Sol_Doc75F40126Q00420(1).docx

ALP: CDRH-2026-135728

Solicitation number: 75F40126Q00420 Short Description: Implantable Medical-Grade Primary Lithium Batteries

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 75F40126Q00420 is issued as a/an ☒ RFQ ☐ RFP ☐ IFB for the one-time acquisition of twenty (20) implantable medical-grade primary lithium batteries of Lithium Silver Vanadium Oxide, Carbon Monofluoride (Li/SVO-CFx) chemistry, consisting of two configurations of ten (10) batteries each. The batteries will support FDA Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) regulatory science research involving battery performance modeling, accelerated aging test method development, and system identification through discharge testing. The batteries will be used exclusively for laboratory testing and will not be implanted in humans or animals. All supplies shall be new and unused and shall meet the salient characteristics and minimum specifications in Section 6 of this combined synopsis/solicitation.

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: 335910 Battery Manufacturing Small Business Size Standard: 1,250 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:

U.S. Food and Drug Administration, Building 62, Room 1216, 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 The requested delivery schedule: Item 2 (medium-rate configuration) within 30 calendar days after award; Item 1 (high-rate configuration) within 180 calendar days after award. Split delivery is acceptable. The latest acceptable delivery date for all items is March 31, 2028. Delivery dates are firm and may not be extended without prior written approval of the Contracting Officer.

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 delivery 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: Maria Finan Email: Maria.Finan@fda.hhs.gov Phone: 240- 461-5276 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. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that charges are accurate.

f. 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.

g. 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.

h. 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.

i. 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

Implantable Medical-Grade Primary Lithium Batteries — The contractor shall furnish twenty (20) new and unused implantable medical-grade primary lithium batteries of Li/SVO-CFx chemistry, in two configurations of ten (10) units each. No manufacturer, brand, model, or manufacturer part number is specified. Any product meeting every stated salient characteristic is acceptable.

Item 1 — High-rate configuration (Qty 10 EA): Rated capacity 1.70 Ah minimum to 1.90 Ah maximum (nominal 1.78 Ah); OCV-BOL 3.15 V minimum to 3.40 V maximum (nominal 3.25 V); capable of pulse discharge with continuous background load ≥95.3 kΩ, pulse amplitude ≥3.0 A, pulse duration 10 seconds, pulse frequency up to once every 150 days, and 2.0 V cutoff. Stainless steel case; negative case polarity; molybdenum or equivalent terminal; hermetically sealed; weight ≤17 g; volume ≤6.5 cc; approximate dimensions 34.93 mm × 27.94 mm × 6.30 mm and shall not exceed these values by more than 5%; storage temperature –20°C to +60°C. All 10 units shall be from the same manufacturing lot.

Item 2 — Medium-rate configuration (Qty 10 EA): Rated capacity 4.80 Ah minimum to 5.00 Ah maximum (nominal 4.92 Ah); OCV-BOL 3.15 V minimum to 3.40 V maximum (nominal 3.25 V); capable of medium-rate sustained discharge with pulsing, background load 9.53 kΩ, pulse amplitude 20 mA, pulse duration 900 seconds, pulse frequency up to once every 63 days, cutoff voltage 2.0 V minimum, with usable capacity 4.80 Ah to 5.00 Ah between OCV-BOL and cutoff at 37°C. Titanium case; negative case polarity; titanium or equivalent terminal; hermetically sealed; weight ≤22 g; volume ≤12.5 cc; approximate dimensions 46.48 mm × 31.70 mm × 9.63 mm and shall not exceed these values by more than 5%; operating temperature 37°C nominal; storage temperature –20°C to +60°C. All 10 units shall be from the same manufacturing lot.

For both configurations, each battery shall have a minimum of two (2) years remaining from the date of manufacture at delivery. Product documentation shall include battery specifications, safety data sheets (SDS), and other applicable product documentation at no separate charge. Packaging shall follow standard commercial practice and applicable safety and transportation regulations for lithium-based medical-grade components, including applicable DOT and IATA Dangerous Goods Regulations. Lot number and date of manufacture shall be marked on each package. Advance shipping notification shall include carrier, tracking information, and estimated delivery date, and delivery logistics shall be coordinated with the Government POC before shipment. The Government will accept the contractor's standard commercial warranty to the maximum extent practicable. The batteries are passive supply items with no embedded or companion software, no FDA network connection, and no storage or transmission of data.

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): Award will be made to the lowest-priced offeror whose offer is determined technically acceptable. Technical acceptability will be determined on a pass/fail basis against the salient characteristics and minimum requirements in Section 6. Offers that do not meet all salient characteristics will be determined technically unacceptable and will not be considered for award. Price will be evaluated for reasonableness.

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 Option A – Hard Date: September 10, 2026, 12pm ET. Questions and answers may be posted as an amendment to this solicitation on SAM.gov.

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. Price quotation

1. Warranty terms (if applicable)

1. UEI and confirmation of active SAM.gov registration

1. Lead time for delivery

1. Country of origin for all items required if Buy American (52.225-2).

1. Other: Product literature/specifications sufficient to demonstrate compliance with every salient characteristic; manufacturing lot information; date of manufacture/shelf-life information; and proposed delivery lead time for each configuration.

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):

Requirements Document: Implantable Medical-Grade Primary Lithium Batteries, CDRH-2026-135728.

U.S. Food and Drug Administration Requirements Document Implantable Medical-Grade Primary Lithium Batteries Office of Science and Engineering Laboratories, Division of Biophysics

1. Purpose This document states the requirements for the acquisition of 20 implantable medical-grade primary lithium batteries of Lithium Silver Vanadium Oxide, Carbon Monofluoride (Li/SVO-CFx) chemistry, in two configurations of 10 units each. The acquisition is for commercial supplies delivered to an FDA location.

2. Background The Food and Drug Administration (FDA), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) requires the acquisition of implantable-grade primary lithium batteries in two configurations for open-access regulatory science research. The research involves battery performance modeling, accelerated aging test method development, and system identification through discharge testing across a range of c-rates. The batteries will not be implanted in humans or animals. They will be used exclusively for laboratory testing and model parameterization.

3. Scope This acquisition is for the supply of the items identified in Section 4, in the quantity stated in Section 5, delivered and accepted per Sections 6 through 8.

This is a one-time purchase. The batteries will be used exclusively in the FDA laboratory setting to support internal research activities conducted by DBP within OSEL. The contractor's responsibility is limited to the supply of batteries that meet the specifications in Section 4 and the delivery of the associated product documentation.

Delivery coordination performed under Section 6 is incidental to the supply purchase and does not convert this action into a service contract.

4. Salient Characteristics and Minimum Specifications All items shall be new and unused. Items shall not be used, refurbished, reconditioned, remanufactured, previously opened, expired, or beyond the manufacturer's shelf-life dating at the time of delivery.

Salient characteristics and minimum specifications This requirement is described by salient characteristics. No manufacturer, brand, model, or manufacturer part number is specified, and none may be added to this document. Any product meeting every characteristic stated below is acceptable.

The supplies shall meet the following salient characteristics and minimum specifications:

Discharge profile: Capable of pulse discharge with a continuous background load of ≥ 95.3 kΩ, pulse amplitude ≥ 3.0 A, pulse duration of 10 seconds, and pulse frequency of up to once every 150 days. Cutoff voltage: 2.0 V Case material: Stainless steel. Case polarity: Negative. Pin/terminal material: Molybdenum or equivalent. Hermeticity: Hermetically sealed. Weight: ≤ 17 g. Volume: ≤ 6.5 cc. Dimensions (L × W × H): approximately 34.93 mm × 27.94 mm × 6.30 mm; shall not exceed these values by more than 5%. Storage temperature: –20°C to +60°C.

