RFQ_75F40122Q00054.pdf

Solicitation No. 75F40122Q00054 Date: September 16, 2022

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13.5 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40122Q00054 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516, Analytical Laboratory Instrument Manufacturing. The Small Business Size Standard is 1,000 employees. The requirement will be awarded as Firm-Fixed Price and 100% small business set-aside. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value Lowest Price Technically Acceptable (LPTA) to the Government and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA), has a need to procure one (1 each) High- Resolution Mass Spectrometer Coupled with a Liquid Chromatography System (LC-HRMS)

*************************BRAND NAME OR EQUAL **************************

Background and Overview

The Center for Drug Evaluation and Research (CDER) requests an LC-HRMS system in order to support its research and testing projects related to small molecule pharmaceutical impurities, including but not limited to nitrosamine carcinogenic impurity analysis, and characterization of extractables and leachables. Nitrosamines are a group of small organic molecules containing one or more N-nitroso groups in their structures. Most of nitrosamines are probable carcinogens that can cause cancers in human subjects even at very low concentrations. Since 2018, some nitrosamines have been found in pharmaceutical products resulting in extensive recalls of some critical medications. CDER has been developing LC-HRMS-based analytical methods to identify, characterize and quantitate nitrosamines in pharmaceutical products. Although a couple of LC- HRMS systems are currently being used for this project, considering the increased number of samples to be analyzed as well as the expanding varieties of nitrosamines identified, an additional LC-HRMS system would provide improved added capabilities to continue the current analytical approach for identification and quantitation of nitrosamine impurities. Similarly, research projects studying extractable and leachable impurities also demand the support of LC-HRMS. Leachables are small molecule impurities that migrate from container closure systems of a pharmaceutical product into the product itself thereby potentially causing serious safety issues. The study of extractables and leachables relies heavily on suitable LC-HRMS systems to identify, characterize and quantitate contaminant chemicals that are leached (leachables) or can possibly be leached (extractables) into drug products. To meet these needs, CDER requests an LC-HRMS system capable of high throughput analyses of small molecule impurities, reliably identifying and characterizing their chemical structures, and accurately quantitating their amounts.

Statement of Work

The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

1) The LC-HRMS system shall consist of a high-resolution mass spectrometer (HRMS) coupled to a liquid chromatography system (LC), a workstation with appropriate software for control of the instruments, data acquisition and basic data processing.

2) The LC system shall consist of the following modules meeting necessary specifications and requirements:

a. An autosampler that can control the sample temperature with a minimum range of 4 – 37 °C.

b. One or multiple binary or quaternary pumps that can deliver a minimum flow rate range of 0.001 – 2 mL/min with a minimum high pressure limit of 1500 bar.

c. A column compartment with minimum temperature control range of 10 – 80 °C.

d. A diode array detector with a minimum wavelength range of 190 – 600 nm, and minimum upper limit of acquisition rate of 200 Hz.

e. A mechanism for high throughput sample analysis. For example, the use of tandem column switching (two identical columns alternating with sample analysis and reconditioning)

3) The mass spectrometer shall meet the following performance characteristics:

a. Have a minimum upper resolving power of 500,000 FWHM at m/z 200 for isotopic fine structure.

b. Provide high mass accuracy defined as ≤ 3 ppm with external mass calibration and

≤ 1 ppm with internal mass calibration.

c. Be capable of performing multistage fragmentation (MSn) (n > 3) of a selected ion and providing high mass accuracy MSn data to allow for the elucidation of chemical structures with high confidence.

d. Provide multiple fragmentation techniques available at any stage of MSn that will allow a selected ion to be fragmented through different mechanisms at various stage to maximize structural information possibly obtained for identification.

e. Be able to perform the methods developed on the existing Q-Exactive systems at CDER/OPQ/OTR (Orbitrap HRMS manufactured by Thermo Electron) with minimum adjustment of the parameters for ionization and detection.

f. Have automated calibration to simplify the process and reduce the burden and time spent on instrument maintenance.

g. Have features utilizing current technologies to enable more reliable data acquisition and interpretation, such as, but not limited to real-time spectral library searches.

h. Be benchtop compatible to accommodate space restrictions

4) Compatible software, spectral database and tools shall be available to enable advanced data analysis and interpretation.

Training The Vendor shall provide on-site training for a minimum of two business days for a minimum of three (3) employees to go over software / hardware familiarization. Training shall be completed within 30 days after installation.

Warranty Shall include a minimum of one (1) year comprehensive parts and labor warranty from the date of installation and acceptance.

Four (4) One Year Option Periods Maintenance Agreement

a) Service contract coverage shall include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

b) Access to the manufacturer’s call center during regular business hours (8 am to 5 pm Eastern Daylight Time (EDT)) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument. Access to the manufacturer’s support center via e-mail.

c) The Vendor shall be able to guarantee that a service engineer will be able to work on-site within 48 hours by Original Equipment Manufacturer (OEM) certified technicians and using OEM replacement parts.

d) The Vendor shall provide annual in-house training and preventative maintenance inspection during the 12-month period with all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the manufacturer.

e) The Vendor shall provide all major and minor software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Period of Performance.

f) The Vendor shall respond to requests for emergency on-site service and/or non-emergency requests (Monday-Friday, excluding Federal holidays) within 3 business days and engineer onsite within 5 business days (120 hours).

g) Upon the on-site visit, the Contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the Contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs (these services will not be a part of the current award). Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed 5 business days (120 hours).

h) For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the Vendor (with proper Government approvals) with a Government Purchase Card.

i) For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a separate Purchase Order for the repairs.

j) Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the Vendor unless the Contracting Officer (CO) has given the Vendor proper authorization.

k) One-year warranty on all parts and labor, including shipping and travel. Parts shall be covered against manufacturing defects and failures occurring during normal usage of the system.

l) Service Records and Reports:

The Vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, on- site hours expended and parts/components replaced.

Delivery and Installation

FDA/CDER/OPQ/OTR

645 S Newstead Ave.

St. Louis, MO 63110

1) The Vendor shall provide 30-day notice prior to shipping. All reports for installation and qualification shall be provided (electronic format preferred). Acceptance shall be made by the Government within 30 days following completion of instrument installation and acceptance.

2) The Vendor shall deliver the instrument within 60 days after receipt of order (DARO).

Security Supervision of installation engineer upon arrival at DCDA (Division of Complex Drug Analysis) shall be required.

Acceptance Criteria FOB: Destination Inspection/Acceptance: Destination

Acceptance shall be made by the Government within 30 days following completion of instrument installation and acceptance.

Period of Performance 90 DARO plus 12-month warranty (Base Period) September 2022 – December 2023

Option Period 1: December 2023 – December 2024

Option Period 2: December 2024 – December 2025

Option Period 3: December 2025 – December 2026

Option Period 4: December 2026 – December 2027

Line Items and Prices

The Contractor shall provide the following deliverables:

NOTE: The Contractor shall complete the pricing table below.

Line Item

Description Qty. Unit Price

Total Price

1 LC-HRMS system in line with technical requirement 1 EA $ $

2 Two Day on-site Training for 3 employees $ $

3 Installation $ $

4 Shipping and Delivery $ $

5 Option Period 1 Preventative Maintenance - High Resolution Mass Spectrometer Coupled with Liquid Chromatography System

(LC-HRMS)

6 Option Period 2 Preventative Maintenance - High Resolution Mass Spectrometer Coupled with Liquid Chromatography System

(LC-HRMS)

7 Option Period 3 Preventative Maintenance - High Resolution Mass Spectrometer Coupled with Liquid Chromatography System

(LC-HRMS)

8 Option Period 4 Preventative Maintenance - High Resolution Mass Spectrometer Coupled with Liquid Chromatography System

(LC-HRMS)

TOTAL $

Provide a fixed price quote in accordance with the Statement of Work identified above.

IT Purchasing Requirements:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

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 (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 clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this award.

Evaluation of Award:

FAR 52.212-2 Evaluation-Commercial Items (Nov 2021)

Lowest Priced, Technically Acceptable (LPTA)

Instructions to Offeror for Proposal Submission FAR 52.212-1 Instructions to Offerors—Commercial Items (Nov 2021)

PROPOSAL SUBMISSION FORMAT:

***Proposal 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 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 offerors or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

***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.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Patricia.Natividad@fda.hhs.gov no later than September 19, 2022, 10:00 a.m. Eastern Daylight Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, no later than September 20, 2022, 4:00 p.m. Eastern Daylight Time, electronically to Patricia Natividad, email: Patricia.Natividad@fda.hhs.gov

NOTE: Quotes shall be valid through October 30, 2022.

General Information Contracting Point of Contact Patricia Natividad,Contract Specialist Email: Patricia.Natividad@fda.hhs.gov

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.

The Following Provisions and clauses apply:

FAR Clauses

FAR 52.211-6 Brand Name or Equal (Aug 1999)

FAR 52.212‐3, Offeror Representations and Certifications‐Commercial Items (May 2022) See Attachment A.

FAR 52.212‐4 Contract Terms and Conditions‐Commercial Items (Nov 2021)

FAR 52.212‐5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders‐ Commercial Items (May 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial 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 on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L.

115-91).

(3) 52.204-25, Prohibition on Contracting for 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 on Contracting with Inverted Domestic Corporations (Nov 2015). (5) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19

U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.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) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Sep 2021) ( 15 U.S.C.

657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Sep 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (13) [Reserved] _X_ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Nov 2021) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

_X_ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Sep 2021) ( 15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Sep 2021) ( 15 U.S.C. 657f).

_X_ (22) (i) 52.219-28, Post Award Small Business Program Representation (Sep 2021) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women- Owned Small Business Concerns (Sep 2021) ( 15 U.S.C. 637(m)).

__ (24) 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 (Sep 2021) ( 15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

_X_ (26) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

_X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C.

793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

_X_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (35) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

_X_ (36) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 ( 42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

_X_ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) ( 42 U.S.C.

8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

_X_ (48) 52.225-1, Buy American-Supplies (Nov 2021) ( 41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2021) ( 41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C.

4001 note, Pub. L. 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) Alternate I (Jan 2021) of 52.225-3.

__ (iii) Alternate II (Jan 2021) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (Oct 2019) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (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 the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C.

5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

_X_ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C.

637(d)(13)).

__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Nov 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) ( 29 U.S.C. 206 and 41 U.S.C.

chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

_X_ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) ( 41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) ( 41 U.S.C. chapter 67).

__ (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) ( 42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make 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 subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be 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 of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are 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 for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C.

3509).

(ii) 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)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L.

115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

(xi) 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 clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) ( 41 U.S.C.

chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) ( 41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) ( 42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

FAR 52.217-5 Evaluation of Options (Jul 1990)

FAR 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

FAR 52.217-9 -- Option to Extend the Term of the Contract. (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

FAR 52.225-2 Buy American Certificate (Feb 2021) (a)

(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

(3) The terms "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(b) Foreign End Products:

Line Item No. Country of Origin

(c) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021)

HHSAR and FDA Clauses

352.232-71 Electronic Submission of Payment Requests

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

***NOTE TO VENDOR***

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) the Unique Entity Identifier (UEI) 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.