Questions Answers.pdf

QUESTIONS & ANSWERS

1. Section 2.3 (page 1): The Pricing table indicates 5 single dose studies should be priced; however, Section 3.4.4 (page 4); table #1 indicates that 6 potential single dose studies may be conducted.

Should we price for 6 single-dose studies as presented in Section 3.4.4 or for 5 studies?

Please price according to the table in Section 2.3 (page 1). The pricing table is used to indicate the difference in price for a certain study type (i.e. single dose BE study or multiple dose BE study) from year to year to adjust for inflation. Table 1 on page 6 is not a pricing table and indicates the possible design types for the single dose and multiple dose studies listed in the pricing table.

2. Section 3.4.2 (page 3): This section states the multiple-dose studies will be bioequivalence studies in the first sentence, then the second sentence states they are pharmacokinetic (PK) studies. Section 3.4.4, table #1 also indicates the multiple dose studies are PK studies.

Please clarify if these studies should be priced as PK studies or bioequivalence studies.

All clinical studies will be bioequivalence studies.

3. Page 34 states:

“Upon award, the contractor shall submit its proposed research protocol and all related documents (including but not limited to informed consent forms, recruitment material, telephone scripts, and questionnaires), through the FDA Contracting Officer's Representative (COR) to the FDA's Research Involving Human Subjects Committee (RIHSC).”

AND

Page 37 states:

“The Offeror shall present its understanding of the program requirements and identify significant difficulties, obstacles and risks in performing the SOW and explain how the perceived difficulties and obstacles will be overcome and the risks managed or mitigated. Include the following:

1. The detailed protocol…”

Please clarify if what is meant by a “detailed protocol” includes a draft protocol that follows RIHSC guidelines for format and content or a detailed outline of each proposed study protocol, including proposed detailed study procedures, schedule of events, safety considerations, etc.

The two excerpts here refer to two different items. The first (page 34) refers to the protocol that the FDA expects to have submitted upon award of the contract. The second (page 37) refers to a detailed protocol that the FDA will use to evaluate potential contractors, and this protocol that shall include items specified in 3.5.2 in draft form where applicable with adherence to RIHSC guidelines for format and content for each study type (i.e. single dose, multiple dose BE studies, and for physico-chemical studies.)

4. Section 5.3 (page 9) states “The contractor’s key personnel shall be full-time employees at the time of contract award. All key personnel shall be assigned full time to the project within fifteen (15) business days after contract award.”

Please define what is meant by all key personnel shall be assigned “full-time” to the project.

Additionally, is it mandatory to have a full-time employee as a key personnel team member rather than identifying a sub-contractor with appropriate expertise to perform the required tasks on the project?

A key person must be an employee of the prime (i.e. Principle Investigator). A subcontractor in this position is unacceptable.

5. Part 10, Section 52.212-1 (Proposal Format):

Please clarify that FOB point is intended to mean the location where the clinical research studies will be conducted.

For this requirement, FOB is intended to be at the contractor’s place of performance.

6. The RFP specifies that one of the key personnel must be a board certified neurologist. The RFP also states that "key personnel shall be full-time employees at the time of contract award." While we feel that we could provide the physician requested at the level of commitment required, that person would be a contractor. Would our proposal be considered non-responsive if the neurologist is not an employee?

Please refer to Question #4.