Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ

Closed Solicitation Posted

Solicitation number
75F40126R00009
Agency
Responses due
Set-aside
Service-Disabled Veteran-Owned Small Business

Opportunity facts

Place of performance
Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The Food and Drug Administration, through HHS's Office of Acquisition and Grant Services, is soliciting offers for a single Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ recompete, with proposals due October 6, 2026 under Amendment 0001, which superseded the posted November 5, 2026 date. The acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business concerns, with SDVOSB status determined by SBA under 13 CFR part 128.

The contract covers document control and records management for FDA regulatory submissions across multiple centers, organized into six task areas: program and task order management support, document processing and delivery, scanning and conversion, data entry and tracking, temporary records storage, and transition activities. Amendment 0005 sets the ordering period at December 1, 2026 through November 30, 2031, with a $10,000 guaranteed minimum and a $50,000,000 ceiling. The Government will award a single IDIQ allowing Time-and-Materials, Labor-Hour, and Firm-Fixed Price task orders, or combinations thereof. The NAICS code is 541611 and the PSC is R617.

The notice lists Silver Spring, Maryland 20993 as place of performance. Work is performed at a contractor-hosted off-site FIRF facility, with courier service between that facility and the FDA White Oak Campus. The facility requires an Authorization to Operate (ATO) certificate, FISMA compliance, FIPS 140-validated encryption, controlled physical and network access, and direct FDA data cable connectivity. Personnel must maintain Tier 2/Sensitive Moderate Risk security clearances and complete mandatory FDA training. Performance standards include at least 95 percent same-day processing for submissions, expedited courier delivery within one to two hours, and real-time inventory tracking with API access to FDA systems. A Program/Contract Manager must be designated at award.

Attachment F, as amended by Amendment 0005, defines thirteen labor categories, and not all will be used on each task order. Offerors submit fully burdened hourly rates by category in the IDIQ Pricing Worksheet, inclusive of wages, indirect costs, fringe, overhead, G&A, and profit. Attachment B contains Service Contract Act wage determinations effective August 22, 2026 for Maryland, Virginia, and the District of Columbia. Offerors must disclose subcontractors and their estimated participation under FAR 52.219-14. Attachment G, the past performance questionnaire, is due to Contract Specialist Melinda Kim and Contracting Officer Nick Bisher by the proposal due date.

The sample task order (Attachment K) prices CDRH Premarket/Postmarket Tracking Services with a grand total of $1,896,259.06 across a Base Year, four Option Years, and a 6-month extension, and Attachment E estimates 47,240 submissions annually. Amendment 0003 issued the Questions and Answers (Attachment L), and Amendment 0004 (October 19, 2026) and Amendment 0005 (October 27, 2026) revised the ordering period, labor categories, and pricing attachments.

Notice text

6 versions

Update #6 · Latest ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through L) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

*Amendment 0001 to RFP 75F40126R00009 is issued on 09/08/2026 to:

  1. Change the due date for questions to 2:00 PM Eastern Time on 09/15/2026; and
  2. Change the due date for proposals to 2:00 PM Eastern Time on 10/06/2026.

**Amendment 0002 to RFP 75F40126R00009 is issued on 09/30/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/20/2026.

***Amendment 0003 to RFP 75F40126R00009 is issued on 10/07/2026 to:

  1. Revise the solicitation document titled, "2026-10-07 Amendment 0003_RFP 75F40126R00009 FIRF IDIQ.pdf";
  2. Revise the attachment titled, "2026-10-07 Amendment 0003_Attachment E-Sample Task Order Statement of Work.pdf";
  3. Add the new attachment titled, "2026-10-07 Amendment 0003_Attachment L-Questions and Answers.xlsx"; and
  4. Change the due date for proposals to 2:00 PM Eastern Time on 10/22/2026.

****Amendment 0004 to RFP 75F40126R00009 is issued on 10/19/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/29/2026.

