BAA 21R00019_ AMENDMENT 1.pdf

Amendment No. 1 to NIH-BAA-75N93021R00019

Amendment to Solicitation No.:

NIH-BAA-75N93021R00019

Amendment No. 1

Issue Date: January 28, 2022

Effective Date:

Proposal Due Date:

January 28, 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: Anuj Patel, Contract Specialist Anuj.patel@nih.gov

Name and Address of Offeror: To All Potential Offerors

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 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 back to all previous amendments for additional questions and clarification.

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

Question 1: Development of MCMs for ARS and/or DEARE. Can testing of novel vitamin D and lumisterol hydroxyderivatives be proposed and showing radioprotective properties against UVB, in the protection against X-ray or gamma radiation?

Answer 1:

The offerors must propose ONE lead MCM that has demonstrated efficacy (either mortality or major morbidity) in a well-established animal model of irradiation that simulate exposure to radiological/nuclear exposures. The PI’s data on UV exposure is NOT aligned with the exposure models requested. Unless the PI has data to demonstrate efficacy as mitigator (NO pre-exposure

MCM administration) using x-, gamma- rays, their product will not meet the inclusion criteria and will be deemed unresponsive.

Question 2: Does the proposal follow the structure of NIH, VA or DOD application?

Answer 2:

Please refer to Section J – List of Attachments and review the related attachments 1, 7, and 8 for instructions in preparing your proposal.

Question 3: Considering overlapping science in radiation and sulfur mustard exposures of skin and lung, if a proposal to demonstrate "clinically-relevant and statistically significant reduction in mortality and/or major morbidity in appropriate laboratory animal models of acute or delayed radiation injury", would it be of interest for NIH/HHS?

Answer 3:

If the offeror does not have background data for radiation efficacy in an appropriate animal model of acute or delayed radiation injury, their application is not suitable for this BAA.

Question 4: Please share more details about this initiative, specifically mechanism of application and timelines?

Answer 4:

Please review the solicitation and Attachments 3, 4, and 5 for more details.

Question 5: In the Opportunity, the contract cost is listed as TBD. When should we expect it to be available?

Answer 5:

The contract costs will be announced in 2023, after awards are issued.

Question 6: Is there an arrangement that would make it possible if a Prime contractor to collaborate with a Federal Agency and its employee?

Answer 6:

If a Prime Contractor receives an award, an Interagency Agreement will be created to transfer funds directly from one agency to the other to cover the cost of the work performed by another Federal Agency/its employee. A contractor may not bill the Government directly for any work performed by another Federal Agency and its employee.

Question 7: Please provide more details regarding the eligibility criteria for this BAA.

Answer 7:

Refer to Attachments 3, 4, and 5 for details and information related to the subject solicitation.

Question 8: Is the Development of Radiation/Nuclear Medical Countermeasures (MCMs) and Biodosimetry Devices (BAA) NIH-BAA-75N93021R00019 call open to foreign organizations?

Answer 8:

The Solicitation is open to the public, including foreign organizations.

Question 9: Is it required to have a US-based partner inside our applicant consortium?

Answer 9: A US-base partner is not required.

Question 10: Please share the complete written description of the eligibility criteria for the Development of Radiation/Nuclear Medical Countermeasures (MCMs) and Biodosimetry Devices (BAA) NIH-BAA- 75N93021R00019?

Answer 10:

Please refer to Section L.2. Instructions to Offerors, section b. Technical Proposal Instructions and also Section M – Evaluation Factors for Award, for further information.

Question 11: What is the budget for this call?

Answer 11:

Please refer to Attachment 3, Broad Agency Announcement Description, page 80/107, last paragraph for the budget information.

Question 12: Is the funding reimbursement-based, or the funds are released on a timeline/deliverable basis?

Answer 12:

The anticipated award will be a Cost-Reimbursement type contract.

Question 13: If we apply by ourselves for the second project and have the company apply with us on the first project? i.e., are contracts awarded to academic labs without an industry partner?

Answer 13:

The solicitation is open to all sources, commercial, non-profit, educational, and hospital. Offeror(s) can propose to address MCM or biodosimetry development. If offeror(s) intend to respond to both goals, two separate proposals must be submitted addressing MCM and biodosimetry, respectively.

Question 14: Is the expectation that we are mature enough to go through GMP manufacture and GLP tox studies fairly soon and if so, is it fair to assume that it is preferable to apply through an industry partner who would shoulder the commercialization responsibility?

Answer 14:

It is expected that the offeror provides a clear path forward to advancing their MCM or assay, and include appropriate entities that can help realize the goals that the offeror proposes in their SOW.

Question 15: Can work under this contract solicitation be carried out by a subcontractor in China?

Answer 15:

Yes.

Question 16: Are there any restrictions to using a Chinese subcontractor and carrying out work in China that are different from using a United States based contractor doing work in the United States?

Answer 17:

Currently there are no restrictions.

Amendment No. 1 to NIH-BAA-75N93021R00019