Amendment 1(Final).pdf

AMENDMENT #1:

RFP 75N95023R00020

The purpose of this Amendment is to:

(1) Clarify that all questions regarding the solicitation, of a contractual nature or technical nature, must be submitted in writing via email to samson.shifaraw@nih.gov, no later than May 26, 2023, 3:00 PM, Eastern Time. All questions, as well as the Government's responses, will be posted to SAM.Gov.

(2) Replace the definition of “DEC” on pg. 43 as follows:

DEC means the Determination of Exceptional Circumstances signed by The National Institutes of Health (NIH), Office of Acquisition and Logistics Management (OALM) on May 12, 2023 and titled "NCATS Division of Pre-Clinical Innovation DEC."

(3) Revise Attachment 1-Packaging_and_Delivery_of_Proposals-Section II(B)(1), and (3) to reflect as follows:

1. The total page count of the technical proposal shall not exceed 50 pages per Technical Area, and 150 pages in total.

3. Each Curriculum Vitae (CV) shall not exceed 2 pages and will be included in the total page count.

(4) Replace Attachment 4-SampleTO_Area1 with Attachment 4-Revised_SampleTO_Area1(5.18.23)

(5) Clarify in Attachment 7-Additional_Technical_Proposal_Instructions_5.9.23, that the total page count of the technical proposal shall not exceed 50 pages per Technical Area, and 150 pages in total.

(6) Answer the following questions that were received during the period of May 12-15, 2023:

Q: Is it a requirement to be able to supply services for every aspect of the RFP or is a “No Bid” section permitted?

A: It is not necessary to bid on all three technical areas. It is entirely acceptable to propose on only one technical area, and that does not put an offeror at a disadvantage. Our expectation is that many vendors specialize in only one or two areas at the most. Each technical area proposed upon is evaluated on its own merits. We expect to make multiple awards within each technical area so that the Government has a roster of qualified vendors to serve the needs of each technical area. See Attachment 7-Additional Technical Proposal Instructions, and Attachment 12-Additional Business Proposal Instructions for additional guidance.

Q: Wondering if you have a detailed RFP, meaning the chemistry part of the deliverables for this request?

All I saw was the general information in the documents. I am looking for specific product or chemical structures, quantities, qualities, timelines, etc.

A: The more specific technical details are to be found in the Sample Task Orders. One Sample Task Order is provided for each Technical Area, and they are to be found in Attachments 4, 5, and 6. Please note that Sample Task Order 1 was revised via this Amendment. See “Attachment 4- REVISED_SampleTO_Area1(5.18.23)”.

AMENDMENT #1:

RFP 75N95023R00020

Q: Will you be able to share the current process and chemical structure of the molecule?

A: There is no specific compound structure or detailed, step-by-step synthetic scheme, but additional clarifying details are now provided. Please note that an offeror’s response to the Sample Task Order is not meant to contain a highly precise cost estimate directed to a defined molecule / therapeutic candidate per se (e.g., costs of specific raw materials) or to include a fully realized proposed cGMP process. The Technical Evaluation Factors (Section M.), provide more details about how the responses to the Sample Task Orders will be evaluated. In brief, the response will be used to assess the offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach. The additional clarifying details should help offerors frame their response and provide a basis for estimating key cost elements (e.g., labor, potential process improvements).

Note that all questions raised between the period of May 16-26, 2023 will be answered by the Government by June 2, 2023 via another Amendment.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.