FBODaily.com | FedBizOpps: PRESOL | 66 | NMR Spectrometer - FDA-RFQ-1179584

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 14, 2017 FBO #5651
SOLICITATION NOTICE

66 -- NMR Spectrometer - FDA-RFQ-1179584

Notice Date: 5/12/2017
Notice Type: Combined Synopsis/Solicitation
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
ZIP Code: 20857-0001
Solicitation Number: FDA-RFQ-1179584
Point of Contact: NAOMI CARTER,
E-Mail Address: NAOMI.CARTER@FDA.HHS.GOV
(NAOMI.CARTER@FDA.HHS.GOV)
Small Business Set-Aside: Total Small Business
Description: PART 1 - DESCRIPTION The FDA's Center for Drug Evaluation and Research requires a 600-MHz NMR 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) 2005-95. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 1000 employees. This is for a small business set-aside. PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS Base Year Purchase Order Type: Firm-Fixed Price Description Quantity Price 600-MHz NMR Spectrometer 1 The spectrometer shall come with three levels of training (Basic, Advanced and Remote see Salient Characteristics) and On-site headquarter training installation focused on software and good laboratory practice longer than 5-day inclusive 1 System rigging and cryogens for the energizing and installation (Inclusive necessary magnet charging, and connection of the system, peripherals, and support utilities to operate the system.) 1 Shipping One (1) year field warranty on parts and labor 1 Total Firm-Fixed Price Option Years Option Year Description Price 1 Service Agreement 2 Service Agreement 3 Service Agreement include additional advanced training for 1 FDA employees on servicing the NMR system including routine maintenance. 4 Service Agreement Total Firm Fixed Price The total price for the base and four option years is tiny_mce_marker___________. PART 3 - DESCRIPTION/SPECIFICATIONS 3.1 Background Public demand and acceptance for generic and biosimilar drug products are ever increasing. Though generic drugs are cheaper and more accessible to patients, it is FDA/CDER's priority to ensure their safety and efficacy. It is crucial to ensure bio-equivalency between the generic or biosimilar drug products and its reference drug product through extensive chemical and structural analysis. In application review, a range of analytical methods, including Nuclear Magnetic Resonance (NMR), are being implemented to achieve "totality of evidence approach" (Biosimilar Draft Guidance documents, 2012). In fact, NMR has been applied to generic complex drug products and raw materials in assessing physiochemical quality attributes such as chemical impurity, structural fingerprints, and even particle size. The USP chapter for heparin products (2012) required an identification test of NMR spectra acquired at a magnetic field stronger than 500 MHz. More NMR methods are drafted in FDA generic drug guidance and response to citizen petitions. In addition, regulatory research and decision rely on statistical analysis of NMR results on multiple lots of drug products. In pharmaceutical industry NMR spectrometer at 600-MHz has been a workhorse instrument. Therefore, a modern and sustainable 600-MHz NMR spectrometer with high-throughput functionality is crucial for CDER's regulatory research mission. The upgraded instrument requested here will provide FDA scientists with state-of-the-art NMR technology, enabling research into the development of efficient and realistic analytical methods, establishing the quality of complex drug products and concomitantly improving regulatory decisions that impact patient outcomes. 3.2 Salient Characteristics The features represent key requirements on the 600-MHz NMR equipment in order for FDA to perform regulatory research. Equipped with 2 room-temperature probes and 1 liquid nitrogen refrigerated probe. It should have high-throughput functionality to characterize drug products and raw materials. The primary applications requiring the enhanced capabilities are complex drug products and its generic or biosimilar versions. FDA requires a modern 600-MHz NMR spectrometer equipped with 2 room-temperature probes and 1 liquid nitrogen refrigerated probe. It should have high-throughput functionality. It will be for use on CDER regulatory samples and for FDA-wide research on novel NMR methods to characterize drug products and raw materials. The primary applications requiring the enhanced capabilities are complex drug products and its generic or biosimilar versions. The 600-MHz NMR spectrometer shall "meet or exceed" the following salient characteristics/specifications: 1. Shall actively shielded superconducting magnetic system. The drift of the magnetic field shall be less than 5 Hz per hour, as measured on a 1H resonance, averaged over a 24-hour period in the unlocked mode of operation. 2. In the unlikely event that the magnet undergoes a quench (complete or partial loss of magnetic field or cryoshims) the vendor shall agree to take responsibility for reestablishment of the resonance condition. 3. Helium hold time shall be for one year with continuous cryogenic cooling with liquid nitrogen. 4. External Disturbance Suppression. 5. Vibration isolation posts shall reduce the effects of strong floor vibration in both vertical and horizontal directions. 