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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 Cancer Institute (NCI), (http://www.cancer.gov)

Title: SBIR Phase II Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics toward Commercialization (R44)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-CA-08-021.

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

Request For Applications (RFA) Number: RFA-CA-10-009

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) 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).

IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.394, 93.395

Key Dates
Release/Posted Date: January 5, 2010
Opening Date: February 1, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 1, 2009
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 Due Date: March 1, 2010
Peer Review Date: May-June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 2, 2010

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
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

Purpose

The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) helps bring innovative solutions to public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of medical biotechnology products is often impeded by a significant funding gap, known as the Valley of Death, between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA) solicits SBIR grant applications from SBCs to support the next stage of development for projects that were previously funded by NIH SBIR Phase II awards. A similar NCI SBIR Bridge award FOA was first issued as a pilot initiative (RFA-CA-08-021) in 2008. The scientific scope of the currently issued FOA is strictly limited to the specific areas listed below.

To be responsive to this FOA, proposed projects must be applicable to one of the following technical/scientific areas:

(1) Cancer Therapeutics;

(2) Cancer Imaging Technologies, Interventional Devices and In Vivo Diagnostics; or

(3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics.

SBIR Phase II Bridge Awards are designed to facilitate the continuation of promising SBIR Phase II projects in order to pursue the next appropriate milestone(s) toward ultimate commercialization. To achieve this goal, this FOA is designed to promote partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners. In particular, this FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by the applicant’s ability to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NCI funds). NCI support is thus intended to benefit cancer patients by accelerating the development of novel cancer-relevant products and technologies toward commercialization.

This FOA is specifically intended to provide additional support for products and technologies that require ultimate approval by a Federal regulatory agency; therefore, proposed projects may address preclinical and/or clinical stages of development (including clinical trials).

Background

Since its inception in 1982, the NIH SBIR program has provided the small business community with critical seed funding to support the development of a broad array of commercial products for the detection, diagnosis, treatment, and prevention of disease. The SBIR Program is structured in three phases. The main objective in Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in Phase II it is to continue the R&D efforts initiated in Phase I. The objective in Phase III is for the small business to commercialize their product or technology using non-SBIR funds. However, many of the early-stage projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to achieve commercialization. In particular, the development of therapeutics and medical devices often requires several years and substantial capital investments, due in large part to the costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process.

Among the areas of R&D supported by the NCI’s SBIR Program, cancer therapeutics, imaging technologies, interventional devices, diagnostics and prognostics typically require substantial levels of additional financing beyond the SBIR Phase I and Phase II funding. Moreover, a number of emerging products in these areas are becoming increasingly complex due to the technological advances in multi-disciplinary fields. For example, new products may involve measurements of both physical and molecular signatures, combine device(s) and molecular probe(s), or perform dual functions of diagnosis and therapy. These products are referred to as combined technologies by the Food and Drug Administration (FDA), and examples in oncology include those related to genomics, proteomics, certain approaches to imaging, image-guided diagnosis and therapy, and other therapeutics. Importantly, the developers of such technologies often face additional challenges during the regulatory approval process, requiring even more time and effort to commercialize such technologies.

Large pharmaceutical and biotechnology companies, as well as venture capital firms, have traditionally provided the resources needed to fully develop and commercialize biomedical products and technologies initiated with NIH SBIR funding. More recently, however, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses. Consequently, an increasing number of NIH-funded SBIR awardees are successfully completing their Phase II activities but are still unable to attract sufficient investment by the end of the Phase II award to continue the development of the product or technology, thus exhausting their financial resources at a critical stage. The purpose of this FOA is to address this funding gap between the end of the SBIR Phase II award and the point at which non-NIH financing can be secured for the subsequent stages of product development a phase often referred to as the Valley of Death.

A number of public and private organizations have begun to recognize the challenges associated with the Valley of Death and are taking steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. Importantly, these organizations are not only providing financial support to the medical biotechnology sector, but also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds (focused on supporting projects in the pre-clinical stages of development), and have also established technology incubators to provide regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and several state-sponsored technology funds have also been created to support start-up companies. Taken together, these programs can provide critical financing and commercialization support for SBCs that have received initial seed funding and a rigorous technical evaluation through the NIH SBIR program. Thus, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.

