S05_Prospective Offerors to RFP 36C79126R0011_All Offerors Questions and All Government Responses_Posted at the GPE on 29SEP2026.pdf

S05_Vendor Questions and Government Answers

DEPARTMENT OF VETERANS AFFAIRS (VA)

VA’S FY26 ETMPM-TENS Procurement Program Recompete

Solicitation Number: 36C79126R0011 Date Posted at the GPE: September 18, 2026 Common Response Date/Time: October 19, 2026, at 3:00PM CDT Offerors Q & A Closure Deadline: October 5, 2026, at 3:00PM CDT

Clarification-Only Statement: The following Government responses are provided solely for clarification purposes and do not amend, alter, or supersede any terms, conditions, or requirements of Solicitation Number 36C79126R0011. Any material changes or official clarifications to the solicitation will be issued via a formal amendment and posted to the official SAM.gov opportunity listing.

Q1. (From Offeror Received 9/18/2026): “The instructions to Attachment 0005 state that it is a mandatory submission for "Other-Than-Small Business (e.g., Large Business Concerns) Offerors." As a certified Small Business and SBA VetCert-certified SDVOSB under NAICS 334510, is Attachment 0005 required as part of my proposal submission or whether it applies only to large business Offerors?”

Government Response 1. (Issued 9/19/2026, Updated on 9/21/2026): Your understanding is correct regarding the original instructions to Offerors in Attachment 0005 and thank you for finding this error!

The Attachment 0005 document to the Solicitation Number 36C79126R0011 posting within the System For Award Management Government-wide Point of Entry (GPE) at website at https://www.sam.gov has been revised to align with the solicitation’s requirements (Attached). The following revised statement has been incorporated within the Instructions to Offerors: “Attachment 0005, FAR Provision 52.225-6, Trade Agreements Certificate, is a mandatory, fillable document required for all Offerors submitting a proposal under Solicitation Number 36C79126R0011. Submission of a fully completed, signed, and dated Trade Agreements Certificate is a material condition of responsiveness. Any Offeror that fails to submit this attachment exactly as required will be deemed nonresponsive and will be eliminated from further evaluation and ineligible for award.” Therefore, all Offerors are required to complete and submit an Attachment 0005 as part of their proposal package. This requirement is consistent with the instructions in the solicitation and ensures compliance with FAR Part 25 and the Trade Agreements Act (TAA). The revised Attachment 0005 has been posted to the official SAM.gov opportunity listing for this solicitation. Furthermore, the purpose of the Attachment 0005 being a mandatory submission for all Offerors is to ensure that all Offerors are eligible to compete in all four (4) Tiers 1 through 4. The TAA applies across all tiers of the competition, the VA’s application of the tiered set aside evaluation approach does not affect the preference for domestic end-products, nor does it affect the eligibility of all TAA-compliant end-products ability to compete for award across all tiers of the competition.

Q2. (From Offeror Received 9/18/2026): “As an emerging SDVOSB with no prior federal contract history and no Business-to-Business (B2B) commercial customers from whom to obtain a completed Past Performance Questionnaire (PPQ), does clearly stating this circumstance within my proposal, along with appropriate justification satisfy the past performance submission requirement and allow my proposal to remain eligible for evaluation and award on CLIN X001 and the associated SLINs

X001AA/AB/AC/AD?”

Government Response 2. (Issued 9/19/2026, Updated on 9/21/2026): Your understanding of the past performance documentation requirements is correct and aligns with both the solicitation and FAR 15.305(a)(2)(iv). As stated in the solicitation: “All Offerors shall submit the three (3) most recent official CPARS Evaluation Reports, if an Offeror is unable to submit completed CPARS Evaluation Reports due to a lack of past performance, the Offeror shall submit Past Performance Questionnaires (PPQs) completed by the Offeror’s three (3) most recent customers. Offerors that lack recent or relevant past performance, or that cannot obtain three (3) past performance documents due to unavailability, shall clearly state such circumstance, which are to be prominently displayed within their proposal documentation with adequate supporting evidence and appropriate justifications for consideration by the Source Selection Authority (SSA). In the case of an Offeror without past performance or insufficient past performance, those Offerors will be evaluated in accordance with FAR 15.305(a)(2)(iv). The Government shall assign a Neutral Confidence rating in such cases, and the Offeror shall not be evaluated unfavorably solely on the basis of lacking past performance. A Neutral Confidence rating satisfies the past performance factor requirement for LPTA and Best Value - Tradeoff evaluations and allows the Offeror to remain eligible for award, provided all other solicitation material requirements are met.” Accordingly, if you or any other Offeror does not possess previous federal or commercial past performance, this fact must be clearly stated in your proposal within your Technical Capability Statement document submission and sufficient supporting rationale, and justification must be provided to support this claim of no or inadequate past performance to meet the requirement of submitting three

(3) past performance documents for Government evaluation. If the Source Selection Authority (SSA) concurs with the Offerors’ certification of a lack or past performance, the Government will assign a Neutral Confidence rating for the Past Performance Factor evaluation rating, and your proposal will remain eligible for evaluation and award consideration, provided all other material requirements are met. There is no guarantee the SSA will approve, which is the reason the Technical Capability Statement must adequately make to case the Offeror has no past performance or not enough past performance to meet the requirement of submitting three (3) past performance documents for Government evaluation. If an Offeror is a small business concern and the VA determines nonresponsibility, the matter will be referred to the Small Business Administration (SBA) for a Certificate of Competency (CoC) in accordance with FAR Subpart 19.6. All Offerors must certify TAA compliance with a responsive submission of the certification at FAR Provision 52.225-6 (Attachment 0005 to the solicitation).

