Part I Overview Information


Department of Health and Human Services

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

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

Title: SBIR E-learning for HAZMAT and Emergency Response (SBIR [R43/R44])

Announcement Type
This is a reissue of RFA-ES-06-002, which was previously released on May 15, 2006.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) SBIR/STTR Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-ES-07-004

Catalog of Federal Domestic Assistance Number(s)
93.142

Key Dates
Release/Posted Date:  April 19, 2007
Opening Date:  May 7, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): June 19, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  July 18, 2007
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): November\December 2007 
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July 19, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to promote research and training that will ultimately reduce the burden of human disease and illness occurring as a consequence of exposure to hazardous environmental substances. The major objective of the NIEHS Worker Education and Training Program is to prevent work related harm by assisting in the training of workers in how best to protect themselves and their communities from exposure to hazardous materials encountered during hazardous waste operations, hazardous materials transportation, environmental restoration of contaminated facilities or chemical/biological/radiological emergency response and clean-up. The creation of prevention partnerships between employers, employees, universities and community members has been a hallmark of the program. A major goal of the NIEHS program is to assist organizations efficiently and effectively with the development of institutional competency to provide appropriate model training and education programs to hazardous materials handlers, chemical emergency responders, and waste cleanup workers, as specified in Section 126 (g) of the Superfund Amendments and Reauthorization Act of 1986 (SARA), and skilled support personnel as defined in CFR 1910.120.

The NIEHS program has been funded primarily on the basis of the worker protection statutes of the Superfund Amendments and Reauthorization Act of 1986 (Section 126 of SARA).  Since its authorization by Congress in 1986, the NIEHS Worker Education and Training Program (WETP) has been funding the development, deployment, and utilization of state-of-the–art safety and health training for hazardous waste operations workers and chemical emergency responders.  In addition, the WETP began administering additional grant awards for such training that has been funded by the Department of Energy to meet that Department's expanding high hazard operations training needs associated with the massive environmental restoration program being undertaken by the DOE Office of Environmental Management (EM).  Additional training grant awards have been executed and managed by WETP targeting minority Hazardous Waste Operations and Emergency Response Standard (HAZWOPER) workers and the EPA Brownfields program. More recently, the WETP developed a new program, the Hazmat Disaster Preparedness Training Program (HDPTP), in response to the experiences and lessons learned in recent national disasters including terrorist attacks.

Through the encouragement of multi-state, university-based consortia and the development of national non-profit organizations which have focused on specific workforce sectors, the program has established technically-proficient curriculum materials and quality-controlled course presentations. These courses have been delivered to hazardous materials workers, emergency responders, and skilled support personnel in every region of the country and have established new national benchmarks for quality worker safety and health training. 

The immediate goal of worker health and safety training is educational in nature, designed to provide students with relevant information, program-solving skills, and the confidence needed to use these tools.  Long-term goals of the model training programs should be to assure that workers become and remain active participants in determining and improving the health and safety conditions under which they work and that avenues for collaborative employer-employee relationships in creating safe workplaces are established.

In recent years there have been enormous technological advancements in computer-based technologies and applications. These Advanced Training Technologies (ATT) include a wide variety of electronic learning (e-learning) components. Distance learning, electronic classrooms, interactive TV, multimedia, computer-based training, computer-assisted training, virtual reality training simulations, CD, CD-R, DVD and video teleconferencing, among others, have and are being developed and advanced to support expanding training needs and requirements.

NIEHS intends to build on its program experience in environmental safety and health training by stimulating creative Small Business Innovative Research (SBIR) application 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) program. 

NIEHS/WETP, in considering the development and application of ATT to worker safety and health training, has realized that there is a substantial challenge of integrating this new technology to our awardee organizations. This challenge is associated with the fact that each of the WETP awardee organizations is different with regard to its training target audience, the computer literacy and access to such technology among its target audience, the work its training target population performs, and training delivery methods and means among others. In many ways, these challenges reflect the current reality of delivering job-related training content to any adult population in the United States. The digital divide in its various manifestations is a reality for anyone who attempts to use ATT approaches to effectively reach target populations with low levels of computer experience and knowledge. This concern for hazardous waste workers and chemical emergency responders has been particularly acute for a high risk target population, which is characterized by ethnic and cultural diversity, low levels of formal education, and minimal prior computer fluency.

