NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required)

NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required) is sponsored by National Eye Institute (NEI) - NIH. This Notice of Funding Opportunity (NOFO) encourages SBIR grant applications from small business concerns proposing investigator-initiated clinical trials related to the NEI's research mission (eliminating vision loss and improving quality of life through vision research).

Expired PAR-24-066: NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies .

Contact the eRA Service Desk for any submission issues. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Eye Institute ( NEI ) Notice of Funding Opportunity Title NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required) U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 February 28, 2024 - Notice of Change for PAR-24-066 NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required). See Notice NOT-EY-24-002 November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029 .

June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements­­. See NOT-OD-23-139 . February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants­­.

See 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 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number Notice of Funding Opportunity Purpose The NEI uses this U44 Notice of Funding Opportunity to support SBIR grant applications from small business concerns (SBCs) that propose to implement investigator-initiated, early-stage clinical trials with greater than minimal risk and typically are Phase I or II trials.

The risk level of the U44 trial requires appropriate performance oversight and safety monitoring. For purposes of this NOFO, the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders. Applicants are strongly advised to consult with NEI program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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.

New Date November 17, 2025 per issuance of NOT-OD-26-006 . 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 This Notice of Funding Opportunity (NOFO) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NEI.

This program provides support for milestone-driven, commercialization-oriented clinical trials and will involve participation of NEI program staff in negotiating the final project plan before award and monitoring of research progress. Applications supported by this NOFO must meet the NIH definition of a clinical trial (see https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-15-015. html) and must be greater than minimal risk trials. As defined in 45 CFR § 46.

102, a minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

This NEI SBIR Cooperative Agreement (U44) for Clinical Trials is designed to support SBIR grant applications specifically from small business concerns (SBCs). Currently, the NEI uses U01 cooperative agreement mechanism https://grants. nih.

gov/grants/guide/pa-files/PAR-22-149. html to support early-stage, small-scale clinical trials that are greater than minimal risk; and UG1 https://grants. nih.

gov/grants/guide/pa-files/PAR-21-041. html to support large-scale, multi-center clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. The scope of this NOFO is to support U44 applications for clinical trials to investigate the safety and/or efficacy of screening, diagnostic, preventative, or therapeutic interventions for eye diseases or disorders.

Applicants seeking a Phase II or Phase IIB award must have received an eligible predicate award that is appropriate and relevant (e.g., pre-clinical studies, planning activities, etc.) to this NOFO. An application without an eligible predicate award must be submitted as a Direct to Phase II application.

This NOFO is specifically intended for early-stage clinical trials with greater than minimal risk that meet all of the following criteria: Include strong preliminary and/or pre-clinical data Are early-stage clinical trials Have a well described Commercialization Plan (see Section IV for details) Examples of appropriate studies include, but are not limited to, those designed to: Evaluate and optimize the dose, formulation, safety, tolerability, or pharmacokinetics of an intervention in healthy volunteers or the target population.

Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity, target engagement, dose-response trends, pharmacodynamic response) in a human “proof of concept” trial. Select or rank the best of two or more potential interventions or dosing regimens to be evaluated in a subsequent trial, based on tolerability, biological activity, or preliminary clinical efficacy.

Determining the optimal outcome measure (endpoint), its variability, and/or the optimal timing of outcome evaluations in the context of the intervention. Establish proof-of-principle and optimize techniques, operation, and usability of a device, inform the final device design decisions, and estimate the magnitude of treatment effects. Collecting information on the utility of questionnaires, rating scales, or biomarkers.

This NOFO will support the conduct, completion, and analysis of a clinical trial, including activities related to the conduct of the clinical trial, which include but are not limited to the following: training of study personnel enrollment and recruitment of study subjects investigational product costs data collection, management and quality control laboratory work and data analyses study management and oversight establishment of committees to manage the complexity of the trial preparation of the final study report and other related post-trial activities regulatory activities and site monitoring can be covered if required Clinical trial planning activities should be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

If the proposed clinical trial involves the use of a drug or a device that has not been approved by the FDA for the proposed investigational use, then evidence of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) application submission to the FDA that meets all requirements under 21 CFR 312 is required at the time of the U44 grant application submission.

It is the responsibility of the applicant to provide evidence from the FDA if an IND or an IDE is not required. NEI reserves the right to deny or postpone the award until evidence of IND/IDE authorization from FDA is provided. Delineation of milestones is a key characteristic of the NEI Cooperative Agreement (U44) for Early-Stage Clinical Trials with greater than Minimal Risk.

A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. See Section IV. Application and Submission Information for more specific instructions.

Applications Not Responsive to this NOFO: The following types of activities remain outside of the scope of this NOFO, and applications proposing such activities will be considered non-responsive to this NOFO and will be withdrawn without review: Applications that do not meet NEI Mission: https://www. nei. nih.

gov/about/strategic-planning Applications involving a clinical experiment that is not directly intended to evaluate a screening, diagnostic, preventative, or therapeutic intervention Applications that aim to test a drug, a device, or service with limited or no commercialization potential NIH-defined clinical trial applications proposing only mechanistic and/or minimal risk studies Applications that are large-scale, multi-center clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource clinical trials Applications that propose a project that extends beyond a three-year project period Applications that propose animal studies Applications that lack appropriate attachments (See Other Attachments in Section IV.

Application and Submission Information) Data Monitoring and Safety Committee (DSMC) A DSMC is required for this mechanism.

The DSMC is an independent group composed of individuals not directly involved in patient care or data collection for the study who are responsible for safeguarding the interests of all trial participants, assessing the safety and efficacy of the treatment during the trial, and for monitoring the overall conduct of the trial. The DSMC operates under the guidance of an approved Charter.

Do not name individuals for the DSMC but include areas of expertise that will be pertinent in forming this committee. NEI reserves the right to specify the requirements for the establishment of a DSMC (Data and Safety Monitoring Committee). Applicants are encouraged to discuss those decisions and requirements with NEI prior to submission of the application.

NEI program staff will closely monitor progress in meeting the milestones of all projects funded by cooperative agreements under this NOFO and will also oversee the management and reporting of adverse events and have regular communications with the PD(s)/PI(s). The NEI Program Official(s) will participate in the DSMC meetings and will serve as a technical representative to the DSMC.

Applicants are strongly encouraged to contact Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts), and no later than 12 weeks prior to the anticipated application submission date.

All research and development activities associated with awards made under this NEI SBIR Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44) NOFO must be performed within the United States (the United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia).

See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed 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. Required: Only accepting applications that propose clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NEI permits Phase II or IIB budget requests up to $1,000,000 (total costs) per year, but the total costs for the entire project period should not exceed $2,000,000 total costs. Phase 1 application(s) is not permitted. The scope of the proposed project should determine the project period.

Durations up to three years maximum for Phase II may be requested. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this 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: 1.

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; 2.

Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; SBIR and STTR.

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

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

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

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

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 Organizations) 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.

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.

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.

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.

Such a relationship does not necessarily involve a salary or other form of remuneration The primary employment of the PD/PI must be with the SBC or the Research Institution (where they are PD/PI at) at the time of award and during the conduct of the proposed project. Each PD/PI must commit a minimum of 10% effort to the project. 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 does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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, 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 ). 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, normally, two-thirds or 67% of the research or analytical effort is carried out by the small business concern.

The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort is generally not more than 33% of the total amount requested (direct, F&A/indirect, and fee). In 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 not more than 50% of the total Phase II amount requested (direct, F&A/indirect, and fee). Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information.

Deviations must be approved