Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44 Clinical Trial Not Allowed)
Activity Code

U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II


Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-AG-21-026
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) utilizes the SBIR cooperative agreement (U44) activity code to support the preclinical development of emerging therapeutics targeting fundamental mechanisms of aging (e.g., inflammation, cell senescence, proteostasis). This includes the translation of a broad range of potential geroscience-based therapies, such as new classes of compounds (e.g., senolytics), biologics, stem/progenitor cell-based therapies, repositioning of existing investigational drugs, and repurposing of Food and Drug Administration (FDA)-approved drugs for the treatment and prevention of clinical conditions related to aging and common in the aged. Examples of translational research activities eligible under this FOA include target validation, optimization of lead compounds, pharmacokinetics and drug disposition studies, and preclinical safety/toxicology studies. NIA encourages the submission of applications which involve translational research activities across all stages of preclinical drug development. The development and validation of new methodologies (e.g., organoids, in silico approaches) necessary to advance preclinical development of a given therapeutic are also allowed. While the use of relevant human in vitro systems (e.g., organoids, microphysiological systems (MPS), induced pluripotent stem cells (PSCs)) is strongly encouraged in the preclinical development process, the conduct of first-in-human (FIH) studies and/or early phase clinical trials are outside the scope of this FOA.

Applicants must include a Target Product Profile (TPP) based on FDA guidance in their applications. In addition, U44 awardees will be required to convene periodic meetings with the FDA to discuss any necessary modifications to the TPP based on research progress or to meet specific regulatory requirements (e.g., pre-IND meeting).

Preclinical development of new drugs for Alzheimer’s disease and its related dementias (AD/ADRD) are outside the scope of this FOA, as several other NIA FOAs are available for this purpose. Information on current NIA FOAs on AD/ADRD is available at https://www.nia.nih.gov/ad-foas.

Key Dates

Posted Date
June 25, 2020
Open Date (Earliest Submission Date)
October 10, 2020
Letter of Intent Due Date(s)

October 10, 2020

Application Due Date(s)

November 10, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed 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)

Not Applicable

Scientific Merit Review

February/March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
November 11, 2020
Due Dates for E.O. 12372

Not Applicable

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 toall 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. Applicationsthat do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Recent health statistics indicate that the prevalence of multiple chronic conditions (two or more) in the United States is 50% among individuals age 45-64 years and 81% among individuals age 65 years and older. Examples of chronic conditions include diabetes, arthritis, chronic obstructive pulmonary disease (COPD), heart disease, cancer, stroke, and dementia and other cognitive impairments. Individuals with multiple morbidities experience more functional limitations and usually have worse health outcomes than those affected by a single disease. This public health burden is expected to increase,as the over-65 population is projected to triple by 2030. In addition, there are age-related conditions, such as sarcopenia/skeletal muscle function deficit, heart failure with preserved ejection fraction (HFpEF), and mobility disabilities, for which effective therapies remain to be identified. Thus, there is substantial interest in the identification of new compounds and the repurposing of FDA-approved drugs which can modulate fundamental mechanisms of aging (e.g., cell senescence, autophagy, mitochondrial dysfunction, etc.). Not only would such therapies be applicable to a wide variety of aging-related conditions, but they also have the potential to prevent multiple chronic conditions. Ultimately, the goal of translational aging research is to promote health span--the maintenance of good health as we age.

Investigators involved in translational aging research continue to generate proof-of-concept data in model organisms and/or in vitro experimental systems for a variety of compounds which have been found to either extend life span, modulate various aging mechanisms, or alleviate specific age-related deficits in physiological functions (e.g., endothelial cell dysfunction, impaired wound healing, alterations in cardiomyocyte function). Yet only a small fraction of these geroscience-based discoveries enters preclinical drug development pathways. Consequently, the prospects for taking potentially novel therapies for aging conditions to first-in human (FIH) studies and clinical trials continue to remain low.

