NHLBI SBIR Phase IIB Bridge Awards

NHLBI SBIR Phase IIB Bridge Awards is sponsored by National Institutes of Health (NIH). Supports the commercialization of technologies for heart, lung, blood, and sleep disorders and diseases.

Expired RFA-HL-23-009: NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional) R44 Small Business Innovation Research (SBIR) Grant - Phase II only Notices of Special Interest associated with this funding opportunity November 19, 2024 - This RFA has been reissued as RFA-HL-26-014 .

September 11, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional). See Notice NOT-HL-24-031 December 18, 2023 -Notice of Pre-Application Webinar for NHLBI SBIR Phase IIB Small Market Awards and Bridge Awards (RFA-HL-23-008 and RFA-HL-23-009).

See Notice NOT-HL-23-125 November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029 June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See NOT-OD-23-139 .

( See updates incorporated into NOFO content in Sections IV, V, VI, and VIII applicable for applications submitted for due dates on or after September 5, 2023. ) March 16, 2023 -NHLBI Notice of Clarification and Availability of Frequently Asked Questions (FAQs) for RFA-HL-23-008 and RFA-HL-23-009. See Notice NOT-HL-23-082 .

February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092 . December 9, 2022 - Notice of Pre-Application Webinar for NHLBI SBIR Phase IIB Small Market Awards and Bridge Awards (RFA-HL-23-008 and RFA-HL-23-009).

See Notice NOT-HL-22-062 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Small Business Innovation Research Grants (SBIR) - Phase II See Section III.

3. Additional Information on Eligibility . Assistance Listing Number 93.

837, 93. 838, 93. 233, 93.

839, 93. 840 Funding Opportunity Purpose The Small Business Innovation Research (SBIR) Program is an important funding mechanism that the National Institutes of Health (NIH) uses to develop innovative solutions that address public health challenges. A major objective of the program is to facilitate the commercialization of technologies developed by small business concerns (SBCs).

Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage.

This Funding Opportunity Announcement (FOA) invites SBIR grant applications from SBCs to support later-stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR Phase II awards and will require eventual Federal regulatory approval/clearance.

The goal of this FOA and the resulting Phase IIB awards is to assist applicants in pursuing the milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners. Projects proposed under this FOA MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope).

This FOA is specifically intended to benefit clinical practice by accelerating the commercialization of novel products that require ultimate approval/clearance by a Federal regulatory agency.

This FOA will give competitive preference and funding priority to applications deemed likely to result in a clinically-relevant commercial product as indicated by the applicant’s ability to secure independent third-party investor funds that equal or exceed the requested NHLBI funds (total costs).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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. Required Application Instructions 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 Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

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

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease. It provides an important funding mechanism for bringing new interventions to patients and clinicians.

The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III, an SBC will be able to launch a product commercially with non-SBIR funds.

However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the validation studies required to obtain regulatory approval and launch a product.

In particular, the development of therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs assciated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process.

Thus, despite the extensive R&D performed on such products during Phase II projects, the results are often insufficient to attract the substantial private investment needed for the eventual commercialization of the product. Many small businesses, therefore, become cash-starved before reaching the next critical milestone along the path toward commercialization.?

Hence, this FOA is designed to address this funding gap between the end of the SBIR or STTR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development.

A number of public and private organizations have begun to recognize the challenges associated with this funding gap and are taking steps to provide additional resources to advance a greater number of promising early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but are also establishing programs to provide commercialization guidance.

For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the preclinical stages of development, and some of these firms have established technology incubators to provide development support, including regulatory guidance.

In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies.

Such programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.

It is anticipated that funding by third-party investors will be predicated on significant due diligence, thus encouraging awardees to formulate credible business plans for product commercialization. In addition, it is expected that third-party investors will maintain an active role in supporting the awardee during the product development phase and during pursuit of follow-on funding for commercialization.

Specific Objectives for SBIR Phase IIB Bridge Award Applications A. Independent Third-Party Investor Funds This FOA specifically encourages business relationships between applicant SBCs and third-party investors/strategic partners who can provide financing to help accelerate the commercialization of promising new products whose development was initiated with SBIR or STTR funding.

Applicants are expected to leverage their previous SBIR or STTR support, as well as the opportunity to compete for additional NHLBI funding under this FOA, to attract and negotiate third-party financing needed to advance a product or technology toward commercialization.

The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NHLBI funds being requested over the entire Phase IIB Bridge Award project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in review (refer to Section V.

