RFP-2012144 - Amendment 2.pdf

RFP NIAID-DMID-NIHAI2012144

Amendment #2 (07/23/2012) Page 1 of 9

Amendment #2

“VACCINE AND TREATMENT EVALUATION UNITS (VTEU)”

Amendment Issue Date: July 23, 2012

Proposal Due Date/Time:

September 27, 2012., at 3:00 P.M., local time

[Unchanged]

Issued By: Michael C. Finn

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

ryanes@niaid.nih.gov

E. Shane Ryan, Contract Specialist

Phone: 301-451-3692

SECONDARY:

aileene.mitchellford@nih.gov

Aileene Mitchell Ford, Contracting Officer

Phone: 301-496-7288

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted. Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal.

The hour and date specified for receipt of proposals HAS NOT been extended.

General Notes;

1. Offerors should develop the Task Order B-1 protocol using the DMID greater than minimal risk template. This should be include as an attachment to the Technical Proposal and will not count toward the 200 page limit. All other responses to the sample Task Orders should be included in the Technical Proposal and be included in the 200 page limit.

2. Section J, Informational Attachments is amended to include link as attachment 33: (referred to on page 46) “SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS”; http://oamp.od.nih.gov/DGS/rc.html

3. It is anticipated the Government will issue an IDIQ contract with a seven year ordering period and ten year completion date. This means the Government can place task orders with awardees during the seven year ordering period. Years eight thru ten will allow the awardees time to mailto:ryanes@niaid.nih.gov mailto:aileene.mitchellford@nih.gov http://oamp.od.nih.gov/DGS/rc.html

Amendment #2 (07/23/2012) Page 2 of 9 complete task orders placed during the ordering period. The Government will NOT issue any new task order after the seven year ordering period.

4. Offerors should provide a summary of proposed costs based on the sample task orders, additional technical and business instructions as given in the RFP. The summary of proposed costs should provide the details as stated in the RFP for performing each sample task order one time. Offerors should use the NIH provided spreadsheet to meet this requirement.

FAQ’s and RESPONSES

1. In the Statement of Work, Attachment 3, Task Area C, 2.C.1 The RFP states that the contractor will collaborate and coordinate with the DMID and SDCC in the analysis of final study data. Can the

Government further define the scope of this activity for the contractor?

Response: The offeror, SDCC, and DMID are responsible for preparing the final study report. The offeror is expected to work with the protocol team to determine the analysis that will be performed, determine which tables and listings to include, interpret data/results, complete technical sections of the CSR, and review draft completed CSRs.

2. In the Statement of Work, Attachment 3, Task Area C, 2.A. 7, The Government requires the Offeror to participate in SMC, DSMB and related committee oversight meetings. Section M.3.d states the

Offerors plan must include a general description of the DSMB plan for all clinical trials. Attachment

4 states that the Safety Oversight Structure will be established by the DMID. Can the Government confirm that the Contractor’s role in Safety Oversight will be to define the plan if awarded Task B, and that the DMID will execute the oversight committee?

Response: Correct.

3. The RFP states that for domestic clinical trials and clinical studies the Contractor is not anticipated to serve as the IND sponsor. Can the Government confirm that they anticipated that there are no circumstances during this award that the Contractor will be expected to maintain responsibilities as the IND sponsor. If so, can the Government describe these circumstances?

Response: The Government does not anticipate any circumstances where the contractor will maintain the responsibilities as IND sponsor.

4. Will Qualification visits be performed for each of the sites in the scope of monitoring visits?

Response: The Government does not anticipate qualification visits.

5. Section M, 5, A Requires the Offeror to demonstrate their ability and capability to perform clinical site monitoring (including ISM and SMC members and interactions). Can the Government confirm that CROMs will be performing monitoring in the form of site visits and source verification and the

Contractor’s role in this is to support this activity? Will the contractor be required to develop the

Monitoring Plan? In respect to safety oversight and ISM and SMC members and interactions, is the

Offeror to include in their plan the type of members for SMC or is the requirement to be interpreted otherwise?

