FDA-RFP-2021-1243291.pdf

Food and Drug Administration (FDA)

Notice Type: Combined Synopsis/Solicitation

Subject: FDA-RFP-2021-1243291- 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-2021-1243291 and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC 2021-06). 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

Center for Devices and Radiological Health (CDRH) ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with comprehensible and accessible science-based information about the products it 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.

Following the Center’s public health mandate regarding safety of medical devices, the main objective of this healthcare data acquisition is to analyze adverse health outcomes that may result from the use of metal-containing implantable devices (metal implants).

This effort requires collation of patient- and device-related information using real-world data (RWD) from multiple healthcare facilities and other available sources. The gathered demographic, clinical, and epidemiological RWD regarding patients with metal implants (or their non-metal counterparts as controls) will be analyzed in relation to corresponding device/ material characteristics, in order to further improve health outcomes in patients with metal implants.

3.2. OBJECTIVE

The main objective of this data acquisition is to define the true scope of adverse health outcomes resulting from the use metal implants and thereby enhance implant safety assessment in clinical settings and help optimizing implant/material biocompatibility testing in the preclinical setting, respective to immune response. This study will explore putative correlations between demographic characteristics (e.g., sex, age, race/ ethnicity) and metal implant related clinical sequalae, to enhance predictive safety assessment in specific patient subpopulations. Overall, the study’s goals are as follows:

• Reveal the true scope and occurrence of clinically manifested adverse outcomes attributable to metal implants versus their non-metal counterparts;

• Clarify terminology/ ontology of implant-related adverse outcomes and delineate their likely biological underpinnings;

• Identify device/material-related characteristics which are more likely to result in implant reactivity, as indicated by clinically manifested adverse consequences potentially attributable to metal hypersensitivity and other aberrant immune and tissue responses

To meet these goals, CDRH is requesting patient-/ device-related RWD regarding certain groups of implantable devices.

CDRH recognizes that many devices of interest may not be a part of systematic surgical intervention within all healthcare facilities, therefore relevant information may not be readily available. To overcome this potential data limitation, the contractor shall obtain data from multiple hospitals/ patient care facilities providing the same types of data for each group with metal implants of interest as well as their non-metal counterparts identified as controls.

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

3.3. SCOPE.

Year #1: Metal-containing cardiovascular implants:

The contractor will work with FDA to define appropriate cardiovascular device categories that include non-metallic control devices, where possible. Examples of device categories of interest include: occluders and embolization devices, bare metal and coated stents, stent grafts, and heart valves.

Optional Year #2: Other metallic devices of interest

The contractor will work with the FDA to define additional categories of highest interest. These may include additional validation studies on patient data already obtained by the FDA related to large joint arthroplasty and Essure sterilization devices. These categories may also involve other device areas, such as temporomandibular joint (TMJ) arthroplasty, gastrointestinal implants, and intrauterine devices (IUD).

TASKS

TASK 1: GATHER CLINICAL/EPIDEMIOLOGICAL RWD ON METAL-CONTAINING IMPLANTS

AND THEIR NON-METAL COUNTERPARTS AS CONTROLS.

Year #1: Data Acquisition

Decision-making regarding data sources and selection approaches shall be made in collaboration with the CDRH team to ensure the appropriateness of gathered RWD for the project’s goals. Special attention shall be paid to the need for maintaining de-identified status of implant recipients when dealing with demographic/ socioeconomic and other identifiable Protected Health Information (PHI).

The stepwise data acquisition process shall include the following stages:

1. Data Sourcing:

a. Identification of healthcare facilities that possess device-related data most likely to meet the project’s objectives

2. Data Management:

a. Development of systematic approaches to ensure unbiased selection of clinical cases with implants of interest:

i. Selection of appropriate diagnosis/ procedure codes (e.g., ICD-9/10, CPT, HCPCS) for identifying implant recipients and creating comprehensive datasets with different implants of interest;

ii. Efforts to minimize potential selection biases (per year, hospital type, patient demographics, etc.);

iii. Efforts to produce a study sample which, by and large, is representative of the overall US patient populations with devices of interest;

iv. Inclusion of facilities that have surgical device information with associated manufacturer part number data within their Electronic Medical Records (EMR) system, in order to match the part number in the EMR data to the Global Unique Device Identification Database (GUDID) and thereby provide a link to device-related metadata (e.g. Product Code, Submission Number);

v. Inclusion of individual demographic information for the target cases as well as matching of the target cases to demographic/ socioeconomic meta-data, e.g., the zip code-based categorization per characteristics such as age, income, presence and type of healthcare, insurance, etc.

b. Data extraction and aggregation including but not limited to the following principles:

i. The final dataset shall be comprised of ≥10K unique patients per year;

ii. The selected cases shall satisfy a metric for reasonable pre-/post-implantation timeframe for identifying conditions that likely represent device-related complications rather than concurrent (unrelated to devices) comorbidities;

iii. In at least 10% of the target cases, implants of interest shall be linked to entries in the GUDID database and corresponding device-related metadata as explained above;

3. Data Transmission to CDRH:

a. Preparation of the final dataset and corresponding meta-data as the primary deliverable;

b. Preparation and review of Draft/Final Summary Reports as additional deliverables

c. Preparation of example datasets for CDRH to examine as an intermediary to the final data set prior to delivery

Prior to completing the Year 1 data acquisition, a data audit shall be performed by a third party to inspect the quality and consistency of collected data and verify its appropriateness for the study goals.

Following the stepwise aata acquisition process as described above, the Contractor shall provide de-identified patient/ device related RWD which shall include (but not be limited to) the following pre-and post-implantation information regarding all identified target cases:

1. Available device/ material characteristics (defined per device type)

2. Patient characteristics: e.g. DOB, age, sex, and race/ethnicity;

3. Detailed information on all primary diagnoses and comorbidities (diagnoses concomitant or concurrent with a primary condition) as well as procedures before and after implantation:

a. Description and dates (when available) for each diagnosis;

b. Description and date(s) of primary implant surgery as well as revision surgery

(explantation) and/or other noted surgical intervention(s) due to implant-associated complications

4. Clinical information shall include all reported diagnoses (e.g., diabetes, cancer) per International Classification of Diseases (ICD) as well as symptoms and signs (e.g., rash, fatigue, hair loss, “memory fog”), regardless of their assumed relationship to implants or constituent materials. Clinical information shall include any indications of the following conditions in particular:

a. Metal and/or other hypersensitivities or allergies, e.g., dermatitis, eczema, food or drug allergies, etc.

b. Autoimmune and other systemic inflammatory diseases, e.g., rheumatoid arthritis, lupus, etc.

5. Additional clinical information (e.g., surgeon notes, histopathological reports, radiographic and other imaging results, lab test data) shall be included when available

6. The gathered RWD shall include systematically obtained cases with implants of interest and their counterparts, without selecting for presence or absence of any diagnosed conditions or otherwise detectable manifestations potentially related to devices.

Year #2 (Optional): Verification of Preliminary Results and Additional Data Acquisition:

Based on project needs, Year 2 data acquisition shall follow the data sourcing and management principles described above.

The contractor shall obtain data from multiple hospitals/patient care facilities providing the same types of data for each of the device categories.

Complementary data searches (which may include natural language processing) shall be performed as needed to verify the initial findings. Additional third-party data audits shall be performed as needed to derive more granular subject-level data and further corroborate the validity of findings per main and complementary data searches.

TASK 2: TASK/PROJECT MANAGEMENT

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.

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.

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 10th workday of each month) monthly progress to date and financial status reports to the COR.

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

Summary Report on Data Acquisition

The contractor shall provide draft and final summary reports that summarize all work conducted and provide all the data details specified in the SOW. Reports shall be submitted via email as attachments in Microsoft Word and/or Microsoft Excel. Details on “big data” data transfer and reporting shall be further clarified per data curation.

Draft Summary Report

A draft of the ‘Final Study Report’ shall be provided to CDRH for review and comments before completion of the study. It shall summarize all work conducted during performance of the tasks and shall include tables representing aggregated data as well as a narrative summary describing the stepwise data sourcing and management process and the final RWD dataset.

Final Summary Report

Final Summary Report shall be included with the last bi-monthly report and shall adequately address any CDRH comments made during review of the draft report. This will outline what was completed/implemented during the period of performance.

3.10. DELIVERABLES

FORMAT OF DELIVERABLES

Deliverables (both in draft and final versions) shall be provided in hard and soft copies 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.

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.

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.

3.13. 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.

3.14. 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

3.15. Period of Performance

The anticipated period of performance is 12 months from date of contract award for the first year.

Projected dates are 09/21-08/22. If the second, optional year is exercised, the anticipated period of performance will be an additional 12 months extending from 09/22-08/23.

3.16. Contracting Officer’s Technical Point of Contact (TPOC) The TPOC is responsible for the acceptance of the items or services requested.

3.17. 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."

3.18. 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 52.252-2 - 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) 52.212-4 Contract Terms and Conditions –

Commercial – Items Oct 2018

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

4.2. 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 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://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses http://www.hhs.gov/policies/hhsar/subpart352.html#Subpart352.1-InstructionsforUsingProvisionsandClauses 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.

FAR 52.217-9 Option To Extend the Term of the Contract (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed Twenty-four (24) months.

(End of clause)

4.3. 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 http://nitaac.nih.gov/downloads/ciosp2/Contractor%20Employee%20Non-Disclosure.doc 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.

4.4. 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.

4.5. 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 http://www.cpars.csd.disa.mil/cparsmain.htm 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.

4.6. 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 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 http://www.ppirs.gov/ http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm accordance with the Contractor's established accounting policy.

4.7. 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 shall 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.

4.8. Inspection and Acceptance:

4.8.1. 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.

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

RFQ.

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

4.12. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items. (Jul 2021)

(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 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366

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.

(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)).

https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt29t32%2B1665%2B30%2B%2B%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_233_240.html#wp1113344 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ 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_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1135955 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1135970 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

(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).

https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt13t16%2B492%2B90%2B%2B%2815%29%20%20AND%20%28%2815%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_217_221.html#wp1144950 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147479 https://www.acquisition.gov/sites/default/files/current/far/html/52_222.html#wp1147630 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%2Buscview%2Bt37t40%2B200%2B2%2B%2B%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%2Buscview%2Bt29t32%2B2%2B78%2B%2B%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20…