NIDA Developmental Studies Biorepository and Analysis Center
The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from BOTH Other than Small Business and Small Business organizations to provide the Government a resource that can establish and 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.
This is a SOURCES SOUGHT NOTICE to determine the availability of BOTH Other than Small Business and 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 establish and maintain the NIDA Developmental Studies Biorepository and Analysis Center.
A Capable Offeror must demonstrate its ability to process, store, analyze and distribute high-quality biological materials, data files, and supporting documentation. Biological materials may include but may not be limited to the following items; DNA, RNA, serum, whole blood, saliva, hair, deciduous teeth, placenta, meconium, breastmilk, urine, and fecal matter. Biological materials will be collected primarily from participants in the ABCD and HBCD studies. The current repository contains over 15,000 samples. It is anticipated that the biorepository will grow to contain approximately 30,000 samples over the next 12-months. NIDA expects to receive an additional volume of approximately 170,000 to 220,000 samples between 2020 and 2025.
An interested organization must demonstrate its capabilities and experience in performing the requirements listed below:
(1) Provide Site Coordinators with collection kits containing all necessary collection materials including barcoded tubes with human readable labels for the collection of biospecimens which will be registered in the Contractor's Laboratory Information Management System (LIMS);
(2) Provide Site Coordinators and Research Staff with training for collecting samples and interfacing with the LIMS system;
(3) Provide positive, auditable sample tracking and chain of custody to manage sample handling;
(4) Receive, process, analyze and store a wide array of de-identified biosamples (e.g. blood, serum, plasma, DNA, RNA, saliva, hair, urine, teeth, fecal matter, placenta, meconium, breastmilk) at a variety of storage conditions, and perform expert quality control and assurance procedures;
(5) Create databases that contain phenotypic, genotypic, pedigree, and other relevant information about the samples as well as all participant and sample IDs;
(6) Provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories for performing metabolic, hematologic, and other assays;
(7) Perform cutting-edge, high-throughput genotyping, sequencing, and gene-expression analyses as needed;
(8) Establish a strong collaborative relationship with the ABCD and HBCD Data Centers as well as their genetics and biospecimen experts from the study teams, to enable modifications that may be required as the study matures;
(9) Develop an Application Programming Interface (API) for the transmission of data to the Data Centers and a cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources;
(10) Widely distribute biosamples in the repository to qualified investigators in the scientific community who have received awards from the affiliated Biospecimens Access Programs in a highly efficient and cost-effective manner;
(11) Lead Investigators and Support Staff must demonstrate experience in molecular genetic and molecular biology techniques, including biological specimen processing, metabolic, hematologic, and environmental exposure assays in a CLIA-certified environment, microarray analyses, genomic sequencing, transcriptome analysis, and nucleic acid extraction; and
(12) Demonstrate expertise in conducting quantitative genetic research.
Given the highly technical nature of this endeavor, interested Offerors must be able to meet the following Mandatory Criteria:
(1) Demonstrate an ability to safely process and store between 200,000 and 250,000 biospecimen samples;
(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 co-signatory of the Material Transfer Agreement developed by NIDA.
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.
4) Compliance with Mandatory Criteria: Offerors must identify and demonstrate specifically how they will meet the Mandatory Criteria listed above.
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) phone/fax/email;
4) NAICS Code(s),
5) business size and status;
6) capability information in response to the requirement and qualifications identified in this notice; and
7) type(s) of business, if applicable (e.g., Other than Small, 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 PROPOSAL: 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.
Any 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, Josh Lazarus at Josh.Lazarus@nih.gov, NO LATER THAN 4:00 p.m. EST on Thursday, October 31st, 2019. The Subject line for the submission should include this Sources Sought Number.
NIDA will not accept paper or faxed capability statements.
Joshua T. Lazarus, Contract Specialist, Phone 3014436677, Email josh.lazarus@nih.gov
