75F40125Q128458 Amendment 1.pdf

75F40125Q128458

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. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. The solicitation number is 75F40125Q128458. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-04 dated June 11, 2025.

The associated North American Industry Classification System (NAICS) Code is 492110 – Couriers and Express Delivery Services; Small Business Size Standard is 1,500 employees. This RFQ is issued as a small business set-aside.

Schedule of Supplies or Services and Prices/Costs. Price shall be inclusive of Pick-up and delivery to the locations listed herein.

Current annual projections anticipate an estimate of blood and biologics courier trips.

Line

Item Description Unit Price

Estimated

Quantity Total Annual Price

1 Base Year: Morning Service $ 15 $

2 Base Year: Afternoon Service $ 200 $

Option Items (FAR 52.217-9).

3 Option Year 1: Morning Service $ 15 $

4 Option Year 1: Afternoon Service $ 200 $

5 Option Year 2: Morning Service $ 15 $

6 Option Year 2: Afternoon Service $ 200 $

7 Option Year 3: Morning Service $ 15 $

8 Option Year 3: Afternoon Service $ 200 $

9 Option Year 4: Morning Service $ 15 $

10 Option Year 4: Afternoon Service $ 200 $

Grand Total Including (Items 1 – 10) $

Background

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research’s (CBER’s) requires a courier service for picking up, securing, transporting, and delivering of pre-packaged biological materials which may contain potentially infectious materials such as blood products, patient specimens, DNA samples, and synthesized peptide products between the NIH

Bethesda Campus and the FDA Silver Spring Campus. These materials are critical to projects for supporting the FDA’s mission of protecting and advancing public health.

Operational and Specific Tasks

The contractor shall furnish all necessary services, qualified personnel, material, and equipment, as needed to perform the Statement of Work as stated herein. Specifically, the contractor shall:

1. Provide a Service Plan. The plan shall include outlining the methodology for meeting the requirements to provide pickup and delivery of blood and biological specimens between locations. The plan shall identify how the methodology proposed complies with all OSHA and DOT/IATA regulations, including CFR

1910.1030 and relevant trainings as it pertains to these regulations. Some items that should be covered as part of the plan are compliance with Code of Federal Regulations (CFR) 1910.1030 regarding Blood Borne Pathogens, specific types of training provided to medical couriers, transportation safety training specific to medical couriers, hazardous materials training, and compliance with the Health Insurance Portability and Accountability Act (HIPPA).

2. Provide the Government a minimum of one person to maintain the courier service.

The individual shall have a valid driver’s license, vehicle registration, and proof of insurance. The courier shall have a vehicle capable of transporting required samples.

3. The courier shall provide two hard sided insulated containers with a minimum capacity of 400 cubic inches each that prevent leaking during transport (e.g. personal sized hard- walled coolers). The containers shall allow adherence to established temperature requirements for the specimen being handled. For the room temperature packages, their temperature range shall be within 18-25 °C. For the refrigerated packages, their temperature range shall be within 2-6 °C. The maximum shipment will consist of the two containers. Follow standard precautions when handling specimens, all of which may contain potentially infectious materials. The specimens shall remain sealed, and personnel shall comply with the OSHA and HIPAA guidelines for all items in their possession from one point of origin to the final destination.

4. Contractor’s personnel shall present a neat appearance and shall be easily recognized. This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges which contain the company’s logo and employee’s name. The wear of open-toed shoes, eating, drinking, applying make-up, or smoking in the vehicle is prohibited to comply with infection/contamination control requirements. Vehicle shall only carry the reported individual assigned by contractor or possible trainees and no other passenger(s).

5. Maintain integrity of package through final delivery including temperature requirements by providing for the following:

a) Avoid exposing packages to extreme temperatures, both hot and cold.

b) All pre-packaged biological materials shall be sealed in secondary containments.

c) Using leak-proof, insulated and hard-side containers as transport carriers.

d) Directly drive the picked-up packages to the delivery locations.

e) Using a dedicated room temperature transport carrier for the room temperature packages.

f) Using a transport carrier with wet ice or cold packs for the refrigerated packages.

6. Pick-up and deliver the specimens within the timeframes identified in the pick-up and delivery schedule.

7. Be easily recognizable as couriers of the biological materials.

8. Provide the courier with a cellular phone capable of receiving/sending email and texts, and the number shall be provided to the Government.

9. Provide a Contractor’s Point of contact (POC) responsible for successful performance of the work. The contractor’s POC shall have full authority to act for the contractor on matters relating to the daily performance of this contract.

