Combined Synopsis for Vehicle installation and Removal of Emergency Equipment .pdf

COMBINED SYNOPSIS/SOLICITATION FOR Installation and Removal of Emergency Equipment SOLICITATION NUMBER: FDA-RFQ-25Q1282808

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i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

ii. The solicitation number is FDA-RFQ-25Q1282807. This requirement is issued as Request for Quote

(RFQ).

The solicitation is issued as a Full and Open competition.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-07, Effective 08/29/2024.

iv. The associated North American Industry Classification System (NAICS) Code is 811198 with a small business size standard of $10 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions submitted shall reference the solicitation number and name.

Quote Due Date & Time: 8 August 2025; 10:00 AM

Question Due Date &Time: 5 August 2025; 10:00 AM

Point(s) of Contacts: Warren Jackson; warren.jackson@fda.hhs.gov

Period for Acceptance of Quotes: The quoter agrees to hold the prices firm for 60 calendar days after quote due date.

Quotes that do not provide pricing for all line items may be deemed non-responsive.

The quoter shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals 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). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an quoter to correct the document submission and the Government will not inform the quoter that their submission is non-responsive prior to award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

mailto:warren.jackson@fda.hhs.gov

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QUOTE SUBMISSION INSTRUCTIONS

The quoter shall submit all quotes to the point(s) of contact listed by the due date and time indicated in the solicitation. Discounts are requested from the established GSA schedule prices.

All quotes shall be submitted with the following.

a) Pricing for all line items with the total price

b) Quote issue date and expiration date

c) Autoclave serial numbers and type

d) The information requested under section x of this solicitation.

A list of line-item number(s) and items, quantities, and/or units of measure (including option(s), as applicable) can be found in sections iv of the solicitation.

i. BASIS OF AWARD

The Government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under this solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to quoter whose quote is determined to be Lowest Price Technically Acceptable.

A written notice of award or acceptance of an offer furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

ii. DESCRIPTION OF REQUIREMENT

1. Background

The Food & Drug Administration (FDA), Office of Criminal Investigations (OCI) is responsible for conducting and coordinating agency criminal investigations relating to violations of the Federal Food, Drug, and Cosmetic Act, Federal Anti-Tampering Act, Title 18 offenses and other areas over which FDA has jurisdiction. The special agents of the OCI are charged with investigating alleged criminal violations within FDA’s jurisdiction. These violations include counterfeit, unapproved and illegal drugs or medical devices;

product substitution; health fraud and health care fraud and application fraud among other violations.

As law enforcement officers (LEO), OCI special agents are provided with Government-owned vehicles (GOVs) that are required to be outfitted with communication accessories (i.e. radios), emergency equipment (i.e.

3 | Pag e lights and sirens), truck bed covers, and tinted windows in order for special agents to carry out OCI investigations.

2. Scope

The scope of this contract shall include the installation and removal of radios, emergency equipment, truck bed covers and window tinting in GOVs for federal law enforcement officers at FDA OCI. The Contractor shall manage the installation and removal of vehicle radios, emergency equipment, truck bed covers, and window tint for OCI’s GOVs.

3. Requirement

The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, non-personal services, and other items necessary to perform the services as defined in each task of this Performance Work Statement.

Task 1 – Project Management

The Project Management task is required for oversight of the contract activities and all tasks of this contract. This task includes participating in a kickoff meeting as well as providing monthly status reports and monitoring quality of contract services.

• Kickoff Meeting Requirements:

The Contractor shall schedule a kickoff meeting with OCI personnel within 14 days of contract award. The purpose of the meeting shall be to introduce the Contractor Key Personnel and the OCI stakeholders and to identify the overall project layout and expectations. The Contractor shall provide the kickoff meeting presentation within 3 days off the meeting.

• Monthly Status Report Requirements:

The Contractor shall provide monthly status reports to OCI along with the monthly invoices submitted for payment. The monthly status reports shall include a summary of work performed during the month, any problems incurred, and any updates on any outstanding issues. The Contractor shall provide tracking and reporting of each service request submitted. Reports shall be due no later than 10 days after the end of the month for the previous month’s services.

• Quality Control Requirements:

The contract is for performance-based commercial services. The Contractor shall develop and maintain a standardized quality control system to ensure services are performed in accordance with commonly accepted commercial practices and existing quality control systems throughout the life of the contract.

