6515--Clitoral Therapy Device (CTD) (VA-24-00037945)

Amendment / Modification

This amendment confirms the status of Solicitation 36C10G26Q0004 for the Clitoral Therapy Device (CTD).

• The solicitation for the Clitoral Therapy Device (CTD) is closed.

• The solicitation number 3610G26Q0004 will not be used for a future CTD requirement.

• The government has determined not to award a CTD contract under this solicitation.

• Potential bidders should note that this opportunity is no longer active and will not proceed.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the Clitoral Therapy Device (CTD) solicitation.

• Invoicing Frequency: Invoices can be submitted after each delivery, as purchases are likely per facility for individual patients.
• Customer Service Staffing: No specific staffing requirements for the toll-free number, but service should be available during normal business hours (ET to PST) via phone or weblink. (See MTR 8 update).
• FDA Approval: FDA clearance (510(k)) is acceptable, as Class II devices require clearance, not approval. No CTD devices meet FDA approval standards.
• Authorization/Supply Letters: A single document combining the Letter of Authorization and Letter of Supply is sufficient if all required information is present.
• Order Size: No minimum or maximum order size per delivery order; typically one at a time, though some facilities may stock units.
• Emergency Orders: Unlikely to be required for this device.
• Anticipated Order Volume: Approximately 2,600 units per year are estimated.
• Daily Order Handling: Anticipate 10-20 orders per day, not 100-500, due to manufacturing limitations and unpredictable usage.
• Product Refresh Pricing: Pricing for product refreshes will be reviewed per FAR guidance when initiated, allowing for annual adjustments considering the 5-year IDIQ.
• Pricing Sheet (Attachment I): Unit pricing should reflect the price with the 3% Service Level Agreement (SLA) Fee. The spreadsheet will not be revised; bidders can provide their own proposal and use that data to populate Attachment I. Totals and grand totals including base and option periods are required. Estimated quantities by contract year are not provided, refer to Question #7 response.
• Attachment I Requirement: Attachment I, "Items" tab, is the only required format for Volume III - Price, but bidders can submit their own pricing proposal document in addition.

These clarifications provide specific guidance on invoicing, customer service, regulatory compliance, order processing, and pricing submission requirements. Bidders should ensure their proposals address these points, particularly regarding the pricing format in Attachment I.

Amendment / Modification

This amendment (36C10G26Q0004 0001) to the Clitoral Therapy Device (CTD) solicitation introduces several key changes:

• Maximum Aggregate Value: The maximum aggregate value for all orders under this solicitation has been updated to $6,373,844.00.
• Pricing Clarification: The requirement for unit pricing to include the 3% Service Level Agreement (SLA) Fee has been clarified. The phrase "and without" was removed, specifying that unit pricing must reflect the price with the SLA Fee.
• Physical Evaluation Samples: For the physical evaluation, offerors are now required to ship two (2) complete samples of both automatic and manual devices, along with all associated manuals and supplies necessary for operation.
• Removed Term: The term "Patient Unique Identifier" has been removed from the document.
• Updated MTRs: Manual and Automatic MTRs 6, 7, and 8 have been updated.

• FAR Clause 52.212-1 Instructions to Offerors, Phase 3, Volume III – Price
• FAR Clause 52.212-2 Evaluation – Commercial Products and Commercial Services, Phase 2: Technical – Physical Evaluation
• Section B.1.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES
• Minimum Technical Requirements (MTRs) 6, 7, and 8

Offerors should ensure their pricing reflects the 3% SLA Fee and that they are prepared to submit the updated number of samples for the physical evaluation. No changes to proposal deadlines were indicated in this amendment.

Solicitation / RFP / RFQ

This solicitation is for the procurement of Clitoral Therapy Devices (CTD) and accessories for the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Prosthetic and Sensory Aids Service (PSAS). The VA aims to standardize CTDs to reduce costs while ensuring quality.

• Clitoral Therapy Device (CTD) and accessories as specified in the Minimum Technical Requirements (MTRs).

• MTRs include a handheld, battery-operated therapy device with 2 removable cups, 1 extension tubing, AAA batteries, a carrying/storage accessory, visual and written instructions (English/Spanish), a toll-free customer service number, and a 1-year manufacturer warranty.

• Availability of replacement parts: Removable Cups (15-pack and 5-pack), Extender (2-pack).

• Devices must be Food and Drug Administration (FDA) approved.

• Contractor must provide sufficient inventory, warehousing, and the ability to handle 100-500 orders daily.

• Contractor must avoid gray market products and safeguard Protected Health Information (PHI) and Personally Identifiable Information (PII).

• Offerors must provide a Letter of Supply if a distributor, or authorization if a manufacturer.

• Offerors must disclose any pending litigation from the past five years.

• Contract Type: Single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with Firm-Fixed Price Delivery Orders.

• Period of Performance: One (1) year base period with four (4) one-year option periods.

• Minimum Guaranteed Amount: $1,000.00 obligated at award.

• Maximum Aggregate Value: TBD.

• Questions Deadline: December 15, 2025, 2:00 PM ET.

• Quotation Submission Deadline: January 6, 2026, 2:00 PM ET.

