FBO_-_RFQ1220763_ORS_Laboratories.docx

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Third party accreditation by Internationally Recognized and ISO 17011 conforming accrediting body for ORS Laboratories
Solicitation number
FDA-20-RFQ-1220763
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FDA-20-RFQ-1220763 Page 2 of 6 Third party accreditation by Internationally Recognized and ISO 17011 conforming accrediting body for ORS Laboratories

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.501(a), as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-06 dated October 10, 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is 813920 – Professional Organizations, with an associated size standard of $16.5M. This requirement is being solicited as a Full & Open/Unrestricted.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

See Attachment A- Pricing Template

PART 3 – DESCRIPTION OF REQUIREMENT

Background The objective of an accreditation assessment is to establish whether a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals.

In the past, FDA’s laboratories operated under a variety of formal and informal quality management systems. All of these systems had the same aim – to assure the quality of laboratory results upon which regulatory decisions are made. However, these systems differed in their rigor and in the amount of independent oversight exercised. An FDA quality management system that is accredited to international standards (ISO 17025) enabled FDA managers to better maintain high quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. Through laboratory accreditation, FDA Laboratories maintain their reputation as a source of scientifically sound information and guidance. The accreditation process started in 2003 and FDA laboratories undergo a full on-site assessment every two years depending upon the expiration of their Accreditation Certificate.

Objectives

The objective of an accreditation assessment is to establish whether or not a laboratory complies with the accrediting body’s requirements for accreditation and can competently perform the types of tests or calibrations for which accreditation is sought. Accreditation is required to demonstrate compliance with additional criteria of the Association of Official Agricultural Chemists (AOAC) Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals. The purpose of this contract is to have an independent, third-party Contractor perform the accreditation assessments and make the proper determinations and to identify any deficiencies.

Scope

Laboratory accreditation is an important aspect of maintaining Field Laboratories and is an important commitment by FDA. It recognizes the need for FDA laboratories to have international recognition and parity; to share data and other information with other accredited labs around the world; to share a common set of policies and procedures in improving operations and harmonization; and, to provide excellent work products that are defensible and consistent.

An FDA quality management system that is accredited to international standards (ISO 17025) enables FDA managers to better maintain high-quality laboratory operations; to more easily control resources; and, to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations result in greater regulatory impact and better consumer protection. Uniform laboratory procedures enhance data reliability and resource sharing with FDA domestic and international partners.

FDA has 12 field laboratories that are currently accredited to ISO 17025 and the AOAC International specific requirements for food and pharmaceutical testing. The expectation is that the laboratories have an on-site assessment which occurs every two years resulting in accreditation. In addition, in the off year, a surveillance assessments to demonstrate maintenance of accreditation will be performed through an off-site documentation review.

Tasks:

Task Number
Work

Milestones Projected Completion Date

1.
Pre-Onsite Requirements: General for all twelve laboratories. See Place of Performance Section below for a list of the ORA laboratories

Six months prior to Accreditation expiration date

1.1
Initiate a request for quality documentation and laboratory standard operating procedures (SOP) from assessing laboratory.
30 –calendar days prior to an assessment
1.2
Provide an assessment agenda prior to the on-site assessment date
Not less than seven (7) calendar days prior to the on-site assessment
2
Accreditation Assessment
Date
2.1
A written report of the assessor(s) findings is presented at the close of the assessment.
Presented at the close out meeting after the on-site assessment
2.2
A written report of the assessor(s) findings is presented to the Office of Regulatory Science.
Presented at the close out meeting after the on-site assessment
3
Laboratory Response to Deficiencies
3.1
Review FDA Laboratory responses to deficiencies
60 days after on-site assessment
3.2
Provide Accreditation Certificate to Assessed Laboratory
30 days after final review of FDA Laboratory response
4.0
Surveillance Assessment
4.1
Document Review
12 months after on-site assessment

