RFQ_maitnenance_for_REQ_1162122_HI_PUT.pdf

RFQ: FDASOL1162122 June 27, 2016

The Food and Drug Administration (FDA) CVM division has a requirement to for an Illumina HiSEQ 2500, brand name or equal, high throughput next-generation sequencing platform capable of producing high quality sequence with a high-depth of coverage level, onsite data storage with a one year option for service maintenance

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation.

The solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitations document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-88.

The associated North American Industry Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing,. Small Business Size Standard is 1,000 employees. This acquisition is full and open.competition.

Contract Type: Commercial Item: Firm Fixed Price: FOB DESTINATION

PART 2 – PRICES/COST:

CLIN Description Unit Price

Qty Unit of Issue

Price

0001 One (1) Illumina HiSEQ 2500, brand name or equal, high throughput next-generation sequencing platform, delivery and installation included.

$ 1 EA $

0002 Cluster Station with BaseSpace Onsite HT System 2X Illumina brand name or equal

$ 1 EA $

0003 Training $ 1 EA $ 0004 Option Year 1: Service Maintenance

Agreement

$ 1 EA $

0005 Total $

Part 3 Minimum System Requirements

• Compatible for use with currently employed methods and workflows for the Illumina

Nextera XT Library preparation protocols and Illumina TruSeq protocol which are the protocols necessary for our assays.

• Instruments must be a newly manufactured unit, not previously used, refurbished, or used for demonstration.

• Data output shall be compatible with multiple standardized data output format (FASTQ, BAM, VCF, and txt) for maximum compatibility with third- party downstream analysis and visualization.

• Must be able to sequence samples prepared by user defined, customized methods.

• Must be a fully integrated system, including any and all computer(s), software(s), and peripheral equipment necessary for instrument operation, data acquisition, and instrument networking capability. Any and all associated computer equipment/software must be compatible with, and include Microsoft Windows 7 operating system (The system shall include a workstation computer, touchscreen Monitor, and computer).

• Must be capable of automated multiplexed sequencing during the same run and include an easy, automated, method of tracking of sequences generated from multiple samples/genomes.

• Must include any and all additional instrumentation or components necessary for automated, high capacity cluster generation.

• Must be capable of fully automated single or paired-end sequencing and the integrated fluidics must be incorporated in the instrument, not as a separate, extra, module or require additional equipment.

• Must use ready-to-use kits of pre-packaged reagents for library preparation and labeling of primer templates for multiplexed reactions that are compatible with existing research protocols employing Illumina based sequencing for data acquisition and data analyses. The pre-packaged reagents for sequencing must contain all reagents for cluster generation and sequencing.

• Reagents shall provide flexibility of data generation (read length of 125 to 250bp) and output (300 to 1000 GB in a single run) depending on required application.

• Generated data shall have high quality score (Q score) distributions at every read length, greater than 75% of bases with Q30 for 2 × 125 bp read length or 80% of bases with Q30 for 2 × 250 bp read length.

• Power system requirements: 110 VAC, 60 Hz

• Instrument needs to be capable of generating 300 to 1000 Gb in a single run.

• Cluster Station w/BaseSpace Onsite HT System 2X

Instrument must be a newly manufactured unit, not previously used, refurbished or used for demonstration

Must include a standalone (local) system for data analysis, management and storage

Must include a minimum of 4 TB for operating space, 24 TB for hard disk space for data analysis and 20TB for data storage. The system must have at least 128 GB memory

• Delivery & Installation: The vendor will be responsible for installation and setup of the instrument. Delivery hours are 10:00 am – 4:00 pm ET , Monday – Friday.

Installation shall be performed by a currently trained technician, certified by the manufacturer.

• Training: The manufacturer, or a manufacturer trained and certified individual, must provide training covering (at a minimum) system operation, routine maintenance of the system, and utilization of the system with custom workflows or programs. Training estimated to be 1-2 days in duration. Training shall be for a minimum of two attendees with the option for additional people to attend the training. All training manuals, documents shall be available electronically and/or by hard copy one week before the training date. Training shall occur within 60 days of date delivery, installation and FDA acceptance.

• Acceptance: The vendor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument will not be accepted until those performance specifications have been met. Warranty period shall commence upon FDA acceptance of system.

• Warranty: The entire system must be warrantied for parts and labor for at least

12 months from the date of acceptance, including one preventative maintenance (PM) visit to occur approximately 1-3 months before the original warranty expires. Warranty service must include the following:

1. Coverage must include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

2. Any necessary service must be provided by service engineers who are trained and certified by the original manufacturer of the instrument.

Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

3. The Project Officer or their designee must have access to the manufacturer’s technical assistance call center during regular business hours (10am to 7pm EST). The technical assistance call center must be staffed by engineers who provide a high level of expertise for troubleshooting the instrument.

4. The supplier must be able to guarantee that a service engineer will be able to work on site within two business days of receiving a call from CVM.

Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed 5 business days (120 hours).

For repairs up to $2,500, not covered by the Maintenance/Support

Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card

For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs

Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization

5. One year warranty on all parts and labor

6. Preventative Maintenance (PM) visit must include all travel, labor, and parts included. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the vendor.

7. All software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

• Option Year Maintenance Agreement: A maintenance agreement is requested as a one year option year in order to ensure proper function throughout the first two years of ownership. The maintenance agreement must be equivalent to the warranty service requirements specified above.

Delivery or Performance-Period Requirements

Award is required by 7/15/2016 with delivery, installation and FDA acceptance occurring by 9/1/2016

Training is required within 60 days of FDA acceptance or by 11/01/2016 Warranty period: 9/01/2016-8/31/2017 Option Year 1 Service Maintenance Agreement: 9/01/2017-8/31/2018

PART 4 – INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of the service maintenance services and if necessary, the repair services to be provided.

• For the purpose of this PART, (TBD) is the authorized representative of the Contracting Officer.

• Inspection and acceptance will be performed at the location identified in Part 5.

Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

• This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available.

PART 5 – DELIVERY ADDRESS

FDA/CVM

8401 Muirkirk Road

MOD 2

Laurel, MD 20708

The preventative maintenance of the scientific equipment and associated items shall be serviced at the FDA’s facility.

PART 6 – CONTRACT ADMINISTRATION DATA

• CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: Not determined at this time.

The COR is responsible for: (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 evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

• The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer:

Gina Jackson

OAGS

5630 Fishers Lane Rockville, MD 20857 Gina.Jackson@fda.hhs.gov Tel: (240)-402-7590

The contact information for the Contracting Specialist is:

Howard S. Yablon

OAGS

5630 Fishers Lane Rockville, MD 20857 Howard.Yablon@fda.hhs.gov Tel: (240)-402-7630

• INVOICE SUBMISSION

FDA Invoice Requirements: 2 Way Match

A. The contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original to the Contracting Specialist:

U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Howard S. Yablon, Contracting Specialist 5630 Fishers Lane Room 2051A, HFA-500 Rockville, MD 20852

Email: Howard.Yablon@fda.hhs.gov

****Acceptable methods of delivery include: mail, hand delivery and email*****

(II) One copy to the contracting officer technical representative (COR), clearly marked “Courtesy Copy Only”:

mailto:Howard.Yablon@fda.hhs.gov

U.S. Food and Drug Administration

ATTN: COR (TBD)

*****Acceptable methods of delivery include: mail, hand delivery and email*****

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 – Central Contractor Registration) and/or 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) Purchase order/Award Number;

(IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: Period of Performance for which costs are claimed

(V) Shipping number and date of shipping, 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;

(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) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

(XIII) 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 and Date Submitted; 2) Corresponding payment amount and 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.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) 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:

Office of Financial Services Food and Drug Administration W032- Second Floor

MAIL HUB 2145

10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments

(301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov

Final payments will occur upon verification by FDA COR and the FDA Technical Advisor, noting successful completion of each task.

Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms. Payment will be made on a task order basis.

PART 7- HHSAR AND FAR CLAUSES

• HHSAR CLAUSES INCORPORATED BY REFERENCE:

TO READ THE FULL TEXT OF THE HHSAR CLAUSES AS STATED BELOW, SEE

HTTP://WWW.HHS.GOV/REGULATIONS/HHSAR/SUBPART352.HTML

HHSAR Clause Description Date 353.211-3 Paperwork Reduction Act (Dec. 18, 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec. 18, 2015) 352-227-70 Publications and Publicity (Dec. 18, 2015)

• FAR Clauses 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one of 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.arnet.gov

FAR Clause Description Date 52.212-1 Instructions To Offerors – Commercial items (Oct 2015) mailto:fdavendorpaymentsteam@fda.gov

52.212-2 Evaluation -- Commercial Items (Oct 2014) 52.212-4 Contract Terms and Conditions – Commercial Items (May 2015)

FAR CLAUSES BY FULL TEXT

52.217-5 Evaluation of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

52.217-8 -- Option to Extend Services. (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 10 (Ten) days, within which the Contracting Officer may exercise the option].

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 anytime prior to contract expiration. 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 2 years.

52.211-6 Brand Name or Equal (1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and https://www.acquisition.gov/far/current/html/Subpart%2017_2.html#wp1078150

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items.

(Mar 2016)

(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:

[Contracting Officer check as appropriate.]

__x_ (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).

___ (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).

__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 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)).

___ (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).

__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, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_x__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__x_ (26) 52.222-19, Child Labor?Cooperation with Authorities and Remedies (Feb 2016) (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 (Feb 2016) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__x_ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

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

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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).

___ (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 (Feb 2016) (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).

___ (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:

[Contracting Officer check as appropriate.]

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__x_ (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).

__x_ (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 (Feb 2016) (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).

(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.

PART 8 – SPECIAL CONTRACT REQUIREMENTS

Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January (New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving)

December (Christmas Day)

PART 9– INSTRUCTIONS TO THE OFFERORS

• CONTRACT TYPE: COMMERCIAL ITEMS-FIRM FIXED PRICE

• EVALUATION AWARD CRITERIA: THE GOVERNMENT WILL AWARD THIS CONTRACT TO

THE LOWEST PRICED TECHNICALLY ACCEPTABLE QUOTE.

PRICE QUOTES SHALL BE FOB DESTINATION INCLUSIVE OF SHIPPING AND HANDLING

EXPENSE

OFFEROR SHALL INCLUDE A PRICE BREAKOUT FOR ALL COMPONENTS FOR ITEM 0001

THROUGH ITEM 0005 WHICH INCLUDED THE EXTENDED TOTAL, (SEE PART 2 FOR TABLE TO

BE COMPLETED) TO INCLUDE DETAILED DESCRIPTION, CATALOG PART/NUMBER, QUANTITY,

AND UNIT PRICE OF EACH ITEM. TO BE ELIGIBLE FOR AWARD, ALL LINE ITEMS MUST BE

QUOTED.

THE OPTION WILL NOT BE FUNDED AT TIME OF AWARD. IF EXERCISED, FUNDING WILL BE

OBLIGATED INDIVIDUALLY EACH YEAR

THE GOVERNMENT IS NOT RESPONSIBLE FOR LOCATING OR SECURING ANY INFORMATION

WHICH IS NOT IDENTIFIED IN THE PROPOSAL. TO ENSURE INFORMATION IS AVAILABLE,

OFFERORS SHALL FURNISH AS PART OF THEIR QUOTE, ALL DESCRIPTIVE MATERIAL

NECESSARY FOR THE GOVERNMENT TO UNEQUIVOCALLY DETERMINE THE SERVICE

OFFERED MEETS THE TECHNICAL REQUIREMENTS

To be considered for award, quotes of “equal” products including “equal products of the brand name manufacturer, must meet the salient physical, functional or performance characteristics as specified in this RFQ;

Clearly identify the item by brand name, if any; and make or model number.

“Equal” quotes must include a narrative describing how the quote meets each salient characteristic as well as a demonstration (documentation) of how each salient characteristic is met.

• PERIOD OF ACCEPTANCE OF OFFERS: THE OFFEROR AGREES TO HOLD THE PRICES IN

ITS OFFER FIRM UNTIL SEPTEMBER 30, 2016.

RESPONSE DATES:

Quotes Due Date: All quotes shall be submitted via email Howard.Yablon@fda.hhs.gov by 3:00 PM EASTERN TIME, Monday, July 11, 2016.