FOOD AND DRUG ADMINISTRATION USA Tender

This Is A Combined Synopsis/solicitation For Commercial Items Prepared In Accordance With The Format In Far Subpart 12.6, As Supplemented With Additional Information Included In This Notice. This Announcement Constitutes The Only Solicitation; Quotes Are Being Requested And A Written Solicitation Will Not Be Issued. The Government Reserves The Right To Award An Order Without Discussions If The Contracting Officer Determines That The Initial Offer Is Providing The Best Value And Discussions Are Not Necessary. solicitation Number 75f40125q00028 Is Issued As A Request For Quotation (rfq) Using Far Part 13 Procedures. the Solicitation Document And Incorporated Provisions And Clauses Are Those In Effect Through Federal Acquisition Circular 2025-02, Dated 01/03/2025. the Associated Naics Code Is 333914 And The Small Business Size Standard Is 1000 Employees. ******************************************************************** statement Of Work (sow): 1.0 Description Of Work 1.1 Background Information: the U.s. Food And Drug Administration’s Los Angeles District Office And Pacific Southwest Food And Feed Laboratory, Herein Referred To As Fda Irvine, Is An Fda Owned Facility Located In Irvine, Ca. Replacement Of End-of-life, Obsolete Vacuum Pump System. The Existing System Is Nearly 23 Years Old, Does Not Have Replacement Parts Available On The Market For Repair, And Represents A Single-point Failure Risk To The Facility's Vacuum System. Therefore, This Critical System Requires Replacement. 1.2 Purpose And Scope Of Work the Purpose Is To Provide A New Vacuum System Replacement And Installation At Fda Irvine. tasks: The Following Tasks Will Need To Be Provided But Are Not Limit To: Demo And Removal Of Existing Laboratory Vacuum System, Provide And Install Laboratory Vacuum System To Match Existing Technology. (current Model: Dekker Vmx0152ma2-00-ds, Minimum Salient Characteristics: Laboratory Vacuum System Model Aes-vmx0153ma2-45-ds. Piping Into And Out Are In Good Condition Without Any Visible Issues, Size Varies From 2” To 3”. Two Single Stage 10 Hp Liquid Ring Vacuum Pump Skids. Capacity Each Vacuum Pump (2 Pumps) 23.3 Scfm @ 25”hgvac. The Existing Voltage Going To The Vacuum Pump Is 460v, At A Minimum Upgrade The Disconnect Due To Its Age) coordinate And Schedule Delivery, Logistics, Preparation Of Site, And Installation Of Laboratory Vacuum System provide Energy, Water And Emissions (if Any) Cost Savings furnish And Install Bms Controls update Engineering And O&m Documentation startup And Testing 1.3 Period Of Performance: Tbd provide A Schedule With Timelines To Include Ordering Of All Parts, Shipping Timeframe, Preparation Of Site, And Install, And Inspection. the Work Shall Proceed Promptly Upon Execution Of The Resultant Contract And Only After The Issuance Of The Notice To Proceed (ntp) By The Government For The Activities Indicated. the Actual Performance Of The Work And Delivery Of The Required Documents Shall Be In Accordance With The Approved Project Schedule And Shall Be Completed Within 222 Calendar Days Of The Ntp Unless Otherwise Agreed Upon By The Project Officer (po) And Contracting Officer (co). 1.4 Place Of Performance u.s Food And Drug Administration Los Angeles District Office, Pacific Southwest Food And Feed Laboratory., Address: 19701 Fairchild Basement Level, Room B301, Irvine, Ca 92612. 2.0 Specific Requirements: the Contractor Shall Perform All Services Described In This Scope Of Services In Accordance With Applicable Requirements And Provisions Set Forth In This Statement Of Work. The Contractor Will Be Responsible For Relocating Any Electrical, Mechanical, Or Structural Building System Components Necessary To Perform This Work. If So, This Will Be Noted In This Scope Of Work And Such Work May Only Be Performed After Approval From Fda. The Contractor Shall Provide All Necessary Supervision, Labor, Material, Insurance, Training, And Equipment To: contractor Shall Provide Any Necessary Survey, Study, Or Technical Expert Services To Understand The Existing Conditions Of The Vacuum System At Fda Irvine. Contractor Shall Provide New Equipment With Matching Capacity, Or Better. The Necessary Constraints Shall Include, But Not Limited To, Vacuum Pump Hp And Tank Capacity. Contractor Shall Provide Equipment Cutsheet Submittals To Fda For Review And Approval Before Procurement Of Material. Contractor Shall Ensure N+1 Redundancy Integrated Into New System For Resilient Facility Operation. contractor Shall Assess And Provide Repairs Or Additions To Any Housekeeping Pad Intended To Support New Equipment, As Needed. Contractor Shall Provide New Control Panel, Field Located In An Accessible Area Near The Vacuum System. Control Panel Shall Be Integrated With Existing Building Automation System (bas) And Include Alarms Both To Bas And Readout Local To The Panel. Contractor Shall Utilize Power Feed To Existing Vacuum System. Contractor Shall Provide Independent Isolations Valves And Disconnect Means To Permit Service Of Each Vacuum Pump While Maintaining The System’s Operation. Contractor Shall Keep Equipment Shutdowns To A Minimum And Schedule/coordinate All Shutdowns With Fda While Providing Adequate Notice. Contractor Shall Provide Temporary Utilities For Any Shutdown Lasting Longer Than Three (3) Calendar Days. Weekend Shutdowns Are Preferred. Contractor Shall Provide All Inspection And Testing, Except Where Required By Code, Specification, Or Detailed Elsewhere In The Requirements Of This Document. familiarization Training On New System. 