While efforts are underway to address the current methodological and regulatory challenges faced by investigators involved in geroscience-based drug development, the lack of funding sources to support the range of studies required for the preclinical development activities represents a major hurdle. Such studies are usually expensive, resource intensive, and time consuming, but crucial to the design and implementation of initial human testing of promising new therapeutics. It is important, therefore, to engage small business concerns (SBCs) in translational aging research since they possess the necessaryinfrastructure and research resources and follow standard operating procedures (i.e., Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)) that will meet regulatory requirements and increase the likelihood of a successful filing of an Investigational New Drug (IND) application. The National Institute on Aging (NIA) is thus establishing a cooperative agreement SBIR (U44) program to facilitate the preclinical development of new, repositioned, and repurposed drugs and other types of therapeutics targeting fundamental aging mechanisms for the prevention and treatment of aging-related conditions.

Research Objectives

This Funding Opportunity Announcement (FOA) utilizes the SBIR cooperative agreement (U44) activity code to support key phases of the preclinical development of emerging therapeutics targeting fundamental mechanisms of aging (e.g., inflammation, cell senescence, proteostasis). This includes the translation of a broad range of potential geroscience-based therapies, such as new classes of compounds (e.g., senolytics), biologics, stem/progenitor cell-based therapies, repositioning of existing investigational drugs, and repurposing of FDA-approved drugs for the treatment and prevention of clinical conditions related to aging and common in the aged.

NIA encourages the submission of applications which involve translational research activities across all stages of preclinical drug development. It is anticipated that the type and amount of data to be included in the U44 applications will vary in accordance with the stage of preclinical development of an investigational compound and with drug repositioning and repurposing. Applicants with promising in vivo data on a lead compound being proposed for further development are encouraged to consider the Direct-to-Phase II mechanism, while earlier stage applicants are encouraged to consider the Fast-Track mechanism. All applicants are encouraged to contact the scientific contacts listed in this RFA to discuss their application and the most appropriate funding mechanism.

Applications must present a strong scientific rationale for the intended clinical application of the proposed therapeutics based on the aging mechanism(s) of interest and, at the very least, include high-quality proof-of-concept data obtained in aging-relevant experimental models and human in vitro systems. Moreover, because the effects of targeting a fundamental aging mechanism may differ between organs/tissues and thereby influence the outcomes (beneficial and adverse), applicants should consider possible tissue- or organ-specific effects in their rationale.

Applications involving the repositioning of an existing investigational drug or repurposing of an existing FDA-approved therapeutic should include information on the feasibility of an IND submission. In addition to any other information the applicant feels is pertinent, applications should include documentation to show access to existing pharmacokinetics/pharmacodynamics (PK/PD) data, toxicology data, and any relevant clinical data required by the FDA.

Applicants must include a Target Product Profile (TPP) based on FDA guidance in their applications. In addition, U44 awardees will be required to convene periodic meetings with the FDA to discuss any necessary modifications to the TPP based on research progress or to meet specific regulatory requirements (e.g., pre-IND meeting). These requirements are intended to increase the probability of a successful IND submission (if the preclinical results are sufficiently promising to support an IND submission).

The range of translational research activities appropriate for this FOA include, but are not limited to, the following:

