FDA-RFQ-CDER-2022-112816-CTL ImmunoSpot S6 Macro M2 Analyzer Brand Name Or Equal.docx

Request for Quotations: FDA-RFQ-CDER-2022-112816-CTL ImmunoSpot S6 Macro M2 Analyzer, Brand Name or Equal, plus two (2) option years of Preventative Maintenance Agreement (PMA)

Request for Quotations: FDA-RFQ-CDER-2022-112816-CTL ImmunoSpot S6 Macro M2 Analyzer, Brand Name or Equal, plus two (2) option years of Preventative Maintenance Agreement (PMA)

Section 1 – General This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued.

Solicitation Number # FDA-RFQ-CDER-2022-112816 is being issued as a Request for Quotations (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2022-06. This requirement is being solicited as a total small business only set-aside 100% (for small businesses only) FAR 52.219-6, Notice of Total Small Business Set-Aside, using the Simplified Acquisition Procedures per FAR Subpart 13.5.

The U. S. Food & Drug Administration, (FDA) Office of Acquisition and Grants Services (OAGS) has a requirement to procure a CTL ImmunoSpot S6 Macro M2 Analyzer, Brand Name or Equal, plus two (2) option years of Preventative Maintenance Agreement (PMA), under solicitation FDA-RFQ-CDER-2022-112816.

Section 2 - Contract Type The Government intends to award a Firm Fixed-Price (FFP) Purchase Order to procure the requested system.

The NAICS Code for this procurement is: 334516 Laboratory analytical instruments (except optical) manufacturing.

Section 3 - Description/Specifications, salient characteristics and Statement of Work

3.1. At a minimum, the requested system shall have the technical/salient/functional, operational characteristics and specifications here below described:

1. Background/Statement of Need Influenza is a common public health problem that can result in local annual epidemics and worldwide pandemics. Circulating influenza viruses become resistant to currently FDA-approved anti-influenza drugs (i.e., M2 ion-channel, neuraminidase, and polymerase inhibitors) very rapidly. FDA is planning to examine whether newly arising drug-resistant influenza mutants affect viral fitness and/or replicative ability in cultures of primary human respiratory epithelial cells. FDA will also investigate the relationship between the magnitude of viral replication and the levels of drug resistance. To assess virus yields of the viral infection, we need to purchase the CTL ImmunoSpot S6 Macro M2 Analyzer, which is a compact instrument that performs high throughput plaque counting in larger well formats and is specifically designed for regulated or academic visible light analysis. FDA’s project addresses CDER Goal #2, OPQ strategic plan Objective b: Ensuring the safe use of approved human drugs. Our proposal also addresses the goal of the Medical Countermeasures (MCM) Regulatory Science Program implemented by FDA to develop the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective MCMs.

2. Objective FDA seeks to purchase the CTL ImmunoSpot S6 Macro M2 Analyzer, which is a compact instrument that performs high throughput plaque counting in larger well formats and is specifically designed for regulated or academic visible light analysis. The CTL ImmunoSpot S6 Macro M2 Analyzer will be detrimental in assessment of replication kinetics of influenza viral infection. This instrument will be used in multiple projects in the lab. Other labs within OBP will also use our instrument to run samples for their individual projects.

3. Scope/Description The CTL ImmunoSpot S6 Macro M2 Analyzer is designed for white light image analysis in the macroscopic spectrum. This instrument has been an industry leader for colony counting in larger well formats; however, this instrument’s motorized zoom optics also extend the field of analysis to 96-well plates. Colonies of up to 12 different colors can be differentially counted in the macroscopic range, in larger well formats. The S6 Macro M2 is high-throughput capable – up to 400 plates per run when equipped with our automated plate loader. It is specifically designed for regulated or academic visible light analysis, supporting 21CFR part 11 compliant workflows.