3.0 General Requirements: the Contractor Shall: adhere To Project Management Responsibilities As Defined Herein. appoint A Project Manager Who Shall Be The Government’s Primary Point Of Contact And Provide All Necessary Project Representation For The Successful Accomplishment Of The Said Work. the Project Manager Shall Be Thoroughly Familiar With All Requirements And Schedules. The Project Manager Shall Be Identified In The Firm’s Proposal Prior To Contract Award. coordinate All Project Related Activities Including Documentation Through The Project Officer (po) For Approval Unless Otherwise Denoted. bring Any Questions And/or Industry Specification Additions To The Attention Of The Po For Direction. perform All Work In A Skillful And Workmanlike Manner As Deemed Applicable To This Project. provide Appropriate Communication And Coordination Efforts With The Facility Department And The Po To Avoid Disruption Of Facility Operations While Performing Contract Work Such As Meetings, Proposed Phasing Plans, Outage Notifications, Etc. (where Applicable). obtain Necessary Badges Per Fda Policies And Guidelines (if Applicable). Fda Binding Process Is To Be Anticipated Of 1 Month. All Badging Must Be Completed Prior To Start Of On-site Construction. (for This Requirement The Contractor Shall Be Escorted) provide (to The Po) A List Of Possible Employees And Sub-contractors Who May Require Access To The Fda Premises Per The Project Being Administered. provide Utility Outage Notifications Per Facility Department Requirements (if Applicable). perform All Necessary Measurements And Sizing Associated With The Work Assigned. confirm Existing Conditions Of Work Assigned. perform All Associated Project Work In Accordance With Fda; Executive Orders, Energy Policy Act (epact), Energy Independence And Security Act (eisa), Sustainable Design And Federal Regulations; Local City, County, And State Building Codes And Regulations; National Electrical Code (nec), American Society Of Mechanical Engineers (asme), National Fire Protection Association (nfpa), Occupational Safety And Health Administration (osha), Underwriters Laboratories (ul), American National Standards Institute (ansi), And Institute Of Electrical And Electronics Engineers (ieee) Rules And Regulations And Standards; And All Other Applicable Industry Standards. restore All Affected Areas Back To Pre-project Conditions Or Better By The Completion Of The Specified Project Including Necessary Patching, Repairing And/or Replacing. provide All Necessary Drawings, Documentation, And Literature For All Recommended Items Where Applicable. provide All Labor And Equipment Necessary To Accomplish The Above Specified Tasks. assume All Risk And Shall Be Liable For Any Damages To Persons Or Property Caused By The Contractor. be Solely Responsible For The Quality Of His/her Work. Deficiencies And Omissions Shall Be Corrected Prior To Government Acceptance Of Work. be Responsible For Removing Construction And Demolition Debris Daily From Site. The Contractor Shall Provide The Dumpster For The Debris. 5.0 Government Furnished Material And Resources: 5.1 The Government Shall Provide, But Are Not Limited To, The Following Items: site Utility Drawings (upon Request-pdf) point(s) Of Contact At The Fda Site (kickoff Meeting) photographs Of Work-site Conditions And Others As Needed irvine Lab Specification Report Volume 2 (section 15486) (upon Request-pdf) 6.0 Submittals: 6.1 General: Under The Resultant Contract, Unless Otherwise Denoted, The Contractor Shall Provide All Services Necessary To Perform The Following Activities As Related To Completing The Fda Irvine Vacuum Replacement Mentioned Above: project Kick-off Meeting project Schedule (with Earned Value And Loaded Dollar Values) plan Of Action (plan Shall Include Names Of Team Members And Pm – And Phone/email) point-of-contact, Project Manager, Safety And Hazardous Material Plan progress Meetings, Meeting Minutes For Review And Approval By Po (within Five Business Days), 6.2 Deliverables: The Contractor Shall Provide All Deliverables In Accordance With The Project Schedule And Fda Policy Guidelines, And Compliant With Section 508 Requirements. 6.2.1 Physical Deliverables (format): The Documentation Process Shall Be Compiled And Provided Per The Following Submission Requirements Unless Otherwise Denoted: two (2) Copies Of The Operations And Maintenance (o&m) Manuals Shall Be Provided Physically In Binders And Electronically Per Compact Disc And Digital Versatile Disc (cd/dvds) (if Applicable). non-stick, Locking Slant D-style, Three Ring View Binders, 8 1/2x 11 Inches. title, Fda Logo, Contract And Project Number, Submission % (if Applicable), Etc. Shall Be Located On The Front Cover And Spine Of Binder(s). cd/dvds Shall Contain Electronic Copies Of Any Reports, Calculations, Modeling(s), Drawings, Videos, Photos And O&m Manuals Per Final Submission. Cd/dvds Shall Have Printed Labels. cd/dvds Shall Be Placed In Cd/dvd Page Holders With Slaps (like Avery 75263 Or Avery 73721) When Associated With A Binder. Avery 75263 For Multiple Discs And Avery 73721 For A Single Disc. three (3) Signed Copies Of All Warranties Shall Be Provided In Binders And Electronically Per Cd/dvds. Warranty Start Date Shall Begin No Earlier Than The Date Of Installation Acceptance. one (1) Equipment Submission. four (4) Physical Copies Of As-built Marked-up Drawings, Documentation, Etc. For Review And Discussion. Also, Provide Electronic Copies Of The Drawings, Etc. All Electronic Drawings Shall Be Provided In Portable Document Format (pdf) And Computer-aided Design (cad). Deliverables Are To Be Submitted To The Cor And/or Po, Unless Otherwise Stated. four (4) Copies Of Final Drawings Shall Be Provided In Pdf And Cad. *************************************************************************** government Holidays a. The Government Hereby Provides Notification That Government Personnel Observe The Listed Days As Holidays: (1) New Year's Day (7) Labor Day (2) Martin Luther King's Birthday (8) Columbus Day (3) President’s Day (9) Veterans' Day (4) Memorial Day (5) Juneteenth Day (10) Thanksgiving Day (6) Independence Day (11) Christmas Day b. In Addition To The Days Designated As Holidays, The Government Observes The Following Days: (1) Any Other Day Designated By Federal Statute (2) Any Other Day Designated By Executive Order (3) Any Other Day Designated By The President’s Proclamation c. When Any Such Day Falls On A Saturday, The Following Monday Is Observed. Except For Designated Around-the-clock Or Emergency Operations, Contractor Personnel Will Not Be Able To Perform On-site Under This Contract With Fda On Holidays Set Forth Above. The Contractor Will Not Charge Any Holiday As Direct Charge To The Award. d. It Is Understood And Agreed Between The Government And The Contractor That Observance Of Such Days By Government Personnel Shall Not Otherwise Be A Reason For An Additional Period Of Performance, Or Entitlement Of Compensation Except As Set Forth Within The Award. e. Nothing In This Abrogates The Rights And Responsibilities Of The Parties Relating To Stop Work. applicable Provisions And Clauses: far 52.252‐2 Solicitation Provisions Incorporated By Reference (feb 1998) this Contract Incorporates One Or More Clauses By Reference, With The Same Force And Effect As If They Were Given In Full Text. Upon Request, The Contracting Officer Will Make Their Full Text Available. Also, The Full Text Of A Clause May Be Accessed Electronically At This/these Address(es): Https://www.acquisition.gov/far And .https://www.acquisition.gov/hhsar far Provisions: far 52.212-1, Instructions To Offerors—commercial Products And Commercial Services (sept 2023) far 52.212-2, Evaluation—commercial Products And Commercial Services (fill In Evaluation Criteria) (nov 2021) far 52.212-3, Offeror Representations And Certifications—commercial Products And Commercial Services(may 2024) hhsar Provisions: hhsar 352.239-73, Electronic And Information Technology Accessibility Notice.(dec 2015) far Clauses: by Reference far 52.212-4, Contract Terms And Conditions—commercial Products And Commercial Services (nov 2023) by Full Text far 52.212-5contract Terms And Conditions Required To Implement Statutes Or Executive Orders—commercial Products And Commercial Services.(jan 2025) (a)the Contractorshallcomply With The Following Federalacquisitionregulation (far) Clauses, Which Are Incorporated In This Contract By Reference, To Implement Provisions Of Law Or Executive Orders Applicable Toacquisitionsofcommercial Productsandcommercial Services: (1)52.203-19, Prohibition On Requiring Certain Internal Confidentiality Agreements Or Statements(jan 2017)(section 743 Of Division E, Title Vii, Of The Consolidated And Further Continuing Appropriations Act, 2015 (pub. L. 113-235) And Its Successor Provisions In Subsequent Appropriations Acts (and As Extended In Continuing Resolutions)). (2)52.204-23, Prohibition Oncontractingfor Hardware, Software, And Services Developed Or Provided By Kaspersky Lab Covered Entities(dec 2023)(section 1634 Of Pub. L. 115-91). (3)52.204-25, Prohibition Oncontractingfor Certain Telecommunications And Video Surveillance Services Or Equipment.(nov 2021)(section 889(a)(1)(a) Of Pub. L. 115-232). (4)52.209-10, Prohibition Oncontractingwith Inverted Domestic Corporations(nov 2015). (5)52.232-40, Providing Accelerated Payments Tosmall Business Subcontractors(mar 2023)(31 U.s.c. 3903and10 U.s.c. 3801). (6)52.233-3, Protest After Award(aug 1996)(31u.s.c.3553). (7)52.233-4, Applicable Law For Breach Of Contractclaim(oct 2004)(public Laws 108-77 And 108-78 ( 19u.s.c.3805note)). (b)the Contractorshallcomply With The Far Clauses In This Paragraph (b) That Thecontracting Officerhas Indicated As Being Incorporated In This Contract By Reference To Implement Provisions Of Law Or Executive Orders Applicable Toacquisitionsofcommercial Productsandcommercial Services: _x_(1)52.203-6, Restrictions On Subcontractor Sales To The Government(jun 2020),withalternatei(nov 2021)(41u.s.c.4704 And10 U.s.c. 4655). _x_(2)52.203-13, Contractor Code Of Business Ethics And Conduct(nov 2021)(41u.s.c.3509)). __(3)52.203-15, Whistleblower Protections Under The American Recovery And Reinvestment Act Of 2009(jun 2010)(section 1553 Of Pub. L. 111-5). (applies To Contracts Funded By The American Recovery And Reinvestment Act Of 2009.) _x_(4)52.203-17, Contractor Employee Whistleblower Rights(nov 2023)(41 U.s.c. 4712); This Clause Does Not Apply To Contracts Of Dod, Nasa, The Coast Guard, Or Applicable Elements Of The Intelligence Community—see Far3.900(a). _x_(5)52.204-10, Reporting Executive Compensation And First-tier Subcontract Awards(jun 2020)(pub. L. 109-282) (31u.s.c.6101note). __(6)[reserved]. _x_(7)52.204-14, Service Contract Reporting Requirements(oct 2016)(pub. L. 111-117, Section 743 Of Div. C). __(8)52.204-15, Service Contract Reporting Requirements For Indefinite-delivery Contracts(oct 2016)(pub. L. 111-117, Section 743 Of Div. C). _x_(9)52.204-27, Prohibition On A Bytedance Covered Application(jun 2023)(section 102 Of Division R Of Pub. L. 117-328). __(10)52.204-28, Federalacquisitionsupply Chain Security Act Orders—federal Supply Schedules, Governmentwideacquisitioncontracts, And Multi-agency Contracts.(dec 2023)(pub. L. 115–390, Title Ii). __(11)(i)52.204-30, Federalacquisitionsupply Chain Security Act Orders—prohibition.(dec 2023)(pub. L. 115–390, Title Ii). __(ii)alternatei(dec 2023)of52.204-30. _x_(12)52.209-6, Protecting The Government’s Interest When Subcontracting With Contractors Debarred, Suspended, Or Proposed Fordebarment.(nov 2021)(31u.s.c.6101note). __(13)52.209-9, Updates Of Publicly Available Information Regarding Responsibility Matters(oct 2018)(41u.s.c.2313). __(14)[reserved]. __(15)52.219-3, Notice Ofhubzoneset-aside Or Sole-source Award (oct 2022) (15u.s.c.657a). __(16)52.219-4, Notice Of Price Evaluation Preference Forhubzonesmall Business Concerns (oct 2022) (if Theofferorelects To Waive The Preference, Itshallso Indicate In Itsoffer) (15u.s.c.657a). __(17)[reserved] _x_(18)(i)52.219-6, Notice Of Total Small Business Set-aside(nov 2020)(15u.s.c.644). __(ii)alternatei(mar 2020)of52.219-6. __(19)(i)52.219-7, Notice Of Partial Small Business Set-aside(nov 2020)(15u.s.c.644). __(ii)alternatei(mar 2020)of52.219-7. _x_(20)52.219-8, Utilization Of Small Business Concerns (feb 2024) (15u.s.c.637(d)(2) And (3)). __(21)(i)52.219-9, Small Business Subcontracting Plan (sep 2023) (15u.s.c.637(d)(4)). __(ii)alternatei(nov 2016)of52.219-9. __(iii)alternateii(nov 2016)of52.219-9. __(iv)alternateiii(jun 2020)of52.219-9. __(v)alternateiv (sep 2023) Of52.219-9. __(22)(i)52.219-13, Notice Of Set-aside Of Orders(mar 2020)(15u.s.c.644(r)). __(ii)alternatei(mar 2020)of52.219-13. _x_(23)52.219-14, Limitations On Subcontracting (oct 2022) (15u.s.c.657s). __(24)52.219-16, Liquidated Damages—subcontracting Plan(sep 2021)(15u.s.c.637(d)(4)(f)(i)). __(25)52.219-27, Notice Of Set-aside For, Or Sole-source Award To, Service-disabled Veteran-owned Small Business (sdvosb) Concerns Eligible Under The Sdvosb Program (feb 2024) (15u.s.c.657f). _x_(26)(i)52.219-28, Post Award Small Business Program Rerepresentation (feb 2024) (15u.s.c.632(a)(2)). __(ii)alternatei(mar 2020)of52.219-28. __(27)52.219-29, Notice Of Set-aside For, Or Sole-source Award To, Economically Disadvantagedwomen-owned Small Business Concerns(oct 2022) (15u.s.c.637(m)). __(28)52.219-30, Notice Of Set-aside For, Or Sole-source Award To, Women-owned Small Business Concerns Eligible Under The Women-owned Small Business Program (oct 2022) (15u.s.c.637(m)). __(29)52.219-32, Orders Issued Directly Under Small Business Reserves(mar 20x20)(15u.s.c.644(r)). _x_(30)52.219-33, Nonmanufacturer Rule(sep 2021)(15 U.s.c. 637(a)(17)). _x_(31)52.222-3, Convict Labor(jun 2003)(e.o.11755). __(32)52.222-19, Child Labor-cooperation With Authorities And Remedies(feb 2024). _x_(33)52.222-21, Prohibition Of Segregated Facilities(apr 2015). _x_(34)(i)52.222-26, Equal