Technical Requirements

The contractor will conduct third-party assessments on the identified schedule (See: Place of Performance Section below) for twelve laboratories for compliance to ISO 17025 and the AOAC Food and Pharmaceutical Program. At a minimum, the contractor shall:

Provide assessments and accreditation in compliance with ISO 17025

Be a nationally and internationally recognized accrediting body with Mutual Recognition Arrangement (MRA) with International Laboratory Accreditation Cooperation (ILAC) and/or Multi-lateral Recognition Arrangement (MLA) with International Accreditation Forum (IAF)

Have established recognition Memorandum of Understanding (MOUs) with other national and international organizations and accrediting bodies such as International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum (IAF), Asia Pacific Accreditation Cooperation (APAC) or Inter-American Accreditation Cooperation (IAAC)

Possess technical expertise to assess the processes for the following disciplines: Chemical, Biological, Electrical, and Mechanical

Have a defined industry-specific accreditation program for food and pharmaceutical laboratories for the chemical and biological disciplines.

Provide accreditation assessment to established whether or not a laboratory complies with the Association of Official Analytical Chemists (AOAC) Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals.

Task 1- Pre-Onsite Requirements

Upon receipt of award, the vendor will arrange for one or more assessors to conduct an assessment at the laboratory’s site prior to the expiration date of the Accreditation Certificate for that specific laboratory. See the table below for the expiration dates for each laboratory.

Lab
Certificate Expiration
Arkansas Lab
9/30/2021
Pacific SW Lab
7/31/2020
Pacific NW Lab
9/30/2021
San Juan
10/31/2020
WEAC
7/31/2020
Detroit
10/31/2020
Kansas
2/28/2021
San Francisco
1/31/2020
Northeast Lab
10/31/2020
Southeast Lab
1/31/2021
Denver
7/31/2020
Philadelphia
12/31/2019

Prior to the assessment beginning, the FDA Laboratories will provide the assessor team all quality documentation requested, as well as the laboratory’s representative technical SOPs. The quality manual and related documentation must be reviewed by the assessor team before the assessment can begin. This review shall be done before the assessor(s) come on-site for the scheduled assessment. Upon review of submitted documentation, the assessor(s) will provide the document review results to the laboratory in writing before the scheduled onsite assessment and may ask the laboratory to implement corrective action to fill any documentation gaps required by ISO/IEC 17025 before the scheduled assessment. Prior to scheduling the full assessment, the assessor(s) shall review the draft scope(s) to determine the tests they will witness and checks on the availability of the technical personnel who perform the tests. An assessment agenda shall be provided by the assessor at least a week before the scheduled date of the assessment.

Task 2 – Accreditation Assessment Assessments may last from one to four days depending on the extent of the desired scope, number of disciplines, and the size of laboratory. The contractor will provide the assessors with an assessor guide and checklists to follow when performing an assessment. All of the guidelines shall be consistent among the assessors in the various laboratories.

An entry briefing with laboratory management is conducted by the assessor(s). At the entry briefing, the assessor(s) review the assessment agenda and if any changes are necessary due to scheduling conflicts. This briefing lasts approximately 30 minutes.

Interviews with technical staff shall be conducted from the staff matrix document submitted from the laboratory as part of the document review. Interviews shall consist of the sample analysis process for a specific technology and/or method. Assessment can also include a demonstration of selected tests or calibrations by the appropriate technical staff. The assessor(s) shall examine the equipment and calibration records. The assessor(s) audit the management system to verify that it is fully operational and that it conforms to all sections of ISO/IEC 17025, the accrediting body’s requirements, and the AOAC requirements, including documentation. A written report of the assessor(s) findings is presented at the close of the assessment.

An exit briefing with staff is conducted to go over the findings which are identified as deficiencies in the written report. A deficiency is any nonconformity to accreditation requirements, including:

(1) A laboratory’s inability to perform a test, type of test, or calibration for which it seeks accreditation.

(2) A laboratory’s management system does not conform to a clause or section of ISO/IEC 17025, is not adequately documented, or is not completely implemented in accordance with that documentation.