  • Further characterization of candidate compounds/proposed therapy, such as molecular size, bioactivity, and bioavailability, including the development of assay methodologies or research tools to conduct the characterization.
  • Collection of limited additional data regarding target validation.
  • Validation of target engagement assays, including experiments using human biospecimens.
  • Development of stage-appropriate bioanalytical assays and optimization in compliance with regulatory requirements.
  • Generation of pilot data to help design IND-enabling toxicology studies (dose-range determination, routes of administration to be tested, selection of appropriate animal models, etc.).
  • Pilot studies of potential age and/or gender differences in PK/PD characteristics which may influence design of IND-enabling studies.
  • Chemistry, Manufacturing, and Control (CMC)-related activities such as purification, final formulation development, GMP manufacturing/scale-up for IND-enabling pharm/tox testing.
  • Testing to confirm the identity, quality/purity, and potency of lots of the investigational compound that will be used for toxicology studies and intended for the proposed human study.
  • Refinement and validation of assay methodologies to further test pharmacokinetic (PK) properties, or for in vitro studies intended to evaluate drug toxicity.
  • Replication studies if required to establish feasibility of further translation of proposed therapeutics, including assessment of efficacy in additional animal models and testing of the impact of age-related changes (e.g., use of aged animals).
  • For proposed stem/progenitor cell replacement therapies, additional characterization of aging changes in the systemic milieu and/or tissue microenvironment, phenotypic properties, or aspects of cell sorting/isolation which may impact regenerative potential.
  • Assessment of in vivo pharmacology such as determination of dose range, frequency of dosing, route(s) of administration, etc., in appropriate animal models and in different age groups (based on anticipated age range of target clinical population). This includes studies of potential age-related differences in pharmacodynamic (PD) properties and Absorption/Distribution/Metabolism/Excretion (ADME).
  • Studies of the relationships between PK and PD properties with target engagement measurements, correlations between in vitro and in vivo activities, and bioavailability at site of action.
  • Testing of different formulations, optimization of delivery systems, or special formulations (e.g., controlled release, extended delivery).
  • Refinement of manufacturing processes (e.g., purification yield, purity, yield of cells from isolation process) and establishment of scale-up procedures.
  • IND-enabling pharmacology and toxicology studies (acute, subacute, chronic, reproduction studies, mutagenicity and tumorigenicity studies).
  • Any special toxicity studies related to the drug's mode of administration or conditions of use (e.g., intranasal, extended release formulation).
  • Immunogenicity evaluation, as appropriate.
  • Biodistribution studies, as needed.
  • Studies of potential drug interactions, if needed.
  • Translation and validation of assay methodologies used in animal studies for monitoring efficacy or safety outcomes for use in clinical studies.
  • Preparation and submission of an IND package to the FDA.

At the end of the U44 funding period, it is expected that a successful project would be poised to enter the phase of IND-enabling studies or, for projects at more advanced stages of translation, result in the submission of an IND application to the FDA. Investigators who receive U44 awards under this FOA will also have the option of subsequently applying to the NIH SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development FOA to accelerate the pace of their translational research activities. For example, U44 projects could obtain additional funding through the CRP program to conduct additional drug development activities such as IND-enabling studies or for manufacturing costs, regulatory assistance, or a combination of services, including planning for FIH studies or early-phase clinical trials (e.g., Phase I and II).

Applicants should include travel funds for staff to participa ein annual meetings in Bethesda, MD. The first annual meeting should occur within the first four months of the project period.

Non-Responsive Applications

Projects which primarily focus on basic science mechanistic studies or the early phases of target discovery are outside the scope of this FOA. Preclinical development of new drugs for Alzheimer’s disease and related dementias (AD/ADRD) are also outside the scope of this FOA, as several other NIA FOAs are available for this purpose. Information on current NIA FOAs on AD/ADRD is available at https://www.nia.nih.gov/ad-foas.

Milestones

Milestones are quantifiable goals that are used to monitor the progress made by a research project and serve as a basis for go/no-go decision making between NIA program staff and the project research team. Prior to the issuance of an award, NIA program staff will contact the applicant to discuss any modifications to the proposed milestones, as recommended by the review committee or NIA program staff. A final set of approved milestones will be specified in the Notice of Award.

Progress towards achievement of the established milestones, including transition from U44 Phase I to II, will be evaluated by an NIA oversight committee composed of NIA program staff. NIA staff may seek advice from staff at other NIH Institutes and Centers (ICs) with relevant expertise, as necessary. If warranted, the milestones for future years may be revised based on data and research progress during the preceding year.

