RFQ 75F40125Q00183.pdf

Request for Quotation (RFQ) No. 75F40125Q00183 Human Foods Program (HFP)

Spiral Plater and Colony Counter System

1. DESCRIPTION/COMMERICAL PRODUCTS AND COMMERCIAL SERVICES

PROCUREMENT

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. This is Request for Quotation (RFQ) no.

75F40125Q00183 for commercial products and commercial services in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Part 13- Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) code is 334516

- Analytical Laboratory Instrument Manufacturing. The associated small business size standard is 1,000 employees.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, effective January 17, 2025.

The FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov

The Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following website:

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

3. PURCHASE ORDER REQUIREMENTS

See Section 7, Statement of Work, for a full description of the products and services to be acquired.

4. ORDER TYPE

The Government anticipates awarding one (1) Firm-Fixed Price (FFP) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance consists of one (1), 12-month base year and no option periods.

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

6. PRICING

Anticipated Period of Performance: Base Year (June 23, 2025, through June 22, 2026) Item Description (Brand Name or Equal)

Quantity Unit Unit Price Extended Price

Eddy Jet 2W Automatic Plater for Spiral Plater, 115V) (90003800) 1 EA $ $

Plexiglass shelf for Eddy Jet 2

(900011588) 1 EA $ $

Sphere Flash Unit with Colony LITE software included (90007000) 1 EA $ $

Sphere Flash Pro Software Upgrade

(90007001) 1 EA $ $

Laptop Computer 1 EA $ $ 12-month service agreement 1 EA $ $ Eddy Jet Syringe Tips, pack of 1000

(90001780) 1 EA $ $

Eddy Jet Cups/Beakers, pack of 1000

(90001790) 1 EA $ $

TOTAL FIRM-FIXED PRICE (FFP) $

7. STATEMENT OF WORK

U.S. Food and Drug Administration (FDA)

Title: Spiral Plater and Colony Counter System for Campylobacter Method Development and Validation

BACKGROUND

With the recent increase in Campylobacter outbreaks from raw oyster consumption, there is a need to update the current Bacteriological Analytical Manual (BAM) method for detecting Campylobacter in oysters. Additionally, no methods exist to quantify the levels of Campylobacter in oysters, which would allow us to perform applied research to answer industry and policy related questions. Therefore, updated methods need to be developed, optimized, and validated to allow for the appropriate research to be performed. The spiral plater and colony counter system will aid in the evaluation and selection of new selective and differential agars for inclusion into the BAM methods, while decreasing the number of agar plates and inoculations needed. This will ultimately save time, money, and resources while increasing efficiency.

OBJECTIVE

The objective of this Purchase Order is to acquire a spiral plater and colony counter system to update, develop, optimize, and validate new BAM methods for detecting and quantifying thermotolerant Campylobacter in oysters.

SALIENT CHARACTERISTICS (BRAND NAME OR EQUAL)

The salient characteristics are based upon the Eddy Jet 2W Automatic Spiral Plater and the SphereFlash Automated Colony Counter manufactured by the NEU-TEC GROUP INC. To be considered brand name or equal, the spiral plater and colony counter system must be capable of, and include the following:

• Spiral plater, with the following characteristics:

o Able to accommodate a petri dish diameter of 150 millimeters (mm) or 15 centimeters (cm) o Able to use sterile disposable consumables for transferring the culture or dilution to the agar plate. This will eliminate the need for a vacuum pump, waste containers, and bleach sterilization of reusable components, like tubing and waste bottles, that can lead to contamination o The consumables must be fully traceable with quality control documentation available upon request o Able to dispense a calibrated volume of sample onto an agar plate to produce a spiral plate pattern with three serial dilutions o Minimum reproducibility of 99% o Able to pipet or transfer up to 100 microliters (µL) of culture to agar plate o Able to create custom programs for spiral plating o Able to create spiral plating pattern that can be counted by an automatic colony counter o 115 Volt (V) electrical requirements

• Automated Colony Counter:

o Ability to accommodate petri dish sizes up to 150 millimeters (mm) or 15 centimeters (cm) o Ability to capture high quality images of all agar plates (opaque, transparent, etc.)

o Ability to accurate count small (less than 0.1 millimeter; mm) bacterial colonies on an agar plate o Compatible with computer software for analysis o 115 Volt (V) electrical requirements

• Computer software for automated colony counter:

o Automatically counts bacterial colonies on agar plate o Allows for adding or deleting colonies from an agar plate o Ability to record color and size of bacterial colonies o Generates reports with data o Ability to export image files

• Appropriate computer to run software

• Sterile consumables (syringes or equivalent, cups or equivalent)

SPECIFIC TASKS FOR MAINTENANCE AGREEMENT

1. No warranty required.

2. Service agreement for one (1) year after purchase that includes one (1) preventative maintenance and parts and labor for repairs.

