Presolicitation Notice.docx

PRESOLICITATION NOTICE

Clinical Research Operations Core 75N93025R00019

Type of Requirement

Place of Performance

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Duration of contract: 7-year ordering period and 10 year completion.

If Options will be included, describe Options _______N/A________________________

Anticipated award date: July 16, 2026

Presolicitation Notice Information

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research for the investigation, control and prevention of diseases caused by all infectious agents. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts as described in the following link: https://www.niaid.nih.gov/research/resources.

The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a product development-oriented program to provide preclinical development support for multiple vaccine and biologic candidates.

Description

The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID’s mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions.

These services are intended to support:

· A wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies.

· NIAID priority activities including manufacture and characterization of reagents and products to support government supported clinical trials such as those supported by IDCRC.

· Manufacture of critical reagents and clinical trial material to support the wider scientific community and non-government sponsored projects.

NIAID has implemented a Determination of Exceptional Circumstances in accordance with 37 C.F.R. § 401.3(e) (see Advanced Understandings) for NIAID’s preclinical service contracts that include Vaccine (and Other Biologic) Manufacturing Services for Infectious Diseases. Consequently, all contractors are required to operate under a fee-for-service model, and the contractor may be required to assign any intellectual property they file on third part material of information (“Provider Materials”), or new processes, and products relating to Provider Materials they develop and manufacture. The contractor will also be required to delay any public release of results until NIAID and Provider have a chance to review and file patents of their own. The contractors may propose the use of reagents and processes that are proprietary or under license. However, NIAID and the Provider reserve the right to reject the use of these alternative materials and processes.

Project Requirements

The NIAID recognizes that a single organization or institution may not have the full spectrum of expertise or facilities required to perform all activities set forth in the Statement of Work nor have expertise in the wide array of candidate products that NIAID may seek to support. Consequently, NIAID anticipates awarding a single IDIQ contract to meet the overall qualifications needed to fulfill the technical requirements of the Task Areas of this solicitation. Offerors may submit proposals to a single Task Area or multiple Task Areas. Offerors may propose to extend internal expertise and resources by including the expertise and resources of other organizations or persons through subcontracts, partnerships, consortia agreements, and/or use of consultants. However, an awarded Contractor shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management, and communication; evaluation, selection, and management of subContractors; and for all deliverables specified in this contract and each awarded Task Order.

Under the award of the Indefinite Delivery Indefinite Quantity (IDIQ) contract, the future Contractor will support the full range of activities for implementation and conduct of clinical trials using qualified clinical staff with expertise in carrying out all aspects of clinical trial implementation and their operations, biospecimen management, and collaboration specified NIAID grant recipients and Contractors. The IDIQ contract may also serve as NIAID’s mechanism for responding to emerging infectious diseases by establishing domestic or international clinical trials and clinical research activities.

The Government anticipates both single and/or multiple awards for each Task Area.

This solicitation includes the following Task Areas:

· Task Area A: Project Management and Protocol Development

· Task Area B: Protocol Implementation and Clinical Operations

· Task Area C: Research Laboratory Analysis

Offerors may respond to one or multiple Task Areas. Offerors will only be considered for Task Area(s) that they include in their proposal. Offerors must respond to all Sample Task Orders within a task area and will be evaluated on their ability to support proposed work within the task area and sample task order.

Individual Task Orders for specific tasks will be issued after award of the Parent Contract. In cased of multiple offerors, all offerors will be provided a Request for Task Order Proposal and offered the opportunity to submit a Task Order proposal.

Respondents are expected to respond to all areas, including the Parent Contract and Task Areas A, B, and C. Respondents that do not include a response to the Parent Contract and all Task Areas will be considered non-responsive and will not be evaluated.

Respondents lacking the expertise to address all the technical requirements are encouraged to identify collaborations and partnerships that, through combined expertise, can address all these technical requirements.

In the event of a Public Health threat and/or emergency, the Contractor may be required to:

· Manufacture critical reagents or components to support assay development and other support under devices regulations.

· Support vaccines, other biological products, or critical reagents that are intended for product development use in animals that constitute a disease reservoir for pathogen(s) that pose a public health risk.

· Support efforts associated with zoonotic diseases.

· Provide support outside of Phase I/II clinical trials.

For the purposes of this SOW, the following definitions shall apply:

· Vaccines – An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy or eliciting immune-based responses that interrupt pathogenesis. Vaccine products include but are not limited to synthetic peptides, recombinant proteins, nucleic acids including mRNA, viral-like particles, vector-based vaccines, as well as live, modified, and/or attenuated bacteria, viruses, parasites, and other organisms.

· Vaccine Components – Any substance or device that maintains, stabilizes, or enhances a vaccine’s activity or ability to invoke an immune response. Vaccine components include but are not limited to adjuvants to increase immunogenicity, excipients to increase stability, and delivery systems including novel dosage forms and devices.

· Other Biologics – Therapeutic preparations made from living organisms or the components of living organisms and are most likely regulated by the Center for Biologics Evaluation and Research (CBER). Biologics include but are not limited to allergenics; antitoxins; blood and blood products; cellular and gene therapy products, animal derived products, bacteriophage and other modified viruses and pathogens. For the purposes of this contract, challenge material for non-clinical, preclinical, and clinical trials will also be included in the definition of biologics. Other biologics will include BSL-2, BSL-3, and BSL-4 material.

· Reagents – Materials required to manufacture and test vaccines, vaccine components, and other biologics in support of product release and characterization. Reagents include but are not limited to assay components such as polyclonal and monoclonal antibodies, receptors, and cell lines; manufacturing reagents such as affinity resins, product specific components such as conjugation reagents, adjuvant specific reagents; and reagents required for potency assays, pre-clinical assays, and non-clinical assays.

The services shall support countermeasures including but not limited to:

· diseases caused by pathogens and toxins on the NIAID Category A, B, and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx)

· emerging and re-emerging infectious diseases;

· antimicrobial resistant and multi drug resistant infections;

· other bacterial infections;

· fungal infections;

· viral infections; and

· parasitic diseases.

Anticipated period of performance

This is an IDIQ Contract with a seven-year ordering period (10 years for Task Area A). The anticipated start date is on/or about July 16, 2026.

Other important considerations

Assume responsibility for the following list of activities which represents an estimate of tasks the Offerors should assume to perform during the 7 year ordering period.

Assume that the period of performance of task orders may range from one year to multiple years.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 26, 2026, 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 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."