FDA-RFP-1226930 - Amendment No.1.pdf

FDA-RFP-1226930 – Amendment No: 1

Market Research on Cell Cultured Food Industry

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFP-1226930

Posted Date: July 22, 2020

Response Date: August 12, 2020

NAICS Code: 541910, Market Research and Public Opinion Polling, Small Size Standard $15,000,000.00

Set Aside Small Business

Part 1 – Description

The U.S. Food and Drug Administration’s (FDA), Center for Food Safety and Applied Nutrition

(CFSAN), Office of Nutrition and Food Labeling requires a contract to conduct a market research study on the cell cultured food industry. 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 8 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2020-07 dated July 2, 2020. The North American Industry Classification System

(NAICS) code for the proposed acquisition is 541910, Market Research and Public Opinion

Polling, Small Size Standard $15,000,000.00. This requirement set-aside for small businesses only under multiple award schedule category Market Research and Public Opinion Polling.

This requirement is to conduct market research on the current landscape of the cell cultured food industry to gain an understanding of the potential market, including timing, types of products, labeling, and related foods to inform policy decisions regarding the modernization of standards of identity and related issues for labeling these foods produced using cell culture and related technology.

Part 2 – Supplies or Services and Prices Purchase Order Type: Firm-Fixed Price

2.1 Pricing Schedule

CLIN Deliverable Price

0001.

Kickoff Meeting

Initial Project Plan

Bi-Monthly Progress Report

Collection and Analysis of Data

Preliminary Results

Draft Report

Final Report

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

Section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishes the legal authority for the FDA to promulgate standards of identity for food. Under section 401 of the

FD&C Act (U.S.C. 341) the Secretary, can establish for any food, under its common or usual name, a reasonable definition and standard of identity, reasonable standard of quality, or reasonable standards of fill of container, if such action will promote honesty and fair dealing in the interest of consumers.

FDA began establishing Standards of Identity (SOI) shortly after the Federal Food, Drug, and

Cosmetic (FD&C) Act was enacted in 1938 to “promote honesty and fair dealing in the interest of consumers” and, since this time, has established more than 280 SOI for a wide variety of food products. SOI typically set forth permitted ingredients, both mandatory and optional, and sometimes describe the amount or proportion of each ingredient. Many SOI also prescribe a method of production or formulation. A food is misbranded if it purports to be or is represented as a food for which a SOI has been established but fails to conform to the standard. As a large percentage of SOI were issued decades ago, various stakeholders have expressed concerns that many SOI are out-of-date and may impede innovation – including the ability to produce healthier foods.

On March 29, 2018, FDA Commissioner Dr. Scott Gottlieb, M.D. announced a comprehensive, multi-year FDA Nutrition Innovation Strategy (hereinafter the “NIS”). The NIS focuses, among other things, on providing incentives for food manufacturers to produce products that have more healthful attributes. Under the NIS, FDA is seeking to modernize food Standards of Identity

(SOI) in a manner that will achieve three primary goals: (1) protect consumers against economic adulteration; (2) maintain the basic nature, essential characteristics, and positive nutritional attributes of food; and (3) promote industry innovation and provide flexibility to encourage manufacturers to produce more healthful foods. To inform this effort, FDA is seeking information to learn what changes have occurred in food production, manufacturing, and marketing that FDA should be aware of when reviewing its SOI regulations and related labeling regulations and exploring how to modernize. FDA is also seeking information regarding consumer demographics and expectations.

These tasks will support and inform FDA policy decision regarding the modernization of standards of identity and related issues of product labeling for these product categories.

3.2 Objective

The primary objective of this task is to conduct a study of the current landscape of the cell cultured food industry to gain an understanding of the potential market, including timing, types of products, labeling, and related foods. Note that the term “animal” refers to meat, poultry, and seafood.

The study may be used to inform future CFSAN policy.

3.3 Statement of Work

The Government requires general economic consulting and project management services familiar with experience conducting expert elicitations. Independently and not as an agent of the

Government, the Contractor shall furnish the necessary materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein.

3.3.1 Specific Tasks

The Contractor shall furnish the necessary personnel, services, and facilities to collect and conduct an analysis of data relating to the food product from cell culture tech. The Contractor shall help develop the study and analysis design that will best achieve the study objectives, summarize the results, and submit draft deliverables at the schedule shown below. The study design and all deliverables will all be reviewed by the government Project Advisory Group (PAG) for approval before the Contractor begins the next stage of work.

Project Planning

The Contractor shall arrange a kick-off meeting with the Contractor’s team within thirty (30) days of award to achieve a clear and mutual understanding of all contractual requirements. Discussion will include a description of the information to be included in the project, concept requirements, and an estimated timeframe for each phase of the study. All project requirements and expected deliverables must be discussed and agreed upon before moving to the next phase.