The quality control system shall include photos of all installations and a checklist verifying the functionality of the equipment and checking for parasitic draw on the battery prior to the vehicle being released to the agent. The results from the quality control queries shall be maintained by the contractor. Photos of completed work shall be taken by the local vendor. The agent will verify the emergency equipment, communication equipment, truck bed cover and/or window tint are functioning properly after completion of the installation by the local vendor.

• Requesting and Monitoring Service Requests:

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The FDA OCI shall provide the following information to the Contractor for service:

• OCI Agent Name, address and contact number.

• Regional OCI Office

• OCI Agent’s immediate supervisor’s name and contact phone number.

• GSA vehicle tag number or OCI G plate number

• Requested service(s) to be performed on the vehicle.

The Contractor shall report, as requested, the statuses of any in progress and completed service requests.

Task 2 – Emergency Equipment Installation Services

The Contractor shall coordinate with local, pre-identified, vendors in the general geographical area of the GOV (see Place of Performance section) to provide the installation of emergency equipment. The Contractor shall facilitate the appointment time between the regional agent and the local vendor. Upon completion of the services, the contractor shall receive confirmation from the regional agent that the services were satisfactorily completed.

The Contractor shall:

• Manage a group of local vendors that shall perform installations for the communication and emergency equipment.

• Ensure that all installations are performed in an efficient manner that focuses on minimizes agent vehicle downtime.

• Ensure that the required install dates and times are coordinated between local vendor and the OCI regional agent.

• Verify that the local vendor installs all equipment, and that the equipment is mechanically secured to the vehicle.

Installation services requirements:

• Equipment shall be installed in either Bundle 1 or Bundle 2, as specified in the request submission:

o Bundle 1 shall include installation of emergency equipment to include two front red and blue LED lights, two rear red and blue LED lights, an external siren speaker, a mini controller, a siren amp and all necessary wiring and cabling o Bundle 2 shall include all equipment in Bundle 1 plus two additional LED lights to be installed on the side of the vehicle, front headlight wig wag, and rear taillight wig wag

• All equipment shall be connected to an ignition-activated power source that has individual fuses for each system including all wiring from the power source. Cutting or splicing into existing vehicle wiring is not acceptable.

• All wiring/harnesses shall be installed in split wire loom insulation and shall ensure that there is no exposure to abrasion, pinching, snagging, or any danger that can cause failure or fire. All wiring harnesses shall be mechanically secured to the vehicle structure to prevent damage. Insulating grommets shall be used to protect wiring when passing through metal panels or other sharp surfaces. Hot installation is not authorized in OCI GOVs. When the vehicle is turned off, all power to the emergency lights and systems must also be turned off. This is to stop the continuous drain on the car battery and power system while the vehicle is turned off.

• The emergency equipment may be provided by FDA OCI if equipment is available via OCI’s existing inventory.

Otherwise, contractor shall provide emergency equipment for install (see ODC section).

Task 3 – Emergency Equipment Removal Services

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The Contractor shall coordinate with local, pre-identified, vendors in the general geographical area of the OCI regional agent (see Place of Performance section) to provide the removal of the radio and/or emergency equipment to the GOV. The Contractor shall facilitate the appointment time between the regional agent and the local vendor. Upon completion of the services, the contractor will receive confirmation from the regional agent that the services were satisfactorily completed. The Contractor shall:

• Manage a group of local vendors that shall perform removal of the communication and emergency equipment.

• Ensure that all removals are performed in an efficient manner that focuses on minimizes agent vehicle downtime.

• Ensure that the required removal dates and times are coordinated between local vendor and the regional OCI agent.

• Ensure removal of all emergency equipment and radio equipment, if equipped, and return equipment to FDA/OCI.

Removal services requirements:

• All emergency equipment and radio equipment shall be removed from the vehicle. This includes any front, rear and/or side lights, siren speaker and control box, radio vehicle adapter, 100-watt amplifier, VHF glass mount antenna and all wiring and cabling for the equipment.

• After emergency or communication equipment is removed, all holes or openings that remain shall be sealed and covered to prevent water intrusion in the vehicle.

• All removed equipment including wiring/harnesses shall be returned to FDA/OCI, unless there is a concurrent request for equipment to be reinstalled into another GOV.

Task 4 – Window Tinting Application Services

The Contractor shall coordinate with local, pre-identified, vendors in the general geographical area of the OCI regional agent (see Place of Performance section) to apply window tinting to the GOV. The Contractor shall facilitate the appointment time between the regional agent and the local vendor. Upon completion of the services, the contractor will receive confirmation from the regional agent that the services were satisfactorily completed.

The Contractor shall:

• Manage a group of local vendors that shall perform required window tinting services

• Ensure that all window tinting is performed in an efficient manner that focuses on minimizes agent vehicle downtime.

• Ensure that the service dates and times are coordinated between local vendor and the regional OCI agent.

Window Tinting Requirements:

• Window tinting shall be applied to the rear windows, rear passenger windows, driver window, and front passenger window and provide a sun strip on the front windshield with at least Solar Gard Galaxy Window Film or equivalent.

The minimum specifications for equivalent window tinting shall be:

o Guaranteed against fading or color change.

o Non-reflective (no metal) o Signal friendly, including GPS, satellite radios, cellular phones and tire pressure monitoring systems o Blocks more than 99% of UV rays to the car interior o Available in seven varying shades ranging from 5% light transmittance to 52%.

o Limited lifetime warranty

• Visible light transmittance % should start at 5% (limousine tint), however, OCI may designate a higher Visible light transmittance %, up to 52%, if limousine tint/black out is not needed.

Task 5 – Window Tinting Removal Services

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The Contractor shall coordinate with local, pre-identified, vendors in the general geographical area of the OCI regional agent (see Place of Performance section) to provide removal of window tinting to the GOV. The Contractor shall facilitate the appointment time between the regional agent and the local vendor. Upon completion of the services, the contractor will receive confirmation from the regional agent that the services were satisfactorily completed.

The Contractor shall:

• Manage a group of local vendors that shall remove window tint film from GOV windows.

• Ensure that all window tint removals are performed in an efficient manner that focuses on minimizes agent vehicle downtime.

• Ensure that the service dates and times are coordinated between local vendor and the regional OCI agent.

Other Direct Costs - Equipment

Allowable other direct costs in support of the contract may include the emergency equipment (LED lights and siren equipment) and window tint film required to perform the services on the GOVs. Any equipment purchased via ODCs for installation shall be the property of the Government.

Any Other Direct Costs (ODCs) shall be submitted through an invoice. All ODCs, other than those ODC acquired under the firm fixed price line items, must be pre-approved by the Contracting Officer Representative (COR). To be eligible to receive reimbursement for ODCs, the Contractor must obtain at least three (3) quotes for each transaction to ensure that adequate price competition was sought, or the Contractor must provide an acceptable justification as to why it was impracticable to do

so. The Contractor shall maintain documentation of all reimbursable purchases until three (3) years after the contract is completed and shall provide access to and copies of such documentation, when requested by the Contracting Officer.

Travel

Travel for contractor personnel is NOT anticipated for the performance of this contract. However, if the Contractor requires travel, the contractor shall submit a request to the Contracting Officer. The CO must provide approval for the travel prior to incurring any travel costs.

Any Contractor travel must be pre-negotiated and approved and authorized by the CO. Travel shall be reimbursed in accordance with FAR 31.205-46 and Federal Travel Regulations (https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation). Travel requirements under this contract shall be met using the most economical form of transportation available. If economy class transportation is not available, the request for payment voucher must be submitted with justification for use of higher-class travel indicating dates, times, and flight numbers. All travel shall be scheduled sufficiently in advance to take advantage of offered discount rates, unless otherwise directed by the CO.

Other Unique Requirements

Key Personnel:

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation

7 | Pag e requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer.

The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following have been identified as Key Personnel for this contract:

Labor Category

Qualifications Name

Project Manager

• Knowledgeable of the overall organization, direction, and requirements of the contract efforts

• Ability to interface directly with Government designated representatives

• Knowledge of the commercial practices relating to the contract services

TBD at award

4. INSPECTION/ACCEPTANCE CRITERIA

Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

5. CONTRACT TYPE

This is firm fixed price.

6. PERIOD OF PERFORMANCE

The anticipated period of performance for this contract is 12 months.

7. PLACE OF DELIVERY AND PERFORMANCE

The Contractor shall be prepared to perform work nationwide throughout the United States. FDA OCI has GOVs located at the following field offices that require service under this contract:

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OCI Office

Location

Quantity of GOVs for service

OIA Rockville, MD 1 HQS Rockville, MD 5 LAC San Clemente, CA 2 SFC Oakland, CA 1 KCK Mission, KS 3 ATG Atlanta, GA 1 BOM Wakefield, MA 5 NH domicile Manchester, NH 2 HST Houston, TX 1 SAT domicile San Antonio, TX 1 NYN LI domicile Long Island, NY 1 MWM Beltsville, MD 2

HOURS OF OPERATION

Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays.

FEDERAL HOLIDAYS

The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/.

• New Year's Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day https://www.opm.gov/

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GOVERNMENT CLOUSURE

Government operating statuses for offices nationwide can be found on https://www.opm.gov/.

Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level.

In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO.

8. DELIVERABLES AND DELIVERY SCHEDULE

Deliverable Task #

Reference Description Quantity/format Due Date

Task 1 Kickoff Meeting Presentation 1 PowerPoint Presentation sent via email

Within 14 days of contract award

Tasks 2 through 5

Installation of emergency equipment, communication equipment and window tint film

As required per service request

Within 30 days of submission of service request

Task 1 Status updates of service requests 1 for each service request via the online request/dispatch and service tracking system

Within 5 days of completion of request

Task 1 Monthly Progress Reports and Quality

Assurance Reports

Monthly pdf submitted with monthly invoice

Due monthly, within

10 days after end of the month https://www.opm.gov/

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GOVERNMENT POINTS OF CONTACT

Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone: 301-796-7376 Email: warren.jackson@fda.hhs.gov

Contract Representative Officer (COR) Entered at Award

9. CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price.

The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order, and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

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

10. INVOICING INSTRUCTIONS

Instructions for invoicing are indicated below.

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, mailto:warren.jackson@fda.hhs.gov http://www.ipp.gov/vendors/index.htm

11 | Pag e or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

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

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

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

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

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

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

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

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

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

https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

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• 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.

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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.

viii. The provision at 52.212-2, Evaluation—Commercial Items (NOV 2021), is applicable to this requirement.

The government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under the solicitation and is the lowest priced received in response to this solicitation. Therefore, award will be made to quoter is determined to be Lowest Price Technically Acceptable.

ix. The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2023), applies to this acquisition with the addenda for INVOICING provided under HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and invoicing instructions section.

viii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive

Orders—Commercial Items (JAN 2025), The additional FAR clauses cited in the clause that apply under this acquisition are indicated below.

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

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C.

3903 and 10 U.S.C. 3801).

mailto:ERIC@fda.hhs.gov https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-section3903&num=0&edition=prelim https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section3801&num=0&edition=prelim

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(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

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:

☐ 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN2020), with Alternate (NOV 2021) ☐ 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ☒ 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) ☐ 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) ☐ 52.204-14, Service Contract Reporting Requirements (OCT 2016) ☐ 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) ☒ 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) ☐ 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide

Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) ☐ 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (DEC 2023)

☐ Alternate I (DEC 2023) of 52.204–30.

☐ 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ☐ 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ☐ 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ☒ 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) ☐ 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020)

☐ Alternate I (MAR 2020) of 52.219-6.

☐ 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020)

☐ Alternate I (MAR 2020) of 52.219-7.

☐ 52.219-8, Utilization of Small Business Concerns (FEB 2024) ☐ 52.219-9, Small Business Subcontracting Plan (SEP 2023)

☐ Alternate I (NOV 2016) of 52.219-9.

☐ Alternate II (NOV 2016) of 52.219-9.

☐ Alternate III (JUN 2020) of 52.219-9.

☐ Alternate IV (SEP 2023) of 52.219-9.

☐ 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ☐ Alternate I (MAR 2020) of 52.219-13.

☐ 52.219-14, Limitations on Subcontracting (OCT 2022) ☐ 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 https://www.acquisition.gov/far/part-52#FAR_52_203_6 https://www.acquisition.gov/far/part-52#FAR_52_203_13 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://www.acquisition.gov/far/part-52#FAR_52_204_10 https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.acquisition.gov/far/part-52#FAR_52_204_28 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.acquisition.gov/far/part-52#FAR_52_209_9 https://www.acquisition.gov/far/part-52#FAR_52_219_3 https://www.acquisition.gov/far/part-52#FAR_52_219_4 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 https://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_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 https://www.acquisition.gov/far/part-52#FAR_52_219_16

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☐ 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (FEB 2024)

☐ 52.219-28, Post Award Small Business Program Representation (FEB 2024) ☐ Alternate I (MAR 2020) of 52.219-28.

☐ 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022)

☐ 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022)

☐ 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ☐ 52.219-33, Nonmanufacturer Rule (SEP 2021) ☒ 52.222-3, Convict Labor (JUN 2003) ☐ 52.222-19, Child Labor-Cooperation with Authorities and Remedies ☒ 52.222-21, Prohibition of Segregated Facilities ☒ 52.222-26, Equal Opportunity (SEP 2016)

☐ Alternate I (FEB 1999) of 52.222-26.

☒ 52.222-35, Equal Opportunity for Veterans (JUN 2020)

☐ Alternate I (JUL 2014) of 52.222-35.

☒ 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020)

☐ Alternate I (JUL 2014) of 52.222-36.

☒ 52.222-37, Employment Reports on Veterans (JUN 2020) ☐ 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) ☒ 52.222-50, Combating Trafficking in Persons (NOV 2021)

☐ Alternate I (MAR 2015) of 52.222-50 ☒ 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) ☐ 52.224-3 Privacy Training (JAN 2017)

☐ Alternate I (JAN 2017) of 52.224-3.

☐ 52.225-1, Buy American-Supplies (OCT 2022)

☐ Alternate I (OCT 2022) of 52.225-1.

☐ 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023)

☐ Alternate I [Reserved].

☐ Alternate II (DEC 2022) of 52.225-3.

☐ Alternate III (NOV 2023) of 52.225-3.

☐ Alternate IV (Oct 2022) of 52.225-3.

☐ 52.225-5, Trade Agreements (NOV 2023) ☒ 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) ☐ 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) ☐ 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ☐ 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

☒ 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT2018) https://www.acquisition.gov/far/part-52#FAR_52_219_27 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 https://www.acquisition.gov/far/part-52#FAR_52_219_30 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.acquisition.gov/far/part-52#FAR_52_219_33 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 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_223_18 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_5 https://www.acquisition.gov/far/part-52#FAR_52_225_13 https://www.acquisition.gov/far/part-52#FAR_52_225_26 https://www.acquisition.gov/far/part-52#FAR_52_226_5 https://www.acquisition.gov/far/part-52#FAR_52_229_12 https://www.acquisition.gov/far/part-52#FAR_52_232_33

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☒ 52.239-1, Privacy or Security Safeguards (AUG 1996) ☒ 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ☒ 52.242-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ☐ 52.222-41, Service Contract Labor Standards (AUG 2018) ☐ 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) ☐ 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) ☐ 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ☒ 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for

Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) ☒ 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain

Services-Requirements (MAY 2014) ☐ 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022) ☐ 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) ☐ 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)

x. Additional contract requirement(s) or terms and conditions

FAR 52.252-2 -- Clauses Incorporated by Reference. (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/.

(End of Clause)

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 any time 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 five years.

(End of clause)

HHSAR CLAUSES

HHSAR

CLAUSE NO.

DESCRIPTION DATE

https://www.acquisition.gov/far/part-52#FAR_52_239_1 https://www.acquisition.gov/far/part-52#FAR_52_242_5 https://www.acquisition.gov/far/part-52#FAR_52_242_5 https://www.acquisition.gov/far/part-52#FAR_52_222_41 https://www.acquisition.gov/far/part-52#FAR_52_222_42 https://www.acquisition.gov/far/part-52#FAR_52_222_43 https://www.acquisition.gov/far/part-52#FAR_52_222_44 https://www.acquisition.gov/far/part-52#FAR_52_222_51 https://www.acquisition.gov/far/part-52#FAR_52_222_53 https://www.acquisition.gov/far/part-52#FAR_52_222_55 https://www.acquisition.gov/far/part-52#FAR_52_222_62 https://www.acquisition.gov/far/part-52#FAR_52_226_6 https://www.acquisition.gov/

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352.203-70 Anti-Lobbying DEC 2015 352.208-70 Printing and Duplication DEC 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.227-70 Publications and Publicity DEC 2015 352.231-70 Salary Rate Limitation DEC 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.

(END OF CLAUSE)

352.239-79 Information and Communication Technology Accessibility (FEB 2024) (Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility http://www.ipp.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html

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Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility- checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

FAR/HHSAR PROVISIONS

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): https://www.acquisition.gov/.

(End of Provision)

352.239-78 Information and Communication Technology Accessibility Notice (FEB 2024) (Deviation)

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html. The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility.