NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) is sponsored by National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). This program provides funding to U. S.

-owned and operated small businesses to develop promising technologies and products that align with the missions of NIH, CDC, and FDA to enhance health and well-being.

PA-27-100: NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Centers for Disease Control and Prevention ( CDC ) U.S. Food and Drug Administration ( FDA ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of General Medical Sciences ( NIGMS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Library of Medicine ( NLM ) National Center for Complementary and Integrative Health ( NCCIH ) National Center for Advancing Translational Sciences ( NCATS ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health ( ORWH ) CENTERS FOR DISEASE CONTROL AND PREVENTION ( CDC ) Global Health Center ( GHC/CDC ) National Center on Birth Defects and Developmental Disabilities ( NCBDDD/CDC ) National Center for Chronic Disease Prevention and Health Promotion ( NCCDPHP/CDC ) National Center for Emerging and Zoonotic Infectious Diseases ( NCEZID/CDC ) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention ( NCHHSTP/CDC ) National Center for Injury Prevention and Control ( NCIPC/CDC ) National Center for Immunization and Respiratory Diseases ( NCIRD/CDC ) National Institute for Occupational Safety and Health ( NIOSH/CDC ) National Center for Environmental Health ( NCEH/CDC ) FOOD AND DRUG ADMINISTRATION ( FDA ) Center for Biologics Evaluation and Research ( CBER/FDA ) Center for Drug Evaluation and Research ( CDER/FDA ) Human Foods Program ( HFP/FDA ) Center for Devices and Radiological Health ( CDRH/FDA ) Center for Veterinary Medicine ( CVM/FDA ) Funding Opportunity Title NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, Direct to Phase II and Fast-Track Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity Small Business Innovation Research Grants (SBIR) - Phase II Small Business Technology Transfer (STTR) Grants - Phase I/ * Small Business Technology Transfer (STTR) Grants - Phase II Commercialization Readiness Program See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number 93. 837, 93. 233, 93.

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

313, 93. 866, 93. 361, 93.

103, 93. 143, 93. 113, 93.

142, 93. 351, 93. 350, 93.

073, 93. 068, 93. 213, 93.

070, 93. 084, 93. 393, 93.

394, 93. 395, 93. 136, 93.

083, 93. 867, 93. 273, 93.

855, 93. 846, 93. 286, 93.

865, 93. 279, 93. 121, 93.

847, 93. 242, 93. 307, 93.

853, 93. 172, 93. 173, 93.

859, 93. 879, 93. 326 Notice of Funding Opportunity Purpose The Small Business Innovation Research (SBIR) program helps United States small business concerns (SBCs) bring scientific innovations to the marketplace.

The SBIR program supports feasibility studies to later research and development (R&D) needed to develop a commercial product. Funding Opportunity Goal(s) The National Institutes of Health (NIH) NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health; to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease; to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research: in the causes, diagnosis, prevention, and cure of human diseases; in the processes of human growth and development; in the biological effects of environmental contaminants; in the understanding of mental, addictive and physical disorders; and in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.

The Centers for Disease Control (CDC) As the world's premier public health institute, the U.S. Centers for Disease Control and Prevention (CDC) is at the front lines of public health threats to Americans, even when those threats emerge overseas. CDC aims to protect the lives of all Americans, advancing health through science, technology, and innovation.

CDC leads with integrity to prevent and protect from diseases, detect emerging threats, both domestically and internationally, and drive state-of-the-art solutions–empowering communities and strengthening public health systems for a safer, healthier nation.

The Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

The FDA's three key responsibilities include ensuring the safety, effectiveness, and security of human/veterinary drugs, biological products, and medical devices, safeguarding the nation's food supply, and regulating the manufacturing, marketing, and distribution of tobacco products to protect public health. They also provide accurate health information and help speed medical innovations.

Regulating Medical Products: Approving and overseeing drugs, vaccines, blood, cellular therapies, and medical devices (from tongue depressors to pacemakers) to ensure they are safe and work as intended. Protecting the U.S. food supply by regulating ingredients, setting safety standards, monitoring contaminants, and ensuring correct labeling for foods, including dietary supplements. 3.

