Institutional Review Board (IRB) Services – Connecting the Community for Maternal Health Challenge

INTRODUCTIONTHIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).The National Institutes of Health (NIH), National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:Advarra, Inc.:6100 Merriweather Dr., STE 600Columbia, MD 21044-3368NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541990 with a Size Standard $19.5M.REGULATORY AUTHORITYThe resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified

acquisition threshold ($250,000).STATUTORY AUTHORITYThis acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.GENERAL INFORMATION1. Title: Institutional Review Board (IRB) Services – Connecting the Community for Maternal Health Challenge2. Background Information: The Connecting the Community for Maternal Health Challenge was open to community-based and advocacy organizations with the goal of NIH to support research proposals for these challenge participants. There are up to 10 potentially eligible sites who may need IRB and related services.Period of Performance:Base Year: April 20, 2023 through April 19, 2024CLOSING STATEMENTThis synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.All responses must be received by April 10, 2023 at 9:00 AM Eastern time and must reference solicitation number NICHD-23-105. Responses may be submitted electronically to Mr. Michael Falzone, Contracting Officer at Michael.falzone@nih.gov. Fax responses will not be accepted."All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."