March 23, 2023
None
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) supports a comprehensive research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections and co-morbidities, and provides capability to support similar efforts related to emerging infectious diseases. NIAID develops and supports the research infrastructure and biomedical research needed for: 1) the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develops novel approaches for the treatment and cure of HIV and other infections; 3) treats and/or prevents HIV co-infections and co-morbidities of greatest significance; and 4) partners with scientific and community stakeholders to efficiently implement effective interventions.
A variety of immunological laboratory tests are included in NIAID-sponsored or supported clinical trials designed to evaluation of candidate vaccine platforms, immunogens, adjuvants, and monoclonal antibodies. Reliable, regulatory-compliant laboratory data are essential to the clinical evaluation of those products. Data from multiple laboratories performing assays in support of clinical trials testing single or multiple vaccine candidates or monoclonal antibodies must be accurate and reproducible. NIAID employs a variety of contract resources including the External Quality Assurance Program Oversight Laboratory (EQAPOL) to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing to support vaccine immunogen and monoclonal antibody advancement and approval by U.S. and non-U.S. regulatory entities. EQAPOL supports these efforts by participating in the development and availability of validated assays, providing common and well characterized reagents and Standard Operating Procedures (SOPs), and providing External Quality Assurance (EQA) programs to measure and monitor laboratory performance.
These activities are currently being provided under the following NIAID contract:
- HHSN272201700061C with Duke University, 2200 West Main Street Suite 300, Durham, North Carolina 27705-4677
The Government intends to award a single-award IDIQ contract to support these activities. NIAID anticipates Task Orders being issued against the IDIQ contract will be cost reimbursement and/or firm fixed price. While the Base IDIQ contract will not have options, options may be included at the individual Task Order level.
The purpose of the proposed Indefinite Delivery/Indefinite Quantity (IDIQ) contract is to establish and support proficiency testing programs, currently serving both domestic and international sites worldwide, and provide a panel of fully characterized viruses from early acute HIV infections to develop new assays and validate assay platforms. The contract will establish a peripheral blood mononuclear cell (PBMC) bank and an EQA reagent repository of characterized material that supports EQAPOL proficiency testing programs and are made available to NIAID-supported investigators. While it is anticipated that this contract will largely support HIV vaccine efforts, it will also address urgently needed laboratory programs in support of the SARS-CoV-2 activities for prophylactic vaccines and antibodies. The contract may be asked to support other emerging infectious disease as the need arises.
Scope
The Contractor shall provide external quality assurance/internal quality control (EQA/IQC) and operational activities in support of HIV vaccine efforts and SARS-CoV-2 activities for prophylactic vaccines and antibodies. The contractor may be asked to support EQA/IQC activities for other emerging infectious diseases as the need arises.
General Technical Requirements
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 as stated herein.
Work shall follow the applicable NIAID Guidelines for Good Clinical Laboratory Practice (GCLP) Standards https://www.niaid.nih.gov/sites/default/files/gclpstandards.pdf.
Contractor staff shall have appropriate accreditations where applicable (e.g. College of American Pathologists (http://www.cap.org) and/or American Association for Laboratory Accreditation (http://www.a2la.org). When necessary, the Contractor shall have local Institutional Review Board (IRB) approval for its activities.
The Contractor shall design, manage and coordinate logistical support for the optimization and quality assurance of assays for vaccine candidates. When needed provide data management, biostatistics and project management support to participating laboratories.
The Contractor shall acquire, aliquot, store, assemble and ship standardized reagents including PBMCs, peptides, controls, antigens, antibodies, evaluation panels and other reagents. Conduct quality control and quality assurance tests of reagents and materials to define standard performance and ensure optimal quality, consistency, reproducibility and lot-to-lot comparability over time. As appropriate include bridging studies and trend analysis for reagents/materials/specimens to ensure lot-to-lot comparability.
The Contractor shall develop consensus protocols, prepare SOPs and instructions and distribute to participating laboratories.
The Contractor shall receive, process and evaluate proficiency data received from participating laboratories and the Contractor’s facility to define assay acceptability criteria (pass/fail) for performance assessment. Monitor performance of laboratories over time and report trending analyses to participating laboratories. Report trending analyses to demonstrate how each laboratory’s data fit in the overall data set.
The Contractor shall monitor and trend positive/negative control assay results to determine any shifts in data as an indication of laboratory performance, and provide assistance to participating laboratories as directed by the Contract Officer’s Representative (COR) to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
The Contractor shall work with laboratories as directed by the COR to develop corrective action plans.
