Sol_Doc_Amend No.2.doc

FDA-RFP-1241927B – Amendment No: 2 Analysis of Constituents of Leachate from ENDS Components

Small Size Standard $16.5 Millions

Part 1 – Description

The U.S. Food and Drug Administration’s (FDA), Center for Tobacco Product (CTP) requires a contract to conduct laboratory analysis to characterize and quantify the chemical constituents of leachate from the littered e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Part 12.603. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Proposal (RFP) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06 dated July 12, 2021. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541380, Testing Laboratories, Small Size Standard $16.5 Million. This requirement is for full and open competition to all potential proposal.

This requirement is to conduct laboratory analysis to characterize and quantify the chemical constituents of leachate from the littered tobacco product.

Part 2 – Supplies or Services and Prices

Purchase Order Type: Firm-Fixed Price

2.1 Pricing Schedule

0001.

ENDS Component Collection

Total Price

Total Price for the requirement is:

Company Name: ________________________ DUNS Number: _______________________

Point of Contact: _______________________Tel: ____________E-mail: ___________________

Estimated Delivery Date: ________________ Country of Manufacturing: _____________

Payment is only authorized for the respective firm-fixed-price upon successful completion of the respective CLINs, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR) according to the Statement of Work, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. The amount invoiced shall be derivative of the number of ownership verifications performed for that billing period at the approved per unit rate.

Part 3 – Description/Specifications

3.1 Background

Independent data assessing the product lifecycle of e-cigarettes and the accompanying environmental health risks are limited. From manufacturing, use, and disposal, each stage of the e-cigarette product lifecycle presents potentially new environmental burdens compared with traditional cigarettes.1 In recent months, a number of studies focused on impacts related to use of e-cigarettes have been published, ADDIN EN.CITE

2-5 however, studies tracking disposal patterns of e-cigarettes are still limited. Online editorials and a recently published article suggest that like cigarette butts, used e-cigarette capsules or replaceable nicotine-filled plastic pods are often littered.6 Littered or improperly discarded e-cigarette components can leach heavy metals, battery acids, and organic chemicals into the environment. Lead concentration in leachates from some disposable e-cigarettes have been reported to be at levels that are 1.5–10 times the regulatory threshold.7 A study identifying leachable constituents from e-cigarette cartridges, nicotine-filled pods, e-liquid bottles, and disposable e-cigarettes will provide useful data for assessing disposal-related environmental impacts. Additionally, assessing the role of environmental conditions on leaching rates and potential transformation of chemical constituents in the leachate would be essential for modeling the fate and transport of the constituents and their associated ecological risks.

This study will use the US Environmental Protection Agency (EPA) Toxicity Characteristic Leaching Procedure (TCLP, EPA Method 1311) and the California Waste Extraction Test (WET) to assess leachate from e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes under different environmental conditions. Various EPA analytical methods will be used to characterize and quantify chemical constituents in the leachate. The US EPA TCLP is the analytical method used to determine whether a solid waste meets the definition of hazardous waste based on the toxicity characteristic (TC; i.e. target constituents leach at concentrations above specified thresholds). It is the official method in the EPA test methods for evaluating solid waste (SW-846) in complying with Resource Conservation and Recovery Act (RCRA) regulations. While most US states regulate waste in the same ways as the federal rules, some states have adopted additional, more stringent standards. WET is a separate leaching experiment required by the state of California, as part of hazardous waste determination. WET assesses leaching under more aggressive conditions than the TCLP. Additionally, California regulations include copper, nickel, and zinc as metals with a TC concentration, which are not included on the RCRA list of TC metals. Both test methods are prevalent methods and most laboratories in the US have the capacity to perform the tests. These methods provide the most economically effective way to achieve the objectives of this study.

The National Environmental Policy Act (NEPA) requires an analysis of the environment impacts, as well as scenarios that could lead to human health impact, for federal actions, such as tobacco product marketing authorizations. Information about the identities and amounts of constituents that leach from e-cigarette components is limited and is necessary to characterize the hazard and model the fate and transport of the constituents in the environment.

3.2 Objective

The objectives of this study are to:

· Conduct laboratory analysis to characterize and quantify the chemical constituents of leachate from the littered e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes

· Measure the rate at which constituents leach from the collected ENDS components

· Determine the impact of environmental factors such as temperature, salinity, and pH on the composition and concentration of constituents in the leachate

3.3 Statement of Work

Under this fixed price contract, the FDA is interested in conducting a study to support characterization and quantification of chemical constituents of leachate from e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes.

3.3.1 Tasks/Requirements Over the course of a 6-month period, the Contractor shall complete the tasks listed below:

Task 1: Initial Project Briefing Within two weeks of award, the Contractor shall hold a teleconference with the Contracting Officer Representative (COR), Contracting Specialist (CS), Contracting Officer (CO), and other interested FDA personnel. The purpose of this teleconference is to 1) discuss the administration of this contract, and 2) to discuss the project’s objectives, planned course of action, milestones and deliverables, and any other issues the Contractor or government identifies. The Contractor shall be prepared with appropriate briefing materials. PowerPoint slides and other supplementary materials shall be submitted to the COR at least five business days before the briefing.

After receipt of the briefing materials, the COR will either approve the material, or contact the Contractor with comments. After the Contractor’s prepared briefing, the Contractor, COR, CS, CO and other FDA personnel will discuss specific details of the project to resolve any differences in approach and/or expected goals/objectives. Meeting minutes shall be provided to the COR within five business days after the meeting.

Task 2: Monthly Progress Reports The Contractor shall furnish one electronic copy to the FDA COR by the 1st of each month. At a minimum, the progress report shall include a snapshot of progress compared to the approved work breakdown structure (WBS) (see Task 4) and a narrative description of the following items:

1. Accomplishments made during the reporting period.

2. Plans for accomplishments in the next reporting period.

3. Interim results, conclusions, trends or other items of information that the Contractor believes are of interest to the FDA.

4. Problems or delays that the Contactor has experienced in the performance of their services, as well as any quality assurance and control measures taken during the reporting period

5. Specific action(s) that the Contactor would like the FDA to undertake to alleviate a problem.

6. Due dates for upcoming deliverables.

Task 3: Conference Calls The COR may request conference calls to discuss status of deliverables and any other issues which may arise with the contract. The COR will work with the Contractor to determine when the conference calls will occur. CTP is estimating one call per month for the life of this contract.

Task 4: Detailed Analysis Plan The Contractor shall develop a detailed work breakdown structure (WBS), including all project tasks and subtasks. The WBS shall include FDA review of all draft deliverables and, as needed, subsequent contractor revision and delivery of final reports. As identified in the approved WBS, the Contractor may perform multiple tasks at one time for efficiency.

Task 5: ENDS Component Collection The Contractor shall develop and implement an ENDS components collection plan. The Contractor shall submit an e-cigarette components collection plan, test methods for conducting leachate tests, and an analysis plan to the COR for concurrence and feedback. The Contractor shall collect e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes to use for preparing the leachate. This study is not a human subject study. This study is not a research activity involving human subjects for study recruitment. It does not involve obtaining information about living individuals.

There will be no interaction or intervention with individuals. No individuals will be interviewed, nor their individually identifiable information obtained. The study does not involve videotaping, recording, or surveying individuals. The Contractor will collect only e-cigarette cartridges, pods, e-liquid bottles, and disposable e-cigarettes and will not interact with humans from whom e-cigarette components are obtained.

Task 6: Preparation of Leachate The contractor shall use US EPA TCLP and California WET leaching methods, with appropriate modifications to maintain 20-fold and 10-fold dilution, to assess leaching of metals and organic constituents from the collected ENDS litter. The contractor shall perform leaching tests on whole e-cigarette components instead of grinding to satisfy the TCLP sample size requirement. The contractor shall purchase new ENDS components representative of the components collected for use in selecting appropriate extraction solvents and solutions and perform triplicate (TCLP) and quadruplicate (WET) extractions to test repeatability of the leaching methods. The contractor shall run ENDS components identified in the collected ENDS litter in duplicates, triplicates, or quadruplicates depending on the number of identical products identified. The contractor shall store the leachate under appropriate conditions as specified by the leaching method for analytical determination of chemical constituents. The contractor shall determine leaching rates and the influence of pH, temperature, and salinity on the composition and concentration of chemical constituents.

To determine the impacts of environmental conditions on the composition and concentration of constituents, the contractor shall perform TCLP using deionized water and simulated rain water, maintaining the 20-fold dilution and 18-hour extraction time. The Contractor shall compare the leachate from deionized water and simulated rain to determine if differences exist in chemical composition or concentration of constituents.

If differences do exist, the contractor shall perform leaching under different environmental conditions using simulated rainfall, if no differences exist then contractor shall use deionized water. The contractor shall perform leaching test at three different temperatures (10, 20, 30) (C; three salinity levels [0ppt (freshwater), 15ppt (brackish water), 35ppt (seawater)]; and three pH levels (5, 7, 9). The analysis of the leachate shall be completed as described in Task 7 below.

Task 7: Analysis of Leachate Using EPA methods 6000/7000 and 8000 series, the Contractor shall analyze three replicates of the leachate to quantify levels of the inorganic and organic chemical constituents specified below, respectively. The Contractor shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions.

