Laser Multicolor Photocoagulator

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.

1. 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.
   • 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.
   • Select (a)(2)(ii) Nonmanufacturer and provide your firm's details.
   • 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.
   • 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)).
   • 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.
   • Flow down the substance of VAAR 852.219 76 to applicable subcontracts and monitor compliance throughout performance.
6. 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.

1. 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.

1. 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.

1. 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.

1. 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.