Amendment A00003.pdf
PDF 66 KB Posted
- Solicitation number
- 36C26220Q1133
About this file
This document summarizes an amendment to a solicitation requesting offers for viral transport medium and nasopharyngeal swab kits. The amendment provides answers to vendor questions, clarifying that the solicitation is not subject to an FDA enforcement policy on viral transport media distribution during the COVID-19 pandemic. The amendment also lists additional Far clauses that apply, including those related to trade agreements and restrictions on business with certain foreign entities or activities in Iran. The related federal contract opportunity is for RFQ 36C26220Q1133 seeking viral transport medium and flocked nasopharyngeal swab kits to be awarded by the Department of Veterans Affairs Veterans Health Administration VISN 22.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C26220Q1133 A00004_1.pdf | ||
| 36C26220Q1133 A00004.docx | DOCX document | |
| 36C26220Q1133 A00003.docx | DOCX document | |
| 36C26220Q1133 A00002.docx | DOCX document | |
| Amendment A00002.pdf | ||
| 36C26220Q1133 A00001.docx | DOCX document | |
| Amendment A00001.pdf | ||
| 36C26220Q1133.docx | DOCX document | |
| Attachment A VTM _ Swab Kits.xlsx | XLSX spreadsheet | |
| RFQ 36C26220Q1133.pdf | ||
| Attachment B VTM _ Swab Kits.pdf |
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Text version
36C26210Q1133 Amendment A00003
Vendor Questions pertaining to Combined Synopsis/Solicitation 36C26220Q1133:
Questions 1: The FDA announced in July 2020 that only VTM manufactures that were issued with Emergency Use Authorized (EUA) is authorized to supply their VTM to state and government hospitals, clinical Laboratories and that the guidance document is being implemented immediately and applies to all VTM commercial manufactures. Please refer to the attached " Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID19) Public Health Emergency." Question: Does compliance of this FDA Enforcement Policy apply to this RFQ?
Answer 1: The provided document “COVID-19-Viral-Transport-Media-Guidance_0” provides Nonbinding recommendations for the sale of VTM by manufacturers. This document does not restrict VTM distribution to only EUA authorized VTM but instead states that EUA status is not required as per page 3 and 4. The FDA stated it intends to expand the availability of additional VTM supplies in the market, not restrict such supplies. However, VTM is still required to comply with registration and listing requirements but does not require EUA or Approved status at this time. Therefore, this policy is a Nonbinding recommendation and states “Contains Nonbinding Recommendations” at the top of every page and addressed on Page 2, the last paragraph of the introduction. This solicitation is not subject to the attached policy; however, the solicitation does meet the criteria of the policy which requires FDA registration of VTM.
The following additional FAR clauses shall apply to this solicitation:
52.225-5 Trade Agreement Oct 2019
52.225.6 Trade Agreements Certificate May 2014
52.225-13 Restrictions on Certain Foreign Purchases Jun 2008 52.225-20 Prohibition on Conducting Restricted Business
Operations in Sudan-Certification Aug 2009
52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran – Representation and Certifications
Jun 2020
The full text of a clause may be accessed electronically at the following:
http://www.acquisition.gov/comp/far/index.html.
(End of Amendment A00003) http://www.acquisition.gov/comp/far/index.html
File details come from the government source that posted it. Updated .