6. The spectrometer shall provide a minimum of four frequency channels together with the capability of producing different asynchronous or synchronous composite pulse decoupling and different shaped pulses on all channels simultaneously and independently. The composite pulse decoupling schemes must be freely programmable by the user and include the option for pulse shaping of the individual elements of the composite pulses. All channels shall have identical specifications at low RF power levels, except that only two channels require operation over the frequency range from 550 to 600 MHz (for 19F and 1H), and a minimum of two additional channels shall operate over the frequency range from 6 to 365 MHz (all other nuclei). 7. Linear broadband shall amplifier for X-nucleus pulse and decouple, at least 500 Watt linear pulse power, at least 30W linear CW, all operation under computer control. 8. Shall provide 4 enhanced RF generators including Signal Generation Units, for generation of phase, amplitude, and frequency using Direct Digital Synthesis (DDS) covering a frequency range from 6 to 600MHz. Provides <0.01 degree of phase stability and <0.005 Hz frequency resolution. Digital up conversion at 960MHz. Includes high performance wave form memory for programming of experimental sequences including ultra-fast pulse programming, pulse shaping and composite pulse decoupling executable synchronously or asynchronously. 9. Shall provide Preamplifier configuration multilink for 1H/19F, 2H, 13C, 15N and X-BB. 10. The system shall be equipped with hardware and software for mapping the magnetic field profile within the sample in three orthogonal dimensions, and software for making the required homogeneity adjustments under computer control. The spectrometer also shall include the capability to automatically adjust the homogeneity of the magnetic field during the course of multi-hour experiments that include pulsed field gradients, without interruption of the actual experiments or having any other noticeable effect on the acquisition process. 11. Shall provide XYZ-gradient electronics consisting of gradient control unit and 10A amplifier on each axis. At least one probe should have triple axis (xyz) gradient functionality. 12. Extensive library of advanced and modern NMR experiments. The pulse programming system shall permit implementation of user-developed pulse sequences and shall be capable of conducting all experiments published in the volumes 1-10 of the Journal of Biomolecular NMR and publications from FDA in Journal of Magnetic Resonance (JMR, 251, 65-70, 2015). It shall be possible to specify at least 30 independent pulse sequence interval lengths and 30 pulse widths in a single pulse program. The minimum interval length shall be no greater than 500 ns. It shall be possible to specify each interval length in increments of 25 ns or less. It shall be possible to write and execute pulse programs with at least 256 steps (without loops), with each step representing a time period during which any combination of pulses on the four channels is given. The amplitudes and phases of the pulses shall be arbitrarily programmable, subject only to the resolution limits on the phase shifters and RF attenuators. It shall be possible to include at least twenty loops within a single pulse program, with independent loop counters. It shall be possible to nest loops. 13. Shall provide One 5mm 1H optimized room temperature triple resonance probe designed for 1H observation or 1H observation with 13C/15N decoupling, actively shielded xyz triple-axis gradient with automatic tuning and matching accessories. The 1H 90deg. hard pulse should be less than 8 us and S/N on 0.1% Ethylbenzene (EB) should be more than 1100. The splitting of sucrose anomeric peak should be below 15% for a 2 mM sucrose sample in H2O. 14. Shall provide one z-gradient room temperature quadruple resonance (19F/13C/15N/1H) 5-mm pulsed field gradient room temperature probe for observation of 1H/19F while decoupling 13C and 15N and 1H, including a 2H lock. The probe should have automatic tuning and matching functionality. The 19F probe S/N should be over 900 on TFT sample without any 19F hump in background. 15. Shall provide one nitrogen cooled 5 mm cold probe for 1H/13C/15N triple resonance XYZ-axis gradient with inverse detection and X observe. Cold preamplifiers for 1H/2H/13C and automatic tuning and matching accessory are required. The 90º pulse widths must be no greater than 8 us for 1H, 12 us for 13C, 32 us for 15N and 88 us for 2H. In addition, the 1H RF homogeneity of the triple resonance probe-head must be such that an 810 1H pulse (2 x 360 + 90) retains at least 60% of the anomeric proton signal relative to a single 90 pulse, using a 0.5 mL aqueous solution containing 2 mM sucrose in D2O. The 13C RF homogeneity must be such that after a 90 (1H) - 1/2J - 720 (13C) pulse sequence the methyl signal for a sample of 13C enriched acetate is attenuated by less than 40% relative to the 1H signal acquired with a 90 (1H) - 1/2J - 0 (13C) pulse sequence. The 1H S/N on 0.1% Ethylbenzene (EB) should be more than 3000. The 1H S/N on 2mM sucrose should be more than 600. 16. Automated sample changer shall provide random access for up to 24 samples. Temperature control unit of 6 ºC for the sample changer. 17. The console electronics shall be capable of 0.01 degrees phase resolution, 0.005 Hz frequency resolution and a 90 dB attenuation range on all five channels. The RF phase shall vary by no more than 3 over an attenuation range of 45 dB from full power. 