BARDA eCTD Templates Supporting Regulatory Submissions (Renewal of a Site License)
Closed Special Notice Posted
- Solicitation number
- 75A50125C00004
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541512 Computer Systems Design Services
- Place of performance
- Washington, District of Columbia 20201, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR), specifically the Center for Biomedical Advanced Research and Development Authority (BARDA), has issued a Special Notice of intent to sole source a contract with Accenture Federal Services LLC. The notice concerns a renewal site license for StartingPoint, a software solution providing electronic templates for regulatory submission content. The contract will be awarded under Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i), which allows for single-source procurement under specific circumstances. The current contract number is 75A50121C00018 and is set to expire on September 29, 2025. The anticipated contract will be a Firm Fixed Price agreement with a total performance period of sixty months.
The primary objective of this contract is to acquire licensing for Microsoft Word-based templates that are compliant with FDA and International Conference on Harmonization (ICH) guidance for electronic Common Technical Document (eCTD) specifications. The site license will support up to 75 users and is categorized under the Product/Service Code R408 for Professional Support: Program Management/Support. The contract structure includes a twelve-month base period with options for four additional twelve-month periods. Notably, this is not a competitive proposal request, and the government will not honor or acknowledge solicitation requests in response to this notice. The sole source determination is based on the unique circumstances of the contract, which align with FAR provisions allowing single-source procurement when only one source is reasonably available. Contractors should note that this is a targeted procurement specifically for Accenture Federal Services LLC and does not represent an open competitive opportunity.
Notice text
Notice of Intent to Sole Source
In pursuant to FAR 5.203(a), the Center for Biomedical Advanced Research and Development Authority (BARDA), which operates under the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), intends to award a Firm Fixed Price sole source contract to Accenture Federal Services LLC. This company is located at 800 N Glebe Road, Suite 300, Arlington, Virginia 22203-2149. The contract is for the procurement of a renewal site license for StartingPoint, which provides electronic templates for authoring regulatory submission content that complies with the electronic Common Technical Document (eCTD) specifications. The current contract number is 75A50121C00018, which is set to expire on September 29, 2025. The anticipated period of performance for the new contract is sixty (60) months, encompassing a twelve (12) month base period and an option for four (4) additional twelve-month periods.
The anticipated award will be made under Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonable available (e.g. urgency, exclusive licensing agreements, brand name, or industrial mobilization). The contract is intended for the acquisition of licensing BARDA for Microsoft® Word-based templates compliant with current Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidance for CTD dossier content and format compliant with the eCTD specification, along with a site license for up to 75 users.
The Primary Product/Service Code (PSC) for this acquisition is R408 – Support-Professional: Program Management/Support.
This notice of intent is Nota request for competitive proposals. Requests for copies of a solicitation in response to this notice will not be honored or acknowledged.
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