FDA-17-RFQ-1182772.pdf

FDA-17-RFQ-1182772

Solicitation Number FDA-17-RFQ-1182772

Fourier Transform Infrared (FT-IR) Spectrometer System

PART 1 – DESCRIPTION

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Division of Pharmaceutical requires a fourier transform infrared (FT-IR) spectrometer system for protein analysis in aqueous solution. The main applications of this system shall be for the detection of conformational changes, concentration analysis and determination of the secondary structure of proteins.

The FTIR spectra will improve the physicochemical characterization of therapeutic proteins and protein based drug product.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-95. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing.

PART 2 – SERVICES AND SUPPLIES AND PRICES

2.1 Contract Type: Firm Fixed Price

2.2 Pricing Table

CLIN Service and Supply Description Quantity Unit Price Firm-Fixed- Price*

0001 Fourier Transform Infrared (FT-IR) Spectrometer & Accessories 1 $

0002 Optional Quantity: Vibrational Circular Dichroism: Delivery and Installation. 1 $

0003 Delivery, Installation, and Training 1001 Option Year 1: Maintenance Agreement.

2002 Option Year 2: Maintenance Agreement.

3003 Option Year 3: Maintenance Agreement.

4004 Option Year 4: Maintenance Agreement.

TOTAL MAXIMUM POTENTIAL FIRM-FIXED-PRICE $

PART 3 – DESCRIPTION/SPECIFICATIONS

3.1 Background

Infrared spectroscopy can be used to quantitatively determine secondary structure elements in protein and to detect structural changes under varying environmental conditions. All chemical components used in protein samples like certain pH buffers or protein stabilizing agents are represented in IR spectra by characteristic bands. The strong water absorption in mid-IR spectral region makes measurements of protein aqueous solutions challenging. To overcome these problems the FTIR spectrometer system shall provide accurate and reproducible protein measurements, rapid analysis (< 1 minute), and ease of use.

The system shall combine the necessary hardware with software for precise spectral measurement and interpretation using internal calibration models.

3.2 Salient Characteristics of the Fourier Transform Infrared (FT-IR) Spectrometer System

3.2.1 The contractor shall provide the Government with one (1) Fourier Transform Infrared System (FT- IR) Spectrometer System that meets or exceeds the salient characteristics described below:

1. The system shall have a spectral range: 8,000-340 cm-1.

2. The system shall have a spectral resolution: better than 0.4 cm-1

3. The system shall have a Photovoltaic MCT detector, LN2 cooled, with a hold time at least 8 hours.

4. The system shall have a purge kit for the spectrometer.

5. The system shall have a temperature control unit, temperature range: 0°C – 95°C, computer controlled.

6. The system shall have a transmission cell for IR analysis of aqueous sample, low volume about

20 uL, temperature controlled.

7. The system shall have a multi-reflection ATR accessory for IR analysis of aqueous solutions, temperature controlled.

8. The system shall have an extended life mid-IR source.

9. The system shall have a long-life diode laser with lifespan of 50,000 hours or more.

10. The system shall have high sensitivity, capable to measure 0.2 mg/ml of protein in aqueous solution.

11. The system shall have integrated NIST standard for automated instrument tests for OQ and PQ.

12. Shall have the ability for optional upgrade with module for vibrational circular dichroism.

13. The system shall be accompanied by a workstation to control spectrometer with at least Windows

7 professional OS.

14. The contractor shall provide on-site validation including Installation Qualification, Operational

Qualification and Performance Qualification for both hardware and software for the system.

