Amendment 1 - BAA-75N93022R00021.pdf

Amendment No. 1 to BAA-75N93022R00021 “Development of Radiation/Nuclear Medical Countermeasures (MCMs) or Biodosimetry Devices”

Amendment to Solicitation No.: BAA-75N93022R00021

Amendment No.: 1

Issue Date: January 24, 2023

Effective Date:

Proposal Due Date:

January 24, 2023

February 27, 2023 at 3:00 p.m. (EST)

Issued By: Emily Bannister Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane, MSC 9821 Rockville, MD 20892-9821

Point of Contact: Albert Nguyen, Contracting Officer nguyenal@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remain unchanged. Offerors must acknowledge receipt of this amendment. Failure to provide your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to the solicitation and its amendments for additional Questions & Answers.

Question 1: The Period of Performance is listed as "TBD" and the Estimated cost is TBD. Does this mean that guidance will be provided to organizations submitting proposals before the due date on Cost and Period? Or is the organization supposed to propose a Period and Cost that is associated with the work to be carried out in the Proposal?

Response 1: The anticipated start date and total period of performance outlined in ATTACHMENT 3:

BROAD AGENCY ANNOUNCEMENT DESCRIPTION, page 102, of the solicitation quoted below.

“It is anticipated that 1-2 cost reimbursement, completion type contracts will be awarded for a 3-year period of performance beginning on or about March/April 2024.

NIAID estimates that the annual total cost (direct and indirect costs combined) for a non-severable base period and each subsequent, non-severable option period will average $2 million, for a total award of $6 mailto:nguyenal@niaid.nih.gov million over three years. However, it is anticipated that the total cost for any award may vary depending upon the scope of the project and the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance proposed by an offeror shall not exceed 3 years.”

Question 2: Can you kindly confirm that applicants to the BAA for the development of Radiation/MCMs or Biodosimetry Devices can work with a government entity, i.e. a government laboratory, if these services are available to all interested offerors?

Response 2: Prior to receipt of proposals, procurement integrity regulations prohibit us from rendering judgement on the specifics of any potential proposal beyond reiterating what is stated in the referenced

BAA:

Other than those detailed in the Government Furnished Property clause or otherwise publicly available, the Offeror shall not propose government furnished resources, to include government employees, facilities, intellectual property, or biological materials. If you propose government furnished resources, your proposal will not be considered further for award.

However; in general terms, a Government entity (such as the Uniformed Services University) cannot serve as a subcontractor on a Federal Government contract. A non-Federal entity cannot bind a federal entity as a subcontractor under a Federal Government contract issued by a separate Federal entity.

Question 3: Can a foreign private company benefit from this contract and what would be the conditions?

Response 3: There are no exclusions from receiving proposals from an international institution as long as the entity is in good standing with the U.S. Government and the entity is not a Prohibited Source. Please refer to SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS for details on submitting a proposal.

Question 4: The BAA states (Article B.2.) that “The estimated cost of the Base Period of this contract is To Be Determined.” Can you provide a rough and non-binding estimate of the range of potential funds that would be available for a successful proposal?

Response 4: Please refer to Attachment 3 page 102 of the BAA. I have copied the excerpt below for reference.

“It is anticipated that 1-2 cost reimbursement, completion type contracts will be awarded for a 3-year period of performance beginning on or about March/April 2024.

NIAID estimates that the annual total cost (direct and indirect costs combined) for a non-severable base period and each subsequent, non-severable option period will average $2 million, for a total award of $6 million over three years. However, it is anticipated that the total cost for any award may vary depending upon the scope of the project and the technical objectives of the award. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance proposed by an offeror shall not exceed 3 years.”

Question 5: Can NIAID clarify if the definition of ‘concept feasibility’ is intended to mean that the capacity to assess levels of radiation exposure within ± 0.5 Gray applies to a single device, and that ‘concept feasibility’ definition for a single or panel of biodosimetry biomarkers means they must be able to assess…the extent of tissue injuries from ionizing radiation as early as 24 hours post-exposure? Or is the intent that for either a biomarker panel or a single device, either must have demonstrated both the capacity to assess levels of radiation exposure within ±

0.5 Gray (Gy), and the extent of tissue injuries from ionizing radiation as early as 24 hours post-exposure? Given that tissue injury varies by individual and does not always directly correlate with a quantitative dose level, we believe it is the former of these two interpretations but would like to confirm.

Relatedly, later in the RFP (Attachment 5, page 3), it states that Definitive care diagnostic devices for the measurement of absorbed dose must measure the extent and intensity of radiation injuries within a time-window of 7 days post-exposure to help determine the type of medical intervention that is needed. In addition, the device should accurately and precisely measure absorbed radiation exposure levels to the body and/or tissues within ±0.5 Gy. Can we assume a similar interpretation here as well? Further, since the language in the RFP says ‘…the device should accurately…’ [underline added] but does not say ‘must’ as used elsewhere, we interpret this aspect to be desirable but not a firm requirement. Please confirm.

Response 5:

The concept feasibility definition depends on the context of use and there are three possibilities for BioD:

triage, definitive dose, and tissue injury. If tissue injury is the context of use, then the +/-0.5 Gy is not relevant since this is a qualitative approach. However, +/-0.5 Gy would be relevant for a definitive dose assay/device since it is specific to a dose and has a quantitative number assigned. In short, tissue injury varies by individual and does not always directly correlate with a quantitative dose level; therefore, the aspect of +/-0.5 Gy does not apply.

Question 6: Is the subject BAA a one-time solicitation or do you anticipate this BAA to have multiple opportunities to submit a response (e.g., rolling BAA)?

Response 6: This is not a rolling BAA—please note the deadline for proposals on sam.gov.

Question 7: Would these modifications of an existing Laboratory Developed Tests (LDT) to be responsive to a mass casualty event’s Conops and the RFP?

Response 7: The requirements for a triage biodosimeter can be found on page 107. In short, point-of-care triage purposes (within 72 hours) should distinguish between exposed and unexposed populations with a sample-to-answer time of 30 min or less. The decision to pursue an LDT vs IVD is a business decision and something to discuss with the regulatory agency. Guidance - Framework for Regulatory Oversight of 7 Laboratory Developed Tests (LDTs): https://www.fda.gov/media/89841/download. The RESEARCH and TECHNICAL OBJECTIVES can be found on page 105-109 and exclusions are listed on page 110.

Question 8: Can we ask for non-human blood acquisition in this RFP? There are no interventions just anonymous non-traceable specimens. Further, would that be judged as a significant strength or a weakness?

Response 8: Ex vivo studies using human samples are still human; please see inclusions starting on the bottom of page 107 of the BAA, which allows for ex vivo studies using human samples. All proposals undergo peer-review; criteria for technical evaluation can be found on page 96 of the BAA.

Question 9: If the cooperating subcontractor is willing to cost share, would that be something you would encourage?

Response 9: Cost Sharing is allowable for contractors and subcontractors. The cost sharing with any subcontractor would be outlined in the agreement between the Prime Contractor and its subcontractor.

Question 10: Is small disadvantaged business participation one of the factors used to evaluate a proposal?

Response 10: The Government will evaluate proposals in accordance with the factors set forth in PART IV, SECTION M of this RFP beginning on page 91 of the BAA.

https://www.fda.gov/media/89841/download