Attachment C - NMR Certificate.pdf

sizeprotest@sba.gov | www.sba.gov/contracting-officials Size Determination Program | 409 Third Street SW | Washington DC 20416

All SBA programs and services are extended to the public on a nondiscriminatory basis.

Via email: Shavon.Bogan@va.gov

August 19, 2026

Shavon Bogan Contracting Officer Network Contracting Office 22 VHA Regional Procurement Office- West Department of Veterans Affairs 14560 2nd Street, Bld. 2640 Moreno Valley, CA 92518

RE: NMR Individual Waiver Request, Custom Surgical and Non-Surgical Packs

Dear CO Bogan:

Your request for an individual Nonmanufacturing Rule (NMR) waiver is approved.

On July 20, 2026, the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22, submitted a request to the U.S. Small Business Administration (SBA) for an individual waiver of the Nonmanufacturer Rule (NMR) for custom surgical and non-surgical packs. The VA identified the applicable North American Industry Classification System (NAICS) code for this procurement as 339113 (Surgical Appliance and Supplies Manufacturing). The estimated value of this procurement is $2,978,753.82.

The waiver of the NMR on an individual procurement is provided for in section 8(a)(l7) of the Small Business Act, 15 U.S.C. § 637(a)(l7), and section 121.406(b)(5) of title 13 of the Code of Federal Regulations, 13 C.F.R. § 121.406(b)(5). At a minimum, an individual NMR waiver request must include a definitive statement of the specific items sought to be waived, a justification as to why the specific items are required, the proposed solicitation number, the NAICS code, the dollar amount of the procurement, the dollar amount of the item(s) for which a waiver is sought, a brief statement of the procurement history, and a Statement of Work (for contracts expected to exceed $500,000). 13 C.F.R. § 121.1204(b)(l).

In addition, the contracting officer must provide a determination that no small business manufacturer can reasonably be expected to offer each of the item(s) meeting the specifications (including period of performance) for which a waiver is being requested. This determination must be supported by a narrative of market research and supporting documentation. 13 C.F.R. § 121.1204(b)(l)(iii).

According to your submission, the VA seeks an individual NMR waiver for custom surgical and non-surgical packs. The packs will be used for scheduled procedures in operating rooms, interventional radiology, and cardiac catheterization labs. These are the only items that will meet the VA’s needs due to the custom design

All SBA programs and services are extended to the public on a nondiscriminatory basis.

requirements (e.g., sterile packaging per FDA/CGMP) and unique clinical configuration. The packs are not available from catalog or after-market sources.

The VA’s market research to determine if small manufacturers exist included:

• RFI Issued: 36C26226Q0495 [03/16/2026 – 03/29/2026] — No responses from small-business manufacturers.

• Industry Day Held: 12/02/2025 — No small-business manufacturing interest expressed.

• Targeted Outreach: Contacted [5] small businesses under NAICS 339113 and none could manufacture or offer compliant products

Market research identified two small businesses interested in and capable of providing the packs as resellers or distributors:

• Geo-Med LLC (UEI: QB6KPELRH1C7), Lake Mary, FL

• Manus Medical LLC (UEI: M4UBTVGBJMT7), Cheyenne, WY 82001

As the VA has demonstrated that no small business manufacturers or processors can be reasonably expected to manufacture custom surgical or non-surgical packs that meet the VA’s specifications, an individual waiver is appropriate and granted.

This individual waiver applies to this one-time award only and does not apply to modifications to the scope of the contract or other procurement actions. Modifications determined by the contracting officer to be within the scope of the contract will require an additional waiver. 13 C.F.R. § 121.1203(b).

This individual waiver is good for the duration of the contract provided that it does not exceed five years. At the end of the fifth year, whether the contract is in the base period or an option period, the agency must request and receive a new waiver before entering into the contract's sixth year.

Notice that an individual waiver has been granted must be published with the solicitation to ensure that potential offerors are aware of the waiver and the specific item(s) covered. 13 C.F.R. § 121.1206. The effect of this waiver is to allow an otherwise qualified small business to supply the item of an other than-small manufacturer or processor on this intended small business SDVOSB set-aside contract. However, it must be emphasized that this waiver of the NMR does not waive other legal requirements applicable to Government procurements, such as the Buy American Act and the Trade Agreements Act.

This individual waiver must be used within one year of issuance. If that time period expires, the agency may request a waiver extension by contacting nmrwaivers@sba.gov. Please inform SBA of the date you enter a contract using this waiver, the contract number, and the actual dollar value of the contract. Should you have any questions or require any additional information, please contact Dwayne Pugh at (916) 735-1720 or dwayne.pugh@sba.gov.

Sincerely, Laura Maas, Acting Deputy Associate Administrator Office of Government Contracting and Business Development