D. Comb_Synop_Solicit_Amendment 1.pdf
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- Solicitation number
- 75N95024Q00238
About this file
This document is an amendment to a Request for Quotations (RFQ) for Biological Therapeutics Product Development Subject Matter Expert Consulting Services to Support the Development of Cell and Gene Therapy Products. The RFQ is focused on obtaining Chemistry, Manufacturing, and Controls (CMC) subject matter expertise, though experience with product development projects and leading product development teams is also required. Multiple subject matter experts (SMEs) can be proposed, and the Government will choose SMEs for individual projects based on the specific requirements. The RFQ has a one-year base period with one one-year option period, and the Government will fund an estimated 20 hours per consultant annually, with up to an additional 385 optional hours that may be exercised. The Government will also reimburse up to $2,400 per consultant annually for approved travel. The RFQ is a total small business set-aside with a NAICS code of 541690 and a $19 million size standard. Quotes are due by April 26, 2024, and the evaluation will be conducted in two phases, with oral presentations required in Phase Two for the highest-rated offerors.
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AMENDMENT #1:
RFQ 75N95024Q00238
The purpose of this Amendment is to answer the following questions:
1) Besides referring to a CMC SME, the RFQ in places references need for non-clinical development expertise and project management expertise. Please clarify if the RFQ is limited strictly to requesting a CMC subject matter expert.
This RFQ is focused on CMC subject matter expertise, though experience with product development projects and leading product development teams is required. That experience would create broader expertise in drug development and project management processes considered secondary though complimentary to the CMC subject matter expertise.
2) The expansive request for CMC expertise straddles a number of specialized areas of CMC skill-sets. “Contractor” is considering providing a small team (2 – 3) of CMC SMEs whose combination of skills would sufficiently meet all the CMC requirements listed in the RFQ. The SME(s) would be then chosen for utilization based on the specific request(s) for consulting support at the time of the request(s). Does NIH consider this approach to be acceptable?
Multiple SMEs can be proposed, though each SME would need to meet the requirements of the SOW as consultants are deployed on projects individually and not as teams. It would be expected that SMEs chosen would be assigned to projects and remain on those projects without switching among SMEs attending project meetings.
3) In this solicitation related to biological therapeutics product consulting, you reference the Fiscal Year Executive Level II Salary Rate which is $221K/yr which comes out to $106/hr. If we quote a rate higher than that will it disqualify us for this opportunity due to our billing rates?
No, the Fiscal Year Executive Level II Salary Rate is $221,900 per year. We cannot pay in excess of $221,900 per year.
ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.
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