Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
ID: FDA-SSN-75F40125R00014Type: Sources Sought
Overview

Buyer

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

Original Source

https://sam.gov/opp/7404ddf0b986404e91d7a31ae3d188db/view
Timeline
    Description

    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is conducting market research for a Contractor-Hosted Fully Integrated Records Facility (FIRF) services under an Indefinite Delivery-Indefinite Quantity (IDIQ) contract. The objective is to identify potential small business sources capable of providing comprehensive services such as document processing, data entry, and record tracking, aimed at enhancing the management of records related to public health. This initiative is crucial for improving operational efficiency and ensuring compliance with federal regulations, ultimately supporting the FDA's mission to safeguard public health. Interested vendors must submit their responses, including a completed Vendor Feedback Form and comments on the draft Statement of Work, via email to Contract Specialist Noah Wills by 12:00 PM (Eastern) on November 19, 2024, with the anticipated contract period running from September 15, 2025, to September 14, 2030.

    Files
    Title
    Posted
    Sources_Sought_Draft SOW.docx
    The U.S. Food and Drug Administration (FDA) is seeking contractors for the Contractor-Hosted Fully Integrated Records Facility (FIRF) under an Indefinite Delivery-Indefinite Quantity (IDIQ) contract (FDA-SSN-75F40125R00014). This initiative aims to enhance the management of records and documents related to scientific advancement in public health. The scope involves various tasks, including document processing, data entry, scanning, and supporting stakeholders with submissions. The FDA aims to adopt a fully electronic records management system to improve operational efficiency and transparency, complying with federal regulations. Key tasks include program management support, document processing and tracking, scanning services, and managing temporary storage of government records. The contract requires robust infrastructure, compliance with security and accessibility standards, and skilled personnel. The overarching goal of the project is to streamline document handling and ensure regulatory compliance while safeguarding public health interests. Through this contract, the FDA intends to refine document management processes that ensure accountability and effective oversight in its regulatory mission, contributing to enhanced public health outcomes.
    Sources_Sought_Notice FIRF IDIQ.pdf
    The FDA is issuing a Sources Sought Notice (SSN) for Contractor-Hosted Fully Integrated Records Facility (FIRF) services, indicating its intent to explore the market for potential small business providers. This SSN is for market research purposes only and does not imply a commitment to award a contract. The expected contract type is an Indefinite Delivery-Indefinite Quantity (IDIQ), running from September 15, 2025, to September 14, 2030. Interested parties are encouraged to respond by completing a Vendor Feedback Form and providing any comments on the attached draft Statement of Work (SOW), along with a Capability Statement. Email submissions must be directed to Contract Specialist Noah Wills and must be received by November 19, 2024. This effort aims to gather information to inform a future solicitation, primarily steering towards identifying capable vendors for comprehensive FIRF services. The notice emphasizes the importance of responses while clarifying that the Government is under no obligation to acknowledge or provide feedback to submissions.
    Sources_Sought_Vendor Feedback Form.docx
    The FDA Vendor Feedback Form is a critical document associated with the U.S. Food and Drug Administration's Indefinite Delivery-Indefinite Quantity (IDIQ) Contract for a Fully Integrated Records Facility (FIRF). Its primary purpose is to gather essential information from potential vendors regarding their capabilities to fulfill specific services outlined in the draft Statement of Work (SOW). Vendors are prompted to provide their company information, including their Socioeconomic status, SAM UEI number, and recommended North American Industry Classification System (NAICS) codes. The form assesses the vendor's capacity to deliver services such as document processing, data entry, and record tracking, with a focus on prior relevant experiences from the last five years. Vendors must indicate their capability concerning various task areas, providing examples of previous contracts if applicable. The structure of the form facilitates categorical responses, enabling the FDA to identify potential suppliers that meet its operational needs efficiently. This form serves to enhance the procurement process by ensuring that appropriate vendors are considered for government contracts, ultimately supporting FDA’s mission to maintain high standards in public health and safety.
    Lifecycle
    Title
    Type
    Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
    Currently viewing
    Sources Sought
    Similar Opportunities
    FDA Regulated Products Sampling Services
    Active
    Health And Human Services, Department Of
    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.
    Access to Outpatient Longitudinal Drug Utilization Data
    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 access to outpatient longitudinal drug utilization data through a Sources Sought notice. The primary objective is to acquire existing, HIPAA-compliant data resources that will enhance drug safety evaluations, support post-market surveillance, and inform regulatory decisions, rather than developing new databases. This initiative is crucial for monitoring medication utilization trends, particularly in areas such as opioid surveillance, and aims to improve public health outcomes through rigorous analyses of drug safety data. Interested firms must submit their responses by January 23, 2025, including their business size status and DUNS number, and can direct inquiries to Telisha Wilson at telisha.wilson@fda.hhs.gov.
    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.
    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.
    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.
    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.
    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.
    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 across multiple regions in the United States. 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. This initiative is critical for enhancing the FDA's enforcement capabilities and protecting public health by reducing tobacco use among minors. 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 specific funding amounts to be determined for each region.
    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.
    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.