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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 New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR [R44])

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-CA-08-021

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).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Note: Applications submitted for the February 27, 2009 receipt date will use Adobe forms, which will be available in December, 2008 (see NOT-OD-08-117).

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

Key Dates
Release/Posted Date: May 14, 2008
Opening Date: August 19, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Dates: August 19, 2008; January 27, 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 Dates: September 19, 2008; February 27, 2009
Peer Review Dates: November/December 2008; April/May 2009
Council Review Dates: January 2009, August 2009
Earliest Anticipated Start Dates: April 2009; September 2009
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 28, 2009

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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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

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 problems. A major objective of the SBIR Program is to facilitate 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), launched as a pilot initiative at the NIH by the National Cancer Institute (NCI), solicits SBIR grant applications from SBCs that seek additional NIH funding to support the next stage of development for previously-funded NIH SBIR Phase II projects applicable to cancer therapies and cancer imaging technologies. The purpose of this FOA is to support 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. Specifically, 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 new cancer therapies (including anticancer agents and oncological therapeutic devices) and cancer-relevant imaging devices/technologies toward commercialization. Only applications proposing projects in these areas will be considered responsive to this FOA. Proposed projects may address preclinical and/or clinical stages of technology 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, while in Phase II it is to continue the R&D efforts initiated in Phase I. The objective for small businesses in Phase III is to commercialize the technology using non-SBIR funds. However, many of the early-stage projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II awards 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 therapies and cancer imaging devices/technologies are important areas that 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. The developers of combined technologies often face additional challenges during the regulatory approval process, requiring even more time and effort before they can bring those technologies to commercialization. Yet, despite the extensive R&D efforts that are characteristic of SBIR Phase II projects in these areas, the results are often insufficient to attract private capital investments toward the eventual commercialization of a product or service.

Historically, large pharmaceutical companies and biotechnology companies financed through venture capital firms and other private investors have provided the resources needed to advance products and services in the area of medical biotechnology through the various stages of commercial development. In recent years, however, investing trends in life science technologies have shifted to favor later-stage development efforts in established companies over the high-risk early-stage development of emerging products/technologies (e.g., those in the pre-clinical stages). This situation has exacerbated the challenge that many NIH SBIR Phase II awardees face in securing non-NIH financing for their next stage of product/services development. Consequently, an increasing number of SBIR-sponsored SBCs may successfully complete their Phase II activities but still be unable to attract sufficient investment to continue the next stage of commercial development. Moreover, these financing challenges have widened a significant funding gap commonly referred to as the Valley of Death in which many SBCs exhaust their financial resources before reaching the next critical milestone along the path toward commercialization.

SBIR Bridge Award Initiative. Recently, a number of public and private organizations have recognized the challenges associated with the Valley of Death and have taken steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. However, a number of these programs are still in their infancy and face critical challenges in identifying investments with a sound scientific/technical foundation. Importantly, much of the financial support from third-party sources has been focused on the medical biotechnology sector, and many organizations have established technology incubators and other initiatives to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds specifically focused on supporting projects in the pre-clinical stages of development, as well as providing regulatory guidance. In addition, a growing number of universities are creating venture funds to support highly-innovative technologies developed by their resident investigators, and several state-sponsored technology funds have now been created to support start-up companies. Taken together, these third-party programs can provide additional 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 the SBIR Phase II Bridge Award is to support selected NIH SBIR Phase II awardees toward the ultimate commercialization of their emerging products/technologies while simultaneously enhancing their ability to leverage additional third-party funds.

The SBIR Phase II Bridge Award pilot initiative is focused on the continued development of cancer therapies (including anticancer agents and oncological therapeutic devices) and cancer relevant imaging applications/technologies. The development of products/technologies in these areas requires both preclinical and clinical evaluation and, ultimately, approval by an appropriate Federal regulatory agency. Typically, NIH SBIR Phase II projects focus on (and are limited to) the early stages in this process. This FOA is specifically designed to bridge the funding gap between the end of the SBIR Phase II award and the Phase III commercialization stage by creating incentives for third-party investors and/or strategic partners to participate in the product/technology development by NIH’s SBIR Phase II awardees. Incentivizing these critical relationships at an early stage is intended to counteract the attrition of promising SBIR Phase II projects due to the Valley of Death funding gap.