Funding for the project may be restricted or discontinued if there are delays in meeting milestones or if milestones are not met. Continuation of funding will also be based on the overall robustness of the data generated and their interpretability (independently of achieved milestones), overall progress, competitive landscape, and availability of funds.

Intellectual Property (IP)

Applicants are encouraged to prepare this section in consultation with their institutions' technology transfer officials.

NIA strongly encourages the awardees and/or their collaborators to obtain and retain any IP developed during the project period (refer to instructions on attachment of letters to address IP issues in Section IV). In compliance with the Bayh-Dole Act, this cooperative agreement U44 research program is structured so that the awardee institution can elect to retain title to inventions; notwithstanding the rights reserved by the U.S. Government if title is elected by awardee institution, NIA/NIH does not intend to hold any additional IP rights for therapeutics developed under this U44 program. NIH policy requires invention reporting in I Edison.

Patents should also include a reference to NIH funding support by including the grant/cooperative agreement number in the patent. The awardee institution will take responsibility for patent filings, implementation, maintenance, and licensing efforts toward eventual commercialization. PDs/PIs are expected to work closely with their institutional technology transfer/business development officials to ensure that appropriate technology transfer agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated, as required, over the course of the project period. Awardees are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the therapeutics development process.

Pre-Application Webinar

A webinar is planned to provide prospective applicants the opportunity to receive information and ask questions about the scientific scope of this FOA and technical details for applying. The webinar will be open to all prospective applicants. Participation in the webinar is not a prerequisite to applying to this FOA, but prospective applicants will need to register in order to participate. Prospective applicants are also encouraged to submit their questions regarding the FOA in advance of the webinar; further details on where to submit the questions will be provided once the webinar has been scheduled. Please refer to www.nia.nih.gov/RFA-AG-21-026 for further details on the pre-application webinar, including the time and date and registration information.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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 FOA.

Application Types Allowed
New (SBIR Direct Phase II)
New (Fast-Track)

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 FOA.

Clinical Trial?
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

NIA intends to commit $2.15 million in FY 2021 to fund up to 3 awards.

Award Budget

Total funding support (direct costs, indirect costs, fee) normally may not exceed $252,131 for Phase I awards and $1,680,879 for Phase II awards. However, NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics. The current list of approved topics can be found at https://sbir.nih.gov/funding#omni-sbir. Applications that address the approved waiver topics may request total cost budgets up to $450,000 for Phase I and $1,250,000 per year for Phase II for up to three years. Applicants are strongly encouraged to contact NIA 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.

Award Project Period

According to statutory guidelines, award periods normally may not exceed 6 months 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.

A duration of up to one year for Phase I and up to 3 years 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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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;

    1. 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
    2. 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 singleventure capitaloperating company,hedge fund, orprivate equity firmqualifies 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
    3. 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.
  3. 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.

    Definitions:

  • 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.

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 Fast-Track, or Direct Phase II (if available). 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.

Foreign Institutions

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.

Required Registrations

Applicant Organizations

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) – 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 numbernumber to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

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 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.

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, 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).

We encourage you to contact a program officer listed in Section VII with questions about this because occasionally, deviations from these requirements may occur, and must be approved in writing by the funding agreement officer after consultation with the agency SBIR Program Manager/Coordinator. 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, F&A/indirect costs, and fee 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

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

Letter of Intent

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 plan the review.

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 should be sent to:

Chhanda Dutta, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-4161
Email: Duttac@mail.nih.gov

Page Limitations

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.

SF424(R&R) Cover

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 with the following additional instructions:

Other Attachments:

1. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.

Applicants small business concerns who are 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 (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

  1. Download the “VCOC Certification.pdf” at the NIH SBIR Forms webpage.
  1. Answer the 3 questions and check the certification boxes.
  1. The authorized business official must sign the certification.
  1. Save the certification using the original file name. The file must be named “SBIR Application VCOC Certification.pdf”. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
  1. When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the “Research and Related Other Project Information” form.
SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

The following additional instructions apply.

