View Changes The Purpose Of This Amendment To Solicitation 36C25721q0436 Is To Include Extend The Closing Date To Wednesday March 3 2021 At 4 30 P M Cst Include The Place Of Performance Delivery Location Q Amp A All Other Terms And Conditions Remain The Same A Quotes Must Be Received No Later Than Wednesday March 3 2021 At 4 30 P M Cst Email Quotes To Rastreva Upshaw Va Gov And Danise Burt Va Gov The Subject Line Must Specify 36C25721q0436 Quote For Temperature Monitoring Kiosks There Will Be No Automated Email Notification Of Receipt Of Quotes All Quotes Received Without Requested Documentation Will Not Be Considered B Place Of Performance Delivery Location Department Of Veterans Affairs Amarillo Va Health Care System Thomas E Creek Va Medical Center 6010 Amarillo Boulevard West Amarillo Tx 79106 C Question And Answers Due To A Question Contracting Sought Additional Information From A Technical Standpoint Regarding The Salient Characteristics For The Temperature Monitoring Kiosks Specifically Does Cdc Guidelines Require Fda Certification For Covid 19 Kiosks For Monitoring Temperatures And Why A The Policy For Telethermographic Systems Intended For Adjunctive Diagnostic Screening Was Written In Response To The Shortage Of Thermometers In April 2020 At The Beginning Of The Public Health Emergency The Policy States It Will Only Be In Effect During The Public Health Emergency And Is Subject To Change This Policy Is Intended To Remain In Effect Only For The Duration Of The Public Health Emergency Related To Covid 19 Declared By Hhs Including Any Renewals Made By The Hhs Secretary In Accordance With Section 319 A 2 Of The Public Health Service Phs Act 42 U S C 247D A 2 Federal Food Drug And Cosmetic Act Fd Amp C Act 21 U S C 371 H 1 C And 21 Cfr 10 115 G 2 This Guidance Document Is Being Implemented Immediately But It Remains Subject To Comment In Accordance With The Agency S Good Guidance Practices This Policy Contains Nonbinding Recommendations Meaning This Is Not Legally Necessary To Follow Or Obey This Policy Does Not Bind Us To Follow Current Fda Regulations Now Or Any Other Time These Are Only Put Into Place Due To The Public Health Emergency B The Va Shall Utilize Temperature Monitoring Kiosks As Medical Devices With Intended Use In The Diagnosis Of Disease Or Other Conditions Or In The Cure Mitigation Treatment Or Prevention Of Disease C Please Refer To Cdc Resources To Obtain Guidance On Cdc Treatment Of Kiosks For Monitoring Temperatures 2 Can You Confirm That Offerors That Are Current In Sam Only Need To Include Paragraph B And Not Their Entire Reps And Certs Yes
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