Expected Involvement of Third-party Investors. Competitive applicants under this FOA are expected to secure additional funds from third-party investors and/or strategic partners. In addition, programmatic funding priority will be given to applicants that demonstrate the 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 participating third-party investors will provide substantial levels of financing to drive promising technologies toward the marketplace. It is also anticipated that many of these relationships 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 long-term 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.

Scientific/Technical Scope

This funding opportunity is focused on the continued development of cancer therapies and cancer imaging technologies. Applications proposing projects in other scientific/technical areas will be considered non-responsive and will not be reviewed. 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. To be considered for a Phase II Bridge Award, applicants must document the achievement of significant milestones during the previous Phase II award which justify the merit and need for further R&D. To qualify for a Phase II Bridge Award, the SBIR 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 Phase II Bridge Award application must fall within the scientific and technical scope of this FOA (i.e., it must be focused on the development of novel anticancer therapeutics, oncological therapeutic devices, and/or cancer-relevant imaging devices/technologies).

Development Goals. This FOA is specifically intended to help SBCs attract investments and form strategic partnerships that will enable the SBCs to achieve key milestones to accelerate the commercialization of their products/technologies. In particular, this FOA is designed to provide additional support for many products/technologies that require ultimate approval by a Federal regulatory agency. Given that all proposed projects under this FOA must be predicated upon a previously-funded NIH SBIR Phase II project, it is expected that some applicants will have completed the bulk of the preclinical development activities by the time of the SBIR Phase II Bridge Award. Nonetheless, activities proposed for support by a SBIR Phase II Bridge Award may include an extension and expansion of pre-clinical R&D. For example, it is expected that an applicant SBC focused on the development of an anticancer agent would have completed a large portion of the in vitro and in vivo studies as part of the SBIR Phase II activities. In such a case, funds provided through the Phase II Bridge Award could be used to complete additional pre-clinical R&D needed for regulatory filings [e.g., Investigational New Drug (IND) application].

Clinical evaluation (including clinical trials) can be proposed as needed but is not required. Other R&D activities that are needed to meet the requirements and expectations of a relevant Federal regulatory agency may also be proposed.

Full Commercialization. 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 the full commercialization of the product/technology can be accomplished. The full commercialization of the product/technology should be carried out with non-SBIR funds.

Specific types of products/technologies to be pursued in projects proposed for SBIR Phase II Bridge Awards may include, but are not limited to:

The development efforts for these anticancer agents, therapeutic devices and/or imaging devices/technologies may include, but are not limited to:

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]) grant competing renewal mechanism, referred to in this FOA as the SBIR Phase II Bridge Award. The SBIR Phase II Bridge Award is designed to support the next stage of development for previously-funded NIH SBIR Phase II projects that merit further R&D efforts toward the ultimate commercialization of a novel product/technology.

Only ONE Phase II Bridge Award is allowed per each prior, qualifying NIH SBIR Phase II grant award. Following the initial award period under this solicitation (i.e., up to 3 years), recipient SBCs are expected to pursue the commercialization of these SBIR-funded projects using non-SBIR funds. All applications submitted under this FOA will be considered renewal applications of previously-funded SBIR Phase II awards.

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 NCI intends to commit $10,000,000 in fiscal year 2009 to fund five to ten applications submitted in response to this FOA. 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 from the NCI. 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. Future year amounts will depend on annual appropriations.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

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 (SBC) is one that, at the time of award of the Phase II Bridge Award, 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 American 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 consideration is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.

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

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

In addition to the standard SBIR eligibility requirements, applicants must satisfy several other requirements as described under Other-Special Eligibility Criteria (Section III.3).

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).

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

Under the SBIR program (including the Phase II Bridge Award), 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

Not applicable.

