75F40125Q00360_ABI 7500 Fast RT Maintenance COMBINED.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

ARL CODE 16. ADMINISTERED BYCODE

X

X

811210

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

08/26/2025 1000 ET

08/20/2025

ANDREA HOWARD

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40125Q00360

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 60 1285403OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

JEFFERSON AR 72079

3900 NCTR ROAD BUILDING 26

3900 NCTR RD BLDG 26

15. DELIVER TO

Rockville MD 20852 11601 Landsdown Street ATTN: Andrea Howard

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$34

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

ABI 7500 Fast Real-time PCR System Maintenance Service Contract (6EA) S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420 Delivery: 09/01/2025

1 (BASE)

ABI 7500 Fast Real-time PCR System Service Contract (6EA) - Preventative and Corrective Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

SEPHORA A. CALDERON

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Maintenance

S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Anticipated Award Type: Firm-fixed-price

Period of Performance: 09/01/2025 to 08/31/2026

2 (OY1)

ABI 7500 Fast Real-time PCR System Service

Contract (6EA) - Preventative and Corrective

Maintenance

S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Anticipated Award Type: Firm-fixed-price

(Option Line Item)

Period of Performance: 09/01/2026 to 08/31/2027

3 (OY2)

ABI 7500 Fast Real-time PCR System Service

Contract (6EA) - Preventative and Corrective

Maintenance

S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Anticipated Award Type: Firm-fixed-price

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

60 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 60

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75F40125Q00360

(Option Line Item)

Period of Performance: 09/01/2027 to 08/31/2028

4 (OY3)

ABI 7500 Fast Real-time PCR System Service

Contract (6EA) - Preventative and Corrective

Maintenance

S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Anticipated Award Type: Firm-fixed-price

(Option Line Item)

Period of Performance: 09/01/2028 to 08/31/2029

5 (OY4)

ABI 7500 Fast Real-time PCR System Service

Contract (6EA) - Preventative and Corrective

Maintenance

S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Anticipated Award Type: Firm-fixed-price

(Option Line Item)

Period of Performance: 09/01/2029 to 08/31/2030

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

COMBINED SYNOPSIS/SOLICITATION

ABI 7500 Fast Real-Time PCR System Maintenance and Preventative Care Service

SOLICITATION NUMBER: 75F40125Q00360

Offeror Name UEI and CAGE Code

PART I - THE SCHEDULE

SECTION A – GENERAL SOLICITATION INFORMATION

This is a solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.501(a), as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 202-05 dated August 7, 2025.

The associated North American Industrial Classification System (NAICS) code for this procurement is 811210 – Electronic and Precision Equipment Repair and Maintenance, with an associated size standard of $34.0M. This requirement is being solicited as a Sole Source procurement.

Background

The FDA Human Food Program (HFP), Office of Regulatory Testing and Surveillance, Arkansas Human and Animal Food Laboratory (ARHAFL) uses six ABI 7500 Fast Real Time PCR Systems. These instruments are required for the development and execution of efficient, cost-saving, and rapid molecular screening methods in a high through-put format (96 well plates). In Microbiological Branch, ABI 7500 Fast have been validated and intensively utilized for the high throughput screening of high-risk pathogens, such as Hepatitis A, Norovirus, Cyclospora and E.

coli O157:H7 and Salmonella, life threatening neurotoxins-producing pathogen Clostridium botulinum from FDA high priority or CORE regulatory samples, highly pathogenic influenza A virus (HPAI, bird flu) from raw milk and milk products. In Chemistry Branch ABI 7500 Fast PCR system is intensively used for detection of Bovine Spongiform Encephalopathy (BSE).

A service contract including annual instrument preventative maintenance (PM) and calibration, and timely remedial repair by OEM-certified engineer with OEM parts are indispensable for generation of precise and reliable scientific data. It is also a requirement of all ISO/IEC 17025 for Accredited laboratories.

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

Pricing Table

Line Item

Description Quantity Total Price

Base Year ABI 7500 Fast Real-time PCR System (6EA) - Preventative and Corrective Maintenance S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Base Year – Reinstatement Fee for Recertification (S/N: 2750107889, 2750108420)

Option Year 1

Preventative and Corrective Maintenance S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Option Year 2

Preventative and Corrective Maintenance S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Option Year 3

Preventative and Corrective Maintenance S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

Option Year 4

Preventative and Corrective Maintenance S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420

TOTAL

CONTRACT

PRICE

SECTION C – DESCRIPTION / SPECIFICATIONS / STATEMENT OF WORK

Objective To procure a new service agreement for six (6) ABI 7500 Fast Real Time PCR Systems ( S/N: 275013447, 275013452, 275012572, 2750107889, 2750109522, 2750108420). This will ensure that our high priority mission critical work continues without delays, and we follow the ISO/IEC 17025 requirements.

Scope SECTION E – INSPECTION The contractor shall provide on-site recertification and annual preventative maintenance, calibration, and prompt repair(s) if needed as well as a certification report after each PM and/or repair. Service shall be provided by an engineer from Original Equipment Manufacturer (OEM) as described in this Statement of Work (SOW). The maintenance service of the six (6) ABI 7500 Fast systems will occur over a base year plus four, one (1) year option periods.