4. Conditions: Note* that:

i. The Contractor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. The Contractor shall demonstrate how the requested items or services, “MEET” or “DO NO MEET” the salient/functional characteristics and specifications listed here-below. The Contractor shall annotate each salient/functional characteristics and specifications with the following: Meets (if it meets the specification) or Does not meet (if it fails to meet the specification).

ii. Grey market or refurbished products will not be accepted.

iii. The Vendor shall provide all, of the items/services listed or none.

iv. The Vendor shall meet all technical/salient/functional, operational characteristics and specifications listed, and if not the manufacturer, must be able to provide the required service with OEM certified technicians and parts or show proof that they are an authorized third party re seller/provider.

v. Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

5. Minimum Specifications and Salient Characteristics. Technical Specifications.

The requested system, shall at a minimum, meet all the technical/salient/functional, operational characteristics and specifications here-in. The requested system shall be new and include the following:

a. Unique Salient Characteristics/Requirements The CTL ImmunoSpot S6 Macro M2 Analyzer has the following unique salient characteristics:

1) Image Resolution is important, for if you can’t capture a good image then you can’t do the best analysis. The CTL ImmunoSpot S6 Macro M2 Analyzer has the Image Resolution up to 10 megapixels and the ability to recognize over 11,000 spots per well with quality color fidelity.

2) High-end Illumination: The CTL ImmunoSpot S6 Macro M2 Analyzer employs a top white, multi-layered LED ring, and a back light for white and clear plates and for balanced and even illumination.

3) Precision Stage: The CTL ImmunoSpot S6 Macro M2 Analyzer uses an encoder-controlled, slip-proof, high-precision 2-axis ball bearing stage, servo motors operating a closed loop that documents all well coordinates. This precision stage ensures the user that the correct well is being captured, an aspect critical for GLP compliance.

4) Speed: The CTL ImmunoSpot S6 Macro M2 Analyzer can scan and analyze a 96-well plate in under 2 minutes.

5) Versatility: The CTL ImmunoSpot S6 Macro M2 Analyzer can accommodate all 96-, 48-, 24-, 12-, and 6-well plates on the market, white or clear plates, and the researcher can customize their own plate type.

6) Auto Centering and Exposure Control highly optimized motorized lens apparatus with excellent optical performance and wide zoom permitting crisp image capture, one-click solution for zoom and one-click solution for focus. Easy and precise plate type switching. The CTL ImmunoSpot S6 Macro M2 Analyzer employs a complex set of algorithms that centers the well before snapping the image and adjusts to image brightness during image acquisition providing optimized and standardized images.

7) Validation Integration Tool verifies the performance and precision of the stage which is necessary for operational qualification.

8) Scanning and Counting: The CTL ImmunoSpot S6 Macro M2 Analyzer can perform simultaneous multiple plate analysis and accommodate Plate Loaders for 30- and 50-plate cartridges, and Robotics for 100-plate pods.

9) Dual-color analysis the only company with the proven ability to do true dual-color ELISPOT in addition to single-color ELISPOT.

10) Smart Counttm: One-click solution for automating counting parameters, counts the whole plate.

11) BioSpot Software included specifically designed algorithms for the challenging morphologies (different from ELISPOT) of Viral plaque assays and Colony counting.

12) Real-time Parameter set-up in Counting and Quality Control, if the researcher prefers to set their own Parameters, all of them can be adjusted simultaneously, live changes can be made to Sensitivity, Size-gating, Spot separation, Diffuse spot processing, background balance, hair removal, add/remove a spot, region of interest, and more to 40 parameters. Intelligent counting parameters provide consistent and objective results.

13) The CTL ImmunoSpot S6 Macro M2 Analyzer allows for the software to reanalyze/recount plates unlimited, and also recount them unlimited in quality control, which automatically records all annotations and saves images.

14) Quality Control Module is a GLP compliant revision module for handling assay artifacts during the quality assurance routine and allows the user to add notes/annotations to each well recording, correcting wells, validating counts.

15) The CTL ImmunoSpot S6 Macro M2 Analyzer includes a computer, monitor, and keyboard. The S6 Macro’s components are robust, fully integrated within the unit and versatile.

16) Implementation of Part 11 GLP requirements, many competitors claim to have fully validated 21 CFR Part 11 Software compliance with audit trails, however it is important to recognize that compliance needs to be established by the customer for their particular requirements and structure and cannot be achieved by purchasing a device or software. The CTL ImmunoSpot S6 Macro M2 Analyzer implements GLP features including audit trails, access control, quality control, and more. CTL has solutions that permits the entire ELISPOT process to take place in a GLP compliant environment with the ImmunoQualify Reference Plate and the ImmunoCompliance Package.