• Submission Format: Separate electronic volumes for Technical (non-price), Past Performance, Price, and Solicitation Documents/Certifications.

• Evaluation Criteria: Offers will be evaluated on Technical (Literature Review and Physical Evaluation), Past Performance, and Price. Technical and Past Performance combined will be approximately equal in weight to Price.

• This acquisition is a Small Business set-aside.

• Unauthorized, 3rd Party resellers will not be eligible for award.

• Various attachments are referenced for detailed information, including Schedule of Supplies, Pay.gov instructions, reporting tools, and forms.

Form / Attachment / Pricing Sheet

This Excel file, "Attachment 3 - Quarterly Reporting Tool.xlsx", contains a tool designed for quarterly reporting. It appears to be structured to capture data related to contract performance, potentially including quantities sold and sales figures, broken down by facility and reporting quarter.

• Sheet 2: Contains numerical data and corresponding facility names and VISN (Veterans Integrated Service Network) identifiers. It seems to map specific line items or CLINs to various VA facilities across different networks.
• Sheet 3: Provides a template for reporting contract performance. It includes fields for Contract Number, Reporting Quarter, CLIN Number, Description/Salient Characteristics, and Price Inclusive of SLA Fee. It also lists VISNs and Facilities, with columns for "Quantity Sold of Item or Performance Description" for each reporting quarter (1-22).
• The sheet includes summary rows for "Total Quarterly Quantity Sold," "Total Quantity Sold of All Items," "Total Quarterly Quantity Sold x Price," "Total Quarterly Sales inclusive of the SLA," "Anticipated SLA," and "Total Sales amount without the SLA."

This document is crucial for bidders to understand the reporting requirements associated with the opportunity. It outlines the specific data points that will need to be tracked and reported on a quarterly basis, including quantities sold and sales figures, categorized by facility and CLIN. Bidders should review this tool to ensure they have the capability to collect and report this information accurately as part of their contract performance.

Form / Attachment / Pricing Sheet

This document is an "Authorized Government Distributor Letter" template. It is intended to be completed by a manufacturer to certify that a specific offeror is an authorized distributor of their Vacuum Erection Devices (VEDs) and accessories. This letter is required as part of the offeror's submission in response to a specific solicitation.

• Date: The date the letter is issued.
• Offeror Information: Name, Point of Contact (POC), and Address of the company submitting the offer.
• Solicitation Reference: The solicitation number to which the offeror is responding.
• Manufacturer Certification: A statement certifying that the offeror is an authorized distributor of the specified manufacturer's VEDs and accessories.
• Product Applicability: Reference to an attached list of product categories and/or brand names covered by the authorization.
• Distribution Authorization: Specifies the geographic area(s) (states or nationwide) where the offeror is authorized to distribute and provide technical assistance.
• Authorized Signatory: Name, title (must be an Officer of the company), and contact information of the individual authorized to sign on behalf of the manufacturer.

Bidders responding to the solicitation must obtain and submit this letter from the manufacturer of the VEDs and accessories they intend to supply. This document verifies the legitimacy of the supply chain for the required products and ensures the offeror has the proper authorization to distribute them. Failure to provide a correctly completed letter may impact the bid's responsiveness or eligibility.

Form / Attachment / Pricing Sheet

This document, titled "Attachment 5 - CTD Questions - Clitoral Therapy Device.xlsx", appears to be a collection of questions related to the Clitoral Therapy Device opportunity. It is likely intended to capture vendor inquiries or provide a structured format for submitting questions regarding the solicitation.

• The document is an Excel spreadsheet.
• It contains columns for 'Question #', 'RFP Section/Paragraph #', and 'Questions'.
• The header indicates "Clitoral Therapy Device - Questions Limit 1- page 36C10G26Q0004".

This attachment serves as a template or a record for questions pertaining to the solicitation. Bidders may use this document to understand common inquiries or to submit their own questions in a standardized format, ensuring clarity and completeness in their communication with the government regarding the opportunity.

Form / Attachment / Pricing Sheet

This document is a Past Performance Questionnaire (PPQ) used by the Department of Veterans Affairs (VA) to gather feedback on a contractor's performance for the Clitoral Therapy Device (CTD) solicitation (RFP No. 36C10G26Q0004). It is intended for references to complete regarding a contractor's record under a previous contract.

• The questionnaire requests ratings on several performance areas, including overall quality/satisfaction, delivery performance, quality of service, problem resolution, and quality of contractor personnel.
• It includes specific questions about cure notices, terminations for default, willingness to re-award, discussions of adverse performance, and the use of past performance databases.
• Fields are provided for contract details such as period of performance, dollar value, and a description of services provided.
• Evaluators are asked to provide comments and attach supporting documentation.

Bidders should be aware that this questionnaire will be sent to references to evaluate their past performance. The responses will be used by the VA in the evaluation of proposals. Offerors must ensure their references are prepared to complete this questionnaire accurately and promptly. If the questionnaire is for a subcontractor, both prime and subcontractor names must be included.