Application Review Information) and making funding decisions. If a Phase IIB Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Finance Plan submitted as part of the application) will become a term of award as described in Section VI. 1 Award Notices.

It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects.

In light of these goals, the NHLBI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in commercializing emerging biomedical technologies. B.

Scientific/Technical Scope The technical and commercial objectives described in the SBIR Phase IIB Bridge Award application MUST represent an extension of the development efforts that were pursued in a previously funded SBIR or STTR Phase II awar d. It is essential that significant progress was accomplished during the current/preceding SBIR or STTR Phase II project and that the proposed product has significant commercial potential.

Applicants are expected to demonstrate that the proposed product has a clear advantage over existing and/or competing products and to define an appropriate path toward ultimate product commercialization. This FOA is specifically designed to provide additional support for products that require ultimate approval/clearance by a Federal regulatory agency.

Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under this FOA, proposed projects MUST be relevant to the NHLBI? mission . Applicants are strongly encouraged to contact the NHLBI to discuss whether their proposed project meets this criterion.

The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood, and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on products related to the?

mission ? of the NHLBI. The NHLBI program priority areas for technology development research include: Cardiovascular Diseases areas: ?

heart failure, atherothrombosis, heart attack, high blood pressure, atrial fibrillation along with other atrial and ventricular arrhythmias, sudden cardiac death, adult and pediatric congenital heart disease, cardiovascular complications of diabetes, and obesity, acquired valve disease, cardiomyopathies, and peripheral vascular diseases. Lung Diseases areas:?

asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, sleep-disordered breathing, critical care, and acute lung injury, developmental biology and pediatric pulmonary diseases, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis.

Blood Diseases and Resources areas: sickle cell disease (SCD), the thalassemias, Fanconi anemia, Diamond-Blackfan anemia, and other bone marrow failure syndromes, iron chelation, fetal hemoglobin production, white blood cell disorders, myeloproliferative and myelodysplastic syndromes, hematopoietic stem cell transplantation and novel cell-based therapies, transfusion medicine (red blood cells, platelets, and plasma) and blood banking including technologies to store, process, and screen blood, thrombosis and hemostatic disorders including but not limited to idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, and coagulation factor deficiencies and disorders.

Rare diseases: Please note that the companion NHLBI SBIR Phase IIB Small Market Awards funding opportunity,? RFA-HL-23-008 , supports the development of products addressing rare and pediatric diseases. Applicants working with applications in this area are encouraged to consider this funding opportunity.

Examples of appropriate development activities to be proposed under this FOA include, but are not limited to the following areas: For projects pertaining to the development of therapeutics - Applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application or clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).

For projects pertaining to imaging technologies, interventional devices, and in vivo diagnostics - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, or an Investigational Device Exemption (IDE) application.

For projects pertaining to ex vivo or in vitro diagnostics, prognostics, and screening tests - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, an Investigational New Drug (IND) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay.

NHLBI expects that activities to be pursued under this FOA will address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology. Specific activities to be proposed will vary among applications. C.

Plan for Full Commercialization The goal of the SBIR Phase IIB Bridge Award is to advance SBIR or STTR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Bridge Award project period) that outlines how and when full commercialization can be accomplished.

The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization plan for the product should extend beyond the period of SBIR funding. ?

Criteria for Complete, Compliant, and Responsive Applications Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:?

Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period") Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract) Applications that do not propose R&D that falls within the technical scope of this FOA as described under Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications) Applications that do not contain a Commercialization Plan that includes all sections (a-l) and the required elements for each section, as described under Section IV ("SBIR/STTR Information: Commercialization Plan") Applications that do not include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan"), and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments") See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Renewal - Phase IIB Competing Renewal (Phase IIB) Resubmission - (Phase IIB previously submitted under this FOA or RFA-HL-19-017 ) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the FOA.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? 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.

NHLBI intends to commit total costs of $5,000,000 in FY2023; $10,000,000 in FY2024; $15,000,000 in FY2025; $10,000,000 in FY2026; and $5,000,000 in FY2027 to fund up to five new awards in FY2023, FY2024, and FY2025 Total funding support (direct costs, indirect costs, fee) for the entire budget period MUST not exceed $3,000,000.

For any single year of the project period, it is recommended that the budget not exceed $1,000,000 total costs. Applicants that intend to request budgets greater than $1,000,000 total costs in any year are strongly encouraged to communicate with the Scientific / Research Contact(s) listed under Section VII before applying.

In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. Phase IIB is an allowable application type . The maximum project period is 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III. Eligibility Information Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.

A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 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. 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 means 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 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 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