Biologics consulting vendor questions.pdf

Vendor Questions

1. The solicitation states that the only key personnel will be the single POC (Program Manager) who brings SMEs into a project and that SMEs will be added as key personnel on individual task orders. The SOW describes the qualifications and experience requirements for SMEs.

Is there a separate qualifications criterion for the single POC/Program Manager? Please confirm that this POC/Program Manager doesn't have to meet the SME qualifications and experience requirements.

The Program Manager does not need to meet the qualification and experience requirements for the SMEs. They need to demonstrate experience and training relevant to program management, particularly a history of deploying high-level SMEs for drug development projects.

2. Since the individual task orders issuance timeline is unavailable, and the SMEs would be added only at the task order level, would NIH consider deferring the letter of commitments from SMEs till an appropriate task order becomes available ? This would ensure better candidate availability and reduce risk of churn. Instead, would NIH consider a letter from the proposed SMEs indicating their consent for inclusion, sufficient at the IDIQ stage ?

We apologize for the confusion, but no task orders are anticipated on this contract.

This contract will be a labor hours contract for hours to perform the SME role described in the SOW. NIH will evaluate resumes for relevant SMEs currently available instead of considering potential future SMEs.

3. Since the listed range of SMEs required is quite broad, how many SME resumes are expected to be submitted for phase one ?

NIH expects resumes submitted for all topic areas the offeror can cover with available SMEs.

4. Phase 2 includes oral presentations with personnel (SMEs) who would carry out the projects. Who is expected to attend phase 2 interviews, if a vendor is selected?

POC/Program Manager or proposed SMEs or both ?

NIH expects the Program Manager and as many of the proposed SMEs as possible to join the Phase 2 oral presentations.

5. Given the marked differences between federal and commercial contract delivery, would NIH consider assigning higher weightage to past performances that are with federal customers?

Past Performance is currently a non-scored factor and is therefore not given particular weight that can be adjusted.

Vendor Questions

6. There's a reference to Sample Task Order in the Evaluation Criteria. Maybe we missed it but is that a separate attachment ?

We apologize but that is a typo, there are no sample task orders and updated Evaluation Criteria have been uploaded.

7. Would NIH consider extending the date of submission to COB May 17th ?

Yes, NIH is willing to extend the due date for offers until 5/17.

8. What do these numbers mean besides each task (1,2,3) ?

These numbers refer to the number of times NIH expects to use these options in a given year, though they are only estimates.

9. Could NIH provide some relevant guidance or clarity related to each task to ensure that all bidders are using consistent key assumptions/parameters to develop fixed-price estimates that are fair and reasonable (i.e. not too low) ?

For all regulatory filings, NIH expects vendors to assist project teams with what documents are required, the level of detailed required, review of all packages, meetings with project teams to go over package development, and to assist with ensuring that the necessary data are in place or will be in place before submission.

NIH expects the Principal Investigator from the Sponsor Institution (not the SME and not NIH) to be the primary writer and to be the one to finally submit the package to the regulatory agency. NIH is expecting significant writing could be required as many project teams are new to drug development, but vendors should expect writing to begin with the project teams and that they will not draft regulatory packages wholesale.

10. Can NINDS clarify if the number after each optional task is the estimated number of submissions that will be completed for each “optional task”?

Yes, the numbers are the expected number each year though they are only estimates.

11. Can NINDS clarify if the offeror should provide the fixed unit price to complete each of “optional” tasks listed in rows 21-25? Or, the cumulative total of the fixed unit price x the number of planned submissions?

Please provide the per unit price as they would be exercised individually.

12. Can NINDS confirm the number of submissions the offeror should assume for each optional task in each contract period (Base Period, Option 1, Option 2)?

Yes, the numbers are the expected number each contract period.