RFQ_-_hydrolysis_system.pdf

Request for Quotation FDA-18-RFQ-1199739 Page 1 of 10 Automated Acid Hydrolysis/Extraction 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 2005-98 dated May 31, 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.

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:

Contract Line Item (CLIN) Description

Price

Automated Acid Hydrolysis/Extraction System Includes all required parts and accessories required for fat determination analysis

2 Shipping to FDA SFFL $

Installation and on-site training for up to 10 FDA lab personnel $

Option Item

Option Year I – Service Agreement and Preventive Maintenance visit $

Option Item

Option Year II - Service Agreement and Preventive Maintenance visit $

TOTAL PRICE $

Request for Quotation FDA-18-RFQ-1199739 Page 2 of 10

PART 3 – DESCRIPTION OF REQUIREMENTS

Background:

The Food and Drug Administration’s (FDA’s) Nutrient Analysis Branch of the Southeast Food and Feed Laboratory (SFFL) requires an automated acid hydrolysis/extraction system to replace the traditional fat determination process. The traditional process is dependent upon the use of petroleum ether, and traditional petroleum ether extraction process is inherently dangerous due to its dependence on flammability of the petroleum ether and requires tedious, time consuming manual observation and manipulation to accomplish.

An automated acid hydrolysis in combination with a soxhlet system can perform the required fat determination analysis required by FDA with improved efficiency and precision, while ameliorating the hazards associated with the analysis by eliminating the use of petroleum based ethers.

Purpose:

The purpose of this requirement is to acquire an enclosed automated acid hydrolysis in combination with a soxhlet system for the FDA’s Southeast Food and Feed Laboratory.

Requirements:

The Contractor shall provide an enclosed automated acid hydrolysis in combination with a soxhlet system that is capable of performing fat determination analysis. This requirement is being solicited in accordance with FAR 52.211-6, Brand Name or Equal. The Contractor shall provide a Hydrotherm Hydrolysis HT6 V02.2, in combination with a Soxtherm Unit SOX416-6-pace macro or equivalent. The Contractor shall provide a system that meets the following salient characteristics:

1. Perform Fat Determination via automated acid hydrolysis that performs the following functions while unattended:

a. Adding of all reagents

b. Heating

c. Rinsing

d. Draining

2. Conducts automated comprehensive acid hydrolysis fat determination via software programmed methods to include the Weibull-Stoldt method, or other similar ISO methods, for running every matrix including infant formula, dairy products, and other foods.

3. Each automated hydrolysis unit shall have the capability of processing from 1 to at least 6 samples per system simultaneously or individually.

4. During acid hydrolysis, the system must treat each sample in its own digestion environment (i.e.

each sample is extracted within the separate extraction vessel), and with its own digestion reagents to prevent any carry-over taking place across the samples.

5. Acid hydrolysis process must be capable of testing at least 10g of sample and more

6. The system configuration must include a chiller to keep operation temperatures between 5-15 °C

7. During acid hydrolysis, the system must provide automated monitoring of the process by sensors, and automatically abort when a fault occurs.

Request for Quotation FDA-18-RFQ-1199739 Page 3 of 10

8. The acid hydrolysis functionality and extraction process must be performed by/in a self-contained system designed and intended for use without a fume hood, and designed so that laboratory personnel will not be exposed to any acid fumes or other reagents.

9. The acid hydrolysis fat determination extraction functionality must be user programmable/activated via integrated touchpad or key pad input, or from a connected computer via Contractor provided software (included).

10. The required volume of each extraction vessel (“beakers”) shall be more than 300 mL, capable of holding ca. 250 mL extraction solution (including a mix of highly concentrated acid and water)

11. The system must be expandable, supporting the connection of additional extraction systems in tandem (esp. automated extraction system)

12. Extraction system must be equipped with pneumatically operated moving parts (piston carriage), to minimize the wear on all moving parts inside the extraction unit

13. Different sizes of thimbles (including cellulose and/or re-usable ones with glass) shall be used for the filtration and drying processes in the extraction

14. The fat portions/residues from the sample after the completion of hydrolysis and extraction cycles shall be solid forms in almost all the cases (from the most sample matrix types). If final extracted fat residues are not in the solid form, explanation and/or justification is necessary.

15. The system must be equipped “extraction vessels” compatible with concentrated hydrochloric acid. These extraction vessels (where the acid hydrolysis takes place) shall have a minimum of 2 different sizes depending on the amount of samples and/or hydrolysis solutions used.

16. System must operate on 220V AC power and require no more than five (5) AC outlets for operation.

17. System must be compatible with the usage of DI water for rinsing.

18. Installation and on-site training for up to 10 lab personnel shall be included

19. All components of the system must be covered by a one year parts and labor warranty for non-consumable items after the installation is completed and operation is certified by the Contractor.

The original manufacturer’s warranty must include:

a. unlimited telephone/e-mail support for questions regarding operation

b. minimum of one on-site visit on a day of the eleventh (11th) month from the date of installation, which includes all maintenance parts, labor and travel fees

c. repairs services with an engineer on site, when needed, with labor, parts and engineer fees to be included.

20. The automated acid hydrolysis/extraction system shall be delivered with all necessary supplies and accessories required for installation and start-up.

