PHS 2023-2: Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42], Clinical Trial Not Allowed)

PHS 2023-2: Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42], Clinical Trial Not Allowed) is sponsored by Department of Health and Human Services (HHS) - National Institutes of Health (NIH). This omnibus solicitation invites Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) that collaborate with research institutions to develop innovative technologies.

Expired PA-23-232: PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL 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 ) National Cancer Institute ( NCI ) Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs ( ORIP ) Notice of Funding Opportunity Title PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) R41 / R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track Notices of Special Interest associated with this funding opportunity October 22, 2024 - Notice of Participation of NCCIH in NOT-ES-24-002, "Notice of Special Interest (NOSI): Innovative Technologies for Research on Climate Change and Human Health".

See Notice NOT-AT-25-001 July 3, 2024 - This PA has been reissued as PA-24-247 April 8, 2024 - Notice of Information: Anticipated Publication of the PHS 2024-2 Omnibus Solicitations of the NIH, CDC and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications.

See Notice NOT-OD-24-087 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 20, 2023 - Notice of Change to Award Budget for PHS 2023-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications.

See Notice NOT-OD-24-014 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 Notice NOT-OD-23-139 .

February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity Small Business Innovation Research Grants (SBIR) - Phase I/ Small Business Innovation Research Grants (SBIR) - Phase II 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 See Section III.

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

113, 93. 394, 93. 395, 93.

121, 93. 361, 93. 173, 93.

847, 93. 879, 93. 853, 93.

859, 93. 213, 93. 350, 93.

867, 93. 307, 93. 865, 93.

286, 93. 351, 93. 846, 93.

242, 93. 273, 93. 279, 93.

855, 93. 837, 93. 838, 93.

233, 93. 839, 93. 840, 93.

866 Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO), issued by the National Institutes of Health (NIH) invites eligible United States small businesses to submit Small Business Technology Transfer (STTR) grant applications.

United States small businesses that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH awarding components identified in this NOFO are encouraged to submit STTR grant applications in response to identified topics (see PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA ). This Parent Notice of Funding Opportunity does not accept clinical trials.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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. 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 Application Guide and the NOFO) 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. 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 one of the largest sources of early-stage capital for technology commercialization in the United States.

These programs enable US-owned and operated small businesses to conduct research and development that has a strong potential for commercialization.

National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) support small businesses through the SBIR and STTR programs to develop promising technologies and products that align with their mission to improve health and save lives.

The SBIR program, as established by law and reauthorized under Public Law 114-328, Section 1834, Public Law 115-232 and Public Law 117-183 ,is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting federal research and development needs; increase the private sector commercialization of innovations developed through federal research and development funding; and foster and encourage participation in innovation and entrepreneurship by women and socially or economically disadvantaged persons .

The STTR program aims to foster technology transfer through cooperative research and development between small businesses and research institutions. Federal agencies with extramural research budgets over $100 million are required to set-aside 3. 2% of their extramural research budget to the SBIR program, and those with extramural research budgets over $1 billion are required to set aside an additional 0.

45% to the STTR program. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

See Notice of NIH’s Interest in Diversity, NOT-OD-20-031 . Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs ( https://www. sbir.

gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2. pdf ). This Notice of Funding Opportunity (NOFO) issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, Fast-Track, and Phase IIB grant applications.

Small business applicants interested in submitting an SBIR grant application should submit to PA-23-230 or PA-23-231 . SBIR and STTR are phased programs. The main objective in SBIR and STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts.

An SBIR and STTR Phase II continues the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal).

Small businesses that are eligible to submit Phase II applications 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.

NIH Fast-Track: An NIH STTR Fast-Track incorporates a submission and review process in which both Phase I and Phase II applications are submitted and reviewed together as one application to reduce or eliminate the funding gap between phases. 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.

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 Agency and Institute/Center (IC) based on their mission and the science proposed. For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.

All applications submitted to this Parent Notice of Funding Opportunity are not allowed to propose clinical trial(s) . STTR applications that propose clinical trial(s) should be submitted to PA-23-233 . 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.

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, Fast-Track) Renewal (Phase II, Phase IIB) 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 NOFO.

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 The number of awards is contingent upon NIH appropriations, reauthorization and extension of the SBIR and STTR programs, and the submission of a sufficient number of meritorious applications.

Total funding support (direct costs, indirect costs, fee) normally may not exceed $306,872 for Phase I awards and $2,045,816 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_Program_Descriptions. pdf .

Each participating component may also set their own budget limit (higher or lower than the above) in the Limited Amount of Award Section of their respective topics section. 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. Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current PHS 2023-2 SBIR/STTR Program Descriptions and Research Topics for the NIH, CDC and FDA.

According to statutory guidelines, award periods normally may not exceed 1 year 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; i.

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 ii.

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 iii. 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.

4. 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-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.

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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted 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 SF424 (R&R) SBIR/STTR 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.

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.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

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.

For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement .

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 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 ). A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure.

To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

Contractual/Consortium Arrangements In Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, partnering research institution.

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

A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C.

3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor. The basis for determining the percentage of work to be performed by each of the cooperative