Given the WETP core values for hands-on learning, instructor-to-learner, and learner-to-learner interaction is viewed as a very valuable part of the learning experience. Thus, wholesale replacement of an instructor-led course with ATT methods is not normally desirable. The virtual unanimity of views expressed by participants at the initial WETP ATT workshop in 1999 indicates that successful ATT insertion into an NIEHS-type program would require a careful understanding of the relationship between individual skill-based components and hands-on, instructor and worker-oriented training. The consensus of the workshop participants was that these elements need to be clearly identified and that any ATT enhancements must be clearly shown to be compatible with these skill objectives for an ATT driven training program to be successful.

It is clear that there is a growing convergence between both Learning Management Systems (LMS) and Knowledge Management Portals, which should merge into more learner-centered technology. Moreover, there is a continuing synthesis of traditional classroom pedagogy and the purely on-line or computer-based method of learning, which have been characterized as a blended learning approach. The NIEHS/WETP Advanced Training Technology (ATT) Initiative has already created a wealth of background materials that have explored the application of technology-supported learning to the safety and health field.

NIEHS encourages applicants to this SBIR RFA to review the relevant program documentation, to pursue partnerships and collaboration with awardees of the WETP program, and to design new ATT or e-learning products that can extend the existing NIEHS supported curricula and training programs into the digital world. Proposals to assist NIEHS with its internal management and operations are not solicited under this SBIR RFA. NIEHS urges applicants to review the descriptions of current NIEHS SBIR awards found at http://www.niehs.nih.gov/wetp/program/att.htm#awardees and to avoid duplicating the curricula and subject matter content of these awards. The following five areas describe the type of products that will be supported under this SBIR RFA. Examples include but are not limited to:

A. Products to support e-collaboration in safety and health training:

"E-collaboration in safety and health training" involves enabling collaborative development of course materials by personnel widely separated geographically within the same organization and between collaborators working for different organizations. Some of these course materials exist and can be transmitted electronically via the Internet to the instructors and/or learners across the nation or world. 

In addition to traditional face-to-face meetings and phone calls, a number of electronic tools and online approaches can be used to facilitate distributed teams in their creating or updating instructional products. These capabilities include email, list serves, bulletin boards, chat rooms, threaded discussion groups, ftp, and web-enabled database-oriented development tools. Potential products include but are not limited to:

1. Create a database enabling instructors from all over the country to add new case studies in hazardous materials response. As an instructor is preparing to teach a course, he or she searches through this database to find the four most applicable problems. These problems are then downloaded and printed and included in the learner's binders.

2. Develop a technology application to enable electronic distribution of self-study and classroom based curriculum materials to instructors and learners who are involved hazardous materials response. This saves significant dollars in shipping and allows for an entire community to have the latest materials always available to them.

3. Create an electronic forum with collaboration tools to discuss needs and provide feedback regarding new or existing courses via list serve or enable hazardous materials instructors to post requests/recommendations to others in the training community regarding existing courses, resources, and lessons learned that have been deployed. 

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

"E-certification in safety and health training" involves preparing and maintaining instructor competence as a critical issue in creating and maintaining the quality of health and safety training delivery and assuring adequate worker protection. This ATT option entails the use of online resources to improve instructor competence. The role of the instructor is highly valued in the WETP. Many grantee programs have systematic approaches to train, certify, and maintain instructor competence in both the content matter and in teaching skills. Potential products include but are not limited to:

1. Developing a system to provide pre-class training as an approach to deliver information before a class event to learners. For example, the International Union of Operating Engineers (IUOE) has created three ATT knowledge-oriented courses to be completed by prospective peer trainers prior to attending their live Instructor Certification course.

2. Creating a web-based product for supporting online discussions among instructors as an approach that can stimulate exchange before a formal training begins. For example, the International Association of Firefighters (IAFF) has created an online bulletin board that instructors can use to ask content and teaching methodology questions.

3. Sharing electronic or printable resources as an approach that can make large reference materials and resources open to learners at any time. The IAFF has also created an online bulletin board that supports posting and sharing of instructor produced electronic resources.  

4. Providing access tools to knowledge-oriented resources through innovative technology deployment to extend training effectiveness and continuity. Pre-assessments (knowledge self-checks) could be posted as an "Am I ready" (useful prior to teaching various courses), coupled with learning resources, online reviews, or FAQ's (Frequently Asked Questions). 

5. Facilitating learning technology for ATT-augmented classroom teaching as an effective feedback and collaboration approach for training in multiple locations. Stored streaming video clips of effective live classroom techniques including how to use ATT effectively as a tool in the classroom can also be a resource to trainers.

