75A50424R00006 AMD 0001 - Multi-antigen Diagnostic Test Kits - FE.pdf

(x)

75A50424R00006 x x

1 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 ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY 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.

x

ASPR-ORM-IBMSC

Washington DC 20024 Constitution Center 400 7th St SW

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-ORM-IBMSC

09/10/20240001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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: (a) By completing

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/10/2024

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to correct a typo in the solicitation and provide

Government responses based on questions received in response to the solicitation. See continuation page

Period of Performance: 09/30/2024 to 09/29/2025

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

TONYA W. PURCE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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

Solicitation Number 75A50424R00006 Amendment 0001

Description Multi-Antigen Diagnostic Tests Page 2 of 6

1) The solicitation is hereby revised to correct a typo throughout in its entirety as follows:

From: SARS, CoV-2, and Influenza A/B To: SARS-CoV-2 and Influenza A/B

2) The Government hereby provides official responses to all questions received from industry prior to the closing of the question period as follows:

Q1. Vendor Question: Domestic Manufacturing Requirements: We currently operate two manufacturing facilities, one in Korea and one in San Diego, California. Could you please clarify whether there are any specific requirements or preferences for domestic manufacturing under this RFP? Specifically, can the product be produced at our Korean facility, or does the government prefer that manufacturing be done in the U.S. under the Buy American Act or other related regulations?

GOVERNMENT RESPONSE: 52.225-1, Buy American-Supplies does not apply to this solicitation. The exception, FAR 52.225-5, Trade Agreements (NOV 2023) applies. See

pg. 20, Section I.2 FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED

TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (MAY 2024).

In accordance with FAR 52.225-5 Trade Agreements (Nov 2023), Designated country end product means a WTO GPA country end product, a Free Trade Agreement (FTA) country end product, a least developed country end product, or a Caribbean Basin country end product. Korea is listed as a country with a Free Trade Agreement and World Trade Organization Government Procurement Agreement (WTO GPA). As such,

(b) Delivery of end products. The Contracting Officer has determined that the WTO GPA and FTAs apply to this acquisition. Unless otherwise specified, these trade agreements apply to all items in the Schedule. The Contractor shall deliver under this contract only U.S.-made or designated country end products except to the extent that, in its offer, it specified delivery of other end products in the provision entitled "Trade Agreements Certificate."

Q2. Vendor Question: Shelf-Life Clarification: Regarding the shelf-life requirement, could you provide further clarification on the minimum acceptable shelf life for the multi-antigen diagnostic test kits?

GOVERNMENT RESPONSE: In accordance with Section C – PRODUCT TECHNICAL SPECIFICATION, C.3 Specifications, the Government will only accept test that are manufactured within 60 days from the date of delivery. Tests with a manufacture date greater than 60 days when it is received at the Government warehouse will not be accepted for delivery into our facility.

Q3. Vendor Question: Transition from FDA EUA to 510(k): Our product is currently under FDA Emergency Use Authorization (EUA) and is expected to transition to full FDA 510(k) approval in the near future. If awarded the contract, and we begin supplying the product under FDA EUA while the 510(k) application is still under review, would we be permitted to transition to supplying the FDA 510(k)-approved product once the approval is completed?

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Description Multi-Antigen Diagnostic Tests Page 3 of 6

Government Response: Yes, if awarded the contract supplies under this transition will be accepted because the Government anticipates that your company’s approval will transition to the FDA 510(k) approval.

Q4. Vendor Question: Our company is not categorized as a Small-Business. Can you please confirm whether the contracting agency would accept and/or consider our bid offer if submitted or are we ineligible to submit because we are not a Small-Business?

GOVERNMENT RESPONSE: This solicitation was issued with a total 100% small business set-aside. See Section I.2 FAR 52.212-5 CONTRACT TERMS AND

CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024), specifically #18 FAR 52.219-6, Notice of Total Small Business Set-Aside. Only offers which meet all terms and conditions of the solicitation will be considered for a contract award.

