Automated Dry Heat Diffusion System
ID: 75F40125Q00181Type: Combined Synopsis/Solicitation
Overview

Buyer

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

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/14b7a4d7b8ed403eb6f86e843e1d0964/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the acquisition of an Automated Dry Heat Diffusion System to enhance research capabilities within the Division of Product Quality Research. This system, which includes 24 vertical diffusion cells, is essential for conducting in vitro diffusion studies on transdermal and topical drug products, providing critical data on drug release and permeation across various barriers. Interested vendors must submit their quotations by May 30, 2025, with the contract anticipated to be awarded on a Firm-Fixed-Price basis, evaluated through a Lowest Price-Technically Acceptable (LPTA) process. For further inquiries, potential bidders can contact Amanda Lusk or Nicholas Bisher via their respective emails at the FDA.

    Point(s) of Contact
    Amanda Lusk
    Amanda.Lusk@fda.hhs.gov
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    5-16-2025 RFQ No. 75F40125Q00181.pdf
    The U.S. Food and Drug Administration (FDA) issued a Request for Quotations (RFQ) No. 75F40125Q00181 for the purchase of one Automated Dry Heat Diffusion System to enhance drug testing quality and safety. The system is intended for research within the Division of Product Quality Research, focusing on transdermal and topical drug products. Key features include 24 vertical diffusion cells, automated temperature control, sampling mechanisms, and real-time monitoring capabilities. The solicitation outlines the expected delivery timeframe of 30 days post-award, a one-year service warranty, and specific requirements for quotes, including technical and pricing proposals. The government anticipates awarding a Firm-Fixed-Price contract with a selection process based on a Lowest Price-Technically Acceptable (LPTA) basis. Quotations must be received by May 30, 2025, and all submissions will be evaluated on technical merit and compliance with outlined specifications. The document incorporates various federal regulations and outlines compliance requirements related to accessibility and confidentiality. This procurement exemplifies the FDA's commitment to advancing pharmaceutical research, ensuring quality and safety through the acquisition of essential laboratory equipment.
    Attachment A - Pricing Worksheet.pdf
    The document outlines a Request for Quotations (RFQ) for an Automated Dry Heat Diffusion System under RFQ No. 75F40125Q00181. It includes a pricing table that vendors must complete, specifying the requirement for a Logan transdermal diffusion system, installation services, operation qualification, and end-user training. Each item includes fields for quantity, unit cost, and total cost, while emphasizing a firm-fixed price for the total purchase order. The RFQ seeks vendor quotations in compliance with federal procurement processes, focusing on a specific brand name or equivalent products. The structure provides clarity regarding the items, pricing, and requisite services needed for the successful implementation and operation of the transdermal diffusion system. Ensuring compliance with these specifications is crucial for federal project funding and execution under government guidelines.
    Attachment B - 52-212-5-Contract-Terms-and-Conditions w Deviation.pdf
    Request for Quotations (RFQ) No. 75F40125Q00181 seeks proposals for the purchase of an Automated Dry Heat Diffusion System, outlining specific contract terms and conditions necessary for compliance with federal regulations. The document incorporates various Federal Acquisition Regulation (FAR) clauses related to commercial products and services, including prohibitions on certain telecommunications services, confidentiality agreements, and provisions for accelerated payments to small business subcontractors. Key requirements also emphasize compliance with labor standards, veteran and disability rights, and environmental policies. Additionally, it mandates safeguarding against trafficking in persons and requires proper documentation and record retention for audit purposes. The RFQ is anchored in statutory frameworks designed to promote ethical business practices, ensure equal opportunity, and engage small businesses in federal contracting. Overall, the RFQ establishes a comprehensive foundation for bidders to understand compliance, expectations, and the legal landscape essential for contract fulfillment.
    Attachment C- RFQ Question Submittal Form.xlsx
    The document comprises the RFQ Question Submittal Form related to Request for Quotations No. 75F40125Q00181, which concerns the purchase of an Automated Dry Heat Diffusion System. It serves as a guideline for offerors to submit inquiries related to the RFQ, incorporating references to various sections such as solicitation instructions, the statement of work, and attachments, including performance questionnaires and labor category descriptions. This structured approach enables participants to present questions systematically, ensuring clarity and transparency throughout the bidding process. The form is integral to facilitating communication between prospective vendors and the agency, thereby supporting an effective procurement process. The intent behind this document is to streamline inquiries and enhance the right acquisition of the necessary automated system for governmental needs.
    Lifecycle
    Title
    Type
    Automated Dry Heat Diffusion System
    Currently viewing
    Combined Synopsis/Solicitation
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