FDA Regulated Products Sampling Services
ID: 75F40125R00032Type: Sources Sought
Overview

Buyer

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

NAICS

All Other Professional, Scientific, and Technical Services (541990)

Original Source

https://sam.gov/opp/cd174100dff54b4abb2b9588f3991477/view
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is seeking qualified vendors to provide Sampling Services for FDA-regulated products through a Sources Sought Notice (Ref No. 75F40125R00032). The primary objective of this procurement is to identify capable businesses that can collect physical samples of food, drugs, medical devices, and other products for laboratory analysis, ensuring safety and verifying labeling accuracy. This initiative is crucial for the FDA's regulatory oversight, as it supports the monitoring of product safety and quality, which may include both domestic and imported goods. Interested parties must submit their responses by January 9, 2025, and can contact Amanda Lusk at Amanda.Lusk@fda.hhs.gov or Nicholas Bisher at Nicholas.Bisher@fda.hhs.gov for further information.

    Point(s) of Contact
    Amanda Lusk
    Amanda.Lusk@fda.hhs.gov
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    12-19-2024 Sources Sought Notice.pdf
    The FDA is seeking to gather information on potential vendors for Sampling Services related to FDA-regulated products through a Sources Sought Notice (SSN) identified as Ref No. 75F40125R00032. This notice is not a solicitation, but a market research effort aimed at identifying qualified businesses, including various classifications such as small businesses, veteran-owned, and women-owned firms. The primary objective is to assess the capability of vendors to collect physical samples of food, drugs, medical devices, and other products for laboratory analysis, ensuring safety and verifying labeling accuracy. Vendors are invited to respond by answering specific questions regarding their qualifications, geographic capabilities, and relevant experience. The responses may inform future requests for proposals, with the anticipated performance period spanning 12 months. Interested parties must submit their responses by January 9, 2025. This initiative underscores the FDA's commitment to regulatory oversight and maintaining the safety and quality of products available in the market.
    Attachment A - Draft Statement of Work.pdf
    The U.S. Food and Drug Administration (FDA) is planning to award an Indefinite Delivery-Indefinite Quantity (IDIQ) contract for Regulated Product Sampling Services over five years, with key labor categories including Program Manager, Project Manager, Quality Assurance Specialist, and Sampling Technician. The contract aims to enhance FDA's regulatory oversight by supporting sample collection of food, drugs, and medical devices, both domestically and from imports, to ensure safety and compliance. The contractor will be responsible for sample collection, maintaining chain of custody, documentation, and shipping to laboratories. A Quality Assurance Plan will be required to ensure compliance with industry standards, and the contractor must also manage program tasks, complete reporting, and handle any conflicts of interest. Key objectives include increasing sampling efficiency, supporting FDA's core inspection functions, and ensuring comprehensive quality management per FDA guidelines. The contract will also specify standard operating procedures and provide the FDA with a reliable stream of samples for laboratory analysis. The document outlines specific labor requirements, a schedule for deliverables, and access control measures for contractor personnel, reflecting the FDA's commitment to ensuring product safety through effective oversight.
    Lifecycle
    Title
    Type
    FDA Regulated Products Sampling Services
    Currently viewing
    Sources Sought
    Similar Opportunities
    Safe Medication Use
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is conducting a Request for Information (RFI) to identify potential sources capable of providing medication error reports, an analytics platform, and related services aimed at preventing and analyzing medication errors. This initiative, led by the FDA's Center for Drug Evaluation and Research, seeks organizations that can supply nationwide data from healthcare providers, consumers, and patient safety organizations, emphasizing the importance of robust reporting, data analysis, and training in enhancing medication safety protocols. Interested parties, particularly small businesses, are encouraged to submit their capability statements by January 6th, 2025, and should note that responses are voluntary and do not imply a commitment for a contract. For further inquiries, contact Brian Wodzisz at Brian.Wodzisz@fda.hhs.gov or call 301-796-7376.
    Solicitation: Tobacco Retailer Inspections - 75F40125R00018
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is soliciting proposals for an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to conduct tobacco retailer inspections under solicitation number 75F40125R00018. The primary objective of this procurement is to ensure compliance with federal laws regarding the sale and advertising of tobacco products, particularly focusing on preventing youth access to these products across multiple regions in the United States. This initiative is crucial for enhancing the FDA's enforcement capabilities and protecting public health by reducing tobacco use among youth. Interested contractors should contact Janice Heard at janice.heard@fda.hhs.gov or Brandon Rafus at brandon.rafus@fda.hhs.gov for further details, with the contract period spanning five years and funding amounts varying by region.
    Bruker Maldi TOF Maintenance