18. The ability to pulse and observe 2H nuclei shall be available from the console without physically re-cabling the console, and the instrument must be capable of applying 90 2H pulse widths of less than 65 microseconds. 19. The long-term pulse amplitude stability on all channels shall be less than 1% and phase stability shall be better than 1 as measured over a 24 h period in a room where the temperature changes by less than 1.5C. This phase stability is measured from the relative differences between 1D spectra recorded with a 30 flip angle pulse, at various times during a 24 h period. 20. The dynamic range shall be at least 2,000,000:1 as measured for a 90 1H pulse by a S/N of at least 60:1 on a t-butanol peak in a 1/10,000 1H molar ratio to water. No spurious resonances shall be larger than 1/2000 times the largest resonance in the spectrum when operating in locked mode, using sample temperature control at 30C and an air flow which is sufficient to change the sample temperature from 30C to 25C within 0.1C in less than 3 minutes. 21. Shall provide Linux work station with Intel Xenon 3GHz or faster Processor, 16 GB Memory, 1TB hard drive, 24 Inch flat panel monitor. 22. The system shall be covered under full parts and labor hardware and software warranty coming with the vendor, starting from the date that all guaranteed specifications resulting from this contract have been met in the buyer's laboratory. 23. The spectrometer shall come with three levels of training (Basic, Advanced and Remote) for 4 agency-designated individuals. The Basic and Advanced training will be performed by a mutually agreed upon (by the vendor and the FDA) representative of the vendor on-site after the spectrometer is fully installed and passes the other qualification specifications outlined in this document. The Basic and Advanced training shall occur over at least 2 full days at the FDA site. The Remote training shall occur at a mutually agreed upon site (by the vendor and the FDA) for 4 (four) agency designated individuals. 24. Shall provide Helium transfer lines for liquid helium refill 25. Shall provide UPS for power backup. Parts- The service plan will use all Original Equipment Manufacturer (OEM) certified parts. PART 4 -PERFORMANCE AND DELIVERABLES 4.1 Place of Performance and Work Hours All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (ET). Service visits shall be coordinated with, see below. Delivery location will be as follows: The US Food and Drug Administration 645 S. Newstead Ave. St. Louis, MI 63101 ATTN: TBD TBD@fda.hhs.gov The 600-MHz spectrometer and the corresponding equipment and accessories, including but are not limited to console, sample changer, cryo-platform, probes, will be delivered within 1 year of contract award. 4.2 PERIOD OF PERFORMANCE From date of award for and be in effect for one year. Optional Service/Maintenance Agreement The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below: Period of Performance Start Date Period of Performance End Date System delivery Date of award 08/01/2018 Installation 08/01/2018 12/31/2018 1-year Warranty 12/31/2018 12/31/2019 4-year Service Contract (optional) 01/01/2020 12/31/2023 The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses. OPTIONAL PERIODS Deliverable Period of Performance Option Period 1 -Service Agreement To begin one year following Base award Option Period 2 -Service Agreement To begin one year following Option Period 1 Option Period 3 -Service Agreement To begin one year following Option Period 2 Option Period 4 -Service Agreement To begin one year following Option Period 3 • Extended warranties shall include annual preventive maintenance (PM) and repairs. Any necessary parts, labor and/or travel necessary for proper repair and function of the system will be included in the cost of the service contract. • Option Year 3 is to include services listed above with additional advanced training for 1 FDA employees on servicing the NMR system including routine maintenance. • The vendor must also be capable of servicing the instrument throughout the entire warranty or service contract. PART 5 -CONTRACT ADMINISTRATION 5.1 Representative's The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR TBD - TBD@fda.hhs.gov) is the authorized representative of the Contracting Officer. The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following: Ronald Rouse U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Ronald.Rouse@fda.hhs.gov; (240) 402-7615 The contact information for the Contract Specialist is the following: Naomi Carter U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Naomi.Carter@fda.hhs.gov; (240) 402-7575 The contact information for the Contractor is the following: (TBD) 5.2 Invoice Submission A. The contractor shall submit all invoices to: U.S. FOOD AND DRUG ADMINISTRATION FDA Three-Way Match Invoicing Procedures Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (insert name and email address.) B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements); (iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; (c) any other supporting information necessary to clarify questionable expenditures; (d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30); (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer Identification Number (TIN); (x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT); (xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award; (xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance; (xiii) Any