Autism Data Science Initiative Frequently Asked Questions

View the ADSI Pre-Application Webinar video: https://youtu.be/WPq_99zXhkk 

View an audio-described version of the ADSI Pre-Application Webinar video: https://youtu.be/_Vq2g83-APg 

Navigation #navigation

General Information #generalinfo

  • What is the title of this Research Opportunity Announcement (ROA)?
    • Autism Data Science Initiative
  • What is the Announcement Number of this ROA?
    • OTA-25-006
  • What is the purpose of this announcement?
    • The purpose of this Research Opportunity Announcement (ROA) is to invite applications from eligible organizations to support the Autism Data Science Initiative (ADSI). ADSI will bring together diverse data resources and community members with lived experience to explore novel contributors and/or to characterize the collective contributions of numerous factors to the causation of autism spectrum disorder (ASD), hereafter referred to as autism, and their potential role in increasing the prevalence of autism. ADSI will also seek to identify how existing treatments/interventions are used and better understand their outcomes to inform the design of future clinical studies. This initiative will achieve these goals through four strategic aims: 1) to create new integrated data resources, by applying innovative approaches across existing data from research studies or other valid sources,1 with rigorous privacy protections, for use by the autism research community; 2) to identify and address gaps in available data through targeted data generation; 3) to support the analysis of these integrated data resources that link data on genetic and nongenetic factors (e.g., diagnostic, clinical, behavioral, neurophysiological, pharmaceutical and environmental exposures, complications of pregnancy and peri-natal events) to explore contributors to the causes of autism and/or to identify patterns associated with treatment/intervention outcomes and the use of services for autism; and 4) to provide a venue for replication of these analyses by independent teams to validate findings and increase transparency in the conduct of science.
  • What is an ICO?
    • ICO stand for NIH Institutes, Centers and Offices. The National Institutes of Health is made up of 27 different components called Institutes and Centers. Each has its own specific research agenda, often focusing on particular diseases or body systems. All but three of these components receive their funding directly from Congress, and administrate their own budgets. The Office of the Director (OD) is the central office at NIH. The OD is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components, and is organized into Offices; to which the “O” in “ICO” refers.
  • Whom can I reach out to with questions about this announcement?
    • All questions are welcome. Please reach out to the ADSI Team at ([email protected]) for general questions.  Please also reach out to the ADSI team ([email protected]) with additional financial/agreements questions. For financial/agreement questions, please put “FINANCE” in the subject line.  
  • Can I request a meeting with a NIH program official to discuss my proposal?
    • To provide the most efficient response and due to the large volume of inquiries, our preference is that you send your specific questions, with sufficient detail, to the ADSI Team ([email protected]). Submitting questions through the mailbox will allow program staff to consult with one another before replying, to ensure consistency of our response. Any questions we receive that are likely to be relevant to other investigators will be posted to this FAQ page, so please check the FAQs before submitting to determine if your question has been answered previously. If your question remains unanswered, please contact us and we will do our best to accommodate your request to meet with a program official.   

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Key Dates #keydates

  • What are the key dates in the timeline for planning our application?

    Research Opportunity Announcement ReleasedMay 27, 2025 

    Letters of Intent (LOI) Due

    LOIs are optional, not required.  

    		June 6, 2025, by 5:00 PM local time of applicant organization 
    Application Due June 27, 2025, by 5:00 PM local time of applicant organization 
    Award NegotiationsTo begin on or about July 28, 2025
  • Will late applications and/or resubmissions be accepted?
    • The submission date is June 27th by 5:00 PM local time of applicant organization. Late submissions will not be accepted nor reviewed.
  • Will applicants with PIs and/or key personnel serving on NIH peer review panels (i.e., Study Sections) overlapping with the application submission timeline be granted additional time for submission?
    • No. Regrettably, we are unable to provide applicants with additional time to respond to this ROA due to Study Cection commitments. The funding for this opportunity must be obligated within the current fiscal year, and to ensure compliance with this requirement, we are unable to extend the application deadline beyond June 27, 2025.   
  • Will there be additional submission deadlines for this opportunity beyond June 27, 2025?
    • At this time, there is only this funding opportunity with a deadline of June 27, 2025. Any future funding opportunities in future fiscal years as part of the Autism Data Science Initiative will be separate from the current Research Opportunity Announcement (OTA-25-006) and subject to congressional appropriations and the agency’s programmatic priorities.
  • What factors influence the shortened timeline?
    • The timeline is shortened to allow NIH to commit the funds for this ROA by the end of the fiscal year (September 30, 2025). 

