United States - HPLC Upgrade

Description

Added: Jun 12, 2019 10:24 am

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) 2019-01. 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
FDA requires an upgrade to an existing Agilent 1260 Infinity Series II HPLC system into a HPLC-single-quad-MS system with the intent of characterizing nucleic acid sequence impurities through exact mass measurements of each nucleic acid sequence impurity eluting from the HPLC column. The nucleic acid sequence impurities to be analyzed include but are not limited to shorter than full length native or modified DNA or RNA sequences, phosphorothioate DNA or RNA sequences and uncharged nucleic acids including peptide nucleic acid (PNA) and phosphorodiamidate morpholino (PMO) sequences. The instrument shall also be used to identify and characterize routine and modified deoxyribonucleosides and ribonucleosides that are needed for the chemical synthesis of nucleic acid-based drugs.

CLIN DESCRIPTION PRICE
0001 HPLC Upgrade $
Installation $
S&H $

Total Cost $
REQUIREMENTS
The following add-on instruments/parts (Agilent part number listed below) are required for the configuration of an Agilent LC-MS system; salient, physical, functional, or performance characteristics of the add-on instruments/parts which "equal" products shall meet are also listed:
1. The add-on MS system shall be compatible with a single-point control software that has full control of the existing Agilent 1260 Infinity Series II HPLC system and the MS system
2. Liquid chromatograph/mass selective detector (LC/MSD ) (G6125BA):
• mass range 2-2,000 m/z
• selected ion monitoring (SIM) sensitivity at electrospray ionization (ESI) positive mode: 1 pg of reserpine injected on column, quantifying the m/z 609 ion with signal-to-noise (STN) ratio RMS >100:1
• SIM sensitivity at atmospheric pressure chemical ionization (APCI) positive mode: 1 pg of reserpine injected on column, quantifying the m/z 609 ion with STN ratio RMS >30:1;
• Maximum scan speed: 10,400 u/sec (Da/sec)
• Switching time from positive to negative polarity: 300 msec
• Mass resolution for full width at half maximum: Unit resolution ≤ 0.7 u (Da)
• Mass stability (drift): over 12 hours ≤ 0.1 u (Da) or 100 ppm, whichever is larger
• Mass accuracy: ±0.005 u (Da)
• Spectral accuracy: 99.0%
• Dynamic range: > 6 × 106 (electronic)
• Agilent LC/MSD for OpenLAB CDS ChemStation Edition
• Includes an AP-ESI Ion Source, an OpenLAB CDS ChemStation Edition software, and MS Connection (G6125BA)
• Compatible and comes with drivers to support the existing Agilent 1260 Infinity Series II HPLC system
3. Multicolumn Thermostat MCT (G7116A) shallstack with the existing Agilent 1260 Infinity Series II and come with valve drive. Supports temperatures from 10C below ambient to 110C
4. Two-position, 6 port switching valve (G4231A) shallfit into MCT above that stacks with existing Agilent modules
5. Quick Connect Assy ST 0.12x150mm (5067-5958) InfinityLab Quick Connect Assy ST 0.12mm x 150mm includes 1x Quick Connect fitting, 1x Quick Connect capillary, 1x Swagelock fitting
6. PEAK Nitrogen Generator System (G1953A, option 004).
• Gas flow: 32 L/min
• Outlet pressure: 100 psi
• Noise level: 54 dB(A) @1m
• Particles: < 0.01 µm
• Offered with a 110V plug
SHIPPING/INSTALLATION/TRAINING/SUPPORT
• Shall deliver 2 days of on-site consulting for the total solution of existing 1260 Infinity Series II system configured with new single quad mass spec (H2149A, option 002)
• Shipping, installation, familiarization and on-site training
• Manufacturer's 1-year Warranty
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 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 (Oct 2018)
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 (May 2019)
(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 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.
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/.
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 will be evaluated and awarded as Lowest Price Technically Acceptable. Quoters must demonstrate they are capable of satisfying the maintenance requirements set forth in this solicitation.
Faxed quotes will 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 June 19, 2019 with the subject titled "Requisition 1213455".
Quotes must be valid through September 30, 2019

Opportunity closing date

19 June 2019

Value of contract

to be confirmed