Biosimilar and Interchangeable Continuing Education
ID: 75F40125R00056Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Professional and Management Development Training (611430)

PSC

GENERAL SCIENCE AND TECHNOLOGY R&D SERVICES; GENERAL SCIENCE AND TECHNOLOGY; BASIC RESEARCH (AJ11)
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for a contract to provide accredited continuing education on biosimilar and interchangeable products aimed at healthcare providers, including physicians, pharmacists, and nurses. The objective is to develop various educational formats, such as video courses and written materials, to enhance understanding of biosimilars, focusing on their safety, effectiveness, regulatory processes, and clinical applications. This initiative is crucial for building healthcare providers' confidence in prescribing biosimilars, ultimately improving patient education and public health outcomes. The contract has a funding ceiling of $15 million, with a performance period of one year and options for four additional years. Interested parties should contact Sheila Brown at Sheila.Brown1@fda.hhs.gov for further information.

    Point(s) of Contact
    Files
    Title
    Posted
    The document primarily addresses updates and requirements related to federal acquisition regulations under the United States-Mexico-Canada Agreement (USMCA). Key topics include annual representations and certifications, simplified acquisition procedures, and emergency acquisition flexibilities. It emphasizes provisions for domestic preferences and trade agreements when acquiring supplies, stipulating specific thresholds for products sourced from designated countries, including Canada, Israel, and Mexico. For procurements above certain monetary thresholds, contractors must uphold certifications related to the Buy American Act and related trade agreement clauses, outlining procedures for compliance with labor laws, particularly concerning forced or indentured child labor. The document specifies guidelines around patented technology usage, noting exceptions during national emergencies or extreme urgency. Overall, it reinforces the necessity for compliance with various statutory and executive order requirements, ensuring that acquisitions align with domestic sourcing preferences and international trade agreements. The detailed regulations serve as a framework for governmental entities when conducting procurements, ensuring transparency and adherence to laws governing federal acquisitions.
    The HHS FAR Class Deviation 2020-02 pertains to the accelerated payment procedure for small business subcontractors within federal contracts. It mandates that agencies expedite payments to eligible small business subcontractors—ideally within 15 days upon receipt of proper invoices and documentation—when no specific payment date is outlined in the contract. The critical provision emphasizes that prime contractors must also adhere to these accelerated payment protocols to their small business subcontractors without imposing additional fees. Importantly, this policy does not create new rights under the Prompt Payment Act nor alter its late payment interest terms. The deviation aligns with oversight requirements established by the Office of Management and Budget and is to be integrated into all solicitations and contracts, ensuring effective flow-down to subcontracts. The overarching aim of this text is to promote quicker cash flow for small businesses participating in government contracting, thereby enhancing their financial stability and operational capacity within federal acquisition processes.
    The FDA is soliciting proposals for a contract to deliver accredited continuing education on biosimilar and interchangeable products for healthcare providers, including physicians, pharmacists, and nurses. This Request for Proposal (RFP), number FDA-RFP-126418, is structured as a sole-source acquisition under the NAICS code 611430, specifically targeting professional and management development training services, with a funding ceiling of $15 million. The project includes developing various educational formats, such as video courses and written materials, to enhance the understanding of biosimilars, focusing on their safety, effectiveness, regulatory processes, and clinical applications. Contractors will be required to provide quarterly metric reports on usage and effectiveness of the courses, as well as engage target audiences through digital marketing initiatives. The period of performance is one year, with options to extend for up to four additional years. The contractor must have access to a network of accredited healthcare professionals and experts in relevant clinical areas to ensure the high-quality delivery of educational content. This project aims to build healthcare providers' confidence in prescribing biosimilars, thereby enhancing patient education and improving public health outcomes.
    Lifecycle
    Title
    Type
    Combined Synopsis/Solicitation
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