Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R41)

Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R41) is sponsored by National Institute on Drug Abuse (NIDA) via National Institutes of Health (NIH). This Funding Opportunity Announcement encourages small businesses to develop and commercialize novel technologies and products that may enhance microbiome research with relevance to neurosciences, particularly the microbiome-brain axis.

Expired RFA-DA-17-016: Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R41) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title Laboratory and Diagnostic Tools to Advance Microbiome-Brain Research (R41) R41 Small Business Technology Transfer (STTR) Grant - Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-DA-17-017 , R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I and Fast-Track Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this FOA is to encourage small business to develop and commercialize novel technologies and products that may enhance microbiome research with relevance to neurosciences.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) August 17, 2016 by 5:00 PM local time of applicant 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 instructions in (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description The complex and dynamic human microbiota profoundly affect human health and diseases in a variety of ways.

Microbiota affect physiological processes including digestion, growth, immune defense and nervous systems. Mounting evidence indicates that components of the human microbiome change over time and are affected by a patient disease state and medication. It was also shown that microbiome composition influences mood disorder, level of stress and vice versa.

This modulation of systemic immune response and physiology has an impact on pain and cognition in neurodegenerative, neurodevelopmental and behavior Illicit drug use and HIV are associated with altered nutrition and metabolism, depressed immune function, and decreased diversity of the intestinal microbiota.

However, the mechanisms of microbial translocation and role of the microbiome in Substance Use Disorders (SUD) as well as in the majority of Central Nervous System (CNS) disorders are still unclear. There is a growing number of research projects that aim to develop a deeper understanding of the microbiome function and its vital and dynamic role in human health and diseases.

Several challenges have been identified that may significantly influence future studies of microbiome and CNS conditions: - State of Knowledge. We still do not have enough understanding and data about the microbiome contribution to brain diseases. - Sample Quality.

The samples for microbiome analysis have reduced stability. Additional research is needed to identify the optimal sample collection and preservation. - Cost.

The cost of microbiome analysis remains high. - Time and Labor. The prolonged analysis and lack of available microbiome monitoring services are making it difficult to study the dynamic of microbiota after changing the diet, the life style or having medical treatment.

Addressing technological gaps in microbiome research would allow researchers to perform the integrative analysis of the human microbiome; to improve our knowledge regarding the pool of mobile genetic and metabolomic elements associated with the human gut microbiome and SUD; and to create databases or catalogs of bacterial metagenomics associated with SUD and NIDA expects that small business will enable innovative technologies for microbiome research and diagnostics.

Availability of developed tools/resources may facilitate research to clarify associations between the human microbiome and the brain.

Through an STTR grant, this FOA will support cooperative R&D projects between small business concerns and research institutions to establish the technical merit and feasibility of ideas that have potential for The specific scope of National Institute on Drug Abuse (NIDA): This FOA aims to support the development of novel analytical tools, technologies and research resources to study the microbiome, including its composition, genetics, and bioactivity.

Examples of these analytical tools, technologies and research resources may include, but are not limited to: Novel high-throughput sequencing (as it relates to microbiome Flow cytometry and/or cell sorting technologies to investigate the composition, specificity and dynamics of the microbial communities Laboratory assays for preparation and processing of samples for Diagnostic and laboratory tools to isolate, dissect, and analyze complex microbial communities in various tissues Clinical diagnostic tests for express microbiome analysis Gut microbiome monitoring systems or tests for the analysis of functional and genetic dynamics of microbiota Microbiome targeted small molecular and biological markers Informatics tools and resources for metagenomics data, databases of genome sequences, and informational resources about the association of microbiome strains with human health and diseases Metagenomic tools for drug screening The specific scope of National Center for Complementary and Integrative Health (NCCIH): NCCIH is interested in the role of gut microbiota, and the potential for pre- and probiotics in modulating gut microbiota to prevent and treat a variety of diseases, and disorders including those that may be associated with the brain-gut axis (e.g., pain and anxiety).

Novel assays (e.g., high dimensional methods, analytical and informatics tools) need to be developed and widely used to characterize and determine the bioactivity of, and interactions among prebiotics, probiotics and commensal microbiota.

Tool-enabling discovery examining the range and complexity of bioactivity, and diversity among prebiotics and probiotics and gut-microbiota will advance research, and clinical application aimed at the diagnosis, treatment, and prevention of disease and disorders. 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 Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types. Funds Available and Anticipated Number of Awards NIDA intends to fund an estimate of 4 Phase I awards, corresponding to a total of $600,000, for fiscal year 2017.

NCCIH intends to fund 1 Phase I award, corresponding to $125,000, for fiscal year 2017 Budgets up to $150,000 total costs per year may be According to statutory guidelines, award periods normally may not exceed 1 year for Phase I.

Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.

A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; and STTR.

Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.

No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.

705(b) concerning registration and proposal requirements. its affiliates, not more than 500 employees. If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV.

Application and Submission Information for additional instructions regarding required application certification. If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)).

The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C.

1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Venture capital operating company means an entity described in 121.

103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. SBCs must also meet the other regulatory requirements found in 13 C.

F. R. Part 121.

Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq. , are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program. Transition Rate Benchmark In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011.

This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year.

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

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

The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The benchmark minimum Transition Rate is 0. 25.

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

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

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

The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 ( 78 FR This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years. Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.

15 (15%) patents per Phase II award resulting from these awards. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years. Information on the Phase II to Phase III Commercialization Benchmark is available at SBIR.

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

Applicants that fail this benchmark will be notified by SBA annually and will not be eligible to receive New Phase I, Fast-track or Direct Phase II awards for a period of one year. Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , may be allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. SBA Company Registry See Section IV. Application and Submission Information , SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package.

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

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

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the 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 The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure.

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

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

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide. and Submission Information Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

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

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

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Office of Extramural Policy and Review National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Suite 4243, MSC 9550 All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

for Application Submission The following section supplements the instructions found in the SF 424 (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, with the following additional instructions: All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and . pdf file.

If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM , but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM.

If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

to the SBA Company Registry . previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to a first time applicant, click the " New to the SBIR Program?

" link on lower right of registry required information on the Basic Information and Eligibility Statement Registration on the lower right of the Eligibility Statement screen and and save your SBA registry PDF locally. The name will be in the format of SBC_123456789. pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID.

DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application. completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the Research and Related Other Project Information form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir. gov/feedback? type=reg .

SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. Named individuals who represent end users, relevant expert technologists, microbiome researchers and where applicable, experts in appropriate manufacturing technologies for sustainable dissemination. who will serve as consultants for the project are encouraged.

Investigators should highlight experience in microbiome research and/or diagnostics, as well as utilizing the proposed tool or developing new tools, as well as making a health care technology available to users. All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide 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, with the following additional instructions: This FOA is for both new technologies and/or novel approaches, as well as optimization of existing technologies.

Applications should describe the current technological barriers and needs for microbiome-brain research and/or diagnostics. The significance of the proposed approach and potential advantages should be clearly described. It is particularly important that there be discussion of how technical capabilities relevant to microbiome research and/or diagnostics be improved.

For optimization of existing technologies, investigators should specifically define the current state of technology as a benchmark against which their proposed improvements will be measured.

Applications should include a plan for ongoing consultation with end users, relevant expert technologists, microbiome researchers and where applicable, experts in appropriate manufacturing technologies for sustainable Applicants are strongly encouraged to solicit design requirements from the end-users incorporating the context of the experiments to be enabled and potential advantage, and clear, quantifiable performance metrics that encompass as many aspects of the end-use experience.

It is anticipated that the selected user-groups will provide iterative feedback and further refine requirements in the context of conducting proposed experiments, as well as metric-driven validation of the technology in comparison to current best practices, where appropriate. Applications should outline strategy to develop the technology towards reliable, sustainable manufacture suitable for broad dissemination and integration.

A timeline should be included as part of the Research Strategy and should include a distinct final section, entitled "Milestones," that briefly proposes indicators of progress at critical junctures. Milestones should be tailored to the unique scope of each project, and written concretely enough to evaluate what exactly will have been achieved during the course of the project.

Sharing Plans : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) SBIR/STTR Application Guide. the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide.

Note that Phase I SBIR/STTR Appendix materials are not PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 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), SBA Company Registry, eRA Commons, and Grants. gov. 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 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 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