3. Other-Special Eligibility Criteria

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. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant or cooperative agreement applications with essentially the same research focus from the same applicant organization. This restriction includes derivative or multiple applications that include proposals to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant or cooperative agreement 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 or cooperative agreement 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 or cooperative agreement 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 or cooperative agreement 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 applications 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. Eligible applicants may submit only ONE Phase II Bridge Award application per each prior, qualifying NIH SBIR Phase II grant award. To be competitive for the SBIR Phase II Bridge Award, an applicant 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.

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.

Independent Third-Party Investor Support

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. Specifically, it is expected that the level of this independent third-party funding will equal or exceed the NCI funds being requested throughout the Phase II Bridge Award project period. Furthermore, 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 substantial independent third-party investor funds.

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.

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, and/or self funding.

Applicants are encouraged to discuss their plans for third-party investor support with members of the NCI SBIR staff. 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: [email protected].

Total Independent Third-Party Investment During the Project Period

Applicants are expected to obtain a substantial third-party commitment from investors and/or strategic partners generally at least $750,000 in total third-party investor funds over the entire project period. If the project period spans multiple years, NCI expects that the third-party traunch (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. The NCI also expects that the total level of independent third-party funds secured throughout the project period will equal or exceed the NCI funds being requested.

Documentation of Independent Third-Party Commitment to SBC

At the time of application, applicants should provide detailed, verifiable documentation of any independent third-party investor support that has already been secured (at least up to one year prior to application receipt date). Applicants must also provide a specific commercialization plan that includes details on any independent third-party investor funding that is anticipated during the project period. Examples of adequate documentation of planned third-party support could 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.

If the Phase II Bridge Award application is selected for funding, NIH will request Just-In-Time information from the applicant prior to award. See Section VI. Award Administration Information for details. This information will include the following:

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.

Plan for Obtaining Independent Third-Party Investor Funds

If the Phase II Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (submitted as a part of application) will become a term of award. Note that 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.

Section IV. Application and Submission Information

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

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

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

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

1) Organizational/Institutional Registration in Grants.gov/Get 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 SBC:

  1. PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/PI.)
  2. Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
  3. Administrator selects "Administration" tab and then "Accounts" tab.
  4. Administrator selects "Create Affiliation" tab.
  5. Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

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

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

Several of the steps of the registration process could take 4 weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

For further assistance, contact GrantsInfo Telephone: 301-710-0267; Email: [email protected].

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.

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

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, 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).

All applications submitted under this FOA will be considered renewal applications of previously-funded SBIR Phase II awards. Qualifying Phase II awards will generally be limited to those that have ended within 24 months of the application receipt date.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 19, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Dates: August 19, 2008; January 27, 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 Dates: September 19, 2008; February 27, 2009
Peer Review Dates: November/December 2008; April/May 2009
Council Review Dates: January 2009, August 2009
Earliest Anticipated Start Dates: April 2009; September 2009

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 by email) to:

Andrew J. Kurtz, Ph.D.
Small Business Innovation Research Development Center
National Cancer Institute
31 Center Drive, Building 31 Room 10A19, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 594-6846
Fax: (301) 480-0482
Email: [email protected]

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.

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

3.C. Application Processing

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

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

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

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

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

The NIH will not accept any application in response to this 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 restriction 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 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 Phase II Bridge 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 Phase II Bridge 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 and Information

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

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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

SBIR Phase II Bridge Award applications:

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 20-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):

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 already been secured (at least up to one year prior to application receipt date). In addition, applicants MUST provide a Fundraising Plan as part of the Commercialization Plan (within the 20-page limit). This plan is EXPECTED to include the following information:

Documentation of Third-Party Commitment (to be included within the Appendix Materials):

At the time of application, applicants should provide detailed, verifiable documentation (e.g., term sheets, letters of commitment) from any third-party investors and/or strategic partners that will contribute funding to the SBC during the project period. The documentation should include the source(s) of funds, the funding instrument(s), and the total amount(s) provided by each investor during the project period. Note: If the Phase II Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (submitted at the time of application) will become a term of award.

