Sol_SAM.gov Attachment_ORA-2024-120099.pdf

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 and (FAR) 13 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular

(FAC) 2023-06.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is ORA-2024-120099 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 337214, Office Furniture (except Wood) Manufacturing and the Small Business Size Standard is 1,100 employees. This requirement is being solicited as a total small business set-aside; only quotations submitted from small businesses will be considered for award. Prospective quoters are responsible for downloading the solicitation and any amendments from SAM.gov. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial quote is providing the Best Value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) has a requirement for the purchase and installation of lab-grade shelving within the FDA’s Winchester Engineering & Analytical Center (WEAC) laboratory facilities located in Winchester, Massachusetts.

****In order to be considered for award of this requirement, prospective quoters shall attend the scheduled site visit as outlined below****

1. SITE VISIT: A site visit is required for prospective quoters to take the necessary inventory, measurements, dimensions, and gain other pertinent information that will assist with the development of a proper quotation.

Vendors submitting a quotation without attending the site visit will not be considered for award (i.e., will be determined non-responsive). After the site visit, the FDA will accept written quotations with prices from prospective Contractors as to how the quote will meet the overall objectives of the project. Written quotations shall contain sufficient details, such as dimensions/placement, a thorough understanding of the design and installation approach, shelving and equipment to be utilized, and proposed work breakdown schedule to completion by the Contractor to meet FDA’s objectives.

a. Site visit date and time:

Thursday, November 16, 2023 at 10:00 AM Eastern Time (ET, Local)

b. Site visit location:

U.S. Food and Drug Administration 109 Holton St.

Winchester, MA 01890

c. RSVPs:

RSVPs for attending the site visit shall be submitted and confirmed with the Contracting Office Point of Contact (POC) below via email only and not later than Wednesday, November 15, 2023 @ 10 AM ET:

Name: Benjamin Dorgan Email: benjamin.dorgan@fda.hhs.gov

Clearly indicate in the email subject line “Site Visit Attendees for RFQ ORA-2024-120099: WEAC Storage Shelving”

d. The FDA designated POC will meet all site visit attendees. Proper identification is required for the site visit (e.g., Drivers License, State ID, etc.).

e. The site visit coordinator will escort attendees to allow for measurements and to allow for any pertinent questions related to site and location of the shelving only.

f. Prospective quoters shall plan to attend during the time period designated for the site visit. Appointments outside of the specified timeframe will not be permitted.

g. While this site visit is mandatory, please be advised that reimbursement for travel, per diem, and all other mailto:benjamin.dorgan@fda.hhs.gov costs associated with submitting a quotation and/or attending the site visit will not be considered.

2. QUESTION DEADLINE: Interested quoters shall submit all questions concerning the solicitation and site visit at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Contract Specialist Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: Monday, November 20, 2023 at 5:00 PM Eastern Time (ET) may not be considered.

3. QUOTATION DEADLINE: The deadline for receipt of quotations for this requirement is: Monday, November 27, 2023 at 10:00 AM ET. Quotation submissions shall be submitted by email only to Contract Specialist Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. Subject line of the email should be titled: “Quotation Submission:

ORA-2024-120099: WEAC Storage Shelving”.

4. QUOTATION SUBMISSION INSTRUCTIONS:

1.1 The Contractor shall submit a firm-fixed-price quote, including details of all costs supporting the price for the required deliverables.

1.2 The Contractor shall include and complete the pricing chart below. Pricing shall include all applicable fees; any charges presented after contract award shall not be considered/acceptable.

Line Item Description Quantity Unit Unit Price Extended Price

1 Storage Shelving System Dollars $ 2 Delivery and Installation Dollars $ Total $

1.3 Quotes shall be in two volumes: Volume I shall be Technical and Volume II shall be Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I. This volume shall provide the equipment description including specs, proposed work breakdown schedule for completion, warranty, delivery timeframe, etc. and not exceed 10 pages in length.

1.4 Quotes shall clearly reference the solicitation, date of quotation, company quoting and point of contact.

1.5 The Contractor’s current address and System for Award Management Unique Entity ID (UEI) shall be included in the quote.

1.6 Quotes shall be for all the deliverables requested.

1.7 Quotes shall be valid for at least 60 days after close of solicitation.

1.8 The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote. 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.

5. AWARD CRITERIA:

Quotations that do not respond to all requirements in the solicitation may be considered non-responsive without further evaluation, deliberation, or discussion. The Government reserves the right to award without discussions.

The Government contemplates award of a Firm-Fixed-Price Delivery Order resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government and whose quote is the Lowest Priced Technically Acceptable (LPTA).

FAR 52.212-2 EVALUATION -- COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

Lowest Priced, Technically Acceptable (LPTA)

(End of provision)

PERFORMANCE WORK STATEMENT

Project Title: Supply & Install Storage Shelving

November 7, 2023

A. BACKGROUND:

This Performance Work Statement (PWS) outlines the scope, objectives, and requirements for the installation of lab-grade shelving within the U.S. Food and Drug Administration (FDA) Winchester Engineering & Analytical Center (WEAC) laboratory facilities located in Winchester, Massachusetts. The purpose of this project is to enhance the efficiency, organization, and safety of the laboratory environment by providing adequate storage solutions for lab equipment, chemicals, and other essential materials. The primary objectives of this supply and installation project are as follows: To meet the specific requirements and standards for lab-grade shelving, including durability, corrosion resistance, and load-bearing capacity. See Technical Exhibits (TEs) attached for locations, shelving dimensions, and location dimensions.

Secondary objective is to ensure Contractor completes the installation process with minimal disruption to ongoing laboratory activities.

B. SCOPE OF WORK:

The Contractor shall provide all materials, tools and equipment, labor, transportation, and supervision necessary to ensure the work is completed safely and properly. The scope of this project includes the installation of lab-grade shelving units in designated areas (i.e., 11 rooms) of the WEAC laboratory. The shelving shall be strategically positioned to optimize workflow, facilitate easy access to materials, and ensure compliance with safety regulations and best practices.

C. TECHNICAL REQUIREMENTS:

1. Contractor shall provide complete design, purchase and installation services, to include all coordination, supervision, and management necessary to meet the requirements of this PWS.

2. Salient Characteristics: The Contractor shall provide equipment in accordance with the attached TEs for Shelving specifications. Items may be BRAND NAME OR EQUAL to METRO MAX Super Erecta/quikTRAK system in Chrome High density track-mounted rolling shelves between two fixed shelves with Aisle space created by moving each shelf unit sideways. May have center fixed shelf and/or be “Double Deep”. May have one (1) shelf smaller than the rest. MetroMax i 5X557EGX3 5-Shelf Industrial Plastic Shelving Mobile Cart, Solid Bottom Shelf, 24″ x 48″ x 79.3125″.

D. GENERAL REQUIREMENTS:

1. The Contractor shall be responsible to properly remove and dispose of all debris related to their work, including, packing materials, scrap steel, uninstalled materials and/or environmental waste.

2. When performing all work under this PWS, the Contractor shall take extra care not to damage existing structures.

Contractor shall be responsible to repair any damage caused as the result of their work. The limits of installation under this PWS will be clearly identified and areas will be marked to deter unauthorized Contractor personnel access.

3. Storage of any excess supplies and uninstalled materials will be in a location as directed by the Technical Point of Contact (TPOC) listed below in section K.1. At completion of work, the Contractor shall clean any impacted areas to a condition equal to original condition.

E. DELIVERABLES:

1. Contractor shall provide all machines, materials, workers, equipment, etc. necessary to supply and install lab grade shelving using PWS specifications and TEs.

2. Fully installed and secured lab-grade shelving units in designated areas of the laboratory.

3. Final inspection report outlining the successful completion of the installation project.

4. The Contractor shall be responsible to complete installation work properly according to required elevations, available spaces limitation, TEs, and specifications no later than 02/29/2024.