Q3. (From Offeror Received 9/18/2026): “Is the progression through the Tiered Set-Aside Evaluation Approach determined independently for each CLIN/SLIN, specifically for CLIN X005 and SLIN X005AA? For example, if an award cannot be made to an eligible Tier 1 offeror for X005, will the VA then proceed through the subsequent tiers specifically for X005?”

Government Response 3. (Issued 9/19/2026): Yes, the progression through the Tiered Set-Aside Evaluation Approach is determined independently for each CLIN and its associated SLINs. As stated in Section E.4, Addendum to FAR Provision 52.212-2, “Award for CLIN X005 will be made to the Offeror whose proposal provides the best overall value to the Government at the highest tier where award is possible.” If an award cannot be made to an eligible Tier-1 Offeror for CLIN X005/SLIN X005AA, the VA will proceed to evaluate offers in the subsequent tiers (Tier-2 VOSBs, Tier-3 Other Small Business Concerns, and Tier-4 Other-Than-Small Business Concerns or Large Business Concerns) specifically for CLIN X005 and SLIN X005AA, in accordance with the tiered evaluation procedures outlined in the solicitation.

Policy Note: A responsive proposal for CLIN X005 must include a responsive proposal for SLIN X005AA. This is a material condition of a proposal’s responsiveness, parent CLIN devices (CLIN X005) and subordinate SLIN accessories (SLIN X005AA) cannot be separated in a responsive proposal package submission, which includes all required documentation and all required product samples timely submissions. Any award for CLIN X005 is inclusive of an award for SLIN X005AA and shall be made to the same single responsible Offeror. This ensures that the parent CLIN device is compatible with the subordinate SLIN accessories, which is a material condition of Solicitation Number 36C79126R0011.

Q4. (From Offeror Received 9/18/2026): “May an OEM manufacturer submit a direct proposal for CLIN X005 while an independently eligible SDVOSB authorized distributor submits a separate proposal offering the same OEM product? If permitted, will each offer be independently evaluated within the tier applicable to the respective Offeror?”

Government Response 4. (Issued 9/19/2026, Updated 9/21/2026): Yes, an OEM manufacturer may submit a direct proposal for CLIN X005/SLIN X005AA while an independently eligible SDVOSB Authorized Distributor may also submit a separate proposal offering for CLIN X005/SLIN X005AA, even if both proposals offer the same OEM product. Each proposal will be evaluated independently within the tier applicable to the respective Offeror, as determined by the Offeror’s business size and small business socioeconomic status at the time of proposal submission. As stated in Section E.4, Addendum to FAR Provision 52.212-2, “Award for CLIN X005 will be made to the Offeror whose proposal provides the best overall value to the Government at the highest tier where award is possible.”

The tiered evaluation procedures are applied to each proposal based on the Offeror’s eligibility to compete within the applicable tier (e.g., Tier-1 SDVOSBs, Tier-2 VOSBs, Tier-3 Other Small Business Concerns, Tier-4 Other-Than-Small Businesses or Large Business concerns).

Each responsive proposal is considered on its own merits, and award decisions are made in accordance with the tiered set-aside evaluation approach, the evaluation criteria, and the source selection methodology as set forth in the solicitation. The TAA governs exclusively for the ETMPM-TENS procurement program (the BAA does not apply at any tier), while the solicitation still requires all Offerors to submit both certificates (BAA - Attachment 0004 and TAA - Attachment 0005 to the solicitation) for administrative verification under FAR 25.1101. This procurement is solely governed by the Trade Agreements Act (TAA) because each CLIN/SLINs anticipated award total contract value far exceeds the applicable trade agreement supply dollar thresholds listed in FAR 25.402(b); therefore, the Buy American Act (BAA) does not apply to awards under Solicitation 36C79126R0011 (FAR 25.402(a)–(b)). Consistent with FAR 25.1101, the solicitation requires all Offerors to submit both the Buy American Certificate (FAR provision 52.225-2, which is Attachment 0004 to the solicitation) and the Trade Agreements Certificate (FAR Provision 52.225-6, which is Attachment 0005 to the solicitation).

This dual-certificate requirement is permitted to verify all offered end-product’s country-of-origin and to ensure that all responsive Offerors establish and maintain eligibility across all tiers and all CLIN/SLINs award combinations; the dual-certificate material requirement for a responsive proposal submission does not reinstate the BAA applicability. The controlling statute of this acquisition is the TAA.

Q5. (From Offeror Received 9/18/2026): “Please confirm the Government's estimated quantities for CLIN X005 for the Base Year and each Option Year, as well as the anticipated total quantity over the potential five (5) contract lifespan if all options are exercised.”

Government Response 5. (Issued 9/19/2026): The Government’s estimated ordering quantities for CLIN X005 are provided in Section B.3.8, Ordering Procedures and Information, and in the CLIN/SLIN Mapping Tables of the solicitation. The estimated quantities for CLIN X005 are as follows:

Base Year: 20,357 units;

Option Year 1: 23,411 units;

Option Year 2: 26,922 units;

Option Year 3: 30,960 units; and

Option Year 4: 35,605 units.

The anticipated total quantity for CLIN X005 over the full five (5) year contract lifespan, if all options are exercised, is estimated to be 137,255 units. These quantities are estimates for evaluation of the Price Factor only, which is calculated from each Offeror’s Attachment 0001 - Price Matrix submission by multiplying the Offeror’s unit price by the Government’s estimated ordering quantity across all periods of performance, each Offerors Total Estimated Price (TEP) is the sum of the TEP from the parent CLIN and the subordinate SLIN, the sum is the Offeror’s TEP. The Government provided estimated ordering quantities do not constitute, nor shall they be construed as a Government minimum order guarantee.

