S02_JA_Q0111_CO.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-24-AP-0149

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office.

2237 # 760-24-1-050-0277, Leavenworth CMOP, Leavenworth, KS

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific, Med/Surg items (ASCENSIA CONTOUR (GLUCOSE) TEST STRIP 100CT) listed in the above table. The proposed procurement action will be a firm-fixed-priced contract.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Product has been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. Brand Specific products are the same thing as dispense as written on a physician s prescription. No National Drug Code (NDC)/ or specific Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify brand specific products in the VA PRINT NAME. This is not always inclusive where a particular NDC or MPN but has been determined to be “Formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients or perform specific function to match the product code.

4. Description of market research conducted and results or statement why it was not conducted:

The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this Med/Surg item not available from mandatory sources (e.g., prime vendor) and, therefore, has submitted the acquisition to Network Contracting Office (NCO 15) which provides acquisition support to CMOP. This acquisition is for a medical surgical supplies that has been specifically identified using the manufacture part number (MPN) and name. Since the (MPN) identifies the medical surgical item prescribed for the individual patient, market research must utilize (MPN) as the primary search criteria to ensure the correct product (i.e., Med/Surg) is purchased.

Medical Surgical items are not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website.

i. In lieu of DailyMeds, searches begin by utilizing the VA image library – where the requested products manufacture/ OEMs can be confirmed.

ii. Once the OEM was confirmed, (OEM: Ascencia) searches continue in VetCert and SBA’s DSBS databases. First using the NAICS Code: 325413 and then more specifically, searching for the manufacturer/ OEM (Ascensia).

1. VetCert, generated 85 SD/VOSB businesses using NAICS code: 325413.

2. SBA’s DSBS, generated 18 Small businesses using NAICS code: 325413.

a. Both databases (VetCert & SBA DSBS) were checked for the manufacturer/OEM (Ascensia) and the searches yielded no results.

Confirming that the manufactures are not registered with VetCert or the SBA.

b. The business that did generate are distributors of large wholesalers.

SAM.gov was searched to confirm the OEM business size. Ascensia is registered within SAM.gov and confirms they’re a large corporation, under the Certs and Reps section.

i. Cross-referencing the information with databases SAM.gov, the Small Business

Administration’s VetCert, and/or other search engines (e.g., Google, U.S. Securities and Exchange Commission’s EDGAR), the manufacturers of the requested pharmaceutical(s) have been determined large business concerns.

OEM/Manufacturer website was reviewed for product information.

i. Line Item 1: (ASCENSIA CONTOUR (GLUCOSE) TEST STRIP 100CT), MPN 7090G is used to measure Glucouse levels.

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR § 121.406, the requirement that a Non-Manufacturer supply the product of a small business concern is referred to as the NMR. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. There is an existing NMR Class Waiver for NAICS 325413 that covers the diabetic test strips in this requirement. The Class waiver was posted to the Federal Register in 85 Fed. Reg. 43634 on July 17, 2020. The current list of NMR Class Waivers is maintained by the SBA and can be found at Non-manufacturer rule class waiver list | U.S. Small Business Administration (sba.gov). Based on the market research conducted, the CO determined there is a reasonable expectation that quotes would be received from two (2) or more SDVOSBs that can comply with the

NMR.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jennifer Knight Contract Specialist

J. Braden Smith Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.01.04 09:12:32 -06'00'

JUSTIN SMITH

Digitally signed by JUSTIN

SMITH

Date: 2024.01.04 10:44:52 -06'00'

43634 Federal Register / Vol. 85, No. 138 / Friday, July 17, 2020 / Notices

9 17 CFR 200.30–3(a)(12).

proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission’s Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change.

Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR–MIAX–2020–21, and should be submitted on or before August 7, 2020.

For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.9 J. Matthew DeLesDernier, Assistant Secretary.

[FR Doc. 2020–15448 Filed 7–16–20; 8:45 am]

BILLING CODE 8011–01–P

SMALL BUSINESS ADMINISTRATION

[Docket No. SBA–2020–0014]

Class Waiver of the Nonmanufacturer Rule

AGENCY: U.S. Small Business Administration.

ACTION: Notification of waiver of the Nonmanufacturer Rule for diabetic test strips.