(3) A laboratory does not conform to any additional requirements of the accrediting body or specific fields of testing or programs, such as AOAC, necessary to meet particular needs.

If no deficiencies are found, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of the assessment completion.

If deficiencies are found, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of the laboratory’s successful response to rectify any deficiency cited by the accrediting body in the exit briefing report.

Costs for any extraordinary assessment required by the contractor for investigation purposes premised on a complaint or negative assessment resulting in suspension and subsequent reassessment shall not exceed $1,400 per day plus expenses (i.e.travel, lodging, and meals) but not to exceed federal travel regulation rates. The $1,400 per day rate is inclusive of the labor, contractor overhead expense, and profit. The contractor shall supply detailed receipts as support documentation.

Task 3 – Laboratory’s Response to Deficiencies

The FDA laboratory is requested to respond, in writing, detailing either its corrective action or why it does not believe that a deficiency exists. This response is due 30 days from the close of the assessment. The corrective action response must include the laboratory’s root cause analysis and a copy of any objective evidence (e.g., calibration certificates, lab procedures, paid invoices, packaging slips and/or training records) to indicate that the corrective actions have been implemented/completed. It is possible that the laboratory will disagree with the findings that one or more items are deficiencies. In that case, the laboratory is requested to explain in its response why it disagrees with the assessor(s).

Upon the laboratory rectifying and responding to the accrediting body notice of deficiency, and upon the accrediting body confirming corrections, accreditation shall be granted for two years with an accreditation certificate of successful completion issued by the accrediting body within 60 days of confirmation.

Task 4 – Surveillance Assessment

To demonstrate the maintenance of their accreditation, an off-site documentation review will be conducted by the accreditation body. The review will consist of the following:

-Proficiency Testing (PT) data review, -Internal audit results;

-Management review;

-Corrective actions taken;

-Review of changes occurred in the laboratory, and;

-Off-site technical review of at least one item on the scope of accreditation

This review will be conducted approximately 12 months after the on-site assessment.

Delivery

Deliverable Schedule
Deliverable
Description
Quantity/Media
Date Completed
1
Document Review Results: Prior to assessor coming on site.
Email correspondence to Laboratory QSM
Review done 30 days prior to the assessor scheduled on site visit
2
The assessment agenda:
Email correspondence to Laboratory QSM
One week before the scheduled assessment date
3.
The Deficiency report for the on-site findings. If no deficiencies are observed, the deficiency report will state that none were observed
Email correspondence to Laboratory QSM and QSM for Office of Regulatory Science (ORS)
Due at close of the assessment.
4.
The Certificate of Accreditation containing the Scope of Accreditation
Certificate to Laboratory QSM
At the close of the assessment process
5.
Surveillance Assessment-off-site document review
Email correspondence to Laboratory QSM
Off year of on-site assessment

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

No Government-Furnished Property, Material, Equipment or Information will be provided to the Contractor.

Security

The accrediting body will have a policy of confidentially and require that all assessors sign one which is kept on file by the accrediting body and updated before the on-site assessment of an FDA laboratory. Assessors will be escorted during the assessment by assigned FDA personnel.

Other Unique Requirements

Cost for Change Scope items.

Additional cost associated with changing Accreditation Scope items.

Place of Performance

Assessments due in 2020 / 2022 / 2024

Laboratory Name
Laboratory Address
Assessment Due
Lab Contact
Email Address

1. FDA/Pacific SW

19701 Fairchild, Irvine, CA 92612

4/2020 4/2022 4/2024

TBD
TBD
2. FDA/WEAC
109 Holton Street Winchester, MA 01890
4/2020

4/2022 4/2024

TBD
TBD
3. FDA/Denver
6th Ave. & Kipling

Building 20 Denver, CO 80225 4/2020 4/2022 4/2024

TBD
TBD
4. FDA/Detroit
300 River Place, Suite 5900

Detroit, MI 48207 7/2020 7/2022 7/2024

TBD
TBD
5. FDA/San Juan
466 Fernandez Juncos Ave

San Juan, PR 00901 4/2020 4/2022 4/2024

TBD
TBD
6.FDA/Northeast
158-15 Liberty Avenue

Jamaica, NY 11433-1034 7/2020 7/2022 7/2024

TBD
TBD
7.FDA/Southeast
60 Eighth Street NE

Atlanta, GA 30309 10/2020 10/2022 10/2024

TBD
TBD
8.FDA/Kansas City
11630 West 80th St.

