DSCSA_Questions-Content.pdf

Questions for Solicitation No. FDA-RFP-1146043 entitled, “Pilot Project(s) for Drug Supply Chain Security Act”.

Question 1: Can the Government confirm that the citizenship requirements for contractor personnel working on this project will be U.S. Citizens and Lawful Permanent Residents?

Gov’t Response: The Government requires U.S. Citizenship and Lawful Permanent Resident status of contract personal working on this project. Please reference FAR Clause 52.222-54 entitled, Employment Eligibility Verification.

Question 2: Please confirm that the Government will provide facilities, teleconferencing, video conferencing, and webcasting services for the public workshop.

Gov’t Response: The logistics for a public workshop are to be determined. If the facilities and capabilities are available at the Government facility (i.e., the FDA), the Government will provide the facilities and capabilities to support a public workshop.

Question 3: Is there an incumbent?

Gov’t Response: No, there is no incumbent.

Question 4: Is it expected that the contractor should have an existing relationship with pharmaceutical firms and other supply chain members?

Gov’t Response: While not required, it is preferred that the contractor have some relationships or experience with pharmaceutical firms and other supply chain members.

Question 5: How many RFI responses were received?

Gov’t Response: Six.

Question 6: Can the government grant a one week extension?

Gov’t Response: We have granted an extension through August 17, 2015.

Question 7: Expected number of pilots - In our past experience running pilot programs, there are typically a number of pilots that vary in scope and scale, complexity and duration that comprise the overall pilot program. Could the FDA provide some indication of the expected number of pilots they would like to conduct?

Gov’t Response: The exact scale, complexity, and duration of the pilot project programs have yet to be determined. FDA is required to establish 1 or more pilot projects that will cover content and design as described by statue in section 582(j) of the Federal Food, Drug & Cosmetic Act.

Question 8: For each pilot, we envision involving a range of stakeholders e.g. pharmaceutical companies, suppliers, distributors etc. Could the FDA provide some indication on the types of stakeholders they would like to engage in conducting the pilots?

Gov’t Response: As directed under section 582(j) of the Federal Food, Drug & Cosmetic Act, FDA will conduct the pilot programs in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers. Other stakeholders may be identified as needed.

Question 9: Will the Government clarify whether the deliverables associated due dates are calendar or business days?

Gov’t Response: The due dates are business days as the Government is closed on Weekends and Federal Holidays.

Question 10: Does the Government expect that all members of the supply chain be represented in pilots? (Large/Small, Manufacturers, Repackagers, Distributors, Dispensers)

Gov’t Response: As directed under section 582(j) of the Federal Food, Drug & Cosmetic Act, the pilot projects will reflect the diversity of the pharmaceutical distribution supply chain, when taken as a whole, include participants representative of every sector, including both large and small businesses.

Question 11: Could the Government provide an estimate of the number of participants for each pilot?

Gov’t Response: The exact number of participants has yet to be determined.

Question 12: Will the government please define the term “participant” in the context of the pilot programs?

Gov’t Response: Participants of the pilot project(s) include authorized manufacturers, repackagers, wholesale distributors, and dispensers. Other stakeholders may be identified as needed.