NIAID Specimen Repository   3

Introduction

National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducts and supports epidemiological and clinical research on infectious diseases. Many of the large clinical and epidemiological studies funded by NIAID collect biologic specimens from subjects for ongoing and future studies. The collection and storage of these specimens from many different research studies in a single repository is a valuable resource with which researchers can rapidly validate scientific hypotheses and algorithms for clinical decision-making. Comprehensive and well-maintained specimen collections coupled with epidemiologic data have facilitated research on the pathogenesis of HIV disease, development of novel drug approaches, HIV prevention studies of potential microbicides and vaccines, and approaches for eliminating HIV reservoirs

The NIAID Specimen Repository (NSR), first funded in 1988, provides receipt, storage and distribution of biological specimens received from institutions conducting NIAID-sponsored clinical trials and observational cohort studies. Presently the repository largely houses specimens from HIV related clinical trials and cohort studies. The specimens have been collected over many years. Selection of Study Groups storing specimens in the NSR is guided by scientific priorities of NIAID. The current NIAID Study Groups storing specimens in the NSR are: the Women's Interagency HIV Study (WIHS) and the Multicenter AIDS Cohort Study (MACS), now called the MACS/WIHS Combined Cohort Study (MWCCS); and the HIV Vaccine Trials Network (HVTN). The NSR also maintains specimens from other smaller NIAID-sponsored studies that have been completed. There are currently over 8 million specimens in the NSR.

The current contract with Precision Bioservices, Inc., Contract No. HHSN272201400037C, will expire on September 29, 2021.

Description

The purpose of this contract is the short, moderate and long-term specimen storage of domestic and international clinical research specimens through receipt, cryopreservation, and storage of specimens from research sites or laboratories. Specimens include peripheral blood mononuclear cells, serum, plasma, tissue and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, autopsy and biopsy materials and whole blood spots dried on filter paper.

The Contractor shall house, operate and manage the NIAID Specimen Repository (NSR) and perform the following specific tasks: 1) Follow all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific research; 2) Manage specimens (receive, store and maintain specimens); 3) Distribute specimens and materials, including packaging, handling, and coordinating specimen shipments to domestic and international sites. 4) Prepare and aliquot specimens; 5) Provide research materials; 6) Provide or produce additional research materials such as immortalized cell lines, DNA and cDNA, as needed; 7) Withdraw and destroy specimens; 8) Maintain high quality, secure information systems to allow detailed tracking of specimen receipt, processing, storage, inventory and distribution, rapid retrieval of specimens, and storage of QA/QC information associated with the specimen; 9) Establish and maintain Quality Assurance (QA) and Quality Control (QC) Programs; 10) Ensure an orderly transition of the NIAID Specimen Repository at contract initiation and at contract expiration, as needed; and 11) Attend meetings and teleconferences with the COR.

In addition, the Contractor must:

1) Comply with the National Cancer Institute Best Practices for Biospecimen Resources

2) Comply with The International Society of Biological and Environmental Repository Best Practices for Repositories

3) Perform packaging and shipment procedures that meet standards for biologically hazardous materials as Biological Substance Category B, UN3373. Shipments shall comply with current standards as indicated by international, Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances.

4) Handle biological specimens with potential or known blood borne or other potentially infectious pathogens in accordance with OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition CDC Guidelines.

It is anticipated this will be a performance-based acquisition and a cost reimbursement, term/level of effort, type of contract will be awarded. The performance requirement will be the delivery of 20.00 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7), which may be unilaterally exercised by the Government. The option periods may extend the term of the contract beyond the base period for up to 7 years. In addition to the services outlined above to be provided in the base requirement, options for additional level of effort of 1 FTE may be exercised at the discretion of the Government for unanticipated increases in demand that may be exercised up to 2 times in a performance year. Should the Government elect to exercise these options, the Contractor shall provide resources as stated above.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 20, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

PLEASE SEE THE ATTACHMENT BELOW FOR THE SOLICITATION.