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Response: CROMs will be performing monitoring and the Contractor’s role in this is to support this activity; the contractor will not be required to develop the Monitoring Plan; the Offeror is to include in their plan the type of members for SMC.

6. In the Statement of Work, Attachment 3, Task Area C, 2.A.2, can the Government specify if these initiation visits are held on site or is there a requirement for an Investigator Meeting where in the conduct of a multicenter trial the contractor is responsible for coordinating these meetings?

Response: The type of meeting will be protocol specific. The uniformed cost assumptions indicate how many of each type of meeting(s) the offerors should assume will be held.

7. In the Statement of Work, Attachment 3, Task Area C, 2.A.3. b, it states that the Contractor shall assist with the preparation of all FDA required documents and reports and participate in meetings with regulatory agencies. Can the Government specify if the contractor will have a review role in the IND application and Clinical Study Report, or will the support required by the contractor be as needed?

Response: The support will be as needed.

8. The Technical Proposal Instructions on page 61 of the RFP requires a schedule for completion of the work and delivery of items specified in the SOW. Performance or delivery schedules shall be indicated for phases or segments of work as applicable by contract year as well as for the overall contract. Since this is an IDIQ contract, can the Government please give more instructions on the requirements for the schedule for completion of work and delivery time as specified in the SOW? Is this to be related to a specific protocol or to the program in general? If to a specific protocol, is the

Offeror to submit an example of a schedule to be applied to clinical trials? If to the overall program, what specific assumptions should be made as the Offeror cannot anticipate the work to be awarded.

Response: The offeror is to use the Statement of work along with the assumptions as stated in the solicitation to establish a schedule to represent the timeline for each sample task order.

9. In the Technical Proposal Instructions on page 61 of the RFP, the Offeror is to state the estimated time to be spent by the Principal Investigator/Project Director. Since this is an IDIQ contract and the number of awards to the Offeror are unknown, can the Government provide guidance on how this time should be estimated? Should it be estimated for proposal purposes on the Task Orders to which we are responding?

Response: The Offerors should propose the time requirements of the Principle Investigator/Project Director the Offerors determines it would take to complete the tasks outlined in the Statement of Work; and the Additional Technical and Business instructions/assumptions.

10. Section M, Technical Plan/Approach, Task Area C, page 103 of the RFP, Can the Government confirm that the requirement to receive, control and monitor storage, dispense, and maintain inventory of study agents and clinical specimens is at the site level and that the Offeror is not required to provide central facilities and be responsible for study agents?

a. Can the Government confirm that clinical specimens are laboratory specimens or are these items adjunct to the administration of the product?

b. Can the Government confirm our understanding that if the Offeror provides the laboratories for analysis, the Offeror will be responsible for tracking and shipping of clinical specimens?

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Response: Correct, the Offeror is not required to provide central facilities and be responsible for study agents.

11. Attachment 9 - table on page 4, indicates that there will be an average of 13 Phase I-IV clinical trials under Task Area C per year on this contract. The Government also states under 1) Scope of

Activities that the table represents the average number of specific tasks offerors should assume to perform each year under the contract.

a. Question: Is 13 the average total number of clinical trials that DMID expects to conduct under this contract per year (regardless of the number of offerors), or does the Government anticipate awarding an average of 13 clinical trials to each offeror per year?

Response: For purposes of the Offerors proposal submission, offerors should assume completing the number of trials stated in Attachment 9 which states per contract per year.

12. Is it an expectation that the applicant have clinical research sites lined up to do these studies or is the applicant expected to just organize the operational issues under this contract?

Response: The offerors are to show their capabilities to perform the Statement of work, whether through “onsite” capabilities or commitment from partnering sites.

13. In terms of laboratory infrastructure to support these studies, is it sufficient for the applicant to be able to outsource/subcontract this activity or must this all be a part of the application?

