Combined Synopsis-Solicitation_1243230.pdf

COMBINED SYNOPSIS/SOLICITATION

FDA-SOL-1243230

TOTAL SMALL BUSINESS SET-ASIDE

General Information Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA-SOL-1243230 Posted Date: June 27, 2021 Current Response Date: July 12, 2021

The U.S. Food & Drug Administration, Office of Acquisitions and Grants Services is requesting a procure of one (1) Pyrolysis System and Preventative Maintenance for a Base Year and three (1) year option plans. The Government intends to award a Firm Fixed-Price Purchase Order for the items described below

(CLIN 1-7).

1) DESCRIPTION:

The Pyrolysis System will be attached to an existing Agilent - Gas Chromatography (GC)/Mass Spectrometry (MS) system.

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-1243230 and is being issued as a Request for Quote (RFQ). Prospective offerors are responsible for downloading the solicitation and any amendments from SAM.gov (https://sam.gov/content/home).

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

2) BACKGROUND:

The FDA is looking to purchase a Pyrolysis System to be used for all medical device materials as a means to identify polymer composition or as a means to determine a worst-case measure of the total additives/impurities in the material. With the capabilities of thermal desorption as well as pyrolysis at higher temperatures, this pyrolizer provides possibilities to identify and quantify nonvolatile and semi-volatile substances that mostly released from the polymer material.

3) MINIMUM TECHNICAL SALIENT CHARACTERISTICS:

AA.. Shall be compatible with the Agilent Model 7890 GC System and the Control Software

(MassHunter version B. 07.00).

BB.. Shall be newly manufactured unit, not used and refurbished or previously used for demonstration.

CC.. Shall provide all mounting accessories.

DD.. Shall include a septum-less Programmable Temperature Vaporizer (PTV)-style port that serves as a cryo-trap and split interface to the have the connection between the Pyrolizer System and the Agilent GC unit.

EE.. Shall provide a Cooled Injection System (CIS) to assist with cryofocusing of the volatile compounds. CIS hall have following features:

1. Septumless sampling head for 0.64 mm OD dome tip needle;

2. Linear heating (0.5 to 12°C/sec.) with 2 temperature ramps;

https://sam.gov/content/home

TOTAL SMALL BUSINESS SET-ASIDE

3. Split/splitless and solvent vent injection modes;

4. Pneumatic module for electronic pressure control;

5. Temperature range -150°C to 400°C (cooling option dependent).

FF.. Shall contain a Thermal desorption unit (TDU) cooling system that consists of:

1. LN2 cooling for CIS with C506 controller;

2. Universal Peltier Cooling for TDU/TD 3.5+.

GG.. Shall be compatible with a robotic sample handler that serves as the pyrolyzer autosampler and be capable of automated liquid and large-volume liquid injections.

HH.. Shall provide a life cycle greater than five (5) years at full performance.

II .. Shall provide OEM service and technical support from the vendor during its lifecycle.

JJ .. Shall have the ability to manufacture the instrument system with a high degree of quality control as evidenced by units in use by other customers performing applications with similar technical demands.

KK.. Shall have the ability to demonstrate a well-documented customer base within at least the last year, preferably in the United States, and provide contacts to obtain evaluation on system performance from independent users.

LL.. Shall be able to analyze wide range of sample types including nonvolatile samples of solid and liquid form with high reproducibility of pyrolysis temperature up to 1000℃ (± 0.1 °C).

MM.. Shall perform thermal desorption at temperatures ranging from ambient to 350 °C.

NN.. Shall performed at user-defined temperatures from 350 °C to 1000 °C.

OO.. Shall provide a temperature program rate: 0.02 to 100 °C/sec.

PP.. Shall include forty (40) position pyrolysis sample tube rack with transport adapters QQ.. Shall have the ability to perform the multistep fractional pyrolysis (consecutive pyrolysis) in wide range of temperatures. This technology can separate the contaminants or additives in the polymer samples at lower pyrolysis temperature and provide clean sample profile.

RR.. Shall have the ability to operate in “pulsed pyrolysis” and “smart ramped pyrolysis” modes; the latter technique pyrolyzes the sample more slowly and traps them at cold temperatures, thus preserving fragments that might otherwise react with each other.

SS.. Shall be valve less and have a direct connection with the trap, not requiring transfer lines.

• The absence of valves and transfer lines is critical for pyrolysis samples, which often produce residues that can contaminate the system.

TT.. Shall be equipped with automatic sampler which sequences of sample injection can be controlled by software.

UU.. Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/index.html or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.

4) MINIMUM SOFTWARE SALIENT CHARACTERISTICS:

A. Shall be compatible to Agilent Chemstation and MassHunter software platforms, allowing for one method and one sequence table, simplifying system operation and method development.

B. Shall be Windows 10 compatible that does not require custom written scripts as methods change.

C. Shall have the ability to allow for priority sample interrupt and allows for the user to introduce a priority sample within a sequence without stopping or reprogramming the software.

https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

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

E. Shall include a complete Data Acquisition and Data Processing Software Packages.

5) MINIMUM TRAINING REQUIREMENTS:

A. Shall provide on-site training within one (1) month after installation for up to five (5) End Users.

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

C. Shall provide a customized demonstration on how to use the system.

D. Shall include all supplies and authentic parts at no additional cost to the government.

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

6) MINIMUM WARRANTY REQUIREMENTS:

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

BB.. Shall provide a life cycle greater than five (5) years at full performance.

• Shall provide OEM service and technical support from the vendor during its lifecycle.

CC .. Shall include one (1) year of software updates at no additional cost to the government.

DD.. Shall include one (1) year of technical support at no additional cost to the government.

EE.. Shall include all shipping, installation, travel, labor, and parts required at no additional cost to the government.

7) PRICING:

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

CLIN DESCRIPTION QUANTITY PRICE

1 Pyrolysis System 1 EA $

2 Software 1 EA $ 3 Training 1 EA $ 4 Warranty 1 EA $ 5 OPTION YEAR 1 – Annual Preventative Maintenance 1 EA $ 6 OPTION YEAR 2 – Annual Preventative Maintenance 1 EA $ 7 OPTION YEAR 3 – Annual Preventative Maintenance 1 EA $

GRAND TOTAL to include both delivery and installation = $

A. INSPECTION AND ACCEPTANCE:

The Contracting Officer Representative (COR) 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 forty-five (45) days after award.

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

4. Shall remove any packing paper and handling disposal of such material.

C. CONTRACT ADMINISTRATION DATA:

A. Contracting Officer Representative (COR)

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

2. The COR 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 mailto: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:

(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

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:

http://farsite.hill.af.mil/vffara.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20015

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).

52.222-21 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) .

52.246-4 Inspection of Services-Fixed-Price (Aug 1996).

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

(End of Clause)

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 any time 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.

8) INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION FORMAT:b

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 7 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 30, 2021, 8:00 a.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 July 12, 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).

https://sam.gov/content/home