RFQ_-_FDA-18-RFQ_1199633(released).docx

Request for Quotation FDA-18-RFQ-1199633 Page 10 of 12 Sample Oxidizer System

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.1, as supplemented with additional information included in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-100 dated August 22, 2018.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing, with an associated size standard of 1,000 employees. This requirement is being solicited as full and open.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

PART 3 – DESCRIPTION OF REQUIREMENTS

Background The Food and Drug Administration (FDA)’s radionuclides in foods program requires Winchester Engineering and Analytical Center (WEAC) to analyze Tritium (H-3) in food samples collected around domestic nuclear power plants. Currently, WEAC’s analytical system used for analyzing H-3 has the capability of only analyzing H-3 bound to water. The Food and Agricultural Organization of the United Nations/International Atomic Energy Agency/World Health Organization (FAO/IAEA/WHO)'s guideline levels for use in international trade following a nuclear or radiological emergency treat H-3 bound to water and H-3 bound to organic materials differently. Per CFSAN’s guidance, we currently use the FAO/IAEA/WHO guideline levels for laboratory conclusions for H-3 analysis.

Objectives The purpose of this requirement is to acquire an automatic preparation and oxidization system for measuring organic (biological, environmental, industrial), i.e., food samples containing tritium (H3) and/or carbon-14 (C14) bound in organic material for use in liquid scintillation counting. The system (sample oxidizer) will enable the capability of analyzing H-3 bound to organic material, which will allow more accurate analysis of H-3 in foods.

Scope The Contractor shall provide one sample oxidizer with the capability of analyzing H-3 bound to organic material. At a minimum, the system shall meet the specifications identified below:

Minimum Technical Requirements Sample Oxidizer System Performance and Salient Characteristics:

1. System shall contain a single “push button” operation that initiates automatic cycle, positioning of vials and ignition basket, non-catalytic combustion, dispensing of scintillation cocktails and carbon dioxide trapping agent, and system cleaning.

1. System shall be capable of physical separation of H3 and C14 radionuclides from sample material for ease of sample analysis

1. Minimal optical and chemical quenching so that the efficiency for H3 shall be at least 15% with 20 mL counting solution (with Ultima Gold LLT).

1. Shall allow for visual inspection during sample burn.

1. Shall be capable of complete combustion of liquid, wet or dry sample

1. Shall ensure maximum radionuclide recovery for C14 with sample size equivalent up to 40 millimoles of carbon dioxide and up to 85 millimoles of water for samples containing H3 (up to 1.5 grams).

1. Shall Accommodate 20 mL glass or low cost polyethylene vials

1. Capacity to process up to at least 60 samples per hour for each radionuclide.

1. Shall have a Bellows-type reagent metering pumps adjustable from at least 0 to 18 milliliters, automatically dispense accurate volumes of both 3H and 14C scintillation cocktails and carbon dioxide trapping agent.

1. Removable platinum ignition basket.

1. Shall have non-pressurized reagent storage tank capacity of at least five liters for each reagent and allow a maximum of 500 sample combustions between refills.

1. Shall allow for Ambient temperature trapping of water and carbon dioxide for safe and clean operation.

Oxidizer Reagent Delivery System Performance and Salient Characteristics:

Reagent storage tanks shall be accessible for setting dispensing volumes, measuring the liquid level in the tanks, and filling.

1. Each reagent tank shall have a 5 liter capacity, which is sufficient for 500 sample combustions at its maximum.

1. Each tank shall have a measuring dipstick marked in one liter increments.

1. Each tank shall have a bellows-type metering pump which is adjustable from 0-18 mL by simple dial settings.

1. Shall require independent combustion of sample for H3 and C14, i.e., if samples containing only H3 are to be combusted, C14 reagent pumps can be deactivated and vice versa.

Additional Performance and Salient Characteristics:

1. Shall need distilled water reservoir for automatic cleaning, steam injection, and pre-coating of the H3 exchange column.

1. Shall have a distilled water reservoir containing vent valve for depressurizing the tank when the system is turned off, or when checking the distilled water level with the dipstick.

1. Shall have built-in pressure regulators and filters for nitrogen, oxygen, and water.

1. Reaction column shall be capable of eliminating loss of carbon dioxide absorber.

1. Some type of reset button shall allow the combustion timer to restart while the sample is still burning without otherwise affecting the automated process.

1. System Shall have an override button to cut off excessive combustion time after combustion has been completed.

1. System shall have a backpressure indication gauge to monitor pressure in the trapping device during combustion.

1. A test mode that allows the entire system to be checked for leak tightness is required.

Performance Specifications:

1. H3 Recovery: >97%

1. H3 Memory: <0.08%

1. C14 Recovery: >97%

1. C14 Memory: <0.08%

Physical Specifications:

1. Weight of unit: not more than 250 lbs (114 kg) net weight

1. Dimensions: not larger than 35 in (89 cm) high x 40 in (101 cm) wide x 18 in (51 cm) deep

1. Power Requirements: 110-240 V @ 13A, 60 Hz

1. Oxygen Gas Connection: 45-60 psig. (3.1-4.1 kg/cm2)

1. Nitrogen Gas Connection: 45-60 psig. (3.1-4.1 kg/cm2)

Installation and Calibration:

Contractor will conduct installation.

Item need to be received through loading dock; Installation and Calibration to be performed by Contractor Compatibility Requirements:

No Requirements Trade and Service Specifications

1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

2.The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation.

3.Offered system shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, printers, software for initial set up, and that otherwise required to meet these specifications, the FDA’s stated need, and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met. 4) One preventative maintenance (PM) visit shall be included per contract year. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM. The vendor shall also include coverage for software and firmware updates.

4) If subcontractors or other personnel not employed by the offeror are to be utilized for instrument service, that information should be clearly stated in the response.

5) Installation and operator training for at least one operator at the vendor’s training facility shall be included.

6) Onsite installation of the entire system shall be included and inclusive of labor and travel costs. Onsite training should include basic operations and familiarization for quantitative and qualitative analysis.

Unique Considerations:

The Platinum Resistance Thermometer must be initially calibrated by an independent laboratory that is ISO/IEC 17025 accredited and NIST traceable.

Deliverables:

PART 4 – PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be new, not used or refurbished.

PART 5 – INSPECTION AND ACCEPTANCE

The Project Officer will perform inspection and acceptance of equipment, installation and services to be provided. The Project Officer – to be determined upon contract award - is the authorized representative of the Contracting Officer.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the Government to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within 1 business day of task being completed. The Government will provide written notification of acceptance or rejection within 2 business days. Inspection will include review of the deliverables to ensure adequacy.

The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within two 2-business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within 1 day via email.

PART 6 – DELIVERIES OR PERFORMANCE

Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, training, and performance of services described above or and upon acceptance by the Contracting Officer, or the COR, of these products/services. Most deliveries required by the contractor shall be made F.O.B. destination by September 30, 2018 to the address listed below:

Food and Drug Administration Winchester Engineering and Analytical Center 109 Holton Street Winchester, MA 01890 POC: to be identified at time of award

Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility.

Period of Performance: The equipment shall be delivered and installed by September 30, 2018. The manufacturer’s warranty shall not begin until acceptance and installation of the equipment has occurred.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Program Office Technical Representative:

To be determined upon contract award

The Technical POC is responsible for: (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 evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

anthony.wimbush@fda.hhs.gov anthony.wimbush@fda.hhs.gov Tel: (240) 402-7628 Tel: (240) 402-7628

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ;

(2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

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 or Technical Point of Contact (TPOC). The COR/TPOC is (insert name and email address - 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 official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

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

(ix) Taxpayer Identification Number (TIN);

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

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

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

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

Payment Schedule: The Contractor shall submit invoices after the delivery and installation of the required equipment.

PART 8 – CONTRACT CLAUSES AND PROVISIONS

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2016) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 – Contract Terms and Conditions – Commercial Items (Jan 2017) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (Jan 2018) The following FAR clauses cited in the clause are applicable to this acquisition:

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

_X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

_X_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

HHSAR Clauses HHSAR Clauses and Provisions can be viewed in full text at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.1

352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-73 – Electronic Information and Technology Accessibility Notice (Dec 2015)

Contract Provisions FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov/far

52.212-1 - Instructions to Offerors – Commercial Items (Oct 2016)

· See Part 10 below 52.212-2 - Evaluation – Commercial Items (Oct 2014)

· See Part 11 below 52.204-7 - System for Award Management (Oct 2016)

· Prospective awardees shall be registered in the SAM database with completed representations and certifications.