other information or documentation required by the award. C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A. PART 6-CONTRACT CLAUSES 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. FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) HHSAR CLAUSES: 352.203-70, Anti-Lobbying (DEC 2015) 352.222-70, Contractor Cooperation In Equal Employment Opportunity Investigations (DEC 2015) 352.224-71 Confidential Information (DEC 2015) 352.227-70, Publications and Publicity (DEC 2015) 352.237-75, Key Personnel (DEC 2015) 6.2 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) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) 52.217-8 Option to Extend Services (Nov 1999) 6.3 FAR Clauses in Full Text: FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months. FAR 52.212-3 Offeror Representations and Certifications -Commercial Items (MAY 2014) (IAW FAR 12.301(b)(2)) FAR 52.212-4 Contract Terms and Conditions-Commercial Items (JAN 2017) (IAW FAR 12.301(b)(3)) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items (JAN 2017) (IAW FAR 12.301(b)(4)) (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 (Dec 2014) (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). _X__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (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). ___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] _X__ (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 (Aug 2013) (31 U.S.C. 6101 note). _X__ (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 2011) (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] _X__ (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. _X__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). _X__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (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 2014) of 52.219-9. _X__ (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)). _X__ (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). _X__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for 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 (Jul 2014) (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 (Jul 2014) (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 (Aug 2013). (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) (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 (Jun 2014) 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 (Jun 2014) (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). ___ (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. ___ (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). 52.225-18 PLACE OF MANUFACTURE (SEP 2006) (IAW FAR 25.1101(f)) 52.225-25 PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN ACTIVITIES OR TRANSACTIONS RELATING TO IRAN--REPRESENTATION AND CERTIFICATIONS (DEC 2012) (IAW FAR 25.1103(e)) ___ (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). ___ (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 2014) (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 (Apr 2010) (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 $650,000 ($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 (Jul 2014) (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 (Jul 2014) (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) __X__ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 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 (Aug 2013). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (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) 52.222-22 Previous Contracts and Compliance Reports. (Feb 1999) The offeror represents that- It □ has, □ has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; It □ has, □ has not filed all required compliance reports; and Representations indicating submission of required compliance reports, signed by proposed subcontractors, will be obtained before subcontract awards. (End Provision) Conflicts of Interest: The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject order, as defined in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors working or proposed to be working under this order. The Contractor agrees that, if after award, it discovers a conflict of interest with respect to this order, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer for this order. The Government reserves the right to exercise any remedy available at law or equity, including termination of the order for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest. PART 7 - INSTRUCTIONS TO OFFERORS Offerors shall include in the quote, a point of contact (name, telephone number, and email address), proposed firm-fixed-prices estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current. Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote. Offerors shall complete the pricing tables for the base period equipment plus the four (4) option periods. The technical evaluation for this solicitation will be the offeror's ability to meet the required specifications listed in section 3.2, Salient Characteristics. Faxed quotes will not be accepted. Quotes must be valid through September 30, 2017. Offerors Response Date and Time: All quotes and revisions shall be received via email by Naomi.Carter@fda.hhs.gov before 1:00 PM Eastern Time on Tuesday, May 19, 2017. Award shall be made to a responsible party with the lowest priced technically acceptable offer.
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66 -- NMR Spectrometer - FDA-RFQ-1179584