Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

5.101 Presolicitation Notice.

(vii) For noncompetitive contract actions (including those at or below the SAT), identify the intended source and explain why competition is lacking.

Based market research conducted in accordance with FAR Part 10, the contracting officer has determined that soliciting from a single source is appropriate for this requirement under the following circumstances: Unique Capability and Immediate Availability to Complete All Requirements, Highly Specialized Services Requiring Institutional Knowledge, and Time-Sensitive Mission Requirements.

The U.S. Food and Drug Administration (FDA) intends to solicit a 1-year base, sole source (in accordance with FAR 6.103-1), firm-fixed-price order from DIA Inc. 1300 Connecticut Ave NW, Suite 1000, Washington, DC 20036, USA. The North American Industry Classification System (NAICS) code is 611430 - Professional and Management Development Training, anticipated period of performance consists of a 1-year base.

This notice is not a request for competitive proposals.

The Food and Drug Administration (FDA), 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

The objective of this requirement is to develop and deliver a comprehensive professional certification program for foreign regulatory staff on FDA’s generic drug regulation and approaches to regulatory reliance for regulatory staff, reviewers, and policymakers from National Regulatory Authorities (NRAs) in low- and middle-income countries (LMICs). IACET Continuing Education Units (CEUs) must be issued in accordance with the ANSI/IACET Standard.

To accomplish this objective, 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.