NIDDK_Biorepository_Pre-solicitation_Notice___1.pdf

Pre-Solicitation NIDDK Biospecimen Repository

75N94022R00005

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

ONLY. AN RFP WILL BE ISSUED VIA BETA.SAM.GOV ON OR ABOUT JULY 18, 2022. THE

ANTICIPATED DUE DATE FOR SUBMISSION OF PROPOSALS IN RESPONSE TO THE RFP IS ON OR

ABOUT SEPTEMBER 1, 2022.

The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to solicit proposals to award a Research & Development (R&D) Indefinite Quantity- Indefinite Delivery (IDIQ) contract to maintain, enhance, and expand the NIDDK Biorepository component of the NIDDK Central Repository. This announcement is intended to inform interested offerors of a planned RFP, of important background information, and of some key requirements essential for responding to the RFP.

Background information on the NIDDK Central Repository is available on the website https://repository.niddk.nih.gov/home The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts, supports and coordinates epidemiological and clinical research in many of the most serious diseases affecting public health today. In 2003, NIDDK established the Central Repository to archive and redistribute study generated resources from designated large clinical studies, simplifying access and ensuring that biospecimens were stored under uniform conditions. One of the primary goals of the NIDDK Central Repository is to facilitate secondary research using data and biospecimens, thereby enhancing the value of the resources generated by the originating research. In the coming years, in an effort to better align to NIH Strategic Plan for Data Science and NIH Data Management and Data Sharing Policy, NIDDK is seeking to enhance and expand the Central Repository operational areas. There are two operational areas under the NIDDK Central Repository: The NIDDK Data Repository, which receives, archives, maintains, and distributes datasets from studies and serves as the Coordinating Unit for the NIDDK Central Repository, and the NIDDK Biospecimen Repository, hence forth “NIDDK Biorepository” which receives, stores, and distributes renewable and non-renewable biospecimens from active and concluded studies. Biospecimens are collected by large, multi-site clinical studies funded by NIDDK and non-NIDDK funded studies that fall within the research areas and mission of NIDDK. The NIDDK Biorepository maintains biospecimens under high quality conditions, and distributes them in an equitable and ethical manner. In addition, the NIDDK Biorepository receives and processes blood or blood derivatives from select pre-approved studies, to allow for genetic analyses.

Currently, the NIDDK Central Repository makes available online data from over 100 clinical studies and biospecimens from over 85 study collections (> 7.5 million vials) linked at a vial level https://repository.niddk.nih.gov/home to the data in the NIDDK Data Repository. The requirements described below are for the NIDDK Biorepository contract component of the Central Repository. The requirements for this contract include current inventory and the ability to expand and consolidate biospecimen collections currently maintained at outside repositories or laboratory locations, from projects or other NIDDK Central Repository sponsored collections. The NIDDK Biorepository currently uses the Biological Specimen Inventory System (BSI-II) software program (http://www.bsisystems.com), a fully capable relational database system. Contractor will have to use BSI or demonstrate the ability to use a comparable inventory system that will accept the BSI data and link to other central repository data systems.

Project Requirements:

The NIDDK Biorepository contractor shall:

Task Area A: Maintain and Enhance the NIDDK Biorepository Operations.

NIDDK Biorepository supports biospecimen acquisition, processing, storage, inventory maintenance, quality control, and distribution. The NIDDK Biorepository represents a centralized approach to biospecimen processing, storage, and distribution to ensure consistent quality of the biomaterials it holds and associated biological sample metadata that provides the basis for across study secondary analyses. These required services will be used for ensuring daily, overarching performance in the administrative and technical aspects to maintain and enhance the NIDDK Biorepository.

Task Area B: Expand Operations or Services of the NIDDK Biorepository. The Contractor shall expand the NIDDK Biorepository with new services and capabilities. These optional services are to further develop and identify opportunities to align NIDDK/NIH activities with changes and developments in the biorepository field or to support NIDDK funded projects.

Task Area C: Perform contract Close Out and Transitioning. These services are to ensure the safe and orderly transition from this contract should a new contractor be awarded a contract in the future.

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below to support the NIDDK Central Repository’s Biorepository mission. Specifically, the Contractor shall:

Provide a secure environment and the necessary biorepository infrastructure, and provide personnel with the scientific and technical expertise in biorepository science, program management, data management and informatics to maintain, enhance, and expand the NIDDK Biorepository. The NIDDK Biorepository contractor will be provided government owned equipment, materials, and inventory database necessary to maintain the current biospecimen inventory that support the NIDDK Biorepository operations. Additional resources, such as mechanical freezers, cryogenic storage units, and biospecimens, may be added to the program over the period of the contract and will be considered government owned. The contractor shall provide the facilities necessary to optimize support of current inventory and facilitate continued expansion.

Maintain general Quality Management Plan with appropriate Quality Control and Quality Assurance operating procedures, critical to the successful operation of the program, and comply with all necessary regulatory and statutory obligations including but not limited to College of American Pathologist (CAP)- Biorepository Accreditation Program, International Organization for Standardization (ISO) certification, Good Practices compliant for clinical, laboratory, and manufacturing practices applicable to industry biorepositories, and adhere to ISBER Best Practices for Biospecimen Repositories.

Provide detailed plans describing data security, back-up, and disaster recovery measures and incorporate the details into the Information System Security Plan. The plan shall include a daily backup of all changes to the electronic resources to protect against accidental loss. A back-up copy of the electronic resources shall be stored in a remote, secure location and shall be updated at least weekly. Plans shall also include a system for archiving records not needed for daily activities but that need to be retained as records and need to be accessible for audits and inspections.

Ensure that equipment, including mechanical freezers, liquid nitrogen or cryogenic units, and refrigerators in primary and backup facilities are maintained and monitored by trained qualified staff. All equipment is to be operated, maintained, calibrated, and serviced according to manufacturer’s instructions and the contractor’s institution established schedules for preventive maintenance, and as specified in the technical requirements for this contract.

The contractor shall not use the biospecimens, data, and documentation acquired, modified, or developed through the process of this contract for any purpose other than that specified in this contract, without prior written approval of the Contracting Officer (CO) and Contracting Officer Representative (COR).

Comply with NIDDK IT security policies and procedures for contracts including but not limited to IT Security Plan (IT-SP), IT Risk Assessment (IT-RA), FIPS199 Assessment, vulnerability scanning, and Section 508 accessibility. The contractor shall ensure that computer hardware and software procedures comply with all Federal and State regulations related to storage and distribution of inventory data and biospecimens. The contractor shall meet any applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all other relevant Federal and State regulations governing the protection of health information from human subjects.

Ensure that computer programs, databases and other resources, including but not limited to guidance documents and instructions developed through this contract are compliant with terminology and data standards established by NIDDK.

This is not an RFP and this announcement does not commit the Government to award a contract(s). The following tentative schedule of events is anticipated for this acquisition:

The RFP will be available only electronically on or about July 18, 2022 and may be accessed through the beta.Sam.Gov website at: https://beta.sam.gov/. The due date for submission of proposals in response to the RFP is anticipated to be on or about September 1, 2022. It is anticipated that performance will begin on or about May 30, 2023. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement.

OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE BETA.SAM.GOV CONTRACT

OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE

ISSUED.

This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541715. Any questions concerning this announcement must be submitted electronically to: Airron Wiggins at Airron.Wiggins@nih.gov, Contract Specialist and Theresa Ranjit at Theresa.Ranjit@nih.gov, Contracting Officer. The reference number to be used for this announcement is 75N94022R00005. All electronic questions sent must include this reference number in the subject line of the email to both Mr.

Wiggins and Ms. Ranjit concurrently.