom training as a 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. Applications that are specifically aimed at the development of safety and health trainers in the area of hazardous materials. This could include products aimed at peer-trainers or worker-trainers; trainers needing assistance with language, literacy or cultural differences in the classroom; trainers needing assistance in developing small group activities and other teaching methodologies.

2. 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 augmenting the classroom learning experience in very exciting ways.

3. Technology applications for broadcasting safety and health classes and resources to remote learners.

C. 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 a learner's desktop, cell phone or PDA. 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. Potential products include but are not limited to:

1. Creation of topic oriented products that address clearly identified health and safety issues involving hazardous materials. For example, this could include but is not limited to: products in Spanish or other languages; those addressing the needs of young or new workers in this field or those with low levels of literacy; products on building a safety culture, on hazard and work process evaluation, on systems of safety and incident investigation, on the substitution of chemicals and green approaches to environmental remediation; and motivational products including those on historical topics and lessons learned, or on bringing workplace health and safety lessons to the home and community.

2. Creation of applications to provide pre-class assessment and preparatory assignments.

3. 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. 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 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. Animations and simulations including virtual walkthroughs, procedure practice, case studies, problems, assignments and quizzes and tests may also be part of this application approach.

4. 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. The traditional workplace or craft-based EPSS may also be blended with knowledge management or web-based portal applications.

5. 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).

D. Products to support the training of skilled support personnel (SSP) involved in disaster responses:

SSP include a wide range of job categories such as laborers, operating engineers, carpenters, ironworkers, sanitation workers, and utility workers. Training for SSP should be based upon a foundation of HAZWOPER (Hazardous Waste Operations and Emergency Response Standard) training with refresher training used as one vehicle to update and get new information out to SSP. While sections A, B, C, and D above may be interpreted to include SSP, additional training issues were identified in the NIEHS/WETP report "Learning From Disasters: Weapons of Mass Destruction Preparedness Through Worker Training." This report is available on-line at http://www.niehs.nih.gov/careers/hazmat/programs/hdpt/index.cfm. 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.niehs.nih.gov/careers/hazmat/funding/sbir_links/.

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.

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.

3. The need to incorporate awareness-level disaster response training into the basic 40-hour HAZWOPER course.

4. The need to address other, specific training issues. These issues might 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.

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.

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 NIEHS grant management policies. Applicants should request travel funds in their budgets.

Awardees will be required to meet at least twice annually to review progress, share information, and to coordinate training activities. These technical workshops will be 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 training techniques and approaches. Applicants should request travel funds in their budgets.

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

The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project(s) proposed in the application.

Applicants should adequately address the concerns raised in the report HAZWOPER Training: Utilizing Advanced Training Technologies in 1999, http://tools.niehs.nih.gov/wetp/public/hasl_get_blob.cfm?ID=1091&searchTerm=ATT%20reports, the WETP ATT Lessons Learned Report in September 2000, and the Development of an Integrated WETP ATT Program: Final Report 2001: http://www.niehs.nih.gov/careers/hazmat/funding/sbir_links.cfm.

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

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

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

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

Funding Instrument	Grant
Application Types Allowed	New (Phase I, Fast-Track and Phase II) Resubmission (all phases) The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIEHS/DERT/WETP intends to commit approximately $300,000 in FY12 to support two to three awards..
Award Budget	Budgets up to $100,000 total costs per year may be requested for Phase I. Budgets up to $200,000 total costs per year up to 2 years may be requested for Phase II.
Award Project Period	According to statutory guidelines, award periods may not exceed 1 year for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project..

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4. Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 support.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase budget period.

In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).

In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, North Carolina 27709
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) SBIR/STTR Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIEHS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Phase II Applications

For Phase II Applications, 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?

Phase I/Phase II Fast-Track Applications

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

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

2. 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?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the National Institute of Environmental Health Sciences, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Financial Status Report (OMB 269)
• Final Progress Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Ted Outwater
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD: K3-14
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-2972
Fax: (919) 541-0462
Email: [email protected]
http://www.niehs.nih.gov/wetp/home.htm

Jim Remington
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD: K3-14
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-0035
Fax: (919) 541-0462
Email: [email protected]
http://www.niehs.nih.gov/wetp/home.htm

Kathy Ahlmark
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD: K3-14
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7825
Fax: (919) 541-0462
Email: [email protected]
http://www.niehs.nih.gov/wetp/home.htm

Sally Eckert-Tilotta, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD: K3-03
Research Triangle Park, North Carolina 27709-2233
Telephone: 919-541-1446
Fax: 919-541-2503
E-mail: [email protected]

Pamela Clark
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD K3-11
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-7629
Fax: (919) 541-2860
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act).The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.