75F40122Q00079_1255257_Combined Synopsis Solicitation.pdf

Document Type: Combined Synopsis/Solicitation

Solicitation Number: 75F40122Q00079_1255257

Posted Date: May 31, 2022

Response Date: June 14, 2022 (1pm Central Time)

NAICS Code: 541380 – Testing Laboratories; with a Small Business Size Standard of $15 Million

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

1201 Main Street Dallas, TX 75202

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items”, as supplemented with additional information included on this notice and in conjunction with FAR Part 13.106, utilizing Simplified Acquisition Procedures. This announcement constitutes the only solicitation; offers are being requested, and a written solicitation document will not be issued. The solicitation number is 75F40122Q00079_1255257. This solicitation is issued as a Request for Quote (RFQ). This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-06 dated May 1, 2022.

The associated North American Industry Classification System (NAICS) Code for this procurement is 541380 – Testing Laboratories; with a Small Business Size Standard of $15 Million. This combined/synopsis solicitation is full and open competition.

STATEMENT OF WORK

Food and Feed Laboratory Annual Proficiency Testing

Background:

Proficiency Testing (PT) programs are an external quality control to measure a laboratory’s proficiency. FDA field laboratories must maintain ISO 17025 accreditation. According to ISO 17025 requirements and AOAC guidelines, laboratories are required to participate in relevant and available proficiency testing provided by accredited proficiency testing providers administering acceptable proficiency testing programs which are conducted yearly.

Objectives:

The Food and Drug Administration (FDA)/Office of Regional Affairs/Office of Regulatory Science (ORS) has a requirement for the purchase of ORS Food and Feed Laboratory annual Proficiency Testing for the following three programs:

1. Standard Microbiology

2. Pesticide Residue in Fruits and Vegetables

3. Nutrients in Infant Formula and Adult Nutritional’s

Scope:

ORS requires proficiency testing (PT) services, from an ISO 17043-accredited provider whose accreditation scope includes, at a minimum: Microbiology in Foods, Pesticides in foods, and Vitamins and Nutrients in Infant Formulas. The contractor shall conduct accredited Proficiency Testing in all three programs listed in this Statement of Work (e.g. the Standard Microbiology Program, Pesticide Residue in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals) for laboratories that conduct analyses in the area of food safety as specified below:

1. Standard Microbiology Program – Proficiency Testing in this program must demonstrate proficiency in detection of pathogens (including Salmonella, E. coli O157:H7, and Listeria), as well as quantifying E. coli, Coagulase Positive Staphylococcus, yeast and mold, and aerobic organisms. The contractor shall provide test samples, qualitative and quantitative, at a frequency of four shipments per year to each lab. Evaluation of O and H antigens is to be included for Salmonella and identification of Listeria species.

2. Pesticide Residues in Fruits and Vegetables - Proficiency Testing in this program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for possible pesticide residues in fruit and vegetable matrix.

3. Nutrients in Infant Formula and Adult Nutritionals - Proficiency Testing in this Program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol.

4. PT Samples, whose expected values are to be unknown to the labs, are to be shipped to identified FDA labs by the contractor. Labs are to analyze the PT samples and return their results electronically to the contractor. The contractor will collect the returned results and review them to determine whether each participating laboratory passes or fails established performance levels, A performance evaluation will then be issued to both the evaluated lab and to designated technical point of contact (TPOC). The cost of all shipping and handling of PT test materials is to be included as part of the total contract cost and paid by the contractor.

Requirements:

The contractor will independently and not as an agent of the Government, furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incidental to the performance of the work as described below:

A. Detailed Description The contractor will conduct Proficiency Testing for Microbiology, Pesticides in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals as follows:

Microbiology Proficiency Testing Rounds Frequency: Four (4) rounds per year at 3 to 4 month intervals to each of the labs identified in Table 1 Microbiology below.

Tests Required:

Identification of pathogens - Salmonella, E. coli O157:H7, Listeria species Quantification –E. coli, Coagulase Positive Staphylococcus, yeast and mold aerobic organisms.

Stereotyping – O and H antigens for Salmonella.

Matrix: mashed potato

Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to seven (7) different locations as follows:

Table 1 Microbiology Program Site Location and POC Information FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079-9502 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433-1034 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC to be determined at time of award

FDA/San Francisco Laboratory 1201 Harbor Bay Parkway Alameda, CA 94502 POC to be determined at time of award

FDA/Denver Laboratory 6th Ave. & Kipling Building 20 W10 Denver, CO 80225

Pesticide Proficiency Testing Rounds Frequency: Two (2) rounds per year with at least 3-month intervals between rounds to each of the labs identified in Table 2 Pesticide below.

