DIAGNOSTICS PRE-CLINICAL SERVICES PROGRAM

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, has a requirement to support a preclinical services program that will advance the development of promising candidate diagnostic products for a wide array of infectious diseases.

Description

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives 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 other than HIV. Support for basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics is provided through a variety of research grants and contracts.  DMID also supports an array of research resources and services to assist investigators, including programs that provide or make available genomic data and technologies; organisms and state-of-the-art reagents; biocontainment facilities; and preclinical and clinical translational research services https://www.niaid.nih.gov/research/microbiology-and-infectious-diseases-resources.

NIAID supports nearly all stages of the in vitro diagnostic (IVD) product development pipeline from planning and design, through development, verification, and manufacturing using multiple support services contracts.  The purpose of this program is to offer a comprehensive array of capabilities with the intent of providing to product developers a discrete subset of services that will propel new IVD products toward regulatory clearance. This resource is intended to be applied to any/multiple product(s) at any/multiple stage(s) requiring access to services in support of IVD development need rather than to carry a single IVD product candidate through the entire product development pathway. These services are intended to help a wide variety of investigators (including academics and start-up or mature companies) in a number of scientific areas to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support  clinical validation studies), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements.

The development and introduction of new IVD products to detect, identify, and characterize potential agents of bioterrorism, antimicrobial-resistant pathogens, emerging and re-emerging infectious pathogens, as well as infectious pathogens prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide IVD product development support for promising assay technologies that emerge from academia, as well as start-up or mature biotech companies. The suite of services shall encompass those activities commonly associated with the development of IVD tests for infectious disease required for FDA 510(k) clearance, Premarket Approval (PMA), and Emergency Use Authorization (EUA) or pre-EUA authorization. Foreign (ex-US) product developers that request support for Diagnostic pre-clinical services needs to receive approval for the service request from NIAID-authorized officials before the contractor can be evaluated and/or compete for a task order(s) to produce the service.

Since the rapid diagnosis of infectious disease-causing pathogens and/or toxins is crucial for implementing proper treatment and patient management, the commercial development of new diagnostics is a high priority. For that purpose, this solicitation includes services to support the development of new diagnostics for infectious disease-causing pathogens and/or toxins. 

NIAID anticipates awarding one or more Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that best meet the overall qualifications for fulfilling the technical requirements of the Task Areas listed in this solicitation. Offerors may propose on any or all Task Areas. The Government anticipates making awards to those organizations with the best qualifications in each Task Area. Organizations will be considered for contracts only in the Task Area(s) they include in the proposal.  Sample Task Orders are provided in the RFP solely to evaluate offeror responses and capabilities. Task Orders for specific tasks will be issued after award of the Base Contract.

The Task Areas of this solicitation are as follows:

Task Area A- Product Development Processes and Documentation

      Task Area B- Recombinant Proteins and Monoclonal Antibodies

Task Area C- Biochemical Reagents: Nucleic Acids and Oligonucleotides

Task Area D- Clinical Specimens and Bacterial Isolates

Task Area E- Next-Gen Sequencing, Immunoassays, Nucleic Acid Amplification Assays

Task Area F- Pre-Pilot and Pilot-Scale GMP Manufacturing Services

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 15, 2022 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 this solicitation, the NIAID requires proposals to be submitted via  the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. 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."

Please Note:  When opening or downloading the solication in the Chrome browser, select "Open with system viewer" to allow the links in Section J of the RFP to work properly.