10. Records. The contractor shall be responsible for notifying the FDA via email or text message upon delivery to FDA and NIH. In the event that there are no specimens to pick-up/deliver or that the contractor will be delayed, the contractor shall notify the Technical Point of Contact (TPOC) via text or email.

Pick-up and delivery schedule:

Morning pick-up/delivery schedule from NIH to FDA:

- Pick-up pre-packaged samples from a freezer by the receptionist desk inside the main (West) entrance.

Address:

National Institute of Health Campus 9000 Rockville Pike Building 30 Bethesda, MD 20892 As needed, Monday – Friday, by 8:30 AM

- Deliver pre-packaged samples to FDA by 10:00 AM, if not sooner.

FDA Life Sciences Biodefense Complex 10903 New Hampshire Ave.

Bldg. 52 Loading Dock Silver Spring, MD 20993

Morning pick-up/delivery schedule from FDA to NIH:

- Pick-up pre-packaged samples from FDA.

10903 New Hampshire Ave.

Bldg. 52 Loading Dock Silver Spring, MD 20993 As needed, Monday – Friday, by 10:00 AM

- Deliver pre-packaged samples to a freezer by the receptionist desk, inside the main (West) entrance by 11:30 AM, if not sooner.

National Institute of Health Campus 9000 Rockville Pike Building 30

Afternoon pick-up/delivery schedule from NIH to FDA:

- Pick-up pre-packaged samples from three locations in the NIH Blood Bank.

1. Building 10, Room 2S217 for Buffy coats.

2. Refrigerator in Building 10, Room 1S225 for refrigerated packages.

3. Room temperature box in Building 10, Room 1S225 for room temperature packages.

Address:

National Institute of Health Campus 9000 Rockville Pike Building 10

As needed, Monday – Thursday at 3:00 PM

- Deliver prepackaged blood products to the FDA by 4:30 PM, if not sooner.

FDA Life Sciences Biodefense Complex 10903 New Hampshire Ave.

Bldg. 52 Loading Dock or Room 52/72 4375 Silver Spring, MD 20993

Additional Delivery Requirements:

1. The FDA shall request pick-up and deliveries no less than 24 hours prior to required pick-up times. No pick-up and deliveries shall take place unless a request from the FDA has been received by the contractor.

2. When the contractor is picking up the pre-packaged biological materials from the NIH

Blood Bank, the contractor shall only pick up packages properly packaged in secondary containment that are labeled for the FDA and comply with the signing out procedures for taking the packages for the FDA. If the contractor has questions regarding the packages or the sign-out procedure, the contractor shall check with the designated TPOC.

3. When the contractor is delivering the pre-packages biological materials from the NIH Bethesda Campus, after arriving at the building 52 loading dock, the contractor shall:

a) Call the designated TPOC or COR.

b) Follow applicable FDA requirements for signing in.

c) Follow applicable guidelines to transfer the packages to the receiving container at the loading dock or be escorted to 52-72/4375 to place the packages in the appropriate containers.

Deliverable Table:

Deliverable Description Due Date Post-Award Conference Kick-off meeting with

FDA to discuss the details of the service plan, and technical requirements via Conference Call.

Within one (1) week of award

Monthly Report Monthly records of delivery dates. Report shall also include contract funding status.

To designated TPOCs and COR prior to submitting a monthly invoice

Morning pick-up and delivery schedule from NIH to FDA or Morning pick-up and delivery schedule from FDA to

NIH.

8:30 a.m. pick-up of pre-packaged biological material from NIH and deliver to FDA by 10:00 a.m.

if not sooner; or 10:00 a.m. pick-up of pre-packaged biological material from FDA and deliver to NIH by 11:30 a.m. if not sooner.

As notified by designated TPOC(s) or COR with 24-hour notice and up to 15 times during the period of performance (365-day period).

Afternoon pick-up and delivery schedule from NIH to FDA

3:00 p.m. pick-up of pre-packaged biological material (buffy coats, and all other blood products) from NIH and deliver to FDA by 4:30 p.m.

As notified by designated TPOC(s) or COR with 24-hour notice and up to 200 times during the period of performance (365-day period).

Place of Performance:

Services shall be provided between NIH and FDA at the following addresses:

National Institute of Health Campus 9000 Rockville Pike, Building 30 Bethesda, MD 20892

National Institute of Health Campus 9000 Rockville Pike, Building 10 Bethesda, MD 20892

FDA Life Sciences Biodefense Complex 10903 New Hampshire Ave. Bldg. 52/72, Rm. 4375 Silver Spring, MD 20993

Period of Performance:

Base Year: 09/01/2025 – 08/31/2026 Option 1: 09/01/2026 – 08/31/2027 Option 2: 09/01/2027 – 08/31/2028 Option 3: 09/01/2028 – 08/31/2029 Option 4: 09/01/2029 – 08/31/2030

Services are to be provided as needed during the normal working hours of Monday through Friday, 8:00 AM – 4:30 PM, excluding Federal Holidays. Except in cases of emergency, services shall not be required during off-duty hours or during Federal holidays or on days the Federal Government is closed as determined by OPM.gov. If emergency services are required, the COR shall notify the Contractor. In the event of inclement weather, the COR shall provide guidance to the Contractor for required services.

Federal Holidays:

January 1 – New Year’s Day 3rd Monday in January – Martin Luther King, Jr. Day 3rd Monday in February – President’s Day Last Monday in May – Memorial Day June 19 - Juneteenth July 4 – Independence Day 1st Monday in September – Labor Day 2nd Monday in October – Columbus Day November 11 – Veterans Day 4th Thursday in November – Thanksgiving Day December 25 – Christmas Day

Building Security/Entrance Procedures

To access NIH or FDA, non-badged visitors will be required to show one (1) form of identification (a government- issued photo ID (ex: driver’s license, passport, green card, etc.)) and may be asked to state their reason for visit.

NIH Access:

Vehicle access to NIH is via the NIH Gateway Center Vehicle Inspection (Building 66A) complex through NIH Gateway Drive, south of the intersection of South Drive and Rockville Pike located adjacent to the Medical Center Metro Station at the South Drive entrance to campus from Rockville Pike/Wisconsin Avenue.

Commercial vehicle deliveries must undergo security screening at the Commercial Vehicle Inspection Facility (CVIF). This facility is located on Rockville Pike between North Drive and Wilson Drive.

Visitors may be required to log-in, wear a visitor pass or have an employee escort them through the building.

FDA Access:

All visitors must enter the FDA White Oak Campus via Michelson Road and stop at the Vehicle Screening Facility. At the Vehicle Screening Facility, drivers will be asked to provide a license and registration. Drivers may then proceed to the building 52/72 loading dock, park their vehicle, and enter the facility through the double doors.

Visitors may be required to log-in, wear a visitor pass, put their belongings through the x-ray machine, walk through magnetometers, or have an employee escort them through the building.

**Please note all samples shall NOT be placed through x-ray machines.

Security and Privacy

The Contractor shall be responsible for determining that the individuals provided to perform under this contract shall not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.

All Contractor personnel shall have all necessary credential(s) processed. When the Contractor arrives at the Government facility, a Government employee will escort the Contractor into the FDA building. The Contractor will receive a Visitor badge and will need to be escorted by the Government personnel during their visit.

Contract Type: Commercial Product - Firm fixed price

Contract clauses

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

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023), applies to this acquisition. The following addenda apply:

FAR Clauses 52.204-13 System for Award Management and Maintenance (Oct 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 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 5 years.

HHSAR Clauses 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)

352.237-75 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 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.

(End of clause)

Contractor’s Point of Contact (POC): (to be completed at time of proposal submission) Name:

Phone:

Email:

352.239-74[9] Electronic and Information [and Communication] Technology Accessibility.

[(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 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)]

Inspection/Acceptance:

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

Contract Administration

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

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

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

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

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

The contact information for the Contracting Officer is:

Name: Warren Dutter Phone: (870) 543-7577 Email: warren.dutter@fda.hhs.gov

b. The Contracting Officer Representative (COR) is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

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

The following COR will represent the Government for the purpose of this contact (To be completed at time of award):

Name:

Phone:

Email:

c. The Technical Point of Contact (TPOC) is responsible for assisting the COR to:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

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

The following TPOC(s) will represent the Government for the purpose of this contact (To be completed at time of award):

FDA TPOCs Name:

Phone:

Email:

Name:

Phone:

Email:

NIH POC

Name:

Phone:

Email:

Payment Terms: Net 30 days after government acceptance of proper invoice. No advance payments will be made.

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

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

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

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.

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

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

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Jan 2025) [(Deviation Feb 2025)] (a)The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

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

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

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

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

(5)52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

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

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

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

[Contracting Officer check as appropriate.] __ (1)52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2)52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

__ (3)52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4)52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712);

this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5)52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6)[Reserved].

__ (7)52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8)52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

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

__ (10)52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

__ (11) (i)52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii)Alternate I (Dec 2023) of 52.204-30.

_X_ (12)52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) ( 31 U.S.C. 6101 note).

__ (13)52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (14)[Reserved].

__ (15)52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (16)52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (17)[Reserved] _X_ (18) (i)52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii)Alternate I (Mar 2020) of 52.219-6.

__ (19) (i)52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii)Alternate I (Mar 2020) of 52.219-7.

__ (20)52.219-8, Utilization of Small Business Concerns (Jan 2025)( 15 U.S.C. 637(d)(2) and (3)).

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

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

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

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

__ (v)Alternate IV (Jan 2025) of 52.219-9.

__ (22) (i)52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii)Alternate I (Mar 2020) of 52.219-13.

__ (23)52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).

__ (24)52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (25)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) (15 U.S.C. 657f).

_X_ (26) (i)52.219-28, Postaward Small Business Program Rerepresentation (Jan 2025) (15 U.S.C. 632(a)(2)).

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

__ (27)52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

__ (28)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) (15 U.S.C. 637(m)).

__ (29)52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (30)52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15 U.S.C. 637(a)(17)).

_X_ (31)52.222-3, Convict Labor (Jun 2003) (E.O.11755).

__ (32)52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2025)( E.O.

13126).

__ (33) [Reserved] 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__ (34) [Reserved] (i)52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

__ (35) (i)52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (ii)Alternate I (Jul 2014) of 52.222-35.

_X_ (36) (i)52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C. 793).

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

__ (37)52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (38)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (i)52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii)Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (40)52.222-54, Employment Eligibility Verification (Jan 2025) ( Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41) (i)52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii)Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (42)52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43)52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44)52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45)52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

X (46)52.223-23, Sustainable Products and Services (May 2024) [(Deviation Feb 2025] ( E.O.

14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

__ (47) (i)52.224-3 Privacy Training (Jan 2017) ( 5 U.S.C. 552 a).

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

_X_ (48) (i)52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

__ (ii)Alternate I (Oct 2022) of 52.225-1.

__ (49) (i)52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C.

chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109- 53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii)Alternate I [Reserved].

__ (iii)Alternate II (Jan 2025) of 52.225-3.

__ (iv)Alternate III (Feb 2024) of 52.225-3.

__ (v)Alternate IV (Oct 2022) of 52.225-3.

__ (50)52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51)52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52)52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

__ (53)52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54)52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

_X_ (55)52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

__ (56)52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57)52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58)52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_X_ (59)52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (60)52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (61)52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (62)52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

_X_ (63)52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub.

L. 118-31, 41 U.S.C. 3901 note prec.).

__ (64)52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (65) (i)52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii)Alternate I (Apr 2003) of 52.247-64.

__ (iii)Alternate II (Nov 2021) of 52.247-64.

(c)The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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:

[Contracting Officer check as appropriate.] _X_ (1)52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

_X_ (2)52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

Driver Courier $21.14 _X_ (3)52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4)52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

_ _ (5)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) (41 U.S.C. chapter 67).

__ (6)52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

_X_ (7)52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

_X_ (8)52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

__ (9)52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

__ (10)52.247-69, Reporting Requirement for U.S.-Flag Air Carriers Regarding Training to Prevent Human Trafficking (Jan 2025) ( 49 U.S.C. 40118(g)).

(d)Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1)The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2)The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3)As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1)Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i)52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509).

(ii)52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii)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)).

(iv)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).

(v)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).

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

(vii) (A)52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B)Alternate I (Dec 2023) of 52.204–30.

(viii)52.219-8, Utilization of Small Business Concerns (Jan 2025) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ix) [Reserved] 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(x) [Reserved] 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

(xi)52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(xii)52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(xiii)52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xiv)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xv)52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xvi) (A)52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O 13627).

(B)Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xvii)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) (41 U.S.C. chapter 67).

(xviii)52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xix)52.222-54, Employment Eligibility Verification (Jan 2025) ( E.O. 12989).

(xx)52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xxi)52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii) (A)52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B)Alternate I (Jan 2017) of 52.224-3.

(xxiii)52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxiv)52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxv)52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi)52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub.

L. 118-31, 41 U.S.C. 3901 note prec.).

(xxvii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph

(d) of FAR clause 52.247-64.

(2)While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy…