FDA-SOL-18-1194511_fbo.pdf

REQUEST FOR QUOTE

FDA-SOL-18-1194511

Near-infrared Spectrometer

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) 2005-96. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing.

Offerors Response Date and Time

All quotes shall be submitted via email to susan.bechtel@fda.hhs.gov by or before 5:00 PM Eastern Time on March 29,2018 with the subject titled: FDA-SOL-18-1194511.

1 Statement of Work

The FDA requires one (1) near infrared spectrometer, one (1) internal multiplexer to allow multi-probes to be connected to the spectrometer, one (1) external measurement channels for measurement of standards, one (1) NIR sensor for non-contact measurements, one (1) data collection system, and (1) data collection, and analysis software package. Emerging manufacturing technologies that have the capability to increase the assurance of product quality increasing take advantage of advanced sensor-based analytics.

The FDA will use this equipment will be used to obtain scientific knowledge in support of developing quality standards for blend and content uniformity for generic solid oral products, especially with low drug load or poor flow properties. Therefore, the FDA requires one online NIR system consisting of the components mentioned above for the measurement of quality attributes in solids processing with specifications outlined below.

Specifications

Near Infrared Spectrometer System

The system shall allow computer controlled measurements.

The system shall have a rugged design with low maintenance required.

The system shall provide accurate in-line measurements in less than 5 seconds.

RFQ-FDA-SOL-18-1194511

Shall offer built-in multiplexer options that allow control of no less than 6 sensor heads with fiber optic cables by the single spectrometer.

The system shall allow measurements of both using the internal light source and an external light source. The light path can be switched between difference sources.

The detector of the spectrometer shall be thermoelectrically cooled and temperature-controlled.

The system shall provide contactless measurement of moving solid materials including powders and granules in diffuse reflection mode.

The sensor head non-contact analysis shall connect with the spectrometer using fiber optic cable.

The fiber optic cable shall allow extended distance of no less than 5m.

For non-contact analysis, the working distance shall be no less than 100 mm.

For non-contact analysis, the diameter of the measurement area shall be no less than 10 mm.

For non-contact analysis, a reference standard shall be integrated within the probe for automatic background measurements.

Shall provide capability to prevent fouling of the measurement window.

Shall provide mounting hardware for in-line measurement with minimal dead space.

The in-line mounting hardware shall use appropriate materials such as stainless steel and

Polyoxymethylene, sapphire window with thickness of no less than 6mm.

Shall provide laboratory mount for off-line calibration measurements.

The probe head should provide flexible connection to keep measurement area clean from dust and dirt.

Data systems

The data system shall be integrated within the spectrometer system, for the acquisition, processing, evaluation, and reporting measurement data both in laboratory and process environment.

The spectroscopy software shall have configurable use interface.

The spectroscopy software shall allow export of spectral data and evaluation results to other programs, for example Excel, Unscrambler, etc.

The spectroscopy software shall execute common spectroscopic analysis and evaluation functions.

The spectroscopy software shall support the validation of the spectrometer, including operational and performance qualification.

The software shall provide package to offer quantitative analysis for multivariate analysis models.

The software shall be able to offer an automatic routine for the optimization of calibration methods.

The software shall allow storing and managing data in a database.

The data system shall allow communication with process control systems.

Installation and training

Onsite installation and training shall be provided.

Delivery Location

DELIVER TO:

US FOOD AND DRUG ADMINISTRATION

WO64, Room 1076

10903 NEW HAMPSHIRE AVE

SILVER SPRING MD 20993

2 Period of Performance

Delivery shall be made within 90 days of Contract award.

3 Contract Type

The contract type of this purchase order is firm-fixed-price (FFP).

4 Inspection and Acceptance Criteria

Pursuant to the inspection clause as provided in the master GSA contract all items specified in the requirements statement to be delivered under this contract is subject to final inspection and acceptance by an authorized representative for the Government. The authorized representative of the Government is the

Government’s Contracting Officer’s Representative (COR), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

5 Government Points of Contact

Contracting Officer (CO):

Matthew Bucher

Office of Acquisitions and Grants Services

U.S. Food and Drug Administration

5630 Fishers Lane

Rockville, MD 20857

Matthew. Bucher@fda.hhs.gov

Contract Specialist (CS):

Susan Bechtel

Office of Acquisitions and Grants Services

U.S. Food and Drug Administration

5630 Fishers Lane

Rockville, MD 20857

Susan.bechtel@fda.hhs.gov

Contracting Officer’s Representative (COR):

[TBD]

6 Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this contract/order and notwithstanding any provisions contained elsewhere in the contract/order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract/order and modify any term or condition of the contract/order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the contract/order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the contract/order.

7 Order of Precedence

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4 of the underlying GSA contract. Any indemnification language indemnifying the Contractor of any liability and governing law language in the Contractor’s terms and conditions shall be null and void in this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be null and void.

8 Invoicing Instructions

The Contractor shall follow the FDA Three-Way Match Invoicing Procedures delineated within the contract/order form (SF1449).

9 FAR / HHSAR Clauses

FAR Clauses Incorporated by Reference

FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acguisition.gov/far/

52.212-4, Contract Terms and Conditions-Commercial Items (JAN 2017)

52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

52.242-17, Government Delay of Work (April 1984)

3.10 FAR Clause by Full Text

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—

Commercial Items.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial

Items (Jan 2017) http://www.acguisition.gov/far/ https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_3.html#wp1084399

(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 (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 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).

__ (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).

__ (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).

https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

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

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

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

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

__ (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)).

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

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

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

__ (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—Subcon-tracting 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 (Nov 2011) (15

U.S.C. 657 f).

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

_x_ (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).

_x_ (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).

_x_ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147479 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147630 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147656 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147711 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148123

__ (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).

__ (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). (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) 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, GSA, DoD 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) (OCT 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.)

__ (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.

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_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).

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

__ (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 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_x_ (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 (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, Payments to Small Business Subcontractors (Jan 2017)(15 U.S.C. 637(d)(12)).

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__ (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.

(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 (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 (Sept 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.

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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) 52.219-8, 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)

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

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).

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(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, GSA, DoD 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 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)

(End of clause)

6.1 HHSAR Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006)

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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)

10 Instructions to Quoter and Evaluation Criteria

Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions must be provided or the quote will be deemed technically unacceptable.

1) Please submit a quote via email to Susan.Bechtel@fda.hhs.gov no later than 5:00 PM Eastern Time

(ET) on March 29, 2018.

2) The Quoter shall submit one (1) copy of their quotation that clearly states the overall cost to the

Government. The Government requests the Contractor to provide discounts off their established pricing for each line item. The Quoter shall provide all terms, conditions, and assumptions, if applicable, with its quotation as attachments. The Quoter shall certify its quote to be valid for 90 days.

4) Quoter shall submit pricing in the following format specifying any separately priced items to meet the requirement:

ITEM # Description Qty Price Total

NIR Spectrometer 1

Internal Multiplexer 1

NIR Sensor 1

Software 1

Data Systems 1

Installation 1

Training 1

TOTAL: QUOTATION in USD $

EVALUATION CRITERIA:

The Government shall award an order resulting from this solicitation to the responsible Quoter as a firm-fixed-price order. Quotes will be evaluated on a lowest priced, technically acceptable (LPTA) basis. The

Government intends to evaluate the quote and award an order without discussions. The Quoter’s initial quote should contain the Quoter’s best terms from a price standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The

Government may reject any quote if such action is in the best interest of the Government and waive informalities and minor irregularities in offers received.

END OF SOLICITATION