Opportunity(sep 2016)(e.o.11246). __(ii)alternatei(feb 1999)of52.222-26. _x_(35)(i)52.222-35, Equal Opportunity For Veterans(jun 2020)(38u.s.c.4212). __(ii)alternatei(jul 2014)of52.222-35. _x_(36)(i)52.222-36, Equal Opportunity For Workers With Disabilities(jun 2020)(29u.s.c.793). __(ii)alternatei(jul 2014)of52.222-36. _x_(37)52.222-37, Employment Reports On Veterans (jun 2020) (38u.s.c.4212). _x_(38)52.222-40, Notification Of Employee Rights Under The National Labor Relations Act(dec 2010)(e.o. 13496). _x_(39)(i)52.222-50, Combating Trafficking In Persons(nov 2021)(22u.s.c.chapter78 And E.o. 13627). __(ii)alternatei(mar 2015)of52.222-50(22u.s.c.chapter78 And E.o. 13627). __(40)52.222-54, Employment Eligibility Verification(may2022)(executive Order 12989). (not Applicable To Theacquisitionof Commercially Available Off-the-shelf Items Or Certain Other Types Ofcommercial Productsorcommercial Servicesas Prescribed In Far22.1803.) __(41)(i)52.223-9, Estimate Of Percentage Ofrecovered Materialcontent For Epa–designated Items (may2008) ( 42u.s.c.6962(c)(3)(a)(ii)). (not Applicable To Theacquisitionof Commercially Available Off-the-shelf Items.) __(ii)alternatei(may2008)of52.223-9(42u.s.c.6962(i)(2)(c)). (not Applicable To Theacquisitionof Commercially Available Off-the-shelf Items.) __(42)52.223-11, Ozone-depleting Substances And High Global Warming Potential Hydrofluorocarbons(may2024)(42 U.s.c. 7671,et Seq.). __(43)52.223-12, Maintenance, Service, Repair, Or Disposal Of Refrigeration Equipment And Air Conditioners(may2024)(42 U.s.c. 7671,et Seq.). _x_(44)52.223-20, Aerosols(may2024)(42 U.s.c. 7671,et Seq.). _x_(45)52.223-21, Foams(may2024)(42 U.s.c. 7671,et Seq.). _x_(46)52.223-23,sustainable Products And Services(may2024)(e.o. 14057,7 U.s.c. 8102,42 U.s.c. 6962,42 U.s.c. 8259b, And42 U.s.c. 7671l). __(47)(i)52.224-3privacy Training(jan 2017)(5 U.s.c. 552a). __(ii)alternatei(jan 2017)of52.224-3. _x_(48)(i)52.225-1, Buy American-supplies(oct 2022)(41u.s.c.chapter83). __(ii)alternatei(oct 2022)of52.225-1. __(49)(i)52.225-3, Buy American-free Trade Agreements-israeli Trade Act(nov 2023)(19 U.s.c. 3301 Note,19 U.s.c. 2112 Note,19 U.s.c. 3805 Note,19 U.s.c. 4001 Note,19 U.s.c. Chapter 29(sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, And 112-43. __(ii)alternatei [reserved]. __(iii)alternateii(jan 2025)of52.225-3. __(iv)alternateiii(feb 2024)of52.225-3. __(v)alternateiv (oct 2022) Of52.225-3. __(50)52.225-5, Trade Agreements(nov 2023)(19u.s.c.2501,et Seq.,19u.s.c.3301note). x__(51)52.225-13, Restrictions On Certain Foreign Purchases(feb 2021)(e.o.’s, Proclamations, And Statutes Administered By The Office Of Foreign Assets Control Of The Department Of The Treasury). __(52)52.225-26, Contractors Performing Private Security Functions Outside Theunited States(oct 2016) (section 862, As Amended, Of Thenational Defenseauthorization Act For Fiscal Year 2008; 10 U.s.c. Subtitle A, Part V, Subpart G Note). __(53)52.226-4, Notice Of Disaster Oremergencyarea Set-aside (nov 2007) (42u.s.c.5150). __(54)52.226-5, Restrictions On Subcontracting Outside Disaster Oremergencyarea(nov 2007)(42u.s.c.5150). _x_(55)52.226-8, Encouraging Contractor Policies To Ban Text Messaging While Driving(may2024)(e.o. 13513). __(56)52.229-12, Tax On Certain Foreignprocurements(feb 2021). __(57)52.232-29, Terms For Financing Of Purchases Ofcommercial Productsandcommercial Services(nov 2021)(41u.s.c.4505,10 U.s.c. 3805). __(58)52.232-30, Installment Payments Forcommercial Productsandcommercial Services(nov 2021)(41u.s.c.4505,10 U.s.c. 3805). _x_(59)52.232-33, Payment Byelectronic Funds Transfer-system For Award Management(oct2018)(31u.s.c.3332). __(60)52.232-34, Payment Byelectronic Funds Transfer-other Thansystem For Award Management(jul 2013) (31u.s.c.3332). __(61)52.232-36, Payment By Third Party(may2014)(31u.s.c.3332). __(62)52.239-1, Privacy Or Security Safeguards(aug 1996)(5u.s.c.552a). __(63)52.240-1, Prohibition On Unmanned Aircraft Systems Manufactured Or Assembled By American Security Drone Act-covered Foreign Entities(nov 2024)(sections 1821-1826, Pub. L. 118-31,41 U.s.c. 3901note Prec.). __(64)52.242-5, Payments Tosmall Business Subcontractors(jan 2017)(15u.s.c.637(d)(13)). __(65)(i)52.247-64, Preference For Privately Owned U.s.