Attachment No. 6 - Responses to Potential Offeror Questions_Final.docx

Attachment #6 - Responses to Potential Offeror Questions

FDA-RFP-116104

1. Per section 2.1, via the RFP, the purpose of the contract is to obtain Contractor services for scientific/clinical support for monitoring. However, the pricing schedule lists several Key Personnel under the “Labor Categories”. Please confirm these are just sample personnel vs. expected personnel, as the Principal Investigator is always associated with the site and not the monitor.

A: The personnel listed are for examples and it includes personnel from our previous experiences. We understand that not all categories may suit all businesses. To clarify, CRA I and II (not according to the experience level) are included in case of a blinded study and CRA II is not always necessary. In this RFP, the Principal Investigator is meant as the person who is ultimately responsible for this contract and can be the same person as the manager.

2. Section 2.3 “Description of Work” via the RFP states, the contractor will perform work at domestic and foreign sites. Can a list of anticipated domestic and foreign sites be provided to help determine travel pricing and monitor staffing needs?

A: At this time, the sites for the first two task orders will be in St Louis, MO and Barcelona, Spain. The sites for subsequent task orders will be dependent on other corporative agreements and contracts. With the previous IDIQ contract, we had the sites in United Kingdom, Austria and Australia. Please note that this was provided to give some ideas, and this does not mean that there would be future studies in these countries.

3. Per section 2.3, the contractor will assist in preparing the monitoring plan. Is it possible to provide an estimate on the forecasted number of sites, number of screened vs. enrolled subjects per site, and number of visits per month.

A: We typically have single-center, healthy volunteer trials, and the requested information can differ from project to project. The numbers of enrolled and dosed will vary depending on a trial. With the previous contract, the numbers of target completers ranged from 12 to 64 for interventional trials and about 180 for the observational study. Unless there is a special circumstance, we expect one visit per study per month at most during the active enrollment. With the academic site trials, the visit frequency may be less, and it will be determined based on the enrollment rate.

4. The IDIQ ceiling amount appears to firm at $1,100,000.00 over the course of 5 years ($220,000 per year), yet the monitoring plan has yet to be defined (leaving several unknows when determining a pricing schedule) and it appears there could potentially be numerous protocols/studies. Is there flexibility on this ceiling? Are there any plans to amend the ceiling amount after the protocol(s), monitoring plan(s) and enrollment goals per protocol are defined? a. Ex. #1: Section 4.1 states, “The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit.” A yearly breakdown of $220k scarcely covers the cost of (1) experienced monitor at an average hourly rate of $80, with a modest 50 hours per week (40 work hours/10 travel hours) and modest travel dollar amount of $1,200 to (1) site/ (1)x per month/ (1) night.

A: We intend to issue 2-6 task orders per FY under this IDIQ contract. The budget estimate is based on each task order rather than the annual salary for an experienced monitor. As needed, the budget for each task order will be adjusted, and if it becomes necessary to adjust the ceiling, it will be evaluated at an appropriate time. We are not trying to hire one full time monitor, but rather, would like to issue task orders for our project need at that time.

4b. Ex. #2: Per section 4.1, additional labor categories may be added to this IDIQ contract to support the tasks of this contract. It is foreseeable that additional support will be required as the protocol(s) enrollment ramps up (i.e. Ordering Periods 2-5). Adding labor categories means adding “Labor Rates”. Will the contract ceiling be amended as additional staff are needed?

A: We expected those labor categories should cover most needs, however, if an additional labor category is needed, the justification for the additional labor category and labor rates can be included in the proposal. Please also see answer to question 4a.

5. Please confirm if the estimated labor hours listed on the Pricing Schedule should be listed per week or annually?

A: Annually: The total estimated amount of labor hours needed for the entire ordering period/year.

6. The timeline by which payments will be made to the contractor is unclear. Can further clarification be made regarding when the first and subsequent payments will be issued/received (i.e. Net-30, Net-60, etc.)?

A: Payment schedules shall be established at the task order level. We use Net-30 procedures for invoicing.

7. Please confirm if the FDA/HHS will be sourcing the sites/Principal Investigator’s. Or is the intent for the contractor to propose these?

A: This contract is intended for the monitoring of clinical trials funded by our office. It is not our intention to ask our contractor to propose any study sites.

8. Please confirm if the FDA/HHS will provide experienced Medical Monitors to support the contractor?

A: The FDA project team for each clinical trial includes a Medical Officer.

9. Per section 4.3.3, “In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the CO may verbally authorize performance to commence immediately…” Will the dollar ceiling indicated by the CO be negotiable? Can further clarification or an example situation be provided to clarify this scenario?

A: Whether in an emergency situation or otherwise, the currently stated dollar ceiling shall not be changed until a bilateral modification is executed to change the ceiling amount. The ceiling amount may, at some point, be negotiated in the future in the case a higher ceiling amount is needed as determined by the CO.