Response: The offeror are to show their capabilities to perform the Statement of Work whether outsourced or “onsite”.

14. Is it anticipated that the device-associated studies be related to vaccine delivery devices?

Response: it is not anticipated that the device-associated studies be related to vaccine delivery devices.

15. How much vaccine-associated experience (minimum) is expected for the applicant?

Response: There are no mandatory minimum criteria for vaccine-associated experience.

16. Attachment 8 page 5 of 11 asks offerors to describe and demonstrate the capability, plans and procedures, including prior experience, with recruiting and retaining the following populations:

a. c) 600 adult subjects (greater than 18 to 45 years of age)

b. e) 300 mature adult and elderly subjects (greater than 45 years of age)

c. Did the Government intend for item c) 600 adult subjects to be within 18-45 years of age and NOT greater than 45 years of age? (i.e, between the ages of 18 and 45)?

Response: The solicitation should have stated “within” rather than “Greater than”, for item c) 600 adult subjects.

17. Pg 73. Data and Safety Monitoring in Clinical Trials

a. Q: Is the offeror expected to identify DSMB members for trials or is this done in conjunction with/or by DMID?

Response: This is done in conjunction with DMID. DMID is responsible for making the final decision, but the offeror is expected to suggest names of qualified candidates.

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18. Pg. 103, A. 4. Provide for system of records for all documentation required for the conduct of clinical trials; system for reporting safety data and information from clinical trials; and clinic procedures systems needed to control trial data from all affiliated sites.

a. Q: Who will maintain the trial master file after the study, the contractor or DMID CROMS?

Response: The contractor will maintain the file for the duration of the contract and contract terms and conditions.

19. Attachment 3 Page 4, B. 2. Study Product/Pharmacy Management Plan: Develop, maintain, update, and submit to the COR for approval.

a. Q: In the event of a disease outbreak requiring intervention, will the contractor develop the pharmacy management plan or will this be done in conjunction with the CDC and DMID?

Response: For the purposes of the RFP, the offeror should assume responsibility for developing/maintaining/updating and submitting the pharmacy management plan to the COR for approval.

20. Attachment 3 Page 4, C. 2. Revise and refine concepts proposed by the VTEU contractors or other sources.

a. Q: Will the contractor be able to work in conjunction with the VTEU contractors to revise and refine the concepts?

Response: It is anticipated that potential concepts will be discussed in forums that include multiple

VTEU investigators (such as the annual VTEU meeting).

21. Attachment 3 Page 6, 2. A 1, b. Develop, provide, and maintain, as appropriate, Essential

Documentation, as defined by the International Conference on Harmonization ICH-E6-GCP, (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/

E6_R1__Guideline.pdf), including documents designed for the collection of source data and/or blank forms designed by the SDCC to collect clinical data needed for remote data entry into an electronic case report form.

a. Q: Is it the intent for the contractor to provide all study source documents to the sites for the study?

Response: Offerors are expected to provide their own documents for the collection of source data.

22. Attachment 3 Page 8, 2 A, 7 b. Transfer complete and accurate Serious Adverse Event (SAE) information to the central Safety Reporting Database System operated by the NIAID CROMS contractor within twenty-four (24) hours of learning of the SAE. Provide follow-up information as required to meet FDA IND reporting requirements and to support SMC/DSMB meetings.

a. Q: How will safety reports for events outside of the US be handled?

b. Will these be reported to the NIAID CROMS contractor?

c. For purposes of reporting to the appropriate regulatory authority outside of the US, is it the expectation the contractor will maintain a separate safety database and complete the required reporting?

Response:

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a. Notification of events to DMID will occur via the same process regardless of the location of the clinical site;

b. Will be reported to the NIAID CROMS contractor;

c. Per the RFP, the offeror is expected to provide capabilities to meet the reporting requirements of regulatory authorities outside of the U.S. Offerors should propose an appropriate process.