Controlling Tobacco Products: Regulating the marketing, manufacturing, and sale of tobacco products, including e-cigarettes, to reduce tobacco use, especially among minors. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

Applicants must read and follow all application instructions in the How to Apply – Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply – Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs (also known as America's Seed Fund) are major sources of early-stage funding for U.S. technology development and commercialization. By providing awards to SBCs, the SBIR program supports the commercialization of innovative technologies and strengthens U.S. small businesses.

The National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) use these programs to help US-owned and operated small businesses develop promising technologies and products that support their missions to enhance the health and well-being of all Americans. NIH, CDC and FDA are required to set-aside 3. 2% of their extramural research budget for the SBIR program.

This NOFO supports a small business to do the research and development (R&D) needed to develop a commercial product. The small business should propose to do the majority of the research or analytical effort, and the Program Director/Principal investigator (PD/PI) should be primarily employed by the small business. SBIR projects allow for limited research or analytical effort to be done by research partners or consultants.

See eligibility requirements in Section III . Small businesses should apply to STTR NOFO PA-27-102 if the project depends on a formal collaboration with a nonprofit research institution, such as a university. STTRs also allow the PD/PI of the project to be primarily employed by either the small business or nonprofit research partner.

In both the SBIR and STTR programs, the award goes to the small business. Applicants are strongly encouraged to contact program staff prior to applying to help choose the best funding opportunity for their project. The SBIR Program supports projects through multiple phases: Phase I: Establish the technical merit and feasibility of the proposed R&D.

Phase II: Continue R&D to advance toward commercialization. After Phase II, NIH expects small business concerns (SBCs) to fully commercialize the product or technology using non-SBIR/STTR funds (federal or non-federal). This NOFO accepts SBIR Phase I, Phase II, Direct to Phase II (NIH only), and Fast-Track (NIH only), grant applications from eligible United States SBCs.

NIH Fast-Track: The NIH Fast-Track allows both Phase I and Phase II of a project to be submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. NIH Direct to Phase II: S mall businesses that have already demonstrated scientific and technical merit and feasibility but have not received a Phase I SBIR or STTR for that project, can apply for a Direct to Phase II award.

The NIH will accept Direct to Phase II applications regardless of the funding source for the work on which the proposed Phase II research is based. Direct to Phase II awards should be submitted as "New" applications and not continuations ("Renewal") of Phase I SBIR or STTR projects.

Small businesses that are eligible to submit a Phase II application for projects that were supported with a Phase I SBIR or STTR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award.

SBIR Phase IIB Strategic Breakthrough grant applications should be submitted to PA-27-101 . Scientific and Technical Scope Applications from eligible United States SBCs should propose a feasibility and/or R&D study that contributes to the missions of any NIH, CDC or FDA components participating in this NOFO.

See NIH Institutes, Centers, and Offices and Small Business Funding Considerations and Contacts for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations. See the NIH Director's Statement of Priorities (https://www. nih.

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

html ), entitled "CDC Priorities," and the FDA's Mission Statement ( https://www. fda. gov/about-fda/what-we-do#mission ), entitled "FDA Mission."

Staff within the NIH's Center for Scientific Review (CSR) office, the single receiving point for all NIH grant applications, will assign all applications to the most appropriate participating component. Applicants are not required to identify a potential awarding component prior to submission of the application but may request one on the Assignment Request Form.

Applicants are encouraged to contact the appropriate NIH Institute, Center, or Office they believe is the best fit for their proposed research prior to submission. Further information about the SBIR and STTR programs can be found at https://seed. nih.

gov . Frequently asked questions are available to assist applicants and can answer many basic questions about the program. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed: Applications to this Parent NOFO may include clinical trial(s) .

However, the following Institutes and Centers DO NOT ACCEPT clinical trials under this NOFO and applications that propose a clinical trial and only align with the mission of one of the following components are not responsive to this NOFO and will not be reviewed: National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Center for Advancing Translational Sciences ( NCATS ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) All participating components of the Food and Drug Administration ( FDA ) Center for Biologics Evaluation and Research ( CBER/FDA ) Center for Drug Evaluation and Research ( CDER/FDA ) Human Foods Program ( HFP/FDA ) Center for Devices and Radiological Health ( CDRH/FDA ) Center for Veterinary Medicine ( CVM/FDA ) See Section VIII.

