Attachment 1 - Statement of Work.pdf

RFP_75F40125R00021

ORA ORS Laboratory third party laboratory accreditation services for ISO 17025

Statement of Work Third party accreditation by Internationally Recognized and ISO 17011 conforming accrediting body for FDA Regulatory Laboratories

Table of Contents

Background Objectives Scope Tasks Deliverable Schedule Government-Furnished Property and Information Security Place of Performance Period of Performance Contract Type Government Points of Contact Observance of Federal Holidays Clauses

Background

In the past, FDA’s Regulatory laboratories operated under a variety of formal and informal quality management systems. All of these systems had the same aim – to assure the quality of laboratory results upon which regulatory decisions are made. However, these systems differed in their rigor and in the amount of independent oversight exercised.

A quality management system that is accredited to international standards (ISO/IEC 17025) enabled Laboratory managers to better maintain high quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations result in greater regulatory impact and better consumer protection. Uniform laboratory procedures enhance data reliability and resource sharing with FDA domestic and international partners.

Through laboratory accreditation, FDA Regulatory laboratories maintain their reputation as a source of scientifically sound information and guidance. The accreditation process started in 2003 and FDA Regulatory laboratories undergo a full on-site assessment every two years depending upon the expiration of their Accreditation Certificate.

Objectives

The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the “AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, Pharmaceuticals, and Cannabis”. The purpose of this contract is to have an independent, third-party Contractor perform the accreditation assessments and make the proper determinations and to identify any deficiencies.

Scope Laboratory accreditation is an important aspect of maintaining Field Laboratories and is an important commitment by FDA. It recognizes the need for FDA Regulatory laboratories to have international recognition and parity; to share data and other information with other accredited labs around the world; to share a common set of policies and procedures in improving operations and harmonization; and, to provide excellent work products that are defensible and consistent.

FDA has fourteen field laboratories that are currently accredited to ISO/IEC 17025 and the AOAC International specific requirements for food and pharmaceutical testing. The fourteen laboratories cover eleven distinct geographical locations with three laboratories sharing a physical location. Eight Laboratories fall under the Human Foods Program (HFP) and six labs are located within the Office of the Chief Scientist (OCS). (The expectation is that the laboratories have an on-site assessment which occurs every two years resulting in accreditation.

In addition, in the off year, a surveillance assessment to demonstrate maintenance of accreditation will be performed through an off-site documentation review.

Tasks

Task Number

Work Milestones* Projected Completion Date

1.0 Pre-Onsite Requirements

1.1 General for all fourteen laboratories.

Arrange to conduct an assessment at the laboratory’s site prior to the expiration date of the Accreditation Certificate for that specific laboratory

Six months prior to Accreditation expiration date

1.2 Initiate a request for quality documentation

and laboratory standard operating procedures (SOP) from assessing laboratory.

30 calendar days prior to an assessment

1.3 Provide an assessment agenda prior to the on-

site assessment date

Not less than seven (7) calendar days prior to the on-site assessment

2.0 Accreditation Assessment

2.1 Conduct entry briefing with laboratory

management.

Prior to beginning on-site lab assessment

2.2 Conduct assessment of the lab.

2.3 A written report of the assessor(s) findings is

presented at the close of the assessment.

Presented at the close out meeting after the on-site assessment

2.4 A written report of the assessor(s) findings is

presented to the Office of Regulatory Science.

Presented at the close out meeting after the on-site assessment

3.0 Laboratory Response to Deficiencies

3.1 Review FDA Laboratory responses to

deficiencies 60 days after on-site assessment

3.2 Provide Accreditation Certificate to Assessed

Laboratory

30 days after final review of FDA Laboratory response

4.0 Surveillance Assessment

4.1 Document Review 12 months after on-site

assessment

* For additional information for each task please refer to task number under technical requirements

Technical Requirements

The contractor will conduct third-party assessments on the identified schedule (See: Place of Performance Section below) for fourteen laboratories for compliance to ISO/IEC 17025 and the

AOAC International Food and Pharmaceutical Program. See Place of Performance Section below for a list of the ORA laboratories

At a minimum, the contractor shall:

1. Provide assessments and accreditation in compliance with ISO/IEC 17025:2017 or current standard year.

2. Be a nationally and internationally recognized accrediting body with Mutual Recognition Arrangement (MRA) with International Laboratory Accreditation Cooperation (ILAC) and/or Multi-lateral Recognition Arrangement (MLA) with International Accreditation Forum (IAF)

3. Have established recognition Memorandum of Understanding (MOUs) with other national and international organizations and accrediting bodies such as International Laboratory Accredition Cooperation (ILAC), International Accreditation Forum (IAF), Asia Pacific Accreditation Cooperation (APAC) or Inter-American Accreditation Cooperation (IAAC)

4. Possess technical expertise to assess the processes for the following disciplines:

Chemical, Biological, Electrical and Mechanical

5. Have a defined industry-specific accreditation program for food and pharmaceutical laboratories for the chemical and biological disciplines.

6. Provide accreditation assessment to established whether or not a laboratory complies with the “AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, Pharmaceuticals, and Cannabis”.

Task 1- Pre-Onsite Requirements

Upon receipt of award, the vendor will arrange for one or more assessors to conduct an assessment at the laboratory’s site prior to the expiration date of the Accreditation Certificate for that specific laboratory. See the table below for the expiration dates for each laboratory.

Office Lab Name Current Certificate Expiration

HFP Arkansas Human and Animal Food Lab

(ARHAFL) 05/2025

HFP Atlanta Human and Animal Food Lab (ATHAFL) 09/2026 HFP Denver Human and Animal Food Lab (DENHAFL) 04/2026 HFP Irvine Human and Animal Food Lab (IRVHAFL) 03/2026 HFP Kansas Human and Animal Food Lab (KCHAFL) 09/2026 HFP New York Human and Animal Food Lab

(NYHAFL) 06/2026

HFP San Francisco Human and Animal Food Lab

(SANHAFL) 12/2025

HFP Seattle Human and Animal Food Lab (SEAHAFL) 05/2025 https://www.iso.org/standard/66912.html

OCS Detroit Medical Products Lab (DETMPL) 07/2026 OCS Irvine Medical Products Lab (IRVMPL) 03/2026 OCS New York Medical Products Lab (NYMPL) 07/2026 OCS San Juan Medical Products Lab (SNJMPL) 04/2026 OCS Tobacco Products Lab (TPL) 09/2026 OCS Winchester Engineering and Analytical Center

(WEAC) 04/2026

Prior to the assessment beginning, the FDA Laboratories will provide the assessor team all quality documentation requested, as well as the laboratory’s representative technical SOPs. The quality manual and related documentation must be reviewed by the assessor team before the assessment can begin. This review shall be done before the assessor(s) come on-site for the scheduled assessment. Upon review of submitted documentation, the assessor(s) will provide the document review results to the laboratory in writing before the scheduled onsite assessment and may ask the laboratory to implement corrective action to fill any documentation gaps required by ISO/IEC 17025 before the scheduled assessment. Prior to scheduling the full assessment, the assessor(s) shall review the draft scope(s) to determine the tests they will witness and checks on the availability of the technical personnel who perform the tests. An assessment agenda shall be provided by the assessor at least a week before the scheduled date of the assessment.

Task 2 – Accreditation Assessment

Assessments length depends on the on the extent of the desired scope, number of disciplines, and the size of laboratory. The contractor will provide the assessors with an assessor guide and checklists to follow when performing an assessment. All of the guidelines shall be consistent among the assessors in the various laboratories.

An entry briefing with laboratory management is conducted by the assessor(s). At the entry briefing, the assessor(s) review the assessment agenda and if any changes are necessary due to scheduling conflicts.

Interviews with technical staff shall be conducted from the staff matrix document submitted from the laboratory as part of the document review. Interviews shall consist of the sample analysis process for a specific technology and/or method. Assessment can also include a demonstration of selected tests or calibrations by the appropriate technical staff. The assessor(s) shall examine the equipment and calibration records. The assessor(s) audit the management system to verify that it is fully operational and that it conforms to all sections of ISO/IEC 17025, the accrediting body’s requirements, and the AOAC International requirements, including documentation. A written report of the assessor(s) findings is presented at the close of the assessment.

An exit briefing with staff is conducted to go over the findings which are identified as deficiencies in the written report. A deficiency is any nonconformity to accreditation requirements, including:

1. A laboratory’s inability to perform a test, type of test, or calibration for which it seeks accreditation.

2. A laboratory’s management system does not conform to a clause or section of ISO/IEC 17025, is not adequately documented, or is not completely implemented in accordance with that documentation.

3. A laboratory does not conform to any additional requirements of the accrediting body or specific fields of testing or programs, such as AOAC International, necessary to meet particular needs.

If no deficiencies are found, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of the assessment completion.

If deficiencies are found, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of the laboratory’s successful response to rectify any deficiency cited by the accrediting body in the exit briefing report.

Costs for any extraordinary assessment required by the contractor for investigation purposes premised on a complaint or negative assessment resulting in suspension and subsequent reassessment shall not exceed $1,400 per day plus expenses (i.e.travel, lodging, and meals) but not to exceed federal travel regulation rates. The $1,400 per day rate is inclusive of the labor, contractor overhead expense, and profit. The contractor shall supply detailed receipts as support documentation. The laboratory or office requiring the extraordinary audit will be responsible for funding.

Task 3 – Laboratory’s Response to Deficiencies

The FDA laboratory is requested to respond, in writing, detailing either its corrective action or why it does not believe that a deficiency exists. This response is due 30 days from the close of the assessment. The corrective action response must include the laboratory’s root cause analysis and a copy of any objective evidence (e.g., calibration certificates, lab procedures, paid invoices, packaging slips and/or training records) to indicate that the corrective actions have been implemented/completed. It is possible that the laboratory will disagree with the findings that one or more items are deficiencies. In that case, the laboratory is requested to explain in its response why it disagrees with the assessor(s).

Upon the laboratory rectifying and responding to the accrediting body notice of deficiency, and upon the accrediting body confirming corrections, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of confirmation.

Task 4 – Surveillance Assessment

To demonstrate the maintenance of their accreditation, an off-site documentation review will be conducted by the accreditation body. The review will consist at least of the following:

1) Proficiency testing (PT) data review,

2) Internal audit results;

3) Management review;

4) Corrective actions taken;

5) Review of changes occurred in the laboratory, and;

6) Off-site technical review of at least one item on the scope of accreditation

This review will be conducted approximately 12 months after the on-site assessment.

Deliverable Schedule

Deliverable Description Quantity/Media Date Completed

1. Document Review Results: Prior to assessor coming on site.

Email correspondence to Laboratory Quality System Manager (QSM) or Quality Representative (QR)

Review done 30 days prior to the assessor scheduled on site visit

2. The assessment agenda Email correspondence to Laboratory QSM or QR

One week before the scheduled assessment date

3. The Deficiency report for the on-site findings. If no deficiencies are observed, the deficiency report will state that none were observed

Email correspondence to Laboratory QSM/QR and the assessment coordinator QSM

Due at close of the assessment.

4. The Certificate of Accreditation containing the Scope of Accreditation

Certificate to Laboratory QSM or QR

At the close of the assessment process

5. Surveillance Assessment-off-site document review

Email correspondence to Laboratory QSM or QR

Off year of on-site assessment

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Government-Furnished Property and Information

No Government-Furnished Property, Material, Equipment or Information will be provided to the Contractor.

Security

The accrediting body will have a policy of confidentially and require that all assessors sign one which is kept on file by the accrediting body and updated before the on-site assessment of an FDA Regulatory Laboratory. Assessors will be escorted during the assessment by assigned FDA personnel.

Place of Performance

Laboratory Name Laboratory Address Scope Disciplines Arkansas Human and Animal Food Lab (ARHAFL)

3900 NCTR Rd, Bldg. 26 Jefferson, AR 72079-9502

Biological Chemical

Atlanta Human and Animal Food Lab (ATHAFL)

60 Eighth Street NE Atlanta, GA 30309

Biological Chemical

Denver Human and Animal Food Lab (DENHAFL)

6th Ave. & Kipling Denver Federal Center, Bldg. 20 Denver, CO 80225

Biological Chemical

Irvine Human and Animal Food Lab (IRVHAFL)

19701 Fairchild Irvine, CA 92612

Biological Chemical

Kansas Human and Animal Food Lab (KCHAFL)

10749 W. 84th Terrace Lenexa, KS 66214 Chemical

New York Human and Animal Food Lab (NYHAFL)

158-15 Liberty Avenue Jamaica, NY 11433-1034

Biological Chemical

San Francisco Human and Animal Food Lab

(SANHAFL)

1201 Harbor Bay Parkway Alameda, CA 94502

Biological Chemical

Seattle Human and Animal Food Lab (SEAHAFL)

22201 23rd Drive SE Bothell, WA 98021-4421

Biological Chemical

Detroit Medical Products Lab

(DETMPL)

300 River Place, Suite 5900 Detroit, MI 48207 Chemical

Irvine Medical Products Lab

(IRVMPL)*

19701 Fairchild Irvine, CA 92612

Biological Chemical

New York Medical Products Lab (NYMPL)*

158-15 Liberty Avenue Jamaica, NY 11433-1034

Biological Chemical

San Juan Medical Products Lab (SJNMPL)

466 Fernandez Juncos Ave San Juan, PR 00901 Chemical

Tobacco Products Lab (TPL)* 60 Eighth Street NE Atlanta, GA 30309 Chemical

Winchester Engineering and Analytical Center (WEAC)

109 Holton Street Winchester, MA 01890

Biological Chemical Mechanical

*Lab is currently co-located with a Human and Animal Food Lab

Office Assessment Coordinator Contacts

Name Title Email Address Danny Noe OCS/OSLA Quality System

Manager (assessment coordinator) Danny.Noe@fda.hhs.gov

Maren Forsyth HFP/QMS Quality System Manager (assessment coordinator)

Maren.Forsyth@fda.hhs.gov

Laboratory points of contact and email addresses with be provided upon award of the contract.

Period of Performance

The period of performance includes a 12-month base period, with four (4) 12-month option periods.

Base Period: January 01, 2025 – December 31, 2025 Option Period 1: January 01, 2026 – December 31, 2026 Option Period 2: January 01, 2027 – December 31, 2027 Option Period 3: January 01, 2028 – December 31, 2028 Option Period 4: January 01, 2029 – December 31, 2029

The Base Year of the contract will be from 01/01/2025-12/31/2025. During the Base Year an On-Site assessment will be performed for 3 FDA Human and Animal Food (HAF) Laboratories.

Off-Site Surveillance will be performed for 11 FDA Laboratories which consist of 5 HAF labs and 6 OCS Laboratories. See Scheduled of Assessments table below for a listing of the laboratories.

Option Year One of the contract will be from 01/01/2026-12/31/2026. During the Option Year an On-Site assessment will be performed for 5 HAF and 6 OCS Laboratories for a total of 11.

Off-Site Surveillance will be performed for 3 of the HAF Laboratories. (See Scheduled Items below for a listing of the laboratories).

Option Year Two of the contract will be from 01/01/2027-12/31/2027. During the Option Year On-Site assessments will be performed for 3 of the HAF Laboratories. Off-Site Surveillance will be performed for 11 FDA Laboratories which consist of 5 HAF and 6 OCS Laboratories. (See Scheduled Items below for a listing of the laboratories).

Option Year Three of the contract will be from 01/01/2028-12/31/2028. During the Option Year an On-Site assessment will be performed for 5 HAF and 6 OCS Laboratories for a total of 11.

Off-Site Surveillance will be performed for 3 of the HAF Laboratories. (See Scheduled Items below for a listing of the laboratories).

Option Year Four of the contract will be from 01/01/2029-12/31/2029. During the Option Year On-Site assessments will be performed for 3 of the HAF Laboratories. Off-Site Surveillance will be performed for 11 FDA Laboratories which consist of 5 HAF and 6 OCS Laboratories. (See Scheduled Items below for a listing of the laboratories).

Schedule of Assessment Types Due in Base through Option Years (OY) 1-4

Laboratory Base Year 01/2025- 12/2025

OY1

01/2026- 12/2026

OY2

01/2027- 12/2027

OY3

01/2028- 12/2028

OY4

01/2029- 12/2029

Human Food Laboratories

ARHAFL (A) (S) (A) (S) (A)

ATHAFL (S) (A) (S) (A) (S)

DENHAFL (S) (A) (S) (A) (S)

IRVHAFL (S) (A) (S) (A) (S)

KCHAFL (S) (A) (S) (A) (S)

NYHAFL (S) (A) (S) (A) (S)

SANHAFL (A) (S) (A) (S) (A)

SEAHAFL (A) (S) (A) (S) (A)

OCS/ Medical Products and Specialty Laboratories

DETMPL (S) (A) (S) (A) (S)

IRVLMPL (S) (A) (S) (A) (S)

NYLMPL (S) (A) (S) (A) (S)

SJNMPL (S) (A) (S) (A) (S)

TPL (S) (A) (S) (A) (S)

WEAC (S) (A) (S) (A) (S)

(A) = Accreditation/On-site Assessment

(S) = Surveillance/Off-site Assessment

Contract Type

This is a Firm Fixed Price order.

Government Points of Contact

Contracting Officers Representative (COR): Louis Imboden (Louis.Imboden@fda.hhs.gov) Contracting Officer (CO): James Jenrette (James.JenretteIII@fda.hhs.gov) Contracting Specialist (CS): Amanda Edger (Amanda.Edger@fda.hhs.gov)

Observance of Federal Holidays

The Government will not require support at the Government facility on Saturdays, Sundays, or the Federal holidays shown below, or days of government closure due to inclement weather:

1. New Year's Day 1 January

2. Martin Luther King's Birthday Third Monday in January

3. President's Day Third Monday in February

4. Memorial Day Last Monday in May

5. Juneteenth (Observed) 19 June

6. American Independence Day (Observed) 4 July

7. Labor Day First Monday in September

8. Columbus Day Second Monday in October

9. Veteran's Day 11 November

10. Thanksgiving Day Fourth Thursday in November

11. Christmas Day (Observed) 25 December

Note: 2025 will have an additional Federal Holiday, January 20, 2025, will be Inauguration Day.

The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

Inclement Weather – The Vendor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Vendor shall follow directives issued by responsible officials concerning reporting for work.

Clauses

HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for BPA 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 BPA.

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

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

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

(End of clause)

Federal Acquisition Regulation (FAR) Provisions Incorporated by Reference

FAR Clause Title Date 52.204-7 System for Award Management OCT 2018 52.204-8 Annual Representations and Certifications MAY 2024 52.204-8 Annual Representations and Certifications MAR 2020

--Alternate I 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-17 Ownership or Control of Offeror AUG 2020 52.217-5 Evaluation of Options JUL 1990

Federal Acquisition Regulation (FAR) Provisions Incorporated in Full Text

FAR 52.252-1 Solicitation Provisions Incorporated by Reference This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://acquisition.gov/far/

(End of clause)

Federal Acquisition Regulation (FAR) Clauses Incorporated by Reference

FAR Clause Title Date 52.204-9 Personal Identity Verification of Contractor

Personnel JAN 2011 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards JUN 2020 52.204-13 System for Award Management Maintenance OCT 2018 52.204-14 Service Contract Reporting Requirements OCT 2016 52.204-18 Commercial and Government Entity Code

Maintenance AUG 2020 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities NOV 2021

52.204-25 Prohibition of Contracting for Certain Telecomunications and Video Surveillance Services or Equipment NOV 2021

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment NOV 2021

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations NOV 2015

52.217-8 Option to Extend Services NOV 1999 52.217-9 Option to Extend the Term of the Contract MAR 2000 52.219-28 Post-Award Small Business Program

Rerepresentation MAR 2023 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-50 Combating Trafficking in Persons NOV 2021 52.222-54 Employment Eligibility Verification MAY 2022 52.223-10 Waste Reduction Program MAY 2024 52.224-3 Privacy Training JAN 2017 52.226-8 Encouraging Contractor Policies to Ban Text

Messaging While Driving MAY 2024 52.232-33 Payment by Electronic Funds Transfer—

System for Award Management OCT 2018 52.232-40 Providing Accelerated Payments to Small

Business Subcontractors MAR 2023 52.233-3 Protest after Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

Federal Acquisition Regulation (FAR) Clauses Incorporated in Full Text

FAR 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 this/these address(es):

https://acquisition.gov/far/

FAR 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)

(a) Definitions. As used in this clause— Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L.

117- 328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23 13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

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 BPA financing payment or invoice payment by the Vendor. 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 BPA, 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

1. The Agency will enroll the Vendors new to IPP. The Vendor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Vendor 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 BPA 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. Vendor 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 Vendor 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 Vendor 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 BPA 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 Vendor;

• Other Direct Costs - include a listing of all other direct charges to the BPA, 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. Vendor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for BPA 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 BPA 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 Vendor 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 Vendor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Vendor 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 Vendor personnel are performing. This may, however, be justification for excusable delays.

j. The Vendor 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 BPA number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.