HFR-SW360

Lenexa, KS 66214 11/2020 11/2022 11/2024

TBD
TBD

Assessments due in 2021 / 2023

Laboratory Name
Laboratory Address
Assessment Due
Lab Contact
Email Address

1. FDA/ARKL

3900 NCTR Rd Jefferson, AR 72079-9502 6/2021 6/2023

TBD
TBD
2. FDA/Pacific NW
2201 23rd Dr. SE

Bothell, WA 98021 6/2021 6/2023

TBD
TBD
3. FDA/SANFL
120 Harbor Bay Pkwy

Alameda, CA 94502-7070 11/2021 11/2023

TBD
TBD
4. FDA/PHIL
US Customs House

Room 900, 200 Chestnut St Philadelphia, PA 19106-2973 9/2021 9/2023

TBD
TBD

ORS Project Manager and Assessment Coordinator Contact

Name
Title
Email Address
TBD
ORS Quality System Manager
TBD

Period of Performance:

The Base Year of the contract will be from 01/01/2020-12/31/2020. During the Base Year an On-Site assessment will be performed for 8 of ORS Laboratories. Off- Site Surveillance will be performed for 4 of the ORS Laboratories (See Scheduled Items below for a listing of the laboratories).

Option Year One of the contract will be from 01/01/2021-12/31/2021. During Option Year One an On-Site assessment will be performed for 4 of the ORS Laboratories. Off-site Surveillance will be performed for 8 of the ORS Laboratories (See Scheduled Items below for a listing of the laboratories).

Option Year Two of the contract will be from 01/01/2022-12/31/2022. During Option Year One an On-Site assessment will be performed for 8 of the ORS Laboratories. Off-site Surveillance will be performed for 4 of the ORS Laboratories (See Scheduled Items below for a listing of the laboratories).

Option Year Three of the contract will be from 01/01/2023-12/31/2023. During Option Year One an On-Site assessment will be performed for 4 of the ORS Laboratories. Off-site Surveillance will be performed for 8 of the ORS Laboratories (See Scheduled Items below for a listing of the laboratories).

Option Year Two of the contract will be from 01/01/2024-12/31/2024. During Option Year One an On-Site assessment will be performed for 8 of the ORS Laboratories. Off-site Surveillance will be performed for 4 of the ORS Laboratories (See Scheduled Items below for a listing of the laboratories).

Base Year
01/01/2020-12/31/2020
(8 Labs-On Site; 4 Labs-Off Site)
Option Year One
01/01/2021-12/31/2021
(4 Labs-On Site; 8 Labs Off Site)
Option Year Two
01/01/2022-12/31/2022
(8 Labs-On Site; 4 Labs-Off Site)
Option Year Three
01/01/2023-12/31/2023
(4 Labs-On Site; 8 Labs Off Site)
Option Year Four
01/01/2024-12/31/2024
(8 Labs-On Site; 4 Labs-Off Site)

Scheduled Item:

CLIN
Laboratory / Location
Discipline(s)
Current Accreditation Expiration Year
Price (inclusive of travel and labor expense)
Extended Price

