Combined Synopsis-Solicitation_1243364.pdf

COMBINED SYNOPSIS/SOLICITATION

FDA-SOL-1243364

TOTAL SMALL BUSINESS SET-ASIDE

General Information Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA-SOL-1243364 Posted Date: June 14, 2021 Current Response Date: June 28, 2021

The U.S. Food & Drug Administration, Office of Acquisitions and Grants Services is requesting a procure of one (1) Dynamic Headspace and Thermal Desorption Unit that will be integrate with the following existing system: Agilent Technologies Gas Chromatography–Mass Spectrometry (GC/MS) 7890.

The Government intends to award a Firm Fixed-Price Purchase Order for the items described below

(CLIN 1-10).

1) DESCRIPTION:

The Dynamic Headspace and Thermal Desorption Unit will help devise methods for improving the regulatory science mission. This equipment will bring additional capability in assessing volatile organic compounds using dynamic headspace, solid phase microextraction and thermal desorption techniques. This equipment will be used for analysis of organic species in a variety of liquid and solid samples.

The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC)

2021-05. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A

SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-1243364 and is being issued as a Request for Quote (RFQ). Prospective offerors are responsible for downloading the solicitation and any amendments from SAM.gov

The associated North American Industrial Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing.

2) BACKGROUND:

The research supported by this equipment is part of the Biocompatibility and Toxicology Program Charter of OSEL. The research is integral to the modernization of biocompatibility testing, one of CDRH strategic priorities where chemical characterization and analysis is used to address several biocompatibility endpoints.

3) Minimum Technical Salient Characteristics:

A. Shall provide one (1) newly manufactured unit, not used and refurbished or previously used for demonstration. Dynamic Headspace and Thermal Desorption Autosampler Unit.

B. Shall be compatible with the FDA’s Agilent Technologies Gas Chromatograph (GC) System, Model Number 7890.

C. Shall have the ability to mount onto/above the GC, minimizing lab bench space requirements.

D. Shall provide the following General System Capabilities:

1. XYZ robot based autosampler that provides everything needed to perform standard liquid injections with automatic tool exchange. Includes a solvent wash station, tool for liquid syringes, 3 position tool exchange station and trays for 2 mL vials;

2. System can be upgraded to perform headspace and Solid Phase Microextraction (SPME) injections;

3. Headspace Upgrade with Heated agitator; 3 x 15 position trays for 10/20 mL vials and Pressure regulator;

4. Thermal Desorption Unit with Desorption temperature from 20°C to 350°C;

Dynamic desorption flow; Desorption in split or spitless mode; Temperature program rate: 1 to 720°C/min. Capability of cryogenic trap with Temperature range -150°C to 400°C;

5. Automatic tube exchange option.

E. Shall provide the following handling processes & features:

1. Perform liquid injections, Large-Volume Liquid Injections (LVI), Static Headspace (HS), Solid Phase Micro Extraction (SPME), Thermal Desorption (TD), and Dynamic Headspace (DHS) techniques in an automated fashion on the FDA’s existing Agilent GC/MS 7890 System;

2. Ability to be upgraded to add pyrolysis in the future, without loss of existing functionality;

3. The Autosampler/Robot must include movement on an x-/y-/z-coordinate and allow for vials and TD tubes to be moved as appropriate across the platform;

4. The Autosampler/Robot must be a robotic device for liquid injection capable of injection from at least 162 2-mL vials, with the flexibility to accommodate 96- and 384-well microtiter plates, 1-, 4-, 10- 20- and 40-mL vials with the addition of appropriate sample tray holders and trays, in order to maintain sample configuration flexibility and capacity;

5. The Autosampler/Robot must have a Universal Syringe Holder design which incorporates the optional use of multiple syringe sizes, 1µl to 1000µl;

6. The Autosampler must have the ability to change syringes and other “tools” to provide optimum combination of functions/methods in automated sequences;

7. An injection port/inlet for the GC must be a septum-less Programmable Temperature Vaporizer (PTV)-style that can be set up for cooled on column injection with temperature capabilities for GC with temperature capabilities from -150°C to 650°C.

8. An injection system that does not require a septum, thus reducing interferences.

F. Shall include installation at no additional cost to the government.

4) Minimum Termal Desorption (TD) Technical Salient Characteristics:

A. Shall be able to perform TD from 6-mm OD x 60-mm length tubes and Thermal Extraction (TE) of liquids and solids.

B. Shall a valve-less design, eliminating valves and transfer lines that can result in loss of compounds and bias results.