Q5. Vendor Question: I would like to request clarification regarding the qualifications for meeting the small business requirements. Specifically, I would appreciate if you could confirm whether the small business classification is based solely on employee size, or if there are additional criteria that need to be met.

GOVERNMENT RESPONSE: NAICS Code: 325413 - In Vitro Diagnostic Substance Manufacturing applies this solicitation. The size standard for NAICS Code 325413 is 1,250 employees. A size standard, which is usually stated in number of employees or average annual receipts, represents the largest size that a business (including its subsidiaries and affiliates) may be to remain classified as a small business for SBA and federal contracting programs. See www.sba.gov website for further information.

For more information about size standards, contact the size standards specialist at your nearest SBA Government Contracting Area Office. You also can contact the Office of Size Standards by email at sizestandards@sba.gov or by phone at 202-205-6618.

As stated in the solicitation pg. 4, Section VIII, Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, with its offer, if not available in the System for Award Management (SAM). Offerors must self-certify it’s business size and provide a copy in Volume III: Offer, Amendments, and Certifications & Representations if the completed clause is not available in SAM.

Q6. Vendor Question: Additionally, could you please advise if a formal certification or any other documentation is required to prove our small business status as part of the proposal submission?

GOVERNMENT RESPONSE: Yes. See the Government response to Q5.

Q7. Vendor Question: Are they requesting 1 or 2 tests per kit? Regarding multiple distribution center locations, do you have a specific breakout or allotment for each location?

GOVERNMENT RESPONSE: The packaging of each box or kit is at the manufacturer’s discretion. The total requirement is for one million (1,000,000) tests that can detect SARS-CoV-2 and Influenza A/B. A breakdown will not be provided prior to award. See SECTION F - DELIVERIES AND PERFORMANCE for further instructions.

http://www.sba.gov/ https://www.sba.gov/federal-contracting/counseling-help/contracting-area-directors-directory mailto:sizestandards@sba.gov

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Description Multi-Antigen Diagnostic Tests Page 4 of 6

Q8. Vendor Question: This solicitation is for one million multi-antigen diagnostic test kits.

Should that be interpreted as one million tests or one million test kits (boxes)?

GOVERNMENT RESPONSE: That is one million tests each capable of detecting SARS- CoV-2 and Influenza A/B (Multi-Antigen Diagnostic Tests). See Government response to Q7.

Q9. Vendor Question: Is there a preference for the number of tests per test kit box? For example, one test pertest kit box, two tests per test kit box, 5 tests per test kit box, etc.

GOVERNMENT RESPONSE: That is one million tests each capable of detecting SARS- CoV-2 and Influenza A/B (Multi-Antigen Diagnostic Tests). See Government response to Q7.

Q10. Vendor Question: Is the expectation that one million tests (or test kits) must be delivered within 15 days after receipt of award, or that one million tests (or test kits) should be delivered over the 12-month period of performance starting 15 days after receipt of award?

GOVERNMENT RESPONSE: The delivery period will begin fifteen days after receipt of award. Multiple deliveries will occur over the course of 12 months in accordance with the COR approved delivery schedule. See solicitation Section F.1 Delivery Schedule.

Q11. Vendor Question: Does FAR 52.225-1 Buy American Supplies (OCT 2022) apply to this solicitation?

GOVERNMENT RESPONSE: No. See the Government response to Q1.

Q12. Vendor Question: Does FAR 52.225-2 Buy American Certificate apply to this solicitation?

GOVERNMENT RESPONSE: No. See the Government response to Q5 and solicitation Section I.25 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021).

Q13. Vendor Question: Does FAR 52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) apply to this solicitation?

GOVERNMENT RESPONSE: No.

Q14. Vendor Question: Does FAR 52.225-5 apply to this solicitation?

GOVERNMENT RESPONSE: Yes. See the Government responses to Q1 and Q12.

Q15. Vendor Question: Is there a minimum percentage of domestic content required for this solicitation of commercial off-the-shelf (COTS) test kits?

GOVERNMENT RESPONSE: No.

Q16. Vendor Question: Will any preference be given based on the percentage of domestic content?