23. Attachment 3 Page 10, 2, C, 1, b. Collaborate and coordinate with the DMID and the SDCC (Statistical

Data and Coordinating Center) in the analysis of final study data including submission, receipt, collation and interpretation of study data.

a. Q: Will the contractor be responsible for provided statistical support for data analysis?

Response: The contractor will not be responsible for providing statistical support for data analysis.

24. Attachment 3 Page 10, 2, C, 2, b. Final Clinical Study Report: Collaborate and coordinate with the

NIAID SDCC and the protocol team to develop and submit the Final Clinical Study Report. Within 6 months of completion of the study (defined as database lock and data/specimen analysis completed), provide Final Clinical Study Report to the COR.

a. Q: Will the contractor be responsible for preparing the Final Clinical Study Report?

Response: The offeror, SDCC, and DMID are responsible for preparing the final study report. The offeror is expected to work with the protocol team to determine the analysis that will be performed, determine which tables and listings to include, interpret data/results, complete technical sections of the CSR, and review draft completed CSRs.

25. Attachment 9, Section 3, 1) – What does “1.1 direct level of effort” mean? Does this mean 1.1 Full-time equivalents?

Response: Yes, the Governments requirement for this task area is 1.1 full time equivalent.

26. Attachment 9, Section 4, 1) G. – Are calls and meeting specified per year or total over life of contract?

Response: Calls and meeting specified are per year.

27. P.55, 2.a.2. says proposals should be “printed/copied double-sided, on at least 30% post consumer fiber paper;” on Attachment 1, III.A.5. (p. 3 of 3) it says “single sided on standard…paper.” Which is correct?

Response: The Government refers offerors to FAR 4.302 in order for them to determine the method of submission.

28. P. 51, L.1.c.2. says that Task Orders “will be fixed-price/cost reimbursement, term/completion.”

P.95, 11.d. says “the resultant contract will not be Firm Fixed Price.” Which is correct?

a. If there are to be FFP task orders, should Task Order 1 and Sample Task Orders B-1 through

D-1 that we are responding to be prepared as cost reimbursement or FFP? Please specify the type of Task Order pricing to submit for each of the two Task Orders?

Response: The Government reserves the right to request FFP task orders. However, for purposes of proposal submission offerors should submit as cost reimbursement.

29. The Business Proposal instructions, in the Basic Cost/Price Information section (p. 85), provide a list of the cost element items which must be discussed, including fee and profit.

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a. For CPFF proposals does the Government distinguish between fee and profit? If so, please clarify?

b. For FFP proposals, either during this RFP stage or in later Task Order Proposals after award, does the Government require that contractors discuss the element of profit in their

FFP proposal?

Response: For the purpose of this proposal the terms fee and profit are synonymous with one another. The Government will always review the profit on all proposals.

30. The Cost instructions at the top of page 88 of the RFP in the Alternate I clause for 52.215-20 state in

L.2.c.4(b)(1) “The offeror shall submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in the following format: The format specified in paragraph L.2.c.4. Certified Cost or Pricing Data, subparagraph 3 shall be used for the submission of cost data. Submission of all other certified cost or pricing data shall be in accordance with Table 15-

2 in FAR 15.408.“

a. Will there be any need for a separate table matching FAR Table 15-2 if all cost information is contained in the NIH provided spreadsheets? I.e., will properly completed NIH RFP spreadsheets meet the Table 15-2 requirements?

Response: The completed NIH RFP spreadsheets will meet the requirements.

31. Is clinical trials insurance required for every study or just for the Chikungunya virus vaccine? The RFP seems to indicate it is only to be discussed in the context of the Chik study.

Response: The capability to provide Clinical Trial Insurance is required for all studies. The capability only needs to be described for the Chik study.

32. For Task Area A-1, does the labor mix apply to the subcontract sites as well? For instance, should we interpret the RFP to mean that 45% of the PI's effort goes to Task Area A?