-flag Commercial Vessels(nov 2021)(46 U.s.c. 55305and 10u.s.c.2631). __(ii)alternatei(apr 2003)of52.247-64. __(iii)alternateii(nov 2021)of52.247-64. (c)the Contractorshallcomply With The Far Clauses In This Paragraph (c), Applicable Tocommercial Services, That Thecontracting Officerhas Indicated As Being Incorporated In This Contract By Reference To Implement Provisions Of Law Or Executive Orders Applicable Toacquisitionsofcommercial Productsandcommercial Services: _x_(1)52.222-41, Service Contract Labor Standards(aug 2018)(41u.s.c.chapter67). __(2)52.222-42, Statement Of Equivalent Rates For Federal Hires(may2014)(29u.s.c.206 And 41u.s.c.chapter67). __(3)52.222-43, Fair Labor Standards Act And Service Contract Labor Standards-price Adjustment (multiple Year Andoptioncontracts)(aug 2018)(29u.s.c.206 And 41u.s.c.chapter67). __(4)52.222-44, Fair Labor Standards Act And Service Contract Labor Standards-price Adjustment (may2014) (29u.s.c.206and 41u.s.c.chapter67). __(5)52.222-51, Exemption From Application Of The Service Contract Labor Standards To Contracts For Maintenance, Calibration, Or Repair Of Certain Equipment-requirements (may2014) (41u.s.c.chapter67). __(6)52.222-53, Exemption From Application Of The Service Contract Labor Standards To Contracts For Certain Services-requirements(may2014)(41u.s.c.chapter67). __(7)52.222-55, Minimum Wages For Contractor Workers Under Executive Order 14026(jan 2022). __(8)52.222-62, Paid Sick Leave Under Executive Order 13706(jan 2022)(e.o. 13706). __(9)52.226-6, Promoting Excess Food Donation To Nonprofit Organizations (jun 2020) (42u.s.c.1792). __(10)52.247-69, Reporting Requirement For U.s.-flag Air Carriers Regarding Training To Prevent Human Trafficking(jan 2025)(49 U.s.c. 40118(g)). (d)comptroller General Examination Of Record. The Contractorshallcomply With The Provisions Of This Paragraph (d) If This Contract Was Awarded Using Other Than Sealed Bid, Is In Excess Of Thesimplified Acquisition Threshold, As Defined In Far2.101, On The Date Of Award Of This Contract, And Does Not Contain The Clause At52.215-2, Audit And Records-negotiation. (1)the Comptroller General Of Theunited States, Or An Authorized Representative Of The Comptroller General,shallhave Access To And Right To Examine Any Of The Contractor’s Directly Pertinent Records Involving Transactions Related To This Contract. (2)the Contractorshallmake Available At Its Offices At All Reasonable Times The Records, Materials, And Other Evidence For Examination, Audit, Or Reproduction, Until 3 Years After Final Payment Under This Contract Or For Any Shorter Period Specified In Far Subpart4.7, Contractor Records Retention, Of The Other Clauses Of This Contract. If This Contract Is Completely Or Partially Terminated, The Records Relating To The Work Terminatedshallbe Made Available For 3 Years After Any Resulting Final Termination Settlement. Records Relating To Appeals Under The Disputes Clause Or To Litigation Or The Settlement Ofclaimsarising Under Or Relating To This Contractshallbe Made Available Until Such Appeals, Litigation, Orclaimsare Finally Resolved. (3)as Used In This Clause, Records Include Books, Documents, Accounting Procedures And Practices, And Other Data, Regardless Of Type And Regardless Of Form. This Does Not Require The Contractor To Create Or Maintain Any Record That The Contractor Does Not Maintain In The Ordinary Course Of Business Or Pursuant To A Provision Of Law. (e)(1)notwithstanding The Requirements Of The Clauses In Paragraphs (a), (b), (c), And (d) Of This Clause, The Contractor Is Not Required To Flow Down Any Far Clause, Other Than Those In This Paragraph (e)(1), In A Subcontract Forcommercial Productsor Commercial Services. Unless Otherwise Indicated Below, The Extent Of The Flow Downshallbe As Required By The Clause- (i)52.203-13, Contractor Code Of Business Ethics And Conduct(nov 2021)(41u.s.c.3509). (ii)52.203-17, Contractor Employee Whistleblower Rights(nov 2023)(41 U.s.c. 4712). (iii)52.203-19, Prohibition On Requiring Certain Internal Confidentiality Agreements Or Statements (jan 2017) (section 743 Of Division E, Title Vii, Of The Consolidated And Further Continuing Appropriations Act, 2015 (pub. L. 113-235) And Its Successor Provisions In Subsequent Appropriations Acts (and As Extended In Continuing Resolutions)). (iv)52.204-23, Prohibition Oncontractingfor Hardware, Software, And Services Developed Or Provided By Kaspersky Lab Covered Entities(dec 2023)(section 1634 Of Pub. L. 115-91). (v)52.204-25, Prohibition Oncontractingfor Certain Telecommunications And Video Surveillance Services Or Equipment.(nov 2021)(section 889(a)(1)(a) Of Pub. L. 115-232). (vi)52.204-27, Prohibition On A Bytedance Covered Application(jun 2023)(section 102 Of Division R Of Pub. L. 117-328). (vii)(a)52.204–30, Federalacquisitionsupply Chain Security Act Orders—prohibition.