combined_synopsis-Solicitation-automated_cell_imaging_1214299.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. The solicitation number is 1214299. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-05 August 13, 2019.

The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1000 employees. This RFQ is a small business set-aside.

The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) requires an automated cell imaging system.

A. Introduction

The mission of the Division of Cell and Gene Therapy (DCGT), Office of Cellular, Tissue and Gene Therapy within CBER is to develop and promote technology for safer cell and gene therapy products to improve public health. The Branch needs to have assessed identity and characterization of gene and cell therapy products to perform critical path research for its mission to develop and promote technology to regulate cellular and genetic therapeutics. Genetically modified Hematopoietic Stem Cells (HSCs) and T-cell are at the forefront of advanced and complex cellular therapeutics. However, current culture conditions for manufacturing HSC-based therapeutics are suboptimal. To study the advanced manufacturing process of quality HSC-based gene engineered therapeutics, we will use HSC-specific cells tagged with green fluorescent protein. An automatic cell imaging system is being sought to identify critical cultural parameters and advanced manufacturing conditions that affect HSC activity.

B. Background

The high content imaging system allows real time monitoring of cells in a 96-well microtiter plate, such that multiple culture parameters, growth factors and small molecules can be tested in parallel in a semi-high throughput manner. DCGT requires an Automated Cell Imaging System that combines high-resolution imaging with powerful analysis. The system should be self-contained, and automated unit that can also analyze microscopic slides, histo-pathological slides and fluorescent-based assay (such as cytotoxicity, signal transduction, and organoids). The system shall come with preconfigured templates optimized for cell-based experiments including apoptosis, mitochondrial evaluation, 3D cell models, live cell/time lapse, and neurite tracing.

Several investigators are working on engineered cellular therapeutics in DCGT who will use the imaging system for their imaging need and mission-related research.

C. Scope

Cell surface markers-based identification and characterization currently used to define HSCs and mesenchymal stem cells (MSCs) are inadequate to ensure their functional qualities. Therefore more sophisticated attributes and a set of quantitative classifiers that can be measured in-process or in real time during CTP production are urgently needed. Though fluorescence-activated cell sorting (FACS) analysis allows simultaneous detection of several cell surface markers to define the immunophenotype of a given cell type, FACS-based analysis is incompatible with the advanced manufacturing process. A real-time, non-invasive, label-free, in-line assay is most suitable for industrial and advanced manufacturing requirements and automation. Recently, image-based analysis measuring physical characteristics (e.g. shape, size, conductivity, light scattering) and biochemical properties (e.g. metabolic activity status, oxygen consumption, metabolite levels, pH, etc.) have been used for label-free, non-invasive characterization of various cell types and their quality. For example, stem cells have a unique metabolic profile, biochemical/biophysical properties and pathway dependency from their differentiated progeny. HSCs have higher optical redox ratio, higher NADPH levels, and polarized distribution of NADPH, high LDH activity, higher dye efflux activity, and higher intracellular pH than multipotent progenitors and effector cells. This distinct optical metabolic profile can be used to define and monitor stem cell activity during the manufacturing process in a label-free, non-invasive and high throughput manner. In order to develop such a system, we have to first define those characteristics. HSCs with tagged green fluorescent protein allows monitoring of stem cells activity during ex vivo culture condition and expansion. Green fluorescent protein positive cells will be monitored during ex vivo propagation in real time using the imaging system. Physical properties of cells such as shape, size, motility and metabolic characteristics will be recorded. The data set generated using this system will allow us to define key parameters for label-free isolation and purification of engineered HSCs. Moreover, to define the culture conditions for HSC expansion, cells will be cultivated in the presence of various small molecules in 96-well plate and monitor for maintenance of green fluorescent protein expression during ex vivo expansion. The identified conditions will be applied for human HSC/HSPC expansion following treatment with gene therapy/genome editing reagents. Thus, data generated using the imaging system will provide us insight on critical attributes influencing large-scale advanced manufacturing of HSCbased cellular therapeutics. Also, it will enhance our review and regulatory abilities to review stem cell related and genetically engineered cellular product regulatory files.

Performance requirements

General specifications:

The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

Minimum specifications-

• Multiple imaging modes: 4x to 63x objective range and can operate in colorimetric, brightfield, or fluorescence imaging modes.