Salient Characteristics of the Minimum Service Requirements

The following is a description of the minimum performance requirements under this contract:

1. The Contractor shall perform the following on the Life Technologies 7500 FAST Real Time PCR systems:

a. Must provide all necessary parts and labor for service (remedial repair and annual preventative maintenance) at the locations where the instruments reside. PM visit includes coverage replacing parts subject to wear as defined by OEM (Original Equipment Manufacturer)-specific PM checklist. All parts for repair and PM must be OEM factory parts.

b. Service must be performed by an OEM-trained engineer, if not directly from OEM (Thermo Fisher Scientific and Life Technologies), an OEM training certificate of engineer must be provided before dispatch of the engineer. Arkansas Laboratory has the right to reject the service if engineer does not meet the training requirement. This factory-trained engineer shall have (verified by the OEM) the following:

1. access to OEM factory telephone support

2. access to the most current OEM factory training for both hardware and software components

3. Access to all current OEM factory parts, not build-to-order parts. The OEM- trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested OEM quality parts.

4. Shall perform ROI, Optical, Background, and System Dye (all dyes) Calibration at the annual planned preventative maintenance visit.

5. Guaranteed priority response time of 2 business days after receipt of a service call for instruments.

6. Target response time of 3 business days for remedial repairs.

7. Shall be accredited to ISO 17025 standards in the area of this technology.

8. The technician shall have a valid driver’s license that must be shown to security upon arrival at each facility.

9. The technician will bring with them appropriate personal protective equipment to ensure their safety while performing the duties outlined in this Statement of Work.

10. Standards used for inspection, measuring, and testing this equipment shall be traceable to national or international standards (i.e. NIST).

11. A copy of the company’s Standard Operating Procedure (SOP) related to this service will be made available upon request.

12. Performance of the instrument following service is guaranteed/warrantied post-service.

If a unit fails, the service provider will return to the site, at no additional cost to the Government, to troubleshoot the failed instrument.

Records and Reports The Contractor shall, commensurate with the completion of each service call, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER/COR and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

SECTION E - INSPECTION AND ACCEPTANCE

Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). All services specified in this Statement of Work to be performed under this order are subject to final inspection and acceptance by an authorized representative for the Government. Inspection and acceptance will be performed at the performance location. The Technical Point of Contact (TPOC) will perform inspection and acceptance of the services performed. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer to the TPOC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the TPOC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

SECTION F – DELIVERABLES AND PERFORMANCE

1. An electronic or hard copy Field Service Report and associated traceability certificates shall be provided within 24 hours of service completion. The Field Service Report will include the following information:

a. The name and address of the laboratory where the service is performed.

b. Unique identification of the unit, such as serial number, shall appear on each page of a report or certificate ABI 7500 Preventative Maintenance, 3900 NCTR Road, Jefferson, AR 72079

The Contractor shall deliver all items to the (TPOC)/COR] as set forth below:

Deliverable Quantity Delivery Date ABI 7500 Fast Real-time PCR System Service, Full Agreement (including all service checklists) 1 each

Upon contract award execution

Copy of OEM Training Certificate of Service Engineer(s) 1 each

Prior to dispatch of service engineer(s)

Service Reports (including recertification services)

1 per service call

Within 24 hours of service

Place of Performance

U.S. Food and Drug Administration Arkansas Human Food Laboratory 3900 NCTR Rd., Bldg. 26 Jefferson, AR 72079

POC(s): TBD upon contract award

Vendor must contact TPOC or the Contract Officer’s Representative (COR) at a minimum of 3-business days prior to arrival to conduct services.

Performance must occur during regular business hours (Monday – Friday) between the times of 8:00 AM – 4:00 PM local standard time, excluding the following federal Government holidays:

New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Period of Performance The period of performance begins the date of contract award execution. The base period of the contract will be one (1) calendar year from the date of formal Government acceptance of the service(s). The contract also contains four (4), one-year option periods that the Government may exercise unilaterally.

Option periods are for the period of one (1) year each. If exercised, the options may extend the length of the contract by four additional years for a total of five years.

If exercised, the contract period of performance for option years are to be identified in each modification that exercises the respective option(s). The period of performance terms for the options shall extend the performance period of the contract if the Government exercises the option(s) in accordance with FAR 52.217-9. Additionally, in accordance with FAR 52.217-8, the Government may exercise the Option to Extend Services of the contract prior to the expiration of the final option year for no more than six (6) additional months.

The anticipated period of performance (PoP) for the contract is:

Base Period: 9/1/2025 - 8/31/2026 Option Year 1: 9/1/2026 - 8/31/2027 Option Year 2: 9/1/2027 - 8/31/2028 (LEAP YEAR) Option Year 3: 9/1/2028 - 8/31/2029 Option Year 4: 9/1/2029 - 8/31/2030

The 365/24/7 technical support for the six (6) ABI 7500 Fast Real Time PCR Systems shall begin on the date of contract award execution.

Satisfactory performance of this contract shall be deemed to occur upon delivery of services described in the SOW and/or upon acceptance by the Contracting Officer or the TPOC of these products/services. Provided services by the contractor shall be made F.O.B. destination no later than the date agreed upon with the Technical POC. Services scheduled for non-operating workdays shall be executed the following business day.

SECTION G - CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Point of Contact (TPOC)

The TPOC is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms, or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

Contracting Officer (CO): Contract Specialist (CS):

Sephora Calderon Andrea Howard 11601 Landsdown Street 11601 Landsdown Street Rockville, MD 20852 Rockville, MD 20852 sephora.calderon@fda.hhs.gov andrea.howard1@fda.hhs.gov

Payment Schedule

Unless otherwise agreed to by the TPOC, the Contractor shall submit invoices subsequent to the performance of the required service.

mailto:sephora.calderon@fda.hhs.gov

SECTION H – SPECIAL CONTRACT REQUIREMENTS

Security When vendor representatives arrive on site to perform services, they will need to provide proper U.S. photo identification to check-in with the Federal Protective Service (FPS) Security Guards in order to enter the building. The vendor representatives will receive an “Escort Required” temporary badge, which must be worn at all times in the building and will remain escorted by lab personnel during their visit. If vendors need to enter into the laboratory, safety glasses must be worn. When their work is complete, the vendor representatives will provide the lab personnel a work order or service report detailing the work performed. The vendor representatives will check-out with the same FPS Security Guards, turning in their temporary badge. Tobacco, of any form, e-cigarettes, firearms and any weapons are not permitted on Federal Property, in Federal Buildings or parking lots.

Travel The vendor shall schedule and send one technician that has been trained and certified by the OEM to ARHAFL to perform contracted services. The vendor shall be responsible for all aspects of travel cost and accommodation of the technician they send to ARHAFL.

PART II – CONTRACT CLAUSES

SECTION I - CLAUSES AND PROVISIONS

FAR CLAUSES/PROVISIONS Incorporated by Reference (IBR)

52.203-12 Limitation on Payments to Influence Certain Federal

Transactions

JUN 2020

52.203-17 Contractor Employee Whistleblower Rights NOV 2023 52.203-19 Prohibition on Contracting with Entities that Require Certain

Internal Confidentiality Agreements or Statements- Representations

JAN 2017

52.204-13 System for Award Management Maintenance OCT 2018 52.204-19 Incorporation by Reference of Representations and

Certifications

DEC 2014

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations

NOV 2015

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

NOV 2023

52.217-5 Evaluation of Options JULY 1990

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

MAR 2023

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation

APR 1984

52.247-34 F.O.B. Destination NOV 1991

Addendum to FAR 52.212-4, Contract Terms and Conditions – Commercial Items (NOV 2023), applies to this acquisition for (g) INVOICING provided under HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and invoicing instructions section AND

(s) Order of precedence.

(g) Invoice.

Instructions for invoicing are indicated below.

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.

i. 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.

ii. 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.

iii. 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 http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

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

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

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

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

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

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

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

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

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

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

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

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

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

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

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

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

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

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services (DPS) 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

mailto:FDAVendorPaymentsTeam@fda.hhs.gov

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than

NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format.

All items listed in (i) through (xiii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the 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.

(s). Order of Precedence.

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4.

Any indemnification language indemnifying the Contractor of any liability and governing law language in the Contractor’s terms and conditions shall be null and void in this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be null and void.

PROVISIONS and CLAUSES INCORPORATED by FULL TEXT

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-mailto:ERIC@fda.hhs.gov

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.

(End of provision)

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--

REPRESENTATION (OCT 2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) 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”.

(c) Representations.

(1) The Offeror represents that it [ ___ ] does, [ ___ ] 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.

(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 any equipment, system, or service that uses covered telecommunications equipment or services.

(End of provision)

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.

As prescribed in 12.301(b)(4), insert the following clause:

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION

FEB 2025)

(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).

https://www.sam.gov/ https://www.acquisition.gov/far/part-12#FAR_12_301 https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/part-52#FAR_52_204_25

(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:

(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.)

__ (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).

(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).

(9) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

https://www.acquisition.gov/far/part-52#FAR_52_209_10 https://www.acquisition.gov/far/part-52#FAR_52_232_40 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section3801&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_233_3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 https://www.acquisition.gov/far/part-52#FAR_52_203_6 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section4655&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_203_13 https://www.acquisition.gov/far/part-52#FAR_52_203_15 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section4712&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section4712&num=0&edition=prelim https://www.acquisition.gov/far/part-3#FAR_3_900 https://www.acquisition.gov/far/part-52#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27

__ (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.

(12) 52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (JAN 2025) ( 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).

__ (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 (JAN 2025)( 15 U.S.C. 637(d)(2) and (3)).

__ (21) (i) 52.219-9, Small Business Subcontracting Plan (JAN 2025) ( 15 U.S.C. 637(d)(4)).

https://www.acquisition.gov/far/part-52#FAR_52_204_28 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.govinfo.gov/link/uscode/31/6101 https://www.acquisition.gov/far/part-52#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_4 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637&num=0&edition=prelim

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

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

__ (iv)…