Presolicitation Notice.pdf

PRESOLICITATION NOTICE

NIAID DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES:

SINGLE INSTITUTIONAL REVIEW BOARD

75N93022R00037

Type of Requirement

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

Place of Performance

Place of performance is unknown currently Place of performance is known. Address or general location:__________________

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-

Duration of contract: 7 Years

If Options will be included, describe Options: This solicitation will include Severable, Term Options, and Non-Severable, Quantity Options. It is anticipated that all Options will be exercised as firm-fixed price on a unit-price basis. However, other pricing arrangements may be utilized.

Anticipated award date: February 2024

Pre-solicitation Notice Information

Introduction

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.

NIAID, Division of Microbiology and Infectious Diseases (DMID), has a requirement for the services of a single institutional review board (sIRB), also known as an independent ethics committee (IEC), to review the methods proposed for select NIAID-supported clinical research activities.

Description

The recent COVID-19 pandemic has underscored the need for rapid IRB review to support critical and time-sensitive clinical studies. To that end, DMID requires the services of a single IRB to review the methods proposed for select NIAID-supported clinical research activities to ensure studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) are ethical and meet current Federal regulations. Furthermore, NIH Policy requires the use of a single IRB for multi-site, non-exempt human subjects research using the same research protocol for each site.

The Contractor shall provide all services necessary to serve as the IRB of record for US domestic sites for select NIAID studies throughout the conduct of the studies and provide project management to ensure the efficient planning, initiation, implementation, and timely completion of all functions carried out under the contract.

Offerors are expected to have the expertise, personnel, and facilities to meet requirements stated in the RFP, and be able to demonstrate their capability to perform the requirements, to include but not limited to providing for the following:

1. Project management, administrative support, and oversight activities

2. IRB services to include full board, expedited, and urgent reviews

3. Institutional Biosafety Committee services, Genetic Advisory Committee services, and certified translation services

It is anticipated that a single Indefinite Delivery Indefinite Quantity (IDIQ) contract will be awarded.

However, the Government reserves the right to award multiple contracts. Negotiated Task Orders are intended to be created under the IDIQ.

Any responsible offeror may submit a proposal, which, if received timely, will be considered by NIAID.

The RFP will be available electronically on/about May 4, 2023, 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 solicitation, NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or email will not be accepted.

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

https://sam.gov/content/opportunities https://ecps.nih.gov/