75F40123R00152_9-5-2023.docx

75F40123R00152 FDA Solicitation: 75F40123R00152 Offeror Name UEI

EVALUATING TOXIC INTERACTIONS OF ALDEHYDES IN COMPLEX MIXTURES

SECTION 1 – COMBINED SYNOPSIS SOLICITATION

i. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

ii. The solicitation number is 75F40123R0152 and is issued as an RFQ.

iii. This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-04, June 2, 2023.

iv. The is small business set aside with NAICS code 541990, with the size standard of $19.5 Million.

v. See Section 2 for line items.

vi. See Section 3 for Description

vii. See Section 4 for Dates, Places and Acceptance

viii. The provision at 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. See Section 5 for addenda to the provision.

ix. The provision at 52.212-2, Evaluation-Commercial Products and Commercial Services applies to this acquisition. See Section 5 for addenda listing the specific evaluation criteria to be included in paragraph (a) of that provision.

x. A statement advising offerors to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, with its offer.

xi. A statement that the clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause.

xii. A statement that the clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition.

xii. A statement regarding any additional contract requirement(s) or terms and conditions (such as contract financing arrangements or warranty requirements) determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices.

xiv. A statement regarding the Defense Priorities and Allocations System (DPAS) and assigned rating, if applicable.

xv. The date, time and place offers are due.

xvi. The name and telephone number of the individual to contact for information regarding the solicitation.

SECTION 2 – LINE ITEMS AND PRICES

The Government intends to issue a contract. Offerors are requested to provide a fixed price quote in accordance with the Statement of Work.

SECTION 3 - STATEMENT OF WORK (SOW): EVALUATING TOXIC INTERACTIONS OF ALDEHYDES IN COMPLEX MIXTURES Background On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA has authority over cigarettes, smokeless tobacco, and roll-your-own tobacco. The FDA has also obtained deem jurisdiction over other tobacco products, including e-cigarettes, on August 8, 2016.

Use of tobacco products expose the consumer to a variety of harmful and potentially harmful constituents (HPHCs) and other toxic chemicals that commonly result in the occurrence of adverse health outcomes. These HPHCs and other toxic chemicals may interact with each other in ways that enhance their toxic effects. There is a significant research knowledge gap in understanding the mechanisms and magnitude of these interactions between HPHCs and other toxic chemicals and if these interactions result in observable increases in toxic effects. These interactions and resulting enhanced toxicity may partially explain the observed discordance between predicted lifetime cancer risk associated with use of tobacco products and reported epidemiological data.

FDA seeks more information on the occurrence of interactions between HPHCs and other toxic chemicals present in tobacco products, and how these interactions may result in enhanced toxic effects.

Objectives The objectives of this contract are to develop an aerosol co-exposure system for use with a human relevant in vitro air-liquid interface (ALI) airway tissue model, to characterize the occurrence of cytotoxic and genotoxic responses following exposure to single and combined aldehydes, and to assess the occurrence of enhanced cytotoxic and genotoxic responses following co-exposure to this aldehyde mixture to identify if toxic interactions between these HPHCs occur. The human relevant in vitro ALI airway tissue model will consist of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. This aerosol co-exposure system will utilize model aldehyde HPHCs (i.e., formaldehyde and acrolein) that likely undergo toxicologically relevant interactions and have complementary mechanisms of toxicity.

The findings of this study will assist FDA in understanding the occurrence of toxicological interactions between mixtures of HPHCs produced from tobacco products and their effect on the development of toxicity following exposure. These findings will also provide a platform to analyze if these interactions between HPHCs may affect the calculated lifetime cancer and non-cancer risk of tobacco products.

Scope Under this contract, FDA expects the development of an aldehyde HPHC aerosol co-exposure system, using model aldehyde HPHCs (i.e., formaldehyde and acrolein), paired with a human relevant in vitro ALI airway tissue model consisting of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. FDA expects that this aerosol exposure system and human relevant in vitro model will be used to evaluate the occurrence of toxic responses following exposure to single aldehyde HPHCs and a mixture of aldehyde HPHCs. The toxicity data produced from this work will be used to evaluate the occurrence of toxicologically relevant interactions (i.e., additive, antagonistic, synergistic) between these aldehyde HPHCs.

Tasks The FDA COR will approve all tasks and deliverables. The Contractor shall incorporate the FDA’s feedback into its final versions of all deliverables. The Contractor shall deliver all documents to the COR electronically, not in hard copy form, with the document title and contract and task order numbers identified in the subject line of the email submission. Deliverables shall be in MS Word, MS Excel, .PDF, and/or SAS transport (.xpt) format. All submitted documents shall be verified virus-free. The Contractor shall perform the following tasks and provide the following deliverables (as defined below).

Task 1 – Kickoff Meeting

The Contractor shall conduct a kickoff meeting with the COR ten calendar days after issuance of the task order. Within two business days after the kickoff meeting, the Contractor shall provide comprehensive meeting minutes, including a summary of issues and discussions, action items, and due dates.

Task 2 – Bi-weekly Meeting

The Contractor shall conduct bi-weekly teleconferences or web meetings at least every ten business days after the start of experiments, and as needed. At these meetings, the Contractor will discuss and report to FDA any deviations from the planned study protocols and any other issues that develop during the performance of the contract. Within two business days after each meeting, the Contractor shall provide comprehensive meeting minutes, including a summary of issues and discussions, action items, and due dates.

Task 3 – Monthly Report

The Contractor shall submit a concise monthly report describing research activities, progress on completing tasks associated with performance this contract, and completion of contract and project milestones. This report shall be submitted electronically to the COR every thirty calendar days after the kickoff meeting.

Task 4 – Study Protocol Review, Initiate and Complete the Study Experiments

The Contractor shall conduct in vitro cytotoxicity and genotoxicity assessments following aerosol exposure to single aldehyde HPHCs and a mixture of aldehyde HPHCs using a human relevant in vitro ALI airway tissue model. The Contractor shall submit the prepared study protocols for FDA review prior to the commencement of the study experiments. The Contractor shall notify the COR electronically regarding any deviations from the planned study protocols and any other issues that develop during the performance of this contract within three calendar days of their occurrence. The Contractor shall select a research facility and trained personnel to complete the experiments for this study. The Contractor shall conduct the necessary in vitro cytotoxicity and genotoxicity assays needed to evaluate toxicologically relevant interactions between aldehyde HPHCs according to the terms and experiment parameters identified in section 3.4 Task Order Guidelines below.

Task 5 – Execute the Data Analysis Plan

The Contractor shall perform the data analysis indicated in the COR approved Data Analysis Plan. The Data Analysis Plan shall include FDA review of all draft deliverables and as needed, subsequent contractor revision and delivery of final reports.

Task 6 – Draft Study Report

The Contractor shall report the results of the assays and experiments to FDA in the form of a Study Report. The Study Report shall include an executive summary, specific protocols, methods, and equipment used for each assay and experiment, which shall include the number of replicates, products, and chemicals used as controls. The draft Study Report shall also include data analyses, interpretation, and summary of results (see Section 3.4.3 for further detail). The Contractor shall incorporate any revisions as needed based on comments received from FDA.

Task 7 – Final Study Report and Review

The Contractor shall submit a final Study Report to FDA incorporating all edits to the draft Study Report received from the COR. All the data in the final Study Report shall be properly audited. A Quality Assurance Statement shall be issued by the contractor and included in the Final Report. The Final Report shall be supplemented with electronic copies of the raw data associated with performance of this contract. The raw data shall be in MS Word, MS Excel, .PDF, and/or SAS transport (.xpt) format. All submitted documents shall be verified virus-free. FDA will review the Final Report prior to its acceptance as the final deliverable and conclusion of the contract.

Section 3.4 – Task Order Guidelines

3.4.1 Good Laboratory Practices (GLP): When practical, the Contractor shall follow GLP for the documentation and conduct of the assays and experiments involved in the performance of this contract. FDA understands that GLP-compliance is not always practical and expects that the Contractor use its best, reasonable judgement in determining when GLP-compliance is or is not practical and appropriate. For instances where GLP-compliance is determined not to be practical and appropriate, the Contractor shall use laboratory practices that are near GLP compliance and that can be considered to be GLP-like.

3.4.2 Experimental Parameters: The Contractor shall conduct in vitro cytotoxicity and genotoxicity assessments following aerosol exposure to single aldehyde HPHCs (i.e., formaldehyde and acrolein) and a mixture of these aldehyde HPHCs using a human relevant ALI in vitro airway tissue model that consists of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor. The Contractor shall confirm the integrity of the ALI airway tissue model, as well as the maintenance and retention of necessary cell phenotype and characteristics over the timeframe needed to complete the required assays and experiments. The Contractor shall evaluate the occurrence of cytotoxicity and cell viability following aerosol exposure to single HPHCs and the HPHC mixture using a dose-range finding study to identify the IC10 value (i.e., the concentration that produces 10% cytotoxicity) and the no observed effect concentration (NOEC). The Contractor shall use the IC10 and NOEC information to select relevant exposure ranges for the in vitro genotoxicity assays. The Contractor shall evaluate cytotoxic responses and cell viability using standard assays (i.e., lactate dehydrogenase assay for cytotoxicity and MTS assay for cell viability). The Contractor shall assess tissue barrier integrity of the ALI airway tissue model pre- and post-exposure by measuring trans-epithelial resistance (TEER) of the in vitro tissue.

The Contractor shall evaluate genotoxic responses induced by exposure to single aldehyde HPHCs and a mixture of these aldehyde HPHCs. The Contractor shall use exposure concentrations of single aldehyde HPHCs and a mixture of these aldehyde HPHCs that span the observed NOEC and IC10 concentrations. These conditions are necessary to ensure that cytotoxicity does not overshadow or confound the observation of genotoxic responses. The Contractor shall evaluate the following genotoxic responses: i) occurrence of single and double strand DNA breaks using standard assays (i.e., Comet assay and γH2AX assay); ii) occurrence of DNA mutations using error-corrected DNA sequencing methods (i.e., Duplex sequencing or PacBio SMRT sequencing); iii) formation of micronuclei with and without cytokinesis-blocking to distinguish if differing genotoxic responses occur. The Contractor shall evaluate the occurrence of interactions between single aldehyde HPHCs and the effect on resultant cytotoxic and genotoxic responses using objective, mathematical modeling approaches and calculations (i.e., calculation of the Interaction Factor or use of other appropriate equations) and classification of interactions (i.e., additive, synergistic, antagonistic, potentiation).

The Contractor shall select the research facility to perform the required study. The Contractor shall develop all applicable scientific protocols and methodologies, including selection of exposure concentration levels and duration, and time points for collecting all necessary samples; equipment, materials to be used in each experiment; sufficient description of methodologies used to measure and analyze each endpoint; and incorporating the detailed procedures specified below. The Contractor shall provide a written protocol with their proposal that contains the rationale, scientific protocols, and methodologies, including scientific justifications, equipment, and materials and software to be used in the study. The Contractor shall notify the COR electronically regarding any deviations from the planned study protocols and any other issues that develop during the performance of this contract within three calendar days of its occurrence. The Contractor shall also select trained personnel to complete the assays and experiments for this study. The Contractor shall adhere to the following procedures and measures for all assays and experiments, unless indicated by the COR:

1. Duration of exposures shall be reported. Assays and experiments used to evaluate cytotoxicity and genotoxicity shall conform to OECD, ISO, and other standardized testing guidelines when available. If a standardized testing guideline is unavailable, the Contractor will prepare an appropriate protocol for the relevant procedure in consultation with FDA. For protocols proposing to use guidelines or procedures outside of the national or international standardized testing guidelines, the Contractor shall provide the relevant Standard Operating Procedures (SOPs) and method validation, as appropriate, to the COR.

2. Solvents used for solubilization and dilution of test materials and assay components shall be reported.

3. Cytotoxic and genotoxic responses to aerosol exposure of single aldehyde HPHCs and a mixture of these HPHCs shall be assessed using a human relevant ALI in vitro airway tissue model that consists of differentiated normal human primary tracheobronchial epithelial cells collected from a single donor.

4. Appropriate positive and negative controls shall be used for all assays used to assess cytotoxic and genotoxic responses to confirm that the assay is producing an appropriate response.

5. Purity of the test chemicals shall be reported (Certificate of Analysis shall be provided by the Contractor).

6. Data analyses shall be conducted and reported in the Draft and Final Study Reports

3.4.3 Final Report Requirements:

1. Specific protocols, methods, materials, and equipment used for each experiment, including name, concentrations, duration of exposures, and supplier information (including city, state, and country for all test material, equipment, and materials). Information on software and computational models used for the assays, experiments, data analysis, and data interpretation shall be included.

2. Data analyses shall include appropriate statistical analyses. The details of comparative cytotoxicity and genotoxicity assessment parameter calculations, including equations utilized, shall be adequately described and referenced.

3. Interpretation and summary of results. A textual interpretation and summary of results, summary tables, and graphical representations of study compounds shall be provided for a clear visual representation of the data. A brief paragraph summarizing the pertinent conclusions of the study shall be provided. Interpretation of the cytotoxicity and genotoxicity assay results and the identified interactions between aldehyde HPHCs shall be provided. A list of all protocol deviations shall be included and the impact of these deviations on the affected assay/experiment shall be discussed.

4. All individual data needed for conclusions shall be presented in coherent, organized tables. A copy of the raw data shall be provided separately in an appendix.

5. Documentation of the analytical methods shall be provided to demonstrate the sensitivity, linearity, specificity, reproducibility, and conformity of the assays to relevant test guidelines (i.e., OECD guidelines, etc.) and procedural documents (i.e., the study protocol). For protocols proposing to use guidelines or procedures outside of the national or international standardized testing guidelines, the Contractor shall provide the relevant Standard Operating Procedures (SOPs) and method validation, as appropriate, to the COR.

6. The Final Report shall be supplemented with electronic copies of the raw data associated with performance of this contract. The raw data shall be in MS Word, MS Excel, .PDF, and/or SAS transport (.xpt) format. All submitted documents shall be verified virus-free.

Delivery The Contractor shall complete and deliver the following deliverables according to the following schedule:

The Contractor shall complete all work arising out of this order within twenty-four months from the effective date of the order.

CONFLICTS OF INTEREST

The Contractor or Offeror affirms the lack of conflicts of interest or information related to any actual, potential, or apparent conflicts of interest which may affect the offeror’s ability to perform this requirement in an impartial and objective manner or that may result in an unfair competitive advantage in accordance with the Conflicts of Interest terms in Section 3.

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

None. GFP will not be furnished to the Contractor.

Security There are no unique security requirements associated with performance of this contract.

Travel There are no travel requirements associated with performance of this contract.

Special Material Requirements This contract will require the use of a human-relevant air-liquid interface in vitro airway tissue model and the use of an aldehyde HPHC aerosol co-exposure system.

Other Unique Requirements FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work. FDA will retain ownership of the data produced during performance of this contract and retains sole responsibility to draft, prepare, review, and submit any subsequent manuscripts using this data for publication in any format.

Place of Performance The performance of this contract will be conducted at the Contractor’s facility.

Period of Performance The period of performance of this contract is twenty-four months.

SECTION 4 - GENERAL EVALUATION INFORMATION EVALUATION AND AWARD

The Government intends to make award based on best value trade-off.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Unique Entity Identification (UEI); 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. The total number of pages for the technical quote shall not exceed ten (15) pages.

The solicitation does not commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

SECTION 5 – ADDEDUM / CONTRACT CLAUSES AND PROVISIONS / ADDITIONAL TERMS AND CONDITIONS

A.1 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 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:

[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.)

__ (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).

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

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

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

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

__ (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (18) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) ( 15 U.S.C. 637(d)(4)).

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

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

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

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

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

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

__ (20) 52.219-14, Limitations on Subcontracting (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 (Mar 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)).

__ (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).

__ (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).

_X_ (31) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

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

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

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

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

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

__ (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.

__ (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.

__ (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).

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

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

__ (49) (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).

_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).

__ (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).

__ (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 (Oct 2022) ( 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)

A.2 FAR 52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2023)

(a) Definitions. As used in this clause— Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause)

A.3 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at:

1) www.acquisition.gov/far/index.html.

52.212-3

52.212-4

2) http://www.hhs.gov/policies/hhsar/:

HHSAR

NUMBER

A.4 INVOICE INSTRUCTIONS

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…