COMBINED SYNOPSIS SOLICITATION -AED 09142023.docx

Solicitation Number 75F40123Q00523

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.3 as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-05.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00253 and is being issued as a Request for Proposal (RFP). The NAICS Code for this 541611 Solicitation is 75F40123Q00523. The Small Business Size Standard is $24.5 million. The solicitation is 100% Small Business Set Aside. Prospective Offerors are responsible for downloading the solicitation and any amendments from SAM.gov. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the best value to the Government and discussions are not necessary.

PART A

A.1 Brief Description of Supplies or Services

The Food and Drug Administration’s (FDA’s) mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws that are designed to regulate and protect consumers' health and safety. There are 25,000+ FDA employees including all employees who work or visit FDA buildings. Approximately 16,000 employees, roughly 55 percent of the FDA workforce, are in the National Capital Region. The remaining approximate 9,000 employees are located at FDA laboratories and field offices throughout the country and across the world. These field locations include: The National Center for Toxicology Research (in Arkansas), over 200 hundred field offices of the Office of Regulatory Affairs, and multiple research facilities. FDA Occupational Health Services (OHS) oversees and finances a broad range of program elements for FDA Centers and the Office of Regulatory Affairs (ORA) and its field offices to help them develop a safe environment for its employees and visitors. OHS provides national leadership and direction to plan, manage, and coordinate the nationwide administration of comprehensive and supportive programs for its Public Access Defibrillation Programs (PAD) which must be compliant with industry standards, the American Heart Association and Occupational Safety and Health Administration guidelines. As such, OHS recognizes that FDA employee awareness, training, and participation can help make the campus a safer place for all employees and visitors. As a part of the compliance requirement, The FDA PAD Program requires a method to purchase AED units and supplies; as well as a maintenance program to monitor the working order of each AED unit.

In performing the work as described in detail in “Part D Statement of Work” the Offeror shall consider the following:

This is a Single Award Indefinite-Delivery/Indefinite Quantity (IDIQ) Task Order oriented contract providing for a Firm-Fixed Price orders. The IDIQ shall have a Base Period of Ten (10) months and two (2) 12 month Option Periods.

As the need for services covered by this contract arises, the Government will issue individual Task Orders (TOs) to the Offeror with all the necessary documentation of project requirements, under cover of a written request for proposal to perform the required services.

A.2 Minimum and Maximum Contract Amount

During the contract Period of Performance specified in Ordering Clause FAR 52.216-18, the Government will place Task Orders (TOs) against the IDIQ contract. The guaranteed minimum amount for this contract shall be satisfied by the issuance of the first TO. The maximum contract amount, inclusive of the ordering period under the contract shall not exceed $999,900.00.

A.3 Minimum Ordering Requirements/Quantities

The Government has no obligation to issue TOs beyond the stated minimum TO award. There will be a one time “minimum guarantee” during the life of the contract which includes all option periods, if exercised. The guaranteed minimum for this contract shall be satisfied by the award of the first TO.

A.4 Pricing Schedule

For ID/IQ

Pricing Table

(SAMPLE PRICING TABLE)

BASE

10 months Option Period 1 12 months Option Period 2 12 months

New AED unit Package:

Complete AED Unit Package must include:

1 Brand new AED Defibrillator, 1 Samaritan PAD Carrying Case, 2 PAD-PAKs (Electrode Pads & Battery Cartridge), Spare PAD-PAK as required by State of MD, 1 AED+CPR Responder Kit *1 User Manual, 1 Instructional DVD, 1 Quick reference Card, 1 USB data cable, 1 AED Sign (double flanged or 3-way), 1 AED Inspection/Maintenance Tag, 1 AED Storage Wall Cabinet with alarm.

*Responder kit includes all the first-aid essentials required in a cardiac emergency. Two towelettes, scissors, a razor, a pair of nitrile gloves, and a pocket CPR mask are all contained within a zippered nylon pouch

Administrative Hotline Support

Maximum Quantity for ID/IQ Table 2

Service, Maintenance, and Repair of Existing AED Device Premium Management -pad replacements -battery replacements

Task Order One Order:

Service, Maintenance, and Repair of Existing AED Device Premium Management -pad replacements -battery replacements

Funds for the services provided will be obligated, at the task order level, as available, or excess funds de-obligated at the TO level, by modification to the TO contracts by the Government. The Contractor shall only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed if the Contractor meets the requirements as stated in Part A.2

A.5 Marking Instructions for Reports

All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the Contract Number, Task order Number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

A.6 Payment of Postage and Fees

All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid by the Contractor.

A.7 Task Order Process and Procedures

Ordering services under this contract shall be accomplished by the issuance of written TOs specifying the types of services being ordered. The only office authorized to process TOs is the Office of Acquisitions & Grants Services of the Food and Drug Administration (FDA), through the Contracting Officer (CO).

All TOs issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order. All work, under the IDIQ portion of the contract, shall be initiated by the issuance of fully executed TOs issued by the Contracting Officer. The work to be performed under these orders must be within the scope of the contract. The Government is only liable for costs expended under the terms and conditions of this contract, to the extent that a fully executed TO has been issued and covers the required work and costs. Charges for any work not authorized by the CO shall be disallowed.

The general process for individual TOs is as follows:

a) The FDA will prepare a TO Statement of Work. The SOW will include, at a minimum, the following elements:

i. Description of work in terms of the purpose or objectives of the work and location to be performed;

ii. Description of how the work performance is assessed relative to objectives, goals, and outcomes;

iii. Period and place of performance;

iv. Reporting requirements and deliverables;

v. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order.

b) Request for Task Order Proposal (RFTOPs) shall only be issued by the Contracting Officer. For each TO under this contract, the Contracting Office will send a request for proposal to the Contractor. The request shall contain a detailed description of the tasks to be accomplished, a schedule for completion of the TO, and deliverables to be provided by the Contractor. The Contractor shall prepare and submit a TO proposal addressing all areas of the requirement. The Contractor shall submit the TO proposal within the time period specified in the RFTOP. Other direct costs shall be clearly identified, explained, and substantiated. Trips in excess of the approved number set forth in each Task Order will be at the Contractor’s expense. The Contractor shall identify the estimated travel requirements by number, purpose and duration (inclusive of travel days in/out) with the submission of each proposed TO. No separate payment will be made to the Contractor for the cost to prepare, submit and/or negotiate a Task Order proposal. The Government will evaluate TO Proposals as specified in the individual RFTOP on a best value basis.

c) After any necessary negotiations, the Contractor shall submit a final proposal.

d) Task Orders will be considered fully executed upon signature of the Contracting Officer. The Contractor shall begin work on the TO in accordance with the effective date of the order.

e) The Contractor shall notify the Contracting Officer of any instructions or guidance given that may impact the cost, schedule or deliverables of the TO. A formal modification to the TO must be issued by the Contracting Officer before any changes can be made.

f) Task Orders may be placed during the period of performance of the contract. Labor rates applicable to hours expended in performance of an order shall be the contract rates that are in effect at the time the TO is issued.

A.7.1 Period of Performance

The Base Period of Performance of this Contract shall begin on September 30, 2023 through July 31, 2023, plus (2) 12 month Option Periods, which may be exercised at the Government’s discretion.

A.7.2 Place of Performance

National Capital Region and multiple location throughout the United States 50 states and Territories.

A.8 Deliveries

Satisfactory performance of the final Contract shall be deemed to occur upon performance of the work described in the Statement of Work (SOW) in Part D of this Contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule described in Part D of this contract.

Reporting Requirements, Data Management, Required Documents and Reports:

General: The Contractor shall prepare and deliver all reports and documents to the Contracting Officer Representative (COR) TBD. Unless specified otherwise herein all reports shall be delivered electronically in spreadsheet or database format by email. The Contractor’s report(s) shall be complete, accurate and prepared in a grammatically correct manner. Reports delivered by the Contractor shall become a part of the FDA’s official records and subject to review by regulatory authority and the public. Unless otherwise specified herein the format for all reports shall be subject to the approval of the COR and CO.

Ownership and Security of Data and Documents:

All FDA and Contractor collected, maintained, and delivered data files, reports, logs or other documents developed relative to contractual operations are the sole property of the FDA and shall not be released to other parties in any form without the prior written consent of the COR and Contracting Officer (CO).

The Contractor shall take all measures necessary to secure and safely protect all hardware, software, data, and documents from theft, destruction, and unauthorized access. The Contractor shall report any information security or privacy incidents/violation to COR and CO immediately when such incidents/violations occur. Additionally, to the above reports, the Contractor may be requested by the COR or CO to provide special reports on an ad hoc needed basis.

A.9 Contracting Officer’s Representative (COR)

The COR is responsible for the acceptance of work provided hereunder and will be designated by separate correspondence. The term “COR” means the person who monitors the technical aspects of Contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this Contract, or changes in the delivery schedule or period of performance of this contract. The COR is not authorized to receive or act upon any notification or revised price estimate provided by the Contractor of this contract.

A.10 Contract Administration

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

a) Direct or negotiate any changes in the contract or a TO;

b) Modify or extend the period of performance;

c) Change the delivery schedule;

d) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; and

e) Otherwise change any terms and conditions of this contract.

1. Patricia Natividad Contracting Officer FDA, Office of Operations, Acquisition and Grants Services Email: Patricia. Natividad@fda.hhs.gov

A.11 Post Award Evaluation of Offeror Performance

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR 42.15. the final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted within fourteen (14) calendar days following the anniversary date of the Contract if any options are exercised pursuant to the Option Term provided under Part C of the Contract.

Interim and final evaluations will be provided to the Contractor as soon practicable after completion of the evaluation. The Contractor will be permitted thirty (3) days to review the document and to submit additional information or a rebuttal statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the Contract file, and may be used to support future award decisions.

PART B – 52.212-4 Contract Terms and Conditions-Commercial products and Commercial Services (Dec 2022) B. 1 FAR Clauses

FAR 52.252-2 Clauses incorporated by Reference (Feb 1998)

This Contract incorporated 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 address(es): https://www.acquisition.gov/far/; https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

GENERAL

FAR Clause Title and Date

Surveillance Services Equipment (Nov 2021)

1984)

PART C –

C.1 FAR Clauses Incorporated in Full Text

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services. (SEP 2023)

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

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

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

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

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

(5) 52.232-40, 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:

__ (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.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

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

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ( 15 U.S.C. 657a).

__ (13) 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).

__ (14) [Reserved] _X_ (15) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

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

__ (16) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

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

__ (17) 52.219-8, Utilization of Small Business Concerns (SEP 2023) ( 15 U.S.C. 637(d)(2) and (3)).

__ (18) (i) 52.219-9, Small Business Subcontracting Plan (SEP 2023) ( 15 U.S.C. 637(d)(4)).

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

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

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

__ (v) Alternate IV (SEP 2023) of 52.219-9.

__ (19) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

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

__ (20) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

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

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) ( 15 U.S.C. 657f).

_X_ (23)(i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2023)( 15 U.S.C. 632(a)(2)).

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

__ (24) 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)).

__ (25) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) ( 15 U.S.C. 637(m)).

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

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

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

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

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

__ (31)

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

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

_X_ (32) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

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

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

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

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

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

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

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

__ (37) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (38) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

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

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

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

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

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

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

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

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

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

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

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

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

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

__ (48)

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

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

_X_ (49) (i) 52.225-1, Buy American-Supplies (OCT 2022) ( 41 U.S.C. chapter 83).

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

__ (50) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (DEC 2022) ( 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 (DEC 2022) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

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

__ (51) 52.225-5, Trade Agreements (DEC 2022) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (52) 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).

__ (53) 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).

__ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150).

__ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (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).

__ (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).

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

__ (63) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ( 15 U.S.C. 637(d)(13)).

__ (64)

(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.] __ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter67).

__ (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).

__ (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).

__ (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).

(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) 52.203-19, 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)).

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

(iv) 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).

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

(vi) 52.219-8, Utilization of Small Business Concerns (SEP 2023) ( 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.

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

(viii) 52.222-26, Equal Opportunity (SEP 2015) (E.O.11246).

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

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

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

(xii) 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.

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

(xiv) (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).

(xv) 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).

(xvi) 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).

(xvii) 52.222-54, Employment Eligibility Verification (MAY 2022) (E.O. 12989).

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

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

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

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

(xxi) 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).

(xxii) 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.

(xxiii) 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.

(xxiv) 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 its contractual obligations.

(End of clause)

FAR 52.216-19 Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $25,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of $999,999.00

(2) Any order for a combination of items in excess of $999,999.00 or

(3) A series of orders from the same ordering office within thirty days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after expiration date of the contract.

FAR 52.217-8 Option to Extend Services (Nov 1999)

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

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor; provided that the Government gives the Contractor a preliminary written notice of its intent 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 (5) years.

C.2 FDA Clauses

Invoice Submission Requirements

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

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.

c. 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).

d. 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:

1. 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;

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

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

4. 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;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

e. 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:

(1) list of all invoices submitted to date under the subject award, including the following: invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(a) total amount of all payments received to date under the subject contract or order

(b) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

f. 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.

g. 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.

h. 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.

ii. 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.

iii. 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.

C.3 Invoice Payment

Payment will be made after performance of lump sum services on monthly basis. It is the requirement of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and quality standards of this contract. The Government is contracting for satisfactory performance of all work identified in the performance work statement, and deductions will, therefore, be made for any service not provided.

It is agreed that failure to accomplish any work required under this contract; to satisfactorily accomplish such work; or to comply with any provisions of this contract, where due to the carelessness, neglect, or fault of the contractor, shall constitute a deficiency for which a permanent reduction of payment will be made in accordance with the provisions of this contract.

C.4 Smoke Free Environment

The Department of Health and Human Services is the Federal Governments principal agency for furthering the health of Americans and providing them with essential human services.

The health risks of smoking and exposure to smoke are clearly documented by reports of the Surgeon General. It is essential that the Department, in the accomplishment of its mission, provide a smoke-free environment in all HHS owned and leased building space.

It is, therefore, the Departments policy to establish a smoke-free environment in all HHS building space. All HHS owned and leased building space is designated as no-smoking areas. This policy applies to Government employees as well as Contractor employees who are assigned to work at HHS owned or leased building space.

C.5 Restriction on Employment of Unauthorized Alien Workers

The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General."

C.6 Government Furnished Equipment (GFE) Government Furnished Information (GFI)

FDA shall provide a list of locations with AED’s along with key information about each device, including manufacturer, model name, model number, serial number or other unique identifier, physical location, point of contact (Site Coordinator).

Identification Badges

Contractor employees shall be required to always wear the required identification badges when working in Government facilities, which may vary based on the facility requirements.

FDA 1335 Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who…