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking proposals for a full-service maintenance agreement for its Bruker MALDI TOF system, with a contract start date of January 16, 2025, and four optional one-year extensions. The contractor will be responsible for comprehensive maintenance services, including all repairs, annual preventative maintenance, and ensuring compliance with regulatory standards, with a focus on supporting the FDA's mission to monitor antimicrobial resistance in foodborne and zoonotic pathogens. Interested small businesses must submit their quotes by 11:59 PM EST on January 3, 2025, and can direct inquiries to James O’Keefe at 301-796-7371 or via email at James.OKeefeIII@fda.hhs.gov.
    MRC Biosafety Cabinet Evaluation
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking qualified small businesses to provide engineering evaluation services for biological safety cabinets (BSCs) at its Center for Veterinary Medicine. The primary objective of this procurement is to assess existing BSCs that are failing to meet certification standards, particularly focusing on their associated HVAC and control systems, and to provide recommendations for replacements. This evaluation is crucial for maintaining laboratory safety and operational efficiency, ensuring compliance with federal safety standards. Interested parties must attend a mandatory site visit on December 17, 2024, and submit their quotations by January 8, 2025, to the contracting officer, Sheneil Green, at Sheneil.Green@fda.hhs.gov.
    FY25 Docker Enterprise Edition Licenses
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the procurement of Docker Enterprise Edition licenses to support the development of its Containers as a Service (CaaS) platform. The objective of this contract is to enhance the FDA's IT infrastructure by utilizing Docker EE’s container technology, which is essential for improving operational efficiency and reducing costs compared to traditional virtual machines. This procurement is significant as it enables the FDA to deploy applications in various environments while ensuring compliance with federal security mandates. Interested small businesses must submit their quotes by January 2, 2025, and can direct inquiries to Terina Hicks at terina.hicks@fda.hhs.gov or Roosevelt Walker at roosevelt.walker@fda.hhs.gov.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is soliciting proposals through the FY25 Broad Agency Announcement (BAA) aimed at advancing regulatory science and innovation. This opportunity invites organizations, particularly small businesses, to submit research and development proposals that address critical areas such as alternative drug development methods, advanced manufacturing technologies, and predictive toxicology, with a strong emphasis on including diverse populations in research. Proposals must be submitted by February 24, 2025, and will undergo a two-tier evaluation process, with the potential for multiple contracts awarded based on proposal quality and funding availability. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    QIACube Maintenance Agreement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for a maintenance agreement for its QIACube system, essential for the Atlanta Human and Animal Food Laboratory's molecular biology operations. The procurement requires a comprehensive service agreement that includes repair, labor, travel, and a loaner instrument, ensuring compliance with ISO accreditation standards and continuity in critical DNA and RNA extraction processes. The contract will commence on February 1, 2025, and run for one year, with options for four additional years, and proposals are due by 11:59 PM EST on January 3, 2025. Interested vendors can contact James O’Keefe at 301-796-7371 or via email at James.OKeefeIII@fda.hhs.gov for further information.
    PRIMO Software Licensing
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide PRIMO Software Licensing and Maintenance Support Services. The procurement involves supplying 21 PRIMO software licenses for a base year, with two additional option years, to ensure the continuous operation of the FDA's CFSAN CAEMS system. This software is crucial for pharmacovigilance and regulatory compliance, enhancing the FDA's capabilities in monitoring food safety. Interested parties must submit their quotes by August 26, 2024, and are encouraged to contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov for further details. The contract will be awarded as a firm-fixed-price purchase order, emphasizing compliance with federal acquisition regulations and accessibility standards.
    FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Award Notice
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), has announced the FY24 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. This opportunity aims to support innovative research projects that enhance regulatory science, with a focus on health, medical, and biotechnology advancements. The awarded contracts, totaling over $24 million, cover a range of critical topics including drug safety, gene therapy, and methodologies for assessing pediatric opioid exposure, reflecting the federal government's commitment to fostering research initiatives that improve healthcare delivery and regulatory processes. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    Bovine Spongiform Encephalopathy (BSE) Surveillance Sample Collection
    Active
    Agriculture, Department Of
    The United States Department of Agriculture (USDA), through its Animal Plant Health Inspection Service (APHIS), is seeking vendors to provide Bovine Spongiform Encephalopathy (BSE) sample collection services across various cattle populations in the U.S. The procurement aims to establish multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts, focusing on vendors with access to targeted cattle demographics, to enhance the government's BSE surveillance efforts. This initiative is critical for ensuring animal health and public safety, as it involves the collection, documentation, and shipping of brain stem samples for testing, adhering to strict quality control standards. Interested vendors must submit their proposals by 12:00 PM EST on November 20, 2025, with a minimum order requirement of $300 and maximum order limitations not exceeding $2.4 million, while also contacting Amanda Imlach at amanda.imlach@usda.gov for further inquiries.