Investigator-Initiated Exploratory Clinical Trials (R03) for NIDDK Small Business Concerns (SBIR)

Investigator-Initiated Exploratory Clinical Trials (R03) for NIDDK Small Business Concerns (SBIR) is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-17-034: NIDDK Exploratory Clinical Trials for Small Business (R44) 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 ) of Participating Organizations National Institute of Diabetes and Digestive and Kidney Funding Opportunity Title NIDDK Exploratory Clinical Trials for R44 Small Business Innovation Research (SBIR) Grant - Phase II, Phase IIB, and November 28, 2017 - This PA has been reissued as PAR-18-108 for due dates on or after January 25, 2018.

May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies.

The purpose of this Funding Opportunity Announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

The projects must focus on products related to the mission and goals of the NIDDK and may evaluate drugs, biologics, or devices, as well as surgical, behavioral or rehabilitation therapies. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Any due dates on or after Jan 25, 2018 must use reissued FOA. dates apply, by 5:00 PM local time of applicant organization.

*** Note new SBIR/STTR Standard Due Dates. 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.

AIDS Application Due Date(s) New Date January 24, 2018 per reissuance of FOA (Original Expiration Date: September 6, 2019) It is critical that applicants follow the SBIR/STTR (B) Instructions (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description This Funding Opportunity Announcement (FOA) supports applications from Small Business Concerns (SBCs) for exploratory clinical trials that contribute to the justification for a future trial to establish definitive efficacy (such as a Phase 3 clinical trial or a pivotal device trial).

This includes Phase 1 and 2 clinical studies of drugs, biologics and biotechnology products, feasibility studies of devices, as well as preliminary clinical studies of surgical, behavioral or rehabilitation therapies.

A wide range of trials at different stages of development are allowed, including first-in-human (as defined by the Food and Drug Administration), Phase 1 and 2 single-site clinical studies, and Phase 2b multicenter clinical studies. Applications should aim to generate data that inform further clinical development of the proposed intervention.

The earliest studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing, usability, acceptability). Later-stage studies will generally include randomization and blinding and should yield data that allow a clear go/no-go decision regarding whether the intervention should proceed to a definitive efficacy trial.

This FOA is not intended to support the conduct of a clinical trial where the primary aim is to establish or confirm definitive efficacy (pivotal trials). The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will allow SBIR clinical trial applications through this FOA and will no longer accept clinical trial applications to prior small business announcements (see NOT-DK-16-030 ).

The mission of the NIDDK is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; gastrointestinal and liver diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

Traditionally, large pharmaceutical and biotechnology companies, as well as venture capital firms, have provided the resources needed to conduct the clinical studies required to fully develop and commercialize biomedical products and technologies.

More recently, however, many investors in life science technologies have shown a preference toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses. As a result, many small businesses need to have clinical data to attract sufficient third-party investment.

For this funding opportunity announcement, Phase 1 and 2 clinical studies or trials refer to the common phases of a clinical trial. SBIR or STTR Phase I and II refer to the project phases of the SBIR/STTR programs.

Examples of appropriate studies under this FOA include, but are not limited to, those designed to: Evaluate and optimize the dose, formulation, safety, tolerability, usability, acceptability 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., target engagement, dose-response trends, pharmacodynamic response) in a human "proof of concept" trial. Select or rank the best of two or more potential therapeutic approaches or dosing regimens to be evaluated in a subsequent trial, based on tolerability, biological activity, or preliminary clinical efficacy.

NIDDK recognizes that devices can differ greatly in terms of basic form and function, physiological bases for therapy, degree of invasiveness, etc. A pivotal device study, for example, could potentially be used in support of a new indication of an existing market approved device, or Approval (PMA), Humanitarian Device Exemption (HDE), 510(k) or 510(k) De Novo submission.

Due to the broad scope of possible medical devices and the varied nature of the regulatory path, investigators considering applications to evaluate devices are strongly encouraged to contact Scientific/Research Staff as early as possible to discuss these issues and determine the suitability of their project for this FOA.

NIDDK will prioritize applications to develop novel interventions and discourages submission of applications to develop "me-too" strategies. NIDDK will also prioritize applications to develop interventions for indications for which there are no or few effective therapies or prevention strategies.

While repurposing of already approved interventions may be supported under this FOA, NIDDK will not support studies meant to support label expansion. Applicants should take note of the following: (1) Effect Size: A trial will not be considered for funding under this FOA when its primary objective is to estimate intervention effect size to be used in power calculations for a future efficacy clinical trial.

Effect size estimates based on small or short-term studies are often unreliable. Power for an efficacy trial should be based, whenever possible, on the Minimal Clinically Important Difference (MCID). The MCID is the smallest change in a treatment outcome that a patient would identify as important; it is often determined by surveying patients or their physicians.

(2) Secondary Aims: For drugs and biologics, issues of study feasibility and refinement of study procedures may be addressed as secondary aims in an exploratory clinical trial, but not as the primary aim.

Examples of such secondary aims include: Collecting information on the utility of questionnaires, rating Developing and refining standardized methods of assessing outcome Optimizing methods for identifying, recruiting, and retaining Creating clinical trial infrastructure (3) Multiple Trials: There may be multiple questions remaining to be answered before a Phase 3 trial can be designed and conducted.

The proposed study is not required to address all potential questions but the applicant should clearly detail the total clinical development plan.

(4) Regulatory Approvals: If the intervention is a drug, biologic, or device, applicants should be able to provide information from the FDA on one of the following two scenarios: (a) The protocol for the study and population proposed has been submitted under an open IND/IDE and the IND/IDE is not under full or partial hold. Under this scenario, applicants must provide documentation such as a "may proceed" email or letter from the FDA.

