Q&A for Posting.pdf

# Question Type Answer

Section 4 states “The goal of Phase 1 is the successful prediction of higher-dose, 1 to 4 Gray, exposure and the timeline of exposure, days to months, from at least one (1) TEI-REX sample.” By “sample”, do you mean “sample type” or “model”?

Technical This should state "...from at least one (1) model system." and the BAA has been updated to reflect this change.

Section 4 states that in Phase 2, there will be “a greater variety of exposure time points.” Can you be more specific about what this entails?

Technical This has been updated to state "a greater variety of exposure time points comparative to Phase 1."

The second row of Table 4 lists P1/M1 for “Processed approvals” while Figure 3 (Gantt chart) indicates P1/M3. Is the Gantt chart date correct?

Technical The Processed approvals deliverable date will be changed to P1/M3 in Table 4.

We understand that our proposal should address both FA1 and FA2. Will an award necessarily include an award for both FA1 and FA2? If not, does IARPA expect proposals to be written so that tasking and costs for the two focus areas are severable?

Technical Per the BAA, proposals must address both Focus Areas across all Phases. The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this solicitation and to make awards without discussions with offerors. Proposals should clearly delineate Tasks and Costs by Focus Area and Phase.

Can you provide additional details on the T&E team’s irradiation plan? Or will details be established after the program start? For example, in Phase 1, in generating samples exposed to different doses, will the T&E team vary the dose rate or hold it fixed? Will the T&E team restrict to one gender, age category, etc.?

Technical Details will be established after the program start for Phase 1, awarded performers will be briefed on planned approaches at Phase 1 kickoff. Specific confounders and other exposure variables for Phase 2 will be finalized in coordination with T&E, IARPA, and performer teams prior to Phase 2 kick-off.

We understand that “The baseline for reference samples developed and provide by the program will be hair and skin from human-associated or mouse models.” Is it IARPA’s intention to work with each selected performer to find the appropriate sample/model type based on their proposed method?

Technical Each performer will be expected to select model(s) and sample(s) appropriate to their technical expertise and research proposal for internal validaiton. T&E will provide a majority of standardized samples to all performers. In Phase 1, this will align with hair and skin as written in the BAA.

In Section 8, for blinded Phase 2 T&E samples, the BAA states, “These samples will include at least two (2) sample types across two (2) model systems.” However, in Table 3, the extensibility requirement is listed as “1 Sample / 2 Models”. We expect the table is correct – could you please clarify?

Technical The statement referenced describes a process of T&E while the table references quantitative metric requirements performers are expected to meet.

Can you provide additional details, e.g., supplier, longevity, on the “full-thickness 3-D (mouse/human) constructs primarily derived from commercial sources”?

Technical The specific details of commercial products and constructs will be provided at program kick-off.

Does IARPA have any constraints on sample processing (post non-invasive acquisition), other than those imposed by time-to-answer?

Technical No.

I had a question regarding the outlines for the technical volume, The solicitation mentions a 15 page TECHNICAL PROPOSAL (PROJECT DESCRIPTION) on pg 48, as well as a "Detailed Proposal Information" (Up to 15 pages) on pg. 32, are these the same thing? They're titled and outlined differently.... Also, The table of contents template doesn't reference a "detailed proposal information". Structure

These are the same technical portion, terminology and/or title may be distinct based upon submission via Grants.gov. Proposers should not duplicate these sections and submit following the Volume 1 Structure or grants.gov structure as appropriate.

D.2: Content and Form of Application (Volume 2 Cost) Can the Government provide an estimated start date for the project? Programmatic

IARPA is planning for a kick-off by spring or summer of 2022 but this is dependent upon source selection and negotiations. IARPA expects to award all performers simultaneously.

D.2: Content and Form of Application (Volume 1 Attachment 9: Radiation Research Approval Plan) - Can the Government provide a template for the Radiation Research Approval Plan? Programmatic

There is no template, IARPA and ARO require demonstration that proposed research involving radiation exposures has been reviewed and approved by the research institution as appropriate and safe.

D.2: Content and Form of Application (Volume 1 Attachment 12: Privacy Plan) - Can the Government provide a template for the Privacy Plan? Programmatic

There is no template, IARPA and ARO require demonstration that any research activities which may include human subjects has been reviewed and approved by an institutional review board.

14 D.2.d: Content and Form of Application Submission - Submission of Complete Research Proposals - For Subcontractors with proprietary data, do Subcontractors submit their unsanitized cost proposals directly to the Government using the email address provided: TEI_REX-BAASubmission- 2021@iarpa.gov? Programmatic

No, subcontractors should not be submitting anything separate from the prime's proposal. Any elements which are proprietary, including IP assertions, must be appropriately marked or stated within the proposal. For those submitting outside of Grants.gov, the email referenced is correct.

H.9: Three Chart Summary of Proposal - Can the Government please provide instructions for Chart 2? Instructions are provided for Chart 1:

Overview and Chart 3: Expected Impact. Programmatic

The updated BAA includes additional information associated with Chart 2.

BAA email alias issues Programmatic

Issues identified with the email alias were reported and have been corrected. The BAA alias is correct, all submissions of proposals can be done via TEI_REX- BAASubmission-2021@iarpa.gov