Autism Data Science Initiative Frequently Asked Questions

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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.  

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. 

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. 

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). 

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). 
  • 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. 

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 invited to submit a full application 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. If you are invited 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.
  • 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. 

Other Q&A #otherqa

  • 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.
  • 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).
  • If we are not academic PIs should we establish a venture proposal?
    • 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.
  • 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.
  • Are this initiative’s full application requirements similar to the standard R01 with respect to significance, innovation, and approach sections?
    • The ROA outlines the requirements for the full application.
  • 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. 
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