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Eligibility #eligibility

  • What organizations are eligible?
    • Higher Education Institutions
      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education
    • The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
      • Hispanic-serving Institutions
      • Historically Black Colleges and Universities (HBCUs)
      • Tribally Controlled Colleges and Universities (TCCUs)
      • Alaska Native and Native Hawaiian Serving Institutions (ANNHSIs)
      • Asian American Native American Pacific Islander Serving Institutions (ANNAPISIs)
    • Nonprofits Other Than Institutions of Higher Education
      • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Faith-based or Community-based Organizations
      • Regional Organizations
    • For-Profit Organizations
      • Small Businesses
      • For-Profit Organizations (Other than Small Businesses)
    • Governments
      • State Governments
      • County Governments
      • City or Township Governments
      • Special District Governments
      • American Indian/Native American Tribal Governments (Federally Recognized)
      • American Indian/Native American Tribal Governments (Other than Federally Recognized)
      • Eligible Agencies of the Federal Government, including the NIH Intramural Research Program (NIH IRP)
      • U.S. Territory or Possession
    • Other
      • Independent School Districts
      • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Are foreign institutions eligible?
    • Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.
    • Non-domestic components of U.S. organizations are not eligible to apply.
    • Foreign components are not allowed.
  • Are there any other eligibility restrictions?
    • This initiative is not intended to enable incremental extensions of existing research or studies that can be funded by other NIH mechanisms but instead will support transformative and high impact research addressing a knowledge gap that deserves special emphasis and that requires collaborative and interdisciplinary data science approaches.
      • Task I: Dataset Aggregation:
        • Must be accompanied by activities under Task III – cannot do Task I alone
      • Task II: Data Generation:
        • Must be accompanied by activities under III – cannot do Task II alone  
      • Task III: Data Analysis
        • Can be proposed as a stand-alone activity; or in conjunction with Task I, Task II, or Tasks I and II
        • If an applicant proposes activities to perform any analyses under Task III, that leverages the formation of a novel dataset/s developed under Task I, data analysis activities under Task III will be restricted until the awardee can demonstrate they have successfully completed all tasks and requirements for Task I.
      • Task IV: Model Validation or Method Verification
        • Applicants for Task IV cannot propose activities under Tasks I - III  
        • If an applicant proposes activities in support of Task IV, they will be ineligible to receive support for activities in Tasks I – III within this ROA.  
  • Can an NIH Intramural Research Program (IRP) investigator submit an application for the Autism Data Science initiative (ADSI)? #nihirp
    • Yes.  NIH IRP investigators can apply as the prime recipient for the ADSI.   
  • Can NIH IRP investigators participate as collaborators with the lead recipient for the Autism Data Science initiative? 
    • Yes. NIH IRP investigators can participate in the ADSI, with certain limitations. NIH Intramural investigators may collaborate with extramural investigators when both have expertise that could contribute to the goals of the program.  
    • For projects that involve NIH IRP investigators, separate letters originating from and signed by each participating NIH IRP investigator’s Scientific Director must be included in the application, in accordance with the NIH Intramural Sourcebook. The letter(s) must describe the intramural aim(s) and include the requested budget and justification for the intramural activity.  
    • The number of person months and justification for all federal employees who will be committed to the project must be included in the letter, in accordance with the NIH Intramural Sourcebook. This will allow the reviewers to evaluate the suitability of proposed staff to conduct the work.
  • Can IRP investigators from federal agencies request salary funds for their effort in the project?
    • No. No support may be requested from any federal agencies, including the NIH intramural program, for salary or related fringe benefits for career, career conditional or other federal employees (civilian or uniformed series) with permanent appointments under existing position ceilings or any costs related to administration of facilities support.
  • Can NIH IRP investigators request funds for the project besides their salary?  
    • Funds may be requested for NIH IRP investigator participation and are limited to the costs required for carrying out the proposed work, provided those costs can be specifically identified with the Autism Data Science Initiative project. 
    • Costs may include:
      • Salary for staff to be specifically hired under a temporary appointment for the project
      • Consultant costs
      • Equipment
      • Supplies  
      • Travel
      • Other items typically listed under Other Expenses.
  • Where in the application should NIH IRP investigators include a budget request and justification?
    • NIH IRP investigator costs must not be included in the application budget request or budget justification to OTA-25-006.  Instead, a specific NIH IRP budget request must be included in the letter(s) from the investigator’s Scientific Director(s).   
  • In which sections of the application should included NIH IRP investigator participation be described?  
    • Include NIH IRP investigator participation in the Research Strategy, Leadership Plan, Milestone and Deliverables, Biosketches, and PHS Human Subjects and Clinical Trials Information.  Information (if relevant) for all other sections (Equipment and Facilities, Institutional Letter of Support, Budget and Budget Justification, Resource Sharing Plan, Data Management and Sharing Plan) should be provided in the Letter from the NIH IRP investigator’s Scientific Director.
  • How are funds requested for the NIH IRP investigator and/or related to IRP participation provided if the project is selected for funding?  
    • The project budget, including for the NIH IRP investigator and/or NIH IRP participation, will be determined during award negotiation and will not exceed the total cost of the allowable budget (generally up to $5,000,000 total cost per 24-36 month project period).  For projects selected for funding, IRP investigator funds will be issued through an Interagency Agreement (IAA) and terms and conditions of funding included in an associated Memo of Understanding (MOU).
  • Can other federal agencies of the US Government apply to the Autism Data Science Initiative (ADSI) through Research Opportunity Announcement OTA-25-006?  
    • Yes, other federal agencies of the US Government may apply to the ADSI, including NIH Intramural Research Program investigators, who can apply as the prime recipient or as collaborators.  
    • Applications that are submitted by or involve federal agencies, EXCEPT for NIH investigators must include the citation of the agency's statutory authority to receive funding beyond their congressional appropriation in the budget justification.
    • Applications that are submitted by or involve NIH Intramural Research Program investigators must refer to FAQ.
  • I did not submit a Letter of Intent (LOI), am I still eligible to apply?
    • Yes. Letters of Intent (LOIs) were recommended but not required. Submission of an LOI will not impact eligibility or the likelihood of receiving funding through this ROA. 
  • Are PIs required to be from an academic institution in order to apply?
    • You do not have to be a part of academia to be eligible to apply. Academia, industry, US government, and non-profit entities are eligible per the eligibility requirements stated in the ROA. 