(dec 2023)(pub. L. 115–390, Title Ii). (b)alternatei(dec 2023)of 52.204–30. (viii)52.219-8, Utilization Of Small Business Concerns (feb 2024) (15u.s.c.637(d)(2)and (3)), In All Subcontracts Thatofferfurther Subcontracting Opportunities. If The Subcontract (except Subcontracts To Small Business Concerns) Exceeds The Applicable Threshold Specified In Far19.702(a) On The Date Of Subcontract Award, The Subcontractormustinclude52.219-8in Lower Tier Subcontracts Thatoffersubcontracting Opportunities. (ix)52.222-21, Prohibition Of Segregated Facilities(apr 2015). (x)52.222-26, Equal Opportunity(sep 2016)(e.o.11246). (xi)52.222-35, Equal Opportunity For Veterans(jun 2020)(38u.s.c.4212). (xii)52.222-36, Equal Opportunity For Workers With Disabilities(jun 2020)(29u.s.c.793). (xiii)52.222-37, Employment Reports On Veterans(jun 2020)(38u.s.c.4212). (xiv)52.222-40, Notification Of Employee Rights Under The National Labor Relations Act(dec 2010)(e.o. 13496). Flow Down Required In Accordance With Paragraph (f) Of Far Clause52.222-40. (xv)52.222-41, Service Contract Labor Standards(aug 2018)(41u.s.c.chapter67). (xvi)(a)52.222-50, Combating Trafficking In Persons(nov 2021)(22u.s.c.chapter78 And E.o 13627). (b)alternatei(mar 2015)of52.222-50(22u.s.c.chapter78ande.o.13627). (xvii)52.222-51, Exemption From Application Of The Service Contract Labor Standards To Contracts For Maintenance, Calibration, Or Repair Of Certain Equipment-requirements (may2014) (41u.s.c.chapter67). (xviii)52.222-53, Exemption From Application Of The Service Contract Labor Standards To Contracts For Certain Services-requirements(may2014)(41u.s.c.chapter67). (xix)52.222-54, Employment Eligibility Verification(may2022)(e.o. 12989). (xx)52.222-55, Minimum Wages For Contractor Workers Under Executive Order 14026(jan 2022). (xxi)52.222-62, Paid Sick Leave Under Executive Order 13706(jan 2022)(e.o. 13706). (xxii)(a)52.224-3, Privacy Training (jan 2017) (5u.s.c.552a). (b)alternatei(jan 2017)of52.224-3. (xxiii)52.225-26, Contractors Performing Private Security Functions Outside Theunited States(oct 2016)(section 862, As Amended, Of Thenational Defenseauthorization Act For Fiscal Year 2008; 10 U.s.c. Subtitle A, Part V, Subpart G Note). (xxiv)52.226-6, Promoting Excess Food Donation To Nonprofit Organizations(jun 2020)(42u.s.c.1792). Flow Down Required In Accordance With Paragraph (e) Of Far Clause52.226-6. (xxv)52.232-40, Providing Accelerated Payments Tosmall Business Subcontractors(mar 2023) (31 U.s.c. 3903and10 U.s.c. 3801). Flow Down Required In Accordance With Paragraph (c) Of52.232-40. (xxvi)52.240-1, Prohibition On Unmanned Aircraft Systems Manufactured Or Assembled By American Security Drone Act-covered Foreign Entities(nov 2024)(sections 1821-1826, Pub. L. 118-31,41 U.s.c. 3901note Prec.). (xxvii)52.247-64, Preference For Privately Owned U.s.-flag Commercial Vessels(nov 2021)(46 U.s.c. 55305and 10u.s.c.2631). Flow Down Required In Accordance With Paragraph (d) Of Far Clause52.247-64. (2)while Not Required, The Contractormayinclude In Its Subcontracts Forcommercial Productsandcommercial Servicesa Minimal Number Of Additional Clauses Necessary To Satisfy Its Contractual Obligations. (end Of Clause) hhsar Clauses: hhsar 352.203-70, Anti-lobbying (dec 2015) hhsar 352.222-70, Contractor Cooperation In Equal Employment Opportunity Investigations (dec 2015) hhsar 352.239-74, Electronic And Information Technology Accessibility additional Clauses: far 52.204-7, System For Award Management far 52.204-13, System For Award Management Maintenance far 52.204-24, Representation Regarding Certain Telecommunications And Video Surveillance Services Or Equipment instructions To Offerors: addendum To Far 52.212-1 Instructions To Offeror-commercial Items: proposal Submission Format: ***quotes Shall Be In 2 Volumes: 1 Technical And 2 Price. The Volumes Shall Be Separate And Complete. The Volumes Shall Be Separate And Complete, So That Evaluation Of One May Be Accomplished Independently Of, And Concurrently With, The Evaluation Of The Other. No Pricing Information Shall Be Provided In Volume 1.*** the Total Number Of Pages For The Technical Quote Shall Not Exceed Ten (10) Pages, Using 1” Margins, Single Spaced, Font Type Time New Roman, And A Font Size Of 12. ***the Solicitation Does Not Commit The Government To Pay Any Cost For The Preparation And Submission Of A Quote Or Proposal. It Is Also Advised That The Contracting Officer (co) Is The Only Individual Who Can Legally Commit And Obligate The Government To The Expenditure Of Public Funds In Connection With The Proposed Acquisition.*** the Contractor Shall Indicate At A Minimum Salient Characteristics Have Been Met To Be Considered Responsive For This Requirement. The Contractor Shall Demonstrate How The Requested Items Or Services, “meet” Or “do No Meet” The Salient/functional Characteristics And Specifications Listed Here-below. The Contractor Shall Annotate Each Salient/functional Characteristics And Specifications With The Following: Meets (if It Meets The Specification) Or Does Not Meet (if It Fails To Meet The Specification). 1.grey Market Or Refurbished Products Will Not Be Accepted. 2. The Vendor Shall Indicate If Non-domestic Items Are Included In The Quote. 3. The Vendor Shall Provide All, Of The Items/services Listed Or None. 4. The Vendor Shall Meet All Technical/salient/functional, Operational Characteristics And Specifications Listed, And If Not The Manufacturer, Shall Be Able To Provide The Required Service With Oem Certified Technicians And Parts Or Show Proof That They Are An Authorized Third Party Reseller/provider. 5. Be Advised That Fda Does Not Accept Documents Which Contain The Use Of Macros. When Submitting Documents Via Email, Do Not Include .exe, Mso, Or Any Other Executable File Types That Could Potentially Trigger Email Security Protections (i.e. Email Blocks, Quarantine). Document Submissions Required Throughout The Award Period(s) Shall Not Have Macro Enabled Functionality And Any Document Delivered Having That Functionality Will Be Deemed Delinquent, If Not Corrected Prior To The Due Date. addendum Paragraph (b): the Quoter Shall Submit A Written Accessibility Conformance Report (acr) For Each Item Not In Compliance With 508 Standards Identified In Clause 352.239-74, Describing How The Item(s) Will Fully Address The Accessibility Requirements Outlined In The Solicitation; And A Description Of The Evaluation Methods The Offeror Will Use To Validate For Conformance To The Revised 508 Standards. The Acr Should Be Based On The Voluntary Product Accessibility Template Version 2.0 (ms Word) Provided By The Industry Technology Industry Council (itic). the Offeror Or Applicant Shall Submit All Electronic Documents For Microsoft Office Suite Products Without The Use Of “macros”. When Submitting Proposals Via Email, Do Not Include .exe, .mso, Or Any Other Executable File Types That Could Potentially Trigger Email Security Protections (i.e. Email Blocks, Quarantine). If The Offeror Or Applicant Submits Documents That Contain Macros, Macro Referenced Files, And/or Executable Files, The Government Will Not Be Able To View Or Open Such Documents And The Submission Will Be Considered Non-responsive To The Solicitation. No Additional Time Will Be Given To An Offeror Or Applicant To Correct The Document Submission And The Government Will Not Inform The Offeror Or Applicant That Their Submission Is Non-responsive Prior To Award. It Is The Offeror’s Or Applicant’s Responsibility To Ensure All Electronic Documents Are Submitted Without The Use Of Macros. technical Acceptability: Will Be Determined By Review Of Information Submitted By The Offeror Which Must Provide Sufficient Technical Information Necessary For The Government To Determine That The Offered Items, Components, And Services Meet Or Exceed The Technical Requirements Identified Above. Offerors Shall Specifically Address The Performance Specifications And Support Same With Submitted Technical Specifications, Descriptive Material, Literature, Brochures, Scientific Publications Where Proposed Solution Has Been Used For Same Or Similar Purposes, And Other Information Which Demonstrates The Capability Of The Offered Solution At Meeting Or Exceeding The Stated Needs Of The Fda. the Contractor Shall Provide Place Of Product Manufacture Or Service Performance And Any Other Applicable Information To Enable Review And Analysis Pertaining To The Buy American Statute And Requirements Relating To Made In America In The Event Of Nonavailability Waiver Request Through The Miao Digital Waiver Portal Is Needed. price: Provide Detailed Price Quote For Each Item/component Proposed To Meet The Schedule Of Items. Include The Firm’s Unique Entity Id (sam) Number With Quote. the Government Is Not Responsible For Locating Or Securing Any Information Which Is Not Identified In The Proposal However The Government Reserves The Right To Obtain Information For Use In The Evaluation From Any And All Sources Including Sources Outside Of The Government. quotes Must Include: Pricing For Each Line Item, Delivery Schedule, Technical Specifications Of The Offered Product. ************************************************************************************* mandatory Site Visit: Offerors Are Required To Attend At No Cost To The Government. a Mandatory Site Visit Is To Inspect The Current Site Where The Vacuum Pump And Preexisting Conditions Are Located. The Site Visit Is Located At: u.s Food And Drug Administration Los Angeles District Office pacific Southwest Food And Feed Laboratory 19701 Fairchild Road irvine, Ca 92612 date: January 29, 2025, start Time: 9:15 Am Pacific Time offeror Must Electronically Provide No Later Than Friday, January 23, 2025, At 10:00am Eastern Time (et), The Company Name And Attendees Names To The Contracting Officer. Each Attendee Must Possess And Present A Valid Government Issued Identification To Enter The Site. Allow 2 Hours For The Site Visit. Failure To Attend The Site Visit Will Result In The Offeror Considered Nonresponsive To The Combined Synopsis Solicitation. during The Site Visit, Offerors Shall Have An Opportunity To Inspect The Site And Ask Questions. All Questions And Answers Will Be Documented And Provided To All Offerors As An Amendment To The Combined Synopsis Solicitation. The Government Will Maintain A Record Of All Attendees, Including Names, And Affiliations. please See The Attached Combined Synopsis Solicitation Document In Full Text.