Specific Research Objectives and Requirements for SBIR Phase II Bridge Award Applications

A. Independent Third-Party Investor Funds

This FOA is specifically intended to help SBCs attract third-party investments and form strategic partnerships that will enable the SBCs to achieve key milestones to accelerate the commercialization of their products/technologies. In particular, applicants are expected to leverage their previous NIH SBIR support, as well as use the opportunity to compete for additional NCI funding under this FOA, to negotiate and attract third-party financing needed to advance a product or technology toward commercialization. Therefore, competitive preference and funding priority will be given to projects deemed likely to result in a commercial product as evidenced by the applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NCI funds being requested over the entire project period.

The expectation is that this initiative will foster new business relationships in which third-party investors will provide substantial financing to participate jointly with the NCI in advancing promising technologies toward the marketplace. It is further anticipated that many of these partnerships will involve a considerable level of due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NCI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies.

B. Scientific/Technical Scope

The technical and commercial objectives described in the SBIR Phase II Bridge Award application must represent an extension of the development efforts that were pursued in a previously funded NIH SBIR Phase II grant. This FOA is specifically designed to provide additional support for products/technologies that require ultimate approval by a Federal regulatory agency.

For more information about eligibility, see Section III.3 (Other-Special Eligibility Criteria).

Applications received under this FOA must fall within one of three technical/scientific areas: (1) Cancer Therapeutics; (2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; or (3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics. The following descriptions provide additional details on each of these areas, as well as appropriate development activities to be proposed under this FOA. Applications proposing projects in other scientific/technical areas will be considered non-responsive and will not be reviewed.

Area 1: Cancer Therapeutics

Projects proposed under Area 1 may include (but are not necessarily limited to) the development of the following categories of cancer therapeutics:

Therapeutic modalities other than those listed above may also be considered.

Applicants proposing projects under Area 1 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):

For projects pertaining to Area 1, applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application, as well as clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).

Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 1 include (but are not necessarily limited to) the following examples:

Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization.

Area 2: Cancer Imaging Technologies, Interventional Devices & In Vivo Diagnostics

Projects proposed under Area 2 may include (but are not necessarily limited to) the development of the following categories of cancer imaging technologies, interventional devices and in vivo diagnostics:

Cancer imaging modalities and interventional devices/technologies other than those listed above may also be considered.

Applicants proposing projects under Area 2 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):

For projects pertaining to Area 2, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, Investigational Device Exemption (IDE) application, and/or the successful approval of a study protocol by the Radioactive Drug Research Committee (RDRC).

Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 2 include (but are not necessarily limited to) the following examples:

Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization of the technology.

Area 3: In Vitro and Ex Vivo Cancer Diagnostics and Prognostics

Projects proposed under Area 3 may include (but are not necessarily limited to) the development of the following categories of in vivo and ex vivo cancer diagnostics and prognostics:

In vitro and ex vivo cancer diagnostic and prognostic technologies other than those listed above may also be considered.

Applicants proposing projects under Area 3 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):

For projects pertaining to scientific Area 3, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay. Thus, activities to be pursued under this FOA should address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology.

C. Plan for Full Commercialization (all applications)

The goal of the SBIR Phase II Bridge Award is to advance SBIR Phase II projects toward ultimate commercialization. All applicants are expected to provide a realistic plan (beyond the period of the SBIR Phase II Bridge Award), which outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan (see Section IV.6). NOTE: The full commercialization of the product/technology should be carried out with non-SBIR funds.

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

Section II. Award Information

1. Mechanism(s) of Support

This FOA will utilize the NIH Small Business Innovation Research Phase II (SBIR [R44]) competing renewal mechanism, referred to in this FOA as the SBIR Phase II Bridge Award.

The Project Director/Principal Investigator (PD/PI) 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 estimated amount of funds available for support of up to ten projects awarded as a result of this announcement is $10,000,000 for fiscal year 2010. Future year amounts will depend on annual appropriations.

For this funding opportunity, budgets up to $1,000,000 in total costs (direct and F&A costs plus fee) per year and project periods up to 3 years may be requested. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. The budget amounts and project periods stipulated above must not be exceeded under this FOA.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only United States (U.S.) small business concerns (SBCs) are eligible to submit SBIR applications. 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. Organized for profit, with a place of business located in the U.S., which operates primarily within the U.S. or which makes a significant contribution to the U.S. economy through payment of taxes or use of U.S. products, materials, or labor;

2. 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 business entities in the joint venture;

3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the U.S., 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 U.S. -- (except in the case of a joint venture);

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

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).

Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.

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.

Note regarding affiliation arising under stock options, convertible securities, and agreements to merge: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.

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(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. 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.

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. 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

This FOA utilizes the NIH Small Business Innovation Research Phase II (SBIR [R44]) competing renewal mechanism, referred to in this FOA as the SBIR Phase II Bridge Award.

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 will be the total of the requested costs attributable to each party, unless otherwise described and justified in Item 15, Consortium/Contractual Arrangements, of the PHS398 Research Strategy component of SF424 (R&R) application forms.

Resubmissions: Resubmission applications will be accepted but only for applications submitted in response to the previous SBIR Phase II Bridge Award FOA (RFA-CA-08-021). However, such applications must include an Introduction addressing the previous peer review critiques (Summary Statement).

Beginning with applications intended for the January 25, 2009, official receipt date (and any other due dates for FY2010 funding and beyond), all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016.

Only one Phase II Bridge Award is allowed per each prior, qualifying NIH SBIR Phase II grant award. NOTE: A Phase II Bridge Award application may not be predicated on a prior SBIR Phase II contract. Following the initial award period under this FOA (i.e., up to 3 years), recipient SBCs are expected to pursue the commercialization of these SBIR-funded projects using non-SBIR funds.

To qualify for renewal under the Phase II Bridge Award, the prior Phase II award need not have been funded in response to any particular NIH solicitation and could have been funded by the NCI or by another NIH Institute/Center. However, the proposed objectives must fall within the technical scope of this solicitation as described under Research Objectives. SBCs that previously received an NIH SBIR Phase II Competing Renewal (formerly Phase II Competing Continuation) should NOT submit an application under this FOA that is predicated on the same Phase II project as the Competing Renewal award.

This FOA is only open to current and recently expired NIH SBIR Phase II projects. Current NIH SBIR Phase II awardees must be in the final year of their Phase II project period to apply. In general, past Phase II projects should have ended within 24 months of the application receipt date. The NCI will consider longer periods of hiatus on a case-by-case basis. NOTE: The Phase II project period must have ended before a Phase II Bridge Award can be issued.

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. Applicants may not simultaneously submit identical/essentially identical applications under both this SBIR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs.

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.

Other Special Eligibility Information

General Requirements

The SBIR Phase II Bridge Award application must represent a continuation of the R&D efforts performed under a previously funded NIH SBIR Phase II grant. Applicants must demonstrate in their application that significant progress has been accomplished during the current/preceding NIH SBIR Phase II project and that the product/technology has significant commercial potential. Applicants must also demonstrate that the proposed product/technology has a clear advantage over existing and/or competing products/technologies and must clearly define an appropriate path toward ultimate product commercialization.

Independent Third-Party Investor Funds

The NCI considers the raising of independent third-party investor funds to be an important means to facilitate and accelerate the capital-intensive steps that are required to commercialize new products/technologies emerging from NIH-funded SBIR Phase II projects. As such, the NCI expects that applicants for the Phase II Bridge Award will secure substantial independent third-party investor funds, generally at least $750,000 in total third-party investor funds over the entire project period. If the project period spans multiple years, the NCI expects that the third-party tranche (i.e., portion of the total investment) received in any given year will represent a substantial portion of the total investment, generally at least $250,000 in any given year. In addition, it is expected that the total level of independent third-party support will equal or exceed the NCI funds being requested throughout the Phase II Bridge Award project period.

NOTE: Competitive preference and funding priority will be given to projects deemed likely to result in a commercial product as indicated by the applicant’s ability to secure appropriate independent third-party investor funds that equal or exceed the total amount of the NCI funds being requested over the entire project period.

Examples of third-party investors include, but are not necessarily limited to, another company, a venture capital firm, an individual angel investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Third-party investors generally should not include owners of the applicant SBC, their family members, and/or affiliates of the applicant SBC. Preferred independent third-party investor funds under this FOA include cash, liquid assets, and/or convertible debt. Independent third-party investor funds generally should not include in-kind support, intangible assets, self-funding, and/or other debt. SBIR-eligible public companies may include as part of their fundraising plan the issuance of stock (see Section IV.6 for additional details about how to document the issuance of stock). NOTE: Any third-party investment support received up to 1 year prior to the application receipt date may be counted toward the total.

