Attachment 17 - Technical Proposal Readiness Checklist for Research Area 002.pdf
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- Solicitation number
- HHS-NIH-NIAID-BAA2026-1
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This document is a Technical Proposal Readiness Checklist for Research Area 002 ("Therapeutic Candidates") designed to assist offerors in evaluating proposal compliance with RA002-specific requirements and exclusions. The checklist is not comprehensive of all solicitation requirements but serves as a pre-submission verification tool to identify missing required data or proposal exclusions.
Checklist 1 establishes RA002 requirements across thirteen critical compliance areas. Offerors must confirm that proposals do not include basic research; disclose complete structures and compositions of lead products and all variants with supporting data; ensure the product candidate has never undergone Phase 3 clinical trials or been incorporated into human or veterinary products worldwide; and verify the product is not a topical antiseptic, serum-derived, or device-dependent. Additionally, proposals must exclude work involving human fetal tissue. The checklist requires documentation of specific preclinical data aligned with the Target Product Profile (TPP), including in vitro potency data, in vitro ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) data, in vivo efficacy data demonstrating therapeutic benefit, in vivo pharmacokinetics data, and in vivo toxicology data. Offerors are encouraged to conduct comprehensive proposal reviews for completeness and compliance with all requirements and exclusions prior to submission.
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| File | Type | Posted |
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| HHS-NIH-NIAID-BAA2026-1 - Solicitation.pdf |
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Research Area 002- “Therapeutic Candidates” - Technical Proposal Readiness Checklists
The following Technical Proposal Readiness Checklist is to aid Offerors in determining if the Technical Proposal meets the requirements and exclusions of Research Area 002-“Therapeutic Candidates” (RA002). It is not a comprehensive checklist of all proposal requirements of the solicitation. If any statement below is not true for the technical proposal, the proposal may be missing required data for RA002 or may contain an exclusion for RA002. The Offeror is encouraged to review the Technical Proposal for completeness and compliance with all requirements and exclusions before submission.
Checklist 1: Applies to RA002 requirements only and does not include general requirements of the solicitation.
☐Basic research is not proposed.
☐Complete structures and compositions of the lead product and all variants for which data are provided are disclosed.
☐The product or a prodrug or salt form has never been in a Phase 3 clinical trial and/or part of a human or veterinary product for any indication in any jurisdiction worldwide.
☐The product is not a topical antiseptic.
☐The product is not derived from serum.
☐The product does not require device development.
☐The proposal does not include work involving Human Fetal Tissue.
☐In vitro potency data consistent with the Target Product Profile (TPP) is provided in the technical proposal.
☐In vitro Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) data consistent with the TPP is provided in the technical proposal.
☐In vivo efficacy data consistent with the TPP and demonstrating “Therapeutic” efficacy is provided in the technical proposal.
☐In vivo pharmacokinetics (PK) data consistent with the TPP is provided in the technical proposal.
☐In vivo toxicology data consistent with the TPP is provided in the technical proposal.
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