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Description Multi-Antigen Diagnostic Tests Page 5 of 6

GOVERNMENT RESPONSE: No. See solicitation Section M – Evaluation For Award.

Award shall be made to the lowest priced offer that is technically acceptable.

Q17. Vendor Question: Tests are a critical component of a test kit. If the tests are manufactured in the United States and then packaged into finished test kits in Mexico, would those test kits be eligible for this solicitation?

GOVERNMENT RESPONSE: See the response to Q1. Mexico is listed as a Free Trade Agreement (FTA) country. Complete the Trade Agreements Certificate and submit it in proposal Volume III - Offer, Amendments, and Certifications & Representations.

Q18. Vendor Question: We understand that the RFP specifies that submissions must come directly from the OEM. Given our unique situation (see above – confidential), where the OEM does not have the necessary CAGE code or UEI, would the agency consider approving a submission from us as their exclusive distributor, provided that all other solicitation requirements are met?

GOVERNMENT RESPONSE: No. Solicitation Section I.3, FAR 52.204-7 SYSTEM FOR AWARD MANAGEMENT did not include Alt 1 (Oct 2018). Therefore, the offeror must be registered in SAM at the time of proposal submission. Also, please see the technical acceptability requirements in solicitation sections C and M. In order to be considered technically acceptable, the products must be supplied and shipped directly from the OEM.

No product supplied and directly shipped from retailers, dealers, or authorized resellers will be accepted.

Q19. Vendor Question: Please confirm the Govt is requesting 1,000,000 tests in total regardless of the package configuration. The RFP states 1,000,000 test kits. Most of the OTC tests kits are packaged as 2 tests per kits. This would mean 2,000,000 tests.

Government Response: The Government is requesting a quantity of only one million (1,000,000) total tests. If they are shipped in a box that contains a quantity of 2 EA, then a total of 500,000 boxes shall be shipped.

Q20. Vendor Question: Since only one offer will be awarded, will the Federal government disclose the total bid amount?

GOVERNMENT RESPONSE: The announcement of the award will be synopsized via the Contracts Opportunities (SAM.gov) GPE. Since the Government will not determine a competitive rage in this LPTA source selection, the post award notice will include in general the information required under FAR 15.503 Notifications to Unsuccessful Offerors, section (b) Postaward notices (1) as follows:

(i) The number of offerors solicited;

(ii) The number of proposals received;

(iii) The name and address of each offeror receiving an award;

(iv) The items, quantities, and any stated unit prices of each award. If the number of items or other factors makes listing any stated unit prices impracticable at that time, only the total contract price need be furnished in the notice. However, the

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Description Multi-Antigen Diagnostic Tests Page 6 of 6 items, quantities, and any stated unit prices of each award shall be made publicly available, upon request.

Q21. Vendor Question: We are writing to seek clarification on aspects of the recent Request for Proposal (RFP) issued by the Assistant Secretary for Preparedness and Response (ASPR). Our inquiry specifically pertains to the inclusion criteria and the types of testing methodologies considered under this RFP.

We have noted that the RFP appears to focus on antigen tests for Covid-19 and influenza.

Considering this, we would like to emphasize that the FDA recommends repeat testing following a negative COVID-19 antigen test result independent of COVID-19 symptoms. COVID-19 antigen tests are less accurate than molecular tests and may not detect the SARS-CoV-2 virus early in an infection or in people who do not have COVID-19 symptoms. In contrast, FDA and IDSA recommend the use of rapid nucleic acid amplification tests (NAAT) when available. We therefore strongly advocate for the consideration of rapid, at-home molecular tests.

Given these guidelines, we propose that ASPR consider including at-home molecular testing options as part of this RFP. Molecular tests provide higher accuracy and reliability, which are crucial for effective public health management and disease control.

We would appreciate your feedback on whether ASPR would be open to considering at-home molecular testing options.

GOVERNMENT RESPONSE: The governments requirement is for Antigen SARS-CoV- 2 and Influenza A/B. We may consider NAAT test in future acquisitions.