The Federal funds provided by a Phase II Bridge Award can only be used for advancing the research-related elements of the project. The use of any third-party investor funds raised by the applicant will be at the discretion of the SBC. Applicants should provide sufficient information regarding the use of any third-party support to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology (see Section IV.6).

Investments or other partnership arrangements that are not specifically addressed by this FOA will be reviewed on a case-by-case basis. Applicants seeking further information regarding preferred sources and/or types of support that would demonstrate a third-party investor commitment are strongly encouraged to contact NCI SBIR program staff via email at: ncisbir@mail.nih.gov.

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.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).


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 Registered

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 to the administrator of the applicant organization/institution.
  2. Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
  3. Administrator selects "Admin" tab, Accounts tab and then "Manage Accounts" tab.
  4. Administrator enters search criteria provided by PD/PI, removes the check from the Search within your institution checkbox, and clicks Search .
  5. Administrator locates the PD/PI entry in the search results and selects the Create Affiliation Action link.
  6. Administrator clicks Confirm on the Create Affiliation confirmation screen to complete the affiliation.

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: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.


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: 301-710-0267; 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 PD/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 on 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 plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and Multiple PD/PI Leadership Plan , 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, and should include 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 (NoA).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 1, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: February 1, 2009
Application Due Date: March 1, 2010
Peer Review Date: May-June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: September 2010

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 NCI 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 (preferably via email) to:

Andrew J. Kurtz, Ph.D.
Small Business Innovation Research (SBIR) Development Center
National Cancer Institute
31 Center Drive, Building 31, Room 10A19
Bethesda, MD 20892-2580
Telephone: (301) 594-6846
Fax: (301) 480-0482
Email: kurtza@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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.

In order to expedite the review, applicants are requested to notify the NCI Referral Office by email ncirefof@dea.nci.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

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two-Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a 2-day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard Federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the 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 the application status in the Commons.

The 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a resubmission.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

The Federal funds provided by a Phase II Bridge Award can only be used for advancing the research-related elements of the developmental project.

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 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 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

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

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, incorporating "Just-in-Time" information concepts, with the following requirements.

SBIR Phase II Bridge Award Applications (Phase II Competing Renewal)

Resubmissions:

NOTE: All applicants are strongly encouraged to contact program staff prior to submitting SBIR Phase II Bridge Award application.

SBIR/STTR Commercialization History (to be included within the Commercialization Plan)

Applicants should provide an SBIR/STTR Commercialization History as part of the Commercialization Plan (within the 12-page limit) that addresses the questions listed below. Questions regarding previous SBIR/STTR funding should be addressed for all SBIR/STTR awards received from ANY Federal agency:

Fundraising Plan (to be included within the Commercialization Plan)

Applicants MUST provide a Fundraising Plan as part of the Commercialization Plan (within the 12-page limit). This plan is EXPECTED to include the following information:

Statement of Need

Applicants MUST provide a concise Statement of Need as part of the Commercialization Plan (within the 12-page limit). This statement is EXPECTED to provide answers to the questions listed below:

Documentation of Independent Third-Party Investor Support (to be included within the Appendix Materials)

At the time of application, applicants should provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of any independent third-party investor support that has been secured up to one year prior to the application receipt date. At the time of application, applicants should also provide detailed, verifiable documentation (e.g., term sheet, letter of commitment, or other documentation) of any independent third-party investor support that will be provided to the SBC during the proposed Bridge Award project period. Documentation of support from third-party investors should corroborate the Fundraising Plan presented by the applicant as part of the overall Commercialization Plan.

Examples of adequate documentation of planned (i.e., future/expected) third-party funding include a term sheet and/or letter of commitment from the third party (or parties) stipulating the terms of the proposed investment, although other forms of documentation may be considered. At the time of application, evidence of a firm third-party commitment is ideal, but not required. Appropriate documentation of third-party investor support may include a conditional letter of commitment stating that the third-party funding is contingent upon NIH selecting the application for an award. NOTE: If third-party funding is contingent upon an NIH award, then NCI staff will verify the receipt of the first year of funding before an award is issued (see Section VI. Award Administration Information for more details).

