Attachment CTD Q and A.xlsx
XLSX spreadsheet 14 KB Posted
- Solicitation number
- 36C10G26Q0004
About this file
This file is a Questions and Answers (Q&A) document for a Department of Veterans Affairs solicitation for a Clitoral Therapy Device (CTD). The solicitation (36C10G26Q0004) seeks a vendor to provide medical devices with specific requirements, including FDA clearance, customer service support, and flexible delivery options. Key details include an estimated annual demand of approximately 2,600 units, with anticipated order volumes of 10-20 devices per day, and a potential 5-year Indefinite Delivery/Indefinite Quantity (IDIQ) contract.
Pricing and contractual terms include a 3% Service Level Agreement (SLA) fee, with vendors required to submit pricing on an attached spreadsheet. The government allows invoicing after each delivery, expects customer service during normal business hours (Eastern to Pacific time zones), and will support veterans through phone or web channels. The solicitation indicates flexibility in order sizes, with most orders expected to be single-unit purchases for individual patients. The Q&A document also clarifies that FDA clearance (510(k)) is acceptable, and product refresh pricing adjustments may be considered through contract modifications in accordance with Federal Acquisition Regulation (FAR) guidelines.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C10G26Q0004_2.docx | DOCX document | |
| 36C10G26Q0004 0001.docx | DOCX document | |
| Attachment 8 - Authorized Gov Distributor Letter.docx | DOCX document | |
| Attachment 3 - Quarterly Reporting Tool.xlsx | XLSX spreadsheet | |
| Attachment 1 - Schedule of Supplies.xlsx | XLSX spreadsheet | |
| 36C10G26Q0004.docx | DOCX document | |
| Attachment 7 - Sample Letter of Supply.docx | DOCX document | |
| Attachment 6 - Past Performance Questionnaire -CTD.docx | DOCX document | |
| Attachment 2 - Pay.gov Vendor Submittal Instructions.docx | DOCX document | |
| Attachment 5 - CTD Questions - Clitoral Therapy Device.xlsx | XLSX spreadsheet | |
| Attachment 4 - Contract Discrepancy Report.pdf |
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Text version
Sheet1
| Clitoral Therapy Device - Questions and Answers | |||
| Question # | RFP Section/Paragraph # | Questions | Responses |
| 1 | 1.3 | What is “Other” invoicing frequency? Can invoices be submitted after each delivery? | Yes. These will more than likely be purchased per facility for an individual patient. |
| 2 | 2.3 | Are there any specific staffing requirements for the toll free customer service number? Recommend that staff is available on an as-needed basis to support customer service inquiries throughout the lifecycle of the IDIQ. | #1. No there are no specific staffing requirements. #2.Customer service should be available during normal business hours that will accommodate ET to PST time zone. Veterans should be able to contact customer services through a phone line or weblink. See MTR 8 update. |
| 3 | 2.3 | Can the Government confirm whether “FDA approval” is required, or if "FDA clearance" under 510(k) is acceptable? We recommend that the government requires an FDA clearance instead of FDA approval. These devices have been classified as Class II, where the standard is FDA clearance. There are no CTD devices that meet FDA approval standards. | FDA clearance |
| 4 | 2.3 | May the Letter of Authorization and Letter of Supply be combined into one document if both requirements are addressed? | This would be sufficient as long as we can identify the required information for both letters. |
| 5 | 2.5.1 | Is there a minimum and maximum order size per delivery order? | No. Generally we will order one at a time although some facilities may order more to keep some units in stock. |
| 6 | 2.7 | Can the Government clarify whether emergency orders (4‑hour response) will be limited to CONUS facilities, or if OCONUS facilities may also issue them? | It is unlikely this device will warrant emergency orders. |
| 7 | E.6 Volume 1 - Technical | Can the government provide clarity on the magnitude of orders they are anticipating per month? This would be to give the manufacturer the appropriate amount of time and warning if their operations need to scale to meet the government's requirements. | We estimate approximately 2,600 per year. |
| 8 | E.6 Volume 1 - Technical | Can the government provide clarity on the requirement to handle 100 to 500 orders per day? Due to manufacturing limitations, the OEM cannot provide that amount of devices at this time. | We would anticipate no more than 10-20 per day. This product has not been available widely through VHA so it is very hard to predict usage at this time. |
| 9 | E.6 Volume 1 - Technical | Will the Government allow product refresh pricing adjustments via contract modification, or must they be absorbed under existing rates? Following the guidance of other contracting offices/vehicles, will we have the ability to refresh our catalogue annually considering this is a 5 year IDIQ? | Product refresh items are provided when improved items within the awarded product line become obsolete or as appropriate new industry technologies emerge. Pricing for those items will be reviewed IAW with the FAR when a product refresh is initiated. |
| 10 | E.6 Volume 1 - Price | Volume III – Price, requires that unit pricing be reflected showing price with and without the 3% SLA fee. Can the government revise, Attachment I, “Items” tab to reflect this requirement? | The words " and without" has been removed to read the following, "The spreadsheet does require that the unit pricing be reflected showing the price with the 3% Service Level Agreement (SLA) Fee." This means the 3% service fee and the proposed price will be combined and placed in column O. The attachment will NOT be revised. The quoter can provide their own price proposal then use that data to populate attachment 1, items tab. |
| 11 | E.6 Volume 1 - Price | Volume III – Price, requires totals and grand totals that include base and each option period. Can the government revise, Attachment I, “Items” tab to reflect this requirement? Can the government provide estimated quantities by contract year to help structure volume discounts? | 1. See #10 response. 2. See Question #7 Response |
| 12 | E.6 Volume 1 - Price | Volume III – Price. Is Attachment I, “Items” tab the only requirement? | Yes, IAW the RFQ instructions, all Quoters are required to fill in the highlighted columns under the "Items" Tab for Volume III - Price / Attachment I. However, Quoter can submit their own pricing proposal document in addition to the Attachment I |
| 13 | Attachment 1 | Are all of the yellow columns the required information, or does the entire sheet need to be filled out? | See # 12 response. |
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