Stem Cell Therapeutic Outcomes Database (SCTOD)

Added: Feb 01, 2017 2:08 pm Sole Source Notice

This is a Sole Source Synopsis announcement. A written solicitation will not be issued. The Health Resources and Services Administration (HRSA) intends to issue a sole source contract action pursuant to 10 U.S.C. 2304(c)(1) and Federal Acquisition Regulations (FAR),
Part 6.302-1. Market research was conducted prior to the posting of this notice and only one responsible source is able to provide the services which will satisfy agency requirements. The Medical College of Wisconsin is the only known source able to provide the services.

The purpose of this acquisition is to maintain the Stem Cell Therapeutic Outcomes Database (SCTOD), one component of the C.W. Bill Young Cell Transplantation Program (Program). The SCTOD contractor shall:

1 Collect and maintain information related to patients who have received stem cell therapeutic products in a standardized electronic format. This information is defined as the information necessary to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutic product from a donor;
2 Prepare and submit an annual report on patient outcomes at each transplant center; and,
3 Make scientific information available to the public in the form of summaries and data sets.

The scope of data collection under this contract includes:

1 allogeneic transplantation for hematopoietic reconstitution using cells from donors not related to the patient;
2 allogeneic transplantation for hematopoietic reconstitution using cells from donors who are related to the patient; and
3 emerging clinical applications of cells derived from bone marrow, peripheral blood, and umbilical cord blood.

The Medical College of Wisconsin is the current contractor as a result of the competitive award process conducted in 2012. This new requirement is a follow-on effort to the existing SCTOD contract. The anticipated period of performance start date for this requirement is September 27, 2017.

The proposed contract action is for supplies and services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302. This notice of intent is not a request for competitive proposals. However, interested parties may submit their capabilities or responses before the closing date and time of this notice to the Government for considerations. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow up information requests.

Any interested parties may provide a statement of capability to HRSA for consideration. All responses must be received by 10:00 a.m. EST on February 10, 2017.

4 Collect and maintain information related to patients who have received stem cell therapeutic products in a standardized electronic format. This information is defined as the information necessary to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutic product from a donor;
5 Prepare and submit an annual report on patient outcomes at each transplant center; and,
6 Make scientific information available to the public in the form of summaries and data sets.

The scope of data collection under this contract includes:

4 allogeneic transplantation for hematopoietic reconstitution using cells from donors not related to the patient;
5 allogeneic transplantation for hematopoietic reconstitution using cells from donors who are related to the patient; and
6 emerging clinical applications of cells derived from bone marrow, peripheral blood, and umbilical cord blood.

The Medical College of Wisconsin is the current contractor as a result of the competitive award process conducted in 2012. This new requirement is a follow-on effort to the existing SCTOD contract. The anticipated period of performance start date for this requirement is September 27, 2017.

The proposed contract action is for supplies and services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302. This notice of intent is not a request for competitive proposals. However, interested parties may submit their capabilities or responses before the closing date and time of this notice to the Government for considerations. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow up information requests.

Any interested parties may provide a statement of capability to HRSA for consideration. All responses must be received by 10:00 a.m. EST on February 10, 2017.