NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) (PA-27-101)

NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) (PA-27-101) is sponsored by National Institutes of Health (NIH). This program provides non-dilutive funding to small businesses for technology development, specifically focusing on Phase IIB awards for strategic breakthroughs with commercialization potential.

PA-27-101: NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute of General Medical Sciences ( NIGMS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Advancing Translational Sciences ( NCATS ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

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

Office of Research on Women's Health ( ORWH ) Funding Opportunity Title NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) R44 Small Business Innovation Research (SBIR) Grant - Phase II only 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 I/ 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. 233, 93. 837, 93.

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

351, 93. 313, 93. 866, 93.

350, 93. 859, 93. 855, 93.

394, 93. 393, 93. 395, 93.

867, 93. 273, 93. 865, 93.

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

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

Funding Opportunity Goal(s) NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

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.

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. NIH SBIR and STTR awards support 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). However, biomedical projects may need additional support because of a significant funding gap between Phase II and commercialization (known as the "Valley of Death").

This is a particular challenge for technologies that need regulatory approval, use new complex manufacturing methods, or target small markets. This SBIR Phase IIB Strategic Breakthrough NOFO provides previous NIH SBIR or STTR Phase II recipients support to bridge the gap between the Phase II and commercialization. Applicants must secure 100% third-party matching funds for the proposed Phase IIB Strategic Breakthrough award project.

SBCs must demonstrate not less than 100% matching funds from: new private capital (e.g. another company, venture capital firm or other private investor) OR new funding awarded by a government agency (other than a Phase I or II SBIR or STTR award) OR any combination of the above Phase II recipients should consider the Commercialization Readiness Pilot (CRP) program when they need additional technical assistance and/or later-stage R&D, but do not have third-party matching funding and/or require a significant amount of the work to be outsourced.

The CRP program can also support small businesses that need additional support during an active Phase II award. See PAR-27-098 . Applicants are strongly encouraged to contact program staff prior to applying to help choose the best funding opportunity for their project.

Note: This NOFO accepts Renewal/Resubmission "Type 2" Applications from previous recipients of NIH SBIR or STTR Phase II awards. SBCs must meet the eligibility requirements in Section III . Scientific and Technical Scope The NIH Phase IIB Strategic Breakthrough award provides a second Phase II award to support follow-on R&D.

Applications are encouraged for projects that demonstrate strong commercial potential (i.e., the likelihood that a technology will lead to an effective, successful product), and need extra time, effort and funds after Phase II to succeed. Commercial potential will be emphasized during review and when selecting awards (refer to Section V for details).

Applications from eligible United States SBCs should propose a R&D study that contributes to the missions of any NIH components participating in this NOFO. See NIH Institutes, Centers, and Offices and Small Business Funding Considerations and Contacts for Institute, Center, and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations. See the NIH Director's Statement of Priorities ( https://www.

nih. gov/about-nih/nih-director/statements/advancing-nihs-mission-through-unified-strategy ), entitled "Advancing NIH's Mission Through a Unified Strategy." 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 organizations, 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 Center for Advancing Translational Sciences ( NCATS ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) 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 (ONLY allowable when submitting a Phase IIB connected to a Phase II contract) See SF424 (R&R) Form for more information. The OER Glossary and the How to Apply – Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? Not all participating Institutes and Centers accept clinical trials under this NOFO. See "Applications Not Responsive to this NOFO" information in Section 1.

Notice of Funding Opportunity Description. Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Total funding support (direct costs, indirect costs, fee) may not exceed $30,000,000.

00 for Phase IIB Strategic Breakthrough awards. Budget guidelines can vary by participating component and may be at the SBA budgetary limits for Phase II. Total funding support normally may not exceed the guidelines in the table below.

Applicants are strongly encouraged to contact program officials prior to submitting any application and early in the application planning process. See NIH Institutes, Centers, and Offices for Institute, Center and Office (ICO) specific missions, interest areas, funding priorities, and funding considerations. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

Applicants should keep in mind that they must show not less than 100 percent matching funds. See section IV: Application and Submission Information - SBIR STTR Information Form - Commercialization Plan for details. Institute or Center Phase IIB Budget National Cancer Institute $15,000,000.

00 National Eye Institute SBA Guideline National Heart, Lung, and Blood Institute $4,500,000. 00 National Institute on Aging $3,000,000. 00 National Institute on Alcohol Abuse and Alcoholism $4,500,000.

00 National Institute of Allergy and Infectious Diseases $3,000,000. 00 Eunice Kennedy Shriver National Institute of Child Health and Human Development $3,000,000. 00 National Institute of Diabetes and Digestive and Kidney Diseases $3,000,000.

00 National Institute of General Medical Sciences $3,000,000. 00 National Institute of Mental Health $3,000,000. 00 National Institute of Neurological Disorders and Stroke $3,000,000.

00 National Institute on Minority Health and Health Disparities SBA Guideline National Center for Advancing Translational Sciences $3,000,000. 00 Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs SBA Guideline Office of Research on Women's Health SBA Guideline Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations.

According to statutory guidelines, award periods must not exceed 4 years for a Phase IIB Strategic Breakthrough award. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information Only United States small business concerns (SBCs) that have previously received an SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one Phase IIB award is allowed per project.

To maintain eligibility for this program, an NIH Phase II grant or contract recipient should submit a Phase IIB Strategic Breakthrough application within the first six due dates following the expiration of the Phase II budget period.

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) – 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 How to Apply – Application Guide 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 Grants.

gov registration; 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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project.

For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur. The How to Apply – Application Guide should be referenced for specific details on eligibility requirements.

For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the How to Apply – Application Guide . This NOFO requires 100% cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms under the Small Business Innovation and Economic Security Act.

More information on cost matching requirements is in Section IV. 2 R&R. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, NIH Grants Policy Statement 2. 3. 7.

4 Submission of Resubmission Application. This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review. (see NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). To maintain eligibility for this program, an NIH Phase II grant or contract recipient should submit a Phase IIB Strategic Breakthrough application within the first six due dates following the expiration of the Phase II budget period.

Recipients of NIH Phase II grants, cooperative agreements, or contracts are eligible to submit a Phase IIB Strategic Breakthrough grant application for this opportunity in accordance with each awarding component's guidance.

NIH will accept Phase IIB and CRP applications for the same Phase II project concurrently, i.e. Phase IIB and CRP applications for the same Phase II project may be under review at the same time if they are scientifically distinct. The Phase IIB Strategic Breakthrough can be awarded concurrently with the CRP. However, a Phase IIB can only be awarded after the Phase II has ended.

Contractual/Consortium Arrangements In SBIR Phase II, normally, one-half or 50% of the research or analytical effort is carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally