Sol_RFQ Attachment_75F40124Q00325.pdf

This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40124Q00325 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 334516 (Analytical Laboratory Instrument Manufacturing); the Small Business Size Standard is 1,000 employees. This requirement is being solicited using FAR Part 13 Simplified Acquisition Procedures and on an unrestricted basis (i.e., no set-aside). Prospective quoters are responsible for downloading the solicitation and any amendments from SAM.gov. The Government reserves the right to award 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) Center for Drug Evaluation and Research (CDER) Office of Product Quality and Research (OPQR) currently owns and operates a ProteinSimple CE-SDS/cIEF (Maurice) protein characterization and analysis system. The current workload of this instrument requires regular replacement of operational parts, components, and peripherals that are BRAND NAME ONLY to Bio-Techne ProteinSimple for compatibility purposes as outlined in the Statement of Work (SOW) provided below.

1. QUESTION DEADLINE: Questions related to this procurement shall be submitted directly by email to

Contracting Officer Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: Thursday, June 6, 2024 at 1:00 PM Eastern Time (ET) may not be considered.

2. QUOTATION DEADLINE: The deadline for receipt of quotations for this requirement is: Tuesday, June 11, 2024 at 1:00 PM ET. Quotation submissions shall be submitted by email only to Contracting Officer Benjamin Dorgan at: benjamin.dorgan@fda.hhs.gov. Subject line of the email should be titled: “Quotation Submission:

75F40124Q00325_ProteinSimple Maurice Parts & Components”.

3. QUOTATION SUBMISSION INSTRUCTIONS:

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

3.2 The Contractor shall include and complete the following pricing chart. Pricing shall include all applicable fees;

any charges presented after contract award shall not be considered/acceptable.

Line Item Description Quantity Unit Price Per Unit Extended Price

1 Maurice Turbo CE-SDS Application Kit 5 EA $ $

2 Maurice CE-SDS Conditioning Solution 1 4 EA $ $

3 Maurice CE-SDS PLUS, 1x Sample Buffer 4 EA $ $

4 Maurice CE-SDS Separation Matrix 2 EA $ $

5 Maurice CE-SDS Wash Solution 8 EA $ $

6 Maurice cIEF pI Marker - 4.05 3 EA $ $

7 iCE Electrolyte Kit 1 EA $ $

8 0.5% Methyl Cellulose Solution 1 EA $ $

9 Maurice cIEF System Suitability Kit 3 EA $ $

10 Maurice cIEF pI Marker - 8.40 3 EA $ $ mailto:benjamin.dorgan@fda.hhs.gov mailto:benjamin.dorgan@fda.hhs.gov

3.3 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, any applicable warranties, delivery timeframe, etc. and not exceed 10 pages in length.

3.4 A quoter must submit sufficient information for a technical evaluation to be made by the Government to determine if the quoter's quotation meets the minimum requirements of the SOW. The Contracting Officer is not responsible for acquiring any additional information. If description/technical data/specifications are not sufficient to make a technical acceptance decision, the quotation may be determined technically unacceptable.

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

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

3.7 Quotes shall be for all the deliverables requested.

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

3.9 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.

4. 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 purchase order resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government and

11 Maurice 96-Well plates 2 EA $ $

12 Maurice cIEF pI Marker - 5.85 2 EA $ $

13 Maurice cIEF pI Marker - 10.17 2 EA $ $

14 Maurice cIEF Fluorescence Calibration Standard 2 EA $ $

15 SimpleSol Protein Solubilizer for cIEF 1 EA $ $

16 Maurice CE-SDS IgG Standard 4 EA $ $

17 Maurice CE-SDS Orange Pressure Caps 4 EA $ $

18 Maurice Glass Reagent Vials, 2 mL 7 EA $ $

19 Maurice CE-SDS Running Buffer - Bottom 2 EA $ $

20 Maurice CE-SDS Running Buffer - Top 1 EA $ $

21 Maurice CE-SDS Conditioning Solution 2 4 EA $ $

22 Maurice CE-SDS 25x Internal Standard 2 EA $ $

23 Maurice cIEF 500 mM Arginine 6 EA $ $

24 1% Methyl Cellulose Solution 1 EA $ $

25 Maurice cIEF Cartridges 3 EA $ $

26 Maurice CE-SDS PLUS Cartridge 2 EA $ $

27 Shipping and Handling Dollars $

Total Price: $ 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)

