RFA-TS-25-036 Questions and Answers.docx

RFA TS25-036 Questions and Answers

1. Can Objective One (i.e. identify potential risk factors for ALS in humans) contain a combination of epidemiological and genetic investigation? Or does it have to be purely epidemiological?

Objective One can be a combination of epidemiological and genetic investigation, but it must have epidemiological data. As found in Section III. Eligibility Information; 5. Responsiveness (page 20 of the NOFO), the application should include as the primary research aim, a human health epidemiological investigation to identify and evaluate ALS risk factors from human ALS epidemiological data sources.

2. To confirm, is it okay to use laboratory animals to evaluate and characterize the potential environmental factors and/or genes identified in Objective One? Or would there be a preference to do this using cultured human cells. It’s hard to determine this from the current NOFO.

As found on page 20 of the NOFO (Section III: Eligibility Information; 5. Responsiveness), animal models are allowed as long as there is a provided justification on how it will support the epidemiological investigation of human ALS through the use of a human ALS epidemiological registry. An application that includes sole research on animal models will not be considered responsive. Requirements for responsiveness to this NOFO involve human epidemiological data as part of the research study. The primary purpose of this NOFO is to conduct studies to identify potential risk factors for ALS in humans including, but not limited to, environmental risk factors and traumatic brain injuries (TBI) as found on page 10 of the NOFO (Section I: Funding Opportunity Description; 2. Approach).

3. Are US territories (Puerto Rico, USVI, CNMI, American Samoa, Guam) and/or freely associated states (RMI, Palau, FSM), also known as T/FAS, are eligible for RFA-TS-25-036?

T/FAS are eligible to apply for this NOFO. Please see Section III: Eligibility Information for additional eligibility criteria. Please note that Applicant principal investigators are required to provide documentation of their experience in conducting human epidemiological and environmental, ecological empirical research on ALS risk factors. Per Section I: Funding Opportunity Description > 1. Background and Purpose of this NOFO found on page 8, CDC/ATSDR is seeking investigator-initiated research that will identify and evaluate risk factors contributing to ALS, with preferred focus on research proposals that will examine factors related to military service, contact sports, traumatic brain injury, neuroinflammation, and infectious agents.

4. Is animal work supported under Option B of this RFA?

Applicants may use human ALS or ALS-like animal models (e.g. SOD1 or TDP-43 mouse models or other mammalian) in their research plans as appropriate for their research proposals. Applications using animal models must clearly describe and justify in their research plan how the animal model will be used to support the primary human epidemiological investigation to identify and evaluate potential risk factors for human ALS through the use of a human ALS epidemiological registry. Applications proposing research on ALS risk factors in non-human species, including mammalian animal models, as the primary aim of the proposal will be considered non-responsive and will not be forwarded for peer review. Please see page 20 of the NOFO (Section III: Eligibility Information > 5. Responsiveness) for more information.

5. Where can the full announcement be found?

More information about the grant opportunity can be found here on grants.gov under the opportunity number RFA-TS-25-036. The full announcement can be found under section “Related Documents” which provides additional guidance for applying and navigating the application process.