RFI_Response_5-2-2017.pdf

Response to RFI

HRSA received the following comments and questions from industry during the RFI phase. HRSA will take into consideration of information received when developing the solicitation.

1. Security and Privacy requirements in the PWS being too strict and costly to implement.

HRSA Response: HRSA plans to update the final Security and Privacy requirements as necessary in the solicitation.

2. Period of performance being total of only 4 years.

HRSA Response: The total period of performance will be updated in the solicitation to 1 base year and 4 option years.

3. Contract Type

HRSA Response: HRSA will explore the available contract options along with the feasibility of different contract types to be implemented for the program. The final contract type will be stated in the solicitation.

4. Data rights

HRSA Response: Based on the needs of the government, HRSA will include the required FAR clauses to incorporate and ensure that the government retains unlimited rights to the data involved with these CWBYCTP functions. These functions require the government to be in position to provide continuity of services therefore having rights to the data is imperative.

5. How does the organization of the CW Bill Young Transplantation Program suggested by this PWS on the Single Point of Access-Coordinating Center relate to the previous one with four Contracts?

HRSA Response: Based on the legislation, the functions of the Bone Marrow and Cord Blood Coordinating Center are similar to one another, and are interrelated with the Single Point of Access. Therefore, it is logical to combine these functions into one consolidated requirement.

The Office of Patient Advocacy and the Stem Cell Therapeutic Outcomes Database functions are standalone requirements.

6. Are the “Cord Blood functions” and the “Bone Marrow functions” totally included in the SPA-CC

PWS or will there be an additional PWS for those functions?

HRSA Response: The intent is that the single point of access function, cord blood function, and the bone marrow function are completely included within the SPA-CC PWS.

7. Both the recruitment of unrelated volunteer stem cell donors and cord blood donors and the selection processes for BM/PBSC and CBU grafts are different, as practiced by the Transplant Centers. What is the rationale for describing the SPA activities so intermixed in the PWS?

HRSA Response: The reason to have these requirements combined is the Bone Marrow and Cord Blood Coordinating Center functions are statutorily similar and interrelated with the Single Point of Access Function.