Specifically, the Contractor shall:
- MAINTAIN AND EXPAND EQA REAGENT AND MATERIALS REPOSITORY
- Maintain a reagent repository consisting of peptides, antigens/antibodies, serum, plasma, viruses, cell lines and other materials used for EQA programs, panel development, or assay development.
- Maintain a repository consisting of PBMCs from HIV-1 uninfected human volunteers (HIV-1 seronegative, HIV-1 and other infectious disease vaccinated volunteers) and PBMCs from HIV-1 infected/positive human volunteers.
- Expand and/or replenish this PBMC bank with cells from additional human subjects as directed by COR.
- Upon request of the COR characterize PBMC samples:
- For cytomegalovirus (CMV), Epstein Barr Virus (EBV), hepatitis B titer or other pathogens (e.g., SARS-CoV-2).
- Perform molecular based HLA class I typing to 4-digit resolution for A, B and C alleles.
- Provide immunophenotyping and characterize PBMCs to include assessment of viability and recovery and T cell function as determined by ELISpot and/or intracellular cytokine staining (ICS) by flow cytometry.
- Include human leukocyte antigen (HLA) Class II and (killer cell immunoglobulin-like receptors) KIR genotyping.
- Receive, store, ship and inventory PBMC and EQA reagents including:
- Provide for appropriate storage and 24-hours a day/seven days a week monitoring of refrigerator/freezer/liquid nitrogen unit conditions by automatic temperature alarm to guarantee continuous proper storage and integrity of cryopreserved PBMC and EQA reagents to include peptides, antigens, antibodies, serum, plasma, viruses, cell lines, and other biological specimens.
- Provide: (1) uninterruptible power to accommodate freezers and refrigerators; (2) continuously monitored central alarm system connected to refrigerators, freezers and liquid nitrogen units, and staff to be notified in the event of equipment malfunction; (3) emergency stand-by refrigerators, freezers and Liquid nitrogen units to be available in case of mechanical failure of storage space; and (4) equipment maintenance services.
- Ship infectious and non-infectious PBMC and EQA reagents to domestic and international laboratories, using shipping conditions appropriate for preserving the PBMC or EQA reagents. Use biocontainment shipping procedures that comply with International
- Air Transport Association (IATA) Dangerous Goods Regulations
- (www.iata.org) for shipment by air transportation or with Department of Transportation (DOT) regulations for shipment by ground transportation, and obtain export permits as required.
- Establish an inventory control system for PBMC and EQA reagents and materials so that their use and disposition can be monitored.
- ESTABLISH AND CHARACTERIZE UNIQUE CLADE-SPECIFIC HIV VIRUS PANELS
- Receive and catalog source material (e.g. plasma) from NIAID collaborators (domestic and international) and perform HIV virus characterization. This includes isolating, culturing, propagating, and aliquoting clarified supernatant containing virus for storage, testing, and re-distribution as requested by the COR.
- Aliquot and store cultured virus as supernatant and/or in defibrinated plasma.
- Perform HIV viral load assays to support the virus characterization.
- Characterize selected HIV strains for host co-receptor usage, and perform full length sequencing, sterility testing for endotoxin and mycoplasma, p24, and Medium Tissue Culture Infectious Dose (TCID50).
- Store and distribute viruses and/or plasma. Activities shall include reviewing the storage inventory, retrieving the required vials, packaging for safe and proper shipment, and shipment to labs as approved by the COR.
- EQA PROGRAM FOR ELISpot
The Contractor shall submit to the COR, a plan to develop, set up, manage and coordinate an interferon-gamma ELISpot proficiency program for NIAID supported laboratories to provide an unbiased assessment of data quality from participating laboratories. The plan shall be implemented within 30 calendar days after COR approval. The activities shall include the following:- Manage and coordinate an ELISpot EQA Program.
- Develop consensus protocols, prepare SOPs and instructions for participating laboratories.
- Conduct EQC and IQA of reagents and materials to define standard performance and ensure optimal quality, consistency, reproducibility and lot-to-lot comparability over time.
- Acquire, aliquot, store, assemble and ship standardized reagents including PBMCs, peptides, controls, evaluation panels and other reagents.
- Process and evaluate proficiency data received from participating laboratories and the Contractor’s facility to define assay acceptability criteria (pass/fail) for performance assessment. Monitor performance of laboratories over time and report trending analyses to participating laboratories.
- Work with laboratories as directed by the COR to develop corrective action plans.
- EQA PROGRAM FOR FLOW CYTOMETRY-BASED ASSAYS
The Contractor shall submit to the COR, a plan to develop, set up, manage and coordinate an EQA program for flow cytometry assays. The plan shall be implemented within 30 calendar days after COR approval. The activities shall include the following:- Generate a standardized set of reagents consisting of antigens and antibody cocktails that ensure convenience, stability and standardization.
- Develop specifications and perform QC tests based upon physical properties (appearance, residual moisture, etc.) of the lyophilized reagents to ensure consistency and quality. Determine the standard performance of each lot, document and track the lot-to-lot reproducibility of the reagents.
- Create a set of instructions and gating templates for these reagents. The instructions shall provide a suggested method that has been validated to provide optimal results. The Contractor shall determine any unique changes that a particular laboratory may have made in comparison to the suggested instructions to be used in case of troubleshooting.
- Evaluate primary data received from participating laboratories and produced in the Contractor’s facility to define assay acceptability criteria for overall performance assessment. Monitor performance of laboratories over time and report to participating laboratories trending analyses to demonstrate where each laboratory’s data fit in the overall data set. Provide information to the COR to determine the success of the program in maintaining or improving precision across laboratories.
- Work with NIAID supported laboratories in consultation with the COR to develop a corrective action plan as needed.
- As directed by the COR, develop and optimize additional phenotypic and functional flow cytometry panels, develop/implement new flow cytometry assays and/or variations of other flow cytometry-based assays and analysis methodologies, develop/implement novel T cell assays, and evaluate test results as needed.
- EQA PROGRAM FOR MULTIPLEX CYTOKINE ASSAYS
- The Contractor shall submit to the COR, a plan to develop, set up, manage and coordinate an EQA program for multiplex cytokine assays. The plan shall be implemented within 30 calendar days after COR approval. The activities shall include the following:
- Manage and coordinate an EQA program for cytokine assay array such as Luminex and/or Meso Scale Discovery (MSD) to provide participating laboratories with two scheduled evaluations per year. Develop consensus protocols and prepare SOPs and instructions for participating laboratories.
- Acquire, aliquot, store, assemble and ship all necessary reagents and controls to perform a 5-plex Luminex-bead assay to quantify IL-2, IL-6, IL-10, TNF-alpha and IFN-gamma. Conduct QC and QA of reagents and materials to define standard performance and ensure optimal quality, consistency, reproducibility and lot-to-lot comparability over time for different rounds of testing.
- Evaluate primary data received from participating laboratories and the Contractor’s facility to define assay acceptability (pass/fail) criteria for performance assessment. Monitor performance of laboratories over time and report trending analyses to participating laboratories to demonstrate where each laboratory’s data fit in the overall data set.
- Work with NIAID supported laboratories, as directed by the COR, to develop corrective action plans as needed.
- Upon request of the COR, develop and implement additional EQA programs for other multiplex/array platforms and/or inclusion of additional analytes (cytokines).
- EQA PROGRAM FOR MULTIOMICS
The Contractor shall submit to the COR, a plan to develop, set up, manage and coordinate an Omics EQA program. Omics include, but are not limited to, transcriptomics, epigenomics, proteomics, metabolomics, and immune repertoire analysis, as for example single-cell RNA sequencing (scRNAseq) and single-cell Assay for Transposase-Accessible Chromatin using sequencing (scATAC-seq). Such methodologies are currently being employed to assess new vaccine immunogen and adjuvant formulations. For example, the investigation of the B cell receptor repertoire through scRNAseq can help infer whether specific B cell germlines are correctly engaged and activated by the immunogen during vaccination protocols. In order to allow comparisons between laboratories as well as different clinical trials, these new methodologies require a rigorous process of optimization and validation. Key reference reagents for all steps of the assays, development of SOPs, assay validation, and proficiency test panels assays are critical. The activities shall include the following:- Design and execute a program to provide logistical support for the optimization of Omics methodologies employed for the assessment of vaccine candidates by receiving, storing, quality assuring, and redistributing reagents/materials, and tracking shipments to laboratories supporting assay development.
- Prepare stocks of reagents/materials and necessary specimens.
- Prepare and implement EQA/IQC program(s) (including bridging studies and trend analysis) for these reagents/materials/specimens to ensure lot-to-lot comparability.
- Develop and distribute SOPs to the laboratories and assist in implementation of the assay(s) in participant laboratories.
- Receive and analyze data from the participant laboratories. Notify laboratories of performance in collaboration with the COR.
- Provide assistance to participating laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- EQA PROGRAM FOR EVALUATION OF PHARMACOKINETICS AND/OR PHARMACODINAMICS FOR MONOCLONAL ANTIBODY PRODUCTS
The Contractor shall submit to the COR a plan to develop, set up, manage and coordinate EQA/IQC program(s) for pharmacokinetics (PK) and/or pharmacodynamics (PD) assays for evaluation of monoclonal antibody products. The plan shall be implemented within 30 calendar days after COR approval. The activities shall include the following:- Design and execute an EQA/IQC program to monitor and evaluate the ability of laboratories to accurately and reliably perform study-specified pharmacology assays for clinical studies testing monoclonal antibody products.
- Prepare stocks of reagents/materials and necessary specimens.
- Prepare and implement EQA/IQC program(s) (including bridging studies and trend analysis) for these reagents/materials/specimens to ensure lot-to-lot comparability.
- Develop and distribute SOPs to the laboratories and assist in implementation of the assay(s) in participant laboratories.
- Receive and analyze data from the participant laboratories. Notify laboratories of performance in collaboration with the COR.
- Provide assistance to participating laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- EQA PROGRAM TO ASSESS COLLECTION, STORAGE, AND TESTING OF MUCOSAL SPECIMENS
The Contractor shall participate in assay development and validation for mucosal immune parameters and assist in development of an EQA/IQC program to assess collection, storage, and testing of mucosal specimens for host pathogens (microbiota) and/or vaccine-elicited innate and antigen specific immune responses. The activities shall include the following:- Design and execute a program to provide logistical support for assessment of collection, storage, and testing of mucosal specimens employed for the study of vaccine candidates by receiving, storing, quality assuring, and redistributing reagents/materials, and tracking shipments to laboratories supporting assay development.
- Prepare stocks of reagents/materials and necessary specimens.
- Prepare and implement an EQA/IQC plan (including bridging studies and trending analysis) for these reagents/materials/specimens to ensure lotto-lot comparability.
- Develop and distribute SOPs to the laboratories and assist in implementation of the assay(s) in participant laboratories.
- Receive and analyze data from the participant laboratories. Notify laboratories of performance in collaboration with the COR.
- Provide assistance to participating laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- SUPPORT THE DEVELOPMENT OF ANTIBODY CHARACTERIZATION ASSAYS AND EQA PROGRAMS
The Contractor shall participate in assay development and validation of assays for antibody characterization assays and EQA programs. Laboratory assays used to assess candidate vaccine immunogens based on the antibody responses they elicit are continuing to be developed. These include tests to measure neutralizing antibodies and ELISAs to measure binding antibodies in addition to multiplex technologies anti-HIV responses. Various vaccination strategies are likely to produce a variety of antibody isotypes with unique functional abilities, such as antibody dependent cellular cytotoxicity (ADCC), opsonization, fixation of complement, binding of Fc receptors and specific localization of immune mediators (e.g. mucosal immunoglobulin). Assays for these will require a rigorous process of optimization and validation before use in clinical trials. Key reference reagents, development of SOPs, assay validation, and proficiency test panels for newly developed antibody characterization assays are critical. The activities shall include the following:- Design and execute a program to provide logistical support for the optimization of new assays by receiving, storing, quality assuring, and redistributing reagents/materials, and tracking shipments to laboratories supporting assay development.
- Prepare stocks of reagents/materials and necessary cell lines.
- Prepare and implement EQA/IQC program(s) (including bridging studies and trend analysis) for these reagents/materials and cell lines to ensure lot-to-lot comparability.
- Develop and distribute SOPs to the laboratories and assist in implementation of the assay in laboratories.
- Receive and analyze data from the laboratories. Notify laboratories of performance in collaboration with the COR.
- Provide assistance to participating laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- EQA PROGRAM FOR HIV INCIDENCE ASSAYS
The Contractor shall submit to the COR, a plan to develop, set up, manage and coordinate a proficiency program for assessment of performance of HIV Incidence assays to provide an unbiased assessment of data quality from participating laboratories. The plan shall be implemented within 30 calendar days after COR approval. The activities shall include the following:- Identify appropriate specimens and controls for use in an on-going proficiency testing program of assays in widespread use for the differentiation of recent and long-standing HIV infections. These specimens will be of sufficient volume to maintain the program and be adaptable to suitable specimen matrices for available assays.
