NIH Brain Development Cohorts Biobank

SMALL BUSINESS SOURCES SOUGHT NOTICE

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from Small Business organizations to provide the Government a resource that can maintain the NIH Brain Development Cohorts (NBDC) Biobank, a repository to process, store, analyze, and distribute de-identified biological samples and related data from the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study and HEALthy Brain and Child Development (HBCD) Study.

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to maintain the NBDC Biobank.

Capable Vendors must demonstrate the experience and capability necessary to manage a large biobank containing over 550,000 samples, which would be transferred at the outset of the award, if other than the incumbent. Capable Vendors must demonstrate the ability to receive a volume of approximately 170,000 samples over the course of the contract.

Interested small business organization must demonstrate the experience, capabilities, and possess in-depth knowledge in the areas listed below.

Sample and Data Management

1. Demonstrate an ability to safely process, store, and track between 500,000-700,000 biospecimen samples from a wide range of biospecimen types (e.g. blood, serum, plasma, DNA, RNA, saliva, hair, urine, teeth, fecal matter, placenta, umbilical cord blood and tissue) at a variety of storage conditions, and perform expert quality control and assurance procedures;
2. Provide 48 research sites across the country with collection kits including barcoded tubes with human readable labels for the collection of biospecimens which will be registered and tracked in the Contractor's auditable Laboratory Information Management System (LIMS). Provide site coordinators and research staff with training for ordering supplies and collecting samples;
3. Maintain positive chain of custody and resolve data/sample discrepancies (e.g. missing data, incorrect information, samples sent to the wrong location) through management and support of issue tracking and resolution. This involves coordination with sites, site monitors, study staff, and the respective receiving or data management teams at the Biobank.
4. Centrally manage and effectively distribute biosamples in the repository to qualified investigators approved through the Biospecimens Access Programs in a cost-effective manner;

Technical & Informatics Requirements

1. Maintain and update databases linking phenotypic/genotypic information with participant and sample IDs;
2. Manage and enhance the NBDC Biobank portal (both front-end and back-end) to support all currently available features and provide updates and improvements when requested. Requirements include, but are not limited to:
   1. Maintain and update existing databases to accurately reflect available samples, and synchronize this data with the Biospecimen Explorer front-end
   2. Provide for the ordering of kits and supplies for the ABCD and HBCD Study staff
   3. Support the Biospecimen Access Program features (e.g. Biospecimen Explorer, Availability Inquiry and Inquiry Dashboard, Resource Availability and Impact Reports)
   4. Maintain ATO and security documents to keep system compliant with FISMA-low and other NIH requirements;
3. Maintain, update, and develop Application Programming Interfaces (APIs) and a cyberinfrastructure for secure, interoperable data exchange;

Laboratory Requirements

1. Lead investigators and support staff must demonstrate experience in biobanking, LIMS and database management. Additional technical requirements include experience to maintain and further develop all aspects of the NBDC Biobank Portal (e.g. backend logic and server maintenance, creating microservices and PostGreSQL databases, website design and UI/UX);
2. Provide scientific and technical expertise to evaluate and offer feedback to researcher-submitted availability inquiries for ABCD and HBCD biosamples.
3. If requested, provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory capabilities (either directly or through subcontracts) for performing metabolic, hematologic, and/or cutting-edge, high-throughput genotyping, sequencing, and gene-expression analyses as needed; ensure scientific leads have appropriate technical experience;

Collaboration & Governance

1. Establish a strong collaborative relationship with the ABCD and HBCD Data Centers and study teams to enable modifications that may be required as the studies evolve;
2. Be a co-signatory of the Specimen Transfer Agreement developed by NIDA; and
3. Be eligible to receive a Certificate of Confidentiality, with adherence to requirements for protecting sensitive participant information as set forth in 45 CFR Part 75.303(a), NIHGPS Chapter 8.3 and15.2.1, and subsection 301(d) of the Public Health Service Act (see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html).

Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications:

1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above.

2) Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of biomedical research.

3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work.

The Government will assess the appropriateness of professional and technical personnel classifications. The Government will consider any other specific and relevant information about this particular announcement that would improve our evaluation of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, contracts in which the organization performed equivalent tasks (Government and commercial); references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability; and awards or commendations.

The established NAICS code is 541714: Research and Development in Biotechnology (except Nanobiotechnology). The U.S. Small Business Administration establishes a size standard for 541714 of 1,000 employees or fewer.

All capability statements also should include the following: 1) company name and address; 2) point of contact, 3) SAM.gov Unique Entity Identifier (UEI) 4) phone/fax/email; 5) NAICS Code(s), 6) business size and status; 7) capability information in response to the requirement and qualifications identified in this notice; and 8) type(s) of business, if any (e.g., small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone).

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received to provide feedback to respondents with respect to any information submitted.

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.

Small business concerns that believe they possess the capability necessary to successfully undertake the work described above must submit capability statements electronically to the Contract Specialist, Shaun Rostad at shaun.rostad@nih.gov, NO LATER THAN 1:00 p.m. EST on July 2, 2026. The Subject line for the submission should include this Small Business Sources Sought Number.

NIDA will not accept paper or faxed capability statements.