36C10G22Q0090 0002.docx

SUBJECT*

Brand Name or Equal: Medial Syringe Kit Supplies

GENERAL INFORMATION

SET-ASIDE

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contracting Officer Gwennifer Epps Gwennifer.Epps@va.gov 202-870-1882

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Amendment 0002 | RFQ NUMBER: 36C10G22Q0090 | TITLE: BRAND NAME OR EQUAL - MEDICAL SYRINGE KIT SUPPLIES Amendment 0002 1) Provides responses to the received questions for the subject notice; 2) Deletes letter F. Buy American - Supplies 52.225-1 of B.2 Product Description from the solicitation. 3) Adds, Letter G. Trade Agreement Acts, FAR subparts: 25.400(a)(1) and 25.402(a)(1)(2), are added to the solicitation, under B.2 Product Description; and lastly, 4) The solicitation response date is changed from July 18, 2022, to August 1, 2022, 11:00 AM, EST.

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 To all Offerors/Bidders

36C10G22Q0090

X

X TITLE: BRAND NAME OR EQUAL - MEDICAL SYRINGE KIT SUPPLIES | RFQ NUMBER: 36C10G22Q0090

Amendment 0002: 1) Provides responses to the received questions for the subject notice; 2) Deletes letter F. Buy American - Supplies 52.225-1 of B.2 Product Description from the solicitation. 3) Letter G. Trade Agreement Acts FAR subparts: 25.400(a)(1) and 25.402(a)(1)(2), are added to the solicitation, under B.2 Product Description.

and lastly, 4) The solicitation response date is changed from July 18, to August 1, 2022, 11:00 AM, EST.

SEE CONTINUATION PAGE -

ALL OTHER TERMS AND CONDITIONS OF THE SOLICITATION REMAIN UNCHANGED.

A signed and dated copy of the amendment must be returned with the offerors proposal submission.

Brian Shepard Contracting Officer Page 1 of Page 1 of

Page 1 of CONTINUATION PAGE | AMENDMENT 0002 SOLICITATION NUMBER: 36C10G22Q0090, ENTITLED: BRAND NAME OR EQUAL - MEDICAL SYRINGE KIT SUPPLIES | CONTINUATION PAGE QUESTION 1. Can you verify every “brand name” item is BAA or TAA compliant?

RESPONSE: Per FAR 25.402(a)(1) The Trade Agreements Act ( 19 U.S.C.2501), Buy American Act is not applicable to this procurement. As a result, Letter F. Buy American Supplies, FAR 52.225-1 of section B.2 PRODUCT DESCRIPTION is deleted. The Buy American Act requires, with certain exceptions, that only domestic end products be acquired for public use. See, Federal Acquisition Regulation (FAR) sections 25.102, 25.103 (exceptions). In comparison, the Trade Agreements Act provides that eligible product from World Trade Organization Government Procurement Agreement (WTO GPA) countries are entitled to "nondiscriminatory treatment," FAR sect. 25.403(a), and for those eligible products, the President is authorized to and, in fact, has waived the requirements of the Buy American Act. See 19 U.S.C. sect. 2511; Exec. Order No. 12,260, 46 Fed. Reg. 1,653 (Dec. 31, 1980); FAR sect. 25.402(a)(1).

The Trade Agreements Act exemption is applicable to procurements by federal agencies designated as covered by the WTO GPA. See FAR sections 25.400(a)(1), 25.402(a)(1)(2).

The Department of Veterans Affairs, Strategic Acquisition Center (SAC) requires as part of the overall evaluation, a requirement to provide documentation that all items submitted by the Offeror are in Compliance with the Trade Agreement Act, and Offerors must support their Statements of Compliance with a Trade Agreement Act Certification Letter Signed by the Offeror. NEXT: Letter G. Trade Agreement Acts, FAR subparts: 25.400(a)(1) and 25.402(a)(1)(2), are added to the solicitation, under B.2 Product Description. NOTE: Products from CHINA WILL NOT be allowed for this procurement. The vendor must provide the COUNTRY OF ORGIN FOR EACH ITEM IN THE KIT.

