FDA-RFP-2019-1212959_Two_(2)_USP_1_&_2_Dissolution_systems..pdf

Notice Type: Combined Synopsis/Solicitation

Subject: Request for Quotes: FDA-RFP-2019-1212959: Two (2) Dissolution Systems for USP Apparatus1 & 2

Section 1 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued.

Solicitation Number # FDA-RFP-2019-1212959: is being issued as a Request for Quotations (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2019-01. This requirement is being solicited as a total small business set-aside (for small businesses only) using Simplified Acquisition Procedures per FAR Subpart 13.5.

The NAICS Code is: The associated NAICS Code is: 334516 (Analytical Laboratory Instrument Manufacturing with a small business size standard of 500 employees.

Background.

The U. S Food & Drug Administration, Office of Acquisitions and Grants Services, Division of Pharmaceutical Analysis (DPA) has a requirement for the procurement of Two

(2) Dissolution Systems for USP Apparatus1 & 2. The dissolution apparatuses currently used at DPA are very old and have been used over 30 years and need to be upgraded. There is also a need for DPA chemists to become familiar with new technological features of these systems as they appear in manufacturers’ dissolution methods. The new dissolution systems are better integrated to monitor changes in operating parameters, change filters in mid run to prevent clogging and transfer data to a computer network.

Section 2. Contract Type The Government intends to award a Firm Fixed-Price Contract.

Section 3 Description

3.1. Specifications/Salient Characteristics.

The requested USP 1 & 2 Dissolution Systems, shall at a minimum, include the following:

i) The size of dissolution system shall be 80 inches width x 30 inches depth x 40 inches height.

ii) Power shall be 115V.

iii) Shall provide heat circulator.

iv) Shall provide water bath.

v) Shall contain six (6) -Paddle shafts.

vi) Shall contain six (6) -Basket shafts.

vii) Shall contain six (6) -Baskets.

viii) Shall contain six (6) 1-liter vessels.

ix) Shall contain six (6) -Covers for 1-liter vessels.

x) Shall contain six (6) -Sampling probes that are programmable to either stay in the medium during the run and enter and exit the medium when sampling.

xi) Shall provide Auto Sampler with piston or syringe pump.

xii) Shall provide sample collector.

xiii) Shall provide rack for 13mm x100mm test tubes.

ix) Shall provide rack for 12mm x 32mm HPLC vials.

x) Shall contain retrieval reservoir.

xi) Shall provide auto filter changer that uses commercially available 25mm syringe filters.

xii) Shall easily apply American Society for Testing and Materials (ASTM) for mechanical qualification

xiii) Shall provide Installation Qualification, Operational Qualification, and Mechanical

Qualification (IQ/OQ/MQ) upon dissolution system installation

xiv) Shall provide consumables required to execute IQ/OQ/MQ.

xv) Shall have the ability to transfer data to a computer network

3.2. Other Considerations.

i) The requested instruments shall be a newly manufactured unit, not used and refurbished, and previously used for demonstration.

ii) The Vendor shall provide user training to 10 analysts including operations and maintenance upon dissolution system installation.

iii) The Vendor shall provide a One Year (12 Months) warranty for hardware products.

iv) Acceptance Criteria. After the delivery and installation of the system, the Government shall have 30 working days to inspect and verify that the equipment is operational and functional. Acceptance to be made after completion of IQ/OQ/MQ and training.

3.3. Packing, Marking, Delivery and Shipping:

At a minimum, all deliverables shall be marked with the contract number and Contractor’s name and delivered and installed at the US Food and Drug Administration (FDA) facility address listed below:

Food and Drug Administration Division of Pharmaceutical Analysis, 645 S. Newstead Avenue St. Louis, MO 63110

Delivery and installation of the two (2) Dissolution System shall be within 90 days after contract award. Delivery of IQ/OQ/MQ reports shall follow ASTM required reporting within 30 days after completion of system installation.

3.4. Period of Performance

The period of performance is 12 months from date of contract award.

3.5. The deliverables shall be:

Deliverable Table LIN Description Quantity 0001 Two (2) Dissolution Systems for USP Apparatus1 & 2 2

0002 One year (12 Months Warranty) for hardware products. 1 0003 Shipping/Installation/Training 1

Note****: Grey market or refurbished products will not be accepted.

3.6. Contracting Officer’s Technical Point of Contact (TPOC)

The TPOC is responsible for the acceptance of the items or services requested.

3.7. Technical Direction

A. Performance of the work under the resultant contract shall be subject to the technical direction of the TPOC. The term "technical direction" is defined to include the following:

i). Technical directions to the Contractor which shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual scope of work;

ii). Providing information to the Contractor for assistance in the interpretation of specifications, or technical portions of the work description, and iii). Reviewing and, where required by the contract, approving of technical reports, specifications, and technical information to be delivered by the Contractor to the Government under the requirement.

B. Technical direction shall be within the general scope of work stated in the contract. The TPOC does not have the authority to, and may not, issue any technical direction which (1) constitutes an assignment of additional work outside the general scope of the contract; (2) constitutes a change as defined in the contract clause entitled "Changes, FAR 52.212 – 4 (c)." (3) in any manner causes an increase or decrease in the total contract price; or (4) changes any of the expressed terms, conditions, or specifications of the contract.

C. All technical directions shall be issued in writing by the TPOC or shall be confirmed by him/her in writing within five (5) working days.

D. The Contractor shall proceed promptly with the performance of technical directions duly issued by the TPOC in the manner prescribed by this clause and within his/her authority under the provisions of this clause.

E. If, in the opinion of the Contractor, any instruction or direction issued by the TPOC is within one of the categories as defined in B. (1) through B. (4) above, the Contractor shall not proceed but shall notify the Contracting Officer, in writing, within five (5) working days after the receipt of any such instruction or direction and shall request the Contracting Officer to modify the Contract accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate contract modification or advise the Contractor, in writing, that, in his/her opinion, the technical directions are within the scope of this clause and do not constitute a change under the "Changes" clause of the contract. The Contractor shall thereupon proceed immediately with the direction given.

Any failure of the parties to agree upon the nature of the instruction or direction, or upon the contract action to be taken with respect thereto, shall be subject to the provisions of the contract clause entitled "Disputes."

3.8. Contracting Officer’s Authority

The Contracting Officer (CO) is the only person authorized to approve changes in any of the requirements of the statement of work. In the event the Contractor effects any changes at the direction of any person other than the CO or the TPOC the changes shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract and modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds.

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

Section 4. Contract Clauses

4.1 FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Oct 2018).

4.2. 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 these addresses:

www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301- 1.html.

FAR Clause Title Date Reference 52.203-3 Gratuities Apr 1984 3.202 52.204-7 System for Award Management. Oct 2018 4.1105(a)(1) 52.203-17 Contractor Employee Whistleblower

Rights and Requirement to Inform Employees of Whistleblower Rights.

April 2014 3.908-9

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

Dec 2013 32.009-2

HHSAR Title Date Date 352.211-3 Paperwork Reduction Act. Dec, 2015 311.7301

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

Dec, 2015 322.810(h)

352.239-74 Electronic Information and Technology Accessibility Notice.

Dec 2015 339.203-70(b)

Health and Human Services Acquisition Regulation (HHSAR) Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1- InstructionsforUsingProvisionsandClauses

4.3. Service Records and Reports: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), 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 http://www.acquisition.gov/far/index.html http://www.hhs.gov/policies/hhsar/subpart301-1.html http://www.hhs.gov/policies/hhsar/subpart301-1.html http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/03.htm#P208_35152 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/03.htm#P602_101529 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/32.htm#P128_17080 http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses 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 TPOC 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;

negative reports are required.

4.4. FAR 52.217-8 - Option to Extend Services. (Nov 1999)

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

4.5. Security and Privacy

Contractor personnel performing work under the Contract r shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the Contract, unless made public by FDA or upon written approval from the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

The Contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the requirement that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the TPOC, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the Contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each Contractor/Subcontractor employee who may have access to non-public Department information and/or sensitive information under the Contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor’s Commitment to Protect Non- Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the TPOC or designee prior to performing any work under the Contract. The TPOC or designee will inform the Contractor of the forms and training that are required.

However, it is the responsibility of the Contractor to assure that such forms have been signed.

4.6. Contractor Performance Evaluation(s)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions.

Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

4.7. Holidays

FDA personnel observe the FDA following days as holidays:

i) New Year's Day

ii) Columbus Day

iii) Washington's Birthday

iv) Veterans' Day

v) Memorial Day

vi) Thanksgiving Day

vii) Independence Day

viii) Christmas Day

ix) Labor Day

x) Martin Luther King's Birthday

xi) Any other day designated by Federal statue

xii) Any other day designated by Executive Order

xiii) Any other day designated by the President's

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the Contract.

Except for designated around-the-clock or emergency operations, Contractor personnel shall not be able to perform on-site under the Contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the Contract In the event Contractor personnel work during a holiday observed by the Contractor other than http://www.cpars.csd.disa.mil/cparsmain.htm http://www.ppirs.gov/ http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor shall direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the Contract for employees whose regular time is normally a direct charge if they continue to perform on the work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

4.8. Disclosure of Information. Contractors are reminded that information furnished under the solicitation and contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information shall be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government shall be used only for the purpose of carrying out the provisions of the contract and m shall ust not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of the contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

4.9. Inspection and Acceptance:

4.9.1. The TPOC–upon contract award) shall perform inspection and acceptance of materials and services to be provided. Invoices shall be submitted for review and approval by the TPOC (See invoicing instructions). For the purpose of this section, the TPOC is the authorized representative of the Contracting Officer.

4.9.2. Inspection and acceptance will be performed at: the locations identified in this RFQ.

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

4.11. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items. (JAN 2019)

(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:

[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)).

__ (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 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.

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__ (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] _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 (Nov 2016) (15 U.S.C.

637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Nov 2016) (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)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-

Aside (Nov 2011) (15 U.S.C. 657 f).

__x__ (22) 52.219-28, Post Award Small Business Program Re-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 (Oct

2016) (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).

__ (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).

__ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

_x_ (32) 52.222-40, Notification of Employee Rights Under the National Labor

Relations Act (Dec 2010) (E.O. 13496).

_x_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

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

__ (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.)

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__ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

__ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).

__ (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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40)(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.

__ (41)(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.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (43) (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_(44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While

Driving (AUG 2011) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (47) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (48)(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.

__ (49) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

_x_ (50) 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).

__ (51) 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).

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__ (52) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (53) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (54) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (55) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.

4505, 10 U.S.C. 2307(f)).

_x_ (56) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (57) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (58) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (59) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (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:

[Contracting Officer check as appropriate.] __ (1) 52.222-17, Non-displacement 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.

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(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 (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…