Tests Required: Three (3) major pesticide groups covered with a variety of different compounds

Carbamates Organophosphates Chlorinated Hydrocarbons

Matrix: Vegetable and/or fruit matrix

Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to five (5) different locations as follows:

Table 2 Pesticide Program Site Location and POC Information

FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079- 9502 POC to be determined at time of award

FDA/Kansas City Laboratory 10749 W. 84th Terrace Lenexa, KS 66214 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433- 1034 POC to be determined at time of award

Nutrients Proficiency Testing Rounds Frequency: Three (3) rounds per year with 3-4 month intervals to laboratory identified in Table3 Nutrition below.

Tests Required –This program will include vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol

Matrix: Infant Formula/Adult Nutritionals matrix Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for evaluation of results and for trending of data Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to one location as follows:

Table 3 Nutrition Program Site Location and POC Information Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309

Reporting Requirements

A. Reports

For the Standard Microbiology Program, the contractor shall provide the individual labs an electronic copy of their individual results, which is included in the participant cost of the program. There must also be a compiled summary report for each of the four (4) shipments per year for this program.

For the Pesticide Residue Program, the individual labs will receive an electronic copy of their individual results, this is included in the participant cost of the program. There must also be a compiled summary report for each of the two (2) shipments per year for this program.

For the Nutrients in Infant Formula and Adult Nutritionals Program, the individual lab will receive an electronic copy of its results, this is included in the participant cost of the program. There must also be a complied summary report for each of the three (3) shipments per year for this program.

B. Compiled Reports Base Year

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the TPOC, (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three (3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in the base year.

Option Years

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the TPOC (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three (3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in each of the option years.

Delivery Instructions for Reports

Unless otherwise specified, all reports or copies of reports shall be delivered to: E-mail:(to be identif ied at time of award)

Deliverables:

Base Year - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

3 30 Days after end of PT round

Option Year 1 - Proficiency Testing per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

Option Year 2 - Proficiency Testing per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

Option Year 2 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

Option Year 3 - Proficiency Testing per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

Option Year 3 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritional’s Program

1. Infant Formula/Adult Nutritional’s Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 TPOC

**To be identified at the time of the award of the contract

Contract Type: Firm Fixed Price Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized.

An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price Extended Price

1 Proficiency Testing as described in the MinimumTechnical Requirements (Statement of Work) section

12 Mths

2 Optional Year 1 (FAR 52.217-9) Proficiency Testing as described in the Minimum Technical Requirements section

3 Optional Year 2 (FAR 52.217-9) Proficiency Testing as described in the

4 Optional Year 3 (FAR 52.217-9) Proficiency Testing as described in the

Grand Total Items 1 thru 5

Total Price, Base Year and Options: $_______________________ GSA Contract Number (If applicable): _______________________ *Significant price increases beyond those of expected inflation for Option Year services shall be explained and supported in the offer.

Period of Performance

Base Period – August 1, 2022- July 31, 2023 Option Year 1 – August 1, 2023- July 31, 2024 Option Year 2 – August 1, 2024- July 31, 2025 Option Year 3 – August 1, 2025- July 31, 2026

FOB Destination:

Warranty and preventative maintenance visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Place of Performance/Shipping Destinations The Place of Performance is the Contractor’s Place of Business.

Shipping Destinations:

See laboratory addresses in tables in Scope section.

Clauses and Provisions:

The full text of FAR and HHSAR provisions and clauses may be accessed electronically at http://acquisition.gov/far/index.html or https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

CLAUSES

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

The following FAR 52.212-4 addenda apply:

http://acquisition.gov/far/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The Contractor shall only tender for acceptance of those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services.

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.

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Governments Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the Contracting Officer.

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.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The following Technical Point of Contact (TPOC) will represent the Government for the purpose of this contract (To be provided upon contract award):

Name:

Email address:

Phone:

The contact information for the Contract Specialist:

Name: Yolanda Rankin Email Address: Yolanda.rankin@fda.hhs.gov Phone: (214) 253-4954

The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition.

FAR 52.204-13 System For Award Management Maintenance (Oct 2018)

FAR 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

FAR 52.217-9 Option To Extend the Term of the Contract (MAR 2000)

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

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 4 years.

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

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 contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

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

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

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

https://www.acquisition.gov/far/

(END OF CLAUSE)

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

• E207 Software (Appendix A, Application and Scoping Requirements)

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

Payments

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 https://www.hhs.gov/web/section-508/accessibility-checklists/index.html http://www.ipp.gov/vendors/index.htm

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

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

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

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

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

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

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

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

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

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

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

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

https://www.ipp.gov/

• 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.

Payments

Payments will not be made more frequently than monthly in arrears. Advance payments will not be made.

QUESTIONS CONCERNING TERMS OF THIS ORDER (Other than invoice-related) SHOULD BE DIRECTED TO: Yolanda Rankin (214) 253-4954 or yolanda.rankin@fda.hhs.gov

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) Change the delivery schedule

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

The Contract Officer for this order is:

XXXXX, Contracting Officer

3900 NCTR Road

HFT-320

Jefferson, AR 72079

Phone: (870) 543-XXXX

Email: xxxxxx@fda.gov

The TPOC is responsible for:

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;

mailto:yolanda.rankin@fda.hhs.gov mailto:xxxxxx@fda.gov

(5) Assisting in the resolution of technical problems encountered during performance.

The TPOC for this order is:

To be identified at time of award.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (MAY 2022) (Deviation 2017-02, Jun 2017) (Deviation APR 2020) (DEVIATION 2020-05 Oct 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L.

115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

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

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 https://www.acquisition.gov/far/part-52#FAR_52_209_10 https://www.acquisition.gov/far/part-52#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

[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. 2402).

__ (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 and Requirement to Inform Employees of Whistleblower Rights (Jun 2020) (Deviation 2017-02) (41 U.S.C.

4712) relating to whistleblower protections)

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

__ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (SEP 2021) ( 15 U.S.C. 657a).

X (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

https://www.acquisition.gov/far/part-52#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_203_15 https://www.acquisition.gov/far/part-52#FAR_52_203_17 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_209_6 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_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

__ (14) [Reserved]

__ (15) (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.

__ (16) (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.

__ (17) 52.219-8, Utilization of Small Business Concerns (OCT 2018) ( 15 U.S.C. 637(d)(2) and (3)).

__ (18) (i) 52.219-9, Small Business Subcontracting Plan (NOV 2021) ( 15 U.S.C. 637(d)(4)).

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

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

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

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

__ (19) (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.

__ (20) 52.219-14, Limitations on Subcontracting (SEP 2021) ( 15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (SEP 2021) ( 15 U.S.C. 657f).

X (23) (i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2021) ( 15 U.S.C. 632(a)(2)).

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

https://www.acquisition.gov/far/part-52#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_28

__ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (SEP 2021) ( 15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women- Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (SEP 2021) ( 15 U.S.C. 637(m)).

__ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ( 15 U.S.C. 644(r)).

__ (27) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)).

X (28) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (31) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

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

X (32) (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 (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

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

X (34) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

X (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

X (36) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 22 U.S.C. chapter 78 and E.O. 13627).

https://www.acquisition.gov/far/part-52#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/part-52#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-52#FAR_52_222_21 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title29-section793&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50

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

13627).

__ (37) 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.)

__ (38) (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.)

__ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (41) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

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

__ (42) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

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

__ (43) 52.223-15, Energy Efficiency in Energy- Consuming Products (MAY 2020) ( 42 U.S.C. 8259b).

__ (44) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

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

X (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

https://www.acquisition.gov/far/part-52#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_222_54 https://www.acquisition.gov/far/part-22#FAR_22_1803 https://www.acquisition.gov/far/part-52#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_11 https://www.acquisition.gov/far/part-52#FAR_52_223_12 https://www.acquisition.gov/far/part-52#FAR_52_223_13 https://www.acquisition.gov/far/part-52#FAR_52_223_13 https://www.acquisition.gov/far/part-52#FAR_52_223_14 https://www.acquisition.gov/far/part-52#FAR_52_223_14 https://www.acquisition.gov/far/part-52#FAR_52_223_15 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_223_16 https://www.acquisition.gov/far/part-52#FAR_52_223_16 https://www.acquisition.gov/far/part-52#FAR_52_223_18

__ (46) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (47) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (48) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

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

__ (49) 52.225-1, Buy American-Supplies (NOV 2021) ( 41 U.S.C. chapter 83).

__ (50) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV2021) ( 41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C.