Pre-Solicitation_ETSV.pdf

PRESOLICITATION NOTICE

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

75N93023R00026

Type of Requirement

New Requirement Re-competition (Contract/Task Order No.: HHSN272201800013I Expansion of (Contract/Task Order/RFP No.:______________)

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location:__________________

Re-competition

Battelle Memorial Institute 505 King Avenue Columbus, OH 43201

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: September 1, 2025

Presolicitation Notice Information

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 Microbiology and Infectious

Diseases (DMID), has a requirement for contractors to provide a suite of product development services. While the overall suite of services provided is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine candidates and other biologics, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad 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/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials. These testing capabilities may also support vaccines or other biological products that are intended to interrupt or block pathogen transmission (such as vector-borne diseases) or for use in animals that constitute a disease reservoir for, or other disease threat from, a pathogen that has public health significance. Support for efforts associated with zoonotic diseases may be considered on a case-by-case basis dependent on adequate justification for Public Health considerations.

Description

The development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, emerging and reemerging 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, NIAID requires coordinated evaluation and testing services programs to provide preclinical, non-clinical, and clinical testing support for multiple vaccine and biologic candidates that emerge from academia, the private sector, or other sources.

The suite of testing services will encompass those activities commonly associated with the testing of vaccine and biologic products for infectious disease required for Investigational New Drug (IND) and/or Biologic License Applications (BLA). Consequently, NIAID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in the solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. The Contractors 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 the resultant contracts and each awarded Task Order.

In order to meet the demands for vaccine product development, NIAID awarded a single contract in 2018 to Battelle Memorial Institute that provides a suite of product development services using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism. Task Orders have included administration or management of the contract, assay development, immunogenicity and efficacy testing, clinical and non-clinical sample testing, and safety and toxicology testing. The purpose of the upcoming solicitation is to recompete the aforementioned NIAID resource, Contract Number HHSN27220180003I.

NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contracts to the organizations or institutions that best meet the overall qualifications needed to fulfill the technical requirements of the solicitation. Offerors must submit separate proposals to Task Area A and at least one other Task Area, in any combination (from Task Areas B, and/or C, and/or D).

Offerors must submit one proposal per Task Area proposed. If submitting to all four Task Areas, offerors are required to submit four separate proposals. Each successful contractor will be awarded a Parent Contract. Individual Task Orders for specific tasks will be competed and issued after award of the Parent Contract. In case of multiple Offerors, all Offerors will be provided a Request for Task Order Proposal and offered the opportunity to submit a Task Order proposal.

Sample Task Orders will be provided in the RFP solely to evaluate offeror responses and capabilities and include the following Task Areas:

Task Area A – Administrative and Management Support Activities Task Area B – Assay Development, Clinical and Non-clinical Sample Testing Task Area C – Non-clinical Immunogenicity and Efficacy Testing Task Area D – Safety and Toxicity Testing including Specialty Toxicology

The services shall be directed at the following:

• biodefense pathogens and toxins;

• emerging and reemerging infectious diseases;

• antimicrobial resistant and multi drug resistant infections;

• other bacterial infections;

• fungal infections;

• viral infections excluding HIV; and

• parasitic diseases.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 15, 2024, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted.

For the upcoming 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."

https://ecps.nih.gov/