Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (R43/R44 Clinical Trial Not Allowed) PAR-18-303

Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (R43/R44 Clinical Trial Not Allowed) PAR-18-303 is sponsored by National Institutes of Health (NIH). 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.

Expired PAR-13-327: Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (SBIR [R43/44]) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Molecular Analysis Technology Development for Cancer Research and Clinical R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and October 03, 2017 - This PAR has been reissued as PAR-18-303 .

NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications supersedes instructions in Section III. 3 regarding applications that are essentially the same.

May 12, 2014 ( NOT-OD-14-089 ) - 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 Companion Funding Opportunity 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.

Open Date (Earliest Submission Date) Letter of Intent 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, November 4, 2015; May 27, 2016, by 5:00 PM local time of applicant 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) March 2014; July 2014; March 2015; July 2015; March 2016; May 2014; October 2014; May 2015;October 2015; May 2016; July 2014; September 2014; July 2015; September 2015; July Required Application Instructions It is critical that applicants follow the instructions in (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description 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 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 ).

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. 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. 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.

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 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 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.

areas of interest include, but are not limited to, the following: Technologies capable of deciphering basic mechanisms underlying cancer initiation and progression; Technologies that enable substantially-improved early cancer detection and/or cancer risk assessment; Technologies capable of distinguishing, assessing, and/or monitoring cancer stage, and progression; Technologies to facilitate/accelerate the processes of drug discovery or development of generic approaches to improve drug delivery; Technologies that can facilitate and/or enhance molecular analyses in cancer epidemiology (e.g., by allowing for rigorous and/or expeditious collection of various relevant types of data); Technologies for sample preparation and/or processing for improved downstream analysis; Technologies that offer a novel means for assessing general analyte quality to determine sample fitness-for-purpose for a known analytical Technologies or tools that may help overcome various barriers in research on the incidence, prevalence, mortality, and burden of cancer among members of underserved populations.

that are generally not appropriate for this FOA include the following: Projects describing milestones that do not indicate advanced capabilities or offer progress towards commercialization; Projects proposing software/informatics solutions, database development, data mining, statistical tools, and computational/mathematical modeling (including those applicable to drug and/or patient responses); Projects in which the main thrust of effort is on exploring biological or clinical hypotheses (i.e., traditional hypothesis-driven projects) rather than on technology development; Projects proposing whole-body or in vivo imaging methods, or specific Projects centered on development of specific drugs or therapies.

Researchers focusing on new bioinformatics or statistical techniques, tools, and/or software solutions should consider: Technologies for Cancer Research FOAs (ITCR; http://itcr. nci. nih.

gov ) opportunities; or Information Science and Technology Initiative (BISTI; http://bisti. nih. gov ) opportunities.

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 Section II.

Award Information 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) Resubmission (all phases) 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. 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 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.

described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1.

Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2.

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

Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)).

The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C.

1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Venture capital operating company means an entity described in 121.

103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. 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.

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. Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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.

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 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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. SBA Company Registry New requirement . See Section IV.

Application and Submission Information , SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.

gov or eRA Commons registration. must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the 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. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility 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 NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

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 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 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 Section IV. Application and Submission Information 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 (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 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 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. 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. 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 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 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 c. The authorized business official must sign the 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.

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.

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.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions: 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 How is the technology potentially transformative and why may it be expected to produce an unusually high impact on biomedical research and medicine? (i.e., describe the potentially transformative application(s) that might be realized should this technology be successfully developed)?

What are the pioneering approaches for which the potential for groundbreaking or paradigm-shifting results compensates and justifies any What concrete evidence can be provided to substantiate the claim of innovativeness beyond currently available technologies? Strategy: Address the following required aspects: 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