Capable of medium-rate sustained discharge with pulsing; background load of 9.53 kΩ, pulse amplitude of 20 mA, pulse duration of 900 seconds, and pulse frequency of up to once every 63 days. Cutoff voltage: 2.0 V minimum, with usable capacity of 4.80 Ah to 5.00 Ah between OCV-BOL and cutoff at 37°C.

Discharge profile: capable of medium-rate sustained discharge with pulsing; background load 9.53 kΩ, pulse amplitude 20 mA, pulse duration 900 seconds, pulse frequency up to once every 63 days; cutoff voltage 2.0 V minimum;

Case material: Titanium. Case polarity: Negative. Pin/terminal material: Titanium or equivalent. Hermeticity: Hermetically sealed. Weight: ≤ 22 g. Volume: ≤ 12.5 cc. Dimensions (L × W × H): approximately 46.48 mm × 31.70 mm × 9.63 mm; shall not exceed these values by more than 5%. operating temperature 37°C nominal. Storage temperature: –20°C to +60°C.

All 10 units of Item 1 (high-rate configuration) shall be from the same manufacturing lot. All 10 units of Item 2 (medium-rate configuration) shall be from the same manufacturing lot. At the time of delivery, each battery shall have a minimum of 2 years remaining from the date of manufacture.

5. Quantity and Deliverables The contractor shall furnish the following supplies in the quantities shown:

Quantity basis: one-time purchase. Total quantity is 20 batteries, 10 of each configuration.

Confirmed: the requirement is 10 individual batteries of the high-rate configuration and 10 individual batteries of the medium-rate configuration, 20 batteries total. "Cells" in the source document referred to the quantity of batteries, not the cell count within a battery.

6. Delivery Schedule and Delivery Terms FOB point: Destination.

Delivery location:

U.S. Food and Drug Administration Building 62, Room 1216 10903 New Hampshire Avenue Silver Spring, MD 20993 Delivery schedule: the contractor shall deliver all items in a single shipment within [Item 2 (medium-rate configuration): within 30 calendar days after award. Item 1 (high-rate configuration): within 180 calendar days after award. Split delivery is acceptable; the two configurations may be delivered separately. Latest acceptable delivery date for all items: March 31, 2028.

Delivery dates are firm. The contractor shall not extend a delivery date without prior written approval of the Contracting Officer.

The contractor shall provide advance shipping notification prior to shipment, including carrier, tracking information, and estimated delivery date.

The contractor shall coordinate delivery logistics with the Government point of contact identified in the resulting contract to confirm the delivery schedule, location, and any special handling instructions prior to shipment.

7. Packaging, Marking, and Shipping Supplies shall be packaged in accordance with standard commercial practice, sufficient to ensure arrival at destination undamaged and in usable condition. Each shipment shall be marked with the contract or order number, item description, quantity, and destination.

Batteries shall be packaged in accordance with applicable safety and transportation regulations for lithium-based medical-grade components, to prevent damage or degradation during shipment.

Standard commercial shipping practice for lithium primary cells is acceptable, including compliance with applicable DOT and IATA Dangerous Goods Regulations. Lot number and date of manufacture shall be marked on each package.

8. Inspection and Acceptance Inspection and acceptance shall be at destination. Consistent with RFO 46.202-1, the Government will rely on the contractor's existing quality assurance system for commercial products. Final acceptance is based on receipt of the correct items, in the correct quantity, conforming to the specifications in Section 4, in undamaged and usable condition, together with the product documentation required by Section 5.

The contractor shall replace, at no additional cost to the Government, any item found to be damaged, defective, or nonconforming to the specifications upon inspection at receipt. Replacement shall be made within 30 calendar days of notification.

9. Warranty Consistent with RFO 12.105(b), the Government will accept the contractor's standard commercial warranty to the maximum extent practicable.

10. Information Technology and Accessibility The batteries are passive supply items with no embedded or companion software, no connection to an FDA network, and no storage or transmission of data.

11. Period of Performance The period of performance begins upon award and continues through final delivery and acceptance of all items.

12. Points of Contact See contract for points of contact.

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