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Frequently Asked Questions for RFA-HL-14-001 and Recorded Presentation:
Centers for Advanced Diagnostics and Experimental Therapeutics
in Lung Diseases Stage II (CADET II)(UH2/UH3)

To view the recorded presentation for RFA-HL-14-001, see: https://webmeeting.nih.gov/p55596797/

SUBMISSION/RESUBMISSION

Q: Can I resubmit an application that was originally submitted as an R01 (but was not funded) for this FOA?

A: You may submit an application that includes a project that was previously submitted as an R01 if it is responsive to this FOA and none of the work proposed in a CADET application has been funded or submitted to another PHS funding source. (Submissions of identical applications to one or more components of the PHS are not allowed.)

Q: Do I need to submit a letter of Intent?

A: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, it is encouraged as the information allows IC staff to estimate workload and plan the review.

ELIGIBLE APPLICANTS/ ORGANIZATIONS

Q: Other investigators from my organization plan to apply for this FOA. Is there any limit on the number of applications from a single institution?

A: Multiple applications from an eligible organization may be submitted if the proposed science in each application is distinct.

Q: Can I apply for my own grant if I am going to be a co-investigator on a colleague's application for the same FOA?

A: This may be allowable so long as there are sufficient levels of effort committed to each project and there is no scientific, budgetary, or commitment overlap.

Q: I cannot do all of the research (e.g., animal toxicology) at my institution. Can I propose that a toxicology study be done outside my institution?

A: CADET Investigators must conduct at least 40% of the research in the therapeutic development plan at their own institution(s). For any research planned outside of the investigators' institution(s) an estimated cost for the work must be included in the budget. Applications must clearly describe all proposed research even if it will be done outside their institutions. Investigators may identify collaborators outside their institutions or may apply for the use of services provided by the following NHLBI resource organizations: Science Moving towArds Research Translation and Therapy (SMARTT; https://www.nhlbismartt.org/) Program; NHLBI's Production Assistance for Cellular Therapies (PACT; http://www.pactgroup.net/) Program; and NHLBI's Gene Therapy Resource Program (GTRP; http://www.gtrp.org/).

Q: I have already been working with SMARTT. Can I continue to collaborate with SMARTT on my application for this FOA?

A: You may propose to use SMARTT in your application, but work already supported with SMARTT resources cannot be funded through CADET. Your budget must include the cost of any work to be performed through SMARTT. SMARTT staff cannot write your application.

Q: Are NIH intramural programs eligible to apply?

A: The NIH Intramural Programs are not eligible applicant organizations.

Q: I have already been working with NIH National Center for Advancing Translational Sciences (NCATS) scientists. Can I continue to collaborate with NCATS on my application for this FOA and identify NCATS scientists as collaborators?

A: You may propose to collaborate with NCATS. However, NCATS scientists or any other intramural NIH scientist cannot receive funds from your grant and NCATS scientists cannot write or receive compensation for work on your application.

Q: Are foreign institutions eligible to apply?

A: Non-domestic (non-U.S.) Entities (Foreign Institutions) and non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. However, as announced in NOT-HL-13-192, Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Q: I was not part of CADET I. Can I apply for CADET II?

A: Yes.

REQUIREMENTS/ RESPONSIVENESS

Q: I have identified a potential product that may be useful for several lung diseases. Can I use CADET to determine which disease the product is most likely to be used for?

A: A product without a specific target or a target that is ubiquitous and not clearly related to the biology of a specific lung disease would not be appropriate for CADET.

Q: I have a product to deliver drugs to the airway. Can I develop the product in CADET??

A: Applications must include a product development plan for at least one therapeutic product for use in a pulmonary disease or sleep disordered breathing. "Product" refers to a substance intended to be used for therapeutic purposes, such as a drug or biologic, but not a device or test/assay.

Q: I want to use an available chemical that is not widely used, but I did not create it and the patent expired. Can I develop the chemical as a therapeutic for lung disease?

