BAA 21R00019_ AMENDMENT 3.pdf

Amendment No. 3 to NIH-BAA-75N93021R00019

Amendment to Solicitation No.:

NIH-BAA-75N93021R00019

Amendment No. 3

Issue Date: March 30, 2022

Effective Date:

Proposal Due Date:

March 30, 2022

April 15, 2022 at 3:00 pm ET (UNCHANGED)

Issued By:

Liem T. Nguyen

Contracting Officer

NIH/NIAID

Office of Acquisitions

5601 Fishers Lane

Room 3C11 MSC 9821

Rockville, MD 20852

Point of Contact:

Second Point of Contact:

Name and Address of Offerors:

Anuj Patel, Contract Specialist

Anuj.patel@nih.gov

Liem Nguyen, Contracting Officer

Liem.nguyen@nih.gov

To All Potential Offerors

The cut-off date for questions for this solicitation is set at 3:00 pm ET 04/01/2022.

Offerors MUST acknowledge receipt of the amendment by Amendment number(s) and date of the amendment(s). Failure to receive your acknowledgment of this amendment may result in the rejection of your proposal.

PURPOSE OF SOLICITATION AMENDMENT

The purpose of this amendment is to provide additional answers to questions received regarding the solicitation.

The answers are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related answers. All potential offerors are advised to refer to all previous amendments for additional questions and clarification.

The Government’s answers to questions received regarding this solicitation are as follows:

mailto:Anuj.patel@nih.gov mailto:Liem.nguyen@nih.gov

Question 1: Page 82 (last line, point 3 of the solicitation states “development of biomarkers to predict acute and delayed radiation injuries to major organs/physiological systems in the event of a largescale radiological incident.” It is not clear whether offeror is expected to also cover points # 1 (determine exposure) and # 2 (dose determination) as well?

Answer 1: The offeror is required to determine the intended use of their assay/device and respond accordingly. Pg. 85: Intended use of the biodosimetry signature and/or device in a mass casualty setting; specify if use will be for preliminary, point-of-care triage purposes (within 72 hours), for definitive dose medical management in a hospital setting, or for later post-exposure times (for dose assessment and predicting outcome).

Question 2: In our reading of the exclusion criteria #3 of the solicitation, “Screening activities to identify novel biodosimetry biomarkers and/or assays,” (page 89) refers strictly to assess exposure and dose, please provide your clarification for moving forward.

Answer 2: The BAA is intended for advancement of biodosimetry signature/assays or devices as described on Pg. 85, item 5. A target product profile for lead biodosimetry signature/assay must include….

Activities that do not adhere to these requirements will fall outside the inclusion criteria.

Question 3: Pages 84 and 85 of the solicitation specify Biodosimetry development –the question we have is whether NIAID expects us to cover all 5 points within the scope? Will developing a proposal focused on radiation induced organ injury be considered within scope?

Answer 3: The offeror is directed to Pg. 85, bullet# 5: Intended use of the biodosimetry signature and/or device in a mass casualty setting; specify if use will be for preliminary, point-of-care triage purposes (within

72 hours), for definitive dose medical management in a hospital setting, or for later post-exposure times (for dose assessment and predicting outcome).

Question 4: Is foreign company eligible?

Answer 4: The Solicitation is open to all sources: commercial, non-profit, educational, and hospital and open to foreign organization

Question 5: A company operates using a virtual biotech business model and thus partners with contract research organizations, academic laboratories, and government laboratories to conduct research. Would this situation cause eligibility or other challenges?

Answer 5: The situation described does not cause an eligibility challenge to your company in submitting a proposal in response to the subject solicitation. You are recommended to thoroughly review the solicitation and all requirements.

Question 6: Please provide information regarding the total funds available via this BAA and any other details that might help us define a responsive project scope?

Answer 6: Please refer to page 80 of the Solicitation, last paragraph of Attachment 3 – Broad Agency

Announcement, for funding information. Also refer to Attachments 3, 4, and 5 for details and information on funding related to the subject solicitation.

Question 7: We like to know the detail on budget and period for support. Is it an RO1/R21 pattern award?

Answer 7: Please refer to page 80 of the Solicitation, last paragraph of Attachment 3 – Broad Agency

Announcement, for funding information. You are recommended to review previous

Amendments to the subject BAA for Q&As, published in SAM.gov, for more details and related information.

RO1/R021 is for grant, not contract. The subject BAA is for contract award. You are recommended to thoroughly review the subject BAA for details and information to prepare a proposal in response to the subject BAA.