To ensure the project is well thought out in sufficient detail, the Contractor shall work with the

FDA staff to develop the project approach in detail. The Contractor shall provide a written project plan outlining, timelines, and the deliverables.

The project plans for each industry should outline the overall project with government input and approval.

The Contractor shall complete all tasks necessary to successfully coordinate, document and prepare detailed written summary statements of meeting and data analysis results for each task.

The Contractor shall coordinate and prepare correspondence articulately for a broad audience of

FDA stakeholders, which requires minimal rework after being presented to the Contracting

Officer Representative (COR) for execution.

The Contractor, in coordination with the Government, shall identify and finalize the list of possible data sources for each task to analyze based on the objectives of the study. Depending on the data identified as necessary, the Government may share data it owns.

The Contractor shall produce well written, concise, detail summary documents resulting from organizational meetings and forums.

Project Development

The Contractor shall work with the FDA PAG to develop a study to analyze the following characteristics of foods produced using cell culture and related technology:

1. What companies are developing cell culture technologies.

2. Which specific animal species are currently in development to have cell cultured alternatives.

3. The physical forms of food that is anticipated to come into the marketplace.

4. Terms which might be used to describe the physical forms (for example, burgers, chunks, fillets, etc.)

5. Potential claims on products which are derived from cell cultured production.

6. Estimates of when food products produced using cell culture technology will come to market.

7. The number and type of products currently on the market which contain animal products which have been traditionally produced and plant-based proteins combined into one food.

8. The types of proteins which are being used in combination with traditional animal products in these foods.

9. The statements of identity and claims being used on these combined plant and animal foods.

10. The international regulatory landscape for foods produced using cell culture technology.

11. When foods produced from cell culture technology could first appear on the international market.

12. The availability and/or development of other foods produced using technologies similar to cell culture technology, but which do not use the cells of whole animals (for example, milk or egg proteins produced using yeast or bacterial cultures).

Note: Suggested content areas are subject to change/addition dependent on Task 1.

The Contractor shall provide analysis plan outline of research reports and FDA will review and provide approval within set timeframe as requested.

Execute the Study

The Contractor shall collect the relevant data and perform a detailed review of data; analyze gaps and constraints of the data; clean and analyze the data to provide analysis of the characteristics

(discussed in Task 2) of the cell culture technology. Depending on the data identified as necessary, the FDA may share data it owns.

The FDA shall coordinate a bi-monthly (or more frequent as needed) conference call to review the activities during each month, and activities planned for the ensuing month. If needed the FDA representative(s), along with the Contractor shall coordinate in person meetings to ensure that the task is progressing in a timely manner.

Deliverable: The Contractor shall collect and compile the content of the analysis meeting all requirements of the statement of work, contract, and ensure all responses are well documented. Contractor will review, analyze, and evaluate data, and prepare a draft report describing the findings, results and recommendations from this activity, to assist, improve, and otherwise enhance an understanding of the foods produced using cell culture and related technology. Collection and analysis of data should be completed within 90 days after kick-off meeting. The draft report with the related justifications shall be submitted within 30 days after the submission of the preliminary results.

Summarize Findings

The contractor shall provide a summary report to the FDA, along with an executive summary describing the main points, findings, and other significant information that will need immediate internal review and deliberation.

This final report shall provide relevant statistics and visual relationships- utilizing tables, graphs, charts, other visual descriptors, to illustrate the findings of the analysis as necessary. Similarly, the final report summary shall provide an explanation as to the potential impact any gaps or constraints in the data may have representative to the nature of the analysis as applied to the foods produced using cell culture and related technology.

Deliverable: The final report shall include a summation of the work performed and shall be in sufficient detail to describe comprehensively the results achieved for the entire contract period of performance. The final report shall include all deliverables that will fully document the final report and project outcomes, finding and results. The final report should be submitted not later than 21 calendar days prior to the last day of this contract period of performance.

Part 4 –Performance and Deliverables

4.1 Deliverable Table

The contractor is responsible to provide all the services specified above and shall adhere to the following performance requirements.

Format Format Due Date Recipient

Kick-off Meeting

In Person

30 days after award date.

COR/PO

Initial Project Plan

Microsoft 3 weeks after kick-off meeting.

Bi-Monthly

Progress Report

Microsoft Every two Months

Collection and analysis of data

Microsoft 90 days after kick-off meeting

Preliminary Results

Microsoft 30 days after data analysis.

Draft Report Microsoft 30 days after the preliminary results.

Final Report Microsoft Not later than 21 calendar days prior to the last day of this contract period of performance.

