FDA-RFQ-1224989.doc

FDA-RFQ-1224989

Aseptic Sampler with Integration of Nutrient Analyzer Brand Name or Equal

Small Size Standard 1,000 Employees

Part 1 – Description

The U.S. Food and Drug Administration’s (FDA) requires one aseptic autosampler, the Seg-Flow 4800 with its necessary accessories or equivalent, to integrate with the Bioprofile Flex 2 nutrient analyzer for automated sampling and nutrient analysis required to support extended duration bioreactor operations during the production of biologics. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-02 and 03 through 23 December 2019. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516 Analytical Laboratory Instrument Manufacturing, Small Size Standard 1,000 Employees. THIS IS A TOTAL SMALL BUSINESS SET-ASIDE.

This requirement is for a aseptic autosampler, the Seg-Flow 4800 with its necessary accessories (or equivalent) to integrate with the Bioprofile Flex 2 nutrient analyzer Brand Name or Equal Part 2 – Supplies or Services and Prices

Purchase Order Type: Firm-Fixed Price Base Year

BRAND NAME or EQUAL

Total Firm Fixed Price

Optional Period 1

Aseptic autosampler Seg-Flow 4800 Sampling System with accessories

Optional Period 2

Optional Period 3

Company Name: ________________________ DUNS Number: ________________________ Point of Contact: _______________________Tel: ____________E-mail: ____________________

Estimated Delivery Date: ________________ Country of Manufacturing: _____________

Notes:

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 provided below.

Part 3 – Description/Specifications

3.1 Background

Understanding the continuous process of biologics is critical to the mission of the Food and Drug Administration (FDA). Towards this goal, the FDA requires a Seg-Flow 4800 with its necessary accessories or equivalent to integrate with an already owned Bioprofile Flex 2 nutrient analyzer for automated sampling and nutrient analysis required to support extended duration bioreactor operations during the production of biologics. Our current process is established with a biologic produced by a Chinese Hamster Ovary (CHO) cell line. A bioreactor will be operated for extended durations of time (≥14 days) under fed-batch and perfusion mode and will several liters of media containing dilute amounts of the biologic to purify through downstream processing. It is essential to measure the nutrient levels in the bioreactor medium periodically to sustain the cell growth and viability. An autosampler such as Seg-Flow 4800 with its accessories or its equivalent facilitates sampling from the bioreactors periodically into a nutrient analyzer as well as storing samples for off-line analyses. This facilitates measurement of the concentration of specific metabolites in the bioreactor medium to sustain the concentrations at a pre-specified level via replenishment and maintenance of the pH of the medium, during extended durations of bioreactor operation.

3.2 Statement of Work

Scope The contractor shall deliver one aseptic autosampler, the Seg-Flow 4800 with its necessary accessories or equivalent, to integrate with the Bioprofile Flex 2 nutrient analyzer for automated sampling and nutrient analysis required to support extended duration bioreactor operations during the production of biologics. After the installation and integration of the aseptic autosampler to the laboratory’s networked instruments, annual preventive maintenance (PM) and unlimited emergency services coverage shall be performed by the contractor for one calendar year with option years thereafter.

Technical specifications:

A. The aseptic autosampler

1. The aseptic autosampler must work with a Bioprofile Flex 2 that the lab already owns and shall have the following salient characteristics:

a. The autosampler with all accessories, computer and software shall be operational at a “turn-key” level without requiring extensive instrument preparation.

b. The autosampler shall be integrable with Bioprofile Flex 2 to facilitate automatic nutrient analysis and feedback data to the bioreactors for sustaining continuous operation.

c. The autosampler shall be able to draw samples from 6 Stir Tank bioreactors (5L) and 2 wavebag reactors from 5L or 15L liter bioreactors during any bioreactor operation.

d. The autosampler shall be able to draw samples from 6 Stir Tank bioreactors (5L) and 2 wavebag reactors from 5L or 15L liter bioreactors and store them (~4 ˚C) for off-line analyses.

e. The autosampler shall facilitate seamless integration of sampling and scheduling of samples for nutrient analyses as well as communication with bioreactors if necessary, to share the data.

f. Any third-party software utilized for communication between the instruments is integral to the autosampler and shall provide with perpetual licensure.

2. The aseptic autosampler equipment shall be complete with all accessories and software necessary to work with the nutrient analyzer and feedback data to bioreactor for continuous operation. This includes the following:

a. Full system software and peripheral installation (if applicable).

b. On-site hardware and software training. This includes applicable materials, such as user manuals.

c. The results of the Factory Acceptance Tests (FAT) shall be included with the delivery of the instrument. The FAT will not be a replacement for on-site instrument validation that shall be performed at the installation site after the instrument is installed.

B. Preventive maintenance (PM) and emergency service for the aseptic autosampler shall include the following.

1. The annual PM

a. Requested and scheduled by the POC for the contract.

b. Performed within 60 calendar days of request by the POC.

c. The PM shall involve, at the minimum, the following.

i. Replacement of tubing

ii. Replacement of all parts subject to wear

iii. Testing of valves

iv. Repair or replace of valves that do not open and close reliably

v. Testing of the aseptic autosampler to the SegMod networking connection

d. Replacement parts should be genuine original equipment manufacturer (OEM) parts.

e. All costs for labor, travel, replacement parts, and consumables for 4 runs associated with the autosampler.

f. Any packaging and shipping costs associated with servicing or repairing part of the aseptic autosampler or any of the SegMod units when the work cannot be performed on-site.

g. Maintenance and repairs must be performed by OEM factory certified engineers to perform maintenance.

h. A summary report must be provided to the POC after the PM performance.

