HEAL Initiative STTR Program (Phase 1 and Phase 2 grants)

HEAL Initiative STTR Program (Phase 1 and Phase 2 grants) is sponsored by National Institute of Health (NIH). This Small Business Technology Transfer (STTR) program provides funding for small businesses developing medical technologies, tools, or devices related to pain management. Projects must involve a partnership with a research or educational institution for clinical trials.

Expired RFA-NS-23-006: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

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 Institute of Neurological Disorders and National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of General Medical Sciences ( NIGMS ) National Institute of Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) National Center for Advancing Translational Sciences ( NCATS ) National Cancer Institute ( NCI ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) Funding Opportunity Title HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 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 October 16, 2023 - Notice of NIDCR Participation in RFA-NS-23-006. See Notice NOT-DE-24-004 . September 12, 2023 - Notice of Change to correct ORIP’s listing under Components of Participating Organizations for PA-23-080, PA-23-230, PA-23-232, PAR-23-138, RFA-NS-23-006, and RFA-NS-23-007.

See Notice NOT-OD-23-172 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.

) February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092 .

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-EB-22-012 Notice of NIBIB Specific Interests and Guidance in RFA-NS-23-006 September 28, 2022 - Notice of NHLBI Specific Interests and Guidance in RFA-NS-23-007 "HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed).

See Notice NOT-HL-22-051 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 Technology Transfer (STTR) Grants - Phase I/ * Small Business Technology Transfer (STTR) Grants - Phase II See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number 93. 853, 93. 273, 93.

846, 93. 350, 93. 837, 93.

838, 93. 839, 93. 840, 93.

233, 93. 865, 93. 213, 93.

859, 93. 866, 93. 351, 93.

242, 93. 395, 93. 396, 93.

286 Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program.

This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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 The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. Specifically, this FOA is focused on applications directed at improving pain measurement and treatment.

This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://heal. nih.

gov . More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function.

This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options are thus critically needed. A.

Scientific/Technical Scope Applications received under this FOA should have a primary focus on enhancing pain management, such as through measurement of pain-related outcomes.

Applications must fall within the scope of the HEAL Initiative, including but not limited to: Tools and technologies to better understand the biological underpinnings of chronic pain, including new screening tools and models focused on pain and the development of pain therapies Discovery and pre-clinical development of non-addictive pain analgesic treatments with little or no addiction liability, including small molecules, biologicals, and devices Advancing new pain treatments with little or no addiction liability through the clinical pipeline Development of improved pain management strategies for acute and chronic pain conditions, including development of novel pain management technologies and devices, and objective pain measurement The following activities are not within scope of this FOA: Development of pain treatments with potential abuse liability, such as those targeting mu opioid mechanisms Methods to track or reduce opioid use other than through novel pain management solutions NIH-defined clinical trials to investigate novel pain management technologies B.

NIH Institute and Center Interests and Guidance National Institute of Biomedical Imaging and Bioengineering (NIBIB) The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve human health by leading the development and accelerating the application of biomedical technologies.

The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. The Small Business Program at the NIBIB helps to achieve this mission by supporting innovative technologies to improve the prevention, detection, treatment, and monitoring of disease and disorders through various stages of commercial research and development.

The NIBIB welcomes SBIR applications from small businesses proposing ideas relevant to its scientific program areas . NIBIB supports research from early-stage technology development through first in human demonstrations and early feasibility clinical studies .

National Heart Lung and Blood Institute (NHLBI) The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep (HLBS) diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.

The NHLBI is interested in funding technologies for pain management in patients with conditions that include, but are not limited to, the following: sickle cell disease, hemophilia, deep venous thrombosis, chronic obstructive pulmonary disease, cystic fibrosis, primary ciliary dyskinesia, sarcoidosis, acute lung Injury, interstitial lung disease, angina, vasculitis, pericarditis severe chronic cough, peripheral arterial disease, and lymphedema.

The NHLBI is also interested in supporting the development of pain management strategies for patients undergoing cardiac or lung transplant surgery, mechanical ventilation, tube thoracostomy, airway clearance therapy, and patient populations at risk of opioid-induced respiratory depression.

Additionally, the NHLBI is interested in supporting the development of technologies and strategies to reduce barriers to pain management of HLBS conditions in underserved and health disparity populations, culturally-sensitive pain assessment tools, evidence-based strategies to improve the implementation and adaption of pain management regimens in health disparity populations.

Finally, the NHLBI is interested in the development of tools for multi-level interventions to eliminate treatment disparities among HLBS patients dealing with chronic pain. National Institute of Neurological Disorders and Stroke (NINDS) The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of medications with little or no addiction liability, devices, and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) NIAMS supports research to develop therapies and technologies directed at enhanced pain management within the NIAMS mission.

