FY24_Biospecimen_Repository_PreSol_Notice_2_8_24_3.pdf

Pre-Solicitation Notice

Solicitation Number: 75N94024R00001

Solicitation Title: NICHD Biospecimen Repository

Notice Type: Pre-Solicitation Notice

Classification Code: A – Research and Development

NAICS Code: 541 – Professional, Scientific, and Technical Services/541715 – Research and Development in the Physical Engineering, and Life Sciences (except Biotechnology)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION

ANNOUNCEMENT ONLY.

AN RFP WILL BE ISSUED VIA SAM.GOV ON OR ABOUT FEBRUARY 23, 2024

Background:

This project is a contract to store, monitor, and distribute human biospecimens collected by NICHD. The NICHD conducts studies focusing on child health and human development and as such has generated, and will continue to generate, a collection of human biospecimens pertaining to these research activities. The NICHD requires a specimen storage service that will provide a functional inventory system coupled with receipt, storage, disbursement, and occasional destruction of these biological specimens. Currently, the NICHD has approximately 6,000,000 samples from multiple NICHD Divisions and Branches. None of these have on-site facilities for the acceptance, storage, disbursement, or destruction of biospecimens.

This collection of biospecimens ranges from those actively collected in on-going studies to biospecimens that are more than 50 years old. Thus, there are many services required to maintain such a diverse collection. Required repository services include an inventory system to manage all biospecimens, receipt of biospecimens from a variety of sources, storage of biospecimens at required temperatures, quality assurance to monitor proper storage, and shipment of biospecimens upon request. These services will be contracted on a Task Order basis.

Typically, a project leader conceives of the general scientific goals of a project. Initiating the project results in the collection of human biospecimens from multiple sites. Procedures governing collection and routing of these specimens are overseen by a data coordinator, while assurance of proper storage requirements and provenance of the specimens is the purview of the repository. Therefore, communication between all three parties (the NICHD project leader, the data coordinating center, and the repository) is paramount and requires that all parties have the ability to access the inventory of any given project in real-time. Specimens will be shipped to the repository from clinical sites, research subjects’ homes or analytical labs. Inventories and electronic manifests that accompany these collections will be transferred as well, and maintenance of and access to this descriptive information is essential for NICHD. The specimens will be kept in long-term storage under multiple storage temperatures. At the request of the COR or designated representative, samples will be shipped under appropriate conditions to specified laboratories for testing or discarded in an approved manner. At times, specific volumes of specimens will be requested for shipment, which requires aliquoting of samples. NICHD has additional biospecimen collections that were generated in past studies. These collections will be maintained with proper inventories as above. NICHD requires a mechanism for outside researchers to reimburse the Repository for work related to accessing these specimens.

To move specimens from the NICHD biospecimen collection from the current storage site, specimens will be stored on dry ice or by other appropriate methods to the Offeror’s storage facility (facilities).

The Bio-Specimen Repository will be capable of:

1. Safely and efficiently assuming activities from the current repository upon direction of the Contracting Officer Representative (COR), ensuring a seamless initial transition without loss of time or loss of resources in a manner that does not pose obstacles to the conduct of ongoing research.

2. Activities include securing, receiving, cataloging, processing, storing, maintaining, and disbursing human biological specimens from NICHD sponsored studies. All specimens shall have unique, scannable linear or QC barcodes. Re-labeling and destruction of specimens shall occur as necessary at the request of NICHD personnel.

3. Providing a unit pricing schedule for routine activities including receiving, pulling, sorting, labeling, and shipping specimens

4. Providing adequate storage facilities and equipment for securing, cataloging, processing, storing, and disbursing clinical specimens following Biospecimen Repository Best Practices as defined by the International Society for Biological and Environmental Specimens (ISBER). Adequate equipment includes the ability to print and affix scannable barcoded labels to samples.

5. Providing technical assistance and training and communicating with the NICHD Contracting Officer’s Representative (COR) to provide information on repository activities.

6. Developing, performing, and maintaining Quality Assurance systems for the NICHD Repository facility, operations, stored specimens, shipping materials, and personnel in accordance with all applicable Federal, State, and local regulations.

7. Providing a web-based computerized inventory database management and tracking system that is available 24/7 and that can provide downloadable comma separated value (CSV files). The platform shall accommodate filtering on inventory fields prior to downloading information.

Inventory fields might vary per collection. Any proposed inventory system must be capable of ingesting all information from current inventories and or be inter-operable with current inventories such that critical information is retained.

8. Working with other NICHD contractors to establish a technical system to exchange inventory information in real time. This should include the development of, or use of an existing, secure web service application programming interface (API) that enables approved NICHD contractors to query the electronic inventory by study, unique ID, or specimen type, and to filter by these or other inventory fields. If an API is unavailable for an initial period of time, provide another comparable or compatible method to enable real time exchange of inventory information.

9. Providing a technical and administrative infrastructure to ensure efficient planning, initiation, implementation, and management of NICHD repository activities including at least one dedicated Project Manager to oversee the biobank, to supervise all work, and to communicate with

NICHD.

10. Developing and implementing a Final Transition Plan to ensure proper documentation and storage of human specimens upon the termination of each Task.

The anticipated contract type will be a multi-award Indefinite Quantity / Indefinite Delivery (IDIQ) type with an ordering period of 10 years.

The request for proposals (RFP) is anticipated to be posted on or about February 23, 2024, on SAM.gov.

The due date for the submission of proposals is anticipated to be on or about April 8, 2024. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This is not an RFP and this announcement does not commit the Government to award a contract.

Primary Point of Contact:

Gannon White

Contract Specialist gannon.white@nih.gov

Phone: 301.402.9178

Secondary Point of Contact:

Dana Harris

Contracting Officer harrisd@mail.nih.gov

Phone: 301.443.7798

Contracting Office Address:

Contracts Management Branch

6710B Rockledge Dr., Suite 1124, MSC7000

Bethesda, Maryland 20892-7510

United States