52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-3 - Offeror Representations and Certifications -- Commercial Items (Nov 2017)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer 52.219-1 - Small Business Program Representations (Oct 2014)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer

(End of provision)

Section 508 Standard Compliance

Requirements for accessibility based on Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) are determined to be relevant for the following program need: "Data Services or Information Retrieval Systems."

Section 508 Deliverable Requirements The activity to be performed relates to or requires the use of EIT. Section 508 must be considered as a requirement for Systems Administration outputs/deliverables to ensure that it considers specific Section 508 accessibility requirements. Further, Systems Administration outputs/deliverables should not adversely affect accessibility features of existing EIT technologies. Technical standards from 36 CFR part 1194 Subpart B have been determined to apply to this acquisition. Solicitation respondents must describe how their background and experience will enable them to at least meet those technical provisions identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Data Services or Information Retrieval Systems outputs/deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies.

Functional performance criteria from 36 CFR part 1194 Subpart C have been determined to apply to this acquisition. Solicitation respondents must describe how their Solicitation respondents must describe how their background and experience will enable them to at least meet those functional performance criteria identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Information, documentation, and support requirements from 36 CFR part 1194 Subpart D have been determined to apply to this acquisition. Solicitation respondents must describe how the information, documentation, and support proposed for Data Services or Information Retrieval Systems outputs/deliverables will meet at least those information, documentation, and support requirements identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Section 508 Evaluation Factors Responses to this solicitation will only be considered for award after it has been determined that the proposal adequately addresses the requirements for Section 508. Only proposals which contain adequate information to document their responsiveness to the Section 508 requirements (e.g. accessibility capabilities and past performance) will be eligible for any additional merit consideration.

Section 508 Acceptance Criteria Date and Information Services outputs/deliverables resulting from this solicitation will be accepted based in part on satisfaction of identified Section 508 requirements for accessibility. Data Services or Information Retrieval Systems outputs/deliverables must include a completed GPAT, a sample of which is included as a part of this solicitation.

Data and Information Services outputs/deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

Subpart B, 1194.21 - Software Applications and Operating Systems Subpart C, 1194.31 - Functional Performance Criteria Subpart D, 1194.41 - Information, Documentation, and Support

PART 10 – INSTRUCTIONS TO THE OFFEROR

The provision FAR 52.212-1 incorporated above is tailored as follows. Quote is due September 4, 2018 at 3:00 p.m. (Eastern Time). Send via email in native (Word/Excel) or PDF format to the Contract Specialist, Anthony S. Wimbush at anthony.wimbush@fda.hhs.gov.

The offeror’s quote must outline all characteristics of the requirement listed in Part 3 – Description of Requirements. The quote shall include detailed technical qualifications to support the requirements. The Government is not responsible for locating or securing any information which is not identified in the quote. To ensure information is available, offerors must furnish as part of their quote all descriptive material necessary for the Government to determine whether the product and/or service meets all technical requirements specified in Part 3. The quote shall include any applicable technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum performance specification, which demonstrates the capabilities of the offeror.

Price quoted shall be inclusive of all parts, labor, shipping and any other costs associated with the specifications listed in the Requirements (Part 3). If an offeror has not completed annual representations and certifications in the SAM database, offerors shall also include a completed copy of the provisions at 52.212-3 and 52.219-1.

PART 11 – GENERAL EVALUATION INFORMATION

The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. Contractor selection will be based on the lowest priced technically acceptable (LPTA) quote. The quote shall be technically acceptable and price shall be determined fair and reasonable in order to be considered for contract award. This RFQ does not commit the Government to pay any costs incurred in the preparation of the submission of the quotation or to contract for the supplies or services.

Technical Acceptability: The Government will evaluate the degree to which the quote meets or exceeds the requirements and specifications described in Part 3. The Offeror’s quote shall demonstrate the ability to “meet or exceed” the technical specifications of this requirement. Offerors shall confirm that delivery can be made within the delivery requirements. Quotes will be rated either “Technically Acceptable” or “Technically Unacceptable.”

Price: Prices quoted shall be evaluated to ensure the best value to the Government and must be determined to be fair and reasonable in order to be considered for award.