Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (R43/R44)

Activity Code

R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track

Announcement Type

New

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 12, 2014 ( NOT-OD-14-089) - Updated Grant Application Forms (FORMS-C) Now Available for SBIR/STTR Funding Opportunities. Forms-C applications are required for due dates on or after August 5, 2014.
  • March 14, 2014 - See Notice NOT-OD-14-070. Adjustments to May 25-28, 2014 Grant Application Due Dates.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

PAR-13-327

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.394, 93.395, 93.396  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research for commercial development of novel cancer-relevant technologies. The proposed research projects are expected to focus on the development of highly-innovative technologies that improve molecular and/or cellular analysis of cancer with a significant likelihood for either overcoming persistent challenges or obstacles or opening entirely new fields for cancer research or clinical care. Applications should specify milestones relevant to both the development and commercialization of these technologies. This FOA complements the goals of the NCI's Innovative Molecular Analysis Technologies (IMAT) program by facilitating the path towards technology commercialization. Prior participation in the IMAT Program is not required for eligibility for this FOA. Applications are expected to indicate the significant attributes and advantages of the proposed technology over currently available technologies and conventional approaches. 

Key Dates
Posted Date

August 8, 2013

Open Date (Earliest Submission Date)

October 4, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 4, 2013; (Extended to May 29, 2014 per NOT-OD-14-070), Originally May 28, 2014; November 4, 2014; May 27, 2015;

November 4, 2015; May 27, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2014; July 2014; March 2015; July 2015; March 2016; July 2016

Advisory Council Review

May 2014; October 2014; May 2015;October 2015; May 2016; October 2016

Earliest Start Date

July 2014; September 2014; July 2015; September 2015; July 2016; September 2016

Expiration Date

May 28, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research for commercial development of novel cancer-relevant technologies. The proposed research projects are expected to focus on the development of highly-innovative technologies that improve molecular and/or cellular analysis of cancer with a significant likelihood for either overcoming persistent challenges or obstacles or opening entirely new fields for cancer research or clinical care. Applications should specify milestones relevant to both the development and commercialization of these technologies. This FOA complements the goals of the NCI's Innovative Molecular Analysis Technologies (IMAT) program by facilitating a path towards technology commercialization. Prior participation in the IMAT Program is not required for eligibility for this FOA. Applications are expected to indicate the significant attributes and advantages of the proposed technology over currently available technologies and conventional approaches. 

Although this FOA is open only to SBCs, it is run in partnership with NCI's IMAT Program. The IMAT Program uses research project grant activity codes (R21, R33) and these FOAs are broadly open to all qualified investigators. Non-SBC affiliated investigators interested in the development of relevant technologies are encouraged to consider submitting grant applications to one of these IMAT FOAs (for information on specific IMAT FOAs, see http://innovation.cancer.gov).

Background

The NCI IMAT program is aimed at supporting the early-stage development of highly innovative technologies relevant to cancer research, prevention, diagnosis and treatment, and epidemiology. Since 1998, the IMAT Program has facilitated the development of various tools and methods benefiting research and, ultimately, clinical oncological practice. The emphasis of the IMAT Program is on supporting the early-stage development and validation of high-risk and high-payoff innovations.

The NCI recognizes the need for support in translating emerging analytical technologies into commercially available products and services. To facilitate commercial development of promising technologies and thereby widespread adoption of enabling new tools for cancer research, this FOA aims to fill a funding gap for those SBCs that need to perform further development and validation of a commercially viable product or service. This FOA complements other initiatives (including those from the IMAT Program), by supporting efforts aimed at the transition of technological conceptual advances toward broadly available products/tools/services.

Scientific/Technical Scope of this FOA

This FOA will support researchers at SBCs, who wish to develop and validate their innovative technologies in the context of commercial use. These technologies could have been invented, discovered, and/or initially developed with support from any funding source including, but not limited to, the NCI IMAT Program, or may be entirely new invention applications. As mentioned previously, although prior participation in the IMAT Program is not required for this FOA, technologies proposed for this FOA are expected to exhibit a high degree of innovation with transformative potential, or otherwise demonstrate clear advantages over currently available technologies as is required for applications to the IMAT Program. Prospective applicants are advised to visit the IMAT website for more information about the program.