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

Application Types Allowed New (Direct Phase II, Fast-Track, Phase I) Resubmission (Direct Phase II, Fast-Track, Phase I, Phase II) Revision (Direct Phase II, Fast-Track, Phase I, Phase II) The OER Glossary and the How to Apply – Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? Not all participating Institutes and Centers accept clinical trials under this NOFO. See "Applications Not Responsive to this NOFO" Information in Section I.

Notice of Funding Opportunity Description. Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Total funding support (direct costs, indirect costs, fee) normally may not exceed the current SBA budgetary guidelines .

For specific topics, NIH and CDC may exceed these total award amounts. For approved waiver topics, see Small Business Funding Considerations and Contacts . Budget guidelines can vary by participating component.

Total funding support provided by NIH participating components normally may not exceed the budget guidelines in the table below. Total funding support provided by CDC and FDA participating components normally may not exceed the current SBA guidelines.

Applicants are strongly encouraged to contact the appropriate participating component(s) prior to submitting any application in excess of the SBA budgetary guidelines early in the application planning process. See NIH Institutes, Centers, and Offices for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations.

In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. NIH Participating Component Phase I Budget Phase II Budget National Cancer Institute $700,000. 00 $2,500,000.

00 National Eye Institute $400,000. 00 SBA Guideline National Heart, Lung, and Blood Institute $400,000. 00 $3,000,000.

00 National Human Genome Research Institute $400,000. 00 SBA Guideline National Institute on Aging $700,000. 00 $3,000,000.

00 National Institute on Alcohol Abuse and Alcoholism $400,000. 00 $2,500,000. 00 National Institute of Allergy and Infectious Diseases $700,000.

00 $3,000,000. 00 National Institute of Arthritis and Musculoskeletal and Skin Diseases SBA Guideline SBA Guideline National Institute of Biomedical Imaging and Bioengineering SBA Guideline SBA Guideline Eunice Kennedy Shriver National Institute of Child Health and Human Development $400,000. 00 $2,500,000.

00 National Institute on Deafness and Other Communication Disorders $400,000. 00 $3,000,000. 00 National Institute of Dental and Craniofacial Research SBA Guideline SBA Guideline National Institute of Diabetes and Digestive and Kidney Diseases $400,000.

00 $2,500,000. 00 National Institute on Drug Abuse $400,000. 00 $3,000,000.

00 National Institute of Environmental Health Sciences SBA Guideline SBA Guideline National Institute of General Medical Sciences $700,000. 00 $3,000,000. 00 National Institute of Mental Health $700,000.

00 $3,000,000. 00 National Institute of Neurological Disorders and Stroke $700,000. 00 $3,000,000.

00 National Institute of Nursing Research $400,000. 00 $2,500,000. 00 National Institute on Minority Health and Health Disparities SBA Guideline SBA Guideline National Library of Medicine SBA Guideline SBA Guideline National Center for Complementary and Integrative Health $700,000.

00 SBA Guideline National Center for Advancing Translational Sciences SBA Guideline SBA Guideline Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs SBA Guideline SBA Guideline Office of Research on Women's Health SBA Guideline $2,500,000. 00 According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II.

Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information 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. Must be one of the following: a.

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

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR c.

Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (a) or 3 (b) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (b) of this section must comply with § 121. 705(b) concerning registration and proposal requirements.

Has, including its affiliates, not more than 500 employees. If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (b) or 3 (c) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.

If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner. 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 How to Apply – Application Guide should be referenced for detailed eligibility information.

Performance Benchmark Requirements Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.

The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period.

The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently completed year.

The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

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-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 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-fiscal year period, excluding the two most recently completed fiscal years.

Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement , may be allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.

8 Collaborative International Research Awards . Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply – Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2. 3. 9.

2 Electronically Submitted Applications for additional information. System for Award Management (SAM) –