A: Most applications for CADET will include a therapeutic product that is novel as defined in the FOA. Specifically, a product with an existing IND (for any indication) or one previously studied or widely used, even if an IND has never been filed, will not be considered novel.

If the therapeutic product is not novel (i.e., it has been studied, widely used, or has an existing IND), the project in the CADET application must include a product that will require a new IND because it will be used for a new indication and in a "target" patient population defined by disease biology using a novel diagnostic test. Using a product with an existing IND and merely changing the indication (a different disease or outcome) or combining existing products is not sufficiently "novel" to be considered responsive to this FOA.

Q: There is an approved drug, widely used for another indication, that modulates a pathway I recently showed was important in a lung disease. I want to use the existing drug to treat the lung disease, but need to determine the dosing and toxicology of the drug for the lung disease. Can CADET be used to fund this pre-clinical development?

A: Applications for CADET should include a therapeutic product that is novel. A widely used drug will not be considered novel, even if used in a different disease.

Q: I want to use an available chemical for which someone else (or an organization) owns the intellectual property. Can I develop the chemical for lung disease treatment?

A: If the therapeutic product is not novel (i.e., it has been studied, widely used, or has an existing IND), the project in the CADET applications must include a product that will require a new IND because it will be used for a new indication and in a "target" patient population defined by disease biology using a diagnostic test.

CADET requirements do not stipulate who must own the intellectual property. All applicants should consult with their institution's legal authorities to plan for how intellectual property resulting from the research will be protected.

You must demonstrate (through a letter of support) that you have access to the chemical for the proposed research.

Q: I want to study a product to affect the lung's response to infection. Could I propose to study the product that would affect a lung disease that is caused by a pathogen?

A: An application focused on a therapeutic product to alter the host response (and consequent lung disease) would be acceptable. However, a project focused on the microorganism, rather than lung disease, would not be acceptable.

Q: I have created a potential therapeutic agent that inhibits a pathway that is sufficient but may not be necessary for the development of a specific lung disease. I do not know if this will affect a clinically relevant and detectable outcome. Can I apply for CADET?

A: Research activities that are required in the interval of product development between target validation and IND filing are appropriate for CADET support. "Target validation" refers to the identification and demonstration that a target has a sufficient role in disease biology to impact a clinically detectable and significant aspect of the disease. Therefore, you will need to present evidence that modulating the pathway in question will affect a relevant clinical outcome.

Q: I am nearly ready to submit my IND. Can I propose first in human studies in CADET, assuming I complete the pre-clinical work and my IND is acceptable?

A: Applications will be considered non-responsive to this FOA if clinical trials are included.

Q: Can I use previously collected human tissues that may be linked to an individual for research in my CADET application?

A: Research may be conducted on human specimens if previously collected. However, CADET will not support the collection of new specimens or epidemiological and behavioral studies, outcomes research or health services research.

BUDGET

Q: I cannot do all of the necessary toxicology studies to develop the candidate therapeutic I have identified. How should I estimate the cost and time the studies will take? Do I have to find a collaborator or a vendor to do the work?

A: You may propose to work with any appropriate collaborators, including resources such as the SMARTT program (https://www.nhlbismartt.org/) for the research you propose. Your budget must include an estimate of the time and cost of all research you propose in your application, unless it is funded by an alternative source. You should make an estimate of the time and cost by contacting entities that provide the services you need and/or establishing collaborations with needed service providers.

Q: Do we need to obtain permission to apply for funding over $500K?

A: Permission to submit an application requesting $500K or more in direct costs does not apply to applications submitted in response to this FOA which includes specific budgetary limits.

Q: Can I collect data or obtain human specimens that may be linked to an individual for research in my CADET application?

A: CADET will not support the collection of new specimens or data from human subjects. However, such specimens and data may be used if collected with a funding source other than CADET.

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