NMR Individual Waiver Approval Steam Sterilizer.pdf

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Office of Government Contracting and Business Development | 409 3rd Street SW | Washington DC 20416

May 24, 2024

VIA Email: peter.kim@va.gov

Mr. Peter Kim, Contracting Officer US Department of Veterans Affairs, NCO 22 2145 Graeber Street March Air Reserve Base, CA 92518

RE: NMR Individual Waiver for Steam Sterilizers, Solicitation No. 36C26224Q0949

Dear Mr. Kim:

On May 9, 2024, the U.S. Department of Veteran’s Affairs (VA), NCO 20, submitted a request to the U.S. Small Business Administration (SBA) for an individual waiver of the Nonmanufacturer Rule (NMR) for the purchase of Steam Sterilizers (Washer/Disinfectors) for use at the VA’s Sterile Processing Services department at the Loma Linda VA Medical Center. The estimated value of this procurement is $786,426.86.

The waiver of the NMR on an individual procurement is provided for in section 8(a)(17) of the Small Business Act, 15 U.S.C. § 637(a)(17), and section 121.406(b)(5) of title 13 of the Code of Federal Regulations, 13 C.F.R. § 121.406(b)(5). The NMR applies to socioeconomic set asides valued above the micro-purchase threshold (MPT) and to small businesses set asides above the simplified acquisition threshold (SAT). 13 C.F.R. § 121.406(c). At a minimum, an individual NMR waiver request must include the specific item to be waived, why the specific item is required, the proposed solicitation number, the NAICS code, the dollar amount of the procurement, 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)(1).

In addition, the contracting officer must provide a determination that no small business manufacturer can reasonably be expected to offer the product(s) required under the solicitation. This determination must be supported by a narrative of market research and supporting documentation. 13 C.F.R. § 121.1204(b)(1)(iii).

According to your submission, the Loma Linda VA Medical Center has a requirement to replace existing washer/sterilizers that are near the end of their life due to heavy use. Market research methods included:

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• Review of VA’s VIP database which found 911 SDVOSBs and VOSBs nationwide under

NAICS 339113, Surgical Appliance and Supplies Manufacturing, but CO found none who were manufacturers or sold products manufactured by SBs.

• Review of professional journals, catalogs and/or product literature which found one SB manufacturer of similar products but not the specific items required.

• SBA Dynamic Small Business Search (DSBS) database Quick Market Search which found 795 SDVOSBs and 104 VOSBs with NAICS 339113. Further review found only one SB who manufactures a sterilizer that meets the requirement, Steelco-USA. When the CO requested information on Steelco’s steam washers and sterilizers, Steelco responded that they do not offer these items in the United States.

• Post of Sources Sought on SAM.gov on 1/17/24 under notice number 36C26224Q0418 with detailed descriptions of the salient characteristics of the steam washer/disinfectors required. By the 1/25/24 closing date, no responses were received.

• Review of previous acquisitions reported in SAM.gov found an SDVOSB set-aside under solicitation 36C26224Q0418. Two SDVOSB vendors were found to be authorized distributors of the Steris equipment: DME Vet and Beacon Point Associates.

In summary, the CO’s market research found no SB or SDVOSB/VOSB manufacturers of brand name or equal steam washers/disinfectors. However, two SDVOSB distributors of the brand name example steam washer/disinfectors were found.

As the VA has demonstrated no small business can meet the specifications of the contract as a manufacturer, an individual waiver is appropriate in this instance. 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 submit and receive a new waiver before entering into the contract’s sixth year.

This waiver must be published with the solicitation so that potential offerors are aware of the waiver and the specific product(s) covered. 13 C.F.R. § 121.1206. The effect of this waiver is to allow an otherwise qualified small business to supply the product of an other-than-small manufacturer or processor on this intended 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.

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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 the waiver, the contract number, and the actual dollar value of the contract. Should you have any questions or require any additional information, please contact Ms. Yuri Dyson at 503-593-8733 or yuri.dyson@sba.gov.

Sincerely, For Francine H. Morris Director, Office of Government Contracting mailto:nmrwaivers@sba.gov mailto:yuri.dyson@sba.gov