17) Expert Presentation Features: The CTL ImmunoSpot S6 Macro M2 Analyzer employs extensive data output files (EXCEL, text, histogram data, composite images, original well images, unlimited counted images, quality control images, annotations, and well surveys) to allow for print, save, and exporting data/images to EXCEL, Power Point, and to integration to FCS formats. The data/images are provided in user-friendly formats that includes spot size distribution and mean spot sizes.

18) Scientific Expertise and the ELISPOT Source, the only reader manufacturer that has their own CRO for GLP and non-GLP work, and also makes their own ELISPOT Kits and other Consumables PBMC, Control-sets, Serum-free media. CTL built the first ELISPOT reader over twenty years ago pioneering advances, leading developments, publishing extensively in the field of ELISPOT. With the purchase of an ELISPOT instrument, the user not only receives an ELISPOT instrument but can also take advantage of our years of ELISPOT scientific experience.

19) Installation and Training, Warranty and Service of equipment are performed on-site.

Scanning Services shall be offered free of charge until Analyzer is being repaired.

b) Technical Specifications The instrument must include the following specifications:

1) Applications:

Single and Double-Color ELISPOT Viral Infectivity and Neutralization Assays, e.g.: FRNT/FRA and PRNT/Viral Titer Assays Bacterial and Yeast Colony Counting 12 Distinct Visible Light Color Planes

ELISA

Nucleic Acid and Protein Quantification Visible Array Analysis

2) Plate formats:

6, 12, 24, 48 and 96 well plates (upgradable to all Petri dish formats)

3) Advanced Components:

Precision stage (0.24 mm stepping) Digital area scan camera with image resolution of up to 10 Megapixels Computer Interface: USB 3.0 Integrated Barcode Reader Optical Interface: Motorized zoom and focus Lighting Top: 48 LED Ring (rated for 100,000 operating hours) Lighting Bottom: High illumination, uniform luminescent flat light panel

4) Data processing features:

Dell Optiplex SFF computer CPU: 8-core i7; Memory: 16GB RAM, Graphics: Intel HD Storage: 500 GB + 1TB GB (System + Data); Optical Drive: Slimline DVD+/-RW Ports: 1x Serial, 1x USB 3.1 Gen 2 Type-C, 4x USB 2.0 Type A, 5x USB 3.1 Type A, 1x Ethernet, 1x DP Monitor: 24” Professional Widescreen Keyboard/Mouse: US-Layout / Optical Mouse Operating System: Windows 10 Pro x64 with Microsoft Office 2019 Business

5) Software:

ImmunoSpot® Single-Color ELISPOT Enzymatic ImmunoSpot® Double-Color ELISPOT Enzymatic BioSpot™ Image Annotator ODense™ SpotStat™ SpotMap™ ReagentTracker™

6) Dimension:

Imaging Unit (H x W x D); (Weight): 58.4 cm x 56 cm x 56 cm; (23” x 22” x 22”); 45.36 kg (100 lb) Data Processing Unit (H x W x D); (Weight): 29cm x 9cm, 29cm; (11.4” x 3.7” x 11.5”); 4.99kg (11lb)

7) Power requirements:

Voltage: 120/230 V AC, 60/50 Hz

3.2. Tasks/Deliverable Items/ Deliverable Schedule and Performance Requirements. To meet the purpose and objective of this requirement, the Vendor shall meet the established timelines to provide the below Deliverables.

3.3. Contractor Facility Access: Contractor staff, belongings, and their vehicles are subject to search when they arrive at the FDA facility. In addition, Contractor staff will be required to be escorted while in the buildings.

3.4. Period of Performance.

The Period of Performance shall be as follows:

This contract provides for an initial base period of one year and four potential option periods, each 365 calendar days. The options periods (if applicable), if exercised, shall run consecutively and at the discretion of the Government. The purchase order may be modified to adjust the period of performance of the out years, depending upon the date of installation (if applicable).