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

"E-teaching in safety and health training" encompasses live or virtual classroom training as significant part of effective safety and health training delivery. A key WETP core value relative to ATT is to preserve the role of the trainer/instructor in classroom-like environments in the modeling, teaching and verifying of skills and knowledge. This ATT option for safety and health training delivery looks directly at ways technology can be used appropriately in live instructor-led, face-to-face and virtual classrooms. Potential products include but are not limited to:

1. Creating applications for augmenting the face-to-face classroom environment as an approach that can foster collaborative learning. Recent years have seen a remarkable improvement in the capability and quality of what can be presented electronically in the instructor-led classroom. High quality fixed or portable projectors can be attached to desktop or portable computers to enable the instructor to augment the classroom learning experience in very exciting ways. 

2. Technology applications for using special computer-equipped classrooms to bring technology seamlessly into the learning process. Some classrooms, particularly those designed to teach programming or use of the Internet will have several networked computers (one for each learner or pair of learners).  In these classrooms, the instructor can facilitate the hands-on learning of the new skills and may be able to show the entire class what one individual or team is learning. Group brainstorming and decision-making, if appropriate to the class objectives, are also supported in these classrooms.

 3. Technology applications for broadcasting live classes to remote learners that can reach learners who have no access to technical safety and health resources. Various new web broadcasting technologies are making it possible for an instructor to teach in real time over the Internet (similar to video conferencing which works over phone lines or satellite broadcasts that must be up-linked and then picked up through receivers). The most sophisticated systems digitize and send a video (and audio) stream (live) over the Internet that learners can pickup at their desktops or in learning centers.

4. Creating applications that recognize the needs of populations with low rates of literacy and assist instructors in meeting these needs.  This could include products aimed at students with limited computer and Internet skills and access. 

D. Products to support e-learning in safety and health training:

"E-learning in safety and health training" involves technology deployment to provide individualized or small group based training in learning centers, in a technology-enabled "smart classroom" or to learner's desktop is a core part of the technology-supported learning process.  As an ATT option, e-learning is used to enable individualized learning, at the learners' convenience and own pace, prior to, as part of, after, or in place of classroom training. E-learning capability is now available to learners at their workplace (desktop, shared computer/kiosk, or learning center) and optionally at home or at the union hall. While multimedia computers connected to the Internet are much more widely available each year, care must be taken to ensure that a targeted set of learners will in fact have the needed access to workstations or learning centers. Potential products include but are not limited to:

1. Creation of applications to provide pre-class assessment and preparatory assignments. Just as instructors within IUOE program have been required to complete certain online courses prior to coming to their onsite instructor certification course, there may be analogous situations where learners who may have not been required to use what they learned previously to do some online pre-assessing and reviewing. This would enable them to catch up to main group and greatly simplify the instructor's job. It may also enable the classroom activities to be more focused on application and doing than on background information and knowledge.

2. Building a technology-supported learning medium for separating out knowledge-based components of a health and safety course and teaching it via a blended approach. Using primarily online methods, Hazardous Materials Training and Research Institute's (HMTRI) online HAZWOPER course is an excellent example for this application. For courses with objectives beyond familiarization, these knowledge-based components (sub-courses) must be matched with hands-on components (sub-courses). Familiarization-only courses may be appropriate as stand alone online or off-line courses as there is no implied capabilities to be demonstrated other than awareness. The following are types of content and activities that are commonly taught in this manner:  facts and concept knowledge acquisition including drill and practice (e.g. rail-workers first responder course). Animations and simulations including virtual walkthroughs, procedure practice, case studies, problems, assignments and quizzes and tests may also be part of this application approach.

3. Creation of an Electronic Performance Support System (EPSS) as a post-training resource for workers involved in HAZWOPER activities. Providing post-class follow-up, refresher training, review and online reference allows learners to re-access the online course and materials for up to a year after completing it. The traditional workplace or craft-based EPSS may also be blended with knowledge management or web-based portal applications.

4. Learning technology applications and collaboration tools for augmenting live or individualized training with email, discussion groups, and other collaborative tools for not-at-the-same-time (asynchronous) communications and learning. This can be done between instructor and student(s) via email to provide feedback and answer questions or between students working as teams and on group assignments (via discussion groups and collaborative tools).

5. Creating applications that recognize the needs of populations with low rates of literacy. This could include products aimed at students with limited computer and Internet skills. 