• Plate-to-individual cell view: Data can be visualized at multiple levels

• Advanced slide-imaging workflow: scanning an overview image of a whole slide; then, high resolution scans acquire only selected regions of interest.

• Preconfigured analysis protocols ranging from cell counting to sophisticated neurite tracing analysis

• Z-stack acquisition for sharper images and more accurate segmentation

• Environmental control: self-contained unit with control over humidity, CO2, and O2 levels.

• Multi-day, time lapse, and live cell assays can be performed

Installation, Training and Additional System Requirements.

The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements.

Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year.

Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following

- Minimum of one (1) planned preventative maintenance visit per contract period.

- Unlimited phone and email support during the contractor’s normal operating hours.

- Unlimited corrective maintenance, service and repairs shall include all labor and travel.

- Pricing shall be inclusive of all labor and travel;

- Performance by formally trained and certified technicians/engineers, following

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

- Access by the FDA Technical Point of Contact (TPOC) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

- System software and firmware updates required for reliability improvements and correction of any defects;

- Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting 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.

Schedule of Items (shipping, handling, delivery, installation and training included)

Contract Line Item

(CLIN)

Description Quantity Unit Unit Price

Extended Price

Automated cell imaging system as specified herein

1 Each $________ $_________

Option Item (FAR 52.217-9)

Option Year 1: Post-warranty service/maintenance agreement on Automated cell imaging system

12 Months $_______ $_________

Option Year 2: Post-warranty service/maintenance agreement on Automated cell imaging system

12 Months $_______ $_________

Grand Total Items 1 through 3

FOB Point Destination. All items shall include shipping, handling, delivery, installation and training to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, bldg. 52/72, Silver Spring, MD 20903.

Period of Performance

Delivery, installation and on-site training shall occur within 60 calendars days from date of award. Warranty shall commence upon acceptance of the system. Post-warranty Preventative and corrective/remedial maintenance repair service on the system, if exercised, shall commence, upon expiration of the warranty period and continue for a year, which may be extended in annual increments. If/when Option Year 1 is exercised; the periods of performance for all options will be firmed via bilateral modification.

Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day Martin Luther King, Jr.

Washington’s Birthday

Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Contract clauses-

FAR and HHSAR Clauses incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018), applies to this acquisition. The following addenda apply:

FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance. (Jul 2016) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) “… within 1 day of contract expiration; …. at least 15 days before the contract expires...”

(c) “…shall not exceed two years exclusive of the period set forth for delivery, acceptance, training and warranty.”

FAR Clause 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.

(DEC 2013)

HHSAR Clause 352.203-70 Anti-lobbying DEC 2015 HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations DEC 2015 HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility DEC 2015

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer 3900 NCTR Road

HFT-320

Jefferson, AR 72079 Phone: 870-543-7370 Email: nick.sartain@fda.hhs.gov

b. Technical Point of Contact (TPOC The following TPOC will represent the Government for the purpose of this contact:

(To be completed at time of award) Name:

Phone:

Email:

The TPOC is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

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 statement of work;

(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.

Payments

Payment terms Net 30 days after government acceptance. Payments shall be made no more frequently than monthly and will be in arrears. No advance payments will be made.

FDA THREE-WAY-MATCH INVOICE SUBMISSION

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 Technical Point of Contact (TPOC). The TPOC will be determined at the time of award.

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 person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) 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.

Be advised that FDA does not accept documents which contain the use of macros. 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.

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (AUG 2019)

(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)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities () (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

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

(6) 52.233-4, Applicable Law for Breach of Contract Claim ( (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 ( 2006), with Alternate I ( 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct ( 2015) (41 U.S.C. 3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 ( 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 ( 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) [Reserved].

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

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts ( 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. ( 2015) (31 U.S.C. 6101 note).

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

(10) [Reserved].

(11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award ( 2011) (15 U.S.C.657a).

(ii) Alternate I ( 2011) of 52.219-3.

(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns ( 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I ( 2011) of 52.219-4.

(13) [Reserved] X (14) (i) 52.219-6, Notice of Total Small Business Set-Aside ( 2011) (15 U.S.C.644).

(ii) Alternate I ( 2011).

(iii) Alternate II ( 2011).

