Supplies_CSS.docx

ALP: CDRH-2026-132857

Short Description: Automated MTS Load Cell

COMBINED SYNOPSIS/SOLICITATION

1. GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 75F40126Q00276 is issued as a/an [☒ RFQ ☐ RFP ☐ IFB] for one (1) load cell transducer and all labor, materials, equipment, installation services, calibration services, interface hardware, travel, and incidental items necessary to provide a fully operational load measurement solution compatible with the Government-owned MTS Mini-Bionix 858 system. The acquisition includes removal of the existing load cell transducer, fabrication and installation of the required top interface plate and bottom adapter plate, operational verification, documentation, and all accessories necessary to provide a fully operational solution.

This acquisition ☐ is / ☒ is not set-aside for small business concerns.

Set-Aside: ☒ None ☐ Total Small Business ☐ WOSB ☐ SDVOSB ☐ 8(a) ☐ HUBZone ☐ Other: [specify]

NAICS Code: 334519 Other Measuring and Controlling Device Manufacturing Small Business Size Standard: 600 employees This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at: https://acquisition.gov/ | https://acquisition.gov/far-overhaul | https://acquisition.gov/hhsar

All responsible sources may submit a ☒ quotation ☐ bid ☐ proposal, which will be considered by the agency.

2. DELIVERY AND PERFORMANCE

Place of Delivery / Place of Performance:

FDA White Oak Campus Building 62 Room G216 10903 New Hampshire Avenue Silver Spring, MD 20993

FOB Point: ☒ Destination ☐ Origin Inspection and Acceptance: Inspection and acceptance shall be performed at the delivery location in accordance with the terms of clause 52.212-4.

Period of Performance Supplies: Specific Delivery Date Delivery, installation, calibration, and operational verification shall be completed within six (6) weeks after receipt of order unless otherwise agreed to in writing by the Contracting Officer.

Final Government acceptance shall occur following successful installation, completion of required calibration, receipt of NIST-traceable calibration certificates and required documentation, and Government verification that the installed load cell operates successfully with the existing MTS Mini-Bionix 858 system.

Following Government acceptance, the Contracting Officer will issue an administrative modification under RFO 43.203(b)(1) and 43.201 to memorialize the period of performance dates, anchored to the Government acceptance date. The modification does not change scope, price, or any other substantive term. The Contractor's written confirmation of the installation completion date supports inspection and acceptance scheduling; it does not establish the period of performance.

3. CONTRACT LINE ITEMS (CLINs)

4. POINTS OF CONTACT

Contracting Officer:

Name: Iris Johnson Email: Iris.Johnson1@fda.hhs.gov Phone: 301-796-3353 Contract Specialist:

Name: Reagan Davis Email: Reagan.Davis@fda.hhs.gov Phone: 301-796-0910

5. CONTRACT CLAUSES

5A. Clauses Incorporated by Reference

5B. Clauses Incorporated by Full Text

52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://acquisition.gov https://acquisition.gov/far-overhaul https://acquisition.gov/hhsar (End of clause)

FDA Electronic Invoicing and Payment Requirements — Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(1) list of all invoices submitted to date under the subject award, including the following:

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

(2) total amount of all payments received to date under the subject contract or order

(3) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

e. If the services are rejected for failure to conform to the technical requirements of the Delivery Order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

f. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

g. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

h. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of clause)

6. SPECIFICATIONS

The contractor shall provide one (1) load cell transducer and all labor, materials, equipment, installation services, calibration services, interface hardware, travel, and incidental items necessary to provide a fully operational load measurement solution compatible with the Government-owned MTS Mini-Bionix 858 system. The requirement includes removal of the existing load cell transducer, fabrication and installation of the required top interface plate and bottom adapter plate, operational verification, documentation, and all accessories necessary to provide a fully operational solution. The MTS Mini-Bionix 858 system is identified as the reference platform for compatibility purposes only. Equivalent products meeting all stated salient characteristics and interoperability requirements will be considered. This is a non-personal services requirement. The load cell transducer and associated hardware shall include a minimum twelve (12)-month warranty beginning at final Government acceptance. The warranty shall cover all parts, labor, travel, and technical support required to return the transducer to full operating condition.

Minimum Technical Requirements (Salient Characteristics) The following salient characteristics represent the Government's minimum requirements.

· Load cell transducer capable of measuring 0N to ±22,000N in tension and compression.

· Load cell transducer capable of measuring 0Nm to ±200Nm in torsion.

· Compatible with existing MTS controller hardware, software configuration, and data acquisition interfaces without requiring replacement of the existing MTS Mini-Bionix 858 system.

· Compatible with MTS Mini-Bionix 858 load frame model 370.02

· Compatible with existing TDS connectors or provide a complete interface solution.

· Support load and torque reporting functionality.

· Provide all adapters, interface hardware, fabricated top interface plate, fabricated bottom adapter plate, mounting hardware, and all accessories necessary to provide a fully operational solution. The MTS Mini-Bionix 858 system is identified as the reference platform for compatibility purposes only.

· On-site force calibration shall be performed in accordance with ASTM E4-21 from 1% to 100% capacity, and on-site torque calibration shall be performed in accordance with ASTM E2624-17 from 1% to 100% capacity. Calibration shall include NIST-traceable calibration certificates.

· Include calibration certificates and warranty documentation.

The Contractor shall demonstrate successful operation of the installed load cell with the Government's existing MTS Mini-Bionix 858 system prior to Government acceptance.

PRE-AWARD ONLY (DELETE AT AWARD)

The sections below are required for the combined synopsis/solicitation when it is posted on SAM.gov under RFO 12.202. Delete this entire block at award; the content is pre-award only and does not survive award. The combined synopsis/solicitation statements required by RFO 12.202(b)(1)(i) remain in Section 1.

A. SOLICITATION PROVISIONS

A1. Provisions Incorporated by Reference

Basis for Award Lowest Price Technically Acceptable (LPTA): Quotations that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Technical acceptability will be evaluated against all minimum requirements contained in Section 6 and the attached Requirements Document on a pass/fail basis. Lowest Price Technically Acceptable (LPTA): Award will be made to the responsible quoter submitting the lowest-priced quotation determined technically acceptable. Price will be evaluated for reasonableness.

The offeror shall provide the manufacturer, make/model/part number of the proposed load cell and sufficient technical literature or documentation demonstrating compliance with each salient characteristic. The offeror shall identify any exceptions or deviations.

The technical quotation shall include a compliance matrix addressing each applicable minimum requirement and salient characteristic individually and identifying the specific page or section of the supporting technical literature demonstrating compliance. Any exception or deviation shall be clearly identified.

A2. Addenda to 52.212-1

Offer Acceptance Period (if applicable):

Paragraph (b) of the provision is hereby amended to extend the period for acceptance of offers from 60 calendar days to 90 calendar days from the date specified for receipt of offers.

B. OFFER SUBMISSION

Questions Due: Questions regarding this solicitation shall be submitted in writing to the Primary POC identified in the SAM.gov notice Hard Date: August 31, 2026 12pm, ET. Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

Manufacturer and country of origin for the load cell transducer and each separately furnished end item/accessory.

Offers Due: As listed on the SAM.gov notice.

Submission Method: Email to the POCs listed in the SAM.gov posting.

Preferred File Format: Searchable PDF and Excel Page Limit (if applicable): N/A

Offerors Shall Submit:

1. Technical quotation

1. A technical compliance matrix addressing each applicable minimum requirement and salient characteristic individually and identifying the specific page or section of the supporting technical literature demonstrating compliance. Any exception or deviation shall be clearly identified.

1. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Completed Buy American Certificate (FAR 52.225-2).

1. Offerors shall provide unit and extended pricing for each CLIN identified in Section 3.

1. Manufacturer and country of origin for the load cell transducer and each separately furnished end item/accessory

Points of Contact As listed on the SAM.gov notice.

C. ADDITIONAL INFORMATION

Amendments:

Any amendments to this solicitation will be posted to SAM.gov. It is the offeror's responsibility to monitor SAM.gov for any amendments.

Attachments (if applicable):

Buy American Certificate Requirements Document

FDA OAGS | Supplies | Page 1 FSB Version 2.1 (June 14, 2026)