baboon study sol final 4 8 2022.pdf

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-1251506

Posted Date: 08 April 2022

Response Date: 06 May 2022

Contractor Questions Date: 19 April 2021

NAICS Code: 112990 All Other Animal Production

Small Size Standard: $1,000,000.00

FULL AND OPEN COMPETITION

Part 1 – Description The U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is in need of a study to evaluate PET-CT imaging of B pertussis cells in the airways of infected baboons. 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) 2022-04, January 30, 2022. The North American Industry Classification System (NAICS) code for the proposed acquisition is 112990 All Other Animal Production, Small Size Standard $1,000,000.00. THIS IS A FULL AND

OPEN COMPETION.

Part 2 – Supplies or Services and Prices

Contract Type: Firm-Fixed Price

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LI

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Service and Supply Description Quantity Unit Price

Firm- Fixed Price

The contractor shall infect and perform PET-CT imaging of the three infected baboons. The contractor shall meet the specifications below:

a. Three (3) Bordetella-free, six to eight months-old baboons will be provided by the contractor for the study.

b. The contractor shall draw blood and perform nasopharyngeal washes on the animals prior to enrollment of the study. The nasopharyngeal washes will be plated by the contractor to confirm lack of Bordetella colonization and sera will be sent to the CBER laboratories for serological analysis to confirm lack of Bordetella-exposure. FOB DESTINATION

c. The three animals will be inoculated with Bordetella pertussis one animal at a time.

Blood samples for serology and CBCs and nasopharyngeal washes for CFUs will be collected on days three, five and seven post-challenge. Serum will be shipped to CBER FOB DESTINATION. CBC Analysis and plating of nasopharyngeal washes for CFUs will be performed on site by the Contractor.

1 set

d. Imaging of animals will be infused with 124I-labeled FIAU up to five times over 72 hours and will be imaged by PET up to five times over 72 hours. One CT scan will be performed on each animal prior to infection and at the time of final imaging PET imaging session. The timing of dosing and imaging may vary for each animal based on results.

e. Animals will be treated with antibiotics to clear infection. Once cleared of infection, each animal will be infused with 124 I-labeled FIAU up to five times and will be imaged by PET a single time. The number of infusions and timing of imaging will be determined based on results of imaging during infection.

f. Study report delivered to CBER (electronically)

Total Firm Fixed Price

Company Name: ________________________ DUNS Number:

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.

Part 3 – Description/Specifications:

Background:

Pertussis is an acute, highly contagious, potentially life-threatening respiratory disease, caused by the Gram-negative bacterium Bordetella pertussis. The underlying factors leading to the failure of public health measures to control pertussis disease using currently licensed vaccines are poorly understood. A more complete understanding of this disease and of the mechanisms of vaccine-mediated protection is a critical public health need. Currently, the baboon model of pertussis, developed in the laboratories of the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), is the only animal model of pertussis that recapitulates the disease as observed in human patients. The use of this animal model to study Pertussis Pathogenesis and the Immune Response to Infection and Vaccination requires the conduct of a pilot imaging study.

3.1 Objectives/Purpose:

The purpose of this solicitation is to contract for a study evaluating PET-CT imaging of B.

pertussis cells in the airway of infected baboons.

3.2 Statement of Work:

The contractor(s) shall infect and perform PET-CT imaging of three infected baboons. The contractor shall meet the specifications below:

a. Three, Bordetella-free, six to eight-month-old baboons, will be provided for the study.

b. The vendor will draw blood and perform nasopharyngeal washes on the animals prior to enrollment into the study. The nasopharyngeal washes will be plated by the contractor to confirm lack of Bordetella colonization and sera will be sent to CBER laboratories for serological analysis to confirm lack of Bordetella-exposure.

c. The three animals will be inoculated with Bordetella pertussis one animal at a time.

Blood samples for serology and CBCs and nasopharyngeal washes for CFUs will be collected on days three, five and seven post-challenge. Serum will be shipped to CBER. CBC analysis and plating of nasopharyngeal washes for CFUs will be performed on site by the contractor.

d. Imaging of animals will begin on day ten post-inoculation. Animals will be infused with 124I- labelled FIAU up to five times over 72 hours and will be imaged by PET up to five times over 72 hours. One CT scan will be performed on each animal prior to infection and at the time of the final imaging PET imaging session. The timing of dosing and imaging may vary for each animal based on results.

e. Animals will be treated with antibiotics to clear infection. Once cleared of infection, each animal will be infused with 124I-labelled FIAU up to five times and will be imaged by PET a single time. The number of infusions and timing of imaging will be determined based on results of imaging during infection.

f. Study report delivered to CBER (electronically).

3.3 Special Requirements: Animal Welfare

The contracting facility is required to have and maintain AAALAC accreditation. All animals enrolled in the study are owned by the contractor and overseen by the contractor’s IACUC. The contractor shall communicate to CBER any program deficiencies, that impacts the care and use of the study animals, identified by their IACUC or external site visitors within 30 days.

Part 4 - Inspection and Acceptance:

The COR will inspect all deliverables. In the event a deliverable is not accepted, CBER will provide edits to the contractor within 30 days, the contractor has 10 business days to update and resubmit the deliverable.

The COR must approve final deliverable(s).

The COR and contractor will meet monthly to discuss progress of the various tasks.

