Combined Synopsis-Solicitation_1238243.pdf

COMBINED SYNOPSIS/SOLICITATION

FDA-SOL-1238243

TOTAL SMALL BUSINESS SET-ASIDE

General Information

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA‐SOL‐1238243

Posted Date: March 9, 2021

Current Response Date: March 19, 2021

SUBJECT TO AVAIBILITY OF FUNDS

The U.S. Food & Drug Administration, Office of Acquisitions and Grants Services is requesting a procure of one (1) Liquid Chromatography‐high Resolution Mass Spectrometer (LC‐HRMS) system including data acquisition computer and software. The Government intends to award a Firm Fixed‐Price Purchase Order for the items described below (CLIN 1‐10).

1) DESCRIPTION:

The FDA is looking to procure of one (1) Liquid Chromatography‐high Resolution Mass Spectrometer (LC‐HRMS) system including data acquisition computer and software projected to be coupled with DRC’s existing mass spectrometer or to collect data with its own photodiode array detector.

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

2021‐03. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA‐SOL‐1238243 and is being issued as a Request for Quote (RFQ). Prospective offerors are responsible for downloading the solicitation and any amendments from beta.SAM.gov.

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

2) BACKGROUND:

The FDA, Office of Testing and Research (OTR‐STL) develops sophisticated methodology to address special problems as necessary to assure pharmaceutical quality, assess bioequivalence of generic products and provide guidance for reviewers in their negotiations with drug firms. Fourier Transform Infrared (FTIR) microscopy is a technique that will allow for quick identification of the observed APIs. With the increasing number of generic drug applications a rapid form of identification of APIs would be valuable in contributing to development of Product Specific Guidances (PSGs).

3) Minimum MASS SPECTROMETER Salient Characteristics:

A. Shall be a newly manufactured unit, not used and refurbished, or previously used for demonstration. The life cycle for this instrument is intended to be ≥ 5 years at full performance.

B. Shall be a bench‐top system, measuring 75 x 80 x 55 cm (h x d x w, not including vacuum pump, UPLC and workstation) or less due to lab space restrictions.

C. Shall NOT require liquid‐N2 or He for cooling.

D. Shall NOT require external gas supply except nitrogen.

E. Shall be capable of real‐time data acquisition and data processing.

F. Shall be able to obtain high mass resolving power of at least 200,000 FWHM at ~200 m/z.

G. Shall have mass accuracy <3 ppm with external calibration over at least for 24 hrs. without any kind of mass re‐calibration.

H. Shall have mass accuracy <1 ppm (at least 4‐5 days) with an internal calibration preferably outside of ESI ionization region without causing any ionization issues such as ion suppression.

I. Shall have automated data dependent acquisition iterative injections to generate more MS/MS fragmentation spectra of unique precursor ions.

J. Shall have mass/charge range between 40 to at least 6000 m/z (with option to extend the upper mass range at least to 8000 m/z; that enables to go to high mass to optimize it for large molecules).

K. Shall have the ability to scan speed for resolving power 120,000 (for 200 m/z) shall be 18 spectra/6 seconds or higher.

L. Shall have the ability to achieve sensitivity of an ionizable, commercially available compound of MW within 200‐600 Da, that is, (1) in full scan mode, ≤ 500 fg on‐column injection yields S/N ≥ 100:1; (2) in SIM mode, ≤50 fg on‐column injection yields S/N ≥ 100:1.

M. Shall have dynamic range of ≥ 5000:1 within one mass spectrum (single full scan) to enable quantitation.

N. Shall have a quadrupole mass filter in front of the ion accumulation trap that allows for precursor ion selection for both MS/MS and full MS mode.

O. Shall be able to perform parallel ion filling and detection (to increase duty cycle and sensitivity).

P. Shall have a straight multipole collision cell with axial field for high‐energy collisional dissociation.

Q. Shall have the ability to do Stepped Normalized Collision Energy to allow at least 3 activation energies to be applied to the precursor.

R. Shall include both electrospray (ESI) and atmospheric pressure chemical ionization (APCI) source probes; fixed ionization interface shall allow instantaneous switchover.

S. Shall be capable of perform polarity switching during acquisition (e.g., alternatively producing one positive charge spectrum and one negative charge spectrum repeatedly). In polarity switching mode the instrument must perform within the defined mass accuracy specifications above with comparable scan rate.

T. Shall have all the following scan functions (modes) at the minimum:

1. Full Scan MS; Selected Ion Monitoring (SIM) scan.

2. Full Scan and MS/MS spectra.

3. Selected Reaction Monitoring/ Parallel Reaction Monitoring (PRM); Multiplexed SIM and

Multiplexed MS/MS.

4. No‐precursor‐ion‐selection (all‐ion fragmentation) high‐energy Fragmentation.

U. Shall have the ability to acquire and display Selected Ion Monitoring (SIM) scan data for monitoring selected ions for target compound analysis. Shall acquire and display multiplexed SIM mass spectra of up to 20 simultaneously detected precursor ions.

