MIDLIFE Health: Frequently Asked Questions
Is this an NIH grant application?
No. The solicitation, application review, and award oversight are coordinated by Cimit, serving as the RADx® Coordination Center under contract with the National Institutes of Health (NIH). Awards must comply with applicable NIH policies; however, this application is not an NIH grant application and does not count toward the NIH application limit.
Is this a standard NIH R01 application?
No. This program operates through the RADx® Innovation Funnel rather than the standard NIH R01 application process. The final solicitation will specify the funding instrument used by NIH. Due diligence, referred to as the “Deep Dive Assessment”, takes place before award finalization.
What is the “Deep Dive Assessment"?
The Deep Dive Assessment is an interactive due diligence phase for applicants whose proposals advance in the RADx® Innovation Funnel. During this phase, applicants work with the program team to finalize milestone-based work packages with objective go/no-go criteria.
Will I receive feedback on my application?
NIH does not intend to provide Innovators with individual reviews or summaries of reviewer feedback. Innovators who were not selected for RADx support are encouraged to consider other NIH funding opportunities.
Who should I contact if my question is not addressed in the FAQs?
For questions about the program, solicitation, or application, email RADx_MIDLIFE@mail.nih.gov.
Do applicants need to be located in the United States?
Yes. Applicants must have a place of business located in the United States, which operates primarily within the United States, or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor. Organizations should be more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States. All project activities must be performed in its entirety in the United States.
Are foreign subawards allowed?
All project activities must be performed in its entirety in the United States. (The United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia.). Per NOT-OD-25-104, NIH no longer recognizes foreign subawards. Therefore, the only arrangements that will be considered are foreign consultants, foreign vendors or non-monetary international collaborations. These instances will be considered on a case-by-case basis, and they should be discussed with cognizant staff before submitting an application. Whenever possible, work outside the United States, which is necessary to the completion of the project, should be supported by funding other than what is provided in this program.
Are funds available to support projects focused on addressing challenges faced by women in midlife with HIV?
Yes, this program includes $1M funding from the NIH Office of AIDS Research to support technologies relevant for women with HIV.
Does the technology need to have regulatory approval at the time of application?
No, but the submission should describe the anticipated regulatory pathway.
What stage of development should the technology have achieved at the time of submission?
To be competitive for MIDLIFE Health, eligible Innovators must already have developed a working prototype technology with data demonstrating the proof of concept. Innovators will be required to submit detailed descriptions of the current state of the technology and provide sufficient data to demonstrate viability in order to advance through the phases of the competition. Those technologies with the highest potential to be available on the market within the next 3-5 years will be most competitive. Technologies at the design or idea stage will not be considered responsive to this announcement and are unlikely to be selected to advance.
Can the proposed technology be re-purposed from another indication?
Yes, repurposed tools and technologies are acceptable, but solutions must improve women’s midlife health outcomes.
Who retains the rights to any intellectual property generated by a proposal?
Management of intellectual property will be determined by the proposal applicant’s institutional policies.
Should I disclose any unprotected proprietary information in the submission?
Do not include any proprietary information in the Executive Summary as this may be shared publicly if your submission is selected to advance.
Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph. See more detail for the full proposal in the section below. NIH Guidance: 2.3.11 Availability and Confidentiality of Information