BARDA eCTD Templates Supporting Regulatory Submissions (Renewal of a Site License)

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 Not a request for competitive proposals. Requests for copies of a solicitation in response to this notice will not be honored or acknowledged.