Question_and_Answers-RFQ.doc

FDA-RFQ-1114590

Question/Clarifications and Answers Question 1:

Section 1.4.2, letter f, suggests there should be a Relevant Experience section in the Technical Volume. However, Section L.4 does not list a Relevant Experience section as a requirement in the RFP. Please clarify that FDA requires a Relevant Experience section in the Technical Volume in addition to the Relevant Past Performance section and distribution of the three Past Performance Questionnaires.

Answer:

FDA does not require a relevant experiences section. The past performance section and performance questionnaires are sufficient for evaluation.

Question 2:

If FDA requires a Relevant Experience section, can the three projects provided in the Relevant Past Performance section be included in the Relevant Experience section, along with other projects, as appropriate?

Answer:

FDA does not require a relevant experiences section. The past performance section and performance questionnaires are sufficient for evaluation.

Question 3:

Please clarify that FDA requires a one-page narrative for each of the three Past Performance Questionnaires in the Relevant Past Performance section unless the project is in the Relevant Experience section (assuming that this section is a requirement in the RFP).

Answer:

FDA does not require a relevant experiences section.

Question 4:

Please clarify whether this will be a single or multi-award IDIQ.

Answer:

This will be a multi-award IDIQ.

Question 5:

The Past Performance Questionnaire (Attachment 3) states that the reference complete and email the Past Performance Questionnaire. Section L.4.2 (page 28) states that the reference must complete the questionnaire and mail a hard copy to the Contract Specialist. The RFP provides an email address on page 7; however, the RFP does not provide a postal address for the Contract Specialist. Please clarify how FDA wants the completed Past Performance Questionnaires submitted prior to the RFP close date.

Answer:

Please send questionnaires to: Juana.Quinteros@fda.hhs.gov

Question 6:

a. Regarding Attachment 1, Information Collection Request: The instructions state “Please view the following: http://www.hhs.gov/ocio/policy/collection/infocolsub.html for instructions on completing the Information Collection Request required for Government OMB approval.”

b. The link and associated information appear to be Government action items as opposed to offeror/contractor action items. Will Government please identify any tasks the Offeror is required to perform and the dates by which the tasks must be completed as they relate to the “Information Collection Request”?

Answer:

The contractor must assist the FDA in preparing Information Collection Request documents for OMB approval. This includes, but is not limited to: providing IRB letter of approval, study justification, and statistical methods for data collection. The ICR package must be submitted within one month of IRB approval.

Question 7:

Will the FDA be supplying the tobacco products to be administered to participants?

Answer:

Tobacco products may be supplied by the study participants or the investigator, based on the Task Order requirements. FDA will not provide tobacco products.

Question 8:

Will the Government please provide a list of the tobacco products it plans to utilize so that the offeror may address them as needed in the technical and business proposals?

Answer:

Several tobacco products may be included under this contract, including, but not limited to: cigars, electronic cigarettes, and smokeless tobacco.

Question 9:

Page 25 of 32 states "Technical proposal must be organized following technical evaluation criteria in Section C.”

Answer:

It should state section L.

Question 10:

Will Government please clarify the difference between the positions of Data Management Associate (key personnel) and Clinical Data Manager, as they appear to be nearly identical except that the Data Management Associate includes “coding” in the description?

Answer:

The requirements for these positions are similar, and it is expected that personnel will work closely together under this contract.

The clinical data manager manages the studies from the planning stages to the closeout.

The data management associate develops the case report forms through the final study reports and ensures the data collected meets the requirements of the study objectives.

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