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Other Transactions (OT) #ots

  • What are Other Transactions (OT)?
    • Other Transactions (OTs) are funding mechanisms, which are not grants, cooperative agreements, or contracts, authorized under the Other Transaction Authority (OTA) by the 21st Century Cures Act.
    • OTs are used by components within the NIH, which have been authorized by Congress to use them. They allow the NIH to:
      • Seek participation of non-traditional research partners
      • Foster innovation and nimbleness to develop and engage in programmatic activities
      • Alter the course of the project in real-time to meet the overarching goal
      • Conduct objective review of applications
      • Expand, modify, partner, not support, or discontinue awarded activities based on performance and programmatic need.
      • The Other Transactions Authority is governed by 42 U.S. Code § 282 (n)(1)(b). Other Transactions (OT) are used by the NIH to provide considerable flexibility in establishing policies for the awards; policies and terms for individual OT awards may vary between awards, each negotiated with a specific agreement, which may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape and or availability of funds.
  • Are OT applications reviewed by the standard NIH peer review process?
    • Applications to Other Transactions Research Opportunity announcements such as this one, are not reviewed by the standard NIH peer review process, but use custom processes referred to as Objective Review.
    • Responsive full applications submitted in response to the solicitation, will be reviewed by subject matter experts (SMEs) via an objective review process. Objective review will involve the submission of written critiques by SMEs against the Review Criteria provided in the ROA, and interactive individual discussions between those experts and NIH program staff. The SME's may include NIH staff, other federal staff, and individuals external to federal government.
    • Components of the full applications may be accepted into the final plan in whole, in part, or may be omitted. The outcome of each review could result in a modified work plan for each application based on reviewers’ comments and recommendations.
  • Who is eligible to apply for an Other Transaction (OT) Award?
    • Prospective applicants may or may not have received NIH funding in the past. All entities public and private, small or large, for-profit or not-for-profit, eligible Agencies of the Federal Government (including NIH Intramural Research Program) are eligible to apply. For a list of anticipated eligible organizations please see Research Opportunity Announcement (OTA-25-006).
  • When will the award terms and conditions be available? Are there similar Terms and Conditions from other OTA announcements I can look at until they are posted?
    • Unfortunately, there are no OTAs with similar language in the Terms and Conditions. The Terms and Conditions are tailored to each opportunity based on the scientific focus. We hope to have those posted publicly by mid-June.
  • Does submission of an application imply acceptance of the Terms and Conditions?
    • Submission of an application does not imply acceptance of award Terms and Conditions. Applicants that enter into negotiations for funding will have an opportunity to review and request modifications to the Terms and Conditions prior to award. Submitting a statement in the cover letter noting that acceptance is contingent upon review and approval of the final Terms and Conditions is not necessary but acceptable. 
  • Are this initiative’s full application requirements similar to the standard R01 with respect to significance, innovation, and approach sections?
    • No. This ROA is for other transaction (OT) awards, which are substantially different than standard NIH R01 grant awards. The ROA outlines the requirements for the full application. 

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Budget #budget

  • What is the budget for this opportunity?

    • The Autism Data Science Initiative anticipates allocating up to $5,000,000 total (direct + F&A) costs for up to 24-36 months per award. Support of 10-25 projects is anticipated. The funding will depend on (1) the objectives for the project proposed by the applicants and how well they fit with the goals of ASDI, (2) the quality of the applications received, (3) availability of funds and (4) programmatic priorities. The NIH may elect to negotiate any or all elements of the proposed budget. Institutions with an established Facilities and Administrative (F&A) rate should use their federally approved rate to calculate indirect costs for non-compute expenses.