15. Shall include on-site installation and training.

3.2.2 Software and Display

1. Software shall be compatible with Windows 7- 64bit or Windows 10- 64 bit.

2. The software shall be Section 508 of the Rehabilitation act of 1973 as amended in 1998 (29

U.S.C. §794(d)) Compliant

3. The software shall have audit trails

4. The software shall save data in format readable by Microsoft Excel and Matlab

5. The software shall have metadata associated with raw data

6. Data and metadata can be saved in user defined folder

7. The software shall have built-in kernel for real time and post-acquisition data analysis

8. The software shall be CFR 21 part 11 and cGMP/GLP compliant

9. The software shall have quantitative analysis using multivariate algorithms

10. The software shall have module for protein dynamics analysis for temperature experiments

11. The software shall include protein spectra library , containing a minimum of 25 proteins, for determination of secondary structure of proteins

12. The software shall include methods to quantitatively determine secondary structure of proteins and amount of protein in solution

13. The software shall include module for library search

3.2.3 Trade and Service Requirements

1. The FTIR spectrometer system shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this FTIR spectrometer system is intended to be greater than ten years at full performance. CDER must be able to reasonable expect service and technical support from the vendor during its lifecycle.

2. The entire system must be warranted for parts and labor for 12 months from the date of installation. Software updates to be furnished at no additional cost during the warranty period.

Technical support to be furnished at no additional cost during the warranty period. The vendor shall be capable of servicing the FTIR spectrometer system through the extended warranty or service contract.

3. The vendor must demonstrate the that the FTIR spectrometer system will be suitable for the

CDER’s use by disclosing the number units in use by other customers performing applications with similar technical demands.

3.3 Optional Quantity Upgrade Module: Vibrational Circular Dichroism

In addition, the contractor the system shall have the option to include one (1) compatible vibrational circular dichroism as a module. Meeting or exceeding the following salient characteristics:

The PMA shall be for polarization modulation measurements, all optic and electronic components shall be optimized for polarization modulation, both linear and dichroitic measurement techniques and circular dichroitic experiments shall be available using this dedicated system.

The core of the polarization modulation technique is the photoelastic modular with a nominal modulation frequency of 42kHz, and shall have a parallel 24-bit dual-channel data acquisition technology to allow for the sum and the difference of signals to be collected simultaneously with high sensitivity.

This option may be exercised, at any point during the order’s period of performance.

FAR 52.217-7, Option for Increased Quantity- Separately Priced Line Item (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within thirty (30) days prior to the end of the period of performance. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)

3.4 Optional Service/Maintenance Agreement

The FDA shall have a unilateral right to exercise optional periods of service/maintenance coverage on the instrument described in section 3.2. This service agreement shall cover all parts, labor and travel necessary to maintain the instrument.

The option period of performance(s), if exercised, shall commence as follows:

OPTION PERIOD FROM THE EFFECTIVE DATE

OF THE ORDER

Option Year 1: Service/Maintenance Agreement To begin 1st Year following ARO (following expiration of warranty)

Option Year 2: Service/Maintenance Agreement To being 2nd Year following ARO

Option Year 3: Service/Maintenance Agreement To begin 3rd Year following ARO.

Option Year 4: Service/Maintenance Agreement To begin 4th Year following ARO.

FAR 52.217-8, Option to Extend Services (November 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 period of performance of this contract.

(End of Clause)

FAR 52.217-9, Option to Extend the Term of the Contract (March 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of clause)

3.5 Delivery and Installation

The contractor shall deliver and install the equipment at the following address, Monday through Friday, 9:00AM through 3:00PM, within 12 weeks of award:

Food and Drug Administration Attn: TBD Division of Pharmaceutical Analysis 645 S. Newstead Ave St. Louis, MO 63101

Complete installation shall include Installation and Operational Qualification (IQ/OQ) for the testing machine hardware and software. The end user [TBD] shall be notified at least 30 days of delivery time and shall be consulted on all phases of the installation process.

3.6 Contract Administration

Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this order: [TBD]

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Christopher R. McGucken U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville, MD 20857 Christopher.McGucken@fda.hhs.gov

(240) 402-7566

The contact information for the Contractor is the following: [TBD]

3.7 Payment

The Government will pay the Contractor only each respective deliverable’s firm-fixed-price delineated in the table in Subpart 2 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below.

FDA Three-Way Match Invoicing Procedures (Sep 2016)

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

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;

mailto:FDAVendorPaymentsTeam@fda.hhs.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

(d) the contractor shall include the Contract Line Item/Funding line item 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) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(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 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 FDA Payment Office at the e-mail address provided above in Section A.

PART 4 – CONTRACT CLAUSES

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS

(JAN 2017)

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

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

(4) 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:

__ __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sep

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 (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 (Oct 2016) (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. 6101 note).

__ __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

____ (10) [Reserved} __ __ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov

2011)(15 U.S.C. 657a).

__ __ (11) (ii) Alternate I (Nov 2011) of 52.219-3.

__ __ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

__ _ (12) (ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved] __X _ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)(15

U.S.C. 644).

__ __ (14) (ii) Alternate I (Nov 2011).

__ __ (14) (iii) Alternate II (Nov 2011).

__ __ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15

U.S.C. 644).

__ __ (15) (ii) Alternate I (Oct 1995) of 52.219-7.

__ __ (15) (iii) Alternate II (Mar 2004) of 52.219-7.

__ __ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C.

637(d)(2) and (3)).

__ __ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C.

637(d)(4)).

__ __ (17) (ii) Alternate I (Nov 2016) of 52.219-9.

__ __ (17) (iii) Alternate II (Nov 2016) of 52.219-9.

__ __ (17) (iv) Alternate III (Nov 2016) of 52.219-9.

____ (17) (v) Alternate IV (Nov 2016) of 52.219-9.

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

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017)(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 Total Service-Disabled Veteran-Owned Small

Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).

__X __ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul

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 (Dec 2015) (1 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 (Dec 2015) (15 U.S.C. 637(m)).

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

__X __ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies

(Oct 2016) (E.O. 13126).

__X __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__X __ (28) 52.222-26, Equal Opportunity (Sept 2016)(E.O. 11246).

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

__X __ (30) 52.222-36, Equal Opportunity For Workers with Disabilities (Jul

2014)(29 U.S.C. 793).

__ __ (31) 52.222-37, Employment Reports on Veterans (Feb 2016)(38 U.S.C.

4212).

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

__X __ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

__ __ (33) (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

__ __ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O.

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) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017;

applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

_____ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (October 2016).

__ __ (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.)

__ _ (37) (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 (June 2016) (E.O. 13693).

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

__ _ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ _ (40) (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).

__ _ (41) (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).

__ _ (43) (ii) Alternate I (Oct 2015) of 52.223-16.

__X __ (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).

__X __ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (47) (ii) Alternate I, (Jan 2017) of 52.244-3.

__ __ (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).

__ _ (49) (ii) Alternate I (May 2014) of 52.225-3.

__ _ (49) (iii) Alternate II (May 2014) of 52.225-3.

__ _ (49) (iv) Alternate III (May 2014) of 52.225-3.

__ __ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19

U.S.C. 3301 note).

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

__ __ (57) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)(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, Payment to Small Business Subcontractors (Jan 2017) (15

U.S.C. 637(d)(12)).

__ __ (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).

__ _ (62) (ii) Alternate I (Apr 2003) 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:

__ __ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.

13495).

__ __ (2) 52.222-41, Service Contract Labor Standards (May 2014) (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) (May 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 (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).

__ __ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C.

5112(p)(1)).

(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 paragraphs (e)(1) of this paragraph 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) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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.

(iv) 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.

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

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

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

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

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

(x) 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.

(xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xii) __X __ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

13627).

(xiii) 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).

(xiv) 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).

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

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

(xvii) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (e)(1)(xvii): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xviii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

(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 paragraphs (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.

ADDENDUM TO CLAUSE 52.212-4

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE

CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR

STATEMENTS--REPRESENTATION (JAN 2017)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE

(JUL 2016)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND

CERTIFICATIONS (DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS

(JAN 2017)

THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(22):

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION

(JUL 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006)

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS

(JUN 2013)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

352.201-70 PAPERWORK REDUCTION ACT (JAN 2006)

352.239-74 ELECTRONIC INFORMATION AND TECHNOLOGY

ACCESSIBILITY(DEC 2015)

PART 5 – INSTRUCTIONS TO OFFERORS

Offerors shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table in Subpart 2.2), estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote. Faxed quotes will not be accepted.

Offers shall be no more than 21 pages in response, inclusive of cover letter. This documentation should include information on how the offered instrument meets or exceeds each technical requirements listed above, and provide customer endorsements, such as references by expert users in the field of study.

Vendor’s shall provide written assurance that they will be capable of supporting the system during its intended lifecycle, including the date, if known, when the system will no longer be serviceable by the manufacturer. The vendor shall provide a copy of the extended warranties/service contracts quoted.

Quotes must be valid through September 30, 2016.

Offerors Response Date and Time

All quotes and revisions shall be submitted via email to Christopher.Mcgucken@fda.hhs.gov by or before 3:00 PM Eastern Time on Friday, July 7th, 2017.

The Government is not responsible for locating or securing any information which is not identified in the proposal. To ensure information is available, offerors shall furnish as part of their quote, all descriptive material necessary for the Government to unequivocally determine the services offered meets the technical requirements described in the statement of work.

1. Evaluation Award Criteria: The Government will award this contract to the lowest priced technically acceptable quote. Offerors are advised that it is possible that only the lowest-priced, timely submitted quote may be evaluated. Specifically, after obtaining price quotes and ensuring submission compliance, the Government shall prioritize the remaining price quotes from lowest to highest price. Evaluators will then evaluate the lowest price quote first. If the lowest price quote is technically acceptable, there will be no need to evaluate the higher price quote.

2. Offerors shall complete the price chart located in section 2.

3. Award will be made on an all-or-none basis.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JAN 2017)

ADDENDUM TO PROVISION 52.212-1

52.204-22 ALTERNATIVE LINE ITEM PROPOSAL (JAN 2017)

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX

LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(b) The Offeror represents that—

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

52.217-3 EVALUATION EXCLUSIVE OF OPTIONS (APR 1984)

52.225-18 PLACE OF MANUFACTURE (MAR 2015)

(a) Definitions. As used in this clause— “Manufactured end product” means any end product and service codes (PSCs) 1000-9999, except—

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

(2) Product 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.

(b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly—

(1) [ ] In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or

(2) [ ] Outside the United States.

52.225-25 PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN

ACTIVITIES OR TRANSACTIONS RELATING TO IRAN--REPRESENTATION AND

CERTIFICATIONS (OCT 2015)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL

ITEMS (JAN 2017)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. 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— “Civil Judgement” means

(1) In paragraph (h) of this provision: A judgement or finding or a civil offense by any court of competent jurisdiction.

“Economically disadvantage 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.

“Enforcement Agency” means any agency granted authority to enforce the Federal Labor Laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and health Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations board. It also means a state agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13637 are—

(1) Department of Labor Wage and Hour Division (WHD) for--

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for--

(i) The Occupational Safety and Health Act of 1970; and https://www.sam.gov/portal

(ii) OSHA-approved State Plans;

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for--

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for--

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

“Forced or indentured child labor” means all work or service--

(1) Extracted from any person under the age of 18 under the menace of penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“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).

“Labor Compliance Agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor Laws” means the following labor laws and E.O.’s:

(1)The Fair Labor Standards Act.

(2)The Occupational Safety and Health Act (OSHA) of 1970.

(3)The Migrant and Seasonal Agricultural Worker Protection Act.

(4)The National Labor Relations Act.

(5)40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6)41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7)E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8)Section 503 of the Rehabilitation Act of 1973.

(9)The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974.

(10)The Family and Medical Leave Act.

(11)Title VII of the Civil Rights Act of 1964.

(12)The Americans with Disabilities Act of 1990.

(13)The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15)Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

http://www.osha.gov/dcsp/osp/approved_state_plans.html

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of “labor laws”.

“Manufactured end product” means any end 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 materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service--disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) “Service-disabled veteran”…