Solicitation_Questions_Responses_KJJ.docx

RFQ Questions/Responses

1. Will these studies require validated analytical methods and GLP dose formulation, analysis and stability assessment?

Government Response: Yes.

2. Similarly, will validated methods be required for quantitative analysis of analytes in biological matrices (e.g., for pharmacokinetics/pharmacodynamics studies)?

Government Response: Yes.

3. The Solicitation FDA-RFQ-1115032 does not specify route of administration:

I am wondering if FDA considers inhalation as a primary or one of the possible routes of administration of tobacco product constituents?

Government Response: Yes, inhalation is a possible route of administration of tobacco product constituents.

Also I am wondering if exposure to tobacco smoke itself would be of interest or FDA is only interested in constituents (and their mixtures) Government Response: We are interested in constituents and their mixtures.

4. Does the requested ‘material handling fee/charge’ refer to the loading of the ODCs (e.g., fee, G&A, etc) or does it refer to the average percentage of a project cost that is M&S versus labor?

Government Response: The requested material handling fee/charge refers to the average percentage of a project cost that is Material and Service-Non-Labor.

5. If the former, how is the percent M&S calculated?

Government Response: For the material handling charge the Government will apply the proposed percentage against $50,000 per year.

6. Should Subcontractor labor and rates be incorporated into the Contractor’s Pricing Table at Part 2, 2.5, such that Subcontractor labor is categorized, priced, and invoiced using only Contractor Pricing Table rates and categories? Alternatively, should the Contractor propose and invoice Subcontractor costs as a separate Other Direct Cost item and distinct from Contractor labor?

Government Response: The Government will only have “privity of contract” with the Prime contractor; therefore, it is not necessary to price out Subcontractor rates in the pricing table.

7. Should the Small Business Subcontracting Plan be included in Volume III: Price? If not, where should the Small Business Subcontracting Plan be placed?

Government Response: This can be included in the Technical Response

8. The Contractor shall propose its most competitive labor rates for general requirements. May the Contractor also, and compliantly, stipulate that the proposed rates are not-to-exceed ceilings and it reserves the right to discount labor rates for specific task order requirements in order to ensure highly competitive task order pricing?

Government Response: This is allowable, however, the offeror should note that this is a competitive action and that price is a consideration in the awarding of a contract.