FBO_Combined_synopsis-solicitation.doc

18-223-SOL-00062

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-02.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION SHALL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-1211759 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1,000 employees. This shall be awarded as Fixed Price and 100% Total Small Business Set-Aside. Prospective Offerors are responsible for downloading the solicitation and any amendments from FedBizOpps (FBO). The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary.

The Food and Drug Administration (FDA) Office of Regulatory Science, Division of Bioanalytical Chemistry requires the purchase of a two-dimensional gas chromatograph with mass spectrometry detection (GCxGC-MS).

The FDA anticipates awarding a fixed price award for this effort.

A. BACKGROUND AND OVERVIEW:

The Office of Regulatory Science, Division of Bioanalytical Chemistry requires the purchase of a two-dimensional gas chromatograph with mass spectrometry detection to develop methods for the detection of seed oil in olive oil, and the analysis of trans fatty acids in fats and oils. The requested two-dimensional gas chromatograph with mass spectrometry detection will provide the necessary requirements that are critical for the development of new methods for FDA laboratories (CFSAN and ORA) dedicated to food safety. This instrument will replace an existing outdated instrument based on same technology.

B. OBJECTIVES/PURPOSE

The purchase of a two-dimensional gas chromatograph with mass spectrometry detection is critical to support the Agency’s mission in the development and validation of quantitative analytical methods for regulatory use.

The major components of the acquisition plan are as follows:

1. Two-dimensional gas chromatograph with mass spectrometry detection

Including:

a. Mass spectrometer.

b. Gas chromatograph, with auxiliary oven and autoinjector.

c. Thermal two-dimensional modulator.

d. Liquid nitrogen leveler.

e. Heated transfer line connecting the gas chromatograph to the mass spectrometer.

f. All the tubing, fittings, connectors and other supplies needed for the installation and operation of the instrumentation.

g. Integrated computer-based data system capable of controlling the instrument, acquiring data, and performing subsequent data analysis. The instrument should be supplied with appropriate data analysis software including multiple licenses for operation on multiple (minimum 2) computer workstations.

2. Entire system must be warranted for parts and labor for 12 months from date of installation. Service must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

3. The system must be newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument must meet all of the technical and hardware specifications specified below.

4. The vendor is responsible for delivery and installation of the instrument. The FDA project officer will perform inspection and acceptance of the two-dimensional gas chromatograph and mass spectrometer system.

5. The vendor will demonstrate upon installation that the item will be all performance specifications by the manufacturer.

6. An instrument familiarization for FDA users will be provided by the installation engineer.

C. STATEMENT OF WORK (SOW) -- SCOPE OF WORK

The instrument purchased must meet the following technical requirements:

1. The instrument must be capable of separating analytes based on comprehensive two-dimensional chromatography principles.

2. The instrument must be equipped with a dual stage thermal modulator.

3. The instrument must be equipped with a secondary oven holding the second separation columns. The temperature of this oven must be programmable from the temperature of the main oven +5°C up to 350°C.

4. The instrument must be capable of performing split, splitless and PTV injections.

5. The instrument must be equipped with an autosampler capable of injecting in sequence at minimum 100 samples unattended.

6. The mass spectrometer ion source must perform electron ionization with a programmable energy from 40 eV to 200 eV, and an emission current from 0.5 to 5 mA.

7. The mass spectrometer must be capable of acquiring at least 500 full spectra per second.

8. The mass spectrometer must be able to acquire spectra from 50 to 1500 amu.

9. The mass spectrometer must provide a mass resolution greater than 1500 at m/z 1500, and greater than 1100 at m/z 219.

10. The mass spectrometer must be capable of operating with hydrogen carrier gas.

11. The mass spectrometer must be capable of operating at up to 5 mL/min of carrier gas.

The instruments purchased must include the following hardware specifications:

1. Mass spectrometer.

2. Gas chromatograph, with auxiliary oven and autoinjector.

3. Thermal two-dimensional modulator.

4. Liquid nitrogen leveler.

5. Heated transfer line connecting the gas chromatograph to the mass spectrometer.

6. All the tubing, fittings, connectors and other supplies needed for the installation and operation of the instrumentation.

The instrument purchased must include the following additional considerations:

1. The instrument should have an integrated computer-based data system capable of controlling the instrument (e.g. gas chromatography, mass spectrometer, two-dimensional modulation parameters), acquiring data, and performing subsequent data analysis and quantification through spectral deconvolution. The instrument should be supplied with appropriate data analysis software. The software must be compatible with Microsoft Windows 7 and/or Windows 10 operative systems.

2. The requisition must include multi-user data processing software licenses for operation on a secondary computer

D. PLACE OF PERFORMANCE and DELIVERABLES :

1. The vendor is responsible for delivery and installation of the instrument and all components specified above to the FDA/CFSAN laboratory facility located at 5001 Campus Drive, College Park, MD 20740.

2. If the vendor is not installing on the day of delivery, the delivery should be made to the loading dock and moved into location on the date of installation. The vendor is responsible for installation of the instrument.

3. The vendor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument will not be accepted until those performance specifications have been met. The CFSAN project officer will perform inspection and acceptance of the two-dimensional gas chromatograph and mass spectrometer system.

4. The entire system will be warranted for parts and labor for 12 months from date of installation. Service and installation must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. A one-day on-site training for FDA users will be arranged by the CFSAN project officer.

FOB Inspection and acceptance: Destination

E. PERIOD OF PERFORMANCE: The Period of Performance for this effort shall be 60 days after purchase order award.

F. PRICING SCHEDULE

Total:

G. GENERAL INFORMATION

Hours of operation shall be normal business hours (9am-5pm) Eastern Time. However, in matters dealing with National Security and/or significant public health and safety issues, the Contractor shall provide services outside of normal business hours to meet the timely reporting requirements specified above.

GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A.

The Contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Division of Payment Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

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

B.

Invoices submitted under this contract shall 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 shall 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 (shall 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), 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:

(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 shall be included in the electronic invoice. Electronic invoices shall be on company letterhead and shall 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 shall 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.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

Contractor Performance Evaluations Interim and final evaluations of Contractor performance shall be prepared on this contract in accordance with FAR 42.15. The final performance evaluation shall be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually.

Interim and final evaluations shall be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter shall be referred to an individual one level above the Contracting Officer, whose decision shall be final.

Copies of the evaluations, Contractor responses, and review comments, if any, shall be retained as part of the contract file, and may be used to support future award decisions.

H. EVALUATION AND AWARD:

Lowest Priced, Technically Acceptable (LPTA)

FDA will first evaluate all Offerors’ prices, then, evaluate the apparent lowest-priced quote/proposal for acceptability under the technical and past performance factors (if applicable). If the lowest-price Offeror was evaluated as unacceptable, FDA would then consider the acceptability of the next lowest-price Offeror, continuing this process as necessary.

I. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (JAN 2017)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The total number of pages for the technical quote shall not exceed fifteen (15) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Daniel.Weingarten@fda.hhs.gov no later than May 17, 2019, 12:00 p.m. Eastern Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTATIONS DUE: All proposals are due, electronically to contract specialist email: Daniel.Weingarten@fda.hhs.gov for the RFQ no later than May 23, 2019, 12:00 p.m. Eastern Time.

*Quotations must be valid through September 30, 2019 PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/ The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; FAR 52.217-8, Option to Extend Services; FAR 52.219-6, Notice of Total Small Business Set-Aside; FAR 52.219-8, Utilization of Small Business Concerns; FAR 52.219-13 Notice of Set-Aside of Orders; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; 52.219-28, Post-Award Small Business Program Representation; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.

PROVISIONS and CLAUSES:

FAR 52.212-4 - Contract Terms and Conditions -- Commercial Items (Oct 2018) is hereby incorporated by reference 52.217-8 -- Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within one (1) day of contract expiration.

52.232-40 Providing Accelerated Payments to Small Business SubContractors. (Dec 2013)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subContractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subContractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

52.232-18 Availability of Funds. (Apr 1984) Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

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