Notice ID: 7404ddf0b986404e91d7a31ae3d188dbSources Sought
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Archived on December 4, 2024. Original response deadline: . Full description on SAM.gov.
Description
Description The U.S. Food and Drug Administration's (FDA), Office of Acquisitions and Grants Services (OAGS), is conducting market research for obtaining Contractor-Hosted Fully Integrated Records Facility (FIRF) services. THIS IS A SOURCES SOUGHT NOTICE (SSN) ONLY. This SSN is being issued in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research. It is for information, planning and market research purposes only and is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to contact any of the respondents after the submission deadline if additional information is required. The purpose of this SSN is to identify and gain knowledge of potential small business sources that are capable of providing the full range of services described in this SSN and the attached draft Statement of Work (SOW). Responses to this SSN will be utilized for a potential solicitation for an anticipated single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract for FIRF services. The anticipated period of performance for this IDIQ is September 15, 2025 through September 14, 2030. Requested Information Interested parties are highly encouraged to respond to this SSN by providing the following information in their response: Completed Vendor Feedback Form � see attached Vendor Feedback Form If applicable, tracked changes/comments on draft SOW in MS Word format � see attached draft SOW Capability Statement Responses shall be submitted via email with the subject line �Sources Sought Notice � FDA-SSN-75F40125R00014� to the Contract Specialist, Noah Wills (Noah.Wills@fda.hhs.gov), and cc the Contracting Officer, James Jenrette (James.JenretteIII@fda.hhs.gov), no later than 12:00pm (Eastern) on November 19, 2024. Attachments Vendor Feedback Form Draft Statement of Work
Overview
Agency:
Department of Health and Human ServicesFOOD AND DRUG ADMINISTRATION
Office:FDA OFFICE OF ACQ GRANT SVCS
Posted:November 4, 2024
NAICS:Not specified
Last Updated:Jan 23, 2026
PSC:Not specified
Set-Aside:Not specified
Type:Sources Sought
Place of Performance:Silver Spring, MD
Award Overview
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Showing 3 of 3 items
Document | Source | Agency | Posted Date | File Size | Actions | |
|---|---|---|---|---|---|---|
| Sources Sought | FOOD AND DRUG ADMINISTRATION | Nov 4, 2024 | - | |||
| Sources Sought | FOOD AND DRUG ADMINISTRATION | Nov 4, 2024 | - | |||
| Sources Sought | FOOD AND DRUG ADMINISTRATION | Nov 4, 2024 | - |
Lifecycle
Solicitation:
FDA-SSN-75F40125R00014- Market Research
Pre-solicitation or formal solicitation typically follows within 30–180 days. (estimate)
- Market ResearchCurrentNov 4, 2024
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Similar Opportunities
Title | Phase | Agency | NAICS | Set Aside | Posted | Deadline | Location |
|---|---|---|---|---|---|---|---|
The Contractor shall provide comprehensive, enterprise-wide lifecycle support for Electronic Security Systems (ESS) at Department of Health and Human Services (HHS) facilities nationwide. This includes the engineering, design, installation, integration, and commissioning of new systems; preventive and corrective maintenance; inspection, testing, and repair; system modernization and upgrades; system administration and configuration management; software and license support; and 24-hour emergency response. Covered systems include Physical Access Control Systems (PACS), Video Surveillance/Video Management Systems (VSS/VMS), Intrusion Detection Systems (IDS), duress alarms, intercoms, turnstiles, gate arms, elevator-control interfaces, and the associated network infrastructure supporting these systems — primarily built on the Lenel OnGuard and Milestone XProtect platforms. Services span routine, recurring operations and maintenance (priced firm-fixed-price) as well as supplemental, non-routine work such as installations, major component replacement, and modernization projects (priced firm-fixed-price or, when properly justified, time-and-materials). The Contractor is also responsible for staffing key personnel (Program Manager, Project Manager, System Administrator, System Engineer, Lead Technician, and supporting technicians), maintaining a nationwide dispatch/service desk, managing spare parts inventory, supporting cybersecurity and FedRAMP/FISMA compliance for any cloud-based components, and ensuring all work complies with federal physical security, IT security, and records-management requirements — all in support of approximately 35 active facilities at award, with the capacity to scale to roughly 699 facilities nationwide through funded task orders over a 12-month base period plus four option years. The place of performance is nationwide, across Department of Health and Human Services (HHS)-owned, leased, or operated facilities. Specifically: At award: Approximately 35 active facilities, including major National Capital Region (NCR) locations and facilities within all 10 HHS Regions/Hubs. Potential ordering universe: Approximately 699 HHS facilities nationwide, which the contract may expand to through funded task orders (identification in this universe doesn't create an obligation — only facilities in the awarded schedule or a funded task order are actual performance locations | Market Research | 561621 | No Set-Aside | 10/26/2026 | 11/04/2026 | Rockville, MD | |
The goal of this acquisition is to acquire a contractor that offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including DSMB services; (3) analytical solutions, including bioinformatics, and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be capable of providing these services, as required under the individual task orders, to support NHGRI clinical research protocols and related activities within the scope of this IDIQ contract. The contractor should be capable assigning qualified personnel with experience in clinical trial design and regulatory requirements, especially as relates to studies of rare diseases, genetic conditions, gene therapy (including via AAV9 vectors), and pediatric as well as adult populations, as applicable to individual task orders. | Combined Synopsis | 541690 | Total Small Business Set-Aside | 10/26/2026 | 11/13/2026 | Bethesda, MD | |
This requirement will provide assessment and accreditation of the NIH IRP animal program. This will allow the NIH IRP to remain in compliance with the requirements of NIH Policy Manual Chapter 3040-2, Animal Care and Use in the IRP, which requires full accreditation by AAALAC International. See attached NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION. | Special Notice | 811310 | No Set-Aside | 10/26/2026 | 11/06/2026 | Bethesda, MD | |
The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to procure preventative maintenance and service support for seven (7) Miltenyi Biotec CliniMACS Plus instruments from Miltenyi Biotec, Inc. The requirement supports the continued operation of critical cell-processing equipment used in manufacturing patient-specific cellular therapies for patients enrolled in clinical trials at the NIH Clinical Center. CCE manufactures cell-based therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The requirement includes preventative maintenance, calibration, inspections, software updates, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support for CliniMACS Plus instruments bearing serial numbers 2600, 2602, 2632, 2635, 2634, 2619, and 2756. These services are necessary to maintain equipment reliability, validated manufacturing processes, and compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Miltenyi Biotec, Inc., is the original equipment manufacturer and the only known authorized provider capable of performing the required preventative maintenance, calibration, and technical support services for the CliniMACS Plus instruments. The equipment incorporates proprietary software, diagnostic tools, replacement parts, and manufacturer-specific technical requirements that are not available to unauthorized third-party service providers. The seven instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an alternate service provider without the required manufacturer authorization, proprietary software access, and technical expertise could compromise equipment performance, jeopardize regulatory compliance, and require costly requalification activities. Any disruption to these critical instruments could delay manufacturing operations and patient treatment schedules. Accordingly, NIH intends to award this requirement to Miltenyi Biotec, Inc., on a sole-source basis to ensure continued operational readiness and compliance with FDA-regulated manufacturing requirements. The proposed contractor is: Miltenyi Biotec, Inc. Capability Statements This notice is not a request for competitive quotations or proposals. However, responsible sources that believe they can satisfy the Government's requirement may submit a capability statement demonstrating their ability to provide the required preventative maintenance, calibration, and service support for the seven Miltenyi Biotec CliniMACS Plus instruments. Capability statements should clearly demonstrate the vendor's technical qualifications, manufacturer authorization, access to proprietary diagnostic software and replacement parts, and ability to perform the required services in accordance with applicable FDA and cGMP requirements. Vendors must also demonstrate their ability to maintain the instruments' validated operating conditions and provide preventative maintenance reports for review by the CCE Quality Assurance team. All capability statements must be received no later than November 4, 2026, at 7:00 AM Eastern Time (ET). The Government will consider all responses received by the stated deadline. A determination not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. No solicitation package is available at this time. This notice does not constitute a solicitation, and the Government will not reimburse respondents for costs associated with preparing or submitting a response. | Pre-Solicitation | 811210 | No Set-Aside | 10/26/2026 | 11/04/2026 | Bethesda, MD | |
