RFQ Automated High Throughput Patch Clamp System.docx

FDA -20-RFQ-1224178A

Automated High Throughput Patch Clamp System

PART 1: DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. FAR Provisions and Clauses set forth herein are current though Federal Acquisition Circular (FAC) The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2020-05 effective March 30, 2020. The North American Industrial Classification System (NAICS) code for this procurement is 334516. The Government contemplates a firm fixed price contract. This solicitation will be posted SB set aside. This new solicitation was required because the requirements changed.

PART 2: SUPPLIES /SERVICES AND PRICES

2.1 Brief Description of Supplies or Services

The U.S. Food and Drug Administration (FDA) acquires an automated high throughput patch clamp system (HTS).

2.2 Pricing Schedule

CLIN

package

Part 3: Statement of Work

3.1 Background

Electrophysiology is the study of the electrical properties of cells and tissues in the body. It involves recording voltage signals or current flow resulting from ions moving across ion channel proteins in the cell membrane. Because functions of excitable cells in the heart rely on the cells’ abilities to generate electrical signals, drugs and diseases that affect heart ion channels will alter cardiac functions, thereby disturbing the normal heart rhythm and potentially resulting in death. Electrophysiology method is thus employed in drug development programs to screen drug action on heart ion channels to predict unwanted consequences on the heart.

The Division of Applied Regulatory Science (DARS) has a need to obtain an automated high throughput patch clamp system (HTS) to characterize drug effects on heart ion channels. Traditionally patch clamp studies are conducted using manual patch clamp systems operated by experienced electrophysiologists. To increase efficiency and to cut down on cost, the pharmaceutical industry and large contracted research organizations have steadily moved toward using HTS for ion channel screens. However, regulatory review of HTS-generated data is a challenge, since many experimental factors and conditions have to be altered to adapt to the miniaturized technology and materials that make up HTS. Whether these changes from manual systems impact ion channel pharmacology, hence similarity between HTS- and manual system-generated data and predictivity of the former data to human response toward drug treatment, remains a major knowledge gap. Heart ion channel pharmacology data obtained using electrophysiology method is submitted to the FDA as a part of a drug application package. To ensure that the FDA develops expertise to interpret HTS-generated results, DARS is requesting to purchase one unit of the latest HTS in the market to gain first-hand operator experience. This equipment will be evaluated side-by-side with traditional manual patch clamp systems by a team of experienced electrophysiologists to test a large panel of clinical drugs – an effort that will allow the FDA to understand limitations of the HTS, design methods to overcome these if feasibly, and prepare FDA to handle regulatory submissions that include HTS-generated data. The purchase request is thus consistent with the FDA’s mission to protect and advance public health by ensuring drugs are safe and effective.

3.2 Objectives

The objectives of this contract is to purchase an automated HTS to evaluate drug effects on heart ion channels

3.3 Scope of Work

FDA shall purchase an automated HTS to be used for electrophysiology recordings from individual cells that express ion channel proteins. This is an integrated system, allow recording of electrical signals, perfusion of compounds to-be-tested, temperature control, and associated PC(s)/software used for instrument control, data acquisition, and data analysis.

3.4 Requirements

The Contractor shall provide an automated high throughput patch clamp system (HTS) equipped with temperature control, amplifiers, and acquisition/analysis software. The software must operate under the 64-bit Windows 10 operating system. The automated patch clamp system must meet all required criteria listed below. It must be able to:

1. Acquire at least 48 data points or above per each run;

1. Enable single cell measurements and not just no population recording;

1. Perform current-clamp and voltage-clamp recordings from different types of isolated cells, including cultured cell lines, transiently transfected cultured cells, and induced pluripotent stem cell-derived cells such as cardiomyocytes.

1. Achieve seal resistance (define what this value is) with defined success rate (define success rate) without using seal enhancers. Vendor should submit data demonstrating success rate and seal resistance to support claim.

1. Allow stable temperature control from 20-40°C.

1. Perform automated series resistance and whole cell capacitance compensation at the on-set of experiment.

1. Allow the user to enable and disable leak subtraction.

In addition, the HTS must be easily programmable, allowing user to define and adjust experimental protocols. The vendor shall also offer on- and off-site support through service contract, for machine maintenance/fixing, and help the end-users optimize equipment to test end-user defined experimental conditions. It is expected that upon delivery/setup/training of enduser for this instrument that the FDA can use it to acquire ion channel pharmacology data. Thus, consumables including recording chips/plates (for 32,256 cells/datapoints) as well as wearable parts excepted to be changed within the first year not covered by PM service must be included in the proposal for evaluation.

3.5 IT Architectural and Technical Standards

3.5.1 Architecture Standards

Must conform to FDA’s architecture and technical standards and follow the ICT-21 three-tier architecture standards (presentation, application, and data).

3.5.2 Technical Standards

Any software required on FDA client computers, or in FDA data centers, shall not conflict with FDA technical standards. FDA’s Master Approved Technology List (MAT) contains a list of approved and not approved technologies, including applications (software), infrastructure and peripherals (hardware), and scientific software and devices.

Software that is required as part of the solution design that is not already approved for use within FDA shall be evaluated by the FDA IT Investment Management (ITIM) governance process.

3.5.3 EPLC Compliance

All work completed during this project shall be subject to compliance with FDA’s EPLC process as appropriate.

3.6 Deliverables

TASK 1

· Deliver the described automated HTS, consumable parts, and post-set up end-user training.

TASK 2

· Begin service contract coverage once instrument is delivered.

· Services will include all of the following:

· Device service and maintenance – have to be performed according to the maintenance schedule; wearable parts for the first year should be included in the purchase price.

· Remote diagnostic service during regular business hours.

· Telephone support during regular business hours.

· On-site service when needed.

· Upgrades to software and firmware as they become available.

· All work will be performed by service personnel certified by the vendor as properly trained and qualified to maintain and repair the listed system.

5.1 Task 1

5.2 Task 2

3.7 Period of Performance

The period of performance is 12 months from the contract award date plus four option years.

Delivery shall be from three months from the contract award.

3.8 Place of Performance

The instrument shall be delivered and installed at:

Food and Drug Administration White Oak Campus Building #21

3.9 Government Furnished Property

No government furnished property

PART 4: Inspection and Acceptance

The Government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. The contractor shall submit the reporting Requirements/Deliverables to the COR in accordance with the delivery schedule. The COR will perform inspection and acceptance of materials and services. The Contractor shall implement necessary changes within 10 business days from the day of change notification.

PART 5: Contract Administration Data

5.1 Contract Specialist

The contact information for the Contracting Specialist are:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Tara Hobson

Tara.Hobson@fda.hhs.gov Phone: (240) 402-7586

5.2 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: RichardRobinson

Richard.Robinson@fda.hhs.gov Phone: 301-796-6508

5.3 Contracting Officer Representative (COR)

The following COR(s) will represent the Government for the purpose of this IDIQ contract:

Robert Parker Robertj.Parker@fda.hhs.gov

(301) 796-0117

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COR designation.

5.4 Invoice Submission

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

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

MAIL HUB 2145

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

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is Brian Noakes (301) 796-0117 Robertj.Parker@fda.hhs.gov

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 contractor official to whom payment is to be sent (must be the same as that in the contract 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 Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) 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;

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) 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. [amend/delete, as necessary]

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.

PART 6 - Contract Clauses

6.1 FAR and HHSAR Clauses and 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

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

HHSAR clauses

HHSAR Clause 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

6.2 FAR Clauses in Full Text

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAR 2020)

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 (Jul 2018) (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 (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. 3805note)).

(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.] _x_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), 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 (Oct 2015) (41 U.S.C. 3509)).

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

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (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. (Oct 2015) (31 U.S.C. 6101note).

__ (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 (Mar 2020) (15 U.S.C.644).

__ (ii) Alternate I (Mar 2020).

__ (iii) Alternate II (Nov 2011).

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

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

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

_x_ (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 (Mar 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 (Mar 2020) of 52.219-9.

__ (v) Alternate IV (Aug 2018) of 52.219-9 __ (18) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

_x_ (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 Rerepresentation (Mar 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 (Mar 2020) (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) (15 U.S.C. 637(a)(17)).

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

_x_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) (E.O.13126).

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

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

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

_x_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

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

_x_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

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

_x_ (33) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

__ (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 (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter78 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 (Jun 2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (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.

__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

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

__ (46) 52.223-21, Foams (Jun 2016) (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.

_x_ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 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 (May 2014) of 52.225-3.

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

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

__ (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 (June 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. 2302 Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

__ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_x_ (57) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

__ (58) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

__ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

__ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (61) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (62)

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

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

__ (iii) Alternate II (Feb 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 (May 2014)(E.O. 13495).

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

__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 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) (Aug 2018) (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 (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

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

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

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

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 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 (Oct 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 (Jul 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 (Oct 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 (May 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 (Apr 2015).

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

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

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

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

(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 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 (Aug 2018) (41 U.S.C. chapter 67).

(xiv)

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

(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78and 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 (May 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 (May 2014) (41 U.S.C. chapter 67).

(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

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

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

(xx)

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

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

(xxi) 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. 2302 Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 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 (Feb 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)

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 within the term of the contract.

Part 7: INSTRUCTIONS TO OFFERORS

7.1 FAR provisions Incorporated by Reference

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at (System Award Management) http://sam.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website, the offeror shall complete and submit only paragraphs (c) through (m) of this provision.

RFQ Due Date: Questions are due 12:00pm (1200) EASTERN TIME on April 29, 2020.

All quotes and revisions shall be received via email to tara.hobson@fda.hhs.gov before 5:00 PM EASTERN TIME on May 6, 2020. Offerors shall ensure the RFQ number is visible in the header of the email.

FAX QUOTES SHALL NOT BE ACCEPTED.

All Offerors shall be registered in the System Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov.

7.2 TECHNICAL PROPOSAL

a) The Offeror shall demonstrate that they can meet all the technical specifications in Part 3.3.

b) The Offeror shall demonstrate that they can provide PM/Service contract for four years.

c) The Offeror shall demonstrate that if they can provide delivery of HTS within 3 mos. Of award.

7.3 Price Proposal

The Offerors shall complete pricing table in Part 2.2.

PART 8 – EVALUATION FACTORS FOR AWARD

8.1 EVALUATION FACTORS

The Government will evaluate the quote to ensure that it is technically acceptable in accordance with the requirements in Part 3 and that the price is fair and reasonable. Award will be made lowest price technically acceptable offer (LPTA).

8.2 Technical Capability

a) The Offeror meets the capability that they can provide all the technical specifications in Part 3.3.

b) The Offeror meets the capability that they can provide PM/Service contract for four years.

c) The Offeror meets the capability that if they can provide provide delivery of HTS within 3 mos. Of award.

8.3 Price Evaluation

The price proposal shall represent the Offeror’s response to the requirements of the solicitation. The price evaluation consists of the combination of all proposed pricing over the contract’s performance period.