Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance
Closed Pre-Solicitation Posted
- Solicitation number
- OC-2026-135574
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 61143 Professional and Management Development Training
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The FDA's Office of Acquisitions and Grants Services is conducting a sources sought notice (market research under FAR Part 10) for a potential stand-alone contract to develop and deliver a Global Abbreviated New Drug Application (ANDA) Training Program, with responses due by July 28, 2026, and an anticipated solicitation release to follow. This is not a commitment to issue a solicitation or award a contract; the Government reserves the right to contact respondents for additional information and is under no obligation to acknowledge receipt or provide feedback.
The anticipated period of performance runs from September 15, 2026, through September 14, 2031 (base year plus four option years). The contractor will develop comprehensive curriculum materials and deliver training addressing the full generic drug lifecycle from ANDA submission through global regulatory reliance pathways, including U.S. generic drug regulation (Hatch-Waxman Act, bioequivalence, patent certification), global harmonization (ICH, PIC/S, WHO Prequalification), ANDA review processes, Chemistry Manufacturing Controls, and post-approval surveillance activities.
NAICS 61143 (Professional and Management Development Training); PSC R408 (Support—Professional: Program Management/Support). No set-aside is anticipated.
Respondents must submit a completed Vendor Feedback Form and tracked changes or comments on the Draft SOW and Draft Global ANDA Training Curriculum in Microsoft Word format. Vendors should demonstrate: (1) subject matter expertise in FDA generic drug regulatory requirements and regulatory training program development experience within the past five years; (2) established relationships with National Regulatory Authorities in low- and middle-income countries; (3) current ANSI/IACET Accredited Provider status and continuing education unit capability; and (4) experience developing SCORM-compliant e-learning programs optimized for limited technology infrastructure, including low-bandwidth and offline access.
Notice text
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
Files
| File | Type | Posted |
|---|---|---|
| Draft SOW_Global ANDA Training Program_OC-2026-135574.docx | DOCX document | |
| Draft Global ANDA Training_Generic Drug Curriculum_Final.docx | DOCX document | |
| Sources_Sought_Vendor Feedback Form_OC-2026-135574.docx | DOCX document |
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