SAM #OC-2026-135574

FDA Seeks Contractor for Global ANDA Training Program and E-Learning Modules

The U.S. Food and Drug Administration (FDA), Office of Global Policy and Strategy, is seeking vendors to develop and deliver a Global Abbreviated New Drug Application (ANDA) Training Program for regulatory staff in low- and middle-income countries. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of Global Policy and Strategy - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Products/Services Requested: - Development and delivery of a comprehensive professional certification program on generic drug regulation and global regulatory reliance - Creation of eight SCORM-compliant e-learning modules covering the entire generic drug lifecycle - Modules must be optimized for low-bandwidth and offline access - Program includes needs assessment, beta testing, registration management, certification issuance, and sustainability planning - Delivery of project and source files, and compliance with technical and accessibility requirements - Emphasis on global harmonization and case studies relevant to Asia and Africa - Unique or Notable Requirements: - Training must be accessible to regulatory staff in low- and middle-income countries - E-learning modules must be SCORM-compliant and support offline/low-bandwidth environments - Program must include assessments and professional certification - Sustainability planning and delivery of all project/source files are required - No specific products, part numbers, or purchase quantities are listed

Description

The U.S. Food and Drug Administration's (FDA), Office of Acquisitions and Grants Services (OAGS), is conducting market research for obtaining Global Abbreviated New Drug Application (ANDA) Training Program services.

THIS IS A SOURCES SOUGHT NOTICE (SSN) ONLY. This SSN is being issued in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research. It is for information, planning, and market research purposes only and is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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. The Government reserves the right to contact any of the respondents after the submission deadline if additional information is required.

The purpose of this SSN is to identify and gain knowledge of potential business sources and small business sources that are capable of providing the full range of services described in this SSN and the attached Draft Statement of Work (SOW). Responses to this SSN will be utilized for a potential solicitation for an anticipated stand-alone contract for the Global Abbreviated New Drug Application (ANDA) Training Program. The anticipated period of performance for this contract is September 15, 2026 through September 14, 2031 (base year, plus four (4) option years.

Requested Information

Interested parties are highly encouraged to respond to this SSN by providing the following information in their response:

Completed Vendor Feedback Form – See attached Vendor Feedback Form If applicable, tracked changes/comments on Draft SOW and Draft Generic Drug Curriculum in MS Word format – See attached Draft SOW and attached Draft Global ANDA Training - Generic Drug Curriculum.   Capability Statement  

Responses shall be submitted via email with the subject line "Sources Sought Notice - FDA SSN: OC-2026-135574” to the Contract Specialist, Lawrence Edelmann (lawrence.edelmann@fda.hhs.gov), no later than 12:00pm (Eastern) on July 28, 2026.

Attachments

Vendor Feedback Form Draft Statement of Work Draft Global ANDA Training - Generic Drug Curriculum

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