- Design and execute a proficiency test program to externally assess the ability of laboratories to generate accurate, reproducible assay performance data with the CDC’s Limiting Antigen (LAg) avidity assay.
- Provide logistical support by receiving, storing, and provide oversight for quality assurance, and redistributing reagents/materials to the laboratories as well as tracking shipments.
- Process and statistically evaluate primary data received from participating laboratories and produced in the Contractor’s facility to define assay acceptability (pass/fail) criteria for overall performance assessment. Monitor performance of laboratories over time and report trending analyses to participating laboratories to demonstrate where each laboratory’s data fit in the overall dataset.
- Work with laboratories as directed by the COR to develop corrective action plans as needed.
- EQA AND IQC PROGRAM FOR SARS-COV-2 ASSAYS
The Contractor shall develop and provide SARS-CoV-2 EQA Programs to monitor binding and neutralizing antibodies for SARS-CoV-2 viruses and transfer assays to identified laboratories. Similarly, upon request of the COR, the Contractor shall provide a SARS-CoV-2 IQC and EQA program and reagent repository, assay transfer support (from the US-funded laboratories to identified Contract Research Organization (CRO) laboratories), and biostatistical support, for CRO laboratories working in COVID-19 vaccine and/or antibody preparations.- Design, set up, manage, and coordinate EQA programs for neutralization and binding antibodies to SARS-CoV-2 to provide an unbiased assessment of data quality from participating laboratories.
- Maintain, adjust, and expand IQC and EQA programs and reagent repository (e.g., viruses, monoclonal antibodies, convalescent and vaccine clinical trial plasma/serum/cells), to support other SARS-CoV-2 immune assays as relevant (e.g., ACE biding-inhibition assay, anti-Spike MSD etc.).
- Develop and distribute SOPs to the laboratories and assist in implementation of the assay in laboratories.
- Receive and analyze data from the laboratories, and provide data management, biostatistics and project management support for the EQA/IQC program(s).
- Notify laboratories of performance in collaboration with the COR.
- Monitor and trend positive/negative control assay results to determine any shifts in data as an indication of laboratory performance, and provide assistance to participating laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- EQA PROGRAMS FOR EMERGING INFECTIOUS DISEASES
When requested by the COR, the Contractor shall develop and implement EQA programs for emerging infectious diseases, which include but are not limited to binding and neutralization antibody assays as well as cell assays.- Design and execute a program to provide logistical support for the optimization of new assays by receiving, storing, quality assuring, and redistributing reagents/materials, and tracking shipments to laboratories supporting assay development.
- Prepare stocks of reagents/materials and necessary cell lines.
- Prepare and implement EQA/IQC program(s) (including bridging studies and trend analysis) for reagents/materials and cell lines to ensure lot-to-lot comparability.
- Develop and distribute SOPs to participant laboratories and assist in implementation of the assay in the laboratories.
- Receive and analyze data from the participant laboratories. Notify laboratories of performance in collaboration with the COR.
- Provide assistance to laboratories as directed by the COR to troubleshoot assay results and protocol deviations, and report outcomes to the COR.
- CONDUCT LABORATORY AUDITS FOR PROFICIENCY TESTING PROGRAMS UNDER THIS CONTRACT
- Provide laboratories and research sites with support activities, to include:
- capacity assessment, capacity building, and audits to assess EQA program assay-specific expertise and operation capability.
- Provide support services for EQA program assay-specific document preparation, translations, data management, and analysis.
- Conduct laboratory audits to include Good Clinical Laboratory Practices (GCLP) and/or Good Laboratory Practices (GLP) to assess compliance with Federal regulatory requirement and/or applicable NIAID policy requirements and perform EQA program assays.
- OPERATE AND MAINTAIN A CENTRAL PORTAL FOR ACTIVITIES
- Track EQAPOL activities including real time inventory of cells, viral samples, serum, plasma, etc. (including characterization data), reagents and materials.
- Provide an interface to permit participating laboratories to directly provide EQA testing data of primary and processed results.
- Allow participating laboratories to retrieve their individual test data reports.
- Store data analyses and statistical analyses; track protocol/assay deviations and tracking performance of laboratories over time (trending analysis).
- Share technical and scientific documents, SOPs, forms, etc. with laboratories participating in the EQA Programs.
- Maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA). This shall include a comprehensive assessment of the management, operational, and technical security controls in the system to determine the extent to which the controls are implemented correctly, operating as intended, and producing the desired outcome with respect to meeting a specified set of security requirements for the system. These actions are referred to as System Assessment and Authorization (SA&A). The NIAID Information System Security Officer (ISSO) reviews the Contractor’s System Security Plan (SSP), Security Assessment Report, and their Corrective Action Plan to support the Contractor’s decision to authorize operation of an information system and to explicitly accept the risk to NIAID data based on the implementation of an agreed-upon set of security controls. The Contractor shall use the National Institute of Standards and Technology (NIST) Special Publication (SP) NIST SP-800-171 - Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations; https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final
- Upon COR approval the Contractor shall place in operation and maintain the system. COR and CO approval shall be required for updates to the system that include hardware and/or software.
- Although the Contractor may choose to use a different web-based database from the established database, this contract will not cover costs for developing a new database.
- COORDINATE OPTIMIZATION EFFORTS FOR NEW ASSAYS AND ADVISE ON ASSAY VALIDATION, REGULATORY, COMPLIANCE, AND STATISTICAL ISSUES
The Contractor shall provide strategic, product and assay development consulting services to NIAID. The Contractor will perform a complete assessment of the methods, including the validation and “cross-validation” of specific analytical methods performed by NIAID supported laboratories.
- Provide advice to NIAID and NIAID-supported laboratory staff in the development, optimization and validation of novel immunological assays needed for candidate vaccine immune monitoring. This advice shall be provided through teleconferences/videoconferences, participation in site visits, writing and reviewing reports, and writing consensus SOPs.
- Review methods development and validation packages and provide a comprehensive evaluation of the scientific merit and regulatory compliance of these packages. This review shall be provided to the COR in a formal written report within three weeks of receipt of information.
- Provide recommendations to the COR for additional assay development, assay transfer, or validation necessary to meet regulatory agency requirements.
- Provide training or guidance templates on biological assay development, validation, HIV diagnostic algorithms, cross validation, and assay transfer methodologies, as requested.
- At the request of the COR, provide training at investigator meetings and regional training events. Obtain COR pre-approval of training materials at least 3 business days prior to the date of the presentation.
- At the request of the COR and upon approval of the Contracting Officer, share data and research results with the scientific community at investigator meetings and regional training events.
- MEETINGS AND TELECONFERENCES
While meetings and teleconferences are a requirement, this type of requirement shall be specified at the task order level.
- ESTABLISH AN INDEPENDENT EXTERNAL ADVISORY GROUP
While establishing an independent external advisory group will be a requirement, this type of requirement shall be specified at the task order level.
Anticipated Period of Performance
It is anticipated that a single Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract will be awarded on or about July 1, 2024, for a period of 7 years, through June 30, 2031. Task Orders to be issued against the Base contract will primarily be cost-reimbursement type, both term and completion form. The Government reserves the right, however, to issue fixed-price type Task Orders, when appropriate.
At this time, upon award of the Base contract for this single award IDIQ, the Government anticipates awarding one task order as follows:
Task Order #001, External Quality Assurance Program Oversight Laboratory Support Services. The period of performance will be for a one (1) year (Base Period), plus 6 one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about July 1, 2024. The requirement will be for the delivery of 12.62 full time equivalents (FTEs) per year, for the Base Period (Year 1), and 12.62 FTEs per year for Options 1-6 (Years 2-7).
OPTION 7 - 26: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated demand for the activities supported by the base requirements under this task order. Such as increase would require the Contractor’s effort/activities to be activated, at the discretion of the Government, as an Option. Should the Government elect to exercise this option, the Contractor shall provide an additional 1.0 FTE for each option exercised for a total of 20 options during the life of the task order, as follows: Year 1 (Options 7-11), Year 2 (Options 12-15), Year 3 (Options 1618), Year 4 (Options 19 and 20), Year 5 (Options 21 and 22), Year 6 (Options 23 and 24), and Year 7 (Option 25 and 26).
Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about March 23, 2023, and may be accessed through SAM http://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 NIH’s electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. 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."
POINT OF CONTACT
Chris Ray
Contract Specialist
AIDS Research Contracts Branch
Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C28, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852
Telephone: 240-627-3365
Email: chris.ray@nih.gov
Robert Corno
Contracting Officer
AIDS Research Contracts Branch
Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C31, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852
Telephone: 240-669-5151
Email: cornorj@niaid.nih.gov
and Human Services (HHS)