10. There are required monthly reports to the CR. Will routine weekly meetings be required as well?

A: No weekly meetings are required, and a monthly meeting to cover all active task orders is expected. However, an ad-hoc meeting may be scheduled if needed.

11. Reports are required to be submitted in a format specified by the FDA/HHS. However, will the FDA/HHS also provide a Data Management team, Electronic Data Capture system (EDC) for sites to enter the data, a Clinical Trail Management system (CTMS) to store: protocol deviations, reports, and letters to the sites, an Electronic Trail Master File system (eTMF) to upload all the essential documents from the sites, and an Integrated Web Response system (IWRS) to track IP shipment, receipt, dispensation, returns, and excursions? a. If yes, will guidance documents/manuals and system training be provided for each (i.e. EDC Completion Guidelines – guidance docs for to sites which tells them what information is required, the minimum information regarding and “If/then scenarios”).

A: This contract is intended solely for the monitoring purpose, and the details as described above will be dependent on a trial site as they are the responsible party for executing the trial itself. The sites will be responsible for providing the necessary training to the CRAs.

12. Will the response to all questions submitted by all prospective contractors be posted for all to view?

A: Yes, all timely received questions by all prospective offerors will be provided a response in this solicitation amendment in public view for all.

13. The RFP states routine and specialized visits may be required at FDA-funded domestic and foreign clinical sites. Please provide a representative list of the foreign countries offerors should assume may have clinical sites requiring monitoring support.

A: Please see answer to question #2 above.

14. Can the FDA please provide an estimate on the number of RFTOPs to be released each year (Y1-Y5) or over the total period of performance (5 years)?

A: The numbers of task orders will depend on the projects and complexities of trials being funded in each FY. Previously, we had 3-5 task orders per year and most span over multiple years.

15. Please provide the anticipated period of performance for the 5-year ordering period (e.g., 9/1/2023 – 8/31/2028).

A: The period of performance will start as soon as possible after contract award, which is currently estimated to be awarded by sometime in early June.

16. Is the Government requesting a consolidated, standalone Word or PDF Volume I – Technical Proposal that consists of the Technical Approach, Relevant Past Performance, and Key Personnel sections that does not exceed 35 pages (i.e., one Technical Volume attachment) OR separate Word or PDF files with one Technical Approach document, one Relevant Past Performance document, and one Key Personnel document (i.e., three separate attachments that make up the Technical Volume)?

A: Answer is already explained in solicitation, no further clarification will be provided.

17. Please confirm the Cover Letter should be submitted as a separate, standalone PDF attachment, should not be included in the Technical Volume, and does not count against the 35-page limit for the Technical Volume.

A: Answer is already explained in solicitation, no further clarification will be provided.

18. Please confirm the roles the FDA expects to be Key for this contract (i.e., Principal Investigator and Manager only; or are CRAs also included as Key)?

A: The Principal Investigator (if not the same as Manager or vice versa), Manager and CRAs are considered as key.

19. We did not see Attachment 2 – Labor Categories Minimum Qualification in the original set of RFP documents. Please provide.

A: Document has been uploaded to SAM.

20. For purposes of developing a Pricing Proposal / budget assumptions, can the FDA provide a sample Task Order so that the offeror can develop an estimation for number of staff needed for site monitoring, number of sites expected, therapeutic indication, and location of sites – whether domestic or international? Currently, there are no budget assumptions noted in the RFP.

A: A part of this has been addressed in the question #2 and 3. Our trials usually require one CRA with a few exceptions. For a blinded study such as task order #1, another CRA will be required for 1 pharmacy visit, however, our studies often do not involve blinding.

Several key points for the budget estimation are as follows:

Take the CRA experience requirement into a consideration

· Follow the HHS travel policy – the policy allows the use of ridesharing service and is expected to be the primary transportation at the site

· One monthly meeting will cover all active task orders and is expected to be less than 1 hour in duration

· One monthly progress report can cover all active task orders and the format can be negotiable

· Quarterly progress report will follow FDA required format

· Kick-off meeting will be about 15-30 minutes for each task order

· CRA is expected to be at the site by noon on the first day

· CRA is expected to travel back on the last day of monitoring

· The required on-site hours are adjusted to allow for the travel time – see the SOW for each task order

· CRA is expected to work for the required on-site hours – if attending meetings for other studies, CRA or CRA manager needs to notify the COR prior to the meetings

· Travel is to be reimbursed at actual travel cost, with a not-to-exceed amount according to FTR and the per diem rates must align with the rates in: https://www.gsa.gov/travel/plan-book/per-diem-rates

21. The RFP includes language around hourly rates and around firm fixed pricing. The Pricing Schedule requests labor rates and hours consistent with T&M. Please confirm the task orders will indicate the agreement type to be either firm fixed priced or T&M depending on the scope.