Budget:

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

Note: 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); 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 of the Research Plan component. 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, 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 where 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Prior to the review, the NCI SBIR Program staff members will determine whether applications are responsive to this FOA. All applications will be evaluated to determine whether:

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, technical, and commercial merit by an appropriate peer review group convened by 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 merit review, all responsive applications will:

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For the projects proposed in response to this FOA, commercial merit and viability of the proposed R&D efforts will have a substantial impact on the overall evaluation.

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

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

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

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 developmental 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?

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

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

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?

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

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, 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?

In addition to the above review criteria, the following criterion will be applied to ALL Phase II Bridge Award applications:

Commercialization Plan. Is the value proposition compelling and does the discussion clearly demonstrate a market-pull? Has the applicant SBC 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?

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 planned to secure sufficient third-party investor funds to ensure that they will achieve the market-based milestones identified in the commercialization plan? If not, has the applicant described a long-term plan for securing further independent third-party support to achieve its milestones? Has the applicant provided detailed, verifiable documentation (e.g., term sheet) for the investor funds that will be secured during the project period? 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?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See Item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See Item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

Likelihood of Product Commercialization. Competitive preference and funding priority will be given to projects deemed likely to result in a commercial product. Specifically, under this FOA, the NCI will evaluate the applicant’s plans to raise independent third-party funds as a benchmark for the likelihood of product commercialization. Thus, in determining funding priority, the NCI will consider the degree to which applicants are able to secure independent third-party investor funds. Preferred independent third-party investor funds under this FOA include cash, liquid assets, and/or convertible debt. The plan for raising third-party funds must be properly documented with detailed, verifiable information (e.g., term sheets, letters of commitment, etc). For more information, please review Other-Special Eligibility Criteria (Section III.3) and Other Submission Requirements and Information (Section IV.6).

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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.

Applicants under consideration for funding for a Phase II Bridge Award should submit all Just-In-Time information as soon as possible, generally within two months of being notified that their application is being considered for funding:

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.

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 awardees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)

Final Progress Report

Final Invention Statement and Certification (HHS 568)

Annual Invention Utilization Reports

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

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

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

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

All awardees will also be required to submit annual Non-Competing Continuation Progress Reports (using form PHS 2590) as part of the non-competing continuation award process.

In addition, the applicant s Fundraising Plan (submitted at the time of application) will become a term of award. Therefore, the applicant must provide detailed, verifiable documentation (e.g., redacted bank statements or other documentation) in the Annual Report, which clearly demonstrates that any third-party funds have been received by the SBC according to the terms specified in the original Fundraising Plan. If the third-party investment is realized in traunches, the Annual Report should reflect all updated information regarding the receipt of additional third-party investor funds. Other updates or changes regarding the receipt of independent third-party investor funds should also be included in the Annual Report (e.g., the SBC must provide notification to the NCI in the event that the SBC intends to secure new/other third-party investor funds to substitute for any amount which was not paid by the original investors that were identified at the beginning of the project period). The NCI Program Official or NCI Office of Grants Administration may request additional information at any time to confirm receipt of third-party investor funds.

Note: 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.

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:

Inquiries related to cancer imaging-oriented projects:

Andrew J. Kurtz, Ph.D.
Small Business Innovation Research Development Center
National Cancer Institute
31 Center Drive, Building 31 Room 10A19, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 594-6846
Fax: (301) 480-0482
Email: [email protected]

Inquiries related to cancer therapeutics-oriented projects:

Ali Andalibi, Ph.D.
Small Business Innovation Research Development Center
National Cancer Institute
31 Center Drive, Building 31 Room 10A19, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-0763
Fax: (301) 480-0482
Email: [email protected]

2. Peer Review Contacts:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20892 (for non-USPS delivery)
Telephone: 301-496-8634
Fax: 301-496-8601
E-mail: [email protected]

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); and 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).

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (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. Applications that do not provide this information will be returned without review.

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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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 2 years to the research. For further information, please see http://www.lrp.nih.gov/.

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