Specific Aims: The Specific Aims section for Fast-Track applications should include Aims delineated for the U44 Phase I and Phase II awards.

Research Strategy:

A. Significance

Clinical Impact and Feasibility:

  • Describe the current state of knowledge about the relationship between the aging mechanism being targeted for preclinical development and the proposed clinical application/age-related condition(s) of interest.
  • If different treatment modalities are currently available for the selected age-related condition(s), provide a brief discussion of their limitations and how the proposed drug/therapy would provide a therapeutic advantage. The discussion should address all available classes of current treatments and whether the proposed therapy represents a new class of drugs, etc.
  • Discuss how the proposed project relates to therapy development efforts underway in academia and industry, regardless of therapeutic class.
  • Provide a Target Product Profile (TPP) based on FDA guidance (https://www.fda.gov/media/72566/download) which states the ultimate goals of the proposed therapy development effort such as stages of the age-related condition proposed for the project, patient population, mode of administration, dosing regimen, duration of treatment, and criteria for determining clinical efficacy.
  • Briefly discuss the rationale behind the TPP minimally acceptable and ideal parameters for the clinical population and feasibility for evaluation of clinical efficacy should the proposed therapy be tested (for example, describe strategies for gaining access to appropriate patient population, the selection of clinical endpoints).

Data to support further preclinical development:

1. Scientific Rationale

  • Discuss the evidence base for a link between the aging mechanism being targeted and the proposed clinical application.
  • Provide high-quality proof-of-concept data obtained in aging-relevant experimental models and from human in vitro systems (if available) which demonstrate that the candidate drug influences the age-related clinical outcomes and condition(s) of interest. Efficacy should be measured in appropriate animal models and models of appropriate age and sex, using clinically relevant outcome measures and in vivo target engagement, with sufficient detail to allow reviewers to critically evaluate the findings. Include quantitative information on purity and selectivity of the proposed therapeutic.
  • Include a justification for the choice of animal model(s) or assay(s), primary, secondary and/or composite, exploratory endpoints, and explain the basis for their clinical relevance.
  • Any data figures included in the application should be accompanied by a brief description of the study design (e.g., age and sex of animals, animals/group).

2. Proposed therapeutic

  • Provide a description of the structure/identity, selectivity, bioactivity, potency, stability, production, etc. of the candidate drug.
  • Define the anticipated characteristics of the optimized lead. Include quantitative characteristics for structure/identity, in vitro activities and in vivo pharmacology, specificity, selectivity, stability, etc. Explain how the desired quantitative characteristics are consistent with the desired TPP.

3. Methodologies and Assays

  • If the development of new methodologies or assays is proposed in the research plan, describe how these methodologies are critical to advancing the preclinical development of the proposed therapeutic.
  • Provide details on how the new methodologies will be validated and the feasibility of applying them to the preclinical development process within the project period.

Approach:

Detailed Plans for Research Strategy (Including Milestones and Timelines):

In this section applicants should provide a Gantt chart for the entire project period with proposed milestones and points for go/no-go decisions that will be used to gauge research progress for each of the key objectives in the research plan. One or more milestone(s) should be used for each key objective. Details should be provided on the methods, assumptions, experimental design aspects, and data analysis plans for each of the proposed milestones. The quantitative criteria for measuring success and related rationale should be specified. Quantitative criteria should be robust and be consistent with the state-of-the-art in the field. The quantitative criteria for success in the milestones will also be used for making go/no-go decisions, and this should be specified.

Composition and Day-to Day Communications of a Multidisciplinary Research Team:

Applicants are strongly encouraged to form a multidisciplinary research team which consists of individuals with aging research expertise (e.g., gerontology and/or geriatrics) along with investigators experienced in preclinical development of therapeutics including PK experts, chemistry, manufacturing and controls (CMC) experts, regulatory experts, statisticians, a project manager, and other academic/industry experts relevant to the proposed drug development. Describe whether members of the proposed research team, including consultants, have a history of conducting collaborative research and the nature of the collaboration.

