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Bench-top Nanoflow


Maryland, United States
Government : Federal
RFQ
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DESCRIPTION

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 shall 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) 2005-101. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. Business size standard of 500 employees. The solicitation is set aside for small business.


SUPPLIES OR SERVICES AND PRICES/COSTS


SCOPE


FDA has a need for a bench-top Nanoflow liquid chromatographic system coupled to existing triple quadrupole mass spectrometer. Also, to include additional maintenance, a base period of one (1) year and four (4) one (1) year option periods.


The Nanoflow LC system shall provide superior resolution with enhanced sensitivity which supports analysis of large molecules and biomarkers verification.


 


CLIN Description Price
0001 Bench-top Nanoflow $
1001 Option Year 1Maintenanace $
2001 Option Year 2 Maintenanace $
3001 Option Year 3 Maintenanace $
4001 Option Year 4 Maintenanace $
Total Cost $


 


REQUIREMENTS
• The instrument shall be compatible with an existing Waters Xevo TQ-XS bench-top triple quadrupole mass spectrometer
• The system shall support both nano and micro solvent flow rates
• The system shall have option of working with multiple microtiter plates
• Installation and a minimum of 1 day on-site training shall be included
• Additional warranty/maintenance beyond the standard manufacturers 12-month warranty is NOT required


PERFORMANCE / SPECIFICATIONS


The instrument shall meet the following performance / specifications:
• System shall include integral leak management to detect system leaks at nL/min flow rates
• Shall support the flow rates from 200 nL/min to 100 µL/min
• Shall support the wide pH range (2 to 10)
• Shall withstand high operating pressure up to 15000 psi
• Shall support the use of different solvents at time (n=4)
• Shall support the automatic priming or purging controls
• Shall have efficient integrated wash system to avoid injector carry over
• Shall support the injection volumes from 0.1 µL to 100 µL
• Autosampler shall include temperature control
• Shall support the use of microtiter plates and micro centrifuge tube plate
• Shall support the use of multiple micro plates at time
• Shall support the use of micro or nano columns 75 µm to 4.6 mm in diameter
• System shall be compatible with existing Waters MassLynx MS software allowing control of all pump, autosampler and detector operations
• LC system shall include Waters Xevo TQ-XS compatible nanoflow sample input device and MS ion source
• Shall be able to interface with existing Waters Xevo TQ-XS mass spectrometer


PERIOD OF PERFORMANCE


Option Year 1: 2018-2019
Option Year 2: 2019-2020
Option Year 3: 2020-2021
Option Year 4: 2021-2022


DELIVERY LOCATION


10903 New Hampshire Ave
BLDG 64 RM 2019
Silver Spring, MD 20993


CONTRACT ADMINISTRATION


The contact information for the FDA Contracting Officer's Representative is: TBD

The contact information for the FDA Contracting Officer is: TBD


The contact information for the FDA Contract Specialist is the following: TBD


CONTRACT CLAUSES

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 shall 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 (Nov 1999) (The Contracting Officer may exercise the option by written notice to the Contractor within 30 (thirty) days of contract expiration).
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 30 days of expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires.) (c The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years and six (6) months).
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 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).
(
(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 52.219-9.
(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.)
(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.
(38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.
8259b).
(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 shall 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.


 



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 shall 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/.


HHSAR Clause Description Date
352.203-70 Anti-lobbying (Dec 2015)
352.215-70 Late proposals and revisions (Dec 2015)
352.223-70 Safety and health (Dec2015)
352.224-70 Privacy Act (Dec 2015)
352.233-71 Litigation and claims (Dec 2015)


INSTRUCTIONS TO OFFERORS COVER PAGE
Offeror shall include a cover page which shall include a point of contact (name, telephone number, and email address). 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.


The award shall be evaluated and awarded as Lowest Price Technically Acceptable. Quoters shall demonstrate they are capable of satisfying the maintenance requirements set forth in this solicitation.


Faxed quotes shall not be accepted. Offerors Response Date and Time
All quotes shall be submitted via email to Telisha.Wilson@fda.hhs.gov by or before 10:00 AM Eastern Time on December 20, 2018 with the subject titled "Requisition 1208110".


Quotes shall be valid through September 30, 2019


Telisha Wilson , Contract Specialist , Phone 2404027572, Email telisha.wilson@fda.hhs.gov

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