Amendment_3_Questions.doc

1. RFP p. 3, Section 1.4 Pricing

Question/Comment: Please clarify the roles of the Senior and Junior editor. What skill sets are required (e.g. document formatting/editing) over and above technical writing?

Response: The Senior Editor should have experience in managing the production of a technical document and experience in managing junior editors. Along with the tasks included in Section 2.5 of the RFP, senior editors should have advanced knowledge and experience with style guides, grammar and document formatting, and junior editors should have basic knowledge and experience with style guides, grammar and document formatting.

2. RFP p. 4, Section 2.1 Background

RFP Text: The FDA has specifically cited the need for specialized resources to address the variety and complexity of the work.

Question/Comment: Since this will require Subject Matter Experts (SME) at the PhD level with extensive years of experience, would the government consider adding a separate category for SMEs?

Response: FDA specified labor types in the Labor Rate Pricing Chart. We expect the labor rates of subject matter experts to align with the specified chart. Alternatively, consultants can be hired for a project. Once a final contract is awarded, a contractor may work with FDA to consider an additional labor category.

3. RFP p. 31, Section 11.2 Proposal Instructions

RFP Text: Offeror shall demonstrate that they have the personnel requisite to perform high quality economic analyses and experience in related fields (e.g. consumer studies and risk assessment).…Offeror’s shall also indicate which personnel would be participating in individual tasks and what percentages of their time would be devoted to this task. On each task it is expected that at least one (1) economist with extensive training and a minimum of six (6) years of experience will oversee the project and work closely with Office of Planning economists. The individual identified will be considered a key person in conjunction with the contract.

Question/Comment 3.1: Is the government referring to the 6 tasks described in A. Analyses and Evaluations to be performed by Contractor, or B. Anticipated Areas of Analyses for which Task Orders May be Issued to the Contractor?

Response: When using the word “task” in this context, FDA is referring to the individual task orders that are expected to be awarded for this contract. FDA is not referring to either the 6 types of analyses listed in section 2.4.A or the 6 areas of anticipated analysis listed in section 2.4.B.

Question/Comment 3.2: In either case the economist selected for a specific task would vary depending on the research topic. How would FDA prefer that we so identify this person since you request that this be a “key person” with respect to the contract?

Response: FDA is interested in the number and availability of staff members who are capable of handling the lead role in the offeror’s effort for any individual task order, but does not expect offerors to name or describe individual task orders each of these people would lead. These “key persons” can be identified in the tabular format of this section.

4. RFP p.31, Proposal Instructions

Question/Comment: Is there a page limit for the technical proposal and what will be counted against the limit (e.g., table of contents, references, resumes)?

Response: The technical proposal does not have a page limit.

5. Question/Comment: Please identify whether there are specific model tasks in the RFP that should be described in the technical approach, and if so, where in the RFP these descriptions occur.

Response: Section 2.4 includes both the types of analyses and anticipated subject matter areas in which FDA may be interested, but does not require any specific modeling task for any specific area of interest.

6. Question/Comment: Can the technical approach assume that COR will facilitate obtaining data from internal FDA departments and offices? Can the technical approach assume that the FDA will make private or confidential information and datasets available to the contractor or should it assume that only publically-available information is used?

Response: Offerors can assume that FDA will provide the selected contractor with relevant internal datasets to the extent that these datasets are available, subject to meeting FDA confidentiality requirements. Offerors should also demonstrate familiarity with the types of analyses and anticipated areas of interest by including how it could use publicly-available data in their response to “Data Access and Resources” in Section 11.2.

7. Question/Comment: Does FDA anticipate a relatively stable hours input by year over the life of the project or will hours vary by year?

Response: The hours of input from contractor are expected to vary from year to year depending on Congressional and FDA priorities and funding.