Base Year Locations Requiring On-Site Assessment and Recertification

FDA Pacific Regional Lab SW 19701 Fairchild Irvine CA, 92612
Chemical, Biological
2020
FDA Winchester Engineering & Analytical Center 109 Holton St Winchester, MA 01890
Chemical, Biological, Mechanical, Electrical
2020
FDA Denver Laboratory 6th Ave. & Kipling St DFC-Blg 20 Denver, CO 80255
Chemical, Biological
2020
FDA Detroit Laboratory 300 River Place, Suite 5900 Detroit, MI 48207
Chemical, Biological
2020
FDA San Juan Laboratory 466 Fernandez Juncos Ave San Juan, PR 00901
Chemical, Biological
2020
FDA North East Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034
Chemical, Biological
2020
FDA South East Laboratory 60 Eighth Street NE Atlanta, Georgia 30309
Chemical, Biological
2020
FDA Kansas City Laboratory 11630 West 80th Street Lenexa, KS 66214
Chemical
2020

Base Year Locations Requiring Off-Site Surveillance

FDA Arkansas Regional Laboratory 3900 NCTR Rd Jefferson, AR 72079
Chemical, Biological
2020
FDA Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021
Chemical, Biological
2020
FDA San Francisco Laboratory 120 Harbor Bay Parkway Alameda, CA 94502-7070
Chemical, Biological
2020
FDA Philadelphia Laboratory US Customs House Room 900 200 Chestnut Street Philadelphia, PA 19106-2973
Chemical
2020

Total Base Requirement (Line Items ) $

CLIN
Laboratory / Location
Discipline(s)
Current Accreditation Expiration Year
Price (inclusive of travel and labor expense)
Extended Price

Option Period One Locations Requiring On-Site Assessment and Recertification

FDA Arkansas Regional Laboratory 3900 NCTR Rd Jefferson, AR 72079
Chemical, Biological
2021
FDA Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021
Chemical, Biological
2021
FDA San Francisco Laboratory 120 Harbor Bay Parkway Alameda, CA 94502-7070
Chemical, Biological
2021
FDA Philadelphia Laboratory US Customs House Room 900 200 Chestnut Street Philadelphia, PA 19106-2973
Chemical
2021

Option Year One Locations Requiring Off-Site Surveillance

FDA Pacific Regional Lab SW 19701 Fairchild Irvine CA, 92612
Chemical, Biological
2021
FDA Winchester Engineering & Analytical Center 109 Holton St Winchester, MA 01890
Chemical, Biological, Mechanical, Electrical
2021
FDA Denver Laboratory 6th Ave. & Kipling St DFC-Blg 20 Denver, CO 80255
Chemical, Biological
2021
FDA Detroit Laboratory 300 River Place, Suite 5900 Detroit, MI 48207
Chemical, Biological
2021
FDA San Juan Laboratory 466 Fernandez Juncos Ave San Juan, PR 00901
Chemical, Biological
2021
FDA North East Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034
Chemical, Biological
2021
FDA South East Laboratory 60 Eighth Street NE Atlanta, Georgia 30309
Chemical, Biological
2021
FDA Kansas City Laboratory 11630 West 80th Street Lenexa, KS 66214
Chemical
2021

Total Option Year One (Line Items) $

CLIN
Laboratory / Location
Discipline(s)
Current Accreditation Expiration Year
Price (inclusive of travel and labor expense)
Extended Price

Option Year Two Locations Requiring On-Site Assessment and Recertification

FDA Pacific Regional Lab SW 19701 Fairchild Irvine CA, 92612
Chemical, Biological
2022
FDA Winchester Engineering & Analytical Center 109 Holton St Winchester, MA 01890
Chemical, Biological, Mechanical, Electrical
2022
FDA Denver Laboratory 6th Ave. & Kipling St DFC-Blg 20 Denver, CO 80255
Chemical, Biological
2022
FDA Detroit Laboratory 300 River Place, Suite 5900 Detroit, MI 48207
Chemical, Biological
2022
FDA San Juan Laboratory 466 Fernandez Juncos Ave San Juan, PR 00901
Chemical, Biological
2022
FDA North East Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034
Chemical, Biological
2022
FDA South East Laboratory 60 Eighth Street NE Atlanta, Georgia 30309
Chemical, Biological
2022
FDA Kansas City Laboratory 11630 West 80th Street Lenexa, KS 66214
Chemical
2022

Option Year Two Locations Requiring Off-Site Surveillance

FDA Arkansas Regional Laboratory 3900 NCTR Rd Jefferson, AR 72079
Chemical, Biological
2022
FDA Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021
Chemical, Biological
2022
FDA San Francisco Laboratory 120 Harbor Bay Parkway Alameda, CA 94502-7070
Chemical, Biological
2022
FDA Philadelphia Laboratory US Customs House Room 900 200 Chestnut Street Philadelphia, PA 19106-2973
Chemical
2022

Total Option Year Two

CLIN
Laboratory / Location
Discipline(s)
Current Accreditation Expiration Year
Price (inclusive of travel and labor expense)
Extended Price

Option Year Three Locations Requiring Assessment and Certification

FDA Arkansas Regional Laboratory 3900 NCTR Rd Jefferson, AR 72079
Chemical, Biological
2023
FDA Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021
Chemical, Biological
2023
FDA San Francisco Laboratory 120 Harbor Bay Parkway Alameda, CA 94502-7070
Chemical, Biological
2023
FDA Philadelphia Laboratory US Customs House Room 900 200 Chestnut Street Philadelphia, PA 19106-2973
Chemical
2023

Option Year Three Locations Requiring Off-Site Surveillance

FDA Pacific Regional Lab SW 19701 Fairchild Irvine CA, 92612
Chemical, Biological
2023
FDA Winchester Engineering & Analytical Center 109 Holton St Winchester, MA 01890
Chemical, Biological, Mechanical, Electrical
2023
FDA Denver Laboratory 6th Ave. & Kipling St DFC-Blg 20 Denver, CO 80255
Chemical, Biological
2023
FDA Detroit Laboratory 300 River Place, Suite 5900 Detroit, MI 48207
Chemical, Biological
2023
FDA San Juan Laboratory 466 Fernandez Juncos Ave San Juan, PR 00901
Chemical, Biological
2023
FDA North East Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034
Chemical, Biological
2023
FDA South East Laboratory 60 Eighth Street NE Atlanta, Georgia 30309
Chemical, Biological
2023
FDA Kansas City Laboratory 11630 West 80th Street Lenexa, KS 66214
Chemical
2023

Total Option Year Three

CLIN
Laboratory / Location
Discipline(s)
Current Accreditation Expiration Year
Price (inclusive of travel and labor expense)
Extended Price

Option Year Four Locations Requiring Assessment and Certification

FDA Pacific Regional Lab SW 19701 Fairchild Irvine CA, 92612
Chemical, Biological
2024
FDA Winchester Engineering & Analytical Center 109 Holton St Winchester, MA 01890
Chemical, Biological, Mechanical, Electrical
2024
FDA Denver Laboratory 6th Ave. & Kipling St DFC-Blg 20 Denver, CO 80255
Chemical, Biological
2024
FDA Detroit Laboratory 300 River Place, Suite 5900 Detroit, MI 48207
Chemical, Biological
2024
FDA San Juan Laboratory 466 Fernandez Juncos Ave San Juan, PR 00901
Chemical, Biological
2024
FDA North East Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034
Chemical, Biological
2024
FDA South East Laboratory 60 Eighth Street NE Atlanta, Georgia 30309
Chemical, Biological
2024
FDA Kansas City Laboratory 11630 West 80th Street Lenexa, KS 66214
Chemical
2024

Option Period Four Locations Requiring Off-Site Surveillance

FDA Arkansas Regional Laboratory 3900 NCTR Rd Jefferson, AR 72079
Chemical, Biological
2024
FDA Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021
Chemical, Biological
2024
FDA San Francisco Laboratory 120 Harbor Bay Parkway Alameda, CA 94502-7070
Chemical, Biological
2024
FDA Philadelphia Laboratory US Customs House Room 900 200 Chestnut Street Philadelphia, PA 19106-2973
Chemical
2024

Total Option Year Four

Total Base Requirement and Options

PART 4 - PACKAGING, MARKING and SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.

PART 5 – INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

PART 6 – DELIVERIES OR PERFORMANCE

Place of Performance

Satisfactory performance of this contract shall be deemed to occur upon delivery of services described above and/or upon acceptance by the Contracting Officer or the Technical Representative of these products/services. Provides serviced by the contractor shall be made F.O.B. destination no later than January 1, 2020, unless otherwise agreed upon with the Technical POC.

ORS Laboratories shall be performed at:

1. FDA/Pacific SW

19701 Fairchild, Irvine, CA 92612

2. FDA/WEAC
109 Holton Street Winchester, MA 01890
3. FDA/Denver
6th Ave. & Kipling

Building 20 Denver, CO 80225

4. FDA/Detroit
300 River Place, Suite 5900

Detroit, MI 48207

5. FDA/San Juan
466 Fernandez Juncos Ave

San Juan, PR 00901

6.FDA/Northeast
158-15 Liberty Avenue

Jamaica, NY 11433-1034

7.FDA/Southeast
60 Eighth Street NE

Atlanta, GA 30309

8.FDA/Kansas City
11630 West 80th St.

HFR-SW360

Lenexa, KS 66214

9. FDA/ARKL

3900 NCTR Rd Jefferson, AR 72079-9502

10. FDA/Pacific NW
2201 23rd Dr. SE

Bothell, WA 98021

11. FDA/SANFL
120 Harbor Bay Pkwy

Alameda, CA 94502-7070

12. FDA/PHIL
US Customs House

Room 900, 200 Chestnut St Philadelphia, PA 19106-2973

The POC for the laboratory will be identified at the time of award. The Contractor shall contact the Government POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries, installation and trainings shall occur at the Place of performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time)). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Period of Performance

The required professional service shall be performed by January 1, 2020 unless the Government approves an alternate delivery schedule. Installation shall be coordinated with the Technical POC. The required warranty shall not begin until delivery, installation and acceptance of the equipment has occurred.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Representative:

To be determined upon contract award

The Technical Representative is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

Contracting Officer (CO):Contract Specialist (CS):
Gary KlaffTodd Johnston
4041 Powder Mill Road4041 Powder Mill Road
Beltsville, MD 20705Beltsville, MD 20705
Gary.Klaff@fda.hhs.govTodd.Johnston@fda.hhs.gov

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ; (2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract.

Payment Schedule:

Unless otherwise agreed to by the Technical POC, the Contractor shall submit invoices subsequent to the delivery of the required equipment. Installation and training shall be invoiced after installation and training has been completed.

FDA Three-Way Match Invoicing Procedures:

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;
(b) itemized travel costs, including origin and destination;
(c) any other supporting information necessary to clarify questionable expenditures;
(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:
(1) invoice number, amount, & date submitted
(2) corresponding payment amount & date received
(b) total amount of all payments received to date under the subject contract or order
(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2019)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31U.S.C.3553).

(5) 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 2018) (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 (Oct 2018) (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 (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug2018) (15 U.S.C. 637(d)(4)) ___ (ii) Alternate I (Jan 2017) 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 (Aug 2018) 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. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O.11755).

_X_ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

___ (ii) Alternate I (Feb 1999) of 52.222-26.

___ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

___ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

___ (ii) Alternate I (July 2014) of 52.222-36.

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

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

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

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun2016) (E.O. 13693).

___ (45) (i) 52.224-3 Privacy Training (Jan2017) (5 U.S.C. 552 a).

___ (ii) Alternate I (Jan 2017) of 52.224-3.

_X_ (46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C.chapter 83).

___ (47) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (48) 52.225-5, Trade Agreements (Aug 2016) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.Appx.1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

___ (iii) Alternate II (Feb 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] ___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

___ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (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) (Aug 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).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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.

(v) 52.222-17, Nondisplacement of Qualified Workers (May2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C.4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C.4212)

(xi) 52.222-40, Notification of Employee Rights Under the…

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