Definition of “Technologies”: In the context of this FOA, the term “technologies” encompasses novel techniques, materials, instrumentation, and devices that offer significant improvements in terms of novel types of cancer-relevant analyses, and/or greater resolution, specificity, and/or throughput relative to the currently available methods/tools. Highly-innovative platforms for sample preparation and/or processing, and for improved downstream analysis are also within the scope of this FOA. This further includes technologies that offer a novel means for assessing general analyte quality to determine sample fitness-for-purpose for a known analytical platform. The proposed technology and application must correspond to an important unmet need relevant to cancer research and/or clinical aspects. Given the FOA's emphasis on commercial development, these technologies (for both Phase I and Phase II applications) must have a strong potential for commercial success.

For Phase I projects, preliminary data are strongly encouraged but not required. If preliminary data are not available, Phase I projects must be based on rigorous scientific rationale. Phase I projects are expected to prove technical feasibility of the technology (and possibly generate a prototype, if appropriate) in a degree that is sufficient to support the use of the proposed technology in a cancer relevant application.

For Phase II projects, the Phase I results should have already demonstrated technical feasibility of the invention. Phase II projects are expected to concentrate on further technology development and improvements, to address intellectual property protection (including work towards filing patent application if not done already) and preparation for regulatory steps, as applicable, that might be needed for a commercial application of the technology.

Both Phase I and Phase II projects proposed in response to this FOA must be designed to accelerate the development of these technologies and achieve specific benchmarks that are relevant to commercial feasibility. The overall goal is to facilitate technology development to the point that it would warrant a full commercialization effort and would have the potential to attract external investments, as needed. Given the strong emphasis on the commercial development of emerging analysis technologies beyond the prototype stages, project goals must be supplemented with specific key technical and commercially-relevant milestones. Quantitative milestones are required for both Phase I and Phase II projects as well as for both phases of Fast-Track applications.

Projects in any area of cancer-related molecular or cellular analysis are encouraged, provided that the technology proposed meets the requirement for potential as a commercial product or service. Technologies may target atomic, molecular, sub-cellular, and cellular levels of detection and analyses. Beyond the scope of this FOA, it is anticipated (and encouraged) that the outcomes of successful SBIR projects will help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly available product or service. 

Technology areas of interest include, but are not limited to, the following:

Technologies that are generally not appropriate for this FOA include the following:

Alternative Funding Opportunities

Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider:

Researchers who emphasize the assessment of whole body or in vivo imaging technologies as the primary focus of their projects should contact the Cancer Imaging Program (CIP; http://imaging.cancer.gov/) for information on appropriate funding opportunities.     

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
 

New (Phase I, Fast-Track)
Renewal (Phase II)
Resubmission (all phases)

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($225,000 for Phase I and $1,500,000 for Phase II, a hard cap).

Award Project Period

According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

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

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;

3. (i) SBIR and STTR.  Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR

(ii) SBIR-only.  Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.  No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR

(iii) SBIR and STTR.  Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.

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

If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.

If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

Definitions:

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

Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

Contractual/Consortium Arrangements

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

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

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above.  A Federal laboratory, as defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS 398 Research Plan component of SF424 (R&R) application forms.

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

Other Attachments:

1. SBA Company registry

All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration.  Completed registrations will receive a unique SBC Control ID and .pdf file.  If applicants have previously registered, you are still required to attach proof of registration.  The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

a. Navigate to the SBA Company Registry.

b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided.  Identify your company and click “Proceed to Registration”.

c. If you are a first time applicant, click the "New to the SBIR Program?" link on lower right of registry screen.

d. Fill out the required information on the “Basic Information” and “Eligibility Statement” screens.

e. Press “Complete Registration” on the lower right of the “Eligibility Statement” screen and follow all instructions.

f. Download and save your SBA registry PDF locally.  The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID.  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application.

g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the “Research and Related Other Project Information” form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.

2. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive.  Follow the instructions below. 

Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

a. Download the “SBIR Application VCOC Certification.pdf” at the NIH SBIR Forms webpage. 

b. Answer the 3 questions and check the certification boxes.

c. The authorized business official must sign the certification.

d. Save the certification using the original file name.  The file must be named “SBIR Application VCOC Certification.pdf”.  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application.

e. When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the “Research and Related Other Project Information” form.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

R&R Budget

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

Applicants must include travel expenses for at least one PD/PI to attend the annual 2-day meeting of all investigators funded through the IMAT program. The location for the meeting varies from one year to the next, historically alternating between the west coast and east coast. For a listing of past event locations and additional details about the annual meeting, see the http://innovation.cancer.gov/events or contact the NCI IMAT program director.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

PHS 398 Research Plan

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

Specific Aims: Include a brief sub-section "Statement of Potential Impact" on the expected potential of the proposed technology to transform cancer research and clinical practice. The following questions should be addressed.

Research Strategy: Address the following required aspects:

SBIR Phase I applications

Innovative, Cancer-relevant Technology. The proposed project must be focused on the initial development and application of an innovative molecular analysis technology in a biologically relevant system.  Application must describe metrics of success that determine or optimize technical capability and its anticipated long-term use to advance cancer research and/or clinical practice. The proposed technology may be targeted for the needs of basic, preventative, diagnostic, translational, epidemiological, health disparities, and/or clinical cancer research or may have potential for broad use in various fields of cancer research.

Substantial Improvement and/or New Capabilities. All proposed technologies must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by current technologies.

Transformative Potential. Define clearly the novelty of the proposed technology and describe its anticipated use in laboratory research and/or clinical settings. Claimed potential impact is expected to be in line with the specific quantitative milestones (last bullet).

Commercial Potential. Clearly indicate the unmet market need for the proposed technology, describing the marketable product, process, or service along with information regarding market size and growth projections.

Quantitative Milestones. Quantitative Milestones should be carefully selected and precisely defined, and should clearly detail the expected advantages of the proposed approach relative to existing technologies.

SBIR Phase II applications

Validation of Cancer-relevant Technology. Applications must focus on the validation and advanced development of an innovative molecular analysis technology that targets the needs of basic, preventative, diagnostic, translational, epidemiological, and/or clinical cancer research or for broad potential use in cancer research. Provide appropriate background/preliminary data to justify that the proposed technology has passed the pilot developmental stage and shows promise. Describe strategy and specific research steps to evaluate and rigorously validate the proposed technology within the context of its intended use.

Substantial Improvement and/or New Capabilities. All proposed technologies must offer the potential for substantial improvements over conventional approaches and/or add qualitatively new research capabilities not provided by current technologies.

Transformative Potential. Define clearly the novelty of the proposed technology and describe its anticipated use in laboratory research and/or clinical settings. Claimed potential impact is expected to be in line with the specific quantitative milestones (next bullet).

Quantitative Milestones. Quantitative Milestones should be carefully selected and precisely defined, and should clearly detail the expected advantages of the proposed approach relative to existing technologies.

Commercialization Plan. All applications must also describe the commercialization strategy for marketing the proposed technology as a product, process, service, or combination thereof. Commercialization plans should discuss the clear need and window of opportunity within a specific market, highlight the competitive edge over existing products or services, and outline the key steps that will be taken over the period of support towards achieving commercial success.

SBIR Fast-Track Applications

The NIH Fast-Track application is a single application consisting of all Phase I and Phase II activities described above. See the section on “Fast-Track Applications” in the SF424 (R&R) SBIR/STTR Application Guide.

NOTE FOR All APPLICATIONS (Phase I, Phase II, and Fast-Track): The Research Strategy must include quantitative milestones for each specific aim. These milestones serve as a way of determining during the project whether an awardee has successfully reached the specified goal(s). Milestones should be clearly stated as numerical quantitative specifications for relevant measures/properties (as appropriate) and/or distinct stages in technology/product development.

Additional Information on Quantitative Milestones

"Milestones" must be addressed in a dedicated subsection of Research Strategy with that title. Milestones should be well described, quantitative, and scientifically justified. Discuss the milestones as a means of judging the success of the phase I project as well as providing proof-of-principle for justifying further developmental effort (e.g., under a future phase II project). Note that proof-of-principle goes beyond a single observation, so where appropriate, milestones should include the relevant statistical context for the targeted parameter. Whenever appropriate, present the proposed milestones in the context of current technologies to substantiate the anticipated transformative potential. Listing all milestones in a single location is helpful for review of the application.

Specific aims may not be regarded as milestones. The specific aims describe the goals and intended path of the research. Quantitative milestones provide a numerical target of performance or capability for judging how realistic the proposed goals are and what potential impact the technology might have on cancer research. Thus, proper quantitative milestones are expected to include context/project-relevant numerical specifications (such as sensitivity and specificity of a technology/procedure, or a count of some desired or newly discovered molecule, or some other quantifiable metrics of performance). For some types of specific aims, it may be sufficient to define a single milestone. For other types, multiple milestones may be more appropriate. The applicant should also provide a clear strategy for assessing each milestone.