5. Within 10 business days after award, the contractor shall provide the TPOC a project schedule showing start to completion dates including significant milestones and the details of the proposed installation utilizing written description or sketches or both. The contractor shall be responsible to properly layout and prepare all materials based on locations provided in the TEs. All work shall be according to attached TEs, drawings, specifications, and building codes. If there is a conflict between codes, drawings, or specifications the more stringent will apply.

F. ACCEPTANCE/ CORRESPONDENCE:

All correspondence relative to the contract shall be prepared referencing the project title and contract number. Reports of telephone communication and discussion shall be prepared referencing the date, time, persons involved and provided to the TPOC within five (5) working days from the call.

A detailed check off list of Deficiencies & Omissions (D&O) shall be maintained by the Contractor. The Contractor shall notify the TPOC when D&Os are complete and when they shall request a final inspection. The Contractor shall allow the TPOC five (5) business days to notify and coordinate key personnel who must attend. The Contractor shall have all sub-contractors available for the final inspection. If the TPOC personnel identify any D&Os, the Contractor shall provide a ‘by date’ for when these items will be corrected. The Contractor shall request another inspection once all D&Os are complete and each item signed off as complete; substantial completion will be established at that time and then a punch-list will be performed. Contractor shall complete punch list within a reasonable time agreed with the TPOC; project completion shall be no later than February 29, 2024.

G. WARRANTY:

Contractor shall warranty all work for a minimum of one (1) year and provide manufacturer warranties and equipment manuals for all equipment installed to the TPOC, upon acceptance by the Government.

H. PLACE OF PERFORMANCE

109 Holton St. Winchester, MA, 01890. Business hours for installation purposes are 8:00am – 4:30 pm, Monday – Friday.

A loading dock, freight elevator to the 2nd floor, and pallet jack are available for Contractor use.

I. PERIOD OF PERFORMANCE:

All deliverables shall be completed no later than 02/29/2024. A 1-year warranty shall be provided after installation and Government acceptance.

J. SECURITY CONSIDERTAIONS:

Contractor personnel will be required to follow the standard WEAC-ADM-4.0 Physical Security SOP procedures outlined below:

1. Business hours are 8:00am – 4:30 pm, Monday – Friday. Inform the security guard in advance of any deliveries or visitors arriving outside business hours. The responsible employee must be present to escort the visitor at the time of arrival.

2. All persons not wearing FDA badges or FDA contractor badges are considered visitors.

3. All visitors must enter and exit the facility through the front entrance of the building at all times.

4. FDA employees should notify the Security Guard, in advance, when expecting visitors.

5. Visitors must present valid picture identification to the Security Guard. The Guard will confirm the identification, retain possession of the ID, and issue a visitor badge. The Guard will then notify the FDA employee that their visitor has arrived and ask the visitor to sign in on the Visitor record.

6. The visitor must wear their issued visitor badge and remain with their FDA escort at all times.

7. Upon exiting the facility, the Visitor must return their visitor badge to Security Guard and complete the visitor record. The Security Guard will then return the visitor’s picture ID.

K. GOVERNMENT HOLIDAYS:

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

January - New Year’s Day September - Labor Day

January- Martin Luther King Day October - Columbus Day

February - President’s Day November - Veterans Day

May - Memorial Day November - Thanksgiving Day

June - Juneteenth December - Christmas Day

July - Independence Day

L. POINTS OF CONTACT (POCs):

1. Technical Point of Contact (TPOC):

To Be Provided at Award

2. Contract Specialist (CS):

Benjamin Dorgan U.S. Food and Drug Administration Office of Acquisitions and Grants Services Tel: (301) 796-6542 Benjamin.Dorgan@fda.hhs.gov

3. Contracting Officer (CO):

Sheneil Green U.S. Food and Drug Administration Office of Acquisitions and Grants Services Tel: (240) 402-9672 sheneil.green@fda.hhs.gov mailto:Benjamin.Dorgan@fda.hhs.gov mailto:sheneil.green@fda.hhs.gov

CONTRACT CLAUSES

I. FEDERAL ACQUISITION REGULATION (48 CHAPTER 1) CLAUSES

I.1 52.252-2 CLAUSES 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 these addresses: www.acquisition.gov AND www.acquisition.gov/hhsar

I.2 52.212-4 CONTRACT TERMS AND CONDITIONS -- COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2023)

I.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 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:

[Contracting Officer check as appropriate.]