(15)(i) 52.219-7, Notice of Partial Small Business Set-Aside ( 2003) (15 U.S.C. 644).

(ii) Alternate I ( 1995) of 52.219-7.

(iii) Alternate II ( 2004) of 52.219-7.

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

(17)(i) 52.219-9, Small Business Subcontracting Plan ( 2018) (15 U.S.C. 637(d)(4))

(ii) Alternate I ( 2017) of 52.219-9.

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

(iv) Alternate III ( 2016) of 52.219-9.

(v) Alternate IV (Aug 2018) of 52.219-9

(18) 52.219-13, Notice of Set-Aside of Orders ( 2011) (15 U.S.C. 644(r)).

(19) 52.219-14, Limitations on Subcontracting ( 2017) (15 U.S.C.637(a)(14)).

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

(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside ( 2011) (15 U.S.C. 657f).

X (22) 52.219-28, Post Award Small Business Program Rerepresentation ( 2013) (15 U.S.C. 632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns ( 2015) (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 (2015) (15 U.S.C. 637(m)).

X (25) 52.222-3, Convict Labor ( 2003) (E.O.11755).

X (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies ( 2018) (E.O.13126).

X (27) 52.222-21, Prohibition of Segregated Facilities ( 2015).

X (28) (i) 52.222-26, Equal Opportunity ( 2016) (E.O.11246).

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

(29) (i) 52.222-35, Equal Opportunity for Veterans ( 2015) (38 U.S.C. 4212).

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

X (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities ( 2014) (29 U.S.C.793).

(ii) Alternate I (July 2014) of 52.222-36.

(31) 52.222-37, Employment Reports on Veterans () (38 U.S.C. 4212).

(32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act ( 2010) (E.O. 13496).

X (33) (i) 52.222-50, Combating Trafficking in Persons ( 2019) (22 U.S.C. chapter 78 and E.O.

13627).

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

(34) 52.222-54, Employment Eligibility Verification (). (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.)

(35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items ( 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 ( 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.)

(36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons ( 2016) (E.O. 13693).

(37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (2016) (E.O. 13693).

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

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

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

(ii) Alternate I ( 2014) of 52.223-14.

(40) 52.223-15, Energy Efficiency in Energy-Consuming Products () (42 U.S.C. 8259b).

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

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

X (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving () (E.O. 13513).

(43) 52.223-20, Aerosols ( 2016) (E.O. 13693).

(44) 52.223-21, Foams ( 2016) (E.O. 13693).

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

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

X (46) 52.225-1, Buy American-Supplies ( 2014) (41 U.S.C. chapter 83).

(47)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act ( 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301note, 19 U.S.C. 2112note, 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 ( 2014) of 52.225-3.

(iii) Alternate II ( 2014) of 52.225-3.

(iv) Alternate III ( 2014) of 52.225-3.

(48) 52.225-5, Trade Agreements () (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (49) 52.225-13, Restrictions on Certain Foreign Purchases ( 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(50) 52.225-26, Contractors Performing Private Security Functions Outside the United States ( 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;10 U.S.C. 2302 Note).

(51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside ( 2007) (42 U.S.C. 5150).

(52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area ( 2007) (42 U.S.C. 5150).

(53) 52.232-29, Terms for Financing of Purchases of Commercial Items ( 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

(54) 52.232-30, Installment Payments for Commercial Items ( 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

X (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (2018) (31 U.S.C. 3332).

(56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management ( 2013) (31 U.S.C.3332).

(57) 52.232-36, Payment by Third Party ( 2014) (31 U.S.C.3332).

(58) 52.239-1, Privacy or Security Safeguards ( 1996) (5 U.S.C. 552a).

(59) 52.242-5, Payments to Small Business Subcontractors ( 2017) (15 U.S.C. 637(d)(13)).

(60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels ( 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

(ii) Alternate I ( 2003) of 52.247-64.

(iii) Alternate II ( 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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) 52.222-17, Nondisplacement of Qualified Workers ( 2014)(E.O. 13495).

(2) 52.222-41, Service Contract Labor Standards ( 2018) (41 U.S.C. chapter 67).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires ( 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) ( 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment ( 2014) (29 U.S.C. 206and 41 U.S.C. chapter 67).

X (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements ( 2014) (41 U.S.C. chapter 67).