*******************************************************STATEMENT OF WORK********************************************************

U.S. Food and Drug Administration (FDA)

PARTS AND COMPONENTS FOR CE-SDS/CIEF INSTRUMENT (MAURICE)

1. Brief Background and Requirement

2. Scope of Work

3. Technical Specifications

The Contactor shall provide the following items required for continued maintenance and operation of instrument, including calibration and quality control testing:

Maintenance/Operational parts and components

Part No. Quantity Product Name Description

PS-

MAK01-

TS

5 Maurice Turbo

CE-SDS

The Turbo CE-SDS Application Kit contains all components required to run Turbo CE-SDS applications. The kit includes 1 Turbo CE-SDS cartridge, Separation Matrix, Running Buffer, CE-SDS Sample Buffer, CE-SDS PLUS Sample Buffer, Wash Solution, Conditioning Solutions, Internal Standard, Reagent Vials, Pressure Caps and 96-Well Plates.

Molecular weight markers can be ordered separately.

046-014 4 Maurice CE-SDS Conditioning Solution 1

Conditioning solution 1 for use with CE-SDS cartridge, 20 mL. For use with CE-SDS PLUS cartridge (PS-MC02-SP) and Turbo CE-SDS cartridge (PS-MC02-TS, PS-MC01-TS) on Maurice (090-000) and Maurice S. (090-001) systems only.

046-567 4 Maurice CE- SDS PLUS, 1x Sample Buffer

Buffer for samples preparation for CE-SDS PLUS or Turbo CE-SDS application, 25 mL. For use with CE-SDS PLUS cartridge (PS-MC02-SP) or Turbo CE-SDS cartridge (PS- MC02-TS, PS- MC01-TS) on Maurice (090-000) and Maurice S. (090-001) systems.

046-386 2 Maurice CE-SDS Separation Matrix

Separation matrix for CE-SDS application, 15mL. For use with CE-SDS PLUS cartridge (PSMC02-SP) and Turbo CE- SDS cartridge (PSMC02-TS, PS-MC01-TS) on Maurice (090-000)and Maurice S. (090-001) systems only.

The FDA Center for Drug Evaluation and Research (CDER) Office of Product Quality and Research (OPQR) currently owns and operates a ProteinSimple CE-SDS/cIEF (Maurice) protein characterization and analysis system. This system offers high throughput capillary electrophoresis sodium dodecyl sulfate separation for size/purity and capillary isoelectric focusing for isoelectric point determination via assay cartridges. Size/purity and charge are critical quality attributes (CQAs) of biotechnology products assessed during biomanufacturing.

CQAs of the product can vary during the course of biomanufacturing when nutrients drop below critical levels or other process parameters change. To date, this system has provided several significant benefits to OBP research by reducing time and labor qualifying upstream and downstream unit processes in a novel cell production platform for recombinant protein products.

The current workload of this instrument requires that it always perform accurately, which requires regular replacement of operational parts, components, and peripherals that are BRAND NAME ONLY to Bio-Techne ProteinSimple and compatible with OPQR’s ProteinSimple CE-SDS/cIEF (Maurice) system.

The Contractor shall take all actions necessary to provide the products meeting the requirements as outlined below in section 3.

046-569 8 Maurice CE- SDS Wash Solution

Wash solution for CE-SDS application, 20 mL. For use with CE-SDS PLUS cartridge(PS-MC02-SP) or Turbo CE-SDS cartridge (PS-MC02-TS, PS-MC01-TS) on Maurice (090-

000) and Maurice S. (090-001)systems .

046-029 3 Maurice cIEF pI Marker - 4.05

Maurice cIEF pI Marker - 4.05, 210 μL, Lyophilized

102506 1 iCE Electrolyte Kit These 100 mL Anolyte and Catholyte solutions in 0.1% MC are used to fill the electrolyte tanks in Maurice cIEF cartridge as well as FC and HT cartridges. The labels and bottles are color coded to improve safety. The kit contains 2 x 100 mL bottles. The expiration date for this kit is 12 months from date of manufacture. Suitable for use with Maurice, Maurice C., iCE3 and iCE280.

102505 1 0.5% Methyl Cellulose Solution

0.5% Methyl Cellulose Solution, 100 mL Use this concentration for the wash cycle between injections. The solution is filtered to ensure consistent viscosity to coat the capillary lumen to minimize electroosmotic flow (EOF).

Conveniently packaged in 2 x 100 mL bottles. The expiration date for this kit is 12 months from date of manufacture.

Suitable for use with Maurice, Maurice C., iCE3 and iCE280.

046-044 3 Maurice cIEF System Suitability Kit

The cIEF System Suitability Kit is used to run a control test for cIEF application on Maurice and Maurice C. systems on 8 separate occasions. Each time, the performance can be checked up to 24 hours. The kit contains a vial of lyophilized Peptide Panel and a vial of System Suitability Test mix . 8 runs/kit. The expiration date for this kit is 12 months from date of manufacture. For use with the cIEF cartridge (PS- MC02-C) on Maurice and Maurice C. systems only.

046-033 3 Maurice cIEF pI Marker - 8.40

Maurice cIEF pI Marker - 8.40, 210 μL, Lyophilized

046-021 2 Maurice 96-Well plates

96-well plate for high-throughput analysis, 10/pk. For use with Maurice, Maurice C. and Maurice S. systems only.

046-030 2 Maurice cIEF pI Marker - 5.85

Maurice cIEF pI Marker - 5.85, 210 μL, Lyophilized

046-035 2 Maurice cIEF pI Marker - 10.17

Maurice cIEF pI Marker - 10.17, 210 μL, Lyophilized

046-025 2 Maurice cIEF Fluorescence Calibration Standard

Fluorescence Calibration Standard for cIEF application. 5.5 mL. For use with Maurice and Maurice C. systems only.

046-575 1 SimpleSol Protein Solubilizer for cIEF

SimpleSol Protein Solubilizer for cIEF application, 200 mL.

The expiration date for this reagent is 12 months from date of manufacture. Suitable for use with Maurice, Maurice C.

and iCE3 systems.

046-039 4 Maurice CE- SDS IgG Standard

Lyophilized antibody standard for 8 runs

046-572 4 Maurice CE-SDS Orange Pressure Caps

Orange Pressure screw caps with O-ring for glass vials (046- 017), 12/pk. For use with CE-SDS application only.

046-017 7 Maurice Glass Reagent Vials, 2 mL

Screw-top glass vials, 2 mL. 100/pk. Suitable for use with Maurice, Maurice S. and Maurice C. systems only.

046-385 2 Maurice CE- SDS Running Buffer - Bottom

Running buffer for CE-SDS application. 15 mL. For use with CE-SDS cartridge (PS-MC02-S) on Maurice (090-000) and Maurice S. (090-001) systems only.

046-384 1 Maurice CE- SDS Running Buffer - Top

Pre-filled vial assembly containing top running buffer for CE- SDS application. For use with the cartridge insert (046-124) of the CE-SDS cartridge (PS-MC02-S) on Maurice and Maurice S. systems only. 10 Vials.

046-015 4 Maurice CE-SDS Conditioning Solution 2

Conditioning solution 2 for use with CE-SDS cartridge, 20 mL. For use with CE-SDS cartridge (PS-MC02-S) on Maurice (090-000) and Maurice S. (090-001) systems only.

