FDA-20-SOL-1229732.pdf
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FDA-20-SOL-1229732
Statement of Work (SOW)
1. INTRODUCTION:
Winchester Engineering and Analytical Center (WEAC) requires an instrument capable of simulating use of electronic nicotine delivery systems (ENDS), (i.e. e-cigarettes, vapors, mods, e-hookahs, etc.). This equipment will be necessary to conduct research and develop test methods related to such products. A hardware and software upgrade is required to accomplish this method.
2. BACKGROUND:
WEAC has been charged with the development of test methods for ENDS products. To accomplish this method development, we purchased a smoke machine in 2017 under FDA-20-RFQ-1225586; that machine now needs a hardware and software upgrade to accommodate research and regulatory requirements. The smoke machine that is currently at WEAC, the Cerulean (CETI), lacks the ability to sense aerosol on any of the 8 channels. The capability provided by this instrument will enable WEAC engineers to analyze the physical parameters and characteristics while the products are in operation, (i.e. power delivery, battery performance, draw resistance, heating element temperature, etc.). This function is required to verify proper operation of the ENDS product and determine the rate of consumption for the ENDS fluid to study operation as well as confirm when test is complete. Without this instrument, such analysis will not be practical in a laboratory setting.
3. SCOPE:
The contractor shall provide installation and training, and maintenance support for the Smoke Machine and accessories that meets all the performance specifications, when necessary.
4. REQUIREMENTS:
The contractor shall:
This is an upgrade to a system currently owned by the United States government. This hardware and software upgrade must be compatible with the current system in place; the Ceti-8 8 Channel Cigarette Tester, manufactured by Cerulean stock number MF0001.
Minimum Technical Requirements:
At a minimum, the electronic nicotine delivery system (ENDS) testing device shall meet the minimum technical requirements identified below:
• Programmable puffing routines, (i.e. the airflow parameters must be programmable)
• Control of puff shape, volume, duration, interval and number of puffs taken allowing capture on a filter pad
• Ability to determine presence of aerosol in order to determine consumable rate and proper function of ENDS
• Must be able to test various types of ENDS devices
• Capable of testing a single ENDS, or multiple ENDS devices simultaneously.
i.e. Test between 1 and 8 e-cigarettes
• Stand-alone device with built in computer and touch screen display/interface o Windows 7 operating system o LIMS system o Data interface: USB2 / Ethernet / RS232 o Output interface to a printer
• The equipment must be able to tilt the ENDS downward from horizontal
• Ability to test ENDS at various angles e.g. test at 10⁰-20⁰ intervals between ±90° from the horizontal position.
• Automatic push button activation for switch activated ENDS devices
• Ability to test ENDS devices with push button activation.
• Software allowing the operator to setup libraries and test regimes
• Fully password protected with administrator defined user profiles
• Approximate size requirements:
Depth: 25 in; Width: 36 in; Height: 20 in
Trade and Service Specifications
1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.
2. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation. The system must include at least a three (3) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair, and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.
3. System shall be a turn-key solution i.e. the Contractor shall be responsible for providing all hardware, components, and that otherwise required to meet these specifications, the FDA’s stated need, and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Upon installation, the system must meet or exceed all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met.
4. The contractor shall provide assembly and installation of the equipment at time of delivery or shortly thereafter (within 30 days), such that the equipment shall be ready to operate.
5. User and maintenance manuals are required.
6. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.
7. Provide all hardware updates and fixes according to the support level required and the service level agreement established by Original Equipment Manufacturer.
Records and Reports
The Contractor shall, commensurate with the completion of each service call (inclusive of warranty services), 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 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, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).
5. DELIVERABLES:
Description Quantity Delivery Date CETI-8 hardware and software upgrade 1 Within 8 weeks of contract award date
Support Coverage Certificate 1 Within 60 days of contract award date
6. DELIVERY POINT:
ORA/Winchester Engineering and Analytical Center 109 Holton St.
Winchester, MA, 01890
FAR / HHSAR Clauses
52.212-4 Contract Terms and Conditions Commercial Items (JAN 2017)
52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items. (June 2020)
(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
(4) 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 (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)).
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__ (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.)
__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).
__ (5) [Reserved].
__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of
Div. C).
__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct
2016) (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 (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).
__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).
__ (ii) Alternate I (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
__ (iv) Alternate III (Nov 2016) of 52.219-9.
__ (v) Alternate IV (Nov 2016) of 52.219-9.
__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).
_x_ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (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 Representation (Jul 2013) (15 U.S.C. 632(a)(2)).
__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).
__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business
Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).
_x_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).
_x_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).
_x_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
_x_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
_x_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).
_x_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
_x_ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).
__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)
(E.O. 13496).
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__ (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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).
__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).
__ (38)(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.
__ (39)(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.
__ (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 (OCT 2015) (E.O.s
13423 and 13514).
__ (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) (E.O. 13513).
__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).
__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).
__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
__ (ii) Alternate I (JAN 2017) of 52.224-3.
_x_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).
__ (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C.
chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103- 182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
__ (ii) Alternate I (May 2014) of 52.225-3.
__ (iii) Alternate II (May 2014) of 52.225-3.
__ (iv) Alternate III (May 2014) of 52.225-3.
__ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
_x_ (49) 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).
__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct
2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.
2302 Note).
__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42
U.S.C. 5150).
__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
__ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C.
2307(f)).
_x_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)
(31 U.S.C. 3332).
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__ (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).
__ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
_x_ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
__ (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).
__ (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46
U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
__ (ii) Alternate I (Apr 2003) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:
__ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).
__ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).
__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41
U.S.C. chapter 67).
__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment
(Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment
(May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).
__ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).
__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C.
1792).
__ (11) 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).
https://www.acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153375 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/sites/default/files/current/far/html/52_232.html#wp1153445 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section3332&num=0&edition=prelim https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113650 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+2+3++%285%29%20%20AND https://www.acquisition.gov/sites/default/files/current/far/html/52_241_244.html#wp1128833 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1153423 http://uscode.house.gov/ http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148260 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148274 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1155380 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1163027 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1170084 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1120023 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_215.html#wp1144470 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%204_7.html#wp1082800
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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.
(iv) 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.
(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)
(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)
(x) 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.
(xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).
(xii)
52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).
(xiii) 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).
(xiv) 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).
(xv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).
(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xvii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xviii)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
(B) Alternate I (JAN 2017) of 52.224-3.
(xix) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct
2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.
2302 Note).
(xx) 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.
(xxi) 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) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to “paragraphs (a), (b), (c), or (d) of this clause” in the redesignated paragraph (d) to read “paragraphs (a), (b), and (c) of this clause.”
Alternate II (Nov 2017). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:
(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—
(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147587 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147656 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147711 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1148123 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1155380 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1156645 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1163027 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1170084 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1192524 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+1445+65++%2810%20U.S.C.%202302%20Note%29%20%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t45t48+351+1++%2846%29%20%20AND%20%28%2846%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t09t12+37+408++%2810%29%20%252 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_3.html#wp1084399 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_3.html#wp1084399 http://uscode.house.gov/lawrevisioncounsel.shtml
(ii) Interview any officer or employee regarding such transactions.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—
(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and
(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—
(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment
Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).
(C) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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.
(D) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(E) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
(F) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(G) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
(H) 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.
(I) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).
(J) ___(1) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and
E.O 13627).
___(2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).
(K) 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).
(L) 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).
(M) 52.222-54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).
(N) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(O) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(P)(1)52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
(2)Alternate I (JAN 2017) of 52.224-3.
(Q) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;
10 U.S.C. 2302 Note)
(R) 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.
(S) 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.
FAR 52.252-2: Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:
https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/lawrevisioncounsel.shtml https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147656 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147711 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1158632 http://uscode.house.gov/lawrevisioncounsel.shtml https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162802 http://uscode.house.gov/lawrevisioncounsel.shtml https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160019 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1160021 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1155380 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1162590 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1156645 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1163027 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1170084 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1192524 https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_223_226.html#wp1183820 https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 http://uscode.house.gov/lawrevisioncounsel.shtml http://uscode.house.gov/lawrevisioncounsel.shtml http://uscode.house.gov/lawrevisioncounsel.shtml https://www.acquisition.gov/sites/default/files/current/far/html/52_247.html#wp1156217 http://farsite.hill.af.mil/vffara.htm.
(End of Clause)
FAR 52.203-19: Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)
FAR 52.222-26: Equal Opportunity (Sep 2016) FAR 52.232-39: Unenforceability of Unauthorized Obligations (Jun 2013)
This contract incorporates one or more HHSAR clauses by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address:
http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.
HHSAR 352.203-70: Anti-Lobbying (Dec 2015)
HHSAR 352.222-70: Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)
HHSAR 352.239-74: Information and Communication Technology (ICT) Accessibility
• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)
• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)
• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)
• E205 Electronic Content (Appendix A, Application and Scoping)
• 302 Functional Performance Criteria (Appendix C, Application and Scoping Requirements)
Language for Insertion in Acquisition Documentations Based on the Change to Disable Macros in Microsoft Office Documents from Outside Sources Be advised that FDA does not accept documents which contain the use of macros. Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.
(End of Clause) FAR / HHSAR Provisions FAR 52.252-1: Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer.
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