Q6. (From Offeror Received 9/18/2026): “Does VA anticipate issuing a funded Delivery Order for X005 immediately following award? If so, can VA provide the estimated quantity anticipated for the initial Delivery Order?”

Government Response 6. (Issued 9/19/2026): Yes, as stated in Section B.3.5, Contract Guaranteed Minimum Aggregate Order Value, and Section E.4, Addendum to FAR Provision 52.212-2, the VA intends to issue a funded Firm-Fixed-Price (FFP) IDIQ Delivery Order for the Base Year period of performance immediately following award of the Base IDIQ contract for CLIN X005 and SLIN X005AA to the same Offeror. The specific order quantity for the initial Delivery Order will be determined on an as-needed basis based on VA’s operational requirements during contract performance and not at the time of award; however, the minimum guaranteed order value for each Base IDIQ contract is $5,000.00 for the Base Year period of performance only. The initial Delivery Order award will not contain any product ordering quantity at the time of award; product orders will be issued by the VA’s DLS Ordering Officers (OOs) via the VA’s ROES system generated purchase orders, which are electronically transmitted directly to the resultant performing Contractors on an as-needed basis during the Base Year period of performance.

Q7. (From Offeror Received 9/18/2026): “Please provide, if available, the anticipated typical and maximum quantity that may be placed on an individual X005 Delivery Order. We understand the solicitation requires delivery within 30 calendar days after receipt of order and want to ensure that appropriate manufacturing capacity and finished-goods inventory are available.”

Government Response 7. (Issued 9/19/2026): The anticipated typical and maximum quantities of products ordered for any individual FFP/IDIQ Delivery Order under CLIN X005 and SLIN X005AA are not fixed and will vary considerably during contract performance based on VA’s operational needs for the products. As stated in Section B.3.12, Delivery and Shipping Requirements, all product orders must be delivered to the VA’s DLS facility in Golden, Colorado on or before but no later than 30 calendar days after receipt of the order as a material condition of successful contract performance. While the estimated annual ordering quantities provided in the solicitation are for the Price Factor evaluation purposes only, the VA may issue ROES system generated purchase orders against the FFP/IDIQ Delivery Orders for any quantity. The maximum order quantity for any single FFP/IDIQ Delivery Order will not exceed the remaining available ordering quantity/total allowable program spend under the contract ceiling maximum, which shall be established at the time of award to ensure the appropriate allocation of the $500,000,000.00 ceiling maximum is proportioned equitably across all contract awards under the solicitation. All Offerors/resultant performing Contractors must plan manufacturing and inventory capacity to accommodate purchase orders up to the full annual estimated ordering quantity as listed in the solicitation for planning and forecasting purposes only, with the understanding that actual order sizes may vary considerably during the actual contract performance within the Base Year period of performance.

Q8. (From Offeror Received 9/18/2026): “If a Delivery Order is fulfilled through multiple accepted shipments within the required delivery period, may the contractor invoice VA upon Government acceptance of each partial shipment, or must invoicing wait until completion of the entire Delivery Order?”

Government Response 8. (Issued 9/19/2026): Under FAR 52.212-4(g) and VAAR 852.232-72, performing Contractors are authorized to invoice the Government for each Government-accepted partial shipment. Although this authorization increases invoice volume and the resulting administrative burden to the Government, it complies with procurement policy and supports prompt, lawful payment processing. The Government personnel at the VA’s Denver Logistic Center Financial Division will greatly appreciate the restraint of all performing Contractors in the volume of invoicing, but the fact remains that performing Contractors are authorized to invoice the Government for each Government-accepted partial shipment. As stated in Section B.3.19.4, Invoice Submission Requirements, and Section B.3.12, Delivery and Shipping Requirements, the VA allows for partial product order deliveries to ensure that the full ordered quantity of products are received in at the DLS on or before but no later than 30 calendar days after receipt of the order. The resultant performing Contractors may invoice the VA for each partial shipment upon Government acceptance of the delivered items, provided that the invoice accurately reflects the quantity accepted and complies with the invoicing requirements set forth in the solicitation. All invoices must be submitted electronically in accordance with VAAR 852.232-72 and FAR 52.212-4(g).

Q9. (From Offeror Received 9/18/2026): “Please confirm the minimum guaranteed quantity or dollar amount applicable to an X005 IDIQ award and the maximum quantity or contract ceiling applicable to an individual X005 award.”

Government Response 9. (Issued 9/19/2026): As stated in Section B.3.5, Contract Guaranteed Minimum Aggregate Order Value, the minimum guaranteed order value for each Base IDIQ contract, including any resultant contract award for CLIN X005 and SLIN X005AA, is $5,000.00 within the Base Year period of performance only. The maximum aggregate order value (contract ceiling) for the entire ETMPM-TENS procurement program and all resultant contract awards made against this solicitation for the entire five (5) year estimated contract lifespan, if all options are exercised, which includes any contract awards made for CLIN X005 and SLIN X005AA, is $500,000,000.00.

Q10. Agency-posed clarifying question (derived from frequently asked points of clarification from prospective Offerors): We are an SDVOSB authorize distributor, we only offer TAA-compliant end products (no pure BAA products). Will we be pushed to Tier-4, or can we compete in earlier tiers?

Government Response 10. (Issued 9/21/2026): You can compete wherever your business category places you in the tier sequence; TAA applies at every tier because the internal Government’s estimates of the anticipated award values on a per-CLIN/SLINs basis far exceed the TAA dollar thresholds.

Tiering determines order of evaluation, not domestic-origin rules of eligibility. TAA-compliant end-products are eligible to compete at all tiers (FAR 25.402(a)–(b); VAAR 815.101-370 (Class Deviation)).

Q11. Agency-posed clarifying question (derived from frequently asked points of clarification from prospective Offerors): If TAA is the sole governing regulation, why does VA require both 52.225-2 (BAA Certificate) and 52.225-6 (TAA Certificate)?

Government Response 11. (Issued 9/21/2026): The Contracting Officer and designated Source Selection Authority may require any certificates necessary to verify compliance with end-product country-of-origin rules and ensure that all responsive Offerors maintain eligibility across all tiers in accordance with FAR 25.1101, which authorizes the VA to require all responsive proposal submissions to include both BAA/TAA certificates as a material requirement of responsiveness; doing so does not make the BAA applicable to this procurement. It simply ensures complete end-product country-of-origin documentation for all offered end-products proposed. (FAR 25.1101)

Q12. Agency-posed clarifying question (derived from frequently asked points of clarification from prospective Offerors): What happens if a particular CLIN/SLINs combination of a CLIN itself receives only one offer? Will the VA proceed to award?

Government Response 12. (Issued 9/21/2026): If only one (1) offer is received for any CLIN or any CLIN/SLINs combination, the VA will follow the procedure at VAAR 815.370:

1. Take action to promote competition (e.g., extend the response window, consider solicitation amendments if time permits); or

2. Consider the offer received, ensure the offered price is a fair and reasonable price to the Government, including the possibility of requiring the Offeror to submit certified cost or pricing data as needed to make a price reasonableness determination. Award may proceed only after these steps are satisfied; otherwise VA will re-solicit the requirement or decide to not make an awarded on the affected CLIN and/or CLIN/SLINs combination. (VAAR 815.370-1 to -3)

Q13. Agency-posed clarifying question (derived from frequently asked points of clarification from prospective Offerors): Is this acquisition classified as a total small business set-aside or a full and open competition? The “Tiered Set-Aside” title is confusing.

Government Response 13. (Issued 9/21/2026): This procurement action is classified as a negotiated, competitive acquisition conducted under FAR Part 15 source-selection procedures (e.g., competitive negotiated acquisitions) and evaluated per the solicitation’s stated factors and tiering order.

It is not a single-tier “total small business set-aside,” nor is it a pure “full and open” competition without Veterans First tiering; rather, it uses the VA Tiered Set-Aside Evaluation (Veterans First) authorized by VAAR 815.101-370 (Class Deviation) and implemented in VAAR 819.7010. Under this approach, the Government evaluates proposals sequentially, first at Tier-1: SDVOSBs, then Tier-2: VOSBs, then Tier- 3: Other Small Business Concerns, and finally at tier-4: Other-Than-Small Business Concerns or Large Businesses and then attempts to make an award at the highest tier where award is possible.

The tiering establishes the order of evaluation and priority, but the acquisition itself remains a competitive, negotiated procurement governed by FAR Part 15.

Plain Language Summary: The Tiered Set Aside Approach = the proposal evaluation order (Tier-1:

SDVOSBs, then Tier-2: VOSBs, then Tier-3: Other Small Business Concerns, and finally at tier-4:

Other-Than-Small Business Concerns or Large Businesses). It is not a single-tier small business set-aside; it is a competitive negotiated acquisition using Veterans First tiered evaluation methodology to determine the highest tier at which award can be made.

Q14. Agency-posed clarifying question (derived from frequently asked points of clarification from prospective Offerors): Where can I find the official list of TAA designated countries?

Government Response 14. (Issued 9/21/2026): The TAA designated country definitions and lists appear in FAR Clause 52.225-5 (Trade Agreements). Refer to the clause text on Acquisition.gov for the current World Trade Organizations - Government Procurement Agreement (WTO-GPA) designated countries, Free Trade Agreement (FTA) designated countries, Least-Developed Nations, and Caribbean Basin designated country lists. (FAR 52.225-5)

Q15. (From Offeror Received 9/20/2026): We seek clarification regarding CLIN X005/SLIN X005AA and the solicitation’s requirement to deliver all ROES-generated product orders within 30 calendar days after receipt of order (ARO). Specifically, please clarify the following:

1. Does the VA expect a performing Contractor to be capable of manufacturing and delivering the entire estimated annual quantity (example: CLIN X005 20,357 units in the Base Year) within a single 30-day period, or does VA only require the Offeror to demonstrate and certify the capacity to support individual ROES purchase orders issued throughout the Base Year, each order to be delivered within 30 days of order receipt?

2. Would the VA consider establishing a maximum quantity per ROES-issued purchase order or permitting extended/phased delivery schedules for unusually large orders?

3. Will VA provide performing Contractors with the rolling demand forecasts or other advance-planning information to support responsible on-hand inventory management, component staging processes, and manufacturing planning?

4. For unusually large purchase orders, would the VA consider allowing phased deliveries, as long as continuous product shipments occur, and the delivery is fully completed by a mutually agreed-upon date?

5. Would the VA consider modifying the structure of CLIN X005 (e.g., multiple awards, secondary/back-up awardees, or other ordering volume load-sharing flexibility) so that manufacturers are not required to maintain product inventory sufficient to fulfill the entire annual demand within a single 30-day window?

Government Response 15. (Issued 9/21/2026):

Response Part 1. The VA’s intent is not to require any performing Contractors to manufacture and deliver the entire annual estimated quantity (example given, 20,357 devices for Base Year for CLIN X005) within a single 30-calendar-day period.

The requirement is:

Contractors must deliver each ROES-generated purchase order on or before 30 calendar days

ARO.

Regardless of the specific quantity stated in that individual ROES-issued purchase order.

The Government provided annual order quantity estimates in Section B, the CLIN/SLIN Mapping Tables, and the Attachment 0001 - Price Matrix are the Government’s good-faith provided estimated ordering quantities for planning figures only and are used exclusively for the price factor evaluation and have no purposes or designs after award. No single ROES-generated purchase order, which must be fulfilled in full within 30-days of order receipt is ever anticipated to equal the full annual estimated ordering quantities as stated in the solicitation and its attachments. Actual order quantities will vary considerably according to the VA’s operational need. Additionally:

Solicitation section B.3.5 addresses the contract guaranteed minimum amount and maximum aggregate order value amount.

Solicitation section C.4 addresses the Minimum order and Maximum order amounts.

Response Part 2. The solicitation does not establish a fixed “maximum quantity” per ROES-issued purchase order. The only contract “maximum” is addressed at solicitation section B.3.5 and C.4

VA permits partial order shipments within the 30-day delivery schedule window, meaning:

The VA will accept multiple - partial product shipments, which the solicitation clearly states is allowed and permissible;

Each partial product shipment may be invoiced upon Government acceptance;

The full ordered quantity must arrive no later than 30 calendar days ARO.

Any delivery schedule extending beyond the 30 days ARO would constitute a material change and would require a formal solicitation amendment. As written, the 30-day delivery schedule timeline applies to every ROES-issued purchase order and remains a material condition of successful contract performance.

Response Part 3. After award and during contract performance, the VA’s DLS Ordering Officers (OOs) will provide all performing Contractors with ongoing operational insight into anticipated ordering activity.

While the VA does not issue guaranteed ordering demand forecasts, all performing Contractors will have:

Routine communication with the DLS OOs regarding upcoming VA needs;

Visibility into ordering trends on a per-CLIN/SLIN basis on-demand;

The ability to plan component staging, manufacturing capacity, and on-hand product inventory levels based on this ongoing communication and correspondence with the DLS OOs. This process is standard service and transparency policy for all performing Contractors.

Response Part 4. Phased partial-quantity product deliveries are permissible within the 30-calendar day delivery schedule requirement. VA will accept multiple partial order shipments for a single purchase order as long as:

Deliveries are received during the 30-day purchase order fulfillment window; and

The entire ordered quantity is delivered on or before the 30-calendar day delivery schedule requirement.

Deliveries that require a longer period would necessitate either sequencing of orders or a formal execution of a contract modification, which the VA has no intention of ratifying; the VA cannot authorize delivery schedule timelines exceeding the 30-calendar days delivery schedule requirement, which is clearly stated within the solicitation as a material condition of successful contract performance.

Response Part 5. Under Solicitation Number 36C79126R0011:

CLIN X005 and SLIN X005AA will be awarded to a single responsible Offeror, at the highest tier at which award is possible, consistent with the VA’s Tiered Set-Aside Evaluation Approach (Veterans First Program) under VAAR 815.101-370 and VAAR 819.7010.

The contract structure, consisting of multiple single-award Base IDIQ contracts and resultant FFP/IDIQ Delivery Order contracts, cannot be changed without a formal solicitation amendment, which the VA has no intentions of executing.

The structure of any CLINs/SLINs being able to be awarded to more than one (1) responsible Offerors was considered and rejected as posing a logistic risk to the Government, in that such arrangement could present capability issues between parent CLIN and subordinate SLINs, which is exactly the reason that the material condition of inseparability between parent CLIN and subordinate SLINs in the solicitation phase and at the time of award.

Secondary/back-up awardees, multiple-award restructuring, or expanded supply-continuity options are not contemplated under the current solicitation and would require a substantial change to the acquisition strategy, which the VA has no intention of entertaining.

Q16. (From Offeror Received 9/21/2026): Would the VA clarify the RFI Respondent FAQs Section 3, Q14, which lists Taiwan as a non-designated country, but FAR 25.003 and FAR Clause 52.225-5 list Taiwan (Chinese Taipei) as designated country under the WTO GPA. Which classification governs the ETMPM-TENS requirement, the BAA or the TAA?

Government Response 16. (Issued 9/21/2026): Yes, the VA’s Contract Specialist made an error in that RFI Respondents FAQs document, which was identified many weeks ago and corrected in subsequent ideations of the FAQs document, but thank for pointing out again, this is a critically important regulatory concern for all Offerors, and I am happy to address this matter again. For solicitation number 36C79126R0011 and the ETMPM-TENS procurement program in general, the Trade Agreement Act (TAA), as set forth at the Clause FAR 52.225-5 controls. The Buy America Act (BAA), as set forth at the Clause 52.225-1 is not applicable to solicitation number 36C79126R0011 nor is the BAA applicable in any way to the ETMPM-TENS requirement. You are correct, Taiwan (Chinese Taipei) is a designated country under the WTO Government Procurement Agreement and is expressly listed in FAR 25.003 and in the definitions within FAR Clause 52.225-5 (Trade Agreements). Accordingly, end-products that meet the TAA country-of-origin test (i.e., manufactured or substantially transformed in a TAA designated country) are eligible to compete for any CLINs/SLINs within the ETMPM-TENS requirement and eligible to compete for award at all Tiers. Any conflicting FAQs document text should be read consistent with the controlling FAR provisions and the solicitation number 36C79126R0011, which clearly states that in the event of a conflict between any Government documents, responses, or clarifications and the solicitation number 36C79136R0011, the solicitation as written prevails, governs, and controls.

Q17. (From Offeror Received 9/21/2026): A presolicitation notice posted to SAM.gov references a Tiered Set-Aside (Cascading) Evaluation approach, but an FAQs document mentions that the ETMPM- TENS procurement will be conducted under Full and Open Competition. Will VA evaluate small-business tiers first before the other-than-small business (Large Businesses) tier, and how should Offerors reconcile these contradicting statements from the Government?

Government Response 17. (Issued 9/21/2026): Yes, you correctly pointed out that the VA’s acquisition planning and strategy has evolved overtime, and the existence of at least four presolicitation notices’ narratives and various documents have been posted for public visibility and Government transparency throughout this procurement process from January through September 2026. The VA has evolved the level of competition from the Full and Open Competition level, to the SDVOSB Total Set Aside level, and the VA finally settled on the Tiered Set Aside Evaluation Approach due the failure to meet the VA’s Rule of Two on the requirement as a whole.

The market research effort failed to identify two (2) or more responsible and capable SDVOSBs/VOSBs at each CLIN and each SLIN. The Tiered Set Aside Evaluation Approach allows the VA to evaluate proposal and make awards at the highest tier that award is possible in keeping with the statutory requirements of the VA’s Veterans First Program. The ETMPM-TENS procurement is officially classified as a competitive, negotiated acquisition level of competition under FAR Part 15 policies and procedures.

The VA’s is utilizing a Tiered Set-Aside Evaluation Approach (a Veterans First Program compliant methodology). The VA evaluates responsive proposals for all CLINs and CLIN/SLINs combinations sequentially: Tier-1: SDVOSBs, then Tier-2: VOSBs, then Tier-3: Other Small Business Concerns, and finally at Tier-4: Other-Than-Small Business Concerns. The VA makes award at the highest tier where award is possible, if award is possible. This approach is authorized by VAAR 815.101-370 (Class Deviation) and VAAR 819.7010. References to “Full and Open Competition” describe the overall competitive nature of the acquisition (i.e., a negotiated competition acquisition), but tiering sets the order of evaluation and priority. For clarity, tiering sets the order of which Offerors are eligible to compete for award at each tier, but the source selection methodology applied on a per-CLIN/SLINs basis determines the award methodology. Additionally, an SDVOSB concern who submitted responsive Attachment 0004 - BAA certification and Attachment 0005 - TAA certification is eligible to complete in all tiers 1 through 4, an VOSB concern who submitted responsive Attachment 0004 - BAA certification and Attachment 0005 - TAA certification is eligible to complete in tiers 2 through 4, Other-Than-Small Business Concerns who submitted responsive Attachment 0004 - BAA certification and Attachment 0005 - TAA certification are eligible to complete in tiers 3 and 4, and Other-Than-Small Business Concerns or Large Business concerns are only eligible to compete in Tier-4. Thus, the material requirement for all Offerors to submit responsive Attachment 0004 - BAA certification and Attachment 0005 - TAA certifications is a material condition of responsiveness to solicitation number 36C79126R0011, because the VA wants to ensure that all small business concerns are eligible to compete in all tiers that they are eligible to compete within.

Q18. (From Offeror Received 9/21/2026): The FAQs document Q21 requires all resultant performing Contractors to provide a U.S.-based toll-free support. What are the required hours of operation, answer-time/abandonment expectations, live agent vs. IVR, and language requirements? May an OEM teaming partner provide the support in leu of the performing Contractor?

Government Response 18. (Issued 9/21/2026): The solicitation requires all result performing Contractors to provide a U.S.-based toll-free customer support platform as a material condition of submitting a responsive proposal against solicitation number 36C79126R0011; it does not prescribe fixed hours of operation, SLAs, or language quotas beyond ensuring adequate access to meet VA’s operational needs. Offerors may propose reasonable customer service hours, staffing (live-agent/IVR balance), and language capabilities consistent with VA’s national footprint. Customer Service Support may be provided by an OEM or authorized teaming partner, provided the proposal document submitted clearly describes the arrangement and fully meets all material requirements.

This clarification is consistent with FAR 15.201 (e.g., exchanges with industry prior to the receipt of proposals) and does not change requirements. If any minimums are later mandated, they will be set into the solicitation by formal amendment.

Q19. (From Offeror Received 9/21/2026): The RFI Respondents’ FAQs document Q21 requires all resultant performing Contractors to provide a web-based customer service/training platform. What content and formats are required? Does Section 508 (ICT accessibility) apply to contractor-hosted content? We ask because FAQs Q19 explicitly bars all resultant performing Contractors from registration of Veteran patients as customers and strictly prohibits all resultant performing Contractors from the collection of any Veteran patient PII/PHI, does that mean an open-access website with no accounts or no user-identifying analytics?

Government Response 19. (Issued 9/21/2026): Contractor-hosted web content provided to VA or the public must conform to Section 508 accessibility requirements (FAR Subpart 39.2; 36 CFR Part 1194).

At a minimum, the web-based customer service platform and electronic customer-facing training platform and materials must meet applicable WCAG-aligned standards for accessibility; Offerors should be prepared to supply VPAT/ACR documentation upon request at the time of award. Where the solicitation instructs no Veteran PII/PHI collection, customer service platforms must not require user registration nor collect identifying analytics on Veterans; aggregate, non-identifying usage analytics may be acceptable only if consistent with the solicitation’s privacy restrictions. This is a clarification; any prescriptive formats or content scope remain as stated in the RFP and the attachments to the RFP.

Q20. (From Offeror Received 9/21/2026): If we propose only to CLINs X001 and X002 (and the subordinate SLINs X001AA/AB/AC/AD and X002AA/AB/AC/AD respectively) but not to CLINs/SLINs X003–X005, will VA evaluate our proposal without prejudice? Can awards be made on a per-CLIN and per-SLIN basis to more than one (1) Offeror?

Government Response 20. (Issued 9/21/2026): Yes, all proposals should be limited to the specific CLINs/SLINs that an Offeror wishes to be evaluated on and considered for award on a per- CLINs/SLINs basis. The ETMPM-TENS requirement consists of fifteen (15) line items, and all offeror will be evaluated on their own merits, and Offerors are not penalized for declining to make offers on other CLINs/SLINs. The solicitation permits per-CLIN/per-SLIN evaluation and award consistent with the tiered methodology and FAR 15.3 evaluation procedures; the VA may make multiple single-awards across CLINs/SLINs. CLIN X001 and SLINs X001AA/AB/AC/AD are inseparable and shall be awarded to the same responsible Offeror if award can be made. CLIN X002 and SLINs X002AA/AB/AC/AD are inseparable and shall be awarded to the same responsible Offeror. CLINs X003 and X004 are separate unique line items with no subordinate SLINs. Clin X005 and SLIN X005AA are inseparable and shall be awarded to the same responsible Offeror.

Any responsible Offeror may be awarded more than one (1) CLINs/SLINs, but no CLINs/SLINs shall be awarded to more than one (1) responsible Offerors. If awards can be made, the maximum number of Base IDIQ contract awards and resultant FFP/IDIQ Delivery Order contract awards are capped at five

(5) in total, all parent CLINs and all subordinate SLINs awarded to separate responsible Offerors, and no responsible Offeror is awarded more than one (1) CLINs/SLINs. The results of the competition will ultimately determine the total number of awards made, but it shall be between one (1) and five (5) awards made, if award can be made at all line items. Offerors must ensure to submit complete, responsive proposal submissions for each CLIN/SLIN they make an offer on.

Q21. (From Offeror Received 9/21/2026): We intend to offer U.S.-manufactured electrotherapy conductive garments under SLINs X001AD and X002AD (Alternate Options Electrodes). Will VA evaluate these as eligible end products?

Government Response 21. (Issued 9/21/2026): Yes, under TAA coverage for this solicitation number 36C79126R0011, U.S.-made end products and TAA designated-country end products are eligible. For U.S.-manufactured garments, eligibility is satisfied by the U.S.-made end product status; if manufactured outside the U.S., the end-product must be substantially transformed in a TAA designated country per FAR 25.003 and FAR Clause 52.225-5. All offers must also meet the technical specifications for the Alternate Options SLINs and any applicable quality, labeling, and delivery requirements per the material conditions as set forth in the solicitation.

Q22. (From Offeror Received 9/22/2026): Which CLINs or SLINs accept microcurrent devices?

Government Response 22. (Issued 9/22/2026): Microcurrent devices are not included as a distinct CLIN or SLIN categories under Solicitation Number 36C79126R0011. The approved therapeutic modality categories are clearly defined in solicitation Section B.2–B.3, which include TENS Device (CLIN X001) and TENS Electrodes (SLINs X001AA/AB/AC/AD, IFC device (CLIN X002) and IFC Electrodes (SLINs X002AA/AB/AC/AD), Thermal SWD Device (CLIN X003), Non-Thermal SWD Device (CLIN X004), and Portable Neuromodulation Devices for Headache Disorders (CLINX005) and Neuromodulation Electrodes (SLIN X005AA). Microcurrent stimulation is not identified in any CLIN-specific or SLIN-specific Minimum Technical Requirements (MTRs). Therefore, microcurrent devices are not eligible for consideration under this solicitation unless the device strictly conforms to the universal MTRs applicable to all CLINs/SLINs and the CLIN-specific or SLIN-specific MTRs of an existing CLIN or SLIN. If an Offeror believes its device or accessory that meets all universal MTRs and all CLIN-specific and SLIN-specific MTRs, the Offeror may submit product technical capability statement documentation and submit timely product samples for Government evaluation; however, the inclusion of out-of-scope devices and accessories in this requirement is prohibited and non-conforming devices and accessories will be rated as Technically Unacceptable, ineligible for evaluation, and not considered for award.

Q23. (From Offeror Received 9/22/2026): Are CES-specific CLINs limited to devices with ear-clip electrodes?

Government Response 23. (Issued 9/22/2026): No CLIN or SLIN in solicitation number 36C79126R0011 is defined as “CES-specific.” CLIN X005 - Portable Neuromodulation Devices for Headache Disorders does not require ear-clip electrodes, nor does the solicitation identify any CLIN or SLIN requirement for CES (e.g., Cranial Electrotherapy Stimulation ???) as a modality of interest to the VA or included in the requirement as stated in solicitation number 36C79126R0011. Ear-clip electrodes are not required nor are they specified as an MTR in solicitation number 36C79126R0011; any electrode type must comply with the SLIN-specific MTRs (e.g., flexible, reusable gel, latex-free, minimum package quantity, etc.).

Devices employing CES-type ear-clips as an accessory to a CLIN or SLIN must still fully meet all universal MTRs applicable to all CLINs and SLINs and the CLIN-specific and SLIN-specific MTRs and be clinically appropriate for VA’s use.

Q24. (From Offeror Received 9/22/2026): Are “or equal” products acceptable where Alpha-Stim characteristics are referenced?

Government Response 24. (Issued 9/22/2026): There are no brand-name specific “call-outs” and/or brand-named requirements stated or referenced in solicitation number 36C79126R0011, this is a negotiated competitive acquisition under the Tiered Set Aside Evaluation approach as stated in solicitation number 36C79126R0011. The RFP does not specify Alpha-Stim nor any other brand within the CLIN/SLIN descriptions, universal MTRs or CLIN/SLIN-specific MTRs. All Offerors may propose any FDA-cleared device that meets or exceeds every universal MTRs and all CLIN-specific and SLIN-specific MTRs for Government evaluation and consideration for award. Products that fail to meet one or more mandatory MTRs will be rated Technically Unacceptable, ineligible for evaluation, and removed from consideration for award. All proposal package documentation submitted via email message must also include the relevant product samples shipped and delivered to the VA’s DLS facility so the VA can verify full compliance and responsiveness to the solicitation.

Q25. (From Offeror Received 9/22/2026): Will awards be made by individual CLINs/SLINs?

Government Response 25. (Issued 9/22/2026): Yes, awards made against solicitation number 36C79126R0011 are made on a per-CLIN and per-SLINs basis. Each CLIN X001–X005 is evaluated independently, using either LPTA (CLINs/SLINs X001 - X004) or Best Value (CLIN X005/SLIN X005AA). Parent CLINs and subordinate SLINs are inseparable CLIN/SLINs packages (CLIN X001 w/ SLINs X001AA–AD, CLIN X002 w/ SLINs X002AA–AD, and CLIN X005 w/ SLIN X005AA) must be awarded to a single responsible Offeror each. Any responsible Offeror may be awarded more than one

(1) CLIN/SLINs. The total number of awards made against solicitation number 36C79126R0011 will be the result of competition, but the maximum number of awards will be five (5) awards if all awards are made to separate responsible Offerors or as few as one (1) award if all awards are made to a single responsible Offeror.

Q26. (From Offeror Received 9/22/2026): Can a vendor win only certain CLINs?

Government Response 26. (Issued 9/22/2026): Yes, an Offeror can only be considered for award for those CLINs/SLINs they propose to (e.g., proposal documentation package and product samples) and they wish to be evaluated on and considered for award. An Offeror cannot be considered for award on a CLIN/SLIN they did not propose on. All Offerors are encouraged to submit proposal documentation packages and products samples for all CLINs/SLINs they wish to make an offer on against the requirements as stated in solicitation number 36C79126R0011.

There is no requirement stated in solicitation number 36C79126R0011 that an Offeror must propose on all CLINs/SLINs. Any responsible Offeror may be awarded more than one (1) CLIN/SLINs.

Q27. (From Offeror Received 9/22/2026): Can multiple awardees compete for delivery orders after award?

Government Response 27. (Issued 9/22/2026): No. This solicitation creates multiple single-awards of Base IDIQ contracts and the resultant FFP/IDIQ Delivery Order contract awards to a responsible Offeror for each CLIN/SLINs. Therefore, there shall be no post-award competition occurs at the delivery-order level. Delivery Orders are placed only with the single awardee of each CLIN/SLINs, consistent with FAR 16.505(b)(2)(i) and Section B.3.5.

Q28. (From Offeror Received 9/22/2026): For TAA requirements, is compliance governed by the final assembly of the end-product, or does it apply to all individual components sourced from non-U.S.

suppliers?

Government Response 28. (Issued 9/22/2026):

Response Part 1: Scope & Controlling Regime: For solicitation number 36C79126R0011, the Trade Agreements Act (TAA) is the sole domestic-source regime that governs end-product country-of-origin (COO) determinations. For this procurement effort, the VA has established that the BAA does not apply because every possible combination of per-CLIN/SLIN award(s) are expected to exceed the applicable trade agreement supply procurement dollar thresholds, which triggers mandatory TAA coverage and waives the Buy American statute in its entirety. Evaluation of end-products offered will therefore be conducted exclusively under FAR Subpart 25.4 and FAR clauses 52.225-5/-6.

Response Part 2: How the VA will determine end-product COO under TAA:

TAA Test (Substantial Transformation): End-product COO is determined by the country where the finished end product is substantially transformed into a new and different article of commerce with a distinct name, character, or use. The origin of individual components is not controlling; what matters is the transformation of the end product itself.

The VA will apply the definitions and standards in FAR 25.003 and enforce the requirements in FAR Clause 52.225-5 (Trade Agreements).

Eligibility of Offers under TAA: For supply acquisitions covered by TAA thresholds, the VA will consider for award only offers of U.S.-made end products and offers of TAA designated-country end products, which shall be treated on an equal basis.

Non-TAA designated country offers are not eligible unless the clause-specific exception applies (e.g., the Government determines no U.S.-made or designated-country offers are available).

Thresholds & Coverage Confirmation: Trade agreement coverage for supplies is determined by the acquisition value. The current WTO-GPA supply procurement threshold is $174,000.00, with FTA thresholds ranging from $100,000.00 to $174,000.oo depending on the agreement. The VA anticipates that every possible combination of ETMPM-TENS CLINs/SLINs award(s) is expected to exceed these dollar threshold levels, thereby mandating TAA coverage throughout the procurement process and waiving the BAA as not applicable to this procurement…