MODIFICATION
66 -- Standalone temperature monitoring system
- Notice Date
- 8/20/2014
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDASOL1132621
- Archive Date
- 9/11/2014
- Point of Contact
- Howard S. Yablon, Phone: 2404027630
- E-Mail Address
-
howard.yablon@fda.hhs.gov
(howard.yablon@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- PART 1 - Intro The Food and Drug Administration (FDA) has a requirement to purchase one (1) stand- alone temperature monitoring system with options to purchase post warranty service/maintenance options and additional temperature sensing probes. This system is to monitor the temperature of rooms as well as specified equipment within laboratories in order to accurately document the performance of the instruments in the laboratory in regard to temperature stability. 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. This 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 2005-76. 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 set aside 100% for small business concerns. PART 2 - PRICES/COST CLIN Description Unit Price Qty Unit of Issue Price 0001 Stand Alone Temperature Monitoring System, Delivery, Installation, Training, One Year Warranty $ 1 EA $ 0002 Additional temperature sensing probes for the first year, 2014-2015 (A) $ 6 EA $ 0003 Option Year 1- Maintenance Agreement on the Stand Alone Temperature Monitoring System, 2014-2015 $ 1 EA $ 0004 Additional temperature sensing probes for the second year, 2015-2016 (A) $ 6 EA $ 0005 Option Year 2- Maintenance Agreement on the Stand Alone Temperature Monitoring System), 2015-2016 (B) $ 1 EA $ 0006 Additional temperature sensing probes for the third year, 2016-2017 (A) $ 6 EA $ 0007 Option Year 3- Maintenance Agreement on the Stand Alone Temperature Monitoring System), 2016-2017 (B) $ 1 EA $ 0008 Additional temperature sensing probes for the fourth year, 2017-2018 (A) $ 6 EA $ 0009 Option Year 4- Maintenance Agreement on the Stand Alone Temperature Monitoring System), 2017-2018 (B) $ 1 EA $ 0010 Additional temperature sensing probes for the fifth year, 2018-2019 (A) $ 6 EA $ Total Value $ (A) The FDA estimates that a total of 30 scientific instruments will be added to this monitoring system over a 5 year period. Thus, for this price matrix table, the contractor will propose a price for a maximum of 6 additional probes for the first year and per Option Year. (B) Each Option Year Maintenance Agreements should also include service maintenance cost associated on the estimated maximum of 6 additional probes (estimated by the FDA) that will be needed per Option Year. The initial warranty period for additional probes is one year. Thus the added service maintenance cost associated with the additional probes should be calculated after the initial warranty period has expired. PART 3 -STATEMENT OF WORK (SOW) SYSTEM REQUIREMENTS: • The monitoring system shall be a stand-alone system and work within the laboratory system. It shall be capable of monitoring a variety of devices which provide a contact closure to generate a signal to the monitoring system. Devices will include, but are not limited to, temperature and carbon dioxide concentration. It shall simultaneously measure, transmit, centrally collect and analyze the temperature data, from multiple instruments in a multi-floor, multi-room, multi-building laboratory facility Attachments for full dimensions and layouts of the facility and various rooms where the equipment that is to be monitored is located: 1. Attachment 1:Floor Plan of Facility 2. Attachment 2: Freezers, Refrigerators and Incubators • The system must be user programmable to add contact information (up to 10 telephone numbers) for each probe. The system must provide notification of alarm conditions. A phone line can be provided by the government if required for the notification portion of the system. • The system shall include a computer controller/server, sufficient to operate the system proposed, that can be centrally located on a multi-floor laboratory facility. • System shall provide a range of temperature sensing probes that are capable of monitoring temperatures associated with refrigerators, freezers Ultra low freezers (down to -86ºC), environmental chambers, and incubators. All temperature probes shall be of sufficient specificity/sensitivity to calibrate to ±0.2ºC of the specified set temperature monitoring value. • All temperature sensing probes shall be capable of continuous monitoring with on board memory to prevent data loss (minimum of 25 days of data collected at 15 minute intervals for each individual instrument.) • The monitoring system must be capable of archiving data for retrieval and manipulation by users (e.g., data must be retrievable in the form of graphs, tables, etc., from individual probes). • The system must have a back-up power source in the event of loss of power. • Monitoring system must be expandable to incorporate other monitoring probe types which may include but are not limited to particle counts, humidity, air pressure, water pressure, air flow, water flow liquid level sensors, etc. System should be expandable to address the needs of the laboratory as it continues to expand, and adaptable (upgradeable) to accommodate changing technologies with minimal changes required to the system infrastructure/software. The FDA estimates that a total of 30 scientific instruments will be added to this monitoring system over a 5 year period. • Installation of system: 12 hours/space as the maximum disruption possible for each affected space. • Calibration requirements for all temperature sensing devices shall be supportable by the vendor with regard to calibration standards to cover the requirements outlined in A2LA accreditation standards and ISO 17025 using the AOAC guidelines. Additionally the vendor shall provide documentation of full NIST (National Institute of Standards and Technology) traceability for all temperature sensing probes utilized in this system. 1. For A2LA accreditation standards see http://www.a2la.org/, 2. For ISO 17025 guidelines, See http://www.standards.org/standards/listing/iso_17025, 3. For NIST information See http://www.nist.gov/index.html • The system, including system software, must comply with requirements of the FDA Good Lab Practices regulations, including 21 CFR Part 11. 1. For FDA Good Lab Practices regulations, See: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58, 2. For 21 CFT Part 11 See: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm 3. The system has to be approved by the FDA Office of Information Management (OIM) and IT Investment Management (ITIM). 4. The system's software package must be approved by the FDA's Office of Information Management (OIM) and IT Investment Management (ITEM). The system's software package must address the current laboratory operations and provide security that renders it compliant with 21 CFR Part 11 (e.g. certified and approved for use on the FDA business network) and supported on Windows 7-64 bit operation system. • INSTALLATION: The vendor shall provide inside delivery, installation, setup, and optimization of the system. Warranty period will commence after the installation of the system is accepted by the Program.  During installation the contractor may shall coordinate activities with facilities staff and the COR. As this is a facility that is currently operating it is possible that not all rooms or equipment will be available at all times.  If installation of probes inside ultralow freezers requires freezers to be empty or at ambient temperature, then only approximately 20% of the ultralow freezers will be available each week during installation.  After installation vendor is required to demonstrate full system functionality by conducting an IQ/OQ validation. • TRAINING: The Contractor shall provide on-site training to approximately 3-5 laboratory personnel within 2 weeks after the system has been delivered, installed and accepted by the Program.  The purpose of the training is to familiarize staff with the proper use of the system including:  system operations (including software)  calibration  optimization  basic and routine preventative maintenance procedures  cleaning requirements  any safety and related safeguards as appropriate;  information on what users should do if a unit or the system is not functioning properly  any other topics deemed necessary to familiar FDA employees with the system.  This training should last 16 hours.  Contractor shall provide all training materials (web based or written) 7 days before installation. • Warranty and Maintenance/Support Agreement: 1. Warranty: Vendor shall include:  Trouble shooting for issues that arise during normal operation conditions  Vendor will be responsible for parts, travel, and labor for these site visits  All components of the system shall be covered by a minimum one year warranty, with full replacement of any/all components that fail or malfunction within that timeline 2. Maintenance/Support Agreement: Option year maintenance agreement to cover the following:  Unlimited Phone and email support during normal business hours, (Monday-Friday, 8 AM-5PM EST)  Trouble shooting capabilities based on complete knowledge of the entire system, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original equipment manufacturer  Corrective maintenance, service and repairs shall include all labor, travel and parts  At least one (1) preventative maintenance visit (which shall include a calibration program in which a NIST Traceable certificate will be issued by the vendor to the Government) or more as suggested by the manufacturer  All maintenance and repair work activities shall be accomplished with certified technicians/engineers following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.  System software and firmware updates required for reliability.  System software and firmware updates needed for all annual certifications for the Government to comply with the FDA Good Lab Practice Regulations (See Page 3 for reference)  Service Records and Reports: The Contractor shall commensurate with the completion of each service call (inclusive of warranty service work) provide the end user of the equipment with a copy of a 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 affect the repair or otherwise perform the service, the names (s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Period of Performance/Delivery Schedule: • Stand Alone Temperature Monitoring System, Delivery, Installation, Training, One Year Warranty; Period of Performance: 9/15/2014-9/29/2015 • Additional temperature sensing probes for the first year; Period of Performance: 9/15/2014-9/29/2015 • Option Year 1 - Maintenance Agreement on the Stand Alone Temperature Monitoring System; Period of Performance: 9/30/2014-9/29/2015 • Additional temperature sensing probes for the second year; Period of Performance: 9/30/2015-9/29/2016 • Option Year 2- Maintenance Agreement on the Stand Alone Temperature Monitoring System; Period of Performance: 9/29/2016-9/29/2017 • Additional temperature sensing probes for the third year; Period of Performance: 9/30/2016-9/29/2017 • Option Year 3- Maintenance Agreement on the Stand Alone Temperature Monitoring System; Period of Performance: 9/30/2017-9/29/2018 • Additional temperature sensing probes for the fourth year; Period of Performance: 9/30/2017-9/29/2018 • Option Year 4- Maintenance Agreement on the Stand Alone Temperature Monitoring System; Period of Performance: 9/30/2018-9/29/2019 • Additional temperature sensing probes for the fifth year; Period of Performance: 9/30/2018-9/29/2019 PART 4 - INSPECTION AND ACCEPTANCE The Contracting Officer's Representative (COR) will perform inspection and acceptance of the system, training, and repair services to be provided. 4.1. For the purpose of this PART, (COR - to be determined upon contract award) is the authorized representative of the Contracting Officer. 4.2. Inspection and acceptance will be performed at the locations identified in 6.1.3. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt. 4.3. This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available. PART 5 - PLACE OF PERFORMANCE 5.1. DELIVERIES Satisfactory performance of this contract shall be deemed to occur upon delivery, installation of the systems described in PART 3 of this solicitation, training and upon acceptance by the COR, of the services and reports required at the dates specified within PART 3 of this request for proposal. 5.2. PERFORMANCE LOCATION: The stand-alone temperature monitoring system shall be installed and serviced at the following FDA location: Food and Drug Administration CVM MOD 2 8401 MUIRKIRK ROAD LAUREL, MD 20708 PART 6 - CONTRACT ADMINISTRATION DATA 6.1 CONTRACTING OFFICERS REPRESENTATIVE (COR) The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award) 6.1.1 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. 6.1.2 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 RFP; (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. 6.1.3 The contact information for the Contracting Specialist: Gina Jackson Gina.Jackson@fda.hhs.gov Tel: 240-402-7590 6.1.4 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 6.2 INVOICE SUBMISSION FDA Invoice Requirements: 3-Way match : The contractor shall submit one (1) original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor Mail Hub 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov Invoices submitted under this contract must comply with the requirements set fort in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice date and invoice number; (III) 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; and (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 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 financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact as referenced on the purchase order; and (XII) Any other information or documentation required by the purchase order/award. 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 invoice payments should be directed to the FDA Payment Office at telephone number provided above. PART 7- HHSAR AND FAR CLAUSES 7.1 HHSAR CLAUSES INCORPORATED BY REFERENCE 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. HHSAR Clause Description Date 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences, (Jan 2001) and seminars to persons with disabilities 7.2 FAR Clauses 52.252-2 Clauses Incorporated by Reference 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 52.212-2 Evaluation -- Commercial Items (Jan 1999) 52.212-4 Contract Terms and Conditions - Commercial Items (Sep 2013) 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013) 52.243-1 Changes Fixed Price (Aug 1987) FAR CLAUSES BY FULL TEXT 52.217-5 Evaluation of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice anytime prior to contract expiration. 52.217-9 Option to Extend the term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice anytime prior to contract expiration. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (JAN 2014) (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) (Pub. L. 108-77, 108-78). (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 (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). __ (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 (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Jul 2010) (Pub. L. 111-5). __ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (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). __ (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] _x_ (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 (Jul 2013) (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)). __ (ii) Alternate I (Oct 2001) of 52.219-9. __ (iii) Alternate II (Oct 2001) of 52.219-9. __ (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-Subcon-tracting 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). __ (ii) Alternate I (June 2003) of 52.219-23. __ (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 Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). _x_ (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) (15 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)). _x_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X_ (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 (Sep 2010)(38 U.S.C. 4212). _X_ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). __ (34) 52.222-37, Employment Reports on Veterans (Sep 2010) (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.) __ (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) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). __ (39)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423). __ (ii) Alternate I (Dec 2007) of 52.223-16. _x_ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513). __ (41) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (42)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (Nov 2012) (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 (Mar 2012) of 52.225-3. __ (iii) Alternate II (Mar 2012) of 52.225-3. __ (iv) Alternate III (Nov 2012) 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. 255(f), 10 U.S.C. 2307(f)). __ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 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 (Jul 2013) (31 U.S.C. 3332). _x_ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). _x_ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). __ (7) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O.13495). __ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (9) 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 (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (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 (Jan 2013) (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 (Sep 2010) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (vii) 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. (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 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)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (Aug 2013). (xiii) 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). (xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause) 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 OFFEROR 9.1: CONTRACT TYPE: COMMERCIAL ITEM-FIRM FIXED PRICED 9.2: AWARD CRITERIA: THE GOVERNMENT WILL AWARD THIS REQUIREMENT TO THE LOWEST PRICED TECHNICALLY ACCEPTABLE QUOTE. 9.3 INSTRUCTIONS: • The Offeror's price quote shall have a technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary • The Offeror's price quote requires that the vendor propose an installation time line that shall detail demolishing work and/or installation of system and the effects on such installation to continuing FDA operations. The FDA has set a limit of 12 hours/space as the maximum disruption possible for each affected space. • Site Visit: All interested contractors are invited to a site visit on Tuesday, August 19, 2014 from 1pm to 4\pm at the FDA Facility. It is strongly encouraged for all interested contractor to attend this site visit. FDA/CVM Office of Research 8401 Muirkirk Road MOD 2, Conference Room G100 Laurel, MD 20708 To register for the site visit, please contact Howard S. Yablon at howard.yablon@fda.hhs.gov. 9.4: PERIOD OF ACCEPTANCE OF OFFERS: THE OFFERORS AGREE TO HOLD THE PRICES IN ITS OFFER FIRM UNTIL SEPTEMBER 30, 2014. RESPONSE DATES Quotes Due Date: All quotes shall be submitted via email Howard.Yablon@fda.hhs.gov by 2:00 PM EASTERN TIME on Friday, August 29, 2014..
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