Amendment_2_-_RFP_75N93022R00017_0002.pdf

AMENDMENT #2 BAA No. 75N93022R00017 1

Amendment No. 2 RFP No. 75N93022R00017

“RATIONAL SYSTEMIC CHARACTERIZATION AND SELECTION OF ADJUVANTS

FOR HIV VACCINE CANDIDATES (R-CASA)”

Solicitation Number: 75N93022R00017

Amendment Number: Two (2)

Amendment Issue Date: April 26, 2023

Proposal Due Date/Time: July 7, 2023, 04:00PM EDT (Unchanged)

Issued By: Kishan Patel

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY patelki@niaid.nih.gov Kishan Patel, Contracting Officer Phone: 204-669-5157

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment is to provide responses to questions from potential offerors, regarding the solicitation.

1. Since there is a 1-year period between the submission date and the data of the award, can Offerors submit additional preliminary data as it's generated during the review period?

AMENDMENT #2 BAA No. 75N93022R00017 2

RESPONSE: Please refer to Section L- Instructions, Conditions, and Notices to Offerors, Subparagraph, a. Instructions to Offerors--Competitive Acquisition Far 52.215-1 (Nov 2021) of the BAA.

2. On page 108 of the solicitation (Attachment 7, Section 4), "Immunological Characterization" point 2 instructs: "Provide a rationale for down-selection (go/no-go criteria) for up to 5 formulations to further investigation in animal models." Does this mean that this contract will only cover the testing of 5 immunogen-adjuvant formulations in any animal model, including mice? This seems unusually restrictive and would appear to contradict the solicitation's stated goal to "select HIV immunogen-adjuvant formulations via qualified parameters," since current in vitro assays are poorly predictive of in vivo results.

RESPONSE: In Section 4: Technical Discussions, subsection, Technical Approach, the solicitation requests the identification of “up to ten (10) HIV immunogens, plus reference immunogen(s) and up to ten (10) adjuvants, plus reference adjuvant(s), for initial screening. Describe the detailed scientific rationale, technical approaches, proposed methodologies and data analysis tools, and proposed plans and procedures for achieving the objectives of Sections A (Biochemical Characterization), B (Immunological Characterization), and C (Data Analysis) outlined in this solicitation.”

In Section 4: Technical Discussions, subsection B., Immunological Characterization, you will find “in vitro studies using cell lines, primary animal and/or human cells, and/or organoids” can be employed to characterize immune profiles.” Animal studies can also be employed. The offeror’s rationale should reflect the planned strategy for the down-selection for further investigations in animal models.

END OF AMENDMENT NO. 2, RFP No. 75N93022R00017