National Cord Blood Inventory (NCBI)

This notice is provided pursuant to FAR 5.204

Action Code: Pre-solicitation

Classification Code: The North American Industrial Classification System (NAICS) code for this acquisition is 621991 Blood and Organ Banks.

Contracting Office Address:

Health Resources and Services Administration
Office of Acquisition Management and Policy
5600 Fishers Lane
Room 14W31
Rockville, Maryland 20857

Subject: The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation to issue a solicitation for National Cord Blood Inventory (NCBI)

Proposed Solicitation Number: 19-250-SOL-00062

Point of Contact: Curtis Lam, Contract Specialist; clam@HRSA.gov; 301-443-0061

Place of Contract Performance: Contractor's facilities

Description: THIS IS A PRESOLICATION NOTICE ONLY - The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation is planning to issue a solicitation to contract in accordance with the Stem Cell Therapeutic and Research Acts of 2005, 2010 and 2015 with one (1) or more qualified cord blood banks (CBBs), that have an approved U.S. Food and Drug Biologics License Application, to collect and maintain cord blood products for hematopoietic stem cell transplantation in order to meet the statutory goal of building a National Cord Blood Inventory (NCBI) of at least 150,000 new, high-quality, genetically diverse cord blood units (CBUs).

The cord blood units (CBUs) shall be made available through the C.W. Bill Young Cell Transplantation Program (CWBYCTP) on the donor registry. Some donated cord blood units shall be made available for peer-reviewed research.
In performing the activities of the NCBI, the Contractor shall:
1. Operate its established CBB with implemented donor screening, cord blood collection practices and processing methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes;
2. Comply with its approved Biologics License Application as specified by the U.S. Food and Drug Administration for manufacturing and distributing cord blood products intended for unrelated donor transplantation;
3. Add licensed cord blood units to its public inventory from a genetically diverse group of donors;
4. Make CBUs available through the CWBYCTP;
5. Make CBUs available for peer-reviewed research;
6. Maintain a plan for self-sufficiency that demonstrating financial and operational sustainability through the contract period of performance, and recognizing Government funds for sustainability shall not be added to your contract each year; and
7. Comply with the requirements for the CWBYCTP, NCBI Program, and Cord Blood Bank accreditation standards from an NCBI accrediting organization recognized by HRSA.

The solicitation will be issued as a full and open basis with a proposed initial period of performance of five (5) years and as required by statute with the option to extend the period of performance for 10- additional years from the last date that funds are obligated to the contract. The Government intends to issue a solicitation on or about beginning of July, 2019. The required services will be procured in accordance with FAR Part 15 - Contracting by Negotiation.
All future information regarding this acquisition, including the solicitation and any amendments, will be distributed solely through the FedBizOpps website (www.fbo.gov). Copies of the solicitation document and its related documents, as appropriate, will be posted at this website. Interested parties are responsible for monitoring the FedBizOpps website to assure that they have the most up-to-date information regarding this acquisition. The Government will not reimburse interested parties for any costs associated with responding to this notice.

For further information, please contact Curtis Lam, Contract Specialist, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-0061 and CLam@hrsa.gov.

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