__ (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. 4655).

__ (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) 52.203-17, 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 FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (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).

http://www.acquisition.gov/ http://www.acquisition.gov/hhsar

_X_ (10) 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).

__ (11) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

__ (12) [Reserved].

__ (13) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

__ (14) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (15) [Reserved] _X_ (16) (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.

__ (17) (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.

__ (18) 52.219-8, Utilization of Small Business Concerns (Sep 2023) (15 U.S.C. 637(d)(2) and (3)).

__ (19) (i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) (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 2023) of 52.219-9.

__ (20) (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.

__ (21) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 637s).

__ (22) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (23) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) (15 U.S.C. 657f).

_X_ (24) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Sep 2023) (15 U.S.C. 632(a)(2)).

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

__ (25) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (26) 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) (15 U.S.C. 637(m)).

__ (27) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (28) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15 U.S.C. 637(a)(17)).

_X_ (29) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (30) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

_X_ (31) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (32) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

_X_ (33) (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_ (34) (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_ (35) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

__ (36) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (37) (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).

__ (38) 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.)

__ (39) (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.)

__ (40) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (41) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (42) (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.

__ (43) (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.

__ (44) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

__ (45) (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_ (46) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (47) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (48) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (49) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

_X_ (50) (i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (51) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) (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) Alternate I [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

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

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (52) 52.225-5, Trade Agreements (Dec 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (53) 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).

__ (54) 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. Subtitle A, Part V, Subpart G Note).

__ (55) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (56) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (57) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (58) 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. 3805).

__ (59) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C.

4505, 10 U.S.C. 3805).

_X_ (60) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

__ (61) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (62) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (63) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (64) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.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. 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:

[Contracting Officer check as appropriate.]

__ (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) (29 U.S.C.206 and 41 U.S.C. chapter 67).

__ (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) 52.203-17, 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 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).

(v) 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).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117- 328).

(vii) 52.219-8, Utilization of Small Business Concerns (Sep 2023) (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.

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

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

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

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

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

(xiii) 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.

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

(xv) (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).

(xvi) 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).

(xvii) 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).

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

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

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

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

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

(xxii) 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. Subtitle A, Part V, Subpart G Note).

(xxiii) 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.

(xxiv) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxv) 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.

(End of clause)

Health and Human Services Acquisition Regulation (HHSAR) and U.S. Food and Drug Administration (FDA) Clauses:

I.13 HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS

I.14 HHSAR 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.

(c) 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.

(d) 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.

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

I.15 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.

1. 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;

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

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

4. 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;

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

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. 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:

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

(i.) invoice number, amount, & date submitted (ii.) corresponding payment amount & date received

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

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

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

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 Delivery 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.

SOLICITATION PROVISIONS

II. FEDERAL ACQUISITION REGULATION (48 CHAPTER 1) PROVISIONS:

II.1 52.212-1 INSTRUCTIONS TO OFFERORS- COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(SEP 2023)

II.2 52.225-25 PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN ACTIVITIES

OR TRANSACTIONS RELATING TO IRAN--REPRESENTATION AND CERTIFICATIONS (JUN 2020)

II.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services -- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year

2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115- 232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM)

(https://www.sam.gov) for entities excluded from receiving federal awards for ``covered telecommunications equipment or services.''

(d) Representations. The Offeror represents that--

(1) It [_] will, [_] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds ``will'' in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [_] does, [_] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds ``does'' in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded

``will'' in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided;

and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded ``does'' in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

II.4 FAR 52.211-6 -- BRAND NAME OR EQUAL (AUG 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level…