3.5. Packing, Marking, Delivery and Shipping

The Contractor shall deliver the items and quantities ordered, all or none. All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. All required materials shall be delivered in immediate new, usable and acceptable condition, at the U. S. Food and Drug Administration (FDA) facility/address listed below:

Shipment/Destination:

1. The Vendor shall provide shipping, handling and inside delivery to CDER’s facilities on-site at CDER’s facilities in:

Silver Spring, MD (Building 52/72 Room 2154, 10903 New Hampshire Ave, Silver Spring, MD 20993), unless otherwise indicated. The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

2. On-site installation, hardware, software, and applications training shall be provided at the FDA site for a minimum of 1 day for 1-5 FDA scientists. All appropriate training manuals and literature must be supplied either electronically or in hard copy.

3. Technical support shall be provided via common avenues: phone, web and/or fax during standard business hours. For all on-site maintenance, the Contractor’s personnel are required to report to the security guards at the White Oak Building 75, 10903 New Hampshire Ave, Silver Spring, MD 20993, who will contact the TPOC or his or her designated FDA employee. The Contractor’s personnel must be escorted by the TPOC or his or her designated FDA employee at all times while working on-site under this order. The Contractor shall perform all on-site maintenance service during the hours of 9:00 am to 5:00 pm ET, Monday through Friday, unless otherwise indicated by the TPOC. The TPOC will be responsible for determining the acceptance of the work that is completed.

4. The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Project Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables.

The TPOC will be responsible for determining the acceptance of the work that is completed Vendor shall contact TPOC/COR by email or phone to schedule delivery. Deliveries shall be coordinated with the TPOC/COR prior to shipment. No deliveries will be accepted without prior authorization from the TPOC/COR

ii. Delivery and Marking All deliverables shall be marked as follows:

(a) Name and address of the Contractor,

(b) Contract Number

(c) Description of item contained therein; and

(d) Consignee’s name and address.

(e) Each delivery location may provide specific delivery instructions.

iii. Payment of Postage and Fees All postage and fees related to distribution of deliverable including forms, reports, etc., shall be paid by the Contractor.

3.6. Contracting Officer’s Technical Point of Contact (TPOC)

The TPOC is responsible for the acceptance of the items or services requested.

3.7. Technical Direction

A. Performance of the work under the resultant contract shall be subject to the technical direction of the TPOC. The term "technical direction" is defined to include the following:

i). Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work, ii). Providing information to the Contractor for assistance in the interpretation of specifications, or technical portions of the work description, and iii). Reviewing and, where required by the contract, approving of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the requirement.

B. Technical direction shall be within the general scope of work stated in the contract. The TPOC does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes, FAR 52.212 – 4 (c)." (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given. Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

3.8. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

The Contracting Officer is the only person with authority to act as agent of the Government under the Contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of the Contract; or (5) otherwise change any terms and conditions of the Contract.

3.9. Groundskeeping: (if applicable), The Contractor shall use products made from biobased materials to the maximum extent possible.

All supplies and materials shall be of a type and quality that conform to applicable Federal specifications and standards. All supplies and materials to be used in the performance of work described herein are subject to the approval of the Contracting Officer’s Representative (COR).

The following are examples of products that may be used in this contract for which biobased options are available. The list is not all inclusive. It is desirable that Contractors be able to supply the greatest number of biobased products in the performance of this contract.

Hydraulic Fluids Penetrating Lubricants Diesel Fuel Additives Multi-purpose Lubricants Degreasers Lube Chain Lubricants Chain Bar Lubricants All Purpose Cleaners Fertilizers Erosion Control Mulch Soil Amendments

JANITORIAL: All supplies and materials shall be of a type and quantity that conform to applicable Federal specifications and standards, and to the extent feasible and reasonable; include the exclusive use of biobased products. The Contractor shall utilize the greatest number of biobased products possible. Examples:

All-purpose cleaner Heavy-duty cleaner Deodorizer Carpet shampoo Floor finish Floor finish restorer Disinfectant sanitizer Floor sealer / Floor stripper Grout Sealer Glass cleaner Liquid Hand Soap Hand sanitizers

Section 4 - Contract Clauses

4.1 FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Nov 2021).

4.2. FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far; https://www.acquisition.gov/hhsar

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses

4.3. Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA TPOC and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required.