Response: Each offeror should propose the level of effort they believe will accomplish the tasks as defined in the Statement of Work (SOW), Additional Technical and Additional Business proposal instructions. Task Area A has a requirement of 1.1 full time equivalent. The estimated labor mix in Section 3- Level of Effort is a guide for all offerors. Each offeror should account for any proposed subcontracts (technically and costs), including level of effort.

33. How does Task Area A-Task Order A-1 work for the subcontract sites? Do we assume that the entire allotment is given to the 'network' or to each site within the 'network.' Under the current contract, nurses/investigators from the prime as well as the subs typically go to the meetings.

Response: Task Area A, if awarded will only be awarded to each prime contractor and not to any subcontractors of the prime. Each offeror needs to propose the labor mix for Task Area A including the effort of subcontractor(s).

34. Do we allocate the uniform cost assumptions to the subcontract sites based on their work on the sample protocols as given?

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Response: Offerors should incorporate the uniform cost assumptions in the manner in which the proposal describes their capabilities to meet the requirements stated in the solicitation.

35. There are multiple ways in which the budget could be expressed. Could we get clarification on how best to present this?

a. business plan/budget based solely on the Sample Task Orders

b. budget based on sample task orders and uniform cost assumptions, not taking into account the projected scope of work.

c. budget based on sample task orders + uniform cost assumptions + Scope of Activities in Attachment 9.

Response: The option c. follows most of the budget requirements set forth in the solicitation.

Others include for example a task linked budget, etc.

36. For the requirement for 200 international subjects, can this be across multiple international sites, or does the sponsor prefer a single international site?

Response: The offeror may choose multiple sites.

37. For international sites, there is an instruction that they must be classified by the World Bank as low or middle income. At the website the RFP refers the reader to, the World Bank classifies middle income countries as either "lower-middle" and "upper-middle" income. I assume that either of these middle income designations would be acceptable to the government. Is my assumption correct? If not, please clarify.

Response: Either of these middle income designations would be acceptable.

38. Attachment 3: What is a Phase 0 clinical trial?

Response: This is also known as an exploratory IND. I’ve attached a relevant guidance from FDA that describes this in more detail. The link to the guidance is:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM078933.pdf

39. There are 3 versions of guidance about how to perform Task Order C-1, C-2, and C-3: Attachment 3, Attachment 8, #3 (SOW), and Attachment 9? It is not clear whether all elements described in each attachment should be included in our response.

Response: The various sections build on each other and are not mutually exclusive. Attachment 8 of page 6 of the RFP states: “prepare a separate technical response that demonstrates the capabilities, plans and procedures for carrying out the specific tasks and functions specified in each Sample Task Order Statement of Work (i.e., C-1, C-2, and C-3) for Task Area C, as well as the general Technical Requirements for Task Area C described in the Statement of Work. Describe relevant organizational experience with implementing and conducting clinical trials, problems or obstacles encountered, and approaches implemented to resolve or correct identified problems. For purposes of preparing the technical responses, assume that the Offeror will be responsible for the implementation, conduct and oversight of the clinical trial. In preparing the technical responses for each Sample Task Order, do not repeat information, descriptions or discussions common to all Sample Task Orders.”

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf

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As stated in Section 4 of attachment 9, “The following uniform cost assumptions shall be used by all offerors when preparing their cost proposal for activities undertaken under Task Areas A, B, C and

D. The assumptions listed below for Task Area C are repeated from each Task Area C Sample Task

Order (C-1 through C-3) and additional assumptions have been added to facilitate the development of the business proposal.”

40. What BSL facilities are required?

Response: This phrase is referring to adequate facilities (namely regular laminar flow cabinet) needed to prepare (for example, mixing) certain investigational agents prior to administration.

41. Task Order C-2: The title says, “in Canada” but IID says “done in the U.S.” Please clarify where the trial should be conducted.

Response: For the purposes of this RFP, assume that the trial will be conducted in the U.S.