A: The FDA confirms that the task order will state the contract type depending on the scope of the task order.

22. We noticed that the Table of Contents (TOC) lists certain terms and FDA-Specific Contract Requirements (like 7.7-7.17), but we couldn’t find the corresponding detailed terms in the document. Please clarify if these detailed terms were intentionally deleted or they were accidentally missing and will be added?

A: Please disregard the table of contents as there is a editing error within the document preventing updating the table of contents. If there is a section in the table of contents that is missing in the solicitation, please disregard as it does not apply to the solicitation. The missing sections you highlighted do not apply to this solicitation.

23. What is the anticipated start date of the project?

A: Please see answer to question 15.

24. Is the RFP full and open? Is it set aside for small businesses?

A: Answer is provided in solicitation; No further clarification will be provided.

25. Please clarify if the RFP only requires offerors to provide labor categories and hourly rates in Attachment 1, Pricing schedule. Is it not necessary to include estimated hours for the IDIQ proposal?

If estimated hours are required, for budgeting purposes, how many visits of each type per year should offerors assume?

A: Yes, estimated hours for IDIQ proposal are needed and a column in the pricing sheet is included for this information. Please see answers to questions 2 and 3 for additional information.

26. Is monitoring expected to risk based? Will source document verification be 100%?

A: Our intention is to develop the risk-based monitoring plan with the contractor. Depending on a study and its risk level, the goal for source document verification (SDV) will vary, therefore, 100% SDV is not always expected.

27. Please advise, what is the approximate number of sites included in the scope?

A: Please see answer to question 3.

28. Clinical site monitoring for extramural CDER research in human subject’s research projects includes verification that: the rights and well-being of human subjects are protected; the reported trial data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with the applicable regulatory requirement(s). Please advise what percentage of Source Documentation Verification is expected?

A: Please see answer to question 26.

29. Will any site identification (qualification visit) work be included?

A: No.

30. Will assisting investigative site with pre study regulatory documents be included in the estimate (1572, CVs, Lab Certificated, site level ICF, etc)?

A: No pre-study assistance is intended for this contract, however, the review and assistance of Investigator Site File and/or Trial Master File are expected during and post-study.

31. Will we assist in preparing the training materials and protocol presentations for the initiation visits?

A: Usually no. However, in case when these activities become necessary, it will be clarified in the requirements for each task order or the task order can be modified.

32. Will electronic data capture be used standardly? If so, which system? Please advise if we will need to provide it?

A: The electronic data capturing (EDC) is being used for most studies, but not for all. EDC used will depend on the site. The EDCs for the first two task orders are: Medrio and REDCap.

33. Please advise if there will be any remote monitoring?

A: At this time, we will not know as it will depend on the trial and site. For the first two sites, the on-site visits will be required.

34. Please advise if we should assume all monitoring visits are 100% in person?

A: Please see answer to question 33.

35. Is there a preference which system is used for monitoring reports?

A: No. The monitoring report template will be reviewed and where applicable, some adjustments may be needed.

36. Is there a clinical trial management system used? Will we be expected to populate any of the data?

A: Not currently. If anything changes, it will be addressed for each task order.

37. Is there a target therapeutic area and/or trial phase?

A: No target therapeutic area exists at this time. Most of our studies are Phase I type with a few Phase IV.

38. Will Clinical Site Monitors require any specific qualifications?

A: This was included in the evaluation factor description and SOW.

39. Will a Clinical Site Monitor manager be needed?

A: This will depend on a business. Please see answer to question 1.

40. Is a central document specialist needed to assist in trial master file maintenance?

A: No.

41. Please advise how many hours on site per visit? What is the frequency?

A: It will depend on a trial and please see answer to question 3.

42. Please advise if we will create the monitoring plan?

A: We expect the contractor to draft the monitoring plan and please also see answer to question 26.

43. Please advise if we will assist the site level patient recruitment plans?

A: Not expected unless the site encounters a major challenge in recruitment.

44. Please advise if there any expected percentage for QA visits?

A: It will depend on trials and most visits are expected to be monitoring visits.

45. Please advise what rate of Adverse Events should be assumed? Please advise what rate of SAE should be assumed?

A: It will depend on trials; however, we typically seme minor adverse events with low rates since most studies involve healthy volunteers and generic drugs.

46. Can the Government provide an estimate of the number of anticipated TOs and how many may be international sites.

A: See question 14 above.

47. If taking over an ongoing project, how will the trial master file and historic documents be made available?

A: The ongoing trials will not be transferred to another site. The program office may be involved for the monitoring; however, it is expected to be uncommon unless there is a need.