A team management plan which describes the management structure and how the research team will work together over the course of the currently proposed project (e.g., recurring team meetings, review and report of data across disciplines, decision-making, participate in meetings with NIA, communication, etc.) should also be provided.

Letters of Support:

Applicants should include letters of support from consultants, contractors, and collaborators.

If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.

If collaborating with a private entity, include a letter of support that addresses any agreement to provide agent(s), any limits on the studies that can be performed with said agent(s), any limitations on sharing of data (including negative results), and whether a licensing agreement(s) is in place. This letter should come from a senior official within the private entity who has authority to speak on these issues.

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, with the following modification:

Appendix:

Note that Phase I SBIR/STTR Appendix materials are not permitted. Only 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 human subjects research, clinical research, and/or NIH-defined 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.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).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 then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject tointergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) SBIR/STTRApplication Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Projects which primarily focus on basic science mechanistic studies or the early phases of target discovery are outside the scope of this FOA. Preclinical development of new drugs for Alzheimer's disease and related dementias (AD/ADRD) are also outside the scope of this FOA, as several other NIA FOAs are available for this purposed. Information on current NIA FOAs on AD/ADRD is available at https://www.nia.nih.gov/ad-foas.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Isthe prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the project involve a multidisciplinary team, including expertise in geriatrics, gerontology, preclinical drug development, regulations, statistics, and any other experts relevant to the therapeutic modality? Is any expertise lacking? Based on the team management plan, letters of support, descriptions of how the members have already contributed to the design and proposed implementation of the project, and how they will continue working together over the course of the project, does the team seem capable and sufficiently engaged to successfully complete the activities needed to advance the preclinical development of the proposed geroscience-based therapeutic?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Regarding the Section on Detailed Plans for Research Strategy (Including Milestones and Timelines):

Are plans with all necessary steps to optimize the proposed therapeutic (s) clearly spelled out? Can all the proposed parameters be optimized within the project period?

Are there sound rationales for the choice of model(s), specific assays, and advancement criteria?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones and Timelines

Are milestones robust and associated with clear, quantitative criteria for success that allow go/no-go decisions? If a criterion is not to be used for go/no-go decisions, is it justifiable?

Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient (without unnecessary steps)?

Are there any gaps in the proposed milestone?

Market, Customer, and Competition

How well has the applicant described the market niche(s) for the product/ technology, and how urgent is the unmet need(s) being addressed?

To what extent has the applicant identified realistic, market-based milestones that can be achieved over the requested project period?

How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product?

To what extent has the applicant identified their customers and demonstrated a clear understanding of their needs?

How well has the company addressed potential hurdles that may delay or prevent acceptance of their product?

SBC

To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product/technology? For example, how successful have the PD(s)/PI(s) been in commercializing other SBIR/STTR supported technologies and discoveries in the past?


If the SBC has received previous SBIR/STTR funding from ANY Federal agency, then how successful is the company’s track record in commercializing prior SBIR/STTR projects?

Intellectual Property (IP)

How strong is the applicant's intellectual property (IP) portfolio/position (pertinent to the proposed project), and to what extent does the company have a reasonable strategy to protect its IP going forward?

Are potential issues regarding the IP landscape for the therapeutic being developed and the freedom to operate addressed?

Do the IP strategy and related letters of support address potential concerns?

Are there any known constraints that could impede the development of the therapeutic?

Are IP filing plans described?

If multiple institutions are involved, is IP sharing addressed?

 

For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I (or Phase I-like) objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

 

For Phase I/Phase II Fast-Track Applications, reviewers will consider the following:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan.