SUMMARY: The U.S. Small Business Administration (SBA) is granting a class waiver of the Nonmanufacturer Rule (NMR) for diabetic test strips under North American Industry Classification System (NAICS) code 325413 and Product Service Code (PSC) 6515. This U.S. industry comprises establishments primarily engaged in manufacturing diabetic test strips.

DATES: This action is effective August 17, 2020.

FOR FURTHER INFORMATION CONTACT:

Carol J. Hulme, Attorney Advisor, by telephone at (202) 205–6347 or by email at carol-ann.hulme@sba.gov.

SUPPLEMENTARY INFORMATION: Section 8(a)(17) and 46 of the Small Business Act (Act), 15 U.S.C. 637(a)(17) and 657s, and SBA’s implementing regulations require that recipients of Federal supply contracts issued as a small business set-aside (except as stated below), service-disabled veteran-owned small business (SDVO SB) set-aside or sole source contract, Historically Underutilized Business Zone (HUBZone) set-aside or sole source contract, WOSB (women-owned small business) or economically disadvantaged women-owned small business (EDWOSB) set-aside or sole source contract, 8(a) set-aside or sole source contract, partial set-aside, or set aside of an order against a multiple award contract provide the product of a small business manufacturer or processor if the recipient is other than the actual manufacturer or processor of the product. This requirement is commonly referred to as the Nonmanufacturer Rule (NMR). 13 CFR 121.406(b). Note that the NMR does not apply to small business set-aside acquisitions with an estimated value between the micro-purchase threshold and the simplified acquisition threshold. Sections 8(a)(17)(B)(iv)(II) and 46(a)(4)(B) of the Act authorize SBA to waive the NMR for a ‘‘class of products’’ for which there are no small business manufacturers or processors available to participate in the Federal market.

The SBA defines ‘‘class of products’’ based on a combination of (1) the six-digit NAICS code, (2) the four-digit PSC, and (3) a description of the class of products. As implemented in SBA’s regulations at 13 CFR 121.1202(c), in order to be considered available to participate in the Federal market for a class of products, a small business manufacturer must have submitted a proposal for a contract solicitation or been awarded a contract to supply the class of products within the last 24 months.

SBA received a request to waive the NMR for diabetic testing strips under NAICS code 325413 and PSC 6515.

According to that request, submitted with supporting information, there are no small business manufacturers of these items in the Federal market.

On April 20, 2020 (85 FR 08304), the SBA issued a Notice of Intent to grant a class waiver for diabetic test strips.

SBA received no comments in response to the Notice. Therefore, in the absence of a small business manufacturer of diabetic test strips, this class waiver is necessary to allow otherwise qualified regular dealers to supply the product of any manufacturer on a Federal contract or order set aside for small business, SDVOSB, WOSB, EDWOSB, HUBZone or participants in the SBA’s 8(a) Business Development Program. SBA’s waiver of the nonmanufacturer rule has no effect on the requirements in 13 CFR 121.406(b)(1)(i) to (iii) and on requirements external to the Small Business Act which involve domestic sources of supply, such as the Buy American Act or the Trade Agreements Act.

More information on the NMR and Class Waivers can be found at https:// www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/non-manufacturer-waivers.

David Wm. Loines, Director, Office of Government Contracting.

[FR Doc. 2020–15535 Filed 7–16–20; 8:45 am]

BILLING CODE P

DEPARTMENT OF STATE

[Public Notice: 11156]

60-Day Notice of Proposed Information Collection: PEPFAR Program Expenditures

ACTION: Notice of request for public comment.

SUMMARY: The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below.

In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

DATES: The Department will accept comments from the public up to September 15, 2020.

ADDRESSES: You may submit comments by any of the following methods:

• Web: Persons with access to the internet may comment on this notice by going to www.Regulations.gov. You can search for the document by entering ‘‘Docket Number: DOS–2020–0032’’ in the Search field. Then click the ‘‘Comment Now’’ button and complete the comment form.

• Email: SGAC_FinancialOps@ state.gov.

• Regular Mail: Send written comments to: Office of the US Global AIDS Coordinator and Health Diplomacy (S/GAC), U.S. Department of State, SA–22, 1800 G Street NW, Suite 10300, Washington, DC 20006.

• Fax: 202–663–2979.

You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.

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