S05 - RFQ - Questions and Answers.pdf

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Attached to
Laser Multicolor Photocoagulator
Solicitation number
36C25226Q0615-0001
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About this file

This is a Questions and Answers document for RFQ 36C25226Q0615, a simplified acquisition for a complete NIDEK MC-500 medical laser system and its required components.

The document addresses seven key areas of vendor inquiries. The SBA class waiver for NAICS 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) applies to the NIDEK MC-500 system and accessories, which lifts the nonmanufacturer rule requirement to source from small-business manufacturers, though Buy American Act/Trade Agreements Act compliance remains mandatory. Vendors selecting the nonmanufacturer option on VAAR 852.219-76 must identify the domestic manufacturer of the product, which need not be a small business due to the class waiver, and must comply with the 50% subcontracting limitation and similarly-situated subcontractor treatment requirements. The OEM authorization letter must be issued by the manufacturer to the contractor, though no specific RFQ reference requirement is stated. Past performance is not an evaluation factor in this simplified acquisition; vendors are not required to submit past-performance references, and lack of prior federal prime contracts will not render a quotation unacceptable. Country-of-origin information is required only for the complete system as delivered, not for individual accessories or subsystems. All delivery, onsite installation, startup, and training activities must be completed by October 9, 2026. Both the Buy American certificate and VAAR 852.219-76 certificate must be submitted as a single separate attachment (Attachment 3) with the quotation.

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RFQ: 36C25226Q0615 - Questions and Answers

1. The solicitation includes FAR 52.219-33 and VAAR 852.219-76. SBA’s class-waiver database identifies a waiver for Electromedical and Electrotherapeutic Apparatus Manufacturing under NAICS 334510. Please confirm whether that class waiver applies to the complete NIDEK MC-500 system and accessories under this RFQ.

Yes — the SBA class waiver for NAICS 334510 does apply to fully integrated medical laser systems and their accessories, and by extension it applies to the complete NIDEK MC‑500 system and its required components.

2. If the class waiver applies, please explain how vendor’s should complete and sign the VAAR 852.219-76 certification where the posted form references supplying products of a small-business manufacturer.

The solicitation includes VAAR 852.219-76 – VA Notice of Limitations on Subcontracting: Certificate of Compliance for Supplies and Products (JAN 2023) (DEVIATION). Because an SBA class waiver to the Nonmanufacturer Rule applies to the NAICS used for this RFQ, please follow the steps below when completing and signing the certification.

What the clause permits when a waiver applies VAAR 852.219-76 states that a nonmanufacturer must supply the product of a domestic small business manufacturer or processor, unless a waiver has been granted under 13 CFR 121.406(b)(5). Since a class waiver applies here, the requirement to supply the product of a small-business manufacturer is lifted; compliance with Buy American Act/Trade Agreements Act remains separate and still applies.

How to complete the certification (step-by-step)

1. Paragraph (a)(1): Check the correct box.

o If you are not the manufacturer, select (a)(1)(ii) – Nonmanufacturer. This selection explicitly recognizes the waiver language in the clause (“…unless a waiver… is granted”).

2. Paragraph (a)(2): Identify your role.

o Select (a)(2)(ii) – Nonmanufacturer and provide your firm’s details.

o List the domestic manufacturer of the product you will supply. Because the class waiver applies, this manufacturer does not need to be a small business.

3. Limitations on subcontracting.

o Certify that you will comply with the 50% limitation applicable to supply contracts (excluding the cost of materials) and the similarly-situated subcontractor treatment.

4. Signature block (paragraph (d)).

o Complete all fill-ins, including printed name, title, signature, date, and company name, and return the signed certification with your quote. Offers cannot be evaluated or awarded without a completed certification.

5. Subcontracts.

o Flow down the substance of VAAR 852.219-76 to applicable subcontracts and monitor compliance throughout performance.

3. Please confirm whether an OEM authorization letter must be issued specifically to and reference this RFQ, and whether it must accompany the quotation at submission.

The OEM authorization letter must be issued by the OEM to the contractor.

4. Attachment 1 states that past performance will not be considered for simplified acquisitions. Please confirm that vendors are not required to submit past-performance references and that vendor’s truthful lack of completed federal prime contracts will not make the quotation unacceptable.

Q1. Will past performance be evaluated for this RFQ?

No. Attachment 1 states that past performance will not be considered for simplified acquisitions, and therefore it is not an evaluation factor in this procurement.

Q2. Is the offeror required to submit past‑performance references?

No. Offerors do not need to provide past‑performance references or examples as part of the quotation.

Q3. Will an offeror’s lack of prior federal prime contracts affect acceptability?

No. A truthful lack of federal prime contract history will not make the quotation unacceptable. Since past performance is not an evaluated factor in simplified acquisitions, the absence of prior federal prime awards cannot be treated as a deficiencies.

5. Please confirm whether country-of-origin and Buy American information is required for each system component or only for the end item as delivered.

Vendors are not required to provide country‑of‑origin details for each individual accessory or subsystem of the NIDEK MC‑500 package.

6. Please confirm that delivery, onsite installation, startup, and training must all be completed by October 9, 2026, and identify any VA site-readiness prerequisites the contractor must include.

Yes: delivery, onsite installation, startup, and training must all be completed by October 9, 2026.

7. Please confirm whether the signed Buy American certificate and VAAR 852.219-76 certificate must be returned as separate attachments with the quotation.

Buy American certificate and VAAR 852.219-76 certificate should be a separate attachment as attachment 3.

File details come from the government source that posted it. Updated .