(7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements ( 2014) (41 U.S.C. chapter 67).

(8) 52.222-55, Minimum Wages Under Executive Order 13658 ( 2015).

(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 ( 2017) (E.O. 13706).

(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations ( 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct ( 2015) (41 U.S.C. 3509).

(ii) 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)).

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

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns ( 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-17, Nondisplacement of Qualified Workers ( 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

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

(viii) 52.222-26, Equal Opportunity ( 2015) (E.O.11246).

(ix) 52.222-35, Equal Opportunity for Veterans ( 2015) (38 U.S.C.4212).

(x) 52.222-36, Equal Opportunity for Workers with Disabilities ( 2014) (29 U.S.C.793).

(xi) 52.222-37, Employment Reports on Veterans ( 2016) (38 U.S.C.4212)

(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act ( 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xiii) 52.222-41, Service Contract Labor Standards ( 2018) (41 U.S.C. chapter 67).

(xiv)

(A) 52.222-50, Combating Trafficking in Persons ( 2019) (22 U.S.C. chapter 78 and E.O 13627).

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

(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements ( 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (2014) (41 U.S.C. chapter 67).

(xvii) 52.222-54, Employment Eligibility Verification () (E.O. 12989).

(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 ( 2015).

(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 ( 2017) (E.O. 13706).

(xx)

(A) 52.224-3, Privacy Training ( 2017) (5 U.S.C. 552a).

(B) Alternate I ( 2017) of 52.224-3.

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

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations ( 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels ( 2006) (46 U.S.C. Appx.1241(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

Solicitation provisions

FAR and HHSAR Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Contract Type: Commercial Item-Firm Fixed Price.

Note: The non-manufacturer rule does not apply to small business set-aside contracts below $150,000. https://www.sba.gov/partners/contracting-officials/small-business-procurement/set-aside-procurement

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (OCT 2018) applies to this solicitation. The following addenda have been added to this provision:

Addendum Paragraph (b):

Technical Acceptability: Will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered supplies meet or exceed the technical requirements identified above. Offerors shall specifically address the performance specifications and support same with submitted technical specifications, descriptive material, literature, brochures, scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the offered solution at meeting or exceeding the stated needs of the FDA. The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

Any proprietary information shall be marked as such.

Price: Provide detailed price quote for each item proposed to meet the Schedule of Items.

Include the firm’s DUNS number with quote.

The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

Service Contract Act Exemption This solicitation is being issued under the premise that the Contractor will certify that the preventative maintenance/repair services are exempt from the Service Contract Act then Clause 52.222-51 will flow per usual from this solicitation to the resulting order. Offeror shall complete the certifications as applicable in the provision at FAR provision 52.212-3(k) or FAR 52.222-48

(see below) for the application of the Service Contract Act (SCA). The offeror must certify that the maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per conditions set forth in FAR 22.1003-4(c). If this positive certification is not provided the FAR Clauses at 52.222-41, 52.222-42 and 52.222-43 shall be incorporated and the applicable SCA wage determination at the delivery location shall become part in any resultant contract. Wage Determination No.: 2015-4269, Rev 10, dated 07/16/2019 which can be found at:

https://beta.sam.gov/wage-determination/2015-4269/10/document.

FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certifications (MAY 2014).

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that—

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An “established market price” is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Labor Standards statute—

(1) Will not apply to this offeror, then the Service Contract Labor Standards clause in this solicitation will not be included in any resultant contract to this offeror; or

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision—

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service

Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements, will not be included in any resultant contract awarded to this offeror;

and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

(End of provision)

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2019.

The provision at FAR 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the lowest priced technically acceptable responsible offeror. Offers will be evaluated on their ability to meet the minimum requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

Technical acceptability will be determined by review of information submitted by the Offeror which must provide a description in sufficient detail to show that the product and/or service quoted meets the Government's requirement and demonstrate successful performance of the product/service requested as stated herein.

The Government reserves the right to request additional information or conduct discussions at any time.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 Offeror Representations and Certifications—Commercial Items (OCT 2018) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision.

(a) Definitions. As used in this provision— “Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation”, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000- 9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Predecessor” means an entity that is replaced by a successor and includes any predecessors of the predecessor.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

“Sensitive technology”—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational…