Amendment 01_Solicitation N01DA-21-8957.docx

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In Vitro Metabolism and Non-Clinical ADME Studies
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N01DA-21-8957
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Solicitation Number N01DA-21-8957

Amendment 01

The purpose of this amendment # 01 is to clarify the RFP requirements by responding to questions submitted. Unless specifically noted, all other terms remain unchanged.

1) Question: Would you be willing to reconsider this requirement for FFP bid? Respectfully request that this solicitation be issued in accordance with FAR Part 12 Acquisition Procedures for those companies wishing to propose commercial items responsive to this request.

Answer: NIDA anticipates that this contract will be an IDIQ award with the FFP Task Orders that will be requested/issued as needed; however, contract type is a negotiable item.

2) A Sample Task Order has been included in Attachment 20 of the RFP. An estimate of effort has been provided in Section L.1.d (Page 62) of the RFP for the 14 Tasks included in the Statement of Work (SOW). Please clarify if we need to provide costs for the Sample Task Order AND for the individual tasks from the SOW.

A cost proposal should be submitted for the Sample Task Order (TO) only. Section L.1.d. is provided to give offerors an idea of the overall work that may be requested throughout the life of any resulting contract through issuance of separate Task Orders.

3) If costs need to be provided for the 14 Tasks in the SOW, please provide a period of performance for each task and details on the study designs for each task such as type and number of species, sex, specific subcellular fraction, number of samples, etc., as appropriate.

Cost needs to be provided only for the Sample TO (Attachment 20) and its associated Period of Performance.

4) Please clarify if there is a page limit for the Technical proposal, Business proposal and Sample Task Order.

There is no page limitation.

5) Please clarify the contract type for the Sample Task Order and each Task from the SOW, i.e. if it is fixed price or cost plus fixed fee.

It is anticipated that the Government will issue fixed price Task Orders; however, contract type is a negotiable item.

6) Please clarify if the test compounds will be small molecule compounds or biologicals or both.

The test compounds will generally be small molecules. There may be potential for small peptides, but that is unlikely. Larger biological compounds would be beyond the scope of this requirement.

7) Task 6 states that five (5) different concentrations will be tested. Is this correct? Typically, testing is done at a standard concentration, such as, 10 uM. Please clarify.

Testing should be done at a standard concentration. The SOW will be updated accordingly.

8) Estimate of effort (Page 64/127): How many study samples or number of compounds are anticipated per task for the estimated labor hours?

Each iteration of a particular task would be for one compound. A task order may be for multiple tasks (e.g., 6 compounds for metabolic stability), but the pricing per task should assume one compound.

9) Please confirm the animal species to be used for the studies for Tasks 9 and 10.

For Task 9, the animal species would generally be one of various mouse or rat strains. Other small lab animals (e.g., rabbit) may be more appropriate if needed to correlate to toxicology studies in that species, but NIDA does not anticipate that being a likely request. For proposal purposes, assume the experiments in rodent species at a minimum and higher species would be an added benefit. Task 10 does not involve animal experiments.

10) Per FAR Clause 52.222-49, Service Contract Labor Standards – Place of Performance Unknown, will the Contracting Officer consider wage determinations for North Carolina?

The wage determination for any resultant contract will be appropriate to the location of the contractor’s facility.

11) Article G.3 b. Requesting Task Order Proposals: Will NIDA consider adding the classification of services (severable vs non-severable) to the list of items included in the TORFP?

NIDA is open to this consideration, however, it’s not a common practice.

12) Article F.1 Period of Performance: In light of September being the end of the government’s fiscal year, is it feasible that a more accurate start date for budgeting purposes is October 1, 2021?

The current target award date for this contract is September 19th, 2021 but may be adjusted if needed.

13) Section C. Business Proposal, item 3, b (a) direct labor: If the government intends to issue a FFP delivery order, the request for a time phased break down of labor does not seem to be aligned with the intent and requirements of a FFP contract. Please clarify.

NIDA anticipates an R&D IDIQ award with FFP Task Orders that will be requested/issued as needed. A breakdown of labor is requested for evaluation purposes.

14) Please clarify if the government intends to award FFP or FFP/LOE Task Orders.

NIDA anticipates that this contract will be an IDIQ award with FFP Task Orders, however, contract type is a negotiable item.

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