NIH-NIAID docuBridge Upgrade

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1), which requires the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed-price purchase order under the authority of 41 U.S.C. 1901, as implemented by FAR 13.106-1(b) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements. This is not a request for competitive quotes. The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate on a sole source basis with LORENZ International, LLC, located at 1515 Market St, STE 1200, Philadelphia, PA, 19102-1932. This acquisition will provide services to upgrade the NIAID Electronic Common Technical Document (eCTD) LORENZ docuBridge system from version 21.1 to the latest version, 24.2. This upgrade is essential for maintaining regulatory compliance, adhering to current industry standards, and minimizing security vulnerabilities. NIAID's eCTD system was built using commercial off-the-shelf (COTS) software provided by LORENZ International, LLC (LORENZ) named LORENZ docuBridge. The docuBridge eCTD system and implementation services were purchased in 2021 through full and open competition (Purchase Order 75N93021P01495). Services to be provided through this acquisition include: Configuring the existing NIAID LORENZ docuBridge system from version 21.1 to version 24.2 Providing role-based training sessions to appropriate staff Maintaining the Validated State (21 CFR Part 11 / Computer System Validation) of the existing NIAID LORENZ docuBridge System Options will be included to purchase additional configuration, installation, and training services during the performance period. Estimated Period of Performance: January 20, 2025 - September 29, 2025. The North American Industry Classification (NAICS) code for this acquisition is 541512 -Computer System Design Services, which has a size standard of $34.0 million. LORENZ is classified as a small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 25 days of this notice. While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that LORENZ is the only vendor who can provide the requested services for NIAID. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 18 days after publication of this notice. Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID-25-2251632. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Tamara McDermott, Contracting Officer at tamara.mcdermott@nih.gov.