Facility Management System (FMS) Administration and Data Management
ID: 75F40124Q00534Type: 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/ed02167303c74d32af8303da4a53e530/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified vendors for the administration and data management of its Facility Management System (FMS), utilizing the ARCHIBUS software. The contractor will be responsible for providing ongoing FMS support, ensuring compliance with federal reporting requirements, maintaining data integrity, and offering user training and technical assistance. This initiative is crucial for managing the FDA's facilities efficiently in response to increasing service demands and regulatory requirements, with the contract anticipated to span from March 24, 2025, to March 23, 2030. Interested parties must submit their responses, including a Vendor Feedback Form, to Nicholas Bisher and Kimberly Pennix by September 23, 2024, at 2:00 PM EST, as this is a Sources Sought Notice and not a solicitation for proposals.

    Point(s) of Contact
    Kimberly Pennix
    kimberly.pennix@fda.hhs.gov
    Nicholas Bisher
    Nicholas.Bisher@fda.hhs.gov
    Files
    Title
    Posted
    Attachment A_ SOW.pdf
    The Food and Drug Administration (FDA) is seeking contractor support for the administration and data management of its Facility Management System (FMS), specifically the ARCHIBUS software. This initiative is a response to increased service demands linked to population aging and regulatory requirements. The contractor will provide comprehensive FMS administration, user training, software implementation, and technical assistance in real-time. Key responsibilities include maintaining data integrity for real property reporting, user account management, and coordination with project teams on space planning and facility operations. The contractor must possess deep expertise in ARCHIBUS and related CAD management tools, ensuring compliance with Federal Real Property Council reporting requirements. The project’s duration spans from March 24, 2025, to March 23, 2030, with a firm fixed-price contract anticipated and locations primarily based at the FDA’s headquarters in Silver Spring, Maryland, along with other U.S. facilities. Security clearance for contractor staff is mandatory, emphasizing the importance of information confidentiality and compliance with federal regulations, including training in information security. This contract reflects the FDA's commitment to efficient facility management aligned with government space utilization policies and budget constraints.
    Attachment B - Vendor Feedback Form.pdf
    The Vendor Feedback Form is aimed at gathering responses from potential service providers regarding their capacity to fulfill the requirements laid out in the Draft Statement of Work (SOW) for the FDA. The form opens with questions that assess whether companies can deliver all services specified in the SOW, whether they possess existing contracts that could be utilized, and their geographic capabilities to provide services across multiple locations, including the National Capital Region. Furthermore, the form seeks detailed descriptions of the companies' relevant experience in areas such as Facility Management System Administration, report drafting, and training. Companies are also encouraged to provide feedback on the Draft SOW. Finally, respondents are asked to recommend an appropriate NAICS code for the requirements listed. Overall, this document is a crucial tool in the governmental Request for Proposal (RFP) process, helping to evaluate the suitability of vendors for upcoming contracts while ensuring compliance with federal guidelines.
    Attachment C_Personnel Security Requirements and Residency Requirements.pdf
    The Personnel Security Requirements document outlines the standards and procedures that contractor employees must adhere to when working with the Department of Health and Human Services (DHHS). Key personnel who will access DHHS facilities or sensitive information must undergo favorable background checks. Employees working for less than 30 days are classified as visitors, requiring escorting at all times without a mandatory background check. The contractor is responsible for submitting employee rosters, security confirmations, and signed agreements within five days of work commencement. Background investigations will be conducted by the Office of Personnel Management (OPM) at no cost, except for fingerprinting outside the designated facility, which is the contractor's responsibility. Employees must acquire a Personal Identity Verification (PIV) card for access lasting longer than 30 days. All forms must be submitted electronically via the e-QIP system, and non-compliance can result in denied access and impact contractor performance. Additionally, for foreign national employees, at least three years of residency in the U.S. is required for eligibility for PIV cards. Lastly, the document emphasizes the necessity of protecting non-public data and mandates that any lost or unreturned PIV cards must be reported and returned to the government. Overall, this ensures security and accountability within DHHS operations.
    Lifecycle
    Title
    Type
    Facility Management System (FMS) Administration and Data Management
    Currently viewing
    Sources Sought
    Similar Opportunities
    Business Data Enrichment Services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking information on Business Data Enrichment Services to support the establishment of an enterprise master data management program. The primary objective is to enhance the accuracy and completeness of business data across operational and analytical systems, which is crucial for regulatory compliance and public health initiatives. This Request for Information (RFI) is part of the FDA's efforts to gather insights from the marketplace regarding potential solutions and capabilities, particularly in light of legislative requirements such as the Drug Supply Chain and Security Act. Interested stakeholders must submit their responses by November 15, 2024, and can direct inquiries to Noah Padilla at Noah.Padilla@fda.hhs.gov or Peter Lee at peter.lee@fda.hhs.gov.