SBIR-eligible public companies may include as part of their fundraising plan the issuance of stock. In such a case, the preferred documentation is a letter of commitment, signed by the Chairman of the Board of Directors, which stipulates the following: (1) the amount of capital raised from the issuance of stock; (2) the amount of capital that will be dedicated to the proposed project under this FOA; (3) sufficient information regarding the use of the dedicated capital to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology to be developed under this FOA.

It is likely that several months will have elapsed between the time an application is submitted and the time it is peer reviewed and subsequently considered for possible funding. Accordingly, applicants should present a detailed summary of all past and/or planned (i.e., future/expected) third-party investor funds which clearly shows, relative to the estimated award date, when these funds have been and/or will be secured. For example, if the fundraising efforts of the SBC are in progress, and/or if the third-party investment is contingent upon NIH selecting the application for funding, then such plans should be clearly described in the fundraising plan.

Budget

The Federal funds provided by a Phase II Bridge Award can only be used for advancing the research-related elements of the project. Applicants should provide a detailed budget (including budget justification) outlining how the NCI funds will be used to advance the research-related elements of the project. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget component found in the application package attached in this FOA in Grants.gov/Apply.

The use of any third-party investor funds will be at the discretion of the SBC. Applicants should provide sufficient information regarding the use of any third-party support to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology. This information should be included as part of the Commercialization Plan (within the 12-page limit). In particular, applicants are EXPECTED to address the following questions regarding the use of third-party funds.

In Phase II, normally, a minimum of 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); however, deviations from these guidelines may be acceptable with appropriate justification (e.g., when human clinical studies or trials are a component of the research proposed).

Resubmissions

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

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. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing (for example, human subject concerns, the Small Business Act provisions, etc.), this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIH institute/center (IC) program staff likely to accept assignment of their application (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy and NIH Guide NOT-OD-04-042).

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information, see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

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

Review Process

Prior to the review, program staff in the NCI SBIR Development Center, in consultation with the NCI Division of Extramural Activities (DEA), will determine whether applications are responsive to this FOA. All applications will be evaluated to determine whether:

If the previous SBIR Phase II grant (upon which the Bridge application is predicated) has ended more than 24 months prior to the application receipt date, then the application will be evaluated to determine whether the proposed R&D represents a current, scientifically-relevant, commercially-viable opportunity.

Applications that do not meet the requirements listed above will be considered non-responsive and will not be reviewed.

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

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

Enhanced Review Criteria

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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 five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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?)

Specific to this FOA: Is the value proposition compelling, and does the discussion clearly demonstrate a market-pull? Has the applicant identified a realistic market niche for their product/technology which addresses an unmet need? Has the applicant identified market-based milestones that are expected to be achieved over the next five years? Does the applicant SBC demonstrate an understanding of the competitive environment and the market in which they plan to sell their product? Have the customers been identified? Has the company addressed potential hurdles that may delay or prevent acceptance of their product? If appropriate, are the applicant SBC’s plans for generating a revenue stream reasonable, and are the revenue projections realistic? How strong is the applicant SBC’s intellectual property (IP) portfolio/position (pertinent to the proposed project)? Does the company have a reasonable strategy to protect its IP and build a sustainable business? Does the activity, as proposed, address issues related to Federal regulatory approval processes?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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?

Specific to this FOA: Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully commercialize the proposed products/technologies? For example, have the PD(s)/PI(s) commercialized other SBIR/STTR supported technologies and discoveries?

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) Protections for Human Subjects, 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?

Specific to this FOA: How promising are the outcomes of the previously-funded NIH SBIR Phase II project upon which the proposed Phase II Bridge Award is predicated? To what extent does the progress justify the continuation of the development efforts? Are the proposed milestones for the Phase II Bridge Award activities sufficient to determine whether the awardee has successfully reached the specified goals (e.g., IND filing)? If the proposed project involves advancing the product/technology through the Federal regulatory approval process, how sound is the proposed plan to meet these requirements?

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 arrangements?

