Presolicitation Notice 6.16.20.docx

PRESOLICITATION NOTICE

Comprehensive and Rapid Response to NIAID Research Programs 75N93019R00025

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: The ordering period for this contract will be May 1, 2021 through April 30, 2028.

Anticipated award date: May 1, 2021

Presolicitation Notice Information

Introduction Congress has charged the National Institute of Allergy and Infectious Diseases (NIAID) with a dual mandate: to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases along with respond rapidly to emerging or re‐emerging infectious diseases that pose a threat to domestic or global public health. Numerous outbreaks happen around the world every year and NIAID is better positioning itself to respond to these outbreaks efficiently. NIAID’s Intramural research is unique from extramural research in that intramural carries out its own research to respond to each outbreak, wherever it takes place in the world, at all scientific levels including basic science, preclinical research, animal studies, assay development, clinical trials and GMP product development. With the first signs of an outbreak, NIAID intramural must immediately conduct a coordinated plan across all the scientific areas; each area depends on the others. Because outbreaks can quickly appear, spread and disappear for periods of time, NIAID cannot waste unnecessary time finding mechanisms & support to address each unique outbreak because there is a risk of missing the disease curve along with the risk of losing more lives.

In 2017 NIAID Office of the Director (OD), with representatives across NIAID, drafted guidelines for “Emerging Infectious Disease (EID) Outbreak Research Response”, which was based on lessons learned during outbreaks, such as Zika and Ebola. The most recent COVID‐19 outbreak provided further lessons and further demonstrated the immediate need for more efficient reaction times. In line with the NIAID mandate and NIAID OD’s recommendations for EID Outbreak Research Response, NIAID must have mechanisms in place to improve response time and quality using a robust representation of contractors across basic science, preclinical, clinical, assay development and vaccine production.

Toward this end, NIAID manages a complex and diverse research portfolio that aims to expand the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases and develop flexible domestic and international research capacities to respond appropriately to emerging and re‐emerging disease threats at home and abroad.

Description

Contracts awarded from this solicitation shall provide the capacity and capability for a broad range of services necessary to support and conduct biomedical research in support of the NIAID mission and the management of activities specified under the Statement of Work and associated Task Orders. Services include expanding the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases and developing flexible domestic and international research capacities to respond appropriately to emerging and re‐emerging disease threats both domestic and foreign. These capabilities will allow NIAID to rapidly and efficiently address research program needs.

This Indefinite Delivery Indefinite Quantity (IDIQ) contract shall be administered and used primarily to support NIAID’s Division of Clinical Research, Division of Intramural Research, and Vaccine Research Center. However, other NIAID programs may initiate Task Orders under this IDIQ as necessary to help accomplish their mission.

Offerors are expected to have the expertise and personnel to meet the requirements of the project and be able to demonstrate their capability to perform this requirement. The contract will support tasks in the following areas:

A. Clinical Trials and Human Subject Research B. Chemistry Manufacturing and Controls (CMC) Activities C. Non‐Clinical Research: Animal Studies D. Analytics, Bioinformatics, Computational Biology and Biostatistical Services E. Storage and Repository F. Regulatory and Quality Assurance Services G. Basic and Mechanistic Studies and Specialized Services

The anticipated start date is on/or about May 1, 2021.

Instructions

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about July 1, 2020, and may be accessed through beta.sam.gov beta.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 the 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."