3. Upon completion of each service call (inclusive of service/maintenance calls) the

Contractor shall 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 Contracting Officer’s Representative (COR) and Contract Specialist, not later than the 5th workday following the end of each month, summarizing the maintenance and repair activities for the previous month; negative reports are required.

DELIVERABLES

Deliverables are specified in Table 1 below.

Table 1: Deliverables/Schedule

Deliverable Quantity Delivery Date

Spiral Plater 1 June 23, 2025

Automated Colony Counter 1 June 23, 2025

Computer Software 1 June 23, 2025

Computer 1 June 23, 2025

Sterile syringes or equivalent 1 June 23, 2025

Sterile cups or equivalent 1 June 23, 2025

Service Agreement 1 June 23, 2025

8. SHIPPING DESTINATION

FDA Gulf Coast Seafood Lab Victoria Pruente 1 Iberville Drive Dauphin Island, AL 36528

The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays.

9. PERIOD OF PERFORMANCE (POP)

The Period of Performance (PoP) is the 12-month period following the date of award, anticipated to commence on June 23, 2025. The actual PoP will be determined at time of award.

10. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO)

• Name and Position: Nicholas Bisher, Lead Contract Specialist

• Phone: 240.402.2773

• Email: Nicholas.Bisher@fda.hhs.gov

Contract Specialist (CS)

• Name and Position: Melinda Kim, Contract Specialist

• Phone: 301.796.0607

• Email: Melinda.Kim@fda.hhs.gov mailto:Nicholas.Bisher@fda.hhs.gov mailto:Melinda.Kim@fda.hhs.gov

Contracting Officer’s Representative (COR)

• Name and Position: Sonja Dexter, Program Specialist

• Phone: (251) 406-8135

• Email: Sonja.Dexter@fda.hhs.gov

Technical Point of Contact (TPOC)

• Name and Position: Victoria Pruente, Research Microbiologist

• Phone: (251) 406-8146

• Email: Victoria.Pruente@fda.hhs.gov

11. CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting, ensuring compliance with the terms of the Purchase Order, and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this Purchase Order and is the only person authorized to approve changes to any of the requirements under this Purchase Order; notwithstanding any provision contained elsewhere in this Purchase Order, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the CO, shall be interpreted as modifying the terms and conditions of the Purchase Order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the Purchase Order. The Government will not reimburse the Contractor for any work not authorized by the CO.

12. COMPLIANCES

Contractor Compliance The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: https://www.cio.gov/. HHS documents are found at:

https://www.hhs.gov/.

13. GOVERNMENT CLOSURES AND FEDERAL HOLIDAYS

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, D.C. area:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday

Memorial Day mailto:Sonja.Dexter@fda.hhs.gov mailto:Victoria.Pruente@fda.hhs.gov

Juneteenth National Independence Day Independence Day

Labor Day Columbus Day

Veterans Day Thanksgiving Day

Christmas Day

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management (OPM) or other such official for late arrivals due to inclement weather (unless otherwise specified in the Purchase Order).

In the event the Federal Government is closed by order of the President of the United States or OPM for any reason, or the agency, the Center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by the COR or Contracting Officer concerning reporting for work. In the event of early closings, the Contractor may be approved to leave early at the discretion of the COR and/or local policy.

14. INVOICING INSTRUCTIONS AND REQUIREMENTS

Health and Human Services Acquisition Regulation (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.

(End of Clause)

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 http://www.ipp.gov/ 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 FAR 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;

• 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.

15. CONTRACTOR ADVERTISING OF CONTRACT AWARD (SEP 2012)

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies the U.S. Food and Drug Administration’s approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

16. NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENTAL

FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor.

The Contractor and the Contractor’s employees are not employees of the Federal Government and are not eligible for entitlement to benefits given Federal employees.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration, or control over personnel or personnel of other Government contractors or become a part of the Government organization.

• Be used in administration or supervision of procurement activities.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of the contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

17. REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-

TIPS (1-800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-

8164, TTY

1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

18. NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

19. PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this contract prior to being assigned to the awarded contract.

20. GOVERNMENT-FURNISHED DATA AND MATERIALS

The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data. These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

21. TRANSITION

The Contractor shall provide all management, administrative, clerical, and supervisory functions required for the effective and efficient performance of this contract.

A smooth and orderly transition between the Contractor and a predecessor or successor Contractor is necessary to ensure minimum disruption to vital Government business. The Contractor shall cooperate fully in the transition.

The Contractor shall adhere to the same professional and ethical standards of conduct required of Government personnel. The Contractor shall NOT:

• Discuss with unauthorized persons any information obtained in the performance of work under this contract;

• Conduct business not directly related to this contract on Government premises;

mailto:hhstips@oig.hhs.gov

• Use computer systems and/or other Government facilities for company or personal business other than work related to this contract; or

• Recruit on Government premises or otherwise act to disrupt official Government business.

It is the Government’s intention to perform closeout procedures on an individual contract basis.

The Contractor agrees to perform those internal functions necessary to support this process in a timely manner. The contract closeout will occur as soon as possible after required audit and establishment of final rates, as applicable.

22. INSURANCE REQUIREMENTS

The Contractor shall maintain the types of insurance and coverage required in FAR 28.307-2.

23. FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

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):

http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) PROVISIONS:

NUMBER TITLE DATE

52.203-11 CERTIFICATION AND DISCLOSURE REGARDING SEP 2024

PAYMENTS TO INFLUENCE CERTAIN FEDERAL

TRANSACTIONS

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT JAN 2017

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS - REPRESENTATION

52.204-7 SYSTEM FOR AWARD MANAGEMENT NOV 2024

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

REPORTING

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR AUG 2020

52.204-24 REPRESENTATION REGARDING CERTAIN NOV 2021

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OCT 2020

OR SERVICES-REPRESENTATION

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

DOMESTIC CORPORATIONS-REPRESENTATION

52.211-6 BRAND NAME OR EQUAL AUG 1999

http://www.acquisition.gov/comp/far/index.html.

http://www.acquisition.gov/comp/far/index.html.

52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS SEP 2023

AND COMMERCIAL SERVICES

Please note: System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations, including 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

FAR 52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services (MAY 2024) (DEVIATION FEB 2025)

• This provision applies to this solicitation. Offerors shall provide the required data with their quotations in accordance with FAR 52.212-3. (Please include completed representations and certifications, not already completed in SAM.gov.)

24. FAR PROVISIONS INCORPORATED BY FULL TEXT:

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of a Firm-Fixed-Price (FFP) type Purchase Order resulting from this solicitation.

25. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/browse/index/far.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES:

NUMBER TITLE DATE

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN JUN 2020

FEDERAL TRANSACTIONS

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR JAN 2011

PERSONNEL

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

MAINTENANCE

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS DEC 2014

AND CERTIFICATIONS

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL NOV 2023

PRODUCTS AND COMMERCIAL SERVICES

52.227-14 RIGHTS IN DATA – GENERAL MAY 2014

52.232-1 PAYMENTS APR 1984

52.232-23 ASSIGNMENT OF CLAIMS MAY 2014

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL MAR 2023

BUSINESS SUBCONTRACTORS

52.233-1 DISPUTES MAY 2014

52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM OCT 2004

52.237-3 CONTINUITY OF SERVICES JAN 1991

52.242-15 STOP-WORK ORDER AUG 1989

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

52.243-1 CHANGES-FIXED-PRICE AUG 1987

52.243-1 CHANGES-FIXED-PRICE, ALT I APR 1984

52.246-4 INSPECTION OF SERVICES—FIXED-PRICE AUG 1996

52.246-25 LIMITATION OF LIABILITY-SERVICES FEB 1997

52.249-1 TERMINATION FOR CONVENIENCE OF THE APR 1984

GOVERNMENT (FIXED-PRICE) (SHORT FORM)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (JAN 2025)

(DEVIATION FEB 2025)

• The additional FAR clauses cited in this clause that have an “X” next to them are applicable to this solicitation. Full text of this clause is provided in (Attachment A).

26. FAR CLAUSES IN FULL TEXT:

FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(a) Definitions. As used in this clause-

Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with 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) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

(a) Definitions. As used in this clause— Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information ( 44 U.S.C.

3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the Order. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed six (6) months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the Order expires.

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 prior to Order expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend prior to Order expiration. The preliminary notice does not commit the Government to an extension.

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

(c) The total duration of this Order, including the exercise of any options under this clause, shall not exceed one (1) year and six (6) months.

27. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES INCORPORATED BY

REFERENCE:

HHSAR Clauses can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR Clause # Clause Title Date 352.211-3 Paperwork Reduction Act Dec 2015

28. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR CHAPTER 3) PROVISIONS AND CLAUSES IN

FULL TEXT:

HHSAR Provisions and Clauses can be viewed in full text at:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR 352.209-1 CONTRACTOR COMPLIANCE WITH DEFENDING WOMEN

AND PROTECTING CHILDREN REQUIREMENTS – CERTIFICATION (MARCH

2025) (DEVIATION)

(a) Certification. By submission of this offer and during performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor certifies that: [Offeror shall check each item.]

___ (1) It is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Contractor will remain compliant for the duration of the contract.

___ (2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

___ (3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

___ (4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

____ (5) Submitting a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of provision)

HHSAR 352.209-2 CONTRACTOR COMPLIANCE WITH DEFENDING WOMEN AND

PROTECTING CHILDREN REQUIREMENTS (MARCH 2025) (DEVIATION)

(a) During performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor agrees that:

(1) It must remain compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of 177 the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq.

(2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

(3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

(4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

(5) Submission of a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under

18 U.S.C. §§ 287 and 1001.

(b) The Contractor must include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract.

(c) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

HHSAR 352.222-70: RESERVED (DEVIATION)

HHSAR 352.227-70 - PUBLICATIONS AND PUBLICITY (DEC 2015)

(a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor shall promptly send a copy of each article submitted for publication to the Contracting Officer's Representative. The Contractor shall also inform the Contracting Officer's Representative when the article or other publication is published, and furnish a copy of it as finally published.

(b) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo including Operating Division or Staff Division logos on any publications.

(c) The Contractor shall not reference the product(s) or service(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

(d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract.

29. QUOTATION INSTRUCTIONS

The quote must be prepared and submitted in three parts: “Volume I – Executive Summary,” “Volume II -Technical Quote,” and “Volume III – Business Quote.” All parts shall be separate attachments and complete so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The FDA is not responsible for any costs incurred in preparing the documents described in this solicitation.

Volume I - Contains the Executive Summary, which includes the following information:

• Cover Letter – Must be signed by an individual that has the authority to bind the company. The cover letter must include the following, at a minimum:

o Name of Offeror and Address o Unique Entity ID (UEI) o Point of Contact – Name, telephone number and email address o Statement that the quote is valid for 90 days

Volume II –Technical Quote

The Technical Quote must include information on resources required, such as labor categories and hours, subcontractors, travel, etc., but no associated costs should be provided in Volume II -- Technical Quote.

The Technical Quote shall disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the Technical Quote instructions and the technical evaluation criteria listed below. The technical quote (Volume II) shall be limited to 15 pages. This limitation excludes resumes (if provided) and any commitment documentation. The technical quote shall include a table of contents.

The Technical Quote is the most important item in the evaluation of your capability to perform the desired services. Therefore, your quote must present sufficient information to reflect a thorough understanding of the work requirements and a detailed technical approach for achieving project objectives as set forth in the Statement of Work (SOW).

To permit a thorough and effective evaluation, the technical portion of your quote must be as concise, complete and clear as possible to enable the Government to make a sound determination of your ability to successfully complete the requirements set forth in the SOW. The inclusion of any important considerations not covered by this request is encouraged. Statements to the effect that the Offeror “understands and will comply” with the SOW (in whole or in part) or phrases such as “standard procedures will be used” or “well-known techniques will be utilized,” and other such generalities will not constitute compliance with the requirements. It is essential that you present in your quote, information in sufficient detail to permit the Government to make an evaluation of the technical quote without further information being required. The Government reserves the right to award based upon initial quotes received. The Offeror shall clearly state any areas in which assumptions are based or clearly state areas that deviate from the requirements stated in the SOW.

Volume III –Business Quote

The Business Quote shall consist of a cover page, a table of contents, and the information requested in the Business Quote Instructions set forth below. There is no page limitation for the business quote.

Authorized Official and Submission of Quote: The quote must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this solicitation.

The Offeror shall submit a business quote fully supported by underlying cost information (i.e., price breakdown) adequate for the Government to determine the reasonableness of the unit pricing proposed, and to evaluate whether the proposed costs are consistent with…