ATTACHMENT F_NMR INDIVIDUAL WAIVER_NX EQ SCALP COOLING SYSTEMS.pdf

All SBA programs and services are extended to the public on a nondiscriminatory basis. 1

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

April 4, 2024

Via Email: Andrew.Montgomery@va.gov

Mr. Andrew Montgomery, Contracting Officer Department of Veterans Affairs Office of Acquisition Operations Strategic Acquisition Center - Frederick 5202 President’s Court, Suite 103 Frederick, MD 21703

RE: NMR Individual Waiver Request

Dear Mr. Montgomery:

On March 20, 2024, Department of Veterans Affairs (VA) submitted a request to the U.S. Small Business Administration (SBA) for an individual waiver of the Nonmanufacturer Rule (NMR) for Scalp Cooling Systems. The anticipated solicitation number is 36C10X24Q0109. The applicable North American Industry Classification System (NAICS) code is 339112, Surgical and Medical Instrument, and the estimated dollar value of this procurement is $1,350,000.00.

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). At a minimum, an individual NMR waiver request must include a definitive statement of the specific item sought to be waived, a justification as to 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). The term “item” can be a specific broad identifying thing ( e.g., all spare parts related to aircraft X), but cannot be so broad as to have no real identification ( e.g., all medical supplies).

In addition, the contracting officer must provide a determination that no small business manufacturer can reasonably be expected to submit an offer for the item that meets the specifications and solicitation’s requirements (including period of performance). This determination

All SBA programs and services are extended to the public on a nondiscriminatory basis. 2 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 VA seeks an individual NMR waiver for Scalp Cooling System. The VA has identified that this is the only item that will meet its needs and that no small business manufacturer can reasonably be expected to offer this item. This is because there are three (3) FDA approved systems on the market; however, all are manufactured by large businesses. VA conducted market research by talking to Subject Matter Experts (SMEs), reviewing catalogs, researching the internet, and querying GSA e-library, the Dynamic Small Business Search (DSBS), and System for Award Management (SAM). VA also posted a Request for Information (RFI). Based on its market research, VA would like to restrict competition to Service-Disabled Veteran-Owned Small Businesses (SDVOSBs)s as it has identified at least two or more SDVOSBs who are authorized distributors for these systems. VA has also located several small businesses that can provide the required item as resellers or distributors.

As VA has demonstrated no small business manufacturer can reasonably be expected to submit an offer for Scalp Cooling Systems, an individual waiver is 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 so 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 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 mailto:nmrwaivers@sba.gov

All SBA programs and services are extended to the public on a nondiscriminatory basis. 3 the contract. Should you have any questions or require any additional information, please contact Bernard Durham at (202) 510-0292 or Bernard.Durham@sba.gov.

Sincerely, For

Francine H. Morris, Director Office of Government Contracting mailto:Bernard.Durham@sba.gov