EPCTU Presolicitation Notice.pdf

Specification Package

RFP-NIAID-NIH-AI-75N93020R00023

PRESOLICITATION NOTICE

EARLY PHASE CLINICAL TRIAL UNITS (EPCTU)

Check as applicable

Type of Requirement

Other (specify): _______ Re-competition (See below) 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 for the portion of scope applicable to the preceding contracts “ entitled Phase 1 Clinical Trial Units for Therapeutics Against Infectious Diseases” awarded in December 2014:

1. Contract No. HHSN272201500005I, with DynPort Vaccine Company Ltd. (DVC)

2. Contract No. HHSN272201500006I, with Duke University

3. Contract No. HHSN272201500007I, with ICON Government and Public Health Solutions

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 ordering period of the contract: __7__Years

If Options will be included, describe Options _______________________________

Anticipated award date: January, 2022

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, has a requirement to support an early phase clinical trials program in order to move promising candidate products into the clinical pipeline; such studies are often on the critical path for product development.

Description

Research conducted and supported by the National Institute of Allergy and Infectious Diseases (NIAID) strives to understand, treat, and ultimately prevent the myriad infectious, immunologic , and allergic diseases that threaten millions of human lives. NIAID’s Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents.

An essential element of NIAID’s extramural research efforts is evaluating new and improved therapeutic and vaccine candidates or finding additional uses for already approved therapies for selected infectious diseases via clinical trials and clinical studies. These clinical studies are crucial from a public health perspective because they help guide policy decisions regarding product use and/or facilitate development and evaluation of therapeutic candidates critical to advancing product development and, therefore, aid in public health preparedness.

The purpose of the pending solicitation is to implement Phase 0 to Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations—domestically and internationally—in an expeditious and efficient manner, aided by bioanalysis when necessary.

Additionally, in the event of urgent public health need, Phase III studies may be conducted. The candidate products to be evaluated under the Early Phase Clinical Trial Units (EPCTU) IDIQ contracts could include new or tested investigational products, such as small molecules;

monoclonal antibodies; immunoglobulins; convalescent plasma; passive transfer studies; vaccines;

adjuvants; and other immunomodulatory products against infectious diseases, arising within DMID’s preclinical and early product development programs, as well as those arising from other research partners outside of DMID.

Awards under the EPCTU solicitation will succeed the Phase I Clinical Trial Unit research contract (whose ordering period ends December 2021). The new IDIQ contract awards will support tasks, with concomitant bioanalysis when applicable, in the following areas:

• Administrative and Overall Clinical Operations Support and Concept Development (Task Area A)

• Phase 0 Healthy subject studies (Task Area B)

• Phase I Healthy subject studies (Task Area C)

• Phase I Special populations (Task Area D)

• Phase II or III Disease subject studies (Task Area E)

NIAID anticipates awarding Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts to multiple contractors that meet the overall qualifications for individual Task Areas to support the full range of activities for conducting clinical trials using qualified clinical staff with expertise in carrying out all aspects of interventional clinical trials including bioanalysis, and will be based on best value to the US government. . The contractors shall collaborate with companies under contract to NIAID that provide clinical site monitoring, regulatory support, safety oversight, and data management and analysis, to support the EPCTUs. All projects carried out under the IDIQ contract(s) must be conducted in a manner consistent with all applicable U.S. federal regulations or international regulatory authorities, and the DHHS, NIH, NIAID, and DMID policies and guidelines for the conduct and oversight of research involving human subjects.

NIAID, the Contractor, or a third party will serve as the IND sponsor as determined by NIAID for all clinical trials conducted through EPCTU Task Orders.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about November 15, 2020 and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract or Task Order.

For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website.

For directions on using eCPS, go to the website https://ecps.nih.gov/ and then click on "How to Submit."

http://beta.sam.gov/ https://ecps.nih.gov/