Sources_Sought_Vendor_Response.xlsx
XLSX spreadsheet 19 KB Posted
- Solicitation number
- 75F40126Q00420
About this file
This is a Sources Sought Vendor Response template document in Excel format corresponding to a solicitation for implantable medical-grade primary lithium batteries. The solicitation (75F40126Q00420) is issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services and seeks twenty new, unused batteries of Li/SVO-CFx chemistry in two distinct configurations, with ten units each. Item 1 requires a high-rate configuration with rated capacity of 1.70-1.90 Ah (nominal 1.78 Ah), OCV-BOL of 3.15-3.40 V (nominal 3.25 V), stainless steel case with negative case polarity, molybdenum or equivalent terminal, weight of 17 g, volume of 6.5 cc, and approximate dimensions of 34.93 mm × 27.94 mm × 6.30 mm. Item 2 specifies a medium-rate configuration with rated capacity of 4.80-5.00 Ah (nominal 4.92 Ah), OCV-BOL of 3.15-3.40 V (nominal 3.25 V), titanium case with negative case polarity, titanium or equivalent terminal, weight of 22 g, volume of 12.5 cc, and approximate dimensions of 46.48 mm × 31.70 mm × 9.63 mm. Both configurations must be hermetically sealed, operable at specified discharge rates and frequencies, with storage temperature range of -20°C to +60°C, and include a minimum of two years remaining shelf life from manufacture at delivery. All units within each configuration must be from the same manufacturing lot, and the document serves as a template for vendors to respond to the sources sought request for these medical-grade batteries.
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Other files
| File | Type | Posted |
|---|---|---|
| Requirements_Document_Lithium_Batteries_CDRH-2026-135728 Final.docx | DOCX document | |
| Sol_Doc75F40126Q00420.docx | DOCX document |
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Text version
Vendor Response Form
| VENDOR RESPONSE FORM | |
| Sources Sought Notice, Attachment 1. Complete every required (yellow) cell. Answer blue cells only if they apply to you. Return in native Microsoft Excel (.xlsx); do not convert to PDF, scan, or change the layout. File name: [NOTICE ID]_CompanyName.xlsx | |
| Legend: Yellow = required. Blue = answer only if it applies to you. | |
| Notice ID | 75F40126Q00420 |
| Requirement title | Twenty (20) IMPLANTABLE MEDICAL-GRADE LITHIUM BATTERIES |
| NAICS / Size Standard (as stated in the notice) | NAICS 335910 — Battery Manufacturing |
| 4.0 COMPANY INFORMATION | |
| 4.1 Company name and address | |
| 4.2 UEI / CAGE Code | |
| 4.3 Point of contact (name, phone, email) | |
| 4.4 Active SAM.gov registration | |
| 4.5 Business size under the stated NAICS | |
| 4.6 Socioeconomic categories (answer each): | |
| 8(a) | |
| HUBZone | |
| SDVOSB | |
| VOSB | |
| WOSB | |
| EDWOSB | |
| SDB | |
| 4.7 Existing contract vehicles (FSS/MAS, GWAC, IDIQ/BPA); list numbers | |
| 5.0 SMALL BUSINESS CAPABILITY | |
| All respondents answer 5.1. Small business respondents answer 5.2 through 5.4. | |
| 5.1 Your role for the required items | |
| 5.1a If Other, describe | |
| 5.1b If distributor or reseller, identify the manufacturer(s) of the end items you would supply | |
| 5.1c Evidence of authorized distribution (describe, or note the attachment) | |
| 5.2 If you are a small business that is NOT the manufacturer, can you supply end items manufactured by a U.S. small business concern, consistent with the nonmanufacturer rule (13 CFR 121.406)? | |
| 5.2a If yes, identify that small business manufacturer | |
| 5.2b If you would supply the product of an other than small or foreign manufacturer, state this clearly | |
| 5.3 Capability and capacity to fulfill the full scope (quantities and delivery in Section 2.0); identify any portion you could not fulfill | |
| 5.3a Relevant experience (up to three recent contracts or commercial sales). Federal experience is not required | |
| 5.3b Applicable quality or regulatory certifications | |
| 5.4 Teaming, joint venture, or subcontracting arrangements you anticipate | |
| 6.0 DOMESTIC MANUFACTURE AND AVAILABILITY | |
| All respondents answer, regardless of business size. | |
| 6.1 Country (or countries) in which the offered end item is manufactured, and the operations performed at each location | |
| 6.2 If manufactured in the United States, does it meet the domestic content threshold in effect under RFO 25.101 as of the anticipated award date? | |
| 6.2a Approximate domestic content percentage you can certify to | |
| 6.2b Is the item a commercially available off-the-shelf (COTS) item? | |
| 6.2c Is the item wholly or predominantly iron or steel? | |
| 6.3 Country of origin of any critical components, or components for which no domestic source is known to you | |
| 6.4 If you can supply a domestic end product, describe production capacity against the Section 2.0 quantities (sustainable output, available inventory, lead times) | |
| 6.4a If you can satisfy the requirement only in part (insufficient quantity) or with deviations from the salient characteristics (insufficient quality), describe the shortfall specifically | |
| 6.5 If you do not currently manufacture a domestic end product meeting this requirement, state whether and under what conditions you could establish or expand domestic production (timeline, minimum quantities, commitments) | |
| 6.6 Alternative or substitute items manufactured in the United States that could satisfy the Section 2.0 characteristics, plus any other known domestic manufacturers or supply chain constraints | |
| 6.7 CONDITIONAL (answer if the offered item is not a domestic end product): country of origin, and if known, whether it is a designated country end product under the Trade Agreements Act |
File details come from the government source that posted it. Updated .