E. Products to support the training of skilled support personnel (SSP) involved in responses to weapons of mass destruction (WMD) incidents:

SSP played key roles in the Oklahoma City, Pentagon, and World Trade Center terrorist incidence responses. SSP include a wide range of job categories such as laborers, operating engineers, carpenters, ironworkers, sanitation workers, and utility workers. Training for SSP should be based upon a foundation of HAZWOPER (Hazardous Waste Operations and Emergency Response Standard) training with refresher training used as one vehicle to update and get new information out to SSP. While sections A, B, C, and D above may be interpreted to include SSP, additional training issues were identified in the NIEHS/WETP report "Learning From Disasters: Weapons of Mass Destruction Preparedness Through Worker Training." This report is available on-line at http://www.wetp.org/wetp/docs/awardee_mtgs/spring02/WMDreport.pdf.  Additional training issues were also identified in the NIEHS/WETP report "Improving the Training of Secondary Responders to Terrorist Actions: A Review of the Problem and Feasible Solutions." This report is available on-line at http://www.wetp.org/wetp/newsbriefs/jan03/Jan3_NIEHSFeasibility.pdf.

Among the additional training issues identified were:

1. The need for short, incident specific awareness training that can be delivered prior to entry into a response action. This e-product would assist in a training that must include instruction in the wearing of appropriate personal protective equipment, what WMD hazards are involved, and what duties are to be performed.

2. The need for cross training about the roles of other responders.  SSP can provide enhanced assistance to the first responder operations (fire, emergency medical services, search and rescue, and law enforcement) during early phases of an incident response if they better understand the response, rescue, and recovery activities. For example, the scene of a terrorist incident is also a crime scene; therefore, understanding the role of criminal investigators is an important issue for SSP.

3. The need for incident command system training. SSP often do not fully understand their own duties and responsibilities within the incident command system including their place in the incident chain of command.

4. The need to incorporate awareness-level training on WMD into the basic 40-hour 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.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Small Business Innovation Research (SBIR [R43/R44]) grant mechanisms. Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.

Small business concerns that have received a Phase I SBIR grant may apply for Phase II funding of that project. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity. Phase II applications will compete with all SBIR applications and will be reviewed according to the customary peer review procedures

The applicant small business concern (SBC) will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses “Just-in-Time” information concepts. The modular budget format is not accepted for SBIR grant applications. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget component found in the application package attached to this FOA in Grants.gov/Apply.

2. Funds Available

The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II SBIR awards. For this funding opportunity, budgets up to $100,000 total costs per year and time periods up to 1 year for Phase I may be requested. Budgets up to $200,000 total costs per year and up to 2 years may be requested for Phase II. Total costs include direct costs, Facilities & Administrative (F&A)/indirect costs, and fee.

The participating organization NIEHS intends to commit approximately $700,000 dollars in FY 2008 to fund 3-6 Phase I, Phase II, or Fast Track applications under the SBIR set-aside funding mechanism. Although the financial plans of the participating organizations provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.       Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.

2.       Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, 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.

3.       Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in Title 13 Code of Federal Regulations (CFR) Part 121. Business concerns are generally considered to be 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.

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.103. The term "number of employees" is defined in 13 CFR 121.106.

A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's (SBA) Government Contracting Area Office or Office of Size Standards.

One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.

Title 13 CFR 121.3 also states that control or the power to control exists when “key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise.” Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.

For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 – Small Business Size Regulations.

All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.

Note: An applicant organization that has been determined previously by SBA to be “other than small” for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, the organization must be recertified by the SBA prior to any future SBIR/STTR awards.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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. That individual will serve as the Contact PD/PI. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.

If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the Contact PD/PI, if at the time of submission of the application, the Contact PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.

If the Contact PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the Contact PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the Contact PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.

All current employment and all other appointments of the Contact PD/PI must be identified in his or her “Biographical Sketch” required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may not simultaneously submit identical/essentially identical applications under both this SBIR Parent funding opportunity and any other HHS FOA, including the current STTR Parent FOA. The NIH will accept as many "different" applications as the applicant organization chooses. However, the 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.  Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted.  Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review. 

It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. “Essentially equivalent work or effort” occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.

Only one Phase II award may be made for a single SBIR/STTR project.

You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect 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 grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:   

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

To affiliate the PD/PI with the applicant small business concern:

1.       PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/PI.)

2.       Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)

3.       Administrator selects "Administration" tab and then "Accounts" tab.

4.       Administrator selects "Create Affiliation" tab.

5.       Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide for this FOA using the “Apply for Grant Electronically” button in this FOA or through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all SBIR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide. 

The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.

Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above. For SBIR, the contact PI must be employed by the small business.  All funding for SBIR projects goes to the small business awardee, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form. 