Specific to this FOA: Does the applicant SBC have the necessary ability to address regulatory issues (either through their own staff members or through appropriate arrangements with external regulatory consultants)? Is the applicant SBC concentrating on its core competencies in order to maximize its chances of success? Has the applicant SBC established alliances/collaborative partnerships that will facilitate commercialization? Can the applicant SBC sustain itself and grow as a business? If the SBC has received previous SBIR/STTR funding from ANY Federal agency, then what is the company’s record of commercializing prior SBIR/STTR projects or other R&D? Will the third-party investors play an active role in facilitating the development and commercialization of the applicant products/technologies?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Fundraising Plan. Has the applicant demonstrated the ability to raise independent third-party investor funds that may equal or exceed the NCI funds being requested throughout the project period? Has the applicant secured, and/or will the applicant secure during the project period, the preferred types of liquid, third-party investor funds under this FOA (i.e., cash, liquid assets, and/or convertible debt)? Has the applicant provided detailed and verifiable documentation (e.g., term sheet) for the investor funds that will be secured during the project period? Has the applicant planned to secure sufficient third-party support to achieve its milestones? Has the applicant demonstrated that the third-party investor support will provide a substantial, value-added contribution toward the development and commercialization of the product/technology? Has the applicant described the specific activities that the third-party investor funds will support? Have the investors attached any restrictions/triggers/milestones to future payments, and if so, have they been stipulated in the application? In general, have the terms of the future investment rounds been sufficiently described, thus demonstrating a high level of confidence in the SBC’s ability to execute the overall fundraising plan?

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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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 Agents 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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

Selection Process

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:

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 or her Summary Statement (written critique) via the NIH 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.

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 Section IV.5., Funding Restrictions.

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.

SBIR Phase II Bridge Award Applications

If the Phase II Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Fundraising Plan submitted as part of application) will become a term of award. Prior to the issuance of an award, NIH will request Just-In-Time information from the applicant to verify compliance with the Fundraising Plan. Once the NCI grants management official has notified the SBC that their application is being considered for funding, the SBC is encouraged to submit all of the requested Just-In-Time information as soon as possible (i.e., generally within 2 months). Just-In-Time may include, but is not limited to, the following:

Prior to the issuance of an award, any substantive change to the applicant’s original Fundraising Plan (as reviewed by the Special Emphasis Panel) must be discussed with the assigned Program Director during the administrative review process. Substantive changes to the original Fundraising Plan may include, but are not necessarily limited to the following: (1) one or more of the original investors has withdrawn or substantially reduced their committed level of support; (2) the financing mechanism or instrument, or other terms associated with the third-party investment, have been significantly altered relative to the originally proposed plan. Prior to the issuance of award, if the applicant proposes to modify the Fundraising Plan, the assigned Program Director must verify that the updated type(s), source(s), total amount(s), and anticipated schedule(s) for receiving funds represent an equivalent or superior plan as compared to the originally evaluated Fundraising Plan.

All substantive changes to the original Fundraising Plan (i.e., the plan evaluated by the Special Emphasis Panel) will be evaluated on a case-by-case basis. All substantive changes to the applicant’s original Fundraising Plan must be appropriately addressed in a revised fundraising plan. NOTE: If a revised Fundraising Plan is proposed, it must be approved by the Director of the SBIR Development Center and the NCI Office of Grants Administration prior to award. In such a case, the revised Fundraising Plan supercedes the original plan and becomes a term of award.

A grantee’s failure to comply with the terms of award may cause NIH to take one or more enforcement actions, including suspension of the grant, withholding of support, or termination, depending on the severity and duration of the non-compliance. NIH will undertake any such action in accordance with applicable statutes, regulations, and policies.

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.

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.

Compliance with Fundraising Plan: As described in Section VI.1 (Award Notices), the applicant’s Fundraising Plan submitted at the time of application (or the revised Fundraising Plan approved by the NCI), becomes a term of award. Throughout the Bridge Award project period, grantees will be expected to provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of independent third-party investor support that is planned/expected, according to the schedule that is stipulated in the Fundraising Plan.

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:

Andrew J. Kurtz, Ph.D.
Small Business Innovation Research Development Center
National Cancer Institute
31 Center Drive, Building 31, Room 10A19
Bethesda, MD 20892-2580
Telephone: (301) 594-6846
Fax: (301) 480-0482
Email: kurtza@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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 institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement). Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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. 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see http://www.lrp.nih.gov/.

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NIH Funding Opportunities and Notices


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