Optional Preventive Maintenance Visits:

If exercised, the Contractor shall provide up to two additional years of additional service agreement after the original warranty period has expired. Each year shall include one on-site preventive maintenance visit for the acid hydrolysis system. The service agreement shall include preventative maintenance service;

necessary parts, including the replacement of parts (i.e. tubes, fittings, O-rings, gas tubings, seals and other essential for the instrument maintenance as recommended by the manufacturer) prone to the wear-and-tear; and labor charge for the replacement. In the event of an instrument breakdown, the repair shall be conducted by a service representative, who is certified by the manufacturer/vendor, in a reasonable mutually-agreed timeframe.

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Deliverables:

Description of Deliverable Due Date 1 Automated acid hydrolysis/extraction system in combination with a soxhlet system Complete system to be delivered within 30 days after award, installation and training shall be completed within 30 days after delivery, unless otherwise agreed upon by the Technical POC

2 Preventive Maintenance Visit To be scheduled with the Technical POC, and completed on a day of the eleventh (11th) month from the date of installation

3 (Option Year I) Preventive Maintenance Visit To be scheduled with the Technical POC

4 (Option Year II) Preventive Maintenance Visit To be scheduled with the Technical POC

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. If palletized, the delivery vehicle must be equipped with an operational lift gate (the FDA lab has no capability to receive/off load palletized shipment via loading dock).

PART 5 – INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

PART 6 – DELIVERIES OR PERFORMANCE

Place of Performance: Deliveries shall be made to:

FDA SFFL

60 Eighth Street Atlanta, GA 30309-3959

Satisfactory performance of this contract shall be deemed to occur upon delivery and installation of equipment described above. Deliveries required by the Contractor shall be made F.O.B. destination within 30 days from receipt of the award of the order to the addresses listed above. Delivery shall occur

Request for Quotation FDA-18-RFQ-1199739 Page 5 of 10 during regular business hours (Monday-Friday between 9:00am and 3:00pm), excluding Federal Holidays and weather-related closures in accordance with the delivery location time zone (Eastern time, Central time, or Pacific time). The Contractor shall provide the FDA laboratory with a minimum of 24 hours’ scheduling notice prior to delivery or installation.

The FDA laboratory has no capability to receive/off load palletized shipment via loading dock.

Therefore, if palletized, the delivery vehicle must be equipped with an operational lift gate.

Period of Performance: The equipment shall be delivered within 30 days from the date of contract award unless the Government approves a different delivery schedule. Installation and training of the equipment shall occur within 30 days from the date of delivery, unless otherwise agreed upon by the Government. The manufacturer’s warranty for the installed equipment shall not begin until the equipment is delivered, installed, and operation is certified at the Government’s location. The optional additional service agreement shall begin at the expiration of the original manufacturer’s warranty.

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.

Contracting Officer (CO): Contract Specialist (CS):

Gary Klaff Robin Goon 5630 Fishers Lane 5630 Fishers Lane Rockville, MD 20857 Rockville, MD 20857 Gary.Klaff@fda.hhs.gov Robin.Goon@fda.hhs.gov Tel: (240) 402-7555 Tel: (301) 348-1923

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:

mailto:Gary.Klaff@fda.hhs.gov

Request for Quotation FDA-18-RFQ-1199739 Page 6 of 10

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 Technical POC.

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:

mailto:FDAVendorPaymentsTeam@fda.hhs.gov

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(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

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

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

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

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in

(i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

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

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays: The workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January – New Year’s Day September – Labor Day January – Martin Luther King, Jr. Day October – Columbus Day February – President’s Day November – Veterans Day May – Memorial Day November – Thanksgiving Day July – Independence Day December – Christmas Day

PART 9 – 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) mailto:ERIC@fda.hhs.gov https://acquisition.gov/far/

Request for Quotation FDA-18-RFQ-1199739 Page 8 of 10

(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_ (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_ (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).

(End of clause)

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)

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

52.211-6 - Brand Name or Equal (Aug1999) 52.212-1 - Instructions to Offerors – Commercial Items (Oct 2016) https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147479 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147630 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147656 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147711 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1188603 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1169608 https://www.acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153351 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.1 http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.1 http://www.acquisition.gov/far

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

• See Part 11 below 52.217-5 - Evaluation of Options (Jul 1990) 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)

PART 10 – INSTRUCTIONS TO THE OFFEROR

The provision FAR 52.212-1 incorporated above is tailored as follows. Quote is due June 29, 2018 at 12:00 p.m. (Eastern Time). Send via email in native (Word/Excel) or PDF format to the Contract Specialist, Robin Goon at Robin.Goon@fda.hhs.gov.

The offeror’s quote must outline all characteristics of the requirement listed in Part 3 – Description of Requirements. In accordance with FAR 52.211-6 – Brand Name or Equal, offerors shall provide the brand name product referenced in this solicitation unless the offeror clearly indicates that the product being offered is an “equal” product. 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. Offerors shall provide quotes that shall be valid through September 30, 2018.

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 mailto:Robin.Goon@fda.hhs.gov

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(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. 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. Quotes shall be valid through September 30, 2018.