FDA-SOL-18-1194490_fbo.doc.pdf

REQUEST FOR QUOTE

FDA-SOL-18-1194490

Mass Spectrometer (MS)

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 April 13, 2018 with the subject titled: FDA-SOL-18-1194490.

1 Statement of Work

Background

Bioanalysis is a primary component of the Division of Applied Regulatory Science’s (DARS) mission in support of drug metabolism, pharmacokinetics, and toxicology studies. We are requesting mass spectrometer (MS) coupled to ultra-performance liquid chromatographic system to complement the existing technologies in the lab. Particularly, a mass spectrometry with greater sensitivity and increased dynamic range. These advantages will increase laboratory productivity, facilitating biomarker studies, particularly those postulated as surrogate endpoints, as well as pharmacokinetic, pharmacodynamic and toxicology studies that would accompany them. This system will also be useful for therapeutic protein quantification.

Objective

This request is the purchase of a new bench-top triple quadrupole mass spectrometer MS system coupled to ultra-performance liquid chromatographic system. The MS system shall provide superior sensitivity, up to 6 orders of magnitude (dynamic range), an ESI and APCI source, and software for instrument control, data acquisition and analysis of small and large molecules and biomarkers verification. The increase in sensitivity with broad working mass range allow us to measure proteins involved in drug metabolism and transport in tissue samples through select monitoring of unique peptides thus allowing us to quantify proteins in drug metabolism and transport studies associated with drug response and toxicity.

RFQ-FDA-SOL-18-1194490

The FDA has identified the following mass spectrometers with the resolving power and sensitivity specified in the Statement of Work: the Thermo Fisher TSQ Quantiva, Waters Xevo TQS and AB Sciex

QTrap 6500. Equal products that meet all of the salient characteristics will be considered.

Salient Characteristics

The instrument must be a high sensitivity (see specific Sensitivity requirements below) bench-top triple quadrupole mass spectrometer.

The system shall include both electrospray and atmospheric pressure chemical ionization.

The system shall include an uninterruptible power supply and a nitrogen generator.

Installation and a minimum of 1 day on-site training shall be included.

The instrument must be new (not refurbished).

Performance / Specifications: The instrument shall meet the following performance / specifications:

Scan Speed

Up to 20,000 Da/second for the triple quadrupole

Polarity Switching Rate

The instrument must be capable of continuously switching ionization mode polarity with no more than 15 msec settling time between polarities

Minimum MRM Dwell Time

1 msec

Sensitivity

Capable of detecting 1 pg of reserpine on column with SN>500,000:1 in the ESI/MRM/positive ion mode

Capable of detecting 1 pg of chloramphenicol on column with SN>500,000:1 in the

ESI/MRM/negative ion mode

Capable of detecting 1 pg of 17 hydroxy progesterone on column with SN>300:1 in the

APCI/MRM/positive ion mode

Dynamic Range

Up to 6 orders of magnitude linear dynamic range.

Mass Range

The mass spectrometer shall be capable of operating in the mass range of 5-2000 m/z for triple quadrupole

Mass Stability

The instrument must have a mass stability of +/- 0.05 amu over 24 hours at targeted m/z value.

Ion Sources and Probes

Instrument shall support interchangeable ionization sources and probes including ESI, APCI and

APPI.

Compatibility with Ultra Performance Liquid Chromatographic System

Shall be able to interface with an ultra-performance liquid chromatographic system

MS software shall be cable of controlling all LC components including pump, autosampler and diode array detector

MS software shall confer full functionality of LC components including solvent flow, gradient composition, sample injection, UV wavelength and data collection.

Delivery Location

DELIVER TO:

US FOOD AND DRUG ADMINISTRATION

10903 NEW HAMPSHIRE AVE

WO BLDG 64 RM 2018

SILVER SPRING MD 20993

2 Period of Performance

Delivery shall be made within 90 days of Contract award.

3 Contract Type

The contract type will be firm-fixed-price (FFP).

4 Inspection and Acceptance Criteria

Pursuant to the inspection clause 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

CONTRACT CLAUSES

HHSAR Clauses Incorporated by Reference

This order incorporates the following U.S. Department of Health and Human Services

Acquisition Regulation (HHSAR) 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 the following website:

http://www.hhs.gov/policies/hhsar/.