046-144 2 Maurice CE- SDS 25x Internal Standard

Internal standard for addition to each sample for CE-SDS application, 2 vials/pack. For use with CE-SDS cartridge (PS- MC02-S) on Maurice (090-000) and Maurice S. (090-001) systems only.

042-691 6 Maurice cIEF 500 mM Arginine

Maurice cIEF 500 mM Arginine, 500 μL. For use as a cathodic blocker in cIEF application.

101876 1 1% Methyl Cellulose Solution

1% Methyl Cellulose Solution, 100 mL This solution is used to prepare samples for the cIEF applications. The expiration date for this kit is 12 months from date of manufacture.

Suitable for use with Maurice, Maurice C.,iCE3 and iCE280.

PS-

MC02-

C

3 Maurice cIEF Cartridges

Cartridge for cIEF application, 2 Cartridges/Pk. For use with Maurice (090-000) and Maurice C. (090-002) systems only.

PS-

MC02-

SP

2 Maurice CE-

SDS PLUS

Cartridge

Cartridges for CE-SDS PLUS application, 2 cartridges/Pk. For use with Maurice (090-000) and Maurice S. (090-001) systems.

4. Tasks/Deliverables

5. Shipment/ Destination

Contractor shall provide FOB Destination shipping, handling and inside delivery to CDER’s facilities at the address provided below. Contact name will be provided at award:

FDA White Oak Campus Bldg 52/72 Rm 2248 10903 New Hampshire Ave Silver Spring, MD 20993

a. The Contractor shall provide FOB Destination shipping, handling and inside delivery to the delivery location in section 5. Pricing of the quotation shall be wholly inclusive of these accessory charges.

b. To meet the purpose and objective of this requirement, a single Contractor shall provide the parts and components below that must be compatible with the Protein Simple CE-SDS/cIEF (Maurice) system described in Section 1and meet the established delivery timelines.

c. At least 1 week prior to anticipated delivery date, the Contractor shall notify FDA laboratory staff receiving the shipments that they are in route and provide package tracking information.

d. The Contractor shall, commensurate with the completion of each delivery, invoice each delivery for the costs agreed upon in the contract. Invoices that include additional charges for shipping, handling, etc. that were not in the original contract will not be considered.

e. All parts and components shall be delivered during SEPTEMBER 2024 AND NO LATER

THAN SEPT 30TH, 2024.

6. Points of Contact

***************************************************END STATEMENT OF WORK***************************************************

1. Technical Point of Contact (TPOC):

To Be Provided at Award

2. Contracting Officer (CO):

Benjamin Dorgan U.S. Food and Drug Administration Office of Acquisitions and Grants Services Tel: (301) 796-6542 Benjamin.Dorgan@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 52.247-34 F.O.B. DESTINATION (NOV 1991)

I.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

(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 Covered Entities (Dec 2023) (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

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

__ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204-30.

_X_ (12) 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).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C.

2313).

__ (14) [Reserved].

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

_X_ (16) 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).

__ (17) [Reserved] __ (18) (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.

__ (19) (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.

__ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 15 U.S.C. 637(d)(2) and (3)).

__ (21) (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.

__ (22) (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.

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) ( 15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024) ( 15 U.S.C. 632(a)(2)).

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

__ (27) 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)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) ( 15 U.S.C. 637(m)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

_X_ (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

__ (35) (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_ (36) (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.

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

__ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

__ (40) 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.)

__ (41) (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.)

__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44) 52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45) 52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

_X_ (46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

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

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

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I [Reserved].

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

__ (iv) Alternate III (Feb 2024) of 52.225-3.

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

__ (50) 52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside 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).

__ (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 (Nov 2007) ( 42 U.S.C. 5150).

_X_ (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 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).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C.

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

_X_ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (64) (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) ( 29U.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 Covered Entities (Dec 2023) (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) (A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 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.

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

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

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

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

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

(xiv) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

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

(xvi) (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).

(xvii) 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).

(xviii) 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).

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

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

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

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

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

(xxiii) 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).

(xxiv) 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.

(xxv) 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.

(xxvi) 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…