For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below:

· 2-Furancarboxaldehyde

· 1,2-Benzenedicarboxylic acid, diethyl ester

· NNK and NNN

· PAHs (total)

· Phenol

· Glycerol, propylene glycol ethylene glycol, and diethylene glycol

· Formaldehyde

In addition to the above list, the Contractor shall identify and quantify any constituents not on the list that have a mass greater than 10% of the analyzed mass. Analytical results will be reported in mg/L, mg/ENDS component, and mg/kg of ENDS component.

Task 8: Study Implementation The Contractor shall follow all federal, state, and local environmental, health, sanitation and emissions regulations. In addition, the Contractor shall follow all applicable Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations. Disposal of ENDS components, leachates and laboratory waste must follow the above environmental, health and safety regulations.

Task 9: Outline of Final Report

Within 6.5 months of the contract award, the Contractor shall submit a detailed outline of the final report. The outline shall include: 1) bullet points of major highlights of each section, along with subheadings: Method, Results, Discussion, and Conclusions; and 2) proposed appendices.

Task 10: Draft Final Report The Contractor shall submit a draft of the final report within 7 months of contract award. The Contractor shall prepare a detailed final report including: 1) an executive summary; 2) methods, including how the data was collected and analyzed; 3) results of the analysis; 4) discussion, including problems encountered during the study and their solutions; and 5) conclusions; and 6) related appendices.

As a part of the final report, the Contractor shall submit analytical procedures (including details regarding extraction procedures and/or any other procedures used during sample preparation), validation reports, system suitability, and any other pertinent information for measuring the analytes indicated in Task 5.

Task 11: Final Report The Contractor shall submit all raw data and a Final Report within 9 months of contract award that presents the objectives, methods, results of the analyses, and a summary of the findings and conclusions of the project. The Final Report shall include the required elements outlined for the draft report (Tasks 9 and 10 and shall incorporate any revisions based on comments received from the FDA.

The Contractor shall provide the raw data and the Final Report to the COR in the following manner:

1. Microsoft Word electronic versions of the Final Report and all text-based appendices.

2. A print-ready PDF electronic version of the Final Report and all appendices.

3. One bound hard copy, double-sided, including the Final Report and all appendices.

4. Files of all raw data in their native file format (Excel).

Task 12: Final Briefing Within 9 months of the award, the Contractor shall conduct a final briefing to FDA personnel via web conference. This briefing shall consist of a 30- to 40-minute presentation of the project and shall include a background on the problem, descriptions of methods used, the results of the tasks, and a brief discussion of the results and problems encountered during the study. The Contractor shall be prepared with appropriate briefing materials and shall send their presentation materials to the COR for review within two days prior to the presentation date.

Part 4 –Performance and Deliverables

4.1 Performance Milestone and Deliverables

The following performance milestones and deliverables shall apply to this Contract and are considered critical to the successful completion of the project. The Contractor shall deliver all reports to the COR. The COR will receive documents, check for completeness, and communicate Government comments on draft documents back to the Contractor.

Table 1. Milestones and Deliverables Schedule

NOTE: Contractor shall provide raw data from the experiments and analyzed/curated summary data.

All deliverable items notated in Deliverable Table shall be sent to the COR electronically and/or physically, where stated, to the following addresses:

Food and Drug Administration

Center for Tobacco Products

Division of Non-Clinical Science

11785 Beltsville Dr.

Calverton, MD 20705 Attn: Nabanita Nag

Tel: (240) 402-9768 Email: Nabanita.Nag@fda.hhs.gov Electronic File Specifications

Electronic files containing reports (Progress Reports, Draft Reports, and Final Reports) shall be in MS Word (.docx) format.

Report Format:

· Font = 12-point Times New Roman font shall be used throughout the report

· Page Margins = Top, Right, Left, and Bottom shall be 0.75 inches

· Page Numbering = Lower right-hand corner, using 11-12 point Times New Roman font

Raw data and tabulated results (means and standard deviations) of all analyses and quality control samples shall be provided in MS Excel (.xlsx) format.

4.2 Place of Performance and Work Hours

The majority of the work shall be performed at the contractor’s site.

4.3 Inspection and Acceptance

The Contracting Officer’s Representative will perform inspection of the services to be provided. The Contracting Officer’s Representative – to be determined upon contract award - is the authorized representative of the Contracting Officer.

The COR will review and communicate acceptance or rejection of deliverables to the Contractor no later than ten (10) business days prior to the end of the month. The contractor will have five (5) business days to correct and resubmit the rejected deliverables.

4.4. Conflict of Interest

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

a) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of this section applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest

Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities

The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

The contractor will be performing lab analysis of tobacco products and providing that analysis to FDA to inform regulatory decision making. The contractor must thoroughly disclose any relevant information regarding financial relationships with private entities that may be affected by this regulatory decision making in its proposal prior to award. If such financial relationships exist, the contractor shall provide a statement as to whether it believes the relationships present a potential or actual conflict of interest and the basis for that determination. If the contractor has identified a potential or actual conflict of interest, a plan for mitigating the conflict of interest must be submitted prior to award.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities. – The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

4.5 Period of Performance

The period of performance for this contract is for nine (9) months from date of award.