The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to procure preventative maintenance and service support for thirty-six (36) Thermo Fisher Scientific incubators, consisting of thirty-two (32) HERA VIOS 160i CO2 incubators and four (4) VIOS 250i CO2 incubators, for the period of performance January 16, 2027, through March 15, 2028. CCE manufactures patient-specific cellular therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions in support of clinical trials conducted at the NIH Clinical Center. These incubators are critical to validated cell-manufacturing processes and require manufacturer-authorized preventative maintenance, calibration, and technical support to ensure continued operational readiness and regulatory compliance. The requirement includes annual preventative maintenance, calibration, inspections, diagnostic testing, software and firmware updates, troubleshooting, repair support, replacement of proprietary service parts, and technical assistance necessary to maintain the equipment in accordance with manufacturer specifications and applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Thermo Fisher Scientific is the original equipment manufacturer (OEM) and the only known authorized source capable of providing the full scope of preventative maintenance, calibration, software and firmware support, and repair services required for the HERA VIOS 160i CO2 and VIOS 250i CO2 incubators. These instruments incorporate proprietary software, firmware, diagnostic tools, and replacement parts requiring manufacturer-specific technical expertise and authorized access. Market research did not identify alternate vendors possessing the necessary manufacturer authorization and proprietary software access to perform all required services. Additionally, Thermo Fisher Scientific has historically maintained these instruments and has successfully completed CCE's qualification and validation requirements. The company is an approved service provider under CCE's Quality Assurance program. Utilizing an alternate contractor would require additional qualification and validation activities and could result in significant delays, increased costs, and disruptions to critical cell-manufacturing operations. Failure to maintain the incubators could compromise validated manufacturing processes, affect regulatory compliance, and delay patient treatment schedules. Accordingly, NIH intends to procure these services from Thermo Fisher Scientific on a sole-source basis. The proposed contractor is: Thermo Fisher Scientific (Asheville)LLC 275 Aiken Road Asheville, North Carolina 28804-8740 Capability Statements This notice is not a request for competitive quotations or proposals. However, responsible sources that believe they can satisfy the Government's requirement may submit a capability statement demonstrating their ability to provide the required preventative maintenance, calibration, and technical support services for the thirty-six (36) HERA VIOS 160i CO2 and VIOS 250i CO2 incubators. Capability statements should clearly demonstrate the vendor's technical qualifications, manufacturer authorization, access to proprietary diagnostic software, firmware updates and replacement parts, and ability to perform the required services in accordance with FDA and cGMP requirements. Interested vendors must also demonstrate their ability to satisfy CCE's qualification and validation requirements, maintain the equipment's validated operating conditions, and provide appropriate maintenance and calibration documentation. All capability statements must be received no later than November 4, 2026, at 7:30 AM Eastern Time (ET). The Government will consider all responses received by the stated deadline. A determination not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. No solicitation package is available at this time. This notice does not constitute a solicitation, and the Government will not reimburse respondents for costs associated with preparing or submitting a response. | Pre-Solicitation | 811210 | No Set-Aside | 10/26/2026 | 11/04/2026 | Bethesda, MD |
Additional Details
Solicitation Number
FDA-SSN-75F40125R00014
Archive Date
Dec 4, 2024
Office Address
Beltsville, MD, 20705