FDA-RFP-2020-1229385 Clinical Support.doc

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Notice Type: RFQ: Combined Synopsis/Solicitation

Subject: Request for Quotes: FDA-RFP-2020-1229385 - Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.

Section 1 - General 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-2020-1229385: 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 2020-06. This requirement is being solicited as a total small business set-aside 100% (for small businesses only) using the Simplified Acquisition Procedures per FAR Subpart 13.5.

The associated NAICS Code is: 621111 Orthopedic physicians' offices (e.g., centers, clinics).

Section 2 - Contract Type The Government intends to award a Firm Fixed-Price (FFP) Contract, to procure the requested Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.

Section 3 - Description/Specifications and Work Statement.

3.1. Background

The mission of the Center for Devices and Radiological Health (CDRH) or (Center) is to protect and promote the public health. CDRH ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products the Center oversees. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

3.2. Objective

The objective of this acquisition is to identify the true scope of metal-implant related adverse health outcomes. The effort will require multiple sources of demographic, clinical and epidemiological Real-World Data (RWD) on adverse outcomes in relation to device/material characteristics. CDRH expects to explore correlations between patient characteristics and sequalae resulting from metal-associated computability issues in specific patient subpopulations - revealing the true nature and frequency of device-related adverse outcomes. This requires a study that collates patient data on adverse outcomes resulting from implanted metal-based medical devices, in order to:

To meet these goals, CDRH is requesting patient/device-related RWD data regarding metal-based implanted devices. CDRH has prioritized the list of devices as shown below, with orthopedic devices as a primary priority, and additional metal-based implants as secondary areas of interest. CDRH recognizes that many of these devices may not be a part of systematic surgical intervention within all healthcare facilities, and therefore the relevant information may not always be readily available.

Additionally, the Contractor shall obtain data from multiple academic-hospitals/patient care facilities providing the same types of data for each group.

Specifically, CDRH recognizes that conventional RWD sources may have limited information on device-related characteristics such as constituent materials (metal). To avoid potential loss of valuable clinical information, cases with implanted devices (listed below) but of unknown composition can be included in separate subcategories.

3.3. Scope. Priority List of Implanted Metal-based Devices

Priority # 1: Metal-based Orthopedic Devices

Group I Total hip replacement Hip resurfacing Hemiarthroplasty Bi-polar systems, and Dual mobility systems Group II Total knee arthroplasty Unicompartmental knee replacement Shoulder joint arthroplasty Reverse total shoulder replacement Total elbow replacement Wrist joint replacement Total ankle arthroplasty, and Total toe arthroplasty

For orthopedic devices, information on combination materials should be specified using the following categories:

Metal-on-metal (MoM)

Metal-on-polyethylene (MoP) Ceramic-on-metal (CoM) Ceramic-on-polyethylene (CoP)

Priority # 2: Non-Orthopedic Metal-based Implants, including but not limited to:

The Contractor shall obtain data from multiple academic-hospitals/patient care facilities providing the same types of data for each of the groups in Priority 1 and Priority 2. Prior to initiating the study, the Contractor shall provide the Contracting Officer’s Representative (COR) the names of the academic-hospitals/patient care facilities that will be included in the study.

Device composition of metal-based implants should be further specified (e.g., stainless steel or nitinol for bare metal stents).

Cases that represent one of the listed metal-based device categories, but which lack detailed information on device composition should be categorized using “metal” as a category (e.g., bare metal stent, when it’s not known whether a stent is made of nitinol or stainless steel) or unspecified category (e.g., hip replacement – unspecified, when a hip device is expected to contain metal, but the MoM, MoP, or CoM subcategories can’t be specified).

Tasks Task One: Gather Clinical/Epidemiological Information on Metal-based Implants from Real-World Data (RWD) sources.

The Contractor shall provide de-identified patient/device-related data pertaining to the devices described above. This data shall include pre- and post-implantation information, including but not limited to:

1) Device/material characteristics (defined per device type)

2) Patient characteristics:

DOB, age, sex, height, weight, and race/ethnicity History of occupation

3) Detailed information on all primary diagnoses, comorbidities (diagnoses concomitant or concurrent with a primary condition), and procedures before and after implantation With time of diagnosis, when available

4) Date of implant surgery as well as date(s) of explanation and/or other noted surgical intervention(s) due to implant-associated complications

5) Lab test data (including generic tests), if available

6) Reported information should include cases with implanted devices and no diagnosed conditions or otherwise detectable manifestations.

7) Clinical information should include symptoms and signs, in addition to diagnoses, and it should be reported regardless of the supposed relationship to implants/materials.

e.g., fatigue, malaise, or “memory fog”, etc.

8) Patient’s clinical information should include history, and in relation to the following conditions in particular:

e.g., rheumatoid arthritis, lupus, etc.

History of cancer or diabetes Note: This SOW is focused on the first task of gathering clinical/epidemiological information relevant to metal-based implanted devices.

3.4. Kickoff Meeting

The Contractor shall contact the COR and schedule a kickoff meeting within 5 workdays after the date of contract award. The Contractor shall include all Contractor personnel considered critical to performance of the contract. The Contractor shall take notes during the kickoff meeting and provide meeting minutes to the COR within 5 workdays following the kickoff meeting.

3.5. Project Milestone Schedule

The Contractor shall provide a draft milestone schedule outlining planned actions for successful performance of the contract. The draft milestone schedule shall be presented during the kickoff meeting. The final milestone schedule shall be included with the submission of the kickoff meeting minutes. Throughout performance of the contract, the Contractor shall revise the schedule to reflect any changes to the original schedule. The revised schedule shall be submitted to the COR within 2 workdays of the revision date.

3.6. Bi-Monthly Reports

The Contractor shall provide bi-monthly status reports, as identified at the start of the contract. The Contractor shall provide (by the tenth workday of each month) monthly progress to date and financial status reports to the Contracting Officer’s Representative (COR).

These reports shall detail activities performed, potential problems, proposed solutions, progress to date, and, as well as any other specific information relevant to the contract’s successful completion.

Final Summary Report shall be included with the last bi-monthly report. This will outline what was completed/implemented during the period of performance.

Reports shall be submitted via email as attachments in Microsoft Word and/or Microsoft Excel. For “big data” files, further details on data reporting will be clarified further per data curation.

3.7. Summary Report of Study and Results

The Contractor shall provide a draft and final summary report that summarize all work conducted and provide all the results specified in the study. The report shall include tables and aggregated data and a narrative summary of the study results. The final summary report shall adequately address CDRH comments made during review of the draft report.

3.8. Draft Summary Report

A draft of the Final Study Report shall be provided to CDRH for review and comment. It shall summarize all work conducted during performance of the tasks and include tables with aggregated data and a narrative summary of the study results.

3.9. Final Summary Report

The Final Study Report shall address any CDRH comments regarding the draft report.

3.10. Deliverables

a) Format Of Deliverables Deliverables (both in draft and final versions) shall be provided in hard and soft copy using MS Office products as specified below. Interim, informal, and working-copy products may be provided by e-mail to the COR. Final soft copies of deliverables shall be developed using the current FDA version of Microsoft Office products and/or other standard application software. Final hard copies of deliverables shall be typewritten on 8-1/2"x11" white paper. The Contractor shall not use spiral binding or other binding that interferes with photocopying.

b) Deliverables Submission Procedure The Contractor shall submit all deliverables to the COR, unless otherwise stated. The COR will be responsible for the review of all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the guideline requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, and "padding,” or excessive length (if a page limit is imposed), shall be considered deficiencies and will be subject to correction by the Contractor at no additional cost to the Government. Unless specified otherwise, the Government shall have ten (10) working days to complete the review and approve the deliverables. If deficiencies are found or areas require modification, the Contractor will be notified and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the Government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the Government may consider the Contractor as having deficient performance with respect to the subject task.

c) Table Of Deliverables Deliverables SOW Reference Description Quantity / Frequency Due Date 4.2.1 Kickoff Meeting Minutes Once Within 5 workdays following the date of the kickoff meeting 4.2.1 Draft milestone schedule Once Due during the kickoff meeting 4.2.2 Final milestone schedule (initial and revisions) Initial – Once Revisions – each revision The initial schedule is due within 5 workdays following the kickoff meeting. Revisions are due within 2 workdays of the revision date.

4.2.3 Bi-Monthly progress and financial status reports One – Bi-monthly The 10th workday of the month due, beginning on the date of award 4.2.4.1 Draft Summary Report Once Draft: 6 months after the date of award

4.2.4.2 Final Summary Report Once Due first workday of the final month of the period of performance NOTE****: Workdays are Monday - Friday, excluding Government holidays or days the Government or FDA is shut down.

3.11. Place Of Performance

The primary place of performance is the Contractor’s facility.

As required by the COR, the Contractor may need to make visits to Building 66, FDA White Oak campus, Silver Spring, MD, for status updates.

3.12. Payment Schedule.

The Contractor shall submit monthly invoices, documenting the tasks/work accomplished during the period under consideration. For invoicing procedures, see the FDA Invoice Submission Instructions provided later.

Criteria for Acceptance/Surveillance

The FDA TPOC or designee has the authority to accept or reject deliverables. The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverable. The COR will monitor the Contractor’s performance by reviewing Monthly Status Reports and attending teleconference meetings.

Packing, Marking, Delivery and Shipping:

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

The U. S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Division of Biology, Chemistry, and Materials Science (DBCMS) Office of Science and Engineering Laboratories (OSEL) White Oak Building 64 Room 4076 10903 New Hampshire Avenue Silver Spring, MD 20993

Period of Performance

Performance of this contract shall begin on 9/15/2020 THRU 9/14/2021 (One Year) 12 Months.

CLIN

Description Period of Performance Qty Clinical Support

9/15/2020 THRU 9/14/2021

Contracting Officer’s Technical Point of Contact (TPOC)

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

Technical Direction

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.

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.

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.

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."

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

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 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights.

April 2014 3.908-9 52.204-7 System for Award Management.

Oct 2018 4.1105(a)(1) 52.204-14 Service Contract Reporting Oct 2016 4.1705(a)

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) 352.227-14 Rights in Data—Exceptional Circumstances.

Sept 2014 327.409 352.239-74 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

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 any time before the contract expires.

Federal and HHS Information Security Program Policies

This contract requires the Contractor, pursuant to Federal and HHS Information Security Program Policies, and any subcontractor performing under this contract, to comply with the following requirements:

Contractor-Employee Non-Disclosure Agreements: Each Contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete the Commitment to Protect Non-Public Information – Contractor Agreement (http://nitaac.nih.gov/downloads/ciosp2/Contractor Employee Non-Disclosure.doc).

A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COR prior to performing any work under the contract.

Confidential Treatment of Sensitive Information: The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of any task order issued under this contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the task order is of a sensitive or of pre-decisional nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer or designee. Whenever the Contractor is uncertain about the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer or designee (e.g., the COR).

Contractor and Subcontractor Staff: The Contractor shall submit a roster, by name, position and responsibility, for all staff (including subcontractor staff) working under task orders of this contract. The roster submitted to FDA shall be submitted to the COR, with a copy to the Federal Contracting Officer, within 2 business weeks of the effective date of the task order.

Security and Privacy

Contractor personnel performing work under the Contract 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’s personnel agree 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.

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 years 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.

Holidays

FDA personnel observe the FDA following days as holidays:

New Year's Day

Columbus Day Washington's Birthday Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day Labor Day Martin Luther King's Birthday Any other day designated by Federal statue Any other day designated by Executive Order 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 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.

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.

Inspection and Acceptance:

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

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items. (Mar 2020)

(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)).

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.

(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.)

(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).

(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.

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)).

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.

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— 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509).

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.

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).

Note to paragraph (e)(1)(xvi): 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.

(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.

FAR 52.247-34 - F.O.B Destination (Nov 1991)

Order of Precedence

The Contractor shall follow the terms and conditions of this solicitation. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. Any additional terms and conditions shall not be prohibited by applicable laws and regulations.

FAR 52.223-15 ENERGY EFFICIENCY IN ENERGY-CONSUMING PRODUCTS (DEC 2007)

Definition. As used in this clause- “Energy-efficient product”-

subcontractor) unless-

FEMP at…