National Center for Complementary and Integrative Health (NCCIH) The National Center for Complementary and Integrative Health (NCCIH) will support research on development and optimization of technologies relevant to complementary and integrative health approaches and of nonpharmacological therapies for the management of acute or chronic pain conditions.

Examples of research of interest relevant to this FOA include, but are not restricted to, natural products (e.g., herbs, prebiotic, probiotics, and selective medical diets), mind and body practices (e.g., acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), whole person pain management (e.g. the development of sensory/diagnostic devices or applications that utilize Artificial Intelligence/Machine Learning (AI/ML) to elucidate the physiological, biological, and psychological mechanisms of multicomponent interventions on whole person pain management) National Institute on Minority Health and Health Disparities (NIMHD) Areas of interest: The mission of NIMHD is to lead, conduct and support scientific research to improve minority health and reduce health disparities.

In the context of this FOA, NIMHD is interested in applications that focus on (but not limited to) the following areas: Addressing the intersection of chronic pain management and opioid use disorder (OUD): the development of therapeutic strategies and technologies that improve pain management and result in the enhanced continuity of care of patients with chronic pain.

Conducting research/subgroup analyses to identify most effective therapies, technologies, and/or interventions at reducing the need for Opioid pharmacotherapy for specific populations, including the medically underserved and other health disparity populations. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

National Institute of Biomedical Imaging and Bioengineering (NIBIB) The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care.

One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas can be found at https://www. nibib.

nih. gov/research-funding . NIBIB supports research from early stage technology development through first in human demonstrations and early feasibility clinical studies.

National Institute of General Medical Sciences (NIGMS) NIGMS accepts applications directed at improving the treatment and management of pain in the peri-operative period, including the development of non-addictive drugs, devices and objectives measures of pain. NIGMS accepts applications on the development of strategies, methods, or new technologies to improve the delivery, monitoring, safety and efficacy of anesthesia.

NIGMS also accepts applications relevant to pain management of burn injury. National Institute of Mental Health (NIMH) The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

For this FOA, the NIMH is interested in supporting the development of digital health technologies associated with pain and serious mental illness (SMI) or suicide, with the goal to reduce premature SMI mortality and to reduce suicide associated with pain and suffering.

Examples of technology priorities within those specific goals include: automated, real time assessments of behavior in naturalistic environments, intervention refinement and delivery, and service delivery.

Office of Research Infrastructure Programs (ORIP) The Office of Research Infrastructure Programs (ORIP) will support applications proposing relevant technologies to advance the determination, measurement, and/or amelioration/treatment of pain, using appropriate non-clinical models.

National Institute of Dental and Craniofacial Research (NIDCR) National Center for Advancing Translational Sciences (NCATS) NCATS intends to fund applications that meet its mission. For a description of the NCATS SBIR/STTR research priorities see https://ncats. nih.

gov/smallbusiness/priorities . National Library of Medicine (NLM) NLM intends to fund applications that meet its mission. For a description of the NLM SBIR/STTR research interest see https://www.

nlm. nih. gov/ep/grantsbir.

html National Institute of Nursing Research (NINR) NINR supports research programs that are developing and refining technologies to improve symptom risk assessment and identify potential interventions, promote health outcomes in diverse and underserved populations, and/or foster health, prevent illness, and improve health-related quality of life across the lifespan.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NICHD is particularly interested in applications relevant to (a) persistent pain of women with endometriosis, chronic pelvic pain, vulvodynia/vestibulodynia, dysmenorrhea, and other gynecologic pain syndromes, (b) pain (acute and chronic) after minor and major surgical procedures, and (c) pain conditions (acute and chronic) in children, women of reproductive age, pregnant and lactating women, people with intellectual and physical disabilities, and health disparity populations (i.e. racial/ethnic groups, underserved rural and socioeconomically disadvantaged populations, people with limited English proficiency).

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 NEW (Phase I, Direct Phase II) RESUBMISSION (All Phases) 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.

Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIH intends to commit up to $8M annually to fund 5-15 awards, depending on the mix of the different application types (e.g. Phase I or Phase II SBIR applications).

Total funding support (direct costs, indirect costs, fee) normally may not exceed $275,766 for Phase I awards and $1,838,436 for Phase II awards. For specific topics, NIH may exceed these total award amounts. The current list of approved topics can be found at https://seed.

nih. gov/sites/default/files/HHS_Topics_for_Budget_Waivers. pdf .

Each participating component may also set their own budget limit (higher or lower than the above) in the Budget Guidance of their respective topics section in the current PHS 2022-2 SBIR/STTR Program Descriptions and Research Topics for the NIH, CDC and FDA.

Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the total award amounts listed above and early in the application planning process. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. Durations of up to 2 year for Phase I and 2-3 years for Phase II may be requested.

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. System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. 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 UEI to complete this registration. SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; 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 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. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the