Form / Attachment / Pricing Sheet

This document is a sample Letter of Supply template provided for offerors to use when responding to a solicitation. It is intended to be completed by a manufacturer to assure the offeror of an uninterrupted supply of products if awarded a contract.

• Offeror Information: Placeholder for the Offeror's name, POC, and address.
• Solicitation Reference: Space to include the relevant Solicitation Number.
• Manufacturer Assurance: A statement from the manufacturer ([Manufacturer Name]) confirming their ability to supply sufficient quantities of specified products for the duration of the contract, provided the contractor remains in good standing and adheres to partner agreements.
• Product List: Reference to an attached list of product categories and/or brand names covered by the letter.
• Trade Agreements Act (TAA) Compliance: Manufacturer's commitment to supply TAA-compliant products and cooperate with the offeror to support TAA compliance, including providing country of origin information and notifying of any changes.
• Authorization: Signature block for an authorized officer of the manufacturer.

Bidders responding to the solicitation must obtain and submit this letter from their proposed manufacturer(s). It demonstrates the availability of required products and the manufacturer's commitment to supporting the contract, including TAA compliance. Failure to provide this may impact proposal evaluation.

Form / Attachment / Pricing Sheet

This document provides detailed instructions for vendors on how to submit payments for contract fees using the Pay.gov portal. It outlines the step-by-step process for completing the "SAC Contract Fee Remittance Form."

• Accessing the Form: Navigate to Pay.gov, search for "VA SAC," and select the "SAC Contract Fee Remittance Form."
• Completing Agency Form (Step 1):
  • Select "SAC Contract Number" from the dropdown.
  • Enter "Task or Delivery Order Number" if applicable.
  • "Company Name" auto-populates.
  • Enter "Company Contact" name and phone number.
  • Select the "Sales Quarter."
  • Enter total "Quarterly Sales in Dollars."
  • Indicate if the sale is an "MSPV Sale" (Yes/No).
  • For non-MSPV sales, specify if it's a "GSA CRF" or "Assisted" service.
  • Option to attach a .pdf of the Quarterly Report.
• Entering Payment Info (Step 2):
  • Payment is accepted via ACH only (checking or savings accounts).
  • Credit cards and third-party payments are not accepted.
  • Enter "Account Holder Name," "Account Type," "Routing Number," and "Account Number."
• Review and Submit (Step 3):
  • Carefully review all entered information.
  • Option to request an email confirmation.
  • Agree to the "Authorization and Disclosure Statement."
  • Click "Submit Payment."
• Confirmation (Step 4): A confirmation of payment authorization will be displayed.

This document is critical for vendors who have been awarded a contract requiring fee remittance through Pay.gov. It details the mandatory payment process, including specific data entry requirements for both MSPV and non-MSPV sales, accepted payment methods, and the steps to ensure successful submission. Failure to follow these instructions may result in incorrect or delayed payments.

Form / Attachment / Pricing Sheet

This document is DD Form 2772, "Contract Discrepancy Report," dated September 1998. It is used to formally document and track discrepancies or problems encountered within a contract. It also serves to record the contractor's response, corrective actions, and the government's evaluation and actions.

• Contract Information: Contract Number, Report Number, To/From parties.
• Discrepancy Details: A section to describe the discrepancy in detail, with references to PWS Directives and the option to attach continuation sheets.
• Signatures: Signatures of the Contracting Officer and Contractor Representative.
• Contractor Response: Space for the contractor to detail cause, corrective actions, and preventative measures.
• Government Evaluation & Actions: Sections for government assessment (acceptance, rejection) and actions taken (e.g., reduced payment, cure notice).
• Close Out: Fields for documenting contractor notification, QAE, and ACO.

While this form is for tracking issues after a contract is awarded, understanding its existence and purpose can inform bidders about the formal processes for addressing contract performance issues. It highlights the importance of clear communication, adherence to PWS, and timely corrective actions. Bidders should be aware that such formal reporting mechanisms exist for contract management.

Form / Attachment / Pricing Sheet

This document, "Attachment 1 - Schedule of Supplies.xlsx", is an Excel spreadsheet containing detailed line item information for the opportunity. It outlines the specific items, quantities, and related details required for the contract.

• Sheet: Action Line Item Information: Details specific line items, including product titles (e.g., 'Clitoral Therapy Device', 'Removeable Cup'), action types (RFQ), and modification numbers.
• Sheet: Items: Provides a comprehensive list of items with item numbers, descriptions, CLINs, contract periods (Base, Option 1-4), quantities, units of measure, and pricing-related fields. It also includes delivery and packaging information.
• Sheet: RefData: Contains reference data for discount types, options, and receipt types.
• Sheet: UOMRef: Lists Unit of Measure descriptions and their corresponding values.
• Sheet: NAICS: Provides a list of North American Industry Classification System (NAICS) codes and their descriptions.
• Sheet: PROD_SVC_CODE: Lists Product/Service Codes (PSC) with their descriptions.

This attachment is crucial for bidders as it specifies the exact products and quantities being procured. It provides the foundational data for preparing accurate pricing and understanding the scope of supplies required for each contract period (Base and Options). Bidders must carefully review this schedule to ensure they can meet the specified requirements and to formulate their proposals accordingly.