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Report fraud, waste and abuse

The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • All aspects of the study, including any modification of study design; conduct of the study; quality control; data analysis and interpretation; preparation of publications; dissemination of data, tools, and technologies; and collaboration with other investigators. The awardee agrees to accept close coordination, cooperation, and participation of NIA staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.
  • Proposing a feasible timeline with rigorous milestones to monitor translational research progress.
  • Pursuing patent protection. Patents should include a reference to NIH funding support by including the grant/cooperative agreement number in the patent.
  • Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIA support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIA.
  • Obtaining prior written approval from NIA for changes in any of the key personnel identified in the Notice of Grant Award.
  • Convening annual in-person meetings in Bethesda, MD to review research progress and status of interactions with FDA staff and to discuss with NIA any anticipated need for modifications to the preclinical development strategy, including the TPP.
  • Notifying NIA of planned meetings with the FDA and communicating the meeting date and agenda. Awardees agree to NIA staff participation in any meetings with the FDA.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIA staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with DHHS, PHS, and NIH policies.
  • Provide input on project milestones and guidance when modifications to established milestones are needed.
  • Provide guidance and support in the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs/therapeutics, to the U.S. Food and Drug Administration (FDA), and facilitating period meetings with the FDA regarding any necessary modifications to the Target Product Profile (TPP).
  • Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities and advising in the selection of sources or resources (e.g., availability of aged animals), provision of research resources, and management and technical performance through participation in meetings of project subcommittees.
  • Review the progress of the study through consideration of the annual reports, site visits, etc. This review may include, but is not limited to, adherence to uniform data collection procedures and the timeliness and quality of data reporting.
  • Monitor progress of study milestones; as with any award, continuation, even during the period recommended for support, is contingent upon satisfactory progress. As relevant, transition of a project from Phase I to Phase II will be based on research achieved milestones and assessed by an internal NIA panel. In general, continuation of funding will be dependent upon the awardee's ability to show adequate progress towards milestone accomplishment.
  • Funding for the project may be restricted or discontinued if there are delays in meeting milestones or if milestones are not met. Continuation of funding will also be based on the overall robustness of the data generated and their interpretation (independent of achieved milestones), overall progress, competitive landscape, and availability of funds.

  • If a study is finally determined to lack feasibility, awardees are required to submit a close-out plan to NIA staff within two (2) months of the decision either by NIA staff or the grantee that an awarded study is no longer feasible. The plan must be approved and signed by the Institutional Official and the PD(s)/PI(s) listed on the award prior to submission.

Additionally, an NIA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The PD(s)/PI(s) will form a Steering Committee (SC), which will serve as the main decision-making body for the project. The SC will have an important role in clarifying and finalizing the project milestones and timelines. The SC will be composed of the PD(s)/PI(s), specialized core facilities (if any), and one NIA representative (the Project Scientist). The NIA Project Scientist will have voting membership on the SC and, as appropriate, its subcommittees. The SC will have primary responsibility for facilitating the conduct and monitoring of studies and reporting study results. As the components of the SC may be geographically dispersed, the SC should meet with monthly conference calls, supplemented as deemed necessary by face-to-face meetings.

Each full member will have one vote. Awardee members of the SC will be required to accept and implement policies approved by the SC.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

NIH requires that SBIR/STTR grantees submit the following reports within 120 days of the end of the grant budget period unless the grantee is under an extension. When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Scientific/Research Contact(s)

Inquiries regarding the scientific scope of the applications may be directed to:

Chhanda Dutta, Ph.D.
Division of Geriatrics and Clinical Gerontology
National Insitute on Aging (NIA)
Telephone: 301-496-4161
Email: Duttac@mail.nih.gov

and

Rebecca Fuldner, Ph.D.
Division of Aging Biology
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: Fuldnerr@mail.nih.gov

Inquiries specific to the NIA small business research program should be directed to:

Todd Haim, Ph.D.
Office of Small Business Research
National Institute on Aging (NIA)
Telephone: 301-480-7867
Email: Todd.Haim@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Jessica Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: jessi.perez@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, and P.L. 115-232. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.


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