CDER Division of Applied Regulatory Science’s (DARS) Purchase of Cryopreservation System
ID: 75F40124Q00543Type: Combined Synopsis/Solicitation
Overview

Buyer

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

NAICS

Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (333415)

PSC

REFRIGERATION EQUIPMENT (4110)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/0cba3dba5e0a41b899a95388c667ea58/view
Timeline
    Description

    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking quotes for the procurement of a high-performance cryopreservation system to enhance the cryogenic storage capacity for biological materials used in drug metabolism and toxicology studies. The primary objective is to purchase an MVE HECO Vapor Series P-190 cryopreservation system that maintains stable -190°C temperatures and low nitrogen consumption, thereby complementing existing MVE freezers and ensuring consistent storage conditions across studies. This procurement is critical for maintaining the integrity of samples collected in the FDA's Division of Applied Regulatory Science (DARS) and is set aside exclusively for small businesses, with a firm-fixed-price contract expected to be awarded. Interested vendors should direct inquiries to Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov, with delivery anticipated within 90 days of contract award.

    Point(s) of Contact
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    75F40124Q00543 9-12-2024.pdf
    The document is a Request for Quotations (RFQ) No. 75F40124Q00543 issued by the U.S. Food and Drug Administration (FDA) for the purchase of a high-performance cryopreservation system. The requirement aims to support the FDA's Division of Applied Regulatory Science (DARS) by enhancing the cryogenic storage capacity for biological materials essential in drug metabolism and toxicology studies. The RFQ outlines a total small business set-aside, indicating that only small businesses may submit quotes. Key specifications include the procurement of an MVE HECO Vapor Series P-190 cryopreservation system, which must maintain low nitrogen consumption and stable -190°C temperatures. It also details requirements such as delivery within 90 days, with the expectation of a firm-fixed-price contract type. Additionally, regulatory compliance standards, including occupational safety conditions, electronic invoicing, and conflict of interest guidelines, are laid out to ensure transparent and accountable procurement processes. Overall, this RFQ illustrates the FDA's commitment to maintaining high standards in research integrity and operational efficiency, thus ensuring that the capabilities of existing cryogenic systems are matched and improved for reliable sample storage.
    Attachment A - Pricing Worksheet.docx
    The document outlines a Request for Quotations (RFQ) for the purchase of a Cryopreservation System, specifically RFQ No. 75F40124Q00543. It includes a pricing table for various products associated with the system, where vendors are required to fill in highlighted fields for item details. The key items listed are the MVE HECO 1536P-190AF-GB cryopreservation system, various racks, plastic boxes, installation costs, and training requirements. The pricing structure comprises unit costs and total costs for each item, including shipping and freight charges. The overarching goal of this RFQ is to procure the necessary equipment and services to enhance cryopreservation capabilities, indicating a focus on detailed budgeting and accountability. The document is structured to facilitate vendor responses by providing clear categories for product specifications and pricing, which aligns with standard practices in government procurement processes.
    Attachment B - FAR 52.212-5-Contract-Terms-and-Conditions (May 2024) .pdf
    The document outlines the Request for Quotation (RFQ) No. 75F40124Q00543 and specifies the federal acquisition regulations (FAR) clauses that contractors must adhere to for commercial products and services. It details mandatory compliance with various statutes and executive orders, identifying key clauses such as prohibitions on contracting with certain foreign entities, requirements for utilizing small businesses, and standards regarding labor practices and ethics. The RFQ emphasizes contractor responsibilities, including providing accelerated payments to small business subcontractors, and mandates reporting on executive compensation. It also addresses issues of child labor, equal opportunity employment, and environmental sustainability through specific clauses on materials and practices. The structure consists of numbered clauses organized by category (general provisions, specific contract terms, and compliance with laws). The overall purpose is to ensure that contractors understand their legal obligations and the regulatory framework governing the acquisition process, thereby promoting accountability and ethical practices in federal contracting.
    Attachment C- RFQ Question Submittal Form.xlsx
    The document is an RFQ (Request for Quotations) Question Submittal Form related to RFQ No. 75F40124Q00543 for the procurement of a Cryopreservation System. It outlines the process for offerors to submit inquiries regarding the RFQ, including specific sections and attachments relevant to the submission. The form refers to various attachments such as the Statement of Work, Labor Category Descriptions, and Past Performance Questionnaire, each crucial for understanding the requirements and evaluation criteria. The purpose of this form is to streamline communication between the agency and potential offerors, ensuring that all questions regarding the procurement process are formally documented and addressed. This facilitates clarity and compliance for all parties involved in the submission process.
    Lifecycle
    Title
    Type
    CDER Division of Applied Regulatory Science’s (DARS) Purchase of Cryopreservation System
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    Combined Synopsis/Solicitation
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