Draft SOW_Global ANDA Training Program_OC-2026-135574.docx

Draft SOW / Global ANDA Training Program

FDA- OC-2026-135574

STATEMENT OF WORK

FOOD AND DRUG ADMINISTRATION (FDA)

OFFICE OF GLOBAL POLICY AND STRATEGY

Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

1.0 BACKGROUND

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing public health by helping to speed innovations that make biologics, medicines, and foods more effective, safer, and more affordable; and helping the public access accurate science-based information for drug products and foods. The FDA's mission is to ensure the safety, purity, potency, and effectiveness of all regulated products.

The Office of Global Policy and Strategy (OGPS) promotes and protects the public health of Americans by ensuring global considerations are fully integrated into FDA policies and operational activities. OGPS manages FDA's foreign offices and works with regulatory authorities, industry, academia, and international organizations to strengthen regulatory systems globally. Through partnerships, information sharing, and policy coherence, OGPS enhances the capacity of foreign regulatory partners to conduct inspections and laboratory analyses and supports movement toward regulatory convergence and global harmonization.

Generic drugs account for 90 percent of prescriptions dispensed in the United States. The integrity of the global pharmaceutical supply chain depends on the capability of regulatory authorities to effectively oversee pharmaceutical manufacturing facilities and conduct rigorous scientific reviews of generic drug applications. Regulatory authorities in low- and middle-income countries (LMICs) often face resource constraints and technical capacity gaps that limit their ability to conduct comprehensive reviews. Building the technical expertise of regulatory professionals in these countries strengthens global pharmaceutical quality standards, enhances supply chain security, and ultimately protects American patients and consumers. OGPS requires the development of a comprehensive professional certification program for global regulatory staff, reviewers, and policymakers from National Regulatory Authorities (NRAs) in LMICs. The purpose of this program is to provide a thorough understanding of the U.S. FDA's generic drug regulatory framework, global regulatory reliance and its integration with the global pharmaceutical landscape and to award a professional certificate upon successful completion. The training will guide participants through the entire regulatory lifecycle, from foundational U.S. laws and detailed FDA review processes to post-market surveillance and the critical role of international cooperation and regulatory reliance. The final program will serve as an educational tool for regulatory staff, reviewers, and policymakers from NRAs in LMICs ensuring a strong foundational understanding with a high level of regulatory competency.

2.0 OBJECTIVE

The objective of this contract is to develop and deliver a comprehensive professional certification program on FDA’s generic drug regulation and approaches to regulatory reliance for regulatory staff, reviewers, and policymakers from National Regulatory Authorities (NRAs) in LMICs.

Successful completion of this requirement will result in:

· Eight SCORM-compliant e-learning sections covering the complete generic drug regulatory lifecycle from legislative foundations through post-market surveillance and international regulatory reliance

· A professional certificate of completion issued by the contractor in coordination with FDA to participants who successfully complete all sections and pass the final assessment

· IACET Continuing Education Units (CEUs) issued in accordance with the ANSI/IACET Standard

· A fully functional training program optimized for low-bandwidth environments with offline access capability

· Documented improvement in NRA staff competency in generic drug regulation (aligned with FDA’s practices) as measured by assessment scores of 85 percent or higher achieved by at least 90 percent of pilot participants

· A sustainable training program that can be maintained and updated beyond the contract period The contractor shall deliver a complete training solution ready for deployment globally within 15 weeks of contract award.

3.0 SCOPE

The contractor must possess deep subject matter expertise in generic drug regulation aligned with FDA practices, international regulatory harmonization, and regulatory capacity building for LMIC regulatory authorities. The contractor must have established active relationships with foreign NRAs that enable engagement with regulatory personnel from LMICs to support needs assessment, content validation, beta testing, dissemination, and continuous improvement of a structured, competency-based training program. The contractor must incorporate feedback from participating NRAs and other relevant stakeholders throughout program development and delivery to ensure the training remains technically accurate, relevant to regulatory needs, and effective in building global regulatory capacity.

The scope of work includes content development, technical e-learning development, global needs assessment, beta testing with global NRA staff, program management including registration and user tracking, and sustainability planning for program maintenance beyond the contract period.

The contractor shall provide an end-to-end training solution, including instructional design, development, platform delivery or integration, participant management, and evaluation.

The contractor shall design, develop, and deliver a complete professional certification program in generic drug regulation aligned with FDA practices and global regulatory reliance based on the detailed curriculum outline provided by FDA (see Attachment A: Training Curriculum Outline).

The program must be professionally designed for an audience of global regulatory professionals with varying levels of baseline knowledge of FDA processes and limited technology infrastructure. Selected course participants will not pay for taking the course.

The program will consist of the following eight (8) sections:

1. Introduction to the Generic Drug Lifecycle - From Local Regulation to Global Harmonization

1. Global Generic Drug Regulation and Harmonization

1. Historical and Legal Foundations of Generic Drug Regulation

1. GDUFA, OGD Science and Research, and OGD Collaborations

1. ANDA Review Process Within OGD

1. ANDA Review Process within the Office of Pharmaceutical Quality (OPQ)

1. Post-Approval of Generic Drug Lifecycle

1. Conclusion: The Global Lifecycle Continuum

4.0 DELIVERABLES

The contractor shall deliver the following tangible assets:

· 4.1 SCORM-Compliant E-learning:

· Conduct a global needs assessment through surveys, interviews, or focus groups with regulatory professionals in LMICs to understand baseline level of knowledge of U.S. generic drug regulation and global regulatory reliance, technology infrastructure and bandwidth limitations, equipment, and other relevant factors.

· Develop eight (8) e-learning sections based on the detailed curriculum outline provided by FDA one for each topic listed in Section 3.0

· Conduct beta testing for the pilot training program, collect feedback on content accuracy, technical functionality, and user experience, and make necessary adjustments.

· Each module must be SCORM compliant and ready for deployment in a Learning Management System (LMS) or identified digital platform

· Modules must include professional voiceover narration, synchronized on-screen text, relevant graphics, and interactive elements (e.g., knowledge checks, click-to-reveals) to enhance engagement.

· A short (3-5 question) quiz shall be included at the end of each section to reinforce key concepts.

· Manage registration for the training course

· Provide FDA with quarterly metrics on percentage of users who successfully completed the training, average length of time it takes for participants to complete training, summary of survey results, percentage of non-successful participants, and other agreed upon metrics.

· Ensure that only the target audience participates in this training program.

· The contractor shall provide participants who successfully complete the training with a certificate of completion.

· The contractor must be a current IACET Accredited Provider with at least three (3) years of accreditation experience and shall issue IACET Continuing Education Units (CEUs) in accordance with the ANSI/IACET Standard

· General Technical Functionality:

· Ensure browser support: must function on the latest two versions of Google Chrome, Microsoft Edge, and Mozilla Firefox.

· Ensure proper display: designed in a 16:9 aspect ratio, configured to scale to fit the browser while maintaining proportions.

· Allow for bookmarking: must support "resume" functionality, allowing users to exit and return to their last viewed location.

· Dependencies: modules must be self-contained and not require any external plugins (e.g., Flash, Java) to operate.

· Technical and Accessibility Considerations (Addressing Infrastructure Challenges):

· Low-Bandwidth Optimization: All e-learning modules must be aggressively optimized for low-bandwidth environments. The total file size for any single module should not exceed 50 MB.

· Full Offline Access: Provide a complete offline version of the training. This includes making all e-learning modules available as downloadable, executable files (e.g., for Windows/macOS) that can be run locally without an internet connection. All supplementary materials (slides, workbooks) must be provided as a single, consolidated ZIP file.

· Content and Design Considerations (Addressing Language and Culture)

· Clear and Simple Language: The script for narration and on-screen text must use clear, simple English. Avoid complex sentence structures, idioms, and colloquialisms. A glossary of key regulatory acronyms (e.g., ANDA, GDUFA, OPQ, CMC) must be provided and easily accessible within each module.

· Emphasis on Visuals and Text:

· Every spoken word in the narration must be mirrored by on-screen text (captions). Furthermore, a full, printable transcript must be available for every module. Key concepts should be reinforced with simple, universally understood icons and diagrams rather than text-heavy slides.

· Culturally Neutral and Inclusive Imagery: All stock photos, characters, and visual examples must represent a diverse range of ethnicities and geographic settings. Avoid imagery that is specific to a Western or U.S. context (e.g., U.S. holidays, currency, specific cityscapes) unless directly relevant to an FDA case study.

· Contextual and Application-Based Considerations (Addressing Regional Relevance)

· Explicitly Bridge the FDA-to-Local Gap: The training must include specific "call-out" sections or short case studies that explicitly connect the FDA's processes to the reality of local regulatory filings. For example, a section in Module 5 could state: "When the FDA grants a Tentative Approval, your local regulatory authority can use this as a trusted scientific assessment to dramatically speed up their own review process. This is how reliance directly impacts your work and gets medicines to your country faster."

· Highlight the "Why" Behind Global Harmonization: Emphasize that understanding the FDA system is a valuable global skill because its principles (QbD, risk-based review) are being adopted by other major regulators. Frame this knowledge as a tool for working effectively within a multinational company or global regulatory environment

· Reinforce Relevant Case Studies: The training shall place special emphasis on the India and PEPFAR reliance case studies. Frame them not just as FDA actions, but as examples of successful global partnerships that directly impact drug quality and availability in Asia and Africa.

· 4.2 Comprehensive Assessment:

· A baseline assessment of 50 questions (multiple choice, true/false) to be administered before Module 1

· A final summative assessment bank of at least fifty (50) questions (multiple choice, true/false) covering content from all modules.

· Both assessments must be deliverable as both a printable document and a question file compatible with the LMS.

· 4.3 Project and Source Files:

· Full source files for all deliverables, including but not limited to Articulate Storyline or Adobe Captivate project files, all graphic assets, voiceover audio files (.mp3), video files (.mp4), and original document files (.pptx, .docx).

· All training content, SCORM modules, certificate templates, and participant records developed under this contract shall be the property of FDA. The professional certificate credential and learning management system portal shall be co-branded with FDA and prominently display the FDA logo. Upon contract completion or termination, the contractor shall transfer all program materials and participant records to FDA or FDA's designated successor within 30 calendar days.

5.0 MEASURABLE OBJECTIVES

The success of this project will be measured by the following criteria:

· Objective 1: Knowledge Acquisition.

· Measure: At least 90% of pilot-group participants must achieve a score of 85% or higher on the final summative assessment.

· Objective 2: Competency Application.

· Measure: Upon completion of the training, participants in a test scenario must be able to correctly identify the appropriate regulatory pathway (Annual Report, CBE, PAS) for three different post-approval manufacturing change examples.

· Objective 3: Learner Engagement and Satisfaction.

· Measure: The training program must achieve an average satisfaction score of at least 4.2 out of 5.0 on a post-training survey administered to the pilot group.

· Objective 4: Knowledge Improvement Measurement

· Measure: Participants shall complete a baseline assessment before beginning Section 1 and a final assessment upon completion of Section 8. The contractor shall provide FDA with a report analyzing the difference between baseline and final assessment scores, including percentage of participants who demonstrated improvement and average percentage point increase in scores.

· Objective 5: Project Completion.

· Measure: All deliverables listed in Section 4.0 must be completed and delivered by the agreed-upon deadline and meet all acceptance criteria defined in Section 8.0.

6.0 PROJECT TIMELINE

The project will be executed in phases with the following target deadlines (T = Project Kickoff Date):

· Phase 1: Kickoff and Detailed Design Document Delivery - T + 2 Weeks

· Phase 2: Storyboard and Script Delivery for all Modules - T + 6 Weeks

· Phase 3: Alpha Version of E-learning Modules - T + 10 Weeks

· Phase 4: Beta/Pilot Version Incorporating Feedback - T + 13 Weeks

· Phase 5: Final "Gold Master" Delivery of All Assets - T + 15 Weeks

7.0 GOVERNMENT RESPONSIBILITIES

The FDA shall provide:

· Access to the detailed curriculum outline and supporting reference materials.

· A designated single point of contact (SPOC) for all project communications and approvals.

· Access to Subject Matter Experts (SMEs) for a maximum of 5 hours or otherwise agreed upon duration to clarify content ambiguities.

· Timely review and consolidated feedback on all deliverables within ten (10) business days of receipt.

8.0 ACCEPTANCE CRITERIA

Final acceptance of the project is contingent upon the following:

· Written approval of all deliverables by the designated SPOC.

· Successful testing and functionality of the SCORM modules in a sandbox LMS environment

· All delivered materials are free of significant factual, grammatical, or spelling errors.

· All project and source files listed in Section 4.0 have been delivered and are accessible.

9.0 CONTRACT TYPE

The expected contract type is a Firm-Fixed-Price Contract.

10.0 PLACE OF PERFORMANCE

All work may be performed at the contractor's facility. No on-site work at FDA facilities is required.

11.0 PERIOD OF PERFORMANCE

The period of performance is one base period of twelve (12) months with four (4) option periods of twelve (12) months each.