V. Shall targeted MS/MS and can multiplexing for up to at least 20 compounds.

W. Shall have the ability to perform both time‐scheduled (non‐data‐dependent) and data‐ dependent acquisitions; in the latter mode, capable of selecting Scan filters such as Dynamic Exclusion, Intensity, Precursor Fit, Charge State, Targeted Inclusion list, Targeted Exclusion list, MIPS (Monoisotopic Precursor Selection) and Apex Detection

X. Shall have the ability to accept flow rates from 1 to 1000 microliters per minute without splitting or loss of sensitivity.

Y. Shall have the ability to demonstrate (e.g., via publications) (1) the utility in determination of veterinary drug or pesticide residues below the concentration of 5 ng/g in food matrices; (2) the ability to accurately detect and identify a variety of chemical contaminants (e.g., drugs;

pesticides; hormones; mycotoxins; peptides) in complex matrices using known databases of compounds with accurate mass data shall also have precedence; and (3) raw data can be analyzed with the following software already used in the laboratory: Mass Profiler Professional 12.61; Compound Discoverer 3.0 or Tracefinder 4.1.

Z. Shall include dedicated software that can perform direct instrument control, tuning, mass calibration, data acquisition, and data processing (peak integration, m/z assignment, etc.).

AA. Shall include data PC workstation that can support the proper functioning of the software above, plus:

1. DVD‐RW.

2. Ethernet port (network‐card 10/100).

3. 3 PCI slots.

4. Operating System, Windows 10 Professional or higher.

5. Other necessary accessories to enable communication with a liquid chromatograph system.

BB. Shall be capable of providing the following upgrade options that must be fully interoperable with the LC‐MS/MS: Gas‐phase fractionation based on differential ion mobility capability, photo‐ionization source, nanospray sources, a dual source capable of simultaneously running MS/MS in ESI and APCI modes, metabolite identification software and “Option” that enables to go to high mass (about 8000 Da) to optimize it for large molecules. Note: These upgrades are not required as part of this acquisition, however the ability for the instrumentation to be upgraded in the future is a requirement.

4) Minimum Software Technical Salient Characteristics:

A. Shall be a fully integrated system, including computer, software(s), licenses, and peripheral equipment necessary for instrument operation, data acquisition, and instrument networking capability. Associated computer equipment/software shall be compatible with and include Microsoft Windows 10 operating system 64‐bit OS.

B. Shall have two (2) licenses for each accompanied software, one for the acquisition computer and one for the data reprocessing computer. One license is for a computer CVM already owns;

operating on Microsoft Windows 10 operating system 64‐bit OS.

C. Shall have software to be capable of qualitative processing, quantitative processing, and enable automatable presentation of tabular and graphical data.

D. Shall include data acquisition and processing software.

E. Shall include standard features for external/internal standard calibration, linear and quadratic fit, statistical reporting, weighting, and extrapolation.

F. Shall have the ability to allow for data export to common, non‐proprietary file formats such as

.PDF, .TXT, .CSV., Microsoft Word, or Microsoft Excel for downstream compatibility.

G. Shall have the ability to conform to FDA IT Security requirements and be approved by FDA IT prior to award. FDA/IT Specific requirements:

Card Readers. Shall include Federal Information Processing Standard (FIPS) 201‐ compliant smart card (access card) readers (referred to as LACS Transparent Readers) with the purchase of servers, printers, desktops, and laptops.

H. Shall provide any system specific IT information including software names, version numbers, licensing requirements, and any requirements for exclusion from automatic/push updates, and internet/network connectivity requirements.

Note: If the system computer must be supplied by the vendor, that information shall be included in the proposal.

I. Shall have a benchtop format due to space constraints of the laboratory.

J. Shall have a power system requirements/compatibility: 220V, 60 Hz.

5) Minimum Training Requirements:

A. Shall include 4‐5 days of on‐site familiarization training for up to seven (7) users, covering instrument operation, data acquisition software, and basic instrument maintenance.

B. Shall have the training taught by a technician that is certified with the instrument.

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

6) Minimum Warranty Requirements:

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

B. Shall include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

C. Service calls shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument.

D. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

a. The Technical Point of Contact (TPOC) or their designee shall have access to the manufacturer’s technical assistance call center during regular business hours (10am to 8pm EST).

b. The technical assistance call center shall be staffed by engineers who provide a high level of expertise for troubleshooting the instrument.

E. Shall guarantee that a service engineer will be able to work on site within two (2) business days of receiving a call from the End User(s).

a. Upon the on‐site visit, shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement.

b. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs.

c. Turnaround time for an emergency or non‐emergency on‐site visit to completion of repairs shall not exceed five (5) business days (120 hours).

i. For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card

ii. For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs

iii. Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization

F. Shall provide all software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

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

7) Minimum Preventative Maintenance (PM) Agreement Requirements:

A. Shall provide an option year PM agreement covering maintenance of the instrument for the base year plus four (1) year option periods.