352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations

(January 2010)

352.231-71, PRICING OF ADJUSTMENTS (JANUARY 2001)

HHSAR Clause Description Date

352.202-1 Definitions (Jan 2006)

352.203-70 Anti-lobbying (Jan 2006)

352.215-70 Late proposals and revisions (Jan 2006)

352.223-70 Safety and health (Jan 2006)

352.224-70 Privacy Act (Jan 2006)

352.228-7 Insurance--Liability to third persons (Dec 1991)

352.233-71 Litigation and claims (Jan 2006)

352.242-73 Withholding of contract payments (Jan 2006)

352.242-71 Tobacco-free Facilities (Jan 2006)

352.242-74 Final decisions on audit findings (Apr 1984)

FAR Clauses Incorporated by Reference:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

www.acquisition.gov/far/index.html

52.202-1 Definitions (November 2013)

52.203-5 Covenant Against Contingent Fees (May 2014)

52.203-7 Anti-Kickback Procedures (May 2014)

52.212-4 Contract Terms and Conditions-Commercial Items (May 2015)

52.217-8 Option to Extend Services (November 1999)

52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OF EXECUTIVE ORDERS—COMMERCIAL ITEMS (DEC 2015)

(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 http://www.hhs.gov/policies/hhsar/ http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194

Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov

2015) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws

108-

77, 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 (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

2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). (5) [Reserved]

(6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-

117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(Jan 2014) (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).

(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).

(ii) Alternate I (Jan 2011) of 52.219-

4. (13) [Reserved]

(14) (i) 52.219-6, Notice of Total Small Business 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 (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

(17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637

(d)(4)). (ii) Alternate I (Oct 2001) of 52.219-9.

(iii) Alternate II (Oct 2001) of 52.219-9.

(iv) Alternate III (Oct 2015) of 52.2199.

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

X (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (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

(Nov 2011) (15 U.S.C. 657f).

(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 Economically Disadvantaged Women-Owned

Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

(24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB)

Concerns Eligible Under the WOSB Program (Jul 2013) (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 (Jan 2014) (E.O.

13126).

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

X (28) 52.222-26, Equal Opportunity (Apr 2015) (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 (Oct 2015) (38 U.S.C. 4212).

X (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).

X (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) (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.)

X (36) (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.

(37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s

13423 and 13514).

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

X (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.

8259b).

X (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct

2015) (E.O.s 13423 and 13514).

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

X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

(Aug 2011) (E.O. 13513).

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

X (42) (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.

X (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(45) 52.225-26, Contractors Performing Private Security Functions Outside the

United States (Jul 2013) (Section 862, as amended, of the National Defense

Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

(47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area

(Nov

2007) (42 U.S.C. 5150).

(48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41

U.S.C. 4505), 10 U.S.C. 2307(f)).

(49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C.

4505, 10 U.S.C. 2307(f)).

X (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award

Management

(Jul 2013) (31 U.S.C. 3332).

(51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award

Management (Jul 2013) (31 U.S.C. 3332).

(52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

X (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(54) (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:

(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) (E.O.

13658).

(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May

2014)(42 U.S.C. 1792).

(10) 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 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) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (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.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr

2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O.

11246).

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

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

793). (viii) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

(ix) 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.

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

(xi) (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 E.O. 13627).

(xii) 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.)

(xiii) 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) (xiv) 52.222-54, Employment Eligibility Verification (Oct 2015)

(E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 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.

(xviii) 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)

Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or

(d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause”.

Alternate II (Dec 2015). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs

(d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows: (d)

(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions. (e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(A) 52.203–13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509). (B) 52.203-15, Whistleblower Protections Under the American Recovery and

Reinvestment

Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20015 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20015

(C) 52.219–8, Utilization of Small Business Concerns (Oct 2014) (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.

(D) 52.222-21, Prohibition of Segregated Facilities (Apr

2015). (E) 52.222–26, Equal Opportunity (Apr 2015)

(E.O. 11246).

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

(G) 52.222–36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793).

(H) 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.

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

(J)(1) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

(K) 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).

(L) 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).

(M) 52.222–54, Employment Eligibility Verification (Oct 2015) (Executive Order

12989). (N) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015)

(E. O. 13658).

(O) 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.

(P) 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.

10 Instructions to Quoter and Evaluation Criteria

INSTRUCTIONS:

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 no later than 3:00 PM Eastern Time (ET) on April 13, 2018 to

Susan.Bechtel@fda.hhs.gov.

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 the following format specifying any separately priced items to meet the requirement:

GSA item # Description Qty Price Total

Mass Spectrometer system 1

Installation, Training

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 Contract. 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