Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for the operation of the Cellular Immunology Core Laboratory. The current Cellular Immunology Core Laboratory (CICL) is held by Tulane University (HHSN272201700022C).
Description
The purpose of the CICL is to conduct, analyze, develop, optimize, and validate cellular immunologic assays for HIV, Simian Immunodeficiency Virus (SIV), Mycobacterium tuberculosis (Mtb), and other pathogens, performed on fresh and frozen preclinical samples. All assays undergo testing for inter- and intra-assay as well as inter- and intra-operator variability. Standard operating procedures (SOPs) are developed for equipment use and maintenance, laboratory processes, and all assays.
Additionally, all work done by the CICL is considered good laboratory practice (GLP)-like. GLP-like is defined here as the application of the principles of Good Laboratory Practices Regulation, codified in CFR Title 21 Part 58, but without external accreditation or official Food and Drug Administration (FDA) regulatory review of the laboratory. However, conformance to GLP-like procedures is reviewed by an independent quality assurance unit. Thus, the CICL provides high quality assessment on the immunogenicity and efficacy of vaccine or other prevention strategies.
Specifically, the Contractor shall: 1) conduct validated immunological assays using GLP-like processes, 2) perform data analyses; 3) receive, store, catalog, track, and maintain an inventory of the specimens for evaluation; 4) manage, report, and deposit study data; 5) perform project management activities related to contract activities; 6) conduct initial and final transition activities, as needed; and 7) perform option work described below, if required.
The Contractor shall use current state-of-the-art technologies, including at a minimum: ELISPOT, intracellular cytokine staining (ICS), flow cytometry, cell sorting, tetramer staining, and other assays to accomplish the technical objectives, and shall incorporate new and optimized technologies for assay development into contract activities when appropriate. Assays shall incorporate appropriate positive and negative controls using reference panels to define background and dynamic range, and shall demonstrate reproducibility and consistency. The Contractor shall use GLP-like processes to conduct assays.
The Contractor shall use current state-of-the-art methods for analyzing the data generated by the conduct of the assays. This may require different data analysis methods/platforms as appropriate for each type of assay. Data analyses may require the generation of publication quality figures, when directed by the COR.
An independent QA Program, not associated with the Contract, shall conduct regular quality inspections. The frequency of the inspections should occur on a quarterly basis. However, inspections may be conducted on a frequency as appropriate to ensure the integrity of the given study. The inspections will include review of all controlled documents such as protocols and SOPs, as well as raw data. Raw data is defined as all laboratory worksheets, records, memoranda, and notes that result from work conducted that are necessary for the reconstruction and evaluation of the report of that study. Raw data must be generated in accordance with Good Documentation Practices. Additionally, inspections may also review facilities, equipment, personnel, methods, practices, records, and controls.
All data generated, including primary data, assay results, data analyses, figures, graphs, and/or other files/documents that are pertinent to the work being performed shall be deposited in a central data storage repository such as the ImmPort database or other public databases recommended by the COR. The data shall be deposited and summarized in the contract annual report.
Additionally, As directed by the COR, completed assay data and results/analyses shall be electronically sent to the COR and to the individual identified by the COR for deposition into the SVEU Vaccine Study Database.
It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one year options (terms that may be exercised by the Government unilaterally), for a total possible performance period of 7 years, beginning on or about March 1, 2024. The performance requirement will be the delivery of 9.25 full time equivalents (FTEs) per year for the base period (Year 1) and option periods 1-6 (Year 2 through Year 7). Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
In addition, the Government may exercise options to accommodate unanticipated increases in demand as follows:
- Options 7 through 13: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 Full Time Equivalent (FTE) for each option exercised. These options may be exercised once per year during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised. Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
- Options 14 through 27: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of the contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.5 Full Time Equivalent (FTE) for each option exercised. These options may be exercised twice a year during Years 1 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised. Please note that the number of FTEs is exclusive of subcontractor and consultant effort.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about December 16, 2022, and may be accessed through 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 solicitations where proposals will be received via the NIAID electronic Contract Proposal Submission (eCPS) website (ALL R&D solicitations MUST be in eCPS) add the following:
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."
Background
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under the Department of Health and Human Services (DHHS), is dedicated to advancing research in microbiology and immunology. The agency aims to develop vaccines, therapeutics, and diagnostics for infectious and immune-mediated diseases. The NIAID's Division of AIDS has a requirement for the operation of the Cellular Immunology Core Laboratory (CICL), which is currently held by Tulane University. This contract seeks to enhance the laboratory's capabilities in conducting cellular immunologic assays.
Work Details
The Contractor shall:
1) conduct validated immunological assays using Good Laboratory Practice (GLP)-like processes;
2) perform data analyses;
3) manage specimen inventory including receiving, storing, cataloging, and tracking;
4) report and deposit study data;
5) oversee project management activities related to contract tasks;
6) execute initial and final transition activities as necessary;
7) perform additional option work as required.
The Contractor must utilize state-of-the-art technologies such as ELISPOT, intracellular cytokine staining (ICS), flow cytometry, cell sorting, tetramer staining, among others. Assays must include appropriate controls and demonstrate reproducibility. Data analysis may involve generating publication-quality figures as directed by the Contracting Officer's Representative (COR). An independent quality assurance program will conduct regular inspections to ensure compliance with GLP-like standards. All generated data must be deposited in a central repository like the ImmPort database or other public databases as directed by the COR.
Period of Performance
The contract will have a base period of one year with six additional one-year options, totaling a possible performance period of seven years, beginning on or about March 1, 2024.
Place of Performance
The work will be performed at the Cellular Immunology Core Laboratory operated by Tulane University.