C. Shall provide the TD must work in conjunction with a cooled injector cryotrap (see description above for injection port/inlet) to focus what is desorbed in the TD unit.

5) Minimum Dynamic Headspace (DHS) Technical Salient Characteristics:

A. Shall have the ability to perform DHS from 10- and 20-mL vials, a technique offering significantly improved limits of detection compared to static headspace analysis (HS).

B. Shall include aMass Flow Meter (MFM) for use with the DHS system.

C. Shall have the ability to to be upgraded to accommodate up to a 1-L single sample module for

DHS of physically larger samples.

6) Minimum Software Contol Features Salient Characteristics:

A. Shall include all components of the system (autosampler, GC and MS) must be controlled through integrated software, enabling use of one sequence table (sample list) and one method on one PC for automation from sample preparation to GC analysis on the system.

B. Shall have the robot control software must provide multiple sample prep ahead and multiple sample overlap functionality for all applications designed in order to provide for efficient analysis time and sample analysis productivity.

C. Shall provide the Autosampler/Robot software must allow for priority sample interrupt and allow for the user to introduce a priority sample within a sequence without stopping or reprogramming the robot.

D. Shall provide the Autosampler/Robot control software must have sequence editing that provides repeat function, fill-down function, and copy/paste function in order to efficiently create analysis tables for daily operations.

E. The robot software must be easily programmable and customizable by the user by the standard software package and not require fixed scripts for customization.

F. The robot control software must provide Log File and Service Log file functions to ensure traceability and troubleshooting.

G. The Autosampler/Robot control software must provide a Large Volume Injection analysis using the Programmed Temperature Vaporization (PTV)-style injector by calculating the best injection parameters based on the injection liner used, the solvent boiling point and injection volume in order to speed method development.

7) Minimum Training Requirements:

A. Shall provide on-site training within one (1) month after installation for up to four (4) End Users.

B. Shall have the training taught by service engineers who are trained and certified.

C. Shall be scheduled by the Contracting Officer (COR) after installation is deemed by the COR or to be operationally acceptable.

8) Minimum Warranty Requirements:

E. Shall include one (1) year warranty for parts and labor from the date of acceptance.

F. Shall include replacement parts/labor for any preventive maintenance, travel, and any software upgrades necessary at no additional cost to the government.

G. Shall provide on-site repair visit by a factory trained and certified engineer on-site within 2-3 business days and which includes travel and labor at no additional cost to the government.

H. Shall provide on-site preventive maintenance and repair activities from the Original

Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

I. Shall provide support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time.

J. Shall be capable of installing instrument control and data analysis software packages on new computer systems in case of computer system failures.

K. Shall include the life cycle of this instrument is intended to be greater than five (5) years at full performance.

• The FDA must be able to reasonable expect service and technical support from the vendor during its lifecycle

9) PRICING:

All charges must be included in the quote. Any charges presented after contract award shall be unacceptable.

CLIN DESCRIPTION QUANTITY PRICE

1 Dynamic Headspace and Thermal Desorption Unit 1 EA $

2 Termal Desorption (TD) 1 EA $ 3 Dynamic Headspace (DHS) 1 EA $ 4 Software Contol Features 1 EA $ 5 Training 1 EA $ 6 Warranty 1 EA $ 7 OPTION YEAR 1 – Annual Preventative Maintenace 1 EA $ 8 OPTION YEAR 2 – Annual Preventative Maintenace 1 EA $ 9 OPTION YEAR 3 – Annual Preventative Maintenace 1 EA $

10 OPTION YEAR 4 – Annual Preventative Maintenace 1 EA $ GRAND TOTAL to include both delivery and installation = $

A. INSPECTION AND ACCEPTANCE:

The Techincal Point of Contact (TPOC) will perform inspection and acceptance of the service maintenance services and, if necessary, the repair services to be provided.

AA.. For the purpose of this PART, is the authorized representative of the Contracting Officer (To Be Added).

BB.. IT PURCHASE REQUIREMENTS: NOTE to Contractor: Before the purchase order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this purchase order.

