NIDA Developmental Studies Biorepository and Analysis Center   3

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified Offerors having the capability to maintain the NIDA Developmental Studies Biorepository and Analysis Center, a repository to process, store, analyze, and distribute de-identified biological samples from the Adolescent Brain Cognitive Development (ABCD) Study and HEALthy Brain and Child Development (HBCD) Study, and to transfer data to the ABCD and HBCD Data Centers.

BACKGROUND:

The ABCD Study is the largest, longitudinal study of brain development and child health in the United States, having enrolled nearly 12,000 children nationwide who will be followed for 10 years. A vast array of assessments are administered to both the participants and their caregivers, spanning mental health, culture and environment, neurocognition, physical health, and substance use every year. In addition, youth undergo neuroimaging and provide biospecimens, including saliva for hormone analysis, urine and hair for substance use and exposure, deciduous teeth for environmental exposure, and blood for genetic analysis and metabolic and hematologic assays. This rich dataset will allow for the investigation of how different genetic and environmental factors interact with each other and with a child's changing biology to affect brain development and social, behavioral, academic, health, and other outcomes. The results of the ABCD Study will provide families; school administrators and teachers; health professionals; and policymakers with practical information to promote the health, well-being, and success of children.

The recently launched HBCD Study will expand upon ABCD with a similar longitudinal study of brain, cognitive, and behavioral development of children from the perinatal period through 9-10 years of age. The HBCD Study is still in the planning stages and is expected to include neuroimaging, genotyping and/or sequencing, behavioral and cognitive development assessments, and the collection of a wide range of biospecimens such as placenta, meconium, breastmilk, blood, urine, feces, etc.

The ABCD study is entering its fifth year, and the third year of data collection. Until now, the DNA extraction and genotyping have been performed through the NIDA Center for Genetic Studies contract. However, as the study progresses it will increase the types of biospecimens collected and the assays that will be performed. Likewise, the HBCD Study will drastically expand the type and number of biospecimens to be collected and stored.

OBJECTIVE:

The objective of this contract is to establish and maintain the ABCD and HBCD Study Biorepository and Analysis Center, which will:

• Provide a biorepository capable of storing over 2,000,000 samples in a secured, humidity and temperature-controlled facility at each samples' required storage conditions in accordance with current Best Practices for Repositories, Biospecimen Resources, Clinical and Laboratory Standards, and Good Laboratory Practice (GLP; 21 CFR 58). The College of American Pathologist's (CAP) Biorepository Accreditation is preferred;
• Provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for performing metabolic, hematologic, and other assays, and cutting-edge, high-throughput genotyping, sequencing, and gene expression capabilities;
• Develop strong cooperative relationships with the ABCD and HBCD Data Centers and study experts in genetics and biospecimens. The Government may execute task orders or modifications to task orders for changes to the protocols, data structure, or type of services that may be required as the studies mature (see Sample Task Orders for reference);
• Provide or develop an Application Programming Interface (API) for the transmission of data to the ABCD and HBCD Data Centers and a cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources; and
• Create and maintain a data management system including a technical and administrative infrastructure to ensure efficient planning, initiation, implementation, documentation and management of all contract activities. This includes Standard Operating Procedures (SOPs) for tasks such as sample receipt, storage, processing, quality control, and distribution procedures.

REQUIREMENT:

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, and as directed to perform the following tasks on data and biological materials received.

1. Receive, aliquot, process, store, and distribute de-identified biospecimens collected from participants and their relatives.
2. Create and maintain databases and data sharing infrastructure.
3. Create a work plan to be submitted with the proposal.
4. Develop protocols for quality assurance, quality control, and corrective action.
5. Prepare a project management plan.
6. Prepare deliverables.
7. Organize site visits.
8. Prepare a phase out transition plan.

The purpose of this contract is to provide resources to support the NIDA Developmental Studies Biorepository and Analysis Center; however, NIDA reserves the right to have the contracted services benefit NIDA and any other component of the National Institutes of Health (NIH).

MANDATORY CRITERIA:

Given the highly technical nature of this endeavor, Offerors must be able to meet the following criteria:

1. Demonstrate an ability to safely receive and process between 200,000 and 250,000 biospecimen samples, and store approximately 2,000,000 aliquots;
2. Establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of award. Furthermore, Offerors shall prohibit the disclosure of the names of research participants or any information, documents, or biospecimens that contain identifiable, sensitive information collected or used in research by an investigator or institution;
3. Document experience in processing, analyzing, storing, and distributing a wide array of biosamples (e.g. blood, serum, plasma, DNA, RNA, saliva, hair, urine, teeth, fecal matter, placenta, meconium, breastmilk), performing cutting-edge, high-throughput genotyping, sequencing, and gene-expression analyses; and developing an API for the transmission of data to the Data Centers;
4. Provide information on ability to obtain Clinical Laboratory Improvement Amendments (CLIA) certification for metabolic, hematologic, and other laboratory assays; and
5. Participate in the evaluation of the scientific and technical merit of applications to obtain and utilize ABCD and HBCD biosamples. Be a cosignatory of the Material Transfer Agreement developed by NIDA.

ADDITIONAL INFORMATION:

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or options quantities. If options or option quantities are utilized for an individual task order they will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds.

RFP No. 75N95020R00018 will be available electronically on February 25, 2020. You can access the RFP through the beta.SAM.gov or through the NIDA website: (https://www.drugabuse.gov/funding/fundingopportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package.

Responses to the RFP will be due May 8, 2020, 3:00 P.M. EASTERN. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

PLEASE NOTE: THIS SOLICITATION IS AMENDED TO REVISE AND UPDATE ATTACHMENT 19 - SCHEDULE OF CONTRACT PRICING (DATED MAY 7, 2020), PLEASE NOTE THE SPECIFIC REVISIONS TO LINE NO. 15 IN CONTRACT YEAR 4 AND 5. THIS AMENDMENT SHALL ALSOEXTEND THE SOLICITATION DUE DATE TO MAY 13, 2020 . PLEASE SEE THE ATTACHMENT FOR AMENDMENT 02 FOR DETAILS.