QUESTION 2. Are the case quantities flexible based on our GMPs?

RESPONSE: No, for case quantities, see page 9 of the RFQ, Section B. SPECIFIC MANDATORY KIT REQUIREMENTS | TASKS AND ASOCIATED DELIVERABLES.

QUESTION 3. There may be unique components in this RFQ not readily stocked by our facility. Is there any minimum commitment on the Government’s part regarding volumes, or obligation to the unique components?

RESPONSE: The minimum commitment on the Government’s part is Updated to: One (1) case per EACH CLIN as a Minimum Guaranteed, but not less than $1,500.00. NOTE: Number 5. CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES, of Section B.1 CONTRACT ADMINISTRATION DATA, on page 6 of RFQ is CHANGED FROM: “The minimum guaranteed amount awarded under this solicitation is $1,500.00 which shall be obligated at the time of IDIQ award” to READ AS: “The minimum guaranteed amount awarded under this solicitation will be: 1 CASE PER EACH CLIN AS A MINIMUM Guarantee” but not less than $1,500.00.

QUESTION 4. Please verify the educational brochure to be included is 8 pages per the hyperlink and all 8 pages will be included in each kit.

RESPONSE: Yes, the handout is 8 pages, 5.5 x 8.5 inches in color, and must be printed by the vendor. https://www.hiv.va.gov/pdf/Injection-Drug-Use-Brochure-508.pdf QUESTION 5. Pricing in our offer will hold firm for 90 calendar days in accordance with the Proposal Submission Instructions; however, given current significant fuel cost fluctuations, will the Government consider allowing price escalations as needed during option years?

RESPONSE: The Government will not advise the Offerors on recommended pricing, the Consumer Price Index (CPI), or out year price escalation rates. However, all Offerors are reminded that the resultant contract will be Firm Fixed Price. Note: The Contracting Officer, will not be negotiating a PRICE ESCALATION IF NEEDED during option years.

QUESTION 6. Alternatively, will the Government consider a Time-and-Material Contract Line Item separately for transportation costs due to rising fuel costs and unknown points of delivery?

RESPONSE: No, the contract will be Firm Fixed Price, IDIQ Contract.

QUESTION 7. The solicitation references FAR 52.225-1, “BUY AMERICAN SUPPLIES,” which stipulates a preference for supplying domestic-manufactured supplies. However, the referenced syringes (in the referenced sizes) are not manufactured domestically. Will the Government provides a waiver to FAR 52.225-1 allowing for sourcing of the required size of syringes which are manufactured outside of the U.S.?

RESPONSE: No, Please see: SBA regulation 13 CFR 121.406(d)Multiple item acquisitions:

(1) If at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns, then a waiver of the nonmanufacturer rule is not required. There is no requirement that each and every item acquired in a multiple-item procurement be manufactured by a small business.

(2) FAR 19.505 addresses the limitations on subcontracting and nonmanufacturer rule for kit assemblers (see below). It is very specific in that the 50% applies to the components of the kit, which would exclude any credit for work done to assemble the kit.

FAR 19.505(c)(2) Kit assemblers. When the end item being acquired is a kit of supplies— (i)The offeror may not exceed 500 employees; and (ii)At least 50 percent of the total cost of the components of the kit shall be manufactured, processed, or produced in the United States or its outlying areas by business concerns that are small under the size standards for the NAICS codes of the components of the kit.

852.212-71 Gray Market Items and 852.212-72 Gray Market and Counterfeit Items are added to the solicitation, under B.2 Product Description.

852.212-71 Gray Market Items Gray Market Items (APR 2020)

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original Equipment Manufacturers' (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA medical facilities.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of clause)

852.212-72 Gray Market and Counterfeit Items

GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020) (DEVIATION)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM or by an intermediary distributor authorized by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of clause)

QUESTION 8. This is listed as an SDVOSB, but the non-manufacturing rule isn’t checked. Will it be?

RESPONSE: No, the non-manufacturing rule waiver will not be checked (See Question 7 Response). The SBA Nonmanufacturer Rule is provided as further guidance. Nonmanufacturer rule (sba.gov).