B. PLACE OF PERFORMANCE:

1. FOB-Destination Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

2. Delivery shall be no later than 60 days after award.

3. Hours of Delivery 10:00am – 4:00pm (Monday-Friday, excluding holidays and weekends).

C. CONTRACT ADMINISTRATION DATA:

A. Technical Point of Contact (TPOC)

1. The following TPOC will represent the Government for the purpose of this contract: (To Be Determined).

2. The TPOC 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.

B. 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.

The contact information for the Contracting Officer:

Nicole Craig nicole.craig@fda.hhs.gov

D. INVOICE SUBMISSION:

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

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

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:

mailto:nicole.craig@fda.hhs.gov

(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 persons 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:

(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.

E. GOVERNMENT HOLIDAYS:

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) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) July (Independence Day)

September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day)

F. EVALUATION AWARD CRITERIA:

The Government shall award this contract to the Lowest Priced, Technically Acceptable (LPTA).

FDA reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

G. PROVISIONS and CLAUSES:

HHSAR Clauses Incorporated by Reference: Read the full text of the HHSAR Clauses as stated below, see http://www.hhs.gov/regulations/hhsar/subpart352.html

HHSAR Clause Description/Date 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations/(Dec 2015).

352.239-73 Electronic and Information Technology Accessibility Notice/(Dec 2015).

FAR Clauses 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one of 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 http://farsite.hill.af.mil/vffara.htm http://farsite.hill.af.mil/vffara.htm

52.212-4 -- Contract Terms and Conditions -- Commercial Items. Contract Terms and Conditions -- Commercial Items (Oct 2018)

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders --

Commercial Items (Jan 2021).

As prescribed in 12.301(b)(4), insert the following clause:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

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

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

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

52.204-25,Prohibition on Contracting for Certain Telecommunications and Video Services or Equipment (Aug 2020).

52.209-10,Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

52.215-8,Order of Precedence - Uniform Contract Format (Oct 1997).

52.215-17,Waiver of Facilities Capital Cost of Money (Oct 1997).

52.222-1,Notice to the Government of Labor Disputes (Feb 1997).

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

52.222-26,Equal Opportunity (Sept 2016).

52.222-50,Combating Trafficking in Persons (Oct 2020).

52.223-6,Drug-Free Workplace (May 2001).

52.223-18,Encouraging Contractor Policies to Ban Text messaging While Driving (Jun 2020).

52.225-13,Restrictions on Certain Foreign Purchases (Feb 2021).

52.227-1,Authorization and Consent (Jun 2020) - Alternate I (Apr 1984).

52.227-2,Notice and Assistance Regarding Patent and Copyright Infringement (Jun 2020).

52.232-25,Prompt Payment(Jan 2017) - Alternate I (Feb 2002).

52.232-33,Payment by Electronic Funds Transfer-System for Award Management (Oct 2018).

52.232-39,Unenforceability of Unauthorized Obligations (Jun 2013).

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

52.233-1,Disputes (May 2014) - Alternate I (Dec 1991).

52.233-3,Protest after Award (Aug 1996) - Alternate I (Jun 1985).

52.233-4,Applicable Law for Breach of Contract Claim (Oct 2004).

52.243-1,Changes Fixed Price (Aug 1987).

52.246-2, Inspection of Supplies-Fixed-Price (Aug 1996).

52.246-25,Limitation of Liability - Services (Feb 1997).

(End of Clause) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20015

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 anytime before the contract expires.

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

10) INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION FORMAT:

FAR 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020)

A. 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.

B. The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

C. 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.

D. Price Quotes shall be FOB Destination including shipping and handling expense.

E. Offeror shall include a price breakout for all components for Item 1 THROUGH 10 WHICH

INCLUDED THE EXTENDED TOTAL (See part 3 for table to be completed) to include detailed description, catalog part/number, quantity, and unit price of each item to be eligible for award, all line items must be quoted.

F. The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

G. The government is not responsible for locating or securing any information which is not identified in the proposal. To ensure information is available, offerors shall furnish as part of their quote, all descriptive material necessary for the Government to unequivocally.

H. Period of acceptance of offers: The offeror agrees to hold the prices in its offer firm until August 31, 2021.

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to nicole.craig@fda.hhs.gov no later than June 16, 2021, 2:00 p.m. Eastern Daylight Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

Collect calls will not be accepted. No Phone Calls Please.

PROPOSAL DUE: All proposals are due, electronical to nicole.craig@fda.hhs.gov no later than June 28, 2021 at 10:00 a.m. Eastern Daylight Time.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

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 SAM.gov https://sam.gov/content/home.

mailto:nicole.craig@fda.hhs.gov mailto:nicole.craig@fda.hhs.gov https://sam.gov/content/home