Q&A.pdf

Questions and Answers – 75N98019R00005

Number Question Answer

1 Does the RFP include making of Hazardous drugs for this clinical trial?

Task Orders may include requirements for Hazardous drugs and controlled substances;

however, these capabilities are not a requirement for receipt of an IDIQ contract. In accordance with the revised proposal instructions, offerors should indicate hazardous drug and controlled substances capability in its proposal.

Could a collaborative environment be considered and based on the technical strengths from each selected organization (i.e., small business and institution)?

Offerors are responsible for determining their teaming partners. The Government will evaluate proposals in accordance with the evaluation criteria in section M.

Further, once a contractor has been selected for an award, could the NIH officer directly proceed with the work task delegation between collaborators?

Successful prime contractors will be responsible for delegation of work within their teams.

"Studies conducted under this Sample Task Order shall be used to conduct process development to establish formulation as a solid dosage form or injectable form..." To me this implies "either solid dosage form or injectable form" not both. Please advise, as the facility settings are completely different.

Correct. Offerors should submit separate, complete proposals for sterile and non-sterile manufacturing. The proposals shall be evaluated individually.

The Government will not cross reference the proposals to verify required information.

The target dosage form is not clearly defined in the Solicitation # 75N98019R00005. Are we required to submit proposal for both non-sterile and sterile dosage forms?

No. Offerors are not required to submit proposals for both;

however, they may choose to assuming that they meet the eligibility criteria for both.

The RFP on page 66 paragraph 2, requests a Technical Proposal Cost Summary, the form of which is referenced to be in Section J as a downloadable attachment. However, that form is not listed in Section J. Is the Technical Proposal Cost Summary form required? If so can we attach it as an Appendix to the Technical Volume which is not counted against the page limit?

Please see the revised proposal.

The amendment indicates that separate proposals should be submitted for each part. Is it correct to assume that “separate” means:

1) For non-sterile dosage forms :

a. A twenty page (max) Technical Proposal with plan for Sample Task Order # 002-1

b. A corresponding twenty-four page (max) Appendix I, and

c. A business proposal

2) For sterile dosage forms:

a. A twenty page (max) Technical Proposal with plan for Sample Task Order # 002-1

b. A corresponding twenty-four page (max) Appendix I, and

c. A business proposal

The above allows a total of 40 pages for two separate proposals.

Correct, each proposal can include the full number of pages outlined in the limitations;

however, the page limitations have been revised.