*****Amendment 0005 to RFP 75F40126R00009 is issued on 10/27/2026 to:

  1. Revise the solicitation document titled, "2026-10-27 Amendment 0005_RFP 75F40126R00009 FIRF IDIQ.pdf";
  2. Revise the attachment titled, "2026-10-27 Amendment 0005_Attachment F-Labor Category Descriptions.pdf";
  3. Revise the attachment titled, "2026-10-27 Amendment 0005_Attachment K-Sample Task Order Pricing Worksheet.xlsx"; and
  4. Change the due date for proposals to 2:00 PM Eastern Time on 11/05/2026.
Update #5 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through L) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

*Amendment 0001 to RFP 75F40126R00009 is issued on 09/08/2026 to:

  1. Change the due date for questions to 2:00 PM Eastern Time on 09/15/2026; and
  2. Change the due date for proposals to 2:00 PM Eastern Time on 10/06/2026.

**Amendment 0002 to RFP 75F40126R00009 is issued on 09/30/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/20/2026.

***Amendment 0003 to RFP 75F40126R00009 is issued on 10/07/2026 to:

  1. Revise the solicitation document titled, "2026-10-07 Amendment 0003_RFP 75F40126R00009 FIRF IDIQ.pdf";
  2. Revise the attachment titled, "2026-10-07 Amendment 0003_Attachment E-Sample Task Order Statement of Work.pdf";
  3. Add the new attachment titled, "2026-10-07 Amendment 0003_Attachment L-Questions and Answers.xlsx"; and
  4. Change the due date for proposals to 2:00 PM Eastern Time on 10/22/2026.

****Amendment 0004 to RFP 75F40126R00009 is issued on 10/19/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/29/2026.
Update #4 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through L) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

*Amendment 0001 to RFP 75F40126R00009 is issued on 09/08/2026 to:

  1. Change the due date for questions to 2:00 PM Eastern Time on 09/15/2026; and
  2. Change the due date for proposals to 2:00 PM Eastern Time on 10/06/2026.

**Amendment 0002 to RFP 75F40126R00009 is issued on 09/30/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/20/2026.

***Amendment 0003 to RFP 75F40126R00009 is issued on 10/07/2026 to:

  1. Revise the solicitation document titled, "2026-10-07 Amendment 0003_RFP 75F40126R00009 FIRF IDIQ.pdf";
  2. Revise the attachment titled, "2026-10-07 Amendment 0003_Attachment E-Sample Task Order Statement of Work.pdf";
  3. Add the new attachment titled, "2026-10-07 Amendment 0003_Attachment L-Questions and Answers.xlsx"; and
  4. Change the due date for proposals to 2:00 PM Eastern Time on 10/22/2026.
Update #3 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through K) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

*Amendment 0001 to RFP 75F40126R00009 is issued on 09/08/2026 to:

  1. Change the due date for questions to 2:00 PM Eastern Time on 09/15/2026; and
  2. Change the due date for proposals to 2:00 PM Eastern Time on 10/06/2026.

**Amendment 0002 to RFP 75F40126R00009 is issued on 09/30/2026 to:

  1. Change the due date for proposals to 2:00 PM Eastern Time on 10/20/2026.
Update #2 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through K) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

*Amendment 0001 to RFP 75F40126R00009 is issued on 09/08/2026 to:

  1. Change the due date for questions to 2:00 PM Eastern Time on 09/15/2026; and
  2. Change the due date for proposals to 2:00 PM Eastern Time on 10/06/2026.
Update #1 ·

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format set forth at Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR 12.202(b)(1) (Apr. 20, 2026) [adopted via Department of
Health and Human Services (HHS) FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025)]. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. This
acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns in accordance with RFO FAR 19.106-2 (Feb. 20, 2026) [adopted via HHS FAR CD No. 2026-01, Amendment 2 (Apr. 24, 2026)]. Status as an
SDVOSB concern is determined by the Small Business Association (SBA) in accordance with 13 Code of Federal Regulations (CFR) part 128. Solicitation number 75F40126R00009 is issued as a request for proposal (RFP) for Contractor-Hosted Fully
Integrated Records Facility (FIRF) services. The Government anticipates awarding a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract that will allow for Time-and-Materials (T&M), Labor-Hour (LH), and Firm-Fixed Price (FFP) type Task
Orders, or a combination thereof. This anticipated IDIQ will contain a five (5) year ordering period, which will be from the date of award through five (5) years unless extended as applicable.

Please carefully review all the attached solicitation documents (RFP 75F40126R00009, Attachment A: Statement of Work Appendices (Appendix 1 through Appendix 5), and Attachments B through K) for a full description of this effort and for instructions on how to submit questions and proposals within the given deadlines.

Files

File Type Posted
2026-10-27 Amendment 0005_Attachment K-Sample Task Order Pricing Worksheet.xlsx XLSX spreadsheet
2026-10-27 Amendment 0005_RFP 75F40126R00009 FIRF IDIQ.pdf PDF
2026-10-27 Amendment 0005_Attachment F-Labor Category Descriptions.pdf PDF
2026-10-19 Amendment 0004_RFP 75F40126R00009 FIRF IDIQ.pdf PDF
2026-10-07 Amendment 0003_RFP 75F40126R00009 FIRF IDIQ.pdf PDF
2026-10-07 Amendment 0003_Attachment E-Sample Task Order Statement of Work.pdf PDF
2026-10-07 Attachment L-Questions and Answers.xlsx XLSX spreadsheet
2026-09-30 Amendment 0002_RFP 75F40126R00009 FIRF IDIQ.pdf PDF
2026-09-08 Amendment 0001_RFP 75F40126R00009 FIRF IDIQ.pdf PDF
RFP 75F40126R00009 FIRF IDIQ.pdf PDF
Appendix 2-Basic RP LAN Room Layout.pdf PDF
Attachment C-IDIQ Pricing Worksheet.xlsx XLSX spreadsheet
Attachment H-Commitment to Protect Non-Public Information (NPI) Employee Agreement Form FDA 3398.pdf PDF
Attachment K-Sample Task Order Pricing Worksheet.xlsx XLSX spreadsheet
Appendix 3-FDA Physical Security Requirements.pdf PDF
Attachment B-Wage Determinations (2015-4269 and 2015-4281).pdf PDF
Attachment D-Disclosure of Lobbying Activities SF-LLL.pdf PDF
Attachment E-Sample Task Order Statement of Work.pdf PDF
Appendix 5-FDA-CDRH Document Control Ceneter (DCC) Tracking System Requirements.pdf PDF
Attachment F-Labor Category Descriptions.pdf PDF
Appendix 1-OIMT_IT-Spaces-Cabling-Guidelines.pdf PDF
Appendix 3A-Addendum to Physical Security Requirements.pdf PDF
Appendix 4-CDRH Work Functions.xlsx XLSX spreadsheet
Attachment G-Past Performance Questionnaire.docx DOCX document
Attachment I-RFP Question Submittal Form.xlsx XLSX spreadsheet
Attachment J-Contractor Personnel Security Clearance Standards and Residency Requirements (OCT 2017).pdf PDF
Show all 26

Notice history

Notice Type Posted
This notice Latest solicitation Solicitation
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Original Pre-Solicitation

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Opportunity Agency Set-aside Responses due
FDA Scientific & Regulatory Support Services(SRS) Silver Spring, Maryland 20993, United States · NAICS 541990 FDA Office of Acquisition and Grant Services Total Small Business
U.S. Food and Drug Administration Regulatory Support Services BPA Silver Spring, Maryland, United States · NAICS 541611 FDA Office of Acquisition and Grant Services No set-aside
FDA/CDRH Scientific Technical Capacity for Regulatory Review Silver Spring, Maryland 20993, United States · NAICS 541611 FDA Office of Acquisition and Grant Services No set-aside
Fiscal Year 2027 FDA Small Business Fair Silver Spring, Maryland 20903, United States Food and Drug Administration Total Small Business

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