Cellular Immunology Core Laboratory

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) is to help ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by supporting research that can lead to the development of therapies, vaccines, and other biomedical prevention strategies. Since the mid-1980's animal models have played an important role in the Institute's efforts to achieve its mission. Animal models present the opportunity to test a variety of candidate HIV and other infectious disease vaccines. Preclinical studies, and in particular, nonhuman primates (NHP) studies are key to evaluate the immunogenicity, efficacy, and toxicity of vaccine candidates, de-risk the product/platform in costly GMP manufacturing, and lastly, help to inform and guide Phase 1 clinical trial studies. Contracts for the Simian Vaccine Evaluation Units (SVEUs) and four centralized Core Laboratories currently evaluate the immunogenicity and efficacy of candidate AIDS vaccines in NHPs. The SVEUs conduct the studies: acquiring and housing the animals, developing the protocols, administering the vaccine, and collecting the samples. The Core Laboratories conduct cellular and humoral immunology, virology, and functional genomic assays to comprehensively assess the immunogenicity of the candidate vaccines and for potential identification of protective immune responses in efficacy studies. Thus, the objectives of the four Core Laboratories are to ensure standardization of the assays and to provide a common basis for comparability of results across different studies. The Cellular Immunology Core Laboratory (CICL) contract (HHSN272201700022C) is held by Tulane University and is the focus of this solicitation. Purpose and Objectives 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. Project requirements The Contractor shall perform immunologic assays to evaluate and characterize the cellular immune responses of animals (in vivo studies) that have been immunized with a candidate vaccine for, or infected with, a pathogen important to NIAID's mission. The assays may include samples from in vitro studies. The types of assays and the samples will be defined by individual study protocols designed by the collaborating investigator, the COR, and/or other individuals identified by the COR, in collaboration with the Contractor. In vivo studies are anticipated to largely include NHP animal studies but may extend to small animal models including mouse models or others as directed by the COR. Samples from animal models for vaccines studies of candidate Mtb vaccines are also anticipated. Additionally, assays for immune response to vaccines for other emerging infectious diseases may be requested. Specifically, the Contractor shall: 1) conduct validated immunological assays using GLP-like processes, 2) perform data analyses; 2) receive, store, catalog, track, and maintain an inventory of the specimens for evaluation; 3) manage, report, and deposit study data; 4) perform project management activities related to contract activities; 5) conduct initial and final transition activities, as needed; and 6) perform option work described below, if required. Anticipated period of performance 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. Other important considerations 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. Capability statement/information sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) corporate experience and management capability; (6) examples of prior completed Government contracts, references, and other related information; and (7) demonstrated ability to carry out the work. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: Unique Entity Identifier (UEI) Company Name Company Address Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought Do you have a Government approved accounting system? If so, please identify the agency that approved the system Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://sam.gov/content/home. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address) Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Kim Dormer Contract Specialist, at kimberly.dormer@nih.gov and Rosemary Gomes, Contracting Officer, at rosemary.gomes@nih.gov in MS Word or Adobe Portable Document Format (PDF). The email subject line must specify 75N93022R00029. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 2:00pm EST, September 7, 2022. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published at SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).