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One (1) Illumina Neo Preparation System

Department of Health and Human Services, Food and Drug Administration | Published January 5, 2016  -  Deadline January 13, 2016
cpvs

PART 1 - INTRODUCTION The Food and Drug Administration (FDA) has a requirement to purchase one (1) Illumina Neo Library Preparation System BRAND NAME OR EQUAL with two (2) sets of specific reagent kits that is compatible with Illumina brand sequencing systems with four (4) one year service maintenance option years. Delivery, installation and familiarization training of this scientific instrument shall be included. 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 2005-85. The associated North American Industry Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing, Small Business Size Standard is 500 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 Neo Library Preparation System, brand name or equal with two (2) sets of reagent kits, delivery and installation included $ 1 EA $ 0002 Familiarization Training of FDA Scientists on the use and maintenance one (1) Illumina Neo Library Preparation System, brand name or equal $ 1 EA $ 0003 Option Year 1, Service Maintenance Agreement, Period of Performance: 02/15/2017-2/14/2018 $ 1 EA $ 0004 Option Year 2, Service Maintenance Agreement, Period of Performance: 02/15/2018-2/14/2019 $ 1 EA $ 0005 Option Year 3, Service Maintenance Agreement, Period of Performance: 02/15/2019-2/14/2020 $ 1 EA $ 0006 Option Year 4, Service Maintenance Agreement, Period of Performance: 02/15/2020- 2/14/2021 $ 1 EA $ 0007 Total $ $ DELIVERY AND INSTALLATION 30 DAYS AFTER AWARD PART 3 -STATEMENT OF WORK • Salient Characteristics of Library Preparation System  Must be a new system, not used or refurbished  Instrument must be a fully-integrated, closed (self-contained) system allowing for hands off functionality (minimum manual labor or in-person attention required to process a sample through the library preparation for the next-generation sequencing workflow). Instrument must be able to perform all library preparation steps, including PCR amplification quantification, and normalization using a simple workflow (a workflow where there is minimal manual intervention required to go through library preparation steps), Instrument shall not require additional dedicated PCR amplification system or equipment for amplification.  The instrument must come with all auxiliary equipment necessary to make it fully functional.  Instrument must be able to perform bead base normalization (Steps where beads are used to bind and purify DNA).  Libraries prepared with the system must meet requirements for Illumina sequencing system including the FDA's existing MiSeq and NextSeq 500 systems and HiSeq.  FDA's existing MiSeq and NextSeq 400 systems  Miseq: Serial #M02070  MiSeq: Serial # MO3031  MiSeq: Serial # MO3820  NextSeq 500: Serial NS500253  Capable of generating at least 16 sequencing libraries during the same run.  Capable of processing TruSeq Nano DNA and TruSeq Stranded mRNA library preparation kits based on compatibility with existing equipment.  Reagents: System must include two (2) sets of reagents for installation/optimization and testing.  TruSeq nano DNA kit-Quantity 2  TruSeq Stranded nRNA library preparation kits- Quantity 2 • Delivery, Installation and Acceptance Criteria  Delivery, Installation of system  The vendor is responsible for delivery and installation of the instrument to the CVM facility located at 8401 Muirkirk Road, Module II, Laurel Md., 20708. Delivery hours are 10:00 AM-4:00 PM ET, Monday-Friday.  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 specifications have been met. • Training: The proposal must include a half day (four hour), on-site familiarization training for multiple users (the FDA estimates 3 users will attend this training session). This training session will take place at the FDA/CVM location. This training session will be arranged by CVM'S COR. Training session shall take place within 14 days after installation and acceptance by the FDA. This training session should include the following training objectives:  Provide guidance to CVM'S scientists/operators on the proper use of the instrument.  Any routine maintenance required by the users.  Any safety and related safeguards as deemed appropriate.  Information on what the users should do if the unit is not functioning properly.  Other topics deemed necessary by the vendor.  Training and/or service manuals shall be made available to the FDA one week in advance of the delivery and installation by either electronic and/or printed material. • Warranty: One year warranty for parts and labor, telephone and email support, with 4 (four), one year service maintenance option years  Warranty period shall commence when the instrument has been delivered, installed and accepted by the FDA.  The contract must enable the Project Officer or their designee to have access to the manufacturer's call center at regular business hours (8 am to 5 pm ET) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument.  The supplier must be able to guarantee that a service engineer will be able to work on site within four business days of receiving a call from FDA/CVM.  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  Respond to requests for emergency on-site service and/or non-emergency requests (Monday-Friday, excluding vendor and Federal holidays) within 3 business days (72 hours).  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 warranty. If the repairs are not covered under the warranty, 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  Service Records and Reports: The vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, on-site hours expended and parts/components replaced. In addition, the vendor shall provide monthly reports to the FDA COR and Contract Specialist, not later than the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. PART 4 - INSPECTION AND ACCEPTANCE: • The Contractor's Officer's Representative (COR) will perform inspection and acceptance of the library preparation system.  For the purpose of this part, the COR (TBD) is the authorized representative of the Contracting Officer.  Inspection and acceptance will be performed at the location identified in 5.2. 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 1999) 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- PERFORMANCE LOCATION: The system shall be installed and serviced at the following FDA location Food and Drug Administration CVM 8401 Muirkirk Road Module II Room: To Be Determined Laurel, MD 20708 The Contractor shall provide the FDA with a minimum of one (1) week's scheduling notice prior to the delivery and installation of the scientific instrument. . PART 6 - CONTRACT ADMINISTRATION DATA • CONTRACTING OFFICERS REPRESENTATIVE (COR) The following COR will represent the Government for the purpose of this contract: To Be Determined 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 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 5630 Fishers Lane Rockville, MD 20857 Howard.Yablon@fda.hhs.gov Tel: (240)-402-7630 • INVOICE SUBMISSION  FDA Invoice Requirements:  3-Way Match: FDA THREE-WAY-MATCHING INVOICE CLAUSE A. The contractor shall submit all invoices to all addressees in the manner specified below: OFFICE OF FINANCE SERVICES U.S. FOOD AND DRUG ADMINISTRATION 10903 New Hampshire Avenue WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-002 Attn: Vendor Payments 301-827-3742 or 866-807-3742 fdavendorpaymentsteam@fda.gov *** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, AND E-MAIL And one original to the contracting officer representative (COR) or other program center/office designee: U.S. FOOD AND DRUG ADMINISTRATION CVM ATTN: To Be Determined *** Acceptable methods of delivery include: mail, hand delivery, or e-mail 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; SAM Registration) 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) Purchase order/award number; (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; (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; (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 technical representative (COR) or other program center/office point of contact, as referenced on the purchase order; (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, & 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 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. [amend/delete, as necessary] D. Questions regarding invoice payments should be directed to the FDA Payment Office at: Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) FDAVENDORPAYMENTSTEAM@FDA.GOV 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 353.201-70 Paperwork Reduction Act (JAN 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) 352-227-70 Publications and Publicity (JAN 2006) • Far Clauses This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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://farsite.hill.af.mil/VFHHSARA.HTM. 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) 52.212-2 Evaluation -- Commercial Items (Oct 2014) 52.212-4 Contract Terms and Conditions - Commercial Items (May 2015) FAR CLAUSES BY FULL TEXT 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Dec 2015) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 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 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) _x (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) [Reserved]. __ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _x (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note). __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). __ (10) [Reserved]. __ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (ii) Alternate I (Nov 2011) of 52.219-3. __ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (ii) Alternate I (JAN 2011) of 52.219-4. __ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-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-Subcon-tracting 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. 657 f). __ (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)). __ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). __ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212). __ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). __ (31) 52.222-37, Employment Reports on Veterans (OCT 2015) (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). (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 (Oct 2015) of 52.223-13. __ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (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. _x_ (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 (June 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). __ (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 (Sept 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 (l) 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 and 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 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 (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. 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 (SUBJECT TO THE AVAILABILITY OF FUNDS)  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 0007 EXTENDED TOTAL, TO INCLUDE DETAILED DESCRIPTION, CATALOG PART/NUMBER, QUANTITY, AND UNIT PRICE OF EACH ITEM. ALL OR NONE.  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 SCIENTIFIC INSTRUMENT 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 MARCH 31, 2016. • RESPONSE DATES: Quotes Due Date: All quotes shall be submitted via email Howard.Yablon@fda.hhs.gov By 1:00 PM EASTERN TIME on Wednesday , January 13, 2016. .

One (1) Illumina Neo Library Preparation System

Department of Health and Human Services, Food and Drug Administration | Published December 18, 2015  -  Deadline January 5, 2016
cpvs

PART 1 - INTRODUCTION The Food and Drug Administration (FDA) has a requirement to purchase one (1) Illumina Neo Library Preparation System BRAND NAME OR EQUAL with two (2) sets of specific reagent kits that is compatible with Illumina brand sequencing systems with four (4) one year service maintenance option years. Delivery, installation and familiarization training of this scientific instrument shall be included. 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 2005-85. The associated North American Industry Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing, Small Business Size Standard is 500 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 Neo Library Preparation System, brand name or equal with two (2) sets of reagent kits, delivery and installation included $ 1 EA $ 0002 Familiarization Training of FDA Scientists on the use and maintenance one (1) Illumina Neo Library Preparation System, brand name or equal $ 1 EA $ 0003 Option Year 1, Service Maintenance Agreement, Period of Performance: 02/15/2017-2/14/2018 $ 1 EA $ 0004 Option Year 2, Service Maintenance Agreement, Period of Performance: 02/15/2018-2/14/2019 $ 1 EA $ 0005 Option Year 3, Service Maintenance Agreement, Period of Performance: 02/15/2019-2/14/2020 $ 1 EA $ 0006 Option Year 4, Service Maintenance Agreement, Period of Performance: 02/15/2020- 2/14/2021 $ 1 EA $ 0007 Total $ $ DELIVERY AND INSTALLATION 30 DAYS AFTER AWARD PART 3 -STATEMENT OF WORK • Salient Characteristics of Library Preparation System  Must be a new system, not used or refurbished  Instrument must be a fully-integrated, closed (self-contained) system allowing for hands off functionality (minimum manual labor or in-person attention required to process a sample through the library preparation for the next-generation sequencing workflow). Instrument must be able to perform all library preparation steps, including PCR amplification quantification, and normalization using a simple workflow (a workflow where there is minimal manual intervention required to go through library preparation steps), Instrument shall not require additional dedicated PCR amplification system or equipment for amplification.  The instrument must come with all auxiliary equipment necessary to make it fully functional.  Instrument must be able to perform bead base normalization (Steps where beads are used to bind and purify DNA).  Libraries prepared with the system must meet requirements for Illumina sequencing system including the FDA's existing MiSeq and NextSeq 500 systems and HiSeq.  FDA's existing MiSeq and NextSeq 400 systems  Miseq: Serial #M02070  MiSeq: Serial # MO3031  MiSeq: Serial # MO3820  NextSeq 500: Serial NS500253  Capable of generating at least 16 sequencing libraries during the same run.  Capable of processing TruSeq Nano DNA and TruSeq Stranded mRNA library preparation kits based on compatibility with existing equipment.  Reagents: System must include two (2) sets of reagents for installation/optimization and testing.  TruSeq nano DNA kit-Quantity 2  TruSeq Stranded nRNA library preparation kits- Quantity 2 • Delivery, Installation and Acceptance Criteria  Delivery, Installation of system  The vendor is responsible for delivery and installation of the instrument to the CVM facility located at 8401 Muirkirk Road, Module II, Laurel Md., 20708. Delivery hours are 10:00 AM-4:00 PM ET, Monday-Friday.  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 specifications have been met. • Training: The proposal must include a half day (four hour), on-site familiarization training for multiple users (the FDA estimates 3 users will attend this training session). This training session will take place at the FDA/CVM location. This training session will be arranged by CVM'S COR. Training session shall take place within 14 days after installation and acceptance by the FDA. This training session should include the following training objectives:  Provide guidance to CVM'S scientists/operators on the proper use of the instrument.  Any routine maintenance required by the users.  Any safety and related safeguards as deemed appropriate.  Information on what the users should do if the unit is not functioning properly.  Other topics deemed necessary by the vendor.  Training and/or service manuals shall be made available to the FDA one week in advance of the delivery and installation by either electronic and/or printed material. • Warranty: One year warranty for parts and labor, telephone and email support, with 4 (four), one year service maintenance option years  Warranty period shall commence when the instrument has been delivered, installed and accepted by the FDA.  The contract must enable the Project Officer or their designee to have access to the manufacturer's call center at regular business hours (8 am to 5 pm ET) for technical assistance, which is staffed by engineers who provide a high level of expertise for troubleshooting the instrument.  The supplier must be able to guarantee that a service engineer will be able to work on site within four business days of receiving a call from FDA/CVM.  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  Respond to requests for emergency on-site service and/or non-emergency requests (Monday-Friday, excluding vendor and Federal holidays) within 3 business days (72 hours).  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 warranty. If the repairs are not covered under the warranty, 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  Service Records and Reports: The vendor shall, commensurate with the completion of each service call, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, on-site hours expended and parts/components replaced. In addition, the vendor shall provide monthly reports to the FDA COR and Contract Specialist, not later than the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. PART 4 - INSPECTION AND ACCEPTANCE: • The Contractor's Officer's Representative (COR) will perform inspection and acceptance of the library preparation system.  For the purpose of this part, the COR (TBD) is the authorized representative of the Contracting Officer.  Inspection and acceptance will be performed at the location identified in 5.2. 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 1999) 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- PERFORMANCE LOCATION: The system shall be installed and serviced at the following FDA location Food and Drug Administration CVM 8401 Muirkirk Road Module II Room: To Be Determined Laurel, MD 20708 The Contractor shall provide the FDA with a minimum of one (1) week's scheduling notice prior to the delivery and installation of the scientific instrument. . PART 6 - CONTRACT ADMINISTRATION DATA • CONTRACTING OFFICERS REPRESENTATIVE (COR) The following COR will represent the Government for the purpose of this contract: To Be Determined 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 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 5630 Fishers Lane Rockville, MD 20857 Howard.Yablon@fda.hhs.gov Tel: (240)-402-7630 • INVOICE SUBMISSION  FDA Invoice Requirements:  3-Way Match: FDA THREE-WAY-MATCHING INVOICE CLAUSE A. The contractor shall submit all invoices to all addressees in the manner specified below: OFFICE OF FINANCE SERVICES U.S. FOOD AND DRUG ADMINISTRATION 10903 New Hampshire Avenue WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-002 Attn: Vendor Payments 301-827-3742 or 866-807-3742 fdavendorpaymentsteam@fda.gov *** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, AND E-MAIL And one original to the contracting officer representative (COR) or other program center/office designee: U.S. FOOD AND DRUG ADMINISTRATION CVM ATTN: To Be Determined *** Acceptable methods of delivery include: mail, hand delivery, or e-mail 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; SAM Registration) 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) Purchase order/award number; (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; (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; (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 technical representative (COR) or other program center/office point of contact, as referenced on the purchase order; (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, & 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 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. [amend/delete, as necessary] D. Questions regarding invoice payments should be directed to the FDA Payment Office at: Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) FDAVENDORPAYMENTSTEAM@FDA.GOV 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 353.201-70 Paperwork Reduction Act (JAN 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) 352-227-70 Publications and Publicity (JAN 2006) • Far Clauses This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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://farsite.hill.af.mil/VFHHSARA.HTM. 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) 52.212-2 Evaluation -- Commercial Items (Oct 2014) 52.212-4 Contract Terms and Conditions - Commercial Items (May 2015) FAR CLAUSES BY FULL TEXT 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Dec 2015) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 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 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) _x (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) [Reserved]. __ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _x (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note). __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). __ (10) [Reserved]. __ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (ii) Alternate I (Nov 2011) of 52.219-3. __ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (ii) Alternate I (JAN 2011) of 52.219-4. __ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-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-Subcon-tracting 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. 657 f). __ (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)). __ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). __ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212). __ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). __ (31) 52.222-37, Employment Reports on Veterans (OCT 2015) (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). (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 (Oct 2015) of 52.223-13. __ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (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. _x_ (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 (June 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). __ (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 (Sept 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 (l) 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 and 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 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 (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. 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 (SUBJECT TO THE AVAILABILITY OF FUNDS)  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 0007 EXTENDED TOTAL, TO INCLUDE DETAILED DESCRIPTION, CATALOG PART/NUMBER, QUANTITY, AND UNIT PRICE OF EACH ITEM. ALL OR NONE.  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 SCIENTIFIC INSTRUMENT 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 MARCH 31, 2016. • RESPONSE DATES: Quotes Due Date: All quotes shall be submitted via email Howard.Yablon@fda.hhs.gov By 1:00 PM EASTERN TIME on Tuesday, January 5, 2016. .

Combined Service Maintenance Agreement for JEOL USA Scanning Electron Microscope and Transmission Electron Microscope Systems

Department of Health and Human Services, Food and Drug Administration | Published April 27, 2016  -  Deadline May 5, 2016
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Solicitation Number FDA-SOL-1162830 Combined Service Maintenance Agreement for JEOL USA Scanning Electron Microscope and Transmission Electron Microscope Systems PART 1 - DESCRIPTION The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) Division of Product Quality Research (DPQR) has a need for preventative maintenance - service maintenance on the JEOL USA JSM-6701F Scanning Electron Microscope System (Serial #:SM17310051) JEM 1011 Transmission Electron Microscope System (Serial #:EM185400). 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) 2005-87. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. PART 2 - SERVICES AND SUPPLIES AND PRICES 2.1 CONTRACT TYPE: FIRM-FIXED-PRICE 2.2 Pricing TableCLIN Service and Supply Description Quantity Unit Price Firm-Fixed-Price*0001 Service Maintenance Agreement SM-6701F SEM system includes (Serial #:SM17310051) JEM 1011 Transmission Electron Microscope System (Serial #:EM185400) 1 $1001 Option Year 1: Service/Maintenance Agreement 1 2002 Option Year 2: Service/Maintenance Agreement 1 3004 Option Year 3: Service/Maintenance Agreement 1 4004 Option Year 4: Service/Maintenance Agreement 1 TOTAL MAXIMUM POTENTIAL FIRM-FIXED-PRICE $ *The firm-fixed-prices are inclusive of all costs, such as shipping, parts, installation, training, labor, travel, and any other warranty and service maintenance costs. Payment is only authorized for the respective firm-fixed-prices upon successful completion of the respective CLIN, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer's Representative (COR), and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. PART 3 - DESCRIPTION/SPECIFICATIONS 3.1 Full Maintenance Service visit shall include: A SM-6701F SEM system includes (Serial #:SM17310051, a dual pumping Haskriswater recirculator (SN: HB20261), JUS-FEGBB, Battery Backup-96621, a S- 71520MSC 3axis motor stage controller 358436, and a JUS-PCSEM-WS-XPcomputer workstation. A JEM 1011 Transmission Electron Microscope System (Serial #:EM185400- 88/HB20261 system, T7610 computer workstation, and Gatan Orius Part #: 832.10B. SC1000B bottom mounted camera with fiber optically coupled to a CCD camera. • The contractor shall ensure full operating capacity or published performance specifications of each of the microscopes include obtainment of quaranteed resolution of 1.0 nm at 15 kV and 2.2 nm at 1.0 kV for the SM-6701F SEM system and with a SAP10B, High Contrast Pole Piece a ±20°, guaranteed resolution of 0.2nm line resolution or 0.4nm point to point resolution for the JEM-1011 system • The contractor shall cover cost of all major warranty-specific, guaranteed non consumable parts and their installation shall be included in the service agreement. • The plan shall include service visits (unlimited emergency visits or otherwise stated) during regular business hours (From 8 AM to 4 PM, Monday through Friday) to meet published performance specifications for service other than operator function, damage by third party, acts of nature, etc. • The contractor shall provide unlimited technical telephone support, and guaranteed response times (within 1 working day) for the SM-6701F SEM and the JEM 1011 TEM system and 8 service days (emergency response time of one working day). • The contractor shall provide two preventative maintenance checks per year at regular scheduled intervals. • The contractor shall provide all warranty-specific to JEOL SEM (JSM-6701F) and TEM JEM 1011 microscope, guaranteed parts, labor, travel, and expenses necessary for calibrating the equipment and to maintain the equipment at full operating capacity. • The complexity of the equipment and the agency's mission involving the test results of the utilization of the equipment requires timely and professional maintenance and repair of the equipment. • Emergency service shall be provided by the contractor upon government request and can be satisfied in consultation with the Government representative by the contractor responding in one of three ways at no additional cost to the Government: 1) A service representative will be dispatched to the government facility for the repair or service, (Lab G108A-D, MOD1 Facility, CFSAN/ FDA, 8301 Muirkirk Road, Laurel, MD 20708) 2) If a warranty-specific part needs to be serviced by the contractor at their facility the broken warranty-specific part or products will be removed by a service representative, replaced with a loaner part and the broken part will be shipped back to the Contractor's facility for repair. Once the repaired part is returned to the Government facility, the warranty-specific part will be installed by the service representative. 3) Warranty-specific, guaranteed replacement parts with appropriate installation instructions will be sent to the Government for installation by the Government representative. 3.3.7.) Optional Service/Maintenance Agreement• The offerors shall provide pricing for optional service agreement. Agreements offeror shall have a minimum of one (1) preventative maintenance visit per year, and be inclusive of all parts, labor, and travel. The FDA shall have a unilateral right to exercise optional periods. The option period of performance, if exercised, shall commence as follows: OPTION PERIOD FROM THE EFFECTIVE DATE OF THE ORDEROption Year 1: Service/Maintenance Agreement To begin 1st Year following ARO Option Year 2: Service/Maintenance Agreement To being 2nd Year following AROOption Year 3: Service/Maintenance Agreement To begin 3rd Year following ARO.Option Year 4: Service/Maintenance Agreement To being 4th year following ARO. FAR 52.217-8, Option to Extend Services (November 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 the period of performance of this contract.(End of Clause) FAR 52.217-9, Option to Extend the Term of the Contract (March 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within the period of performance of the contract; 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 five years.(End of clause) 3.3.8 Delivery The contractor shall preform services at the following location: Food and Drug Administration8301 MUIRKIRK ROADLAUREL MD 20708 3.4 Contract Administration Contracting Officer's Representative (COR) The following COR will represent the Government for the purpose of this order: [TBD] 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: Naomi CarterU.S. Food and Drug AdministrationOffice of Acquisitions and Grants ServicesRockville, MD 20857Naomi.Carter@fda.hhs.gov(240) 402-7575 The contact information for the Contracting Officer is the following: Nicola CarmichaelU.S. Food and Drug AdministrationOffice of Acquisitions and Grants ServicesRockville, MD 20857Nicola.Carmichael@fda.hhs.gov(240) 402-7568 The contact information for the Contractor is the following: [TBD] PAYMENT The Government will pay the Contractor only each respective deliverable's firm-fixed-price delineated in the table in Subpart 2.2 above, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. INVOICE INSTRUCTIONS The Contractor shall submit all invoices in the manner specified below: The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial ServicesFood and Drug Administration10903 New Hampshire AvenueW032-Second FloorBldg. 32, Rm. 2162, Mail Hub 2145Silver Spring MD 20993-0002Attn: Vendor Payments Phone: (301) 827-3742 or (866) 807-3742 Email: fdavendorpaymentsteam@fda.gov Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer - Central Contractor Registration) and the 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) Purchase Order/Award Number; (IV) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;(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 a 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 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. 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. Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above. Payment will only be made on a firm-fixed-price basis.   52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TOIMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (JUL 2014) (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) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).(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 and 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.]___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sep 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 (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.)_X__ (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]___ (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). ___(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).__X_(10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).___ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011)(15 U.S.C. 657a).___ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).(13) [Reserved]___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)(15 U.S.C. 644).___ (14) (ii) Alternate I (Nov 2011).___ (14) (iii) Alternate II (Nov 2011).___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15 U.S.C. 644).___ (15) (ii) Alternate I (Oct 1995) of 52.219-7.___ (15) (iii) Alternate II (Mar 2004) of 52.219-7.___ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)).___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013)(15 U.S.C. 637(d)(4)). (In accordance with DDP Memo dated 9 Sep 2013, DAR Tracking Number 2013-O0014, Class Deviation-Summary Subcontract Report Submission, this clause is replaced with DFARS Deviation dated Aug 2013. Effective until incorporated into the FAR or DFARS or until rescinded.)___ (17) (ii) Alternate I (Oct 2001) of 52.219-9.___ (17) (iii) Alternate II (Oct 2001) of 52.219-9.___(17) (iv) Alternate III (Jul 2010) 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) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008)(10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)___ (21) (ii) Alternate I (June 2003) of 52.219-23. (In accordance with DDP Memo dated 12 Mar 2010, DAR Tracking Number 2010-O0006, Immediate Cessation of the Use of Price Evaluation Adjustment for Small Disadvantaged Businesses, this clause is suspended in DoD. Effective until incorporated into the FAR or DFARS or until rescinded.)___ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013)(Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).___(23) 52.219-26, Small Disadvantaged Business Participation Program-Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).___(24) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).____(25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).___(26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (1 U.S.C. 637(m)).___(27) 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)).___(28) 52.222-3, Convict Labor (June 2003)(E.O. 11755).____(29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014)(E.O. 13126).__X __(30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).__X __(31) 52.222-26, Equal Opportunity (Mar 2007)(E.O. 11246).____(32) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).__X __(33) 52.222-36, Equal Opportunity For Workers with Disabilities (Jul 2014)(29 U.S.C. 793).____(34) 52.222-37, Employment Reports on Veterans (Jul 2014)(38 U.S.C. 4212).___(35) 52.222-40, Notification of Employee Rights Under the National Labor relations Act (Dec 2010) E.O. 13496).__ __(36) 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.)____(37) (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.)___(37) (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.)____(38) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).____(38) (ii) Alternate I (Jun 2014) of 52.223-13.____(39) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).____(39) (ii) Alternate I (Jun 2014) of 52.223-14.___(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42.U.S.C. 8259b).___(41) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514).___(41) (ii) Alternate I (Jun 2014) of 52.223-16.__X __(42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011).___(43) 52.225-1, Buy American--Supplies (May 2014)(41 U.S.C. chapter 83).____(44) (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).___(44) (ii) Alternate I (May 2014) of 52.225-3.___(44) (iii) Alternate II (May 2014) of 52.225-3.___(44) (iv) Alternate III (May 2014) of 52.225-3.____(45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).__X _(46) 52.225-13, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury).___(47) 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).____(48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007)(42 U.S.C. 5150).____(49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007)(42 U.S.C. 5150).____(50) 52.232-29, Terms for financing of Purchases of Commercial Items (Feb 2002)(41 U.S.C. 4505, 10 U.S.C. 2307(f)).____(51) 52.232-30, Installment Payments for Commercial Items (Oct 1995)(41 U.S.C. 4505, 10 U.S.C. 2307(f)).____(52) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)(31.U.S.C. 3332).____(53) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013)(31.U.S.C. 3332).___(54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).____(55) 52.239-1, Privacy or Security Safeguards (Aug 1996)(5 U.S.C. 552a).___(56) (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).___(56) (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) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).___(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).__ __(3) 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).___(4) 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).____(5) 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).___(6) 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).____(7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).____(8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).____(9) 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 paragraphs (e)(1) of this paragraph 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 (May 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 (l) of FAR clause 52.222-17.(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).(v) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).(vi) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).(vii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).(viii) 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. (ix) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).(x) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104 (g)). Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).(xi) 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).(xii) 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).(xiii) 52.222-54, Employment Eligibility Verification (Aug 2013).(xiv) 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).(xv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraphs (e) of FAR clause 52.226-6.(xvi) 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.ADDENDUM TO CLAUSE 52.212-4 352.201-70 PAPERWORK REDUCTION ACT (JAN 2006) (IAW HHSARFARS 301.106(c)) 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS (MAY 2014) (IAW FAR 12.301(b)(3)) THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(25): 52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013) (g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed: The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________. [Contractor to sign and date and insert authorized signer's name and title]. 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (JAN 2010) (IAW HHSARFARS 322.810(h)) 352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006) (IAW HHSARFARS 327.404-70) 52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013) (IAW FAR 32.706-3) 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) (IAW FAR 32.009-2) SOLICITATION PROVISIONSREPRESENTATIONS, INSTRUCTIONS AND EVALUATIONS 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAY 2014) (IAW FAR 12.301(b)(2))An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. (a) Definitions. As used in this provision-"Economically disadvantage women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program."Forced or indentured child labor " means all work or service--(1) Extracted from any person under the age of 18 under the menace of penalty for its nonperformance and for which the worker does not offer himself voluntarily; or(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties."Inverted domestic corporation," as used in this section, means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code at 26 U.S.C. 7874."Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except-(1) FSC 5510, Lumber and Related Basic Wood Materials;(2) Federal Supply Group (FSG) 87, Agricultural Supplies;(3) FSG 88, Live Animals;(4) FSG 89, Food and Related Consumables;(5) FSC 9410, Crude Grades of Plant Materials;(6) FSC 9430, Miscellaneous Crude Animal Products, Inedible;(7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products;(8) FSC 9610, Ores;(9) FSC 9620, Minerals, Natural and Synthetic; and(10) FSC 9630, Additive Metal Materials."Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture."Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate-(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;(3) Consist of providing goods or services to marginalized populations of Sudan;(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;(5) Consist of providing goods or services that are used only to promote health or education; or(6) Have been voluntarily suspended."Sensitive technology"-(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically--(i) To restrict the free flow of unbiased information in Iran; or(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3))."Service-disabled veteran-owned small business concern"--(1) Means a small business concern--(i) Not less than 51 percent of which is owned by one or more service--disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.(2) "Service-disabled veteran" means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16)."Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation."Subsidiary" means an entity in which more than 50 percent of the entity is owned-(1) Directly by a parent corporation; or(2) Through another subsidiary of a parent corporation."Veteran-owned small business concern" means a small business concern--(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and(2) The management and daily business operations of which are controlled by one or more veterans."Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern--(1) That is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and(2) Whose management and daily business operations are controlled by one or more women."Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127)," means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. (b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.(2) The offeror has completed the annual representations and certification electronically via the SAM website accessed through http://www.acquisition.gov . After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ____________. [Offeror to identify the applicable paragraphs at (c) through (o) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.] (c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern.(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, for general statistical purposes, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002.(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.]The offeror represents that it [ ] is, [ ] is not a women-owned small business concern.Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that-(i) It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ______________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that-(i) It [ ] is, [ ] is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: ______________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is a women-owned business concern.(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:______________________________________________________(10) [Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, or FAR 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.](i) General. The offeror represents that either--(A) It [ ] is, [ ] is not certified by the Small Business Administration as a small disadvantaged business concern and identified on the date of this representation, as a certified small disadvantaged business concern in the SAM Dynamic Small Business Search database maintained by the Small Business Administration, and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth or each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or(B) It [ ] has, [ ] has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted.(ii) Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as a part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(10)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture: [The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: _______________________________________.](11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that-(i) It [ ] is, [ ] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and(ii) It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (c)(11)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: ____________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation. (d) Representations required to implement provisions of Executive Order 11246--(1) Previous Contracts and Compliance. The offeror represents that--(i) It [ ] has, [ ] has not participated in a previous contract or subcontract subject either to the Equal Opportunity clause of this solicitation; and(ii) It [ ] has, [ ] has not filed all required compliance reports.(2) Affirmative Action Compliance. The offeror represents that--(i) It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or(ii) It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor. (e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payment of reasonable compensation were made. (f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American--Supplies, is included in this solicitation.)(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product," The terms "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American-Supplies."(2) Foreign End Products: Line Item No. Country Of Origin _______________ _________________________________ __________________[List as necessary] (3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (g) (1) Buy American--Free Trade Agreements-Israeli Trade Act Certificate.
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