4.4. Certificate of Maintainability

At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five (5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract. The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the equipment is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government. Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any equipment fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the equipment up to the required OEM maintenance level. If equipment is acquired under this contract, without maintenance of such equipment being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such equipment at the time of delivery for each piece of equipment. The certificate shall state that the equipment is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any charges to the Government. All charges required to, obtain the requisite performance of the equipment, up to the later of the time the equipment is accepted by the Government, or the warranty expires shall be borne by the Contractor. The time the equipment is accepted by the Government is the date that the Government determines that the equipment has passed acceptance testing, not the effective date of acceptance. The fact that the equipment may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

4.5. FAR 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.

(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.

4.7. FAR 52.232-18-Availability of Funds (Apr 1984). In relation to the out years: 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.

4.8. Security and Privacy

Contractor personnel performing work under the Contract r shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The Contractor agrees that Contractor personnel will not divulge, or release data or information developed or obtained in connection with the performance of the Contract, unless made public by FDA or upon written approval from the Government. Except as may otherwise be permitted by a data owner, the Contractor personnel agree not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the Contractor without such limitation.

The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the requirement that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the TPOC, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the Contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each Contractor/Subcontractor employee who may have access to non-public Department information and/or sensitive information under the Contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the TPOC or designee prior to performing any work under the Contract. The TPOC or designee will inform the Contractor of the forms and training that are required.

However, it is the responsibility of the Contractor to assure that such forms have been signed.

4.9. Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final Contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration. FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the Contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the Contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and Contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

4.10. Holidays FDA personnel observe the FDA following days as holidays:

i) New Year's Day

ii) Columbus Day

iii) Washington's Birthday

iv) Veterans' Day

v) Memorial Day

vi) Thanksgiving Day

vii) Independence Day

viii) Christmas Day

ix) Labor Day

x) Juneteenth

xi) Martin Luther King's Birthday

xii) Any other day designated by Federal statue

xiii) Any other day designated by Executive Order

xiv) Any other day designated by the President's Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the Contract.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under the Contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the Contract In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the Contract for employees whose regular time is normally a direct charge if they continue to perform on the work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

4.11. Disclosure of Information. Contractors are reminded that information furnished under the solicitation and contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information shall be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government shall be used only for the purpose of carrying out the provisions of the contract and shall not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of the contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

4.12. Inspection and Acceptance:

The performance criteria for this contract shall be timely delivery and closure of all activities and deliverables listed in this RFQ and within the established period of performance. The Government will accept goods and services only if they conform to all terms and conditions of the contract and satisfy the performance standards detailed. The Government will provide written notification of acceptance or rejection within ten (10) business days of receiving the delivery. The Government will reject non‐conforming products and services. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejections notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR/TPOC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

4.13. The COR/TPOC shall perform inspection and acceptance of materials and services to be provided. Invoices shall be submitted for review and approval by the COR (See invoicing instructions). For the purpose of this section, the COR is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at: the locations identified in this RFQ.

4.14. The COR will be responsible for determining the acceptance of the work that is completed. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer or COR within 30 days of receipt.

4.15. FAR 52.212-5 Contract Terms and Conditions. Required to Implement Statutes or Executive Orders-Commercial Items (May 2022).

(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

x (2) 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).

x (3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 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:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_x_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (MAR 2020) of 52.219-3.

__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (MAR 2020) of 52.219-4.

__ (13) [Reserved] _x_ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (JUN 2020) of 52.219-9 __ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

_x_ (22) (i) 52.219-28, Post Award Small Business Program Re-representation (NOV 2020) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (MAR 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15U.S.C. 637(a)(17)).

_x_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

_x_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN2020) (E.O.13126).

_x_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

_x_ (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

__ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

__ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

__ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

_x_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

__ (35) (i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40)

(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41)

(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

_x_ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

_x_ (43)

(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

_x_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47)

(i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) 52.225-1, Buy American-Supplies (JAN2021) (41 U.S.C. chapter 83).

__ (49)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (JAN 2021)(41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (JAN 2021) of 52.225-3.

__ (iii) Alternate II (JAN 2021) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

_x_ (50) 52.225-5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).

_x_ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C.