PA-27-101-Revised-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

NATIONAL INSTITUTES OF HEALTH (NIH)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

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

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

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

NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

Activity Code

R44 Small Business Innovation Research (SBIR) Grant - Phase II only

Announcement Type

Reissue of

PA-24-245

Reissue of

PA-24-246

Related Notices

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

Funding Opportunity Number (FON)

PA-27-101

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-27-102

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

PAR-27-098

, SB1

Commercialization Readiness Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number

93.233, 93.837, 93.838, 93.839, 93.840, 93.351, 93.313, 93.866, 93.350, 93.859, 93.855, 93.394, 93.393, 93.395, 93.867, 93.273, 93.865, 93.847, 93.242, 93.307, 93.853

Notice of Funding Opportunity Purpose

The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R&D).

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 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.

Not Applicable

September 05, 2026 *

Not Applicable

April 2027

Not Applicable

January 05, 2027 *

Not Applicable

July 2027

Not Applicable

April 05, 2027 *

Not Applicable

December 2027

Not Applicable

September 05, 2027 *

Not Applicable

April 2028

Not Applicable

January 05, 2028 *

Not Applicable

July 2028

Not Applicable

April 05, 2028 *

Not Applicable

December 2028

Not Applicable

September 05, 2028 *

Not Applicable

April 2029

Not Applicable

January 05, 2029 *

Not Applicable

July 2029

Not Applicable

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

Background The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs (also known as America's Seed Fund) are major sources of early-stage funding for U.S. technology development and commercialization. NIH SBIR and STTR awards support projects through multiple phases:

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 may need additional support because of a significant funding gap between Phase II and commercialization (known as the "Valley of Death"). This is a particular challenge for technologies that need regulatory approval, use new complex manufacturing methods, or target small markets.

What this NOFO supports This SBIR Phase IIB Strategic Breakthrough NOFO provides previous NIH SBIR or STTR Phase II recipients support to bridge the gap between the Phase II and commercialization. Applicants must secure 100% third-party matching funds for the proposed Phase IIB Strategic Breakthrough award project. SBCs must demonstrate not less than 100% matching funds from:

Phase II recipients should consider the Commercialization Readiness Pilot (CRP) program when they need additional technical assistance and/or later-stage R&D, but do not have third-party matching funding and/or require a significant amount of the work to be outsourced. The CRP program can also support small businesses that need additional support during an active Phase II award. See PAR-27-098. 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 Renewal/Resubmission "Type 2" Applications from previous recipients of NIH SBIR or STTR Phase II awards. SBCs must meet the eligibility requirements in Section III.

Scientific and Technical Scope The NIH Phase IIB Strategic Breakthrough award provides a second Phase II award to support follow-on R&D. Applications are encouraged for projects that demonstrate strong commercial potential (i.e., the likelihood that a technology will lead to an effective, successful product), and need extra time, effort and funds after Phase II to succeed. Commercial potential will be emphasized during review and when selecting awards (refer to Section V for details).

Applications from eligible United States SBCs should propose 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.

See the NIH Director's Statement of Priorities (https://www.nih.gov/about-nih/nih-director/statements/advancing-nihs-mission-through-unified-strategy), entitled "Advancing NIH's Mission Through a Unified Strategy."

Applicants and recipients are encouraged to also refer to the Make Our Children Healthy Again Strategy (https://www.whitehouse.gov/maha/) when structuring their applications. See also the OMB-OSTP Research and Development Budget Priorities memo M-25-34/NSTM- 2.

Further information about the SBIR and STTR programs 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

Renewal (Phase IIB)

Resubmission (Phase IIB)

Revision (Phase IIB)

New (ONLY allowable when submitting a Phase IIB connected to a Phase II contract) See SF424 (R&R) Form for more information.

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 $30,000,000.00 for Phase IIB Strategic Breakthrough awards.

Budget guidelines can vary by participating component and may be at the SBA budgetary limits for Phase II. 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. Applicants should keep in mind that they must show not less than 100 percent matching funds. See section IV: Application and Submission Information - SBIR STTR Information Form - Commercialization Plan for details.

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations.

Award Project Period

According to statutory guidelines, award periods must not exceed 4 years for a Phase IIB Strategic Breakthrough award. 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 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 requires 100% cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms under the Small Business Innovation and Economic Security Act. More information on cost matching requirements is in Section IV.2 R&R.

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:

To maintain eligibility for this program, an NIH Phase II grant or contract recipient should submit a Phase IIB Strategic Breakthrough application within the first six due dates following the expiration of the Phase II budget period. Recipients of NIH Phase II grants, cooperative agreements, or contracts are eligible to submit a Phase IIB Strategic Breakthrough grant application for this opportunity in accordance with each awarding component's guidance.

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 if they are scientifically distinct.

The Phase IIB Strategic Breakthrough can be awarded concurrently with the CRP. However, a Phase IIB can only be awarded after the Phase II has ended.

Contractual/Consortium Arrangements

In SBIR Phase II, normally, one-half or 50% of the research or analytical effort is 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 is generally not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).

Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information. Deviations must be approved in writing by the Grants Management Officer (GMO) after consultation with the agency SBIR Program Manager/Coordinator.

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

For applications where the NIH SBIR/STTR Phase II 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).

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

Type of Application:

Check "Renewal" if this is a first submission to this NOFO AND the NIH SBIR/STTR Phase II connected to this Phase IIB is a grant or cooperative agreement, or in accordance with other submission policies. NIH will not accept a new Phase IIB (A0) application following an unsuccessful resubmission (A1) application.

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

Check "New" if this is a first submission to this NOFO AND the NIH SBIR/STTR Phase II connected to this Phase IIB is a contract. Applicants submitting a Phase IIB connected to a Phase II contract, should include a cover letter indicating that the application is a Phase IIB and the Phase I was from an NIH SBIR contract.

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.

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.

Letters of Support: Letters indicating commitment of matching funds should be included with the Letters of Support. Additional documentation may be requested as part of the Just-in-Time (JIT) process.

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:

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.

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 predicating the Phase IIB application was an SBIR or STTR award.

Application Type: Check "Phase IIB" Commercialization Plan: In addition to addressing all content indicated in the instructions (as above), applications must include the following:

Market, Customer, and Competition The SBC must demonstrate the technology is an effective solution, as determined by market research.

Finance Plan 100% match is required for Phase II Strategic Breakthrough awards under the Small Business Innovation and Economic Security Act. Proposed match must be in compliance with the requirements at 2 CFR 200.306. The SBC must detail the source of the required 100% matching funds. Matching funds must be available for the Phase II Strategic Breakthrough award. Matching funds must come from:

Letters indicating commitment of matching funds should be included with the Letters of Support. Additional documentation may be requested as part of the Just-in-Time (JIT) process.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants.gov.

4. Submission Dates and Times Part I. contains information about Key Dates and time. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Guide. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program…