      Please note: If proposed Task IV - Model Validation or Method Verification activities include replication of a large number of Task III - Data Analysis results, a larger budget request may be appropriate. 

  • Can you provide guidance on indirect costs? Are there any restrictions?
    • Institutions with an established Facilities and Administrative (F&A) rate should use up to their Federally approved indirect rate to calculate indirect costs for non-compute expenses.
    • Indirect costs for compute expenses in any application funded under this OT mechanism will be capped at a rate of ten (10) percent.
  • How should the budget request be organized?
    • The detailed budget request should be submitted using the SF-424 form and should include but is not limited to the following cost categories for each year of the proposed project period (i.e., 24-36mos): personnel, equipment, travel, consultants, funds for third parties (i.e., subrecipients), if applicable, other direct costs, and total cost (with indirect costs included). For full details regarding the budget submission please see the Research Opportunity Announcement (OTA-25-006).  
    • Budget justification must be provided for all budget items and budget years. Detailed quotations are required for equipment items exceeding $5,000.
    • Budgets must adhere to latest NIH salary limitation notice (See Salary Cap Summary/Guidance on Salary Limitation for Grants and Cooperative Agreements). 
  • How should applicants structure and submit their budget and budget justification documentation?
    • Applicants are strongly encouraged to submit their budget information using the SF-424 (R&R) and the R&R Budget – 5 yr template forms that are available to download from the grants.nih.gov website. In addition, applicants should provide a written narrative justification for all budget items; see the Budget section of the ROA for additional information. These documents should be uploaded to ASSIST in the Attachments field. It is permissible and acceptable to upload “flattened” (i.e., not forms and no longer editable) versions of the budget template documents (i.e.  SF-424 (R&R) and the R&R Budget – 5 yr). This grants.nih.gov website provides additional information on flattened PDFs and this eRA website provides step-by-step instructions on how to flatten a PDF. For any technical issues with uploading documents to ASSIST, please contact the eRA Help Desk.
  • Are sub-applicants required to provide a budget?
    • Subrecipients are required to provide details of cost breakdown. Prime recipient should follow their internal policies and procedures to calculate subrecipient’s budget.
  • Can an applicant propose a budget that exceeds $5 million in total costs?
    • There is no firm funding cap for this opportunity. As stated in Section 3 of the ROA, “It is anticipated this ROA will result in 10-25 awards, with a budget not generally exceeding $5,000,000 total costs per award, contingent upon the availability of funds and a sufficient number of meritorious applications.” Applicants are allowed to propose budgets greater than $5,000,000, provided that a detailed budget justification is included for all budget items, regardless of the amount of funding requested.
  • Will No Cost Extensions (NCEs) be considered for this initiative?
    • It is anticipated that a project will not extend beyond the awarded project period. NCEs may be considered on a case-by-case basis and only allowed provided there is strong justification.
  • If our multi-PI application involves PIs at different institutions, can we submit separate budgets for each institution or are we required to submit one overall budget?
    • Applicants that wish to submit a multi-PI, multi-institute application will submit a single application with one overall budget from the lead institution that includes the funding for each of the participating institutions and sites. There will need to be a subcontract/subaward from the lead institution to the additional institutions or sites that will participate in the work.
  • Are detailed quotations from consultants and contract research organizations (CROs) required or recommended as part of the application?
    • Applicants are not required to submit quotes from sub-awardees, including consultants or CROs, as part of the application package. However, applicants may find quotes from sub-awardees helpful as they prepare the budget and budget justification.  Applicants must include any sub-awards in the budget submission and justify any sub-awards in the budget justification.
  • Should applicants include personnel costs associated with graduate students, post-doctoral fellows, and/or research associates in their budgets?
    • The budget and budget justification should include all personnel time that is needed to perform the work described in the application, including graduate studies, postdoctoral fellows, and research associates.
  • Do applicants need prior approval in order to request a budget that exceeds $5 million?
    • Applicants do not need pre-approval for budget requests and there is no maximum allowable budget. As stated in the Budget subsection of Section 4, Eligibility, proposals should generally not exceed $5,000,000 total costs but there is no firm funding limit under this ROA.