2. Emergency service

a. Unlimited

b. Requested and scheduled by the POC for the contract.

c. Performed within 30 calendar days of request by the POC.

d. Replacement of all parts subject to wear.

e. Replacement parts should be genuine OEM parts.

f. All costs for labor, travel, replacement parts, and consumables associated with the autosampler.

g. Any packaging and shipping costs associated with servicing or repairing part of the aseptic autosampler or any of the SegMod units when the work cannot be performed on-site.

h. Maintenance and repairs must be performed by OEM factory certified engineers to perform maintenance.

i. A summary report must be provided to the POC after each emergency service performance.

Part 4 –Performance and Deliverables

4.1 Performance Standards

A. Aseptic autosampler

1. The results of the Factory Acceptance Tests (FAT) shall be included.

2. A live system validation shall be a part of the training of relevant lab personnel after installation and integration.

3. Only OEM certified technicians are to perform the installation, integration, training, and live system validation.

B. PM and emergency services

1. Response times

a. PM performance shall be within 60 calendar days of request by the POC.

b. Emergency services shall be within 30 calendar days of request by the POC.

2. Must be able to provide any needed OEM parts, labor, and travel within 3 to 7 business days.

3. Only OEM certified technicians are to perform the PM and emergency services.

4.2 Delivery, Installation, Training, and Support: 52.247-34 F.O.B. Destination

The vendor is responsible for delivery and installation of the instruments and all components specified above. If the vendor is not installing on the day of delivery, the delivery should be made to the loading dock and moved into location on the date of installation. The vendor is responsible for installation of the instrument. The vendor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument will not be accepted until those performance specifications have been met. The Technical Point of Contact (TPOC) will perform inspection and acceptance of the Aseptic Sampler or Equal. The entire system will be warranted for parts and labor for 12 months from date of installation. Service and installation must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

The vendor shall cover all costs associated with the following:

· Crating and shipping shall be included in this proposal to the delivery address

· On-site installation, hardware, software, and applications training shall be provided at the FDA site.

· All appropriate training manuals and literature must be supplied either electronically or in hard copy

· Technical support shall be provided through common avenues: phone, web, fax, during standard business hour

Place of Performance and Work Hours

Delivery and installation should be coordinated through the Contracting Officer Representative (COR). Work shall be conducted Monday through Friday, excluding federal holidays. The vendor is responsible for delivery and installation of the instrument to the laboratory facility. The vendor will be responsible for shipping and handling costs, inside installation, and on-site training at CDER’s facilities.

The autosampler equipment shall be complete with all accessories and software necessary to work with the nutrient analyzer and feedback data to bioreactor for continuous operation and be delivered to:

Agarabi Bioprocessing Lab

10903 New Hampshire Avenue, Building 52/72 Room 2232

Silver Spring, MD 20993

The aseptic sampler will be installed in the Agarabi Bioprocessing Lab (currently room 2232) and the maintenance must be performed in the Agarabi Bioprocessing Lab. Training will take place in the Agarabi Bioprocessing Lab.

Scheduling Requirements:

1. Coordinated with the POC for the contract, with the COR for the contract informed.

2. Hours of on-site service is business days from 8am to 5 pm.

Security Requirements

1. All technicians must have a valid U.S. Driver’s license for entry through security.

Reporting Requirements and Deliverables:

A. Summary table

B. Inspection and Acceptance Criteria

The POC shall have 30 calendar days to inspect and verify for the following.

1. The delivered aseptic autosampler and necessary accessories for full installation are complete and in good condition for accepted receipt of delivery.

2. The aseptic autosampler is operational and functional after a PM or emergency service performance.

Period of Performance

1. For the aseptic autosampler to be delivered, installed, lab personnel trained, and the live system validation is 7 calendar months.

2. For the PM and emergency service portion is one calendar year for base plus 3 option years.

Warranty/Preventative Maintenance Service Agreement

This is a standard procurement for a commercial product item. Warranty: Vendor must offer a minimum one year warranty for parts and labor for repairs or defects.

Special requirements

· Only certified field technicians must be used for installation and training, maintenance

· Must be able to provide any needed parts, labor, and travel for repair in a timely fashion (3-7 days)

· Scheduling must be Monday-Friday between the hours of 8am-5pm.

· Scheduling to be coordinated through the TPOC on the contract.

· All technicians must have a valid U.S. Driver’s license for entry through security

Section 508 Standard Compliance

C.A. Section 508

This language is applicable to Statement of Work (SOW) or Performance Work Statement (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create, or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft Power Point) or video material that could be placed on a Department-owned or Department-funded Website.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

Part 5 –Contract Administration

5.1 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

The contact information for the Contract Specialist is the following:

Christine Russman U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

Christine.Russman@fda.hhs.gov;

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

Division of Payment Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is _______TBD_______________.

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 award item number 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 contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

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

(ix) Taxpayer Identification Number (TIN);

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

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) 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;

(xiv) Any other information or documentation required by the contract/order 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. [amend/delete, as necessary]

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)

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) 52.212-1, Instructions to Offerors—Commercial Items (Oct 2018) 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

6.3 FAR Clauses Full Text

52.204-22 Alternative Line Item Proposal.

As prescribed in 4.1008, insert the following provision:

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.

As prescribed in 9.104-7(d), insert the following provision:

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) 52.211-6 Brand Name or Equal.

As prescribed in 11.107(a), insert the following provision:

Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.212-3 Offeror Representations and Certifications-Commercial Items.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications-Commercial Items (Dec 2019) 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 applicable to the NAICS code 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:

[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.”…