PAR-27-098-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of The Director, National Institutes of Health (OD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Advancing Translational Sciences (NCATS)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Funding Opportunity Title

SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

Activity Code

SB1 Commercialization Readiness Program

Announcement Type

Reissue of

PAR-23-219

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-27-098

Companion Funding Opportunity

PA-27-100

R43/ R44 Small Business Innovation Research Grants (SBIR) - Phase I/ Small Business Innovation Research Grants (SBIR) - Phase II

PA-27-101

, R44 Small Business Innovation Research Grants (SBIR) - Phase II

PA-27-102

R41/ R42 Small Business Technology Transfer (STTR) Grants - Phase I/ * Small Business Technology Transfer (STTR) Grants - Phase II

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number

93.837, 93.838, 93.839, 93.233, 93.840, 93.351, 93.313, 93.307, 93.866, 93.853, 93.273, 93.847, 93.393, 93.394, 93.395, 93.867, 93.172, 93.865, 93.121, 93.143, 93.113, 93.859, 93.242, 93.350, 93.855, 93.846, 93.286, 93.173

Notice of Funding Opportunity Purpose

The Commercialization Readiness Pilot (CRP) program helps small business concerns (SBCs) move NIH-funded SBIR or STTR projects from late-stage development to commercialization. The CRP supports later-stage research and development (R&D) and/or technical assistance that Phase II and Phase IIB Strategic Breakthrough awards do not typically support. This includes:

SBCs may subcontract (outsource) a significant amount of the work in a CRP to meet the project goals.

Funding Opportunity Goal(s)

NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The goals of the agency are:

In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:

Key Dates

Posted Date

May 28, 2026

Open Date (Earliest Submission Date)

August 05, 2026

The following table includes NIH standard due dates marked with an asterisk.

September 05, 2026 *

September 05, 2026 *

Not Applicable

April 2027

January 05, 2027 *

January 05, 2027 *

Not Applicable

July 2027

April 05, 2027 *

April 05, 2027 *

Not Applicable

December 2027

September 05, 2027 *

September 05, 2027 *

Not Applicable

April 2028

January 05, 2028 *

January 05, 2028 *

Not Applicable

July 2028

April 05, 2028 *

April 05, 2028 *

Not Applicable

December 2028

September 05, 2028 *

September 05, 2028 *

Not Applicable

April 2029

January 05, 2029 *

January 05, 2029 *

Not Applicable

July 2029

April 05, 2029 *

April 05, 2029 *

Not Applicable

December 2029

All applications are due 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date

April 06, 2029

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts).

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description

After Phase II, NIH expects small business concerns (SBCs) to fully commercialize the product or technology using non-SBIR/STTR funds (federal or non-federal). However, biomedical projects often need specialized studies or product development services (for example, market research) to commercialize or attract third-party investment. This additional work is often outsourced to contract research organizations (CROs).

Some NIH Institutes, Centers, and Offices (ICOs) participate in the Phase IIB Strategic Breakthrough program PA-27-101, which provides a second Phase II award to help bridge this gap, but those awards limit the amount of work that can be outsourced and require matching funds.

What this NOFO Supports The Commercialization Readiness Pilot (CRP) NOFO provides later-stage research and development and technical assistance to NIH SBIR or STTR Phase II recipients. The CRP program can support R&D that requires significant outsourcing and/or is needed during an active Phase II awards. This funding opportunity requires a prior (active or ended) NIH Phase II award. New SBIR Phase I and II grant applications should be submitted to PA-27-100 and STTR Phase I and II grant applications should be submitted to PA-27-102.

Phase II recipients that need significant R&D funding to bridge the gap between the SBIR or STTR Phase II award and commercialization should consider the Phase IIB Strategic Breakthrough. See PA-27-101. Applicants are strongly encouraged to contact program staff prior to applying to help choose the best funding opportunity for their project.

Note: This NOFO accepts New "Type 1" Applications from recipients of NIH SBIR or STTR Phase II awards or an NIH SBIR or STTR Phase IIB Strategic Breakthrough award.

SBCs must meet the eligibility requirements in Section III.

Scientific/Technical Scope SBCs may propose to do technical assistance, later-stage R&D activities, or both in the application.

Applications from eligible United States SBCs should propose a technical assistance and/or a R&D study that contributes to the missions of any NIH components participating in this NOFO. See NIH Institutes, Centers, and Offices and Small Business Funding Considerations and Contacts for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations.

Some examples of activities within scope include (but are not limited to):

Technical Assistance:

Late Stage Research and Development Activities:

Outsourcing and project oversight Applicants may outsource a significant portion of CRP work. The expert services should fit the work proposed and be well justified in the application. The SBC must perform a substantial role in oversight and management of the proposed work, which should be reflected in the budget. This includes appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.

Costs and requests not allowed

Further information about the CRP program can be found at https://seed.nih.gov. Frequently asked questions are available to assist applicants and can answer many basic questions about the program.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed:

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New (Commercialization Readiness Program)

Resubmission (Commercialization Readiness Program)

The OER Glossary and the How to Apply – Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Not all participating Institutes and Centers accept clinical trials under this NOFO. See "Applications Not Responsive to this NOFO" information in Section 1. Notice of Funding Opportunity Description.

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

Total funding support (direct costs, indirect costs, fee) may not exceed the SBA budgetary limits for the Commercialization Readiness Pilot (CRP) program. Budget guidelines vary by participating component and may be lower than the SBA budgetary limits. Total funding support normally may not exceed the guidelines in the table below.

Applicants are strongly encouraged to contact program officials prior to submitting any application and early in the application planning process. See NIH Institutes, Centers, and Offices for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period allowed is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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.

Must be one of the following:

a. 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), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR

b. 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, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR

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

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 (b) or 3 (c) 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 How to Apply – Application Guide should be referenced for detailed eligibility information.

Performance Benchmark Requirements Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently completed year. The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements. SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.

Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply – 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – 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. Unique Entity Identifier (UEI) – A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 How to Apply – 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 How to Apply – Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, NIH Grants Policy Statement 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

NIH will accept Phase IIB and CRP applications for the same Phase II project concurrently, i.e. Phase IIB and CRP applications for the same Phase II project may be under review at the same time only if they are scientifically distinct.

Contractual/Consortium Arrangements

A small business concern (SBC) may subcontract a substantial portion of its CRP award to third parties through consultant and contractual arrangements. The SBC must perform a substantive role in planned research and not merely serve as a conduit of funds to another party or parties. At minimum (depending on the nature of out-sourced effort), this includes being able to provide appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.

A small business concern may subcontract a portion of its SBIR 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 How to Apply – Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply – Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply – Application Guide must be followed.

Federal Identifier:

For applications where the SBIR/STTR Phase II or Phase IIB award is a grant: Enter the Federal Identifier of the Phase II or Phase IIB award (e.g., use CA987654 for 2R44CA987654-03A1).

For applications where the SBIR/STTR Phase II or Phase IIB award is a contract: The Federal Identifier will be the awarding IC code, followed by six 0s. (e.g. if NIAID was the awarding institute, use AI000000).

Please note: Applicants with Phase II or IIB Contracts must contact their program officer prior to application and should note the contract number in a cover letter.

Applications that do not include a valid identifier may be administratively withdrawn.

Type of Application:

Check "New" if this is a first submission to this NOFO, or in accordance with other submission policies. NIH will accept a new CRP (A0) application following an unsuccessful resubmission (A1) application or a prior A0 application.

Check "Resubmission" if the application is a resubmission of an application submitted to this NOFO or previous CRP funding opportunities.

Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH within the last 36 months are eligible for this program, as described in Section III.1 Renewal Applications will not be accepted for this NOFO.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply – Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply – Application Guide must be followed.

Other Attachments:

1. 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 and STTR 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 to their application package.

2. Regulatory Plan (Required, 2-Page Maximum) Name the PDF attachment "RegulatoryPlan.pdf" and attach it in the Other Attachments Section of the "Research and Related Other Project Information" form.

Applicants must provide a regulatory plan describing the regulatory pathway that is being or will be pursued and a timeline for achieving regulatory approval with discrete milestones. At minimum, the plan should address regulatory requirements, but a discussion of requirements for Marketing Approval is strongly encouraged. If the proposed product does not require regulatory or marketing approval, applicants should provide rationale for that determination.

If regulatory or marketing approval is required, applicants should provide details of their interaction with the appropriate regulatory authorities in the description of their Regulatory Plan. This should include the regulatory authority contact and date of interaction. Applicants should describe any outside assistance they have obtained or plan to obtain for developing and achieving the proposed Regulatory Plan.

Please note: Applicants may be required to submit evidence that they have contacted the regulatory authority and that their research plan and objectives follow the relevant requirements or guidance of that authority. This documentation (letters, emails and minutes) is NOT submitted with the application but must be furnished upon request of the NIH awarding component. Examples that provide evidence of appropriate interactions are letters or emails between the company and the appropriate FDA (or other regulatory authority) personnel, meeting minutes clarifying the evidentiary requirements to support clinical development or a marketing application or documentation of IRB determination of non-significant risk.

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

All instructions in the How to Apply – Application Guide must be followed.

R&R Budget

All instructions in the How to Apply – Application Guide must be followed.

The following additional instructions apply:

Filing fees associated with patents or FDA submissions are not permissible.

The SBC must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. This includes (at minimum) being able to provide appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Applicants are expected to detail their proposed collaborations as part of the grant application.

CRP applications cannot include separate Technical and Business Assistance (TABA) funding.

R&R Subaward Budget

All instructions in the How to Apply – Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply – Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply – Application Guide must be followed.

The following additional instructions apply:

Specific Aims: If requesting technical assistance, state concisely and realistically what the proposed technical assistance is intended to accomplish for the product under development. A scientific hypothesis is not required.

Research Strategy:

Significance Explain how the proposed project will lead to a marketable product, process, or service. Describe the unmet need(s) being addressed, including the market segment(s) and customers for the product/technology.

Briefly describe the competitive environment and how the proposed project would provide a benefit over existing products and services. Discuss how the proposed project relates to other development efforts underway in academia and industry.

Describe the hurdles that may delay or prevent acceptance of the product.

Innovation Describe how the product being developed is novel to the field of research or clinical practice and/or how it will shift current research or clinical practice paradigms.

Describe the advantage that the proposed product offers over all existing approaches, as well as those in development or early generations.

Approach Describe the technical assistance to be used to accomplish the specific aims of the project. Provide a tentative timetable for the project.

Describe how the successful completion of the aims will advance the product/technology toward commercialization.

Describe quantitative milestones to be used for measuring success in achieving each of the research plan's objectives.

If the proposed project involves advancing the product/technology through the federal regulatory approval process, include a proposed plan to meet the requirements or a clear indication when the plan will be developed.

CRP Progress Report (required for all applicants) Concisely describe the development status of the underlying technology and commercialization progress to date. Discuss how past and ongoing activities (including those beyond the scope of the Phase II project) mitigate commercialization risk and enable third party investment at any point in the development timeline for the proposed product, process or service. Examples of activities may include, but are not limited to validation studies, regulatory compliance, patents and license agreements, IND/IDE-enabling studies, and pre-market submissions.

Letters of Support: In addition to standard letters of support documenting collaborations and access to expertise or unique research resources, applicants should include letters of support documenting commitments from third-party investors to support the Fundraising Plan section if applicable.

Resource Sharing Plans:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide Instructions.

Applicants should include quotes for outsourced services they plan to use if applicable.

SBIR/STTR Information Form

All instructions in the How to Apply - Application Guide must be followed.

Program Type: Check "SBIR" regardless of whether the Phase II or IIB predicating the CRP application was a SBIR or STTR award.

Application Type: Check "Commercialization Readiness Program" Question 7: Answer "No." Separate TABA funding may not be requested by CRP applicants.

Commercialization Plan:

All applicants are expected to describe a realistic plan (extending beyond the CRP), which outlines how and when full commercialization can be accomplished. The full commercialization of the product/technology should be carried out with non-SBIR funds.

The following subsections with the headings should be included within the Commercialization Plan, in addition to the requirements listed in the SF424 Application Guide:

Statement of Need Applicants must provide a concise "Statement of Need". This statement is expected to provide answers to the questions listed below:

What is the perceived "Valley of Death" for the product/technology under development?

Why is additional government funding critically needed to accelerate the development of the product or technology toward commercialization? Specifically, what activities are being proposed under this NOFO that would not otherwise be possible through independent third-party investments OR would be significantly delayed without additional NIH support?

To what extent would a possible award under this NOFO advance the product or technology far enough to attract sufficient, independent third-party financing and/or strategic partnerships to carry out full commercialization?

SBIR/STTR Commercialization History Applicants should provide an SBIR/STTR Commercialization History that addresses the questions listed below. The following questions should be addressed for all SBIR/STTR awards received from any federal agency:

Has the company gone through any name changes within the past five years? If so, then all previous company names should be listed in the application.

Is the company a subsidiary or a spin-off? If so, then the name of the parent company should be provided.

What percentage of the company's revenue was derived from SBIR/STTR funding during each of the past 5 years, including both Phase I and Phase II awards? Applicants should report a percentage value for each year individually.

What is the total number of SBIR/STTR Phase II awards that the company has received from the federal government (as reported in Question 9 of the SBIR/STTR Information Form).

What are the total revenues that have been generated to date as a result of the commercialization of the…