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Application and Submissions #appandsub

  • What are the important dates for the full application?
    • Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by June 27, 2025 at 5:00 pm (based on the local time of the applicant organization). Applications received past this date will not be accepted.  
  • Which applications will be reviewed? Which will not be reviewed?
    • Applications will only be accepted from entities listed in the Eligible Organizations section of this Announcement, who meet the criteria listed in the Eligibility Requirements. Applications submitted from organizations not included in the Eligibility section will not be reviewed. Applications that are deemed non-responsive or incomplete will not be reviewed.
  • How do I register to the NIH eRA Commons ASSIST system?
    • Applicants must submit via the NIH eRA Commons ASSIST system no later than June 27, 2025 by 5 PM local time of applicant organization. Use OTA-25-006 in the Funding Opportunity Announcement field. Here are instructions for submitting via the NIH eRA ASSIST system. Technical assistance is available from the eRA Service Desk.
    • To submit a full application via ASSIST, the applicant organization must be registered in eRA Commons. To submit a full application, you must be registered in eRA Commons, which may take six (6) weeks or more to complete, applicants should therefore begin the registration process as soon as possible.
    • On the eRA Commons home page, select the “Register Organization” link for more details.
    • To complete registration, if you have not done so already, you may need to register for the following:
    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. The same UEI must be used for all registrations, as well as on the other transactions application.
    • eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission of the full application. eRA Commons requires organizations to identify at least one RBO and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • 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.
  • How do I submit my application?
    • Applications must be prepared and submitted using NIH’s eRA ASSIST. Complete applications must be submitted by the Recipient Business Official (RBO). The organization must be registered in eRA Commons with one person designated as the contact Principal Investigator (PI) and one person designated as the RBO. Registration process can take a long time, so applicants should begin the registration process as soon as possible.
    • Failure to complete registrations in advance of the due date is not a valid reason for a late submission. The RBO’s signature certifies that the applicant has the ability to provide appropriate administrative and scientific oversight of the project and agrees to be fully accountable for the appropriate use of any funds awarded and for the performance of the OT award-supported project or activities resulting from the application.
    • For additional guidance on how to submit an application under Other Transactions Authority (OTA) via ASSIST, please refer to the “Instruction Guide for OTA Submissions via ASSIST” available at https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm .
  • How should I upload the application content into the ASSIST platform? There are limited fields to upload documents when compared to submitting a typical NIH grant.
    • The number of required and optional fields displayed within ASSIST is greatly reduced when submitting an application in response to a Research Opportunity Announcement (i.e., OTA-25-006) as compared to a typical NIH grant application. Any sections of the application that are not specifically requested in the fields in ASSIST should be uploaded in the Attachments field.
  • Can you please clarify the page limitations for each application? Is the 13-page limit intended to apply to each individual proposed Task, or must all proposed Tasks be addressed within a single 13-page maximum application?
    • All of the relevant information for the Research Strategy must fit within the page limits set for that section, which is 6 pages. The page limit for the Research Strategy section is 6 pages regardless of whether the applicant proposes to support a single Task or multiple Tasks. Additional appendices are not permitted. The Resource Sharing Plan, Data Management Plan, and Community Engagement Plan are included within the overall 13-page limit, see below for a breakdown of the components and the page limit for each:
      • Cover Page –1 page  
      • Abstract –1 page  
      • Specific Aims –1 page  
      • Research Strategy – 6 pages  
      • Community Engagement Plan – 1 page  
      • Resource Sharing Plan – 1 page  
      • Data Management and Sharing (DMS) Plan – 2 pages  
    • The following are NOT included in the 13-page limit but may have their own individual page limits as noted below:  
      • Biosketches of senior/key personnel and other significant contributors - 3 pages per individual
      • Budget – no page limitation
      • Letters of support
      • Bibliography – 1 page
  • Can you clarify the requirements for the Biosketch component of the application?
    • Applicants may use the NIH biosketch template form available here: https://grants.nih.gov/grants-process/write-application/forms-directory/biosketch. While NIH grant applicants may be used to a 5-page limit for each individual’s biosketch, this ROA requires a 3-page limit for each individual’s biosketch. It is acceptable for applicants in the biosketches to list positions and employment in chronological or reverse chronological order.
