Amendment_2_Questions_and_Responses_Oct_17_2018.pdf

Amendment 2

Questions and Responses to RFP NIHAO201800107

Operation of a Facility for the Study of Infectious Agents, Vaccines and Antimicrobials in Adult and Pediatric Human Subjects

The following Questions and Responses are corrected from Amendment 1.

Question:

d: Can the Government confirm if the complete study report is required to be submitted in eCTD format?

Response: The complete study report is not required to be submitted in the eCTD format.

iii. If the budget should include up to 400, 400, and 60 as specified above, shall costs be integrated into a single budget or presented as separate budgets according to the type of research (core support, pediatric, adult outpatient, adult inpatient).

Response: The costs should be presented as separate budgets according to the type of research conducted.

2.b. Cost assumptions: each sample task order lists personnel for project management, for example, Research Program Coordinator, Administrative and Budget Specialist, Data

Coordinator, Technical Writer, IT Specialist, Compliance Monitoring Specialist, Regulatory

Specialist, but lists no clinical personnel and no laboratory personnel. Could you please clarify?

Response: Cost associated with clinical and laboratory personnel, as deemed necessary by the offeror for the scope of the work described in task orders 1A, 1B, and 1C, should be listed in each cost proposal. To assure that costs for project and data management also be included in each cost proposal, specifications were included in Section 2 of each sample task order.

4.a. If the Government determines that this rule would apply in the situation above, please confirm whether the salary rate limitation rule does not apply to consultants or subcontractors that are paid on a fixed price basis (per project or per deliverable) rather than on an hourly basis?

Response: The salary rate limitation applies in all instances in that the consultant or subcontractor cannot be paid over the Executive Level II Salary for the year.

9. Section 14. Proposer's Annual Financial Report on page 106 of the RFP requires organizations to submit a copy of their most recent annual report. Our organization operates as a business unit of a publicly traded company. As such, we would submit an annual report for just our business unit operations, containing the items: balance sheet, income statement and aged receivables for the most recent year. Is this sufficient for the Government? If not, what additional items would you like to receive?

Response: The Annual Report is sufficient.

10. Will the manufacturer of the study products maintain Products Liability Insurance with coverage for injuries to clinical study subjects for Sample Tasks 1A-1C?

Response: The manufacturer will not offer Products Liability Insurance with coverage for injuries to clinical study subjects for Sample Tasks 1A-1C.

a. If yes, how much? N/A

b. Confirm the manufacturer will issue letters of indemnification related to study subject injury to the prime contractor and clinical sites or other subcontractor requiring confirmation of liability coverage. N/A

c. If not able to confirm, please confirm that the cost of products liability coverage is an allowable direct charge under this response?

Response: Products Liability Insurance will not be provided and is not billable under the contract. Medical liability insurance for study investigators is an allowable charge under the response. Services for short-term treatment of study participants in case of injury or study-related illness is an allowable charge under the response.

11. Will the Sponsor provide access to its own database (CRIMSON) for the proposed SOWs or should the offeror propose and budget for a database?

Response: The Sponsor will not provide access to its own database (CRIMSON). The offeror should propose a budget for a database.

Additional Questions:

Question 1:

Items f./l. in the Clinical Trial section of the Uniform Cost Assumptions for each Sample Task

(Attachment B, pages 2, 3, and 5 of 5) states “Data analysis and specimen storage inventory:

Assume that all clinical data described in Sample Task Order 1B will need to be collected, and that all clinical and laboratory data described in Sample Task Order 1B will need to be analyzed.

Specimens will need to be inventoried and stored.” While the clinical and lab data is typically collected in a clinical database, analysis of data is performed by a biostatistician, can the government confirm whether biostatistical services for analysis for each of the Sample Tasks are to be performed by the Offeror?

Response: Yes, the biostatistical services for analysis of each Sample Task will be performed by the Offeror.

Question 2:

Does the government require offerors to develop safety databases as part of the services provided for each of the Sample Task Areas or in support of this RFP?

Response: Offerors will be required to develop a safety database as part of the services provided for each Sample Task Area.

Question 3:

Task 1B requires a Zika and Yellow Fever serologic assay prior to enrollment of volunteers. Are offerors expected to include the costs for the serologic assays in their budgets?

Response: Yes

Question 4:

Can the government confirm when the PoP starts for each of the Sample Tasks – e.g. from project commencement/contract initiation (60 days following contract award) or from the date of final approved protocol?

Response: The PoP will be associated with each specific Task Order under the Contract.