RFP_Amendment_01.pdf

RFP No. N01DA-17-8935 RFP Amendment No. 01

RESPONSES TO QUESTIONS

QUESTION 1: Is there a page limitation for each Task Order proposal, or for the technical volume overall?

ANSWER 1: There is no page limitation for each Sample Task Order proposal, or for the Technical Proposal.

QUESTION 2: Does the Prime Contractor need to meet both mandatory qualification criteria, or is it acceptable if the Prime Contractor and their proposed subcontractors together meet the required (mandatory) qualifications?

ANSWER 2: The Prime Contractor must meet all mandatory qualification criteria.

QUESTION 3: For Sample Task Order 1 (Single Dose PK Study), is bioanalysis included in this task order? If so, what are the specific compounds for analysis? Will there be bioanalytical methods that are available for the compounds or New Molecule Entity of interest? If not, will we be expected to develop methods from scratch?

ANSWER 3: Bioanalysis is not required for this contract. No bioanalytical work will be required for each Sample Task Order.

QUESTION 4: For Sample Task Order 2 (Interaction Study, Methamphetamine), is bioanalysis included in this task order? If so, what is the study drug of interest? Is it a small or large molecule? Do you also want to measure Methamphetamine concentrations? Will there be bioanalytical methods that are available for the study drug of interest? If not, will we be expected to develop methods from scratch?

ANSWER 4: Bioanalysis is not required for this contract. No bioanalytical work will be

QUESTION 5: In the cocaine interaction study (Sample Task Order 3), the protocol synopsis mentions how to qualify someone at screening as someone who is a cocaine user. Will this be defined for the methamphetamine interaction challenge study (Sample Task Order 2)?

ANSWER 5: Each protocol synopsis should be interpreted separately.

QUESTION 6: For Sample Task Order 3 (Interaction Study, Cocaine), is bioanalysis included in this task order? If so, what is the study drug of interest? Is it a small or large molecule? Do you also want to measure cocaine concentrations? Will there be bioanalytical methods that are available for the study drug of interest? If not, will we be expected to develop methods from

RFP No. N01DA-17-8935 RFP Amendment No. 01 scratch?

ANSWER 6: Bioanalysis is not required for this contract. No bioanalytical work will be

QUESTION 7: For Sample Task Order 4 (Pharmacokinetic/Pharmacodynamic (PK/PD) Study for a New Molecular Entity), is bioanalysis included in this task order? If so, what is the new molecular entity of interest? Will there be bioanalytical methods that are available for the new molecular entity of interest? If not, will we be expected to develop methods from scratch? If this is a large molecule, do you need both bioanalysis for both PK and immunogenicity?

ANSWER 7: Bioanalysis is not required for this contract. No bioanalytical work will be