Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed)

Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed) is sponsored by National Institute of Dental and Craniofacial Research (NIDCR) / National Institutes of Health (NIH). This Funding Opportunity Announcement (FOA) encourages innovation, optimization and customization of core technologies in digital dentistry that improve efficiency of oral healthcare delivery, effectiveness of clinical decision-making and outcomes of treatments associated with d…

Expired PA-19-021: Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Dental and Craniofacial Research ( NIDCR ) Funding Opportunity Title Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed) R41 / R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available.

See Notice NOT-OD-20-077 . Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

See Notice NOT-OD-19-128 . November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PA-19-022 , SBIR R43 / R44 Phase I, Phase II, and Fast Track See Section III. 3. Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages innovation, optimization and customization of core technologies in digital dentistry that improve efficiency of oral healthcare delivery, effectiveness of clinical decision-making and outcomes of treatments associated with dental, oral and craniofacial (DOC) tissues.

Among the areas of interest of this FOA are development of digital imaging and image processing capabilities for dental radiology, and the integration of 3-dimensional (3D) additive manufacturing (e.g., 3D printing) with imaging tools.

This FOA also supports efforts to develop, integrate, adapt, optimize, and validate new and existing dental materials designed for additive manufacturing approaches in the repair, replacement and restoration of DOC tissues.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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) Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (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 Announcement Section I.

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.

Funding Opportunity Description Digital dentistry uses advanced materials and powerful manufacturing technologies aided by 3D imaging and processing software algorithms to produce dental devices and perform complex dental procedures.

This Funding Opportunity Announcement (FOA) encourages innovation, optimization and customization of core technologies in digital dentistry that improve efficiency of oral healthcare delivery, effectiveness of clinical decision-making and outcomes of treatments associated with dental, oral and craniofacial (DOC) tissues.

Among the areas of interest of this FOA, are development of digital imaging and image processing capabilities for dental radiology, and the integration of 3-dimensional additive manufacturing with imaging tools. This FOA also supports efforts to develop, integrate, adapt, optimize, and validate new and existing dental materials designed for additive manufacturing approaches in the repair, replacement and restoration of DOC tissues.

New digital tools and technologies are revolutionizing dental and medical fields and making patient care easier, faster, safer, and more effective. They are modernizing the way dental devices, procedures, and products are enhancing the personalization and delivery of oral health care.

Digital dentistry incorporates computer-controlled components such as: 3D cone beam computed tomography (CBCT) imaging, computer-aided-design/computer-assisted-manufacturing (CAD/CAM), and 3D printing into the clinical workflow.

All disciplines of dentistry, especially prosthodontics, restorative dentistry and orthodontics benefit from routine application of CAD/CAM for inlays, onlays, veneers, crowns, fixed partial dentures, implant abutments and full-mouth reconstruction.

CAD/CAM meets three challenges in dentistry: 1) ensures adequate strength of the restoration, especially for posterior teeth; 2) creates restorations with a natural appearance; and 3) makes tooth restoration easier, faster, and more accurate than other technologies.

CAD/CAM systems are composed of three major parts: 1) data acquisition unit-intraoral scanner; 2) software for designing virtual restorations; and 3) computerized device for creating the restoration, either through subtractive (milling/grinding), or additive (3D printing) manufacturing. Both, subtractive and additive manufacturing approaches present advantages for specific clinical applications.

The integration of 3D CBCT, CAD/CAM, and 3D printing with advances in biomaterials has led to major improvements in dental care and treatment delivery. Paired with CAD/CAM, 3D printing and advanced image processing functionality, CBCT can improve the success rate of interventions.

Dentists can simultaneously plan the implant and restoration, produce a surgical guide, and then fabricate and place the permanent implant restoration, in some cases, all within an office and in a single patient visit with reduced risk of potential complications and improved treatment outcomes. This FOA addresses key technology gaps affecting the productivity and quality of care in dental practices.

In certain cases, dental radiographs and computed tomography offer limited capacity to detect disease and accurately predict post-operative anatomy and physiology. Also, these tools are not always able to estimate mechanical force distribution through soft and hard oral tissues, dental biomaterials and their interfaces.

Development and implementation of novel digital dentistry methods that integrate different imaging modalities (CBCT, MRI, ultrasound, optical) with advanced image processing algorithms and expert systems have the potential to overcome current technical limitations in assessing oral health, and reliable pre-surgical planning and surgical guidance.

To meet this challenge, this FOA is seeking to integrate advanced imaging, surgical expert systems, and computer-aided manufacturing capabilities into clinical workflow to drive patient-focused solutions. Moreover, 3D printing protocols and high-performance materials need to be optimized to complement existing capabilities to produce dental devices in a clinical setting.

CAD/CAM milling uses ceramics to produce restorations while 3D printing primarily uses polymer resins, and more recently, non-precious metal alloys coated with ceramic to produce restorations. 3D printing has capabilities to be highly accurate, handle complex shapes and small dimensions not achievable through CAD/CAM.

Similar to CAD/CAM, 3D printing can also be integrated into a clinical workflow to complement existing clinical capabilities.

The advantages offered by 3D printing create significant opportunities for digital dentistry to achieve more flexible, convenient and precise patient-centered solutions that are timely, cost effective, and complementary to current approaches This FOA invites applications that propose development and implementation of novel digital dentistry methods by integrating different imaging modalities (e.g., CBCT, MRI, ultrasound, optical) with advanced image processing algorithms and expert systems to assist in oral health assessment, pre-surgical planning and surgical guidance.

Development of advanced image processing software, including artificial intelligence (AI) tools, for image detection, classification, interpretation and clinical decision making in dental radiology are highly encouraged. Performance of new imaging-based systems must be verified and validated according to sensitivity, specificity, and accuracy requirements in support of specific intended preclinical and clinical utilities.

This FOA requires that the performance of proposed tools, materials, devices and strategies be verified and validated for human safety and effectiveness according to recognized industry standards.

Product development plans may include performance testing involving preclinical studies, human testing for feasibility, usability evaluation, and use of human tissue samples or secondary analysis of imaging and metadata from existing clinical studies.

A quality systems approach should be applied for product development and testing of performance requirements according to required technical characteristics and clinically relevant conditions. Research of new materials and device production techniques must account for biocompatibility, mechanical, structural, and usability criteria needed to ensure clinical performance.

Examples of research projects may include, but are not limited to the following: Validation of high-performance materials designed for 3D printing approaches that allow the production of dental devices in a clinical setting Development of smart and secure expert software systems for treatment planning that account for oral tissue biomechanics and dental material properties Development of dynamic surgical guidance systems for pre-surgical planning that incorporate real-time tracking capabilities with multimodal image fusion and surgical navigation Implementation of accurate dental image processing and AI software tools to detect disease, stratify risk and optimize patient-specific treatment Development of new technologies for generation of digital impressions that penetrate gingiva non-invasively without fluid effects Development and clinical implementation of multimodal diagnostic imaging and dedicated image processing tools for intra- and extra-oral applications Projects that are not appropriate for this FOA include : Development of imaging reagents (e.g., probes, contrast agents) as a primary focus 3D printing applications that include use of biological materials (e.g., bioprinting using cells) 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* Direct Phase II not allowed) Resubmission (all phases) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. 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 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 project. 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 FOA. 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; 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), 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; 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. 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.

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.

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. 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 apply for 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 do not meet or exceed the benchmark rate 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.

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 at SBIR.

gov. 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.

Phase 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 48537 ).

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 apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. 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 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 submission. Dun and Bradstreet 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 application. 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. eRA Commons - Applicants 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 submit an application. Grants.

gov Applicants must have an active DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 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 Parent announcements.

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

Application and Submission Information 1. Requesting an Application Package 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 in the SF424 (R&R) SBIR/STTR Application Guide , 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 review. For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications . All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. Note that Phase I SBIR/STTR Appendix materials are not permitted. Limited items are allowed in the Appendix of other small business applications.

The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.

PHS Human Subjects and Clinical Trials Information When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. Overview Information contains information about Key Dates and time. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must