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  May 7, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  June 19, 2007
Application Submission/Receipt Date(s):  July 18, 2007
Peer Review Date(s): November/December 2007
Council Review Date(s): January 2008
Earliest Anticipated Start Date(s): April 1, 2008

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute and Center (IC) staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Sally E. Eckert-Tilotta, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 TW Alexander Drive (EC-30)
Building 4401, Room 3173
Research Triangle Park, NC 27709-2233
Telephone: (919) 541-1446
Fax:  (919) 541-2503
Email:  eckertt1@niehs.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants may use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/applicants/apply_for_grants.jsp  and follow steps 1-4. Note:  Applications must only be submitted electronicallyPAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NIEHS Referral Office by email eckertt1@niehs.nih.gov when the application has been submitted.  Please include the FOA number and title, and PD/PI name and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR) and responsiveness by the NIEHS. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application using the standard NIH, CDC, and FDA SBIR submission dates of April 5, August 5, and December 5 (or May 1, September 1, and January 2 for NIH AIDS and AIDS-related SBIR applications). That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Special Requirement

These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements.

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

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

Applicants should adequately address the concerns raised in the report HAZWOPER Training: Utilizing Advanced Training Technologies in 1999, http://www.wetp.org/wetp/docs/workshops/niosh/ATT_report_summary.htm, the WETP ATT Lessons Learned Report in September 2000, http://www.wetp.org/wetp/att/ATTReport2000-09-18.pdf, and the Development of an Integrated WETP ATT Program: Final Report 2001, http://www.wetp.org/wetp/att/ATTFINALDRAFT31JAN01a.doc.

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

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

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

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

PD/PI Credential (e.g., Agency Login)

The NIH requires each PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, with the following requirements.

SBIR Phase I applications:

SBIR Phase II applications:

SBIR Fast-Track applications:

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.)

Sharing Research Resources

Not Applicable

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to this funding opportunity will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIEHS in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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

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

Note that an 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.

Applicants should include information in relevant sections of the grant application that addresses the questions for each review criterion below.

All SBIR Applications

Significance: Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Are the milestones and evaluation procedures appropriate? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PD/PIs, is the leadership approach, including he designated roles and responsibilities governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?

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

Investigator(s): Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers, including consultants and subcontractors (if any)? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

Environment: Do(es) the scientific and technological environment in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there sufficient access to resources (e.g., equipment, facilities)?

Phase II Applications

In addition to the above review criteria:

1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information component?

3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

Phase I/Phase II Fast-Track Application Review Criteria

For Phase I/Phase II Fast Track applications, the following criteria also will be applied:

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

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information component?

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.

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.  Items 2-5 of the Research Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans for a Fast-Track application (for Items 2-5) must be contained within the 25-page limitation.

Phase II Competing Renewal Applications (formerly “Phase II Competing Continuation” applications)

Not Applicable

2.A. Additional Review Criteria:

Not Applicable

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

Not Applicable

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See also Section IV.5., “Funding Restrictions.”     

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the 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.

3. Reporting

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, http://www.whitehouse.gov/omb/grants/grants_forms.html)

Final Progress Report

Final Invention Statement and Certification (HHS 568)

Annual Invention Utilization Reports

Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)

Phase II Data Collection Requirement for Government Tech-Net Database  (http://technet.sba.gov)

Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.

For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF 424 (R&R) SBIR/STTR Application Guide.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Patricia P. Thompson
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3166
79 TW Alexander Drive, EC-25
Research Triangle Park, NC  27709-2233
Telephone: (919) 541-0117
Fax: (919) 541-0462
Email: thompso2@niehs.nih.gov
http://www.niehs.nih.gov/wetp/home.htm

Ted Outwater
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 2972
79 TW Alexander Drive, EC-25
Research Triangle Park, NC  27709-2233
Telephone: (919) 541-2972
Fax: (919) 541-0462
Email: outwater@niehs.nih.gov
http://www.niehs.nih.gov/wetp/home.htm

2. Peer Review Contacts:

Sally E. Eckert-Tilotta, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3173
P.O. Box 12233 (EC-30)

Research Triangle Park, NC 27709-2233
Telephone: (919) 541-1446
Fax:  (919) 541-2503
Email:  eckertt1@niehs.nih.gov

3. Financial or Grants Management Contacts:

Ms. Carolyn Mason
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3405
79 TW Alexander Drive, MD EC-22

Research Triangle Park, NC 27709-2233
Telephone: (919) 541-1373
Fax:  (919) 541-2860
Email:  mason6@niehs.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

Access to Research Data through the Freedom of Information Act:
The OMB Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through the FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA 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 Part 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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.