Frequently Asked Questions

Frequently asked question information will be updated periodically on a rolling basis. 

Check out the technical assistance webinar for more details about this research opportunity. 

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General Information

Key Dates

Eligibility

Other Transactions (OT)

Other FAQs

General Information #geninfo

• What is the title of this Research Opportunity Announcement (ROA)?
  • Computational Modeling of Hormone Homeostasis (OT2)
• What is the Announcement Number of this ROA?
  • OTA-26-004 
• What is the purpose of this announcement?
  • The purpose of this announcement is to invite applications from eligible organizations to support the Computational Modeling of Hormone Homeostasis, a milestone-driven research initiative. With significant community involvement and input, this initiative will advance the development of in silico computational approaches that model and simulate human hormone homeostasis, with an emphasis on applicability to sex-specific efficacy and toxicity evaluation of therapeutics.
• 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 Computational Modeling of Hormone Homeostasis initiative Team: [email protected] (Subject line must include “Computational Modeling of Hormone Homeostasis”). If you have questions about Other Transactions, please reach out to [email protected] (Subject line must include “Computational Modeling of Hormone Homeostasis”).
• Can I request a meeting with an NIH program official to discuss my application?
  • 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 Computational Modeling of Hormone Homeostasis initiative Team [email protected] (Subject line must include “Computational Modeling of Hormone Homeostasis”). 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?

• Are Letters of Intent (LOI) required?
  • Yes, LOIs are required to submit a full application. Select applicants will receive an Invitation to Submit a full application following LOI review. 
• Will applications without LOIs be accepted?
  • No. Applications will only be accepted following successful competition of the corresponding Letter of Intent and must include a copy of the Invitation to Submit.
• Will late applications be accepted?
  • No. Late applications to this ROA will not be accepted. As a result, you are strongly encouraged to use the “Preview” option within ASSIST to review your application and ensure all attachments integrate into the final, combined pdf prior to submitting.

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Eligibility #eligibility

• Are non-domestic Entities eligible to apply?
  • Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.
• Are non-domestic components of domestic organizations eligible to apply?
  • Non-domestic components of domestic organizations are not eligible.
• Are foreign components of domestic organizations eligible to apply?
  • Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
• Are public or private non-domestic entities eligible to apply?
  • Any public or private non-domestic entity is ineligible to apply for this program as a primary applicant. Additionally, any non-domestic components of U.S. Organizations are ineligible to apply for this program as a primary applicant. 
  • Public or private non-domestic entities and non-domestic components of U.S. Organizations are eligible to be listed as sub-contractors/recipients, so long as they are not excluded from applying for Federal programs throughout the U.S. Government (unless otherwise noted) and from receiving certain types of Federal financial and nonfinancial assistance and benefits.
• Are applications eligible for an award if applicants do not receive an Invitation to Submit a full application following LOI review?
  • Letters of Intent (LOIs), due by the “Letters of Intent Due Date” as shown within the "Key Dates" section above and within the ROA, are required. Select applicants will receive an Invitation to Submit a full application following LOI review. Only these full applications will be considered for an award.

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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)(c). 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 SMEs 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 full 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-26-004). 
• 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. 
• Does submission of a full application imply acceptance of the Terms and Conditions?
  • Submission of a full application does not imply acceptance of award Terms and Conditions. NIH intends to negotiate with applicants on the specific Terms and Conditions of the award. 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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Other FAQs #otherfaq

• Is there a preferred data source? 
  • No, the NIH does not have a recommended or preferred data source for this initiative. Applicants are free to use any relevant data consistent with the requirement (See Requirement – ROA) 
• Am I responsible for managing subrecipients?
  • Yes. The Recipient of the OT award is responsible for successfully achieving the project milestones as negotiated with NIH, as well as for managing its relationships and agreements with subrecipients and other partners (both domestic and/or foreign). The terms negotiated in the OT agreement flow down to subrecipients, and the Recipient is responsible for ensuring that all subrecipients comply with applicable requirements. 
• Is the individual serving as Project Manager/Director (PM/PD) for the project expected to have a Ph.D. or faculty appointment?
  • This individual must have relevant scientific expertise and project management experience to support the PI(s) and goals of the project. This individual must commit at least 50% level of effort to the proposed project. It is the responsibility of the applicant organization to select the individuals who have the appropriate expertise to manage the scientific and administrative aspects of the project. 
• Does the PI for the proposed project need to be a U.S citizen?  
  • NIH requires the applicant to determine that individuals' visas will allow them to remain in this country long enough for them to be productive on the research project, but NIH does not provide guidance on or assess the different types of visas. NIH expects recipient organizations to have policies, consistently applied regardless of the source of funds, to address this area. 

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