(b) The protocol for the study and population proposed is exempt from an IND/IDE for the specific protocol, device, and patient population. Under this scenario, applicants must provide a copy of the exemption letter from the FDA, prior to funding. For devices, if the IRB has determined that the device is Non-Significant Risk, documentation from the IRB is acceptable, prior to funding.

Full IRB approval is not required at the time of application submission, but is required prior to funding. As such, NIDDK encourages investigators to begin these processes as early as possible. NIDDK also will require documentation of any other necessary regulatory approvals (e.g., Recombinant DNA Advisory Committee) prior to funding.

Applications are encouraged that utilize early signals of activity on biomarkers or clinical endpoints, or that mechanistically test the activity of an intervention in terms of its presumed target(s). However, in the absence of a suitable biomarker, clinical outcomes may be used. This FOA is not intended to support biomarker discovery.

(6) Adaptive Designs: The use of innovative and efficient study designs is encouraged, such as adaptive dose-finding designs, designs incorporating plans for sample size recalculation, and futility designs. Applications for Phase 1 clinical trials in the patient population are encouraged when appropriate, as are applications that encompass Phase 1 and Phase 2a clinical studies (early proof of mechanism or proof of concept).

For medical devices, Early Feasibility and Traditional Feasibility study designs may include single-arm case series, on-off interventions (patients as own controls), device-device comparisons, comparisons to historic controls, comparisons to performance controls, or adaptive/Bayesian designs.

(7) Pharmacometrics: Applications seeking to obtain data needed for pharmacometric modeling are encouraged, with the ultimate aim of enabling the optimal design of a future efficacy trial of an intervention. (8) Rare Diseases: Trials in rare diseases are encouraged.

Innovative trial designs, including crossover designs and adaptive designs and N of one trials, may allow for the most efficient evaluation of the limited subjects available for study. For trials in rare diseases, it is especially important to ensure that the study design will meet the stated objectives, and the approach should carefully be justified.

(9) Patient Groups: Applicants are strongly encouraged to establish relationships with patient groups and solicit their input on recruitment, the clinical meaningfulness of the question under study, the relevance of the proposed clinical outcomes, and approaches to minimizing the burden on study subjects. See Section IV. 2.

Letters of Support. (10) NIH Resources: As appropriate, applicants are encouraged to make use of the following resources for clinical research Clinical and Translational Science Award (CTSA) program ( https://www. ctsacentral.

org ) NIH Toolbox ( http://www. nihtoolbox. org ) PROMIS ( http://www.

nihpromis. org ) (11) Mobile Technologies: Applicants are encouraged to consider utilizing (at least experimentally) mobile technologies (e.g., wireless or remote) to facilitate data collection and protocol adherence on the part of research participants and study site staff.

(12) Consultation with NIDDK: Applicants are encouraged to consult with NIDDK Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NIDDK policies and guidelines as well as to discuss how to develop an appropriate project timeline and milestone plan, which is subject to peer review.

As well, discussions regarding strategies for recruitment and inclusion of women and minorities are available. (13) Applicants citing preclinical research should ensure it meets high scientific rigor guidelines (for reference see http://grants. nih.

gov/reproducibility/index. htm ). 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 Renewal (Phase II* Direct Phase II not allowed) Resubmission (Fast-Track or Phase II) Phase IIB Competing Renewal (Phase IIB) Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

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. According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards.

With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% as a hard cap ($225,000 for Phase I and $1,500,000 for Phase II). However, NIH has received a waiver from SBA, as authorized by statute, to exceed the hard cap of $225,000 for Phase I or $1,500,000 for Phase II for specific topics. The current list of approved topics can be found at https://sbir.

nih. gov/funding#omni-sbir . Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines 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 Phase IIB budgets may not exceed $1,000,000 total costs Durations up to 2 years for Phase I and up to 3 years for Phase II may be requested. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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: 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, 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; 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), or any combination of 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; OR 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. 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 Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity 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. 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.

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. 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.

This Transition Rate requirement applies to 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.

For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.

Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission.

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 benchmark minimum Transition Rate is 0. 25.

SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.

gov. Information on the Phase I to Phase II Transition Rate requirement is available Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR. gov meets or exceeds the minimum benchmark rate of 0. 25.

II to Phase III Commercialization Benchmark In accordance with guidance from the SBA, HHS, including NIH, SBIR/STTR Programs are implementing the Phase II to Phase III Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011.

The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 ( 78 FR This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years. 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. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years. Information on the Phase II to Phase III Commercialization Benchmark is available at SBIR.

gov. Applicants to this FOA that may have received more than 15 Phase II awards across all federal SBIR/STTR agencies over the past ten (10) years should, prior to application preparation, verify that their company’s Commercialization Benchmark on the Company Registry at SBIR. gov meets or exceeds the benchmark rate listed above.

Applicants that fail this benchmark will be notified by SBA annually and will not be eligible to receive New Phase I, Fast-track or Direct Phase II awards for a period of one year. Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant System for Award Management (SAM) (formerly CCR) 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. SBA Company Registry See Section IV. Application and Submission Information , SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package.

Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

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 Grants. gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants. gov registration.

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the 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 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. Additional Eligibility Guidance Individuals involved in NIH-funded clinical trials must meet the requirements of ICH-Good Clinical Practice [GCP] training in accordance with the NIH Policy on Good Clinical Practice.

This FOA 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 The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 NOT-OD-11-101 ). 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, a minimum of two-thirds or 67% of the research or analytical effort must be 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 generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort must be 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 generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee). 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 The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide. and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the SBIR/STTR (B) Instructions (R&R) SBIR/STTR Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent, preferably electronically, should be sent to: Chief,