Period of Performance (estimated) 7/05/2022-7/04/2023

Place of Performance:

Performance will take place at the contractor’s location.

Delivery Location:

Food and Drug Administration (FDA) White Oak Campus

10903 New Hampshire Avenue

Silver Spring, Maryland 20993

Building 72, CBER Vivarium

PLEASE NOTE: DELIVERY MUST BE COORDINATED WITH THE CONTRACTING

OFFICER REPRESENTATIVE (COR) IN ADVANCE OF DELIVERY.

Government Furnished Property (GFP)/Information

(GFI):

None

Part 5 – Contract Administration

5.1 Government Representatives

For this PART, Tracey Johnson 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 COR is the following:

Tracey Johnson

U.S. Food and Drug Administration

CBER

10903 New Hampshire Avenue

Bldg. 71 CBER Room 3332

Silver Spring, MD 20993 tracey.johnson@fda.hhs.gov

240-402-9612

The contact information for the Contracting Officer is the following:

Kimberly Delong

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

5630 Fishers Lane

Rockville, MD 20857 kimberly.delong@fda.hhs.gov

The contact information for the Contract Specialist is the following:

Howard S. Yablon

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

5630 Fishers Lane

Rockville, MD 20857 howard.yablon@fda.hhs.gov

240-402-7630

5.2 FDA’s Invoicing Processing Platform (IPP)

mailto:kelly.covington@fda.hhs.gov mailto:kimberly.delong@fda.hhs.gov mailto:howard.yablon@fda.hhs.gov

FDA Invoicing Processing Platform Procedures

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

(a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

(b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

(c) -----

(1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re-register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

(d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(a) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

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

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

- Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

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

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

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

(b) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

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

(c) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

(d) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

(e) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

(f) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

(g) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

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.

352.211-3, PAPERWORK REDUCTION ACT (DEC 2015)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (DEC 2015)

352.223-70, SAFETY AND HEALTH (DEC 2015)

352.227-70, PUBLICATIONS AND PUBLICITY (DEC 2015)

352.239-75, ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY

NOTICE (DEC 2015)

352.270-5a, NOTICE TO OFFERORS OF REQUREMENT FOR COMPLIANCE WITH

THE PUBLIC HEALTH SERVICE POLICY ON HUMANE CARE AND USE OF

LABORATORY ANIMALS (DEC 2015

352-270-5b, CARE OF LIVE VERTEBRATE ANIMALS (DEC 2015)

6.1 (a): HHSAR Clause Full Text

352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP

Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

6.2 FAR Clauses Incorporated by Reference

52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sept. 2007)

52.203-12, Limitation on Payments to Influence Certain Federal Transactions (Jun 2020)

52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)

52.204-7, System for Award Management (Oct 2018)

52.204-13, System for Award Management Maintenance (Oct 2018)

52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

52.204-17, Ownership or Control of Offeror (Aug 2020)

52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

52.204-19, Incorporation by Reference of Rerepresentations and Certifications

52.204-20, Predecessor of Officer (Aug 2020)

52.204-22, Alternative Line Item Proposal (Jan 2017)

52.212-1, Instructions to Offerors—Commercial Items (Nov 2021)

52.212-4, Contract Terms and Conditions—Commercial Items (Nov 2021)

52.227-14, Rights in Data – General, (May 2014)

52.232-39, Unenforceability of Unauthorized Obligations (June 2013)

52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Nov 2021)

6.3 FAR Clauses Full Text

52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

(a) Definitions . As used in this clause—

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

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

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

(CNSSI) 4009).

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

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

(b) Safeguarding requirements and procedures.

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

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

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

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

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

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(b) The Offeror represents that—

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

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

52.212-2 Evaluation—Commercial Items. (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

The evaluation factors in order of importance are the following:

Factor 1: Technical Approach and Understanding

Factor 2: Strategy and Tactics to Meet Logistical Challenges

Factor 3: Previous Experience

Factor 4: Price

Technical approach and understanding, strategy and tactic to meet logistical challenges and previous experience, when combined, are more important than price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option (s). Please note that there are no options in this solicitation.

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer , shall result in a binding contract without further action by either party. Before the offer ’s specified expiration time , the Government may accept an offer (or part of an offer ), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 Offeror Representations and Certifications-Commercial Items. (Nov 2021)

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, https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25 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 .

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

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 .

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment .

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 https://www.acquisition.gov/far/part-52#FAR_52_204_25

(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 veteransor, 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 —

(1) 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 .

(2) Affiliates , as used in this definition , means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

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 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

(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 Products and Commercial Services, 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 .

http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201

(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)

(i) The Offeror certifies that each end product , except those listed in paragraph (f)(2) of this provision, is a domestic end product .

(ii) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products .

(iii) The terms "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) https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-25#FAR_Part_25

(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)

(A) The Offeror certifies that each end product , except those listed in paragraph (g)(1)(ii) or

(iii) of this provision, is a domestic end product .

(B) The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product ," "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 :

Line Item No. Country of Origin

[List as necessary]

(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 .

https://www.acquisition.gov/far/part-52#FAR_52_225_3

Other Foreign End Products :

Line Item No. Country of Origin

[List as necessary]

(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.

[List as necessary]

(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 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 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 :

Line Item No. Country of Origin

[List as necessary]

(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 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 Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products ) or Israeli end…