  • The “Application Format and Requirements” section states that applicants must use Arial 10-point font with 1” margins and be single-spaced. Does this formatting apply to specific forms that are required, such as the NIH biosketch template?
    • Where possible, please follow the formatting instructions provided in the ROA. However, when a specific form is provided or referenced, such as the NIH biosketch form, you may use the formatting specified in that form. You will not be penalized if a required form does not allow for adjustments to font, margin, or spacing. 
  • Will NIH provide feedback on my application?
    • NIH will NOT provide feedback on applications, except as a part of follow-up on an as-needed basis.
    • NIH will not accept an appeal of the objective review or funding decision outcomes.
  • Can PIs submit multiple proposals?
    • PIs are welcome to submit multiple proposals so long as the scientific focus is unique for each proposal submitted. As such, the submission of multiple proposals is not encouraged or discouraged.
  • Is it allowable to submit an ADSI application with analyses similar to an R01 application that is currently under review?
    • Yes, it is okay to use a similar strategy provided the two applications address distinct questions. Please be advised that if there is substantial overlap, you will only be eligible to receive funds from one funding opportunity.
  • Is it permissible for the same applicant to submit separate applications for Tasks I-III and for Task V?
    • For the purposes of this ROA, the term “applicant” refers to the eligible entity/institution (Higher Education Institutions, Nonprofits, For-Profit Organizations, etc.) submitting the application and not to the principal investigator (PI) or key personnel listed in the application. The same entity/institution may submit separate applications for Tasks I-III and Task V and be funded for both as long as there is no substantial overlap of the PI or key personnel across both applications.  
    • It is important to note that an applicant cannot propose activities under Tasks I-III and Task V within the sample application. Please refer to Table 1: ADSI Task Areas and Task Area Restrictions under the “Scope and Program Components” section of the ROA.
  • Is it permissible for an applicant to have the same principal investigator (PI) and/or key personnel be awarded to complete activities under Tasks I-III and Task IV?
    • No, there can be no overlap in key personnel between an applicant’s proposals for both Tasks I-III and Task IV. If there is an overlap in the PI and/or key personnel in the two applications and both are selected for funding, the applicant will either have to adjust the PI and/or key personnel so there is no overlap, or the applicant will be deemed ineligible for one of the awards. 
    • In other words, if an individual is listed as a PI or key personnel on an application proposing activities under Tasks I–III and on a separate application proposing activities under Task IV, and both applications are selected for funding, the individual will not be eligible to support both awards.
  • Do applicants need to upload and submit a Leadership Plan that is separate from what is requested in the ROA? There is a Leadership Plan field in ASSIST as part of “5. Project Director/Principal Investigator Contact Information.”
    • No, a separate Leadership Plan attachment is not required regardless of whether the applicant is listing a single PI or multiple PIs. The leadership plan content should be included in the Research Strategy section of the application as part of section 7: “Past performance and expertise of the team members and complementarity with other groups.”
  • Are applicants required to submit PHS Human Subjects and Clinical Trials information, if applicable, as part of their application?
    • The PHS Human Subjects and Clinical Trials information section is not required at the time of submission. However, for teams proposing human subjects work, Human Subjects Protection documents will be required prior to award. To avoid pre-award delays, investigators are encouraged to submit these documents as part of their application. Investigators are encouraged to consult NIH guidance to determine whether their study involves human subject, see this page of the NIH grants website.
  • Does each institution contributing to a single application need to provide an institutional letter of support, or just the lead/primary institution?
    • There is no requirement to submit an institutional letter of support from every institution included in the application. A letter of support is required from the lead/primary applicant’s organization indicating institutional commitment for the project (e.g., relaying support for contributions) including, but not limited to, support for training activities or ADSI meetings, licenses, and other resources; and preparations to enter into negotiated other transactions agreements.
  • What is the maximum allowable number of PIs for this ROA? The ASSIST system appears to limit the number of PI entry fields.
    • Applicants can propose more than two PIs for this ROA. You may provide a complete list of Key Personnel, including additional PIs, within the Research Strategy (see “Section 7 - Past performance and expertise of the team members and complementarity with other groups”) along with Biosketches for each PI/key personnel. For questions related to ASSIST, please contact the eRA help desk.
  • The ASSIST submission page has a “Cover Letter” field. Is this the same as the “Cover Page” that is listed in the ROA as a required component of an application? If so, should I upload my Cover Page using the Cover Letter field?
    • Yes, the Cover Page listed under Section 5 – “Application Information and Submission” of the ROA is equivalent to, and can be uploaded to, the Cover Letter field in ASSIST.
  • We have not been able to secure institutional approval from a sub-awardee prior to the application deadline. Can we still submit with the application with the sub-awardee as tentative or to-be-determined (TBD)?
    • It is acceptable to submit an application with a sub-awardee that is to be determined, provided that the budget and budget justification describe the funding allocation and justification for the sub-awardee.  
  • Can I submit content or information that exceeds the page limit(s) for a section of my application?
    • Applicants should adhere to the stated page limits. Please carefully review the ROA as well as the FAQ above regarding page limits. Reviewers will be instructed to disregard information provided outside the page limits.
  • We are proposing to utilize data from a NIH dataset/resource. Are we required to submit a letter of support from NIH indicating the agency’s support for our use of that dataset/resource? 
    • A letter of support from proposed collaborators or parties who hold governance over data sources is recommended but not required. In this instance, since the data are coming from a publicly accessible repository, a letter of support is less important to assess the overall feasibility of the work being proposed. The applicant should demonstrable whether they have experience accessing and working with the data from the NIH dataset/resource.
  • Is a separate Facilities & Other Resources document required?
    • A separate Facilities & Other Resources document is not required to be attached unless an applicant wishes to include related costs within a budget that extend beyond what is covered by the applicant institution’s negotiated F&A rate. However, Equipment information should be included in the Budget. The following is stated in the Budget section of the ROA (see Section 5: Application Information and Submission): Proposals must provide a realistic budget and cost estimate for performing the work for each year. Provide the overall expected cost for the project including but not limited to each of the following categories:
      • Personnel (to include the fulltime base salary for all key and other personnel)
      • Equipment
      • Travel (to include a breakout of all costs associated with each proposed trip)
      • Subawards/subcontracts/consultants
      • Other direct costs
      • Total costs (with indirect costs included)
      • Proposed cost share contributions (if applicable)
  • Can we include hyperlinks in our application submission?
    • Use of hyperlinks in the application is discouraged. Reviewers are instructed not to review materials outside of the content provided in the application when reviewing applications. 
  • We are experiencing delays in completing one or more of our registrations in the System for Award Management (SAM.gov) and/or eRA Commons. What are our options?
    • Applicants must submit the full application via the NIH eRA Commons ASSIST system no later than Friday, June 27, 2025, by 5 pm local time of applicant organization. Failure to complete registrations in advance of the application deadline is not a valid reason for a late submission.  
    • Per the NIH OER guidance regarding required organization registrations, for eRA Commons Registration - Allow two weeks or more and follow the instructions provided below:
      • A SAM-issued unique entity identifier (UEI) is required to register in eRA Commons, though full SAM registration is not required until application submission. If full SAM registration is not complete, registrants will need to manually provide some eRA Commons registration information that would otherwise be pre-populated from SAM.
      • Registration must be done by a business official with the authority to legally bind your organization in grants and contracts.
      • A signing official (SO) and an optional account administrator (AA) account are created as part of the organization registration. Signing officials have the overall responsibility for managing accounts for their organization, including the creation of additional accounts with the SO or other eRA Commons role (PDF).
      • During registration, select "NIH Grants/Contacts" as the Registration Purpose and read/check the "I acknowledge I have read and understand the NIH Grants Policy statement regarding the Legal Implications of Applications" checkbox. If this step is missed at time of registration, an SO must update the eRA Commons Institutional Profile by checking the right box in the Opportunity Type Eligibility section prior to submitting an application to NIH.
    • NIH considers beginning your eRA Commons registration at least 10 business days prior to an application due date a "good faith effort" to register on time. If your registration is not completed in time to submit due to NIH delays (you have allowed at least 10 business days and have quickly responded to all NIH inquiries regarding your registration), then you may be allowed to submit a late application.
    • We recommend you contact the SAM.gov help desk (https://sam.gov/about/contact) regarding your UEI and the NIH eRA help desk (https://www.era.nih.gov/need-help) to expedite your eRA Commons registration. 

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Data Strategy, Management, & Sharing #data

  • How is “data generation” defined for the purposes of this ROA?
    • For the purposes of this initiative, "data generation" is defined specifically as the collection of new raw data, such as obtaining new physical measurements or administering additional survey instruments to participants. In contrast, activities such as processing existing data sources—like clinical notes from electronic health records—using machine learning or natural language processing (NLP) are considered data analysis methods (Task III), not data generation (Task II). 
  • How are “compute expenses” defined for the purposes of this ROA?
    • In the context of this ROA, “compute” refers to activities, applications, or workloads that include storage, networking, and computation (including, but not limited to, CPU/GPU/neural processing). This may encompass costs such as computing equipment, software, cloud computing, data storage, and hardware. 
  • The data sharing language was confusing, and we wondered whether we were creating a database for our own use or whether we are serving as a vendor to create a database for others to use.
    • Our intention was that applicants would propose linking or co-analyzing existing data sets in new ways. This funding opportunity is not about creating new data infrastructure, rather analyzing existing data in new ways and with new combinations. We expect applicants will distribute any new data and information through existing data infrastructure (i.e., the NIH’s Data Management and Sharing Policy, which states: “NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.” Rather than an individual lab inventing a new data repository and sharing their data through that, we would prefer the data be submitted to an established data repository and shared from there).
  • I plan to utilize a commercial or private dataset as part of my research proposal. Am I required to make this data publicly available?   
    • Awardees are welcome to utilize a commercial or private dataset(s) and will not be required to make the dataset(s) publicly available. However, awardees under Tasks I – III must enable access to the dataset(s) for the awardee of Task IV for validation and replication purposes. Additionally, any data generated under this award should be made available in accordance with the NIH Data Management and Sharing Policy. Please see the Data Management and Sharing Plan section of the Research Opportunity Announcement for more information. 
  • Would the development of new analytical methods for the analysis of autism-related data be considered responsive to Task III?
    • According to the ROA, the development and application of advanced data science methodologies—including new data analytical methods—are considered responsive and encouraged under Task III (Data Analysis). The announcement specifically notes that Task III activities should “entail rich analysis and rigorous evaluation utilizing advanced data science methodologies, such as artificial intelligence (AI), machine learning (ML), and/or other advanced statistical methods.” Applicants are expected to describe the types of data science methodology (including new or innovative approaches) they anticipate using and to demonstrate how these methods will help achieve the aims of the initiative. Therefore, the inclusion of the development of new data analytical methods is appropriate and responsive for Task III, provided these methods are applied to the integrated datasets and are aligned with the goals of the ADSI. 
  • Are algorithm/model validation and/or replication activities permissible under Task III if addressing new questions or analyses? These are often standard approaches in the development and testing of AI/ML methodologies.
    • Yes, validation and replication activities for advanced computational methods such as AI/ML are permitted under Task III as part of standard approaches. However, conducting validation and replication activities under Task III does not obviate the requirement for the research team to work with the independent model validation and method replication partner(s) under Task IV.
  • If certain national datasets cannot be linked at the individual level or fully integrated into a single analytic file, would the proposed approach still be considered responsive to the ROA?
    • Yes, the proposed approach may still be responsive even if some datasets cannot be linked or fully integrated.
  • Many of the data sources we are proposing to us have strict security requirements and cannot be shared. Would applications applying to Tasks I-III that propose making available the code to aggregate and analyze these data, without actually making the data available, be considered unresponsive?
    • The awardee(s) under Task I-III are required to make the data used for analysis available for validation/replication to the extent permissible by policy, regulation, and statute. This requires data access and sharing with the Task IV awardee(s) funded through OTA-25-006. A proposal that cannot fulfill this requirement will be deemed nonresponsive.
  • Given the timeline outlined in the ROA, are applicants expected to have secured access to all proposed datasets, including finalized data use agreements, at the time of submission/award?
    • No, applicants are not expected to have secured access to all proposed datasets or have finalized data use agreements at the time of submission or award.  
  • Would the integration and harmonization of multiple datasets from within one data resource constitute a Task I activity?
    • Using multiple datasets from one database is allowable. If the proposed research is using common data elements and does not need additional data harmonization than this would not be a Task I activity; however, if there is additional data harmonization activities that are being proposed to enable the use of these datasets for analyses under Task III than this would constitute a Task I activity. Obtaining approval or authorization to access and use the data would constitute a Task I activity.
  • Under Task III, the ROA directs applicants to complete pre-registration of planned variables for analysis. Can this be done after submission of an application (i.e. post-award), or is a required component of the project proposal (i.e. pre-award)?
    • Pre-registration of variables for analysis is allowed after submission of an application.
  • Can an applicant propose to use foreign data?
    • For this ROA, the proposed use of valid foreign datasets may be permissible with the appropriate data use agreements provided there are no foreign subawards. Please review the Updated NIH Policy on Foreign Subawards (NOT-OD-25-104) for additional information.
  • For Task IV, are applicants expected to choose either model validation or method replication, or is it acceptable to propose activities that include both?  
    • Applicants to Task IV may propose activities that include both model validation and method replication. Proposals for Task IV may support validation and replication efforts across Tasks I-III.  

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Other Q&A #otherqa

  • How many awards do you anticipate to fund?
    • We anticipate funding up to 10-25 awards by September 30, 2025.
  • Will you potentially look to combine aspects of different projects, akin to ARPA-H?
    • At this point we do not plan to combine aspects of the initial 10-25 awards.
  • If a PI has current funding for research in this area and would like to extend or expand an ongoing study would that be responsive to this initiative?
    • While current work can provide a foundation for the research proposed, this initiative is intended to support highly innovative and transformative research ideas that may be unlikely to be supported through traditional NIH mechanisms. For that reason, proposals that represent straightforward extension/incremental next steps of ongoing work are unlikely to meet the high innovation goals of this initiative.
  • There is some language about sharing applications among applicants for configuring teams, economizing work, and prioritizing activities. Does this mean that one database would be created across all grant recipients?
    • No. This research opportunity is not about creating new data infrastructure. Other Transaction Agreements have the flexibility to create new teams by combining portions of applicant teams across multiple applications. NIH reserves the right to do that in this initiative. But we have no intention of using this funding opportunity to create one database for autism data.
  • I have existing biospecimens from nonhuman studies. Does Task II allow analyses of these existing specimens?
    • This ROA focuses on use of existing data, and this can include a combination of nonhuman and human data, although exclusive use of nonhuman data in Task I or III is not allowed. Limited new data generation can be proposed under Task II but collecting new data in nonhuman subjects, including data derived from analysis of existing biospecimens, is not allowed.
  • A community engagement plan is a required part of the application, can applicants begin engaging with the community prior to application or award?
    • Given the timeline it is not expected that applicants will have begun community engagement activities prior to application or award. However, elements that demonstrate the feasibility or strength of the community engagement plan will likely be reviewed favorably.
  • Would applications that are studying autistic traits be responsive to this initiative?
    • This initiative is meant to focus on autism and diagnosed autism cases. Proposed studies should use autism diagnosis and cases as feasible, however studies can be enriched by using autistic traits in the broader population.  
  • If selected for an award, will the awardee be required to seek prior approval from NIH before disseminating findings or publishing results?
    • No, awardees are not required to seek NIH approval prior to disseminating findings or publishing results from any studies funded through this initiative. 

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