Examples of quantitative milestones include, but are not limited to:

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

Appendix: Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modification:

Note that Phase I SBIR/STTR Appendix materials are not permitted.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

Annual Meeting

An annual 2-day meeting of all investigators funded through the IMAT program will be held to share progress and research insights that may lead to further progress in the program. The location for the meetings will alternate between the west coast and east coast. Funded investigators must accommodate all costs necessary for the PD/PI or other key personnel on the project to attend this meeting in the requested budget. Go to http://innovation.cancer.gov/events  or contact the NCI IMAT program director for more information about the annual meeting.  

6. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

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Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

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

In addition, specific for this FOA: What is the potential of the proposed technology to transform cancer research or clinical practice if the project is successfully completed? Are the expectations in that area realistic and in line with the planned developmental efforts? Do the proposed milestones support a transformative capacity for a cancer-relevant field of research or clinical care?  

Investigator(s)

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

Innovation

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

In addition, specific for this FOA: Does the proposed technology offer clear and significant improvement over currently available methods and platforms? Will the proposed technology offer new possibilities for cancer research or oncological practice relative to the current methods? If the project focuses on a new cancer-relevant application of an existing technology, how innovative is the proposed new type of technology usage?     

Approach

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

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

Environment

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

Additional Review Criteria

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

Milestones

Are the proposed quantitative milestones adequate relative to the specific requirements defined in the FOA? Are they sufficiently realistic? Will the proposed milestones allow determination of whether or not the specific aims of the Phase I project have been accomplished? Would meeting the proposed milestones be sufficient to establish the feasibility of the proposed technology and serve as a foundation for next phase developmental efforts?

Commercialization

Phase I and II: What is the likelihood for substantial market potential to satisfy a clear and present need? Has the applicant identified a realistic market niche for their product/technology that reflects the identified unmet need? How appropriate are plans to secure the applicant SBC’s intellectual property rights? If the proposed activities involve Federally regulated items, how appropriate and realistic are plans to seek and accomplish relevant regulatory milestones?

Phase II: Does the applicant SBC demonstrate a sufficient understanding of the competitive environment and the market in which they plan to sell their product? Have the potential customers been realistically identified? Have the applicants addressed potential hurdles that may delay or prevent acceptance of their product? Do the applicants have a reasonable strategy to protect its IP and build a sustainable business?

Does the applicant SBC have the necessary ability to address various regulatory issues that might be needed for achieving the proposed commercialization-relevant benchmarks (either through their own staff members or through appropriate arrangements with external regulatory consultants)? Has the applicant SBC established alliances/collaborative partnerships that will facilitate commercialization of the proposed technology? 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?

Phase II Applications

For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity? With regards to their Commercialization Plan, how well did the applicant provide an effective strategy for marketing with reasonable revenue and funding stream projections? How well do they describe the commercialization strategy for marketing the proposed technology as a product, process, service, or combination thereof? Are there a clear need and window of opportunity within a specific market? How well do they highlight the competitive edge over existing products or services? Do they outline the key steps that will be taken over the period of support towards achieving commercial success?  

Phase I/Phase II Fast-Track Applications

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

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

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? For the Phase II portion of the Fast-Track application, with regards to their Commercialization Plan, how well did the applicant provide an effective strategy for marketing with reasonable revenue and funding stream projections? How well do they describe the commercialization strategy for marketing the proposed technology as a product, process, service, or combination thereof? Are there a clear need and window of opportunity within a specific market? How well do they highlight the competitive edge over existing products or services? Do they outline the key steps that will be taken over the period of support towards achieving commercial success?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Phase IIB Competing Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR , in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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. More information is provided at Award Conditions and Information for NIH Grants.

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

Report fraud, waste and abuse

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs.  The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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.

Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152)

Final Invention Statement and Certification (HHS 568)

Annual Invention Utilization Reports

Federal Financial Report (FFR) – replaced the Final Cash Transaction Report (PSC 272)

Phase II Data Collection Requirement for Government Tech-Net Database 

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714

TTY: 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application , documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)

Website to Email: http://sbir.gov/feedback?type=reg.

Scientific/Research Contact(s)

Amir Rahbar, PhD, MBA
National Cancer Institute (NCI)
Telephone: 240-276-5230
Email: rahbaram@mail.nih.gov

Peer Review Contact(s)

Syed Musaddaq Quadri, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1211
Email: q3u@drgpo.drg.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.


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