NIHAO200816responses2.pdf

NIHAO200816 Responses to Questions #2 August 14, 2008

Question 1:

Which countries are being considered under this IDIQ?

Response:

No specific countries have been identified at this point. Individual task orders after award will identify the place of performance. The sample task order is based on performance in Mali.

Question 2:

2. How many studies or sites would be expected to be activated/supported each year?

Response:

As an IDIQ contract, the number of studies and sites to be activated or supported under the contract cannot be anticipated at this time. Task orders requests will be issued for requirements as needed.

Question 3:

3. The RFP indicates that this contract will enable NIAID DCR to rapidly establish collaborations with international government agencies, academia, and health research entities in developing countries. What is the anticipated timeframe from when the contractor is told to assess a site to when NIAID DCR expects the site to be ready to perform a study?

Response:

The timeline for specific sites will be highly dependent on the requirements of the individual task order. Each task order request will define the anticipated timeline for a specific project.

Question 4:

4. Are there particular therapeutic areas that are of particular interest to NIAID DCR with regard to this RFP?

Response:

DCR’s interests are in infectious diseases generally for this RFP.

Question 5:

Since the nature, location and scope of the task orders is unknown at this time, would it be acceptable to address only the offerors areas of capability, experience and strength and not all areas of the statement of work?

Offerors must address all areas of the statement of work in their technical proposal.

Proposals which only address a specific portion of the requirement will not be considered for award.

Question 6:

Please clarify your response to question number 15 in Responses to Questions #1: Is there a distinction between the site staff and the offeror relative to providing "ongoing care and treatment?"

Response:

Offeror would be responsible for carrying out objectives as stated in the contract for each individual task.

Question 7:

The response indicates that the offeror is responsible for providing ongoing care, which is typically provided by site staff. What do you expect the offeror will be responsible for and what time period will it cover?

Response:

Requirements will vary according to the project but will be specified in the task order. The offeror does not provide the care but the support services as outlined in the task order.

Question 8:

The responses to the Pre-proposal conference (Questions 17 & 18) talk about 2 clinical trials and one research project. How does this match with Section 1.5 of Appendix C where it describes clinical trials and research projects in the second and final stages? Is the research project in the first stage and a clinical trial in each of the second and final stage?

The research project is in the first stage and a clinical trial in each of the second and final stage.

Question 9:

Throughout the duration of the sample task, is there only one clinical research site?

Response:

The sample task only includes one clinical research site.

Question 10:

Please confirm that the period of performance to be used in pricing the sample task is 2003 through 2007.

Response:

The period of performance is 5 years for the sample task. Offerors should price the task for a 5 year period based on current and future anticipated costs not historical cost information.

Question 11:

Does the contract require the offeror to compile, review, audit and write Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug Application or INDA?

Response:

Writing the CMC section of an IND application is not required for the sample task but may be a requirement for a future task order.

Question 12:

Does the solicitation require the offeror to deliver any materials; such as laboratory specimen, tissues, or any other supplies?

Response:

Shipment of materials and specimens is included in the solicitation. Offerors are to assume shipments to the US are not required.