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

The Contractor shall warrant that, to the best of its knowledge and belief, and except as otherwise disclosed in its proposal, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject procurement, as described in FAR Subpart 9.5 and U.S. Health and

Human Services (HHS) and FDA policies, for its organization, employees, or subcontractors proposed to be working under the procurement.

After award of an order for this procurement, if the Contractor discovers an actual, potential, or apparent conflict of interest with respect to this procurement, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer and COR for this order, including a description of any actions the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any conflict of interest. The Contractor shall act impartially and objectively and must avoid actions that would cause a reasonable person to question their impartiality or engage in activities that may result in an unfair competitive advantage.

The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.

The Contractor shall include a clause substantially similar to this “Conflicts of Interest” clause in any subcontract.

4.5 Period of Performance

The period of performance for this contract is for one year (1) 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.

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:

Richard Robinson

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Rd.

Beltsville, MD 20705

Email: Richard.Robinson@fda.hhs.gov mailto:Richard.Robinson@fda.hhs.gov

Tel: 301- 796-6508

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;

mailto:Ravichandan.palaniandy@fda.hhs.gov mailto:FDAVendorPaymentsTeam@fda.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

(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)

352.239-73 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 http://www.acquisition.gov/far/index.html

Services or Equipment (AUG 2019).

FAR 52.212-1, Instructions to Offerors- Commercial Items (Oct 2018)

FAR 52.225-18, Place of Manufacture (Aug 2018)

FAR 52.233-2, Service of Protest (Sept 2006)

6.4 Solicitation Provisions in Full Text

52.212-3 Offeror Representations and Certifications-Commercial Items (JUNE 2020)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management

(SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v)) of this provision.

(a) Definitions. As used in this provision—

“Covered telecommunications equipment or services” has the meaning provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror.

No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-

9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment

Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets

Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended. “Sensitive technology”—

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the

President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16).

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on

Government contracts, and qualified as a small business under the criteria in 13 CFR Part

121 and size standards in this solicitation.

Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR

124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding

$750,000 after taking into account the applicable exclusions set forth at 13

CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at

13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38

U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

(b)

(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the

Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and

Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it □is, □is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it □is, □is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it □ is, □ is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it □is, □is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is, □ is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-

(i) It □ is, □ is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part

127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each

WOSB concern eligible under the WOSB Program participating in the joint venture.

[The offeror shall enter the name or names of the WOSB concern eligible under the

WOSB Program and other small businesses that are participating in the joint venture:

__________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

[Complete only if the offeror represented itself as a WOSB concern eligible under the

WOSB Program in (c)(6) of this provision.] The offeror represents that-

(i) It □ is, □ is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It □ is, □ is not a joint venture that complies with the requirements of 13 CFR part

127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each

EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it □ is a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

(i) It □is, □is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13

CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: __________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order11246-

(1) Previous contracts and compliance. The offeror represents that-

(i) It □ has, □ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It □ has, □ has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that-

(i) It □ has developed and has on file, □ has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the

Secretary of Labor (41 CFR parts 60-1 and 60-2), or

(ii) It □ has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 http://uscode.house.gov/ U.S.C. 1352). (Applies only if the contract is expected to exceed

$150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of

Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation

(FAR) 52.225-1, Buy American-Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products,i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American-Supplies.”

(2) Foreign End Products:

Line Item No. Country of Origin

[List as necessary]

(3) The Government will evaluate offers in accordance with the policies and procedures of

FAR part 25.

(g)

(1) Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” “Free Trade Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements–Israeli Trade Act.”

(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled

“Buy American-Free Trade Agreements-Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-Israeli Trade Act.” The offeror shall list as other foreign end products those end products manufactured in the

United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.”

Other Foreign End Products:

(iv) The Government will evaluate offers in accordance with the policies and procedures of FAR part 25.

(2) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I. If

Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled “Buy American-Free Trade Agreements-

Israeli Trade Act”:

Canadian End Products:

Line Item No.

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II. If

Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or

Israeli end products as defined in the clause of this solicitation entitled “Buy American-Free

Trade Agreements-Israeli Trade Act”:

Canadian or Israeli End Products:

(4) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate III. If

Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled

“Buy American-Free Trade Agreements-Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade

Agreements, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled “Trade Agreements.”

(ii) The offeror shall list as other end products those end products that are not U.S.-made or designated country end products.

Other End Products:

(iii) The Government will evaluate offers in accordance with the policies and procedures of FAR part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting

Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation.

(h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals–

(1) □ Are, □ are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(2) □ Have, □ have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating

Federal criminal tax laws, or receiving stolen property;

(3) □ Are, □ are not presently indicted for, or otherwise criminally or civilly charged by a

Government entity with, commission of any of these offenses enumerated in paragraph

(h)(2) of this clause; and

(4) □ Have, □ have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied.

(i) Taxes are considered delinquent if both of the following criteria apply:

(A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.