4.6 Government Furnished Equipment Property (GFE/GFP)

Government Furnished Equipment. If necessary, the government shall provide the workspace, telecommunication, data communications, and network security facilities needed to support the tasks and assignments of this contract. The government also will supply email and Internet access capability if necessary.

4.7 Key Personnel

The Contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name

Title Principal Investigator/Project Manager

Lead Scientist

Technician

Key Personnel Qualifications:

· Principal Investigator/Project Manager shall at a minimum be knowledgeable and technically skilled in one or a combination of the following: biological sciences, chemistry, pharmacy, toxicology, physical sciences, medical science, engineering, epidemiology, or related scientific fields that provided knowledge and skills directly related to laboratory research work. In addition to the above educational requirements, the individual shall have at a minimum 1-year experience conducting tobacco related experimentation.

· Lead Scientist shall at a minimum be knowledgeable and technically skilled in one or a combination of the following: biological sciences, chemistry, pharmacy, toxicology, physical sciences, medical science, engineering, epidemiology, or related scientific fields that provided knowledge and skills directly related to laboratory research work.

· Technician shall at a minimum possess be knowledgeable and technically skilled in one or a combination of the following: biological sciences, physical sciences, or natural sciences.

In the event that any of the personnel listed as key personnel are unable to perform because of health, resignation from the contractor’s employ, or any other reasons, the contractor shall promptly submit to the Contract Officer, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Officer. No increase in contract pricing will be allowed when substitutions are authorized by the government.

4.8 Other 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.

Upon acceptance for publication, researchers are also responsible for submitting the author’s final manuscript of any peer-reviewed scientific publication resulting from research supported, in whole or in part, with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications resulting from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. FDA expects timely release and sharing of final research data from FDA-funded studies for the research community’s use in accordance with the submitted Data Management Plan. Please see the FDA Public Access Policy (provided as Attachment/Exhibit XXYY; or, available at http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf).

Part 5 –Contract Administration

5.1 Administrative Points of Contract

Contracting Officer’s Representative’s

For this PART, (COR TBD) is the authorized representative of the Contracting Officer.

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and services to be provided.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Terry L. Frederick U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Terry.Frederick@fda.hhs.gov The contact information for the Contract Specialist is the following:

Ravi Chandan Palaniandy U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Ravichandan.palaniandy@fda.hhs.gov Tel: 301-796-4378

5.2 FDA Three-Way Match Invoicing Procedures

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Office of Financial Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742

Email: FDAVendorPaymentsTeam@fda.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is To Be Determined

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the 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.

Part 6 – Contract clauses

6.1 HHSAR Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses.

352.203-70, Anti-Lobbying (Dec 2015)

352.215-70, Late Proposals and Revisions (Dec 2015)

352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.237-75, Key Personnel (Dec 2015)

352.239-73. Electronic Information and Technology Accessibility Notice (Dec 2015) 352.239-74. Electronic Information and Technology Accessibility (Dec 2015)

6.2 FAR Clauses Incorporated by Reference

52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-22, Alternative Line Item Proposal (Jan 2017) 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

6.3 Solicitation Provisions Incorporated by Reference:

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov/far/index.html FAR 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sept 2007) FAR 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (FEB 2016).

FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016)

FAR 52.204-22, Alternative Line Item Proposal (Jan 2017) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2019).

FAR 52.212-1, Instructions to Offerors- Commercial Items (Oct 2018) FAR 52.233-2, Service of Protest (Sept 2006)

6.4 FAR Clauses Full Text

52.204-21, Basic Safeguarding of Covered Contractor Information Systems (JUN 2016)

(a) Definitions. As used in this clause–

“Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

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

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

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

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

(b) Safeguarding requirements and procedures.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

52.204-22 Alternative Line Item Proposal (JAN 2017)

(a) The Government recognizes that the line items established in this solicitation may not conform to the Offeror’s practices. Failure to correct these issues can result in difficulties in acceptance of deliverables and processing payments. Therefore, the Offeror is invited to propose alternative line items for which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract is economically and administratively advantageous to the Government and the Offeror.

(b) The Offeror may submit one or more additional proposals with alternative line items, provided that alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation. However, acceptance of an alternative proposal is a unilateral decision made solely at the discretion of the Government. Offers that do not comply with the line items specified in this solicitation may be determined to be nonresponsive or unacceptable.

(End of provision)

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that—

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is □ is not □ a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is □ is not □ a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (JUL 2021)

(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 items:

(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 (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 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 items:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

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

_X_ (4) 52.204-10, 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)…