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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II and Phase IIB it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II or Phase IIB award, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the Valley of Death, between the end of the SBIR/STTR Phase II award and the commercialization stage. A number of NIH Institutes and Centers (ICs) participate in the Phase IIB program, which provides additional support to mitigate the funding gap with a second Phase II award. However, Phase IIB programs can be limited in the amount of outsourcing allowed and some projects require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, clinical trials). Some SBCs also require additional funding beyond the Phase IIB to commercialize a technology or attract third party funding. In addition, SBIR/STTR awards may not support activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships.

The SBIR and STTR programs were reauthorized and extended through 2022 under Public Law 114-328, Section 1834 and Public Law 115-232, including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This funding opportunity announcement (FOA) aims to implement the CRP Program at NIH. The goal of this FOA is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs.

This FOA supports CRP awards to:

• Phase II or IIB SBIR/STTR awards that have ended or will close out by the requested start date ("Type 2" Renewal applications).
• Phase II or IIB SBIR/STTR awards that will be active at the requested Project Start date ("Type 1" New applications). Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1.

Phase II and Phase IIB awardees with funding from a non-participating NIH Institute/Center should note that some NIH Institutes/Centers participate in the following:

• The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. (See https://sbir.nih.gov/sites/default/files/2019-2_SBIR-STTR-topics.pdf for more information) Applicants cannot submit a Phase IIB and CRP concurrently; see Section III.
• The Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (Clinical Trial Not Allowed) (PAR-20-128) supports technical assistance activities for Phase II and Phase IIB awardees.
• The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1) (Clinical Trial Not Allowed) (PAR-20-129).

Scientific/Technical Scope

NIH ICs participating in this FOA may accept applications based on any topic within their mission or based on specific topics. While general topic areas are listed below, applicants should read the specific interests of the ICs carefully prior to submission.

Topic areas appropriate for this FOA include, but are not limited to the following:

Technical Assistance:

• Development of regulatory strategy, including assembling the documentation needed for the Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission to the Food and Drug Administration (FDA)
• Design and planning for a clinical trial including: Preparation of documents required to support a clinical trial (e.g., case report forms, pharmacy manual, study coordinator manual, monitoring plan), preparation of clinical trial protocol, and preparation of investigator's brochure
• Development of an intellectual property strategy, including analysis of the patent landscape in the US and abroad
• Technical assistance associated with manufacturing, including industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs).
• Other technical assistance through a third-party technical assistance provider, including market research.

Late Stage Research and Development Activities:

• Independent replication/confirmation of key studies
• Systematic research on development and optimization of industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, batch compounding, dosage form production, in-process sampling, testing, process validation and related production requirements.
• Activities to bring the development process under Design and Quality Systems Control
• Animal studies to develop surgical techniques relevant to a device
• In vitro and animal testing to meet FDA recognized ISO/ASTM Standards
• Optimization of the device design with respect to the human functional anatomy
• Device, software, and firmware design verification and validation activities
• GLP compliant large animal studies
• Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical trials and eventual market approval
• Process optimization and synthesis, including development of analytical methods to determine drug purity and development of a clinical trial formulation
• IND/IDE enabling studies, including toxicology
• Chemistry, Manufacturing, and Control (CMC) activities for IND-enabling pharmacology/toxicology tests
• Pharmacokinetic/ADME (absorption, distribution, metabolism, excretion) studies
• Tumorigenicity, immunogenicity, mutagenicity and teratogenicity evaluations
• GMP manufacturing of clinical trial supplies
• Optimization of delivery systems
• Development and validation of biochemical assays required for clinical trials (e.g., pharmacokinetic, pharmacodynamic, and/or immunogenicity assays)
• Clinical studies and clinical trials (Note: not every Institute or Center at NIH supports clinical trials through this FOA. Please see below the section of Interests of Specific Institutes/Centers)

Unlike typical SBIR and STTR research and development grants or contracts, companies have the option of out-sourcing a significant portion of the work requested through the CRP, provided the expert services are appropriate for the work proposed and well justified in the application. The SBC should perform a substantive role in the oversight and management of the R&D proposed, including appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Therefore, NIH expects the SBC to request enough funds to enable management of the activities. The remainder of the funds can be distributed among the subcontractors, consultants and SBC depending on the type of work proposed.

CRP awards cannot be used to pay filing fees associated with filing patents or FDA submissions.

CRP applicants cannot request the separate Technical and Business Assistance (TABA) funding allowed in Phase I and II projects.

Interests of Specific Institutes/Centers

For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.

National Eye Institute (NEI)

The National Eye Institute (NEI) is interested in CRP applications from NEI Phase II SBIR-funded applicants in the General Topic Areas listed above, provided they are within the NEI mission. The NEI will only accept CRP applications from SBIR Phase II or SBIR Phase IIB awardees.

Applications for research involving human subjects can be submitted in response to this FOA, but NEI may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects are strongly encouraged to contact Scientific/Research staff.

National Heart, Lung, and Blood Institute

The NHLBI will accept CRP applications from NHLBI Phase II and Phase IIB funded institutions, provided they are within the NHLBI mission. NHLBI also participates in the Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (PAR-20-128) so applicants interested in only requesting technical assistance should apply through that funding opportunity.

National Institute on Aging

NIA’s Office of Small Business Research invites NIA Phase II and Phase IIB awardees to apply to the Late-Stage Commercialization Readiness Pilot Program (CRP), provided that the proposed R&D falls within NIA s mission. Applications addressing Alzheimer’s disease (AD) and AD-related dementias (ADRD) are of particular interest. NIA also participates in the Technical Assistance CRP Program (SB1) (PAR-20-128), which is exclusively dedicated to providing funding for technical assistance. NIA will accept budgets up to $1,750,000 total costs per year and up to the 3 years, providing that total proposed award funding support for the entire budget period does not exceed $3,360,358 total costs.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in CRP applications from NIAAA Phase II or Phase IIB funded applicants in the General Topic Areas -listed above, except that NIAAA will not provide support for clinical trial-related activities under this CRP FOA. NIAAA will support only proposed CRP projects on the development of novel therapies that are within the NIAAA mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. Applicants considering projects involving any type of human subjects research are strongly encouraged to contact program staff for consultation before submission. NIAAA also participates in the Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (PAR-20-128) and applicants interested in requesting only technical assistance should apply through that funding opportunity.

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

The NICHD is interested in Late Stage Commercialization Readiness Pilot Program (CRP) applications consistent with the topic areas listed in the NICHD section of the PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA, provided their topics are also within the priority areas of the NICHD extramural research branches and the National Center for Medical Rehabilitation Research. The NICHD will only accept CRP applications from NICHD-funded SBIR Phase II/Phase IIB awardees and may decline funding of any application that includes human subjects for programmatic or administrative reasons. Potential applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission. For information about NICHD's Small Business Program, https://www.nichd.nih.gov/grants-contracts/SBIR_STTR.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in CRP applications in the General Topic Areas listed above, provided their projects are within the NIDCD mission areas. NIDCD will only accept CRP applications from NIDCD SBIR and STTR Phase II or Phase IIB awardees and may decline funding of any application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award early in the process of preparing a submission.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in CRP applications from NIMH Phase II and Phase IIB funded applicants in the General Topic Areas listed above. NIMH will only support proposed CRP projects that are within the NIMH mission. For information about NIMH's Small Business Program, please visit http://www.nimh.nih.gov/funding/small-business-research-programs.shtml

National Institute for Neurological Disorders and Stroke (NINDS)

The National Institute for Neurological Disorders and Stroke (NINDS) is interested in CRP applications from NINDS Phase II/IIB funded applicants, provided they are within the NINDS mission.

For those studies that use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk.

NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission.

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

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

Only United States small business concerns (SBCs) that have had an active NIH SBIR or STTR Phase II or Phase IIB contract, grant or cooperative agreement from NIH within the last 36 months are eligible to submit applications for this opportunity. Only one CRP is allowed per Phase II or Phase IIB project. SBCs with currently active and newly awarded Phase II or Phase IIB awards from one of the participating ICs are also eligible. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

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;

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;

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

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

SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. Has, including its affiliates, not more than 500 employees.

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

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

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

Definitions:

• 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 State.
• Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
• 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.
• ANC mean Alaska Native Corporation.
• NHO means Native Hawaiian Organization.

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

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

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).

• For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.25 will not be eligible to apply for a Phase I, Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period.
• For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period.

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).

• For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period. Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.
• For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.
• For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.

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

Applicant Organizations

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

Dun and Bradstreet 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 application.

• 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.
• SBA Company Registry 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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 submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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 Phase I, Phase II, and CRP, 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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

NIH will not 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 cannot be under review at the same time, even if they are scientifically distinct.

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 the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. 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 or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

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

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

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Cristina Backman, Ph.D.
Telephone: 301-408-9069
Fax: 301-480-2241
Email: [email protected]

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

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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.

4a. Federal Identifier:

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

For applications where the SBIR/STTR Phase II or Phase IIB is a contract: Leave blank

8. Type of Application:

Check "New" if this is the first submission to this FOA or PAR-19-335 and the Phase II or IIB SBIR/STTR award will be active at the requested Project Start date. Check "New" if this is the first submission to this FOA or to PAR-19-335 and the Phase II or IIB SBIR/STTR award was a contract. Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1.

Check "Renewal" if this is the first submission to this FOA or to PAR-19-335 and the Phase II or IIB SBIR/STTR award has ended or will close out by the requested start date.

Check "Resubmission" if an application is a resubmission of an application submitted to this FOA or to PAR-19-335.

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:

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 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 VCOC Certification.pdf at the NIH SBIR Forms webpage.

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

c. The authorized business official must sign the certification.

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

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

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.

Filing fees associated with filing 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 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 applicants cannot request separate Technical and Business Assistance (TABA) funding.

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

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applicants are required to address a Data Management and Sharing Plan, regardless of the amount of direct costs requested for any one year. However, SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

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

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:

A. 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.

B. 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.

C. 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 (for all projects): Describe all relevant concurrent and past activities, including those beyond the scope of the Phase II project, related to commercialization and aimed at mitigating commercialization risk and/or attracting third party investors across the development timeline for the proposed technology or product development. Examples of activities may include, but not are limited to validation studies, regulatory compliance, patents and license agreements, IND-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 SF424 (R&R) SBIR/STTR Application Guide,

Appendix:

Note that Phase I SBIR/STTR Appendix materials are not permitted. 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 SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

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

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"

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:

1) 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 FOA 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 FOA advance the product or technology far enough to attract sufficient, independent third-party financing and/or strategic partnerships to carry out full commercialization?

2) 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? For each award, companies should provide the award number, the award amount, project duration, and the name of the awarding agency.

What are the total revenues that have been generated to date as a result of the commercialization of the SBIR/STTR projects funded within the past 5 years?

3) Project Management Plan

Applicants must provide a Project Management Plan detailing how the research and commercialization plans will be kept on track. The plan should include specific milestones for the commercialization of the product.

4) Regulatory Plan

If applicable, 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. Applicants must also submit evidence that they have contacted the appropriate regulatory authority and that their research plan and objectives follow the relevant requirements or guidance of that authority. Examples that provide evidence of appropriate interactions are letters or emails between the company and the appropriate FDA Center personnel or meeting minutes concerning a pre-submission meeting or regarding a 510(k), IDE, PMA, HDE, BLA, IND, or NDA application. Copies of these letters, emails or minutes should be attached in the Letters of Support section in the PHS398 Research Plan form. Applicants may also provide details of their interaction with the regulatory authority 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.

5) Fundraising Plan

The NIH considers the raising of independent third-party investor funds to be an important means to facilitate and accelerate the capital-intensive steps that are required to commercialize new products/technologies emerging from NIH-funded SBIR/STTR Phase II projects. Applicants are expected to provide a Fundraising Plan, which should be a detailed and specific plan for securing substantial, independent third-party investor funds if they are necessary to bring the product to commercialization. If they are not needed, the company should detail how they are able to bring the technology to market without the use of third-party investor funds.

Answer questions 8 and 9 as specific to the SBIR program. If the applicant has received SBIR/STTR awards issued by NIH or any other Federal Government agency, attach a file that includes for each SBIR/STTR award: (1) name of awarding agency; (2) award number and date; (3) amount of award; (4) title of project; (5) source, date, and amount of Phase III funding agreement; and (6) commercialization status of each Phase II award.

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 SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

See Part 1. 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), SBA Company Registry, eRA Commons, and Grants.gov.

Part I. Overview Information 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 Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy -. Any instructions below are in addition to the instructions in the policy:

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Is the prior research that serves as the key support for the proposed project rigorous? Does the project address an important problem in the field? How will successful completion of the project change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (Does the Commercialization Plan demonstrate a high probability of commercialization?)

How compelling is the value proposition, and to what extent does the application demonstrate a substantial market-pull for the technology under development? How well has the applicant described the market segment(s) and customers for the product/ technology, and how urgent is the unmet need(s) being addressed? How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product? To what extent has the applicant demonstrated a clear understanding of customer needs? How well has the company addressed potential hurdles that may delay or prevent acceptance of their product?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s) or have they demonstrated a record of commercialization? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product/technology? For example, how successful have the PD(s)/PI(s) been in commercializing technologies and discoveries in the past? If applicable, is the Contract Research Organization (CRO) or other technical assistance provider qualified to provide the services proposed?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Is the product being developed novel to the field of research or clinical practice? Will the proposed product under development shift current research or clinical practice paradigms? Is the product substantially innovative compared to all existing approaches as well as those in development? If the proposed product is trying to improve over early generations that may or may not have been marketed, are the potential advantages truly substantial?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? How appropriate are the proposed milestones in determining whether the awardee has successfully reached the specified goals (e.g., IND filing)? If the proposed project involves advancing the product/technology through the Federal regulatory approval process, how sound is the proposed plan to meet these requirements?

Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Have necessary agreements with participating industry partners, if necessary, been established? Is there documentation of the commitment of any subcontractors and consultants as well as service agreements for personnel and facilities? To what extent does the applicant SBC have the resources available to address regulatory issues (if applicable), either through their own staff members or through appropriate arrangements with external regulatory consultants? How well can the applicant SBC sustain itself and grow as a business, providing the appropriate environment for the project to succeed? If the SBC has received previous SBIR/STTR funding from ANY Federal agency, then how successful is the company’s track record in commercializing prior SBIR/STTR projects?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Commercialization Plan

To what extent in the commercialization plan has the applicant identified realistic, market-based milestones that can be achieved over the next five years? How reasonable are the applicant's plans for generating a revenue stream, and how realistic are the revenue projections? How strong is the applicant's intellectual property (IP) portfolio/position (pertinent to the proposed project)?

Fundraising Plan: To what extent will the applicant's business alliances and/or corporate partnerships help in facilitating commercialization? For example, will third-party investors play an active role in facilitating the commercialization of the product/technology, and if so to what extent? If third-party investor funds are not needed, how well does the application support the ability of the SBC to bring the technology to market? If third-party investor funds are needed, how well does the application support the ability of the SBC to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NIH funds)?

CRP Applications

Do the activities provided in the progress report demonstrate progress toward mitigating commercialization risk and/or attracting third party investors in the proposed development timeline for the technology or product? Do the relevant concurrent and past activities provide a solid foundation for the proposed CRP activity and justify continuation of development efforts?

Not Applicable.

Not Applicable.

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

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

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

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

Not Applicable.

Not Applicable.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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

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

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

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

As part of the scientific peer review, all applications:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement (GPS). Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.

NIH requires that SBIR/STTR grantees submit the following reports within 120 days of the end of the grant budget period unless the grantee is under an extension. When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

• Final RPPR (requirements have recently changed - please see the NOT-OD-17-085)
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Federal Financial Report (FFR)
• SBIR.gov
• Quarterly reports are due to the Payment Mangement System 30 days following the end of each calendar quarter

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

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

National Eye Institute (NEI)

Paek Lee, Ph.D.
Phone: 301-451-2020
Email: [email protected]

National Heart, Lung, and Blood Institute (NHLBI)

Mike Pieck, Ph.D.
Phone: 301-496-2149
Email: [email protected]

National Institute on Aging (NIA)

Michael-David A.R.R. Kerns, Ph.D.
Phone: 301-402-7713
Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Megan Ryan, M.B.A.
Phone: 301-443-4225
Email: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Louis Quatrano, Ph.D.
Phone: 301-402-4221
Email: [email protected]

National Institute on Deafness and Other Communication Disorders (NIDCD)

Roger L. Miller, Ph.D.
Phone: 301-402-3458
Email: [email protected]

National Institute of Mental Health (NIMH)

Margaret C. Grabb, Ph.D.
Phone: 301-443-3563
Email: [email protected]

National Institute of Neurological Disorders and Stroke (NINDS)

Emily Caporello, Ph.D.
Phone: 301-496-1447
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

National Eye Institute (NEI)

Karen Robinson-Smith, Acting Chief
Phone: 301-451-2020
Email: kyr@nei.nih.gov

National Heart, Lung, and Blood Institute (NHLBI)

Ann Marie Brasile Mejac
Phone: 301-435-0164
Email: [email protected]

National Institute on Aging (NIA)

Robin Laney

Phone: 301-496-1472

Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Jeffrey Thurston

Phone: 301-443-9801

Email: [email protected]

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Mindy Bixby
Phone: 301-402-3204
Email: [email protected]

National Institute on Deafness and Other Communication Disorders (NIDCD)

Christopher P. Myers
Phone: 301-435-0713
Email: [email protected]

National Institute of Mental Health (NIMH)

Rebecca Claycamp
Phone: 301-443-2811
Email: [email protected]

National Institute of Neurological Disorders and Stroke (NINDS)

Tijuanna Decoster
Phone: 301-496-9231
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, and P.L. 115-232. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.