Final Combined-Synopsis-Solicitation-Commercial-IDIQ Calibration Services (002).pdf

COMBINED SYNOPSIS/SOLICITATION FOR

COMMERCIAL SERVICES

General Information

Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA-2023-RFQ-110138 IDIQ for Calibration and

Preventive Maintenance Lab Instrument Services

Posted Date: 2/3/2023 Original Response Date: 2/13/2023 Current Response Date: 02/13/2023 Product or Service Code: J066- Maintenance/Repair/Rebuild of

Instruments and Laboratory Equipment.

Set Aside: None NAICS Code: 811210

Contracting Office Address

FDA – Office of Acquisition and Grant Services, 4041 Powder Mill Road, Beltsville, MD

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested, and a written solicitation document will not be issued.

This Full and Open Solicitation is a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01.

The associated North American Industrial Classification System (NAICS) code for this procurement is 811210, with a small business size standard of $30M.

The FDA Office of Acquisition and Grant Services, 4041 Powder Mill Road, Beltsville, MD is anticipating a single award Indefinite Delivery/Indefinite Quantity (IDIQ) Firm Fixed Price contract for Calibration and Preventative Maintenance services for a wide assortment of Analytical Precision Instruments located in eleven (11) laboratory locations within the continental US and its territories.

All interested companies must provide Quote for the following:

https://www.acquisition.gov/far/part-12#FAR_Subpart_12_6

Services

Line Item Description Estimated Quantity

FFP Unit Price

Total Price

1 ISO/IEC 17025 Calibration and PM Service Period of Performance 3/1/2023 – 2/29/2024

2 ISO/IEC 17025 Calibration and PM Service Period of Performance 3/1/2024 – 2/28/2025

3 ISO/IEC 17025 Calibration and PM Service 3/1/2025 – 2/28/2026

4 ISO/IEC 17025 Calibration and PM Service Period of Performance 3/1/2026 – 2/28/2027

5 ISO/IEC 17025 Calibration and PM Service Period of Performance 3/1/2027 – 2/29/2028

Statement of Work

Introduction

The Office of Regulatory Affairs (ORA) laboratory network performs scientific testing on products which are regulated by FDA. To ensure that the testing results are competent and suitable for regulatory purposes, the ORA laboratories are accredited to ISO/IEC 17025:2017 (International Standard for Organization - General requirements for the competence of testing and calibration laboratories) standards. A requirement of the ISO/IEC 17025:2017 standard is that scientific instruments are annually calibrated, and such calibration procedures are standardized and documented.

The Contractor will be responsible for all the necessary resources to provide Preventative Maintenance and Calibration services for various instruments onsite at the ORA laboratories.

Throughout the contract period of performance, instruments will age and need replacement, the mission and/or services provided at the various labs may change, the months in which services are required can change.

Preventative Maintenance and Calibration services shall be performed as provided in the Requirements section below:

Statement of Need

Under the IDIQ, the Government will issue orders with specific requirements. It is estimated that contractor will perform ISO/IEC 17025:2017 Preventative Maintenance and Calibration services for no less than five (5) instruments per location per order; an IDIQ contract minimum of 522 calibrations; no more than 560 calibrations per year period of performance; and a maximum estimate of 2,800 calibrations for the life of the IDIQ. Each task order issued under the IDIQ will include the ISO/IEC 17025 quantity needed, location of service, Point of Contact, date required for the service. It is expected that the Contractor will be able to complete the required services on all required instruments in the same visit to each location.

Contractor Requirements

The contractor shall be actively accredited to ISO/IEC 170252017 standards throughout the term of this IDIQ to include the following:

a. The testing (or calibration) laboratory shall be accredited in accordance with the requirements of ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories.

b. The testing (or calibration) laboratory’s current Scope of Accreditation to ISO/IEC 17025:2017 shall encompass calibration parameters for weighing instruments/balances in the 0.1 mg to 5 kg range.

c. The calibration report or certificate must be endorsed by the recognized Accreditation Body’s symbol (or must otherwise indicate accreditation status by a recognized Accreditation Body acceptable to the Government).

d. The accreditation of a testing or calibration laboratory shall be issued by an Accreditation Body (AB) that is an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) Signatory (e.g., American Association for Laboratory Accreditation (A2LA), Perry Johnson Laboratory Accreditation (PJLA), ANSI National Accreditation Board (ANAB)) and that operates in accordance with ISO 17011, General requirements for accreditation bodies accrediting conformity assessment bodies.

B. General Experience:

a. The Contractor must have expertise in preventative maintenance and calibration to perform work on multiple brands of analytical and precision balances, including but not limited to:

i. Ohaus

ii. Mettler-Toledo

iii. Champ

iv. Sartorius

v. Denver Instruments

vi. Fisherbrand

vii. Cahn

Task Requirements

The contractor shall provide ISO/IEC 17025:2017 Preventative Maintenance and Calibration services to include all travel, labor, and supplies (i.e. towels/rags, cleaner, lubricants, clips), for analytical and precision balances instruments utilized by the Food and Drug Administration ORA laboratories. Typical instrument to be calibrated and maintained includes various models of analytical and precision balances, including but not limited to: Ohaus, Mettler-Toledo, Champ, Sartorius Denver Instruments, Fisher brand, and Cahn balances.

While individual orders will detail specific requirements, representative tasks shall include but are not limited to:

C. Scope of Services for Preventative Maintenance (PM) and Calibration Services. Once annually, for each instrument serviced the Contractor shall at a minimum ensure:

a. PM and Calibration services on-site at the 11 ORA laboratories

b. Full cosmetic cleaning of both exterior and interior surfaces

c. Take “as found” weighing checks for Eccentricity, Linearity, and Span; check hysteresis

d. Reproducibility testing (10 replicates per weight)

e. Remove and clean outer case and doors

f. Examine weighing cell and adjustment

g. Lubrication and adjustment of internal parts and drive motors

h. Examine printed circuit boards; Check board voltages; Check board connections

i. Reassemble upper case and replace weighing pan

j. Level Balance

k. Provide cost estimates for labor and repair for any units’