    FDA Headquarters Consolidation Initiative - Workplace Enhancement and Management Services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), intends to award an 8(a) sole source contract for Workplace Enhancement and Management Services as part of the FDA Headquarters Consolidation Initiative. The primary objective of this procurement is to enhance space efficiency at the FDA Headquarters in Silver Spring, Maryland, necessitating comprehensive space planning, project management for office renovations, and furniture coordination. This initiative is crucial for optimizing the operational environment to support the FDA's mission of promoting public health, with a total estimated contract value of $4,269,388.87 for a base year and two optional years, starting January 1, 2025. Interested parties may submit qualifications and capabilities by 10:00 AM ET on November 12, 2024, to Andrea Howard at andrea.howard1@fda.hhs.gov or Sandra Bellinger at sandra.bellinger@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.
    Preventive Maintenance and Repair service for the Cryo-Cooler components of a Bruker Biospec 47/40 magnetic resonance imaging (MRI) unit (base year only)
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking small business sources to provide Preventive Maintenance and Repair services for the Cryo-Cooler components of a Bruker Biospec 47/40 magnetic resonance imaging (MRI) unit located at the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas. The required services will span a one-year period starting from November 30, 2024, following the expiration of the current service contract, and interested vendors must submit capability statements detailing their qualifications, including past performance and the ability to meet specific performance requirements such as on-site maintenance and the use of OEM parts. This opportunity is critical for ensuring the reliable operation and maintenance of the MRI equipment in compliance with OEM specifications. Interested parties must submit their responses via email by November 7, 2024, and can contact Suzanne Martella at suzanne.martella@fda.hhs.gov for further information.
    NTELX Perpetual License, Software Maintenance & Support
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking small business sources to provide a perpetual license, maintenance, and support for NTELX software, specifically for the Office of Regulatory Affairs (ORA). This procurement aims to ensure continuous operational support for mission-critical applications used by ORA staff, which are vital for optimizing import inspections and public health compliance under the Bioterrorism Act of 2002. The NTELX software, including key modules such as PREDICT, FDanalyzer, FDfusion, FDmonitor, and FDauditor, processes approximately 50 million lines of import data annually, making it essential for risk assessment and compliance targeting. Interested small businesses must submit their capability statements by November 14, 2024, and can contact Robert Waite at robert.waite@fda.hhs.gov for further information.
    Notice of Intent to Limiting sources
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to award a fixed-price contract for Preventative Maintenance and Qualification Services for an Agilent GC/MS and HPLC system. The procurement is limited to Agilent Technologies or its authorized service provider network due to the highly specialized nature of the required services, which include diagnostic tests and the replacement of parts compliant with original equipment manufacturer (OEM) specifications. These services are critical for ensuring the safe and effective operation of the FDA's instruments, as using non-authorized providers could invalidate warranties and pose safety risks. Interested parties capable of meeting these requirements may submit written capability statements by 3:00 p.m. EST on November 12, 2024, to Elena Tatarov at elena.tatarov@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, through the Food and Drug Administration (FDA), is soliciting proposals for the FY25 Broad Agency Announcement (BAA) aimed at advancing research and development in regulatory science. This initiative seeks to acquire innovative research proposals that enhance the FDA's mission to protect public health by modernizing the evaluation of FDA-regulated products and improving post-market surveillance. Eligible applicants, including private organizations and academic institutions, are encouraged to submit proposals that address critical knowledge gaps and align with FDA priorities, with a submission deadline for full proposals set for February 24, 2025. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.
    Preventive Maintenance and Repair Services for a PacBio Sequel II next generation sequencer
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking qualified vendors to provide Preventive Maintenance and Repair Services for a PacBio Sequel II next generation sequencer, Serial Number: SQ64096, on behalf of the National Center for Toxicological Research (NCTR). The procurement includes a base year of service and three option years, with requirements for scheduled preventive maintenance visits, unlimited corrective maintenance, and technical support, all performed by OEM-certified engineers using OEM-certified parts. This equipment is crucial for the NCTR's research activities, and responses to this sources sought announcement must be submitted by November 8, 2024, to Warren Dutter at warren.dutter@fda.hhs.gov, with no contract awarded from this announcement.
    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.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for Chemistry, Manufacturing, and Control (CMC) services related to the development of drug substances under RFP number 75N95024R00094. The primary objective is to secure high-quality drug substances to support preclinical and Investigational New Drug (IND)-enabling studies, ensuring compliance with current Good Manufacturing Practices (cGMP) and federal regulations. This initiative is crucial for advancing therapeutic innovations and facilitating collaborations in drug development, with a total funding amount of up to $49.7 million over the contract period from September 1, 2025, to May 14, 2031. Interested parties must submit their proposals by December 3, 2024, and can direct inquiries to primary contact Samson Shifaraw at samson.shifaraw@nih.gov or secondary contact Valerie Whipple at valerie.whipple@nih.gov.