B. Shall cover the same requirements as the warranty requirements with the addition of a PM service meeting the following:

1. Shall provide one (1) scheduled PM visit per year over the term of the contract.

2. Shall include all travel, labor, and parts at no additional cost to the government.

3. Shall include routine PM of the instrument, calibration, electrical safety testing and any other PM measures deemed necessary by the Contractor and/or

CO/TPOC.

8) Minimum Trade‐In Requirements:

A. Shall accept one (1) DRC’s Mass spectrometer as trade‐in (Thermo Scientific Q‐exactive basic MS purchased in 2012; SN: 01227L; last PM done on Aug 26, 2019).

B. Shall have the ability to disassembly, packaging, and ship at no additional cost to the government.

9) PRICING:

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

CLIN DESCRIPTION QUANTITY PRICE

1 Mass Spectrometer with WorkStation 1 EA $

2 Liquid Chromatography 1 EA $

3 Software Preventative Maintenance ‐ Option Year 1 1 EA $

4 On‐site Training for 4‐5 days for Seven (7) End Users 1 EA $

5 Warranty 1 EA $

6 Annual Preventative Maintenance ‐ Option Year 1 12 Months $

7 Annaul Preventative Maintenance ‐ Option Year 2 12 Months $

8 Annual Preventative Maintenance ‐ Option Year 3 12 Months $

9 Annual Preventative Maintenance ‐ Option Year 4 12 Months $

10 Less – Trade‐in (Q‐exactive / SN: 01227L) 1 EA $

GRAND TOTAL to include both delivery and installation minus trade‐in= (FOB‐Destination)

A. INSPECTION AND ACCEPTANCE:

1. The Contracting Officer’s Representative (COR) will perform inspection and acceptance of the service maintenance services and, if necessary, the repair services to be provided.

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

2. NOTE to Contractor – IT Purchase Requirments: 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.

a. This list will need to include:

i. IT hardware: manufacture, nomenclature and model number

ii. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

B. PLACE OF PERFORMANCE:

1. FOB‐Destination

Food and Drug Administration 8401 Muirkirk Road Laurel, MD 20708

2. Delivery shall be no later than sixty (60 days) after contract award.

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

C. CONTRACT ADMINISTRATION DATA:

A. Contracting Officers 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

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:

52.202‐1 Definitions (Jun 2020).

52.203‐3 Gratuities (Apr 1984).

52.203‐6 Restrictions on Subcontractor Sales to the Government (Jun 2020).

Alternate 1(Oct 1995).

52.203‐12 Limitation on Payment to Influence Certain Federal Transactions (Jun 2010).

52.204‐4 Printed or Copied Double‐Sided on Recycled Paper (May 2011).

52.204‐10 Reporting Executive Compensation and First‐Tier Subcontract Awards (Jun 2020).

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

52.204‐14 Service Contract Reporting Requirements (Oct 2016).

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).

52.215‐2 Audit and Records ‐ Negotiation (Jun 2020) – Alternate II (Aug 2016).

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

52.219‐8 Utilization of Small Business Concerns (Oct 2018).

52.219‐28 Post‐Award Small Business Program Re‐representation (Nov 2020).

52.222‐3 Convict Labor (Jun 2003).

52.222‐21 Prohibition of Segregated Facilities (Apr 2015).

52.222‐26 Equal Opportunity (Sept 2016).

52.222‐35 Equal Opportunity for Veterans, (Jun 2020).

52.222‐36 Equal Opportunity for Workers with Disabilities (Jun 2020).

52.222‐37 Employment Reports on Veterans, (Jun 2020).

52.222‐40 Notification of Employee Rights Under the National Labor Relations Act (Dec 2010).

52.222‐50 Combating Trafficking in Persons (Oct 2020).

52.222‐54 Employment Eligibility Verification (Oct 2015).

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 (Jun 2008).

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).

52.227‐11 Patent Rights—Ownership by the Contractor (May 2014).

52.227‐14 Rights in Data ‐ General (May 2014) ‐ Alternate IV (Dec 2007).

52.232.18 Availability of Funds (Apr 1984).

52.232‐23 Assignment of Claims (May 2014).

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).

52.242‐13 Bankruptcy (Jul 1995).

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).

52.249‐2 Termination for Convenience of the Government (Fixed Price) (Apr 2012).

52.249‐8 Default (Fixed‐Price Supply and Service). (Apr 1984).

(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 anytime before te 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.

C. 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.

I.

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to nicole.craig@fda.hhs.gov no later than March 11, 2021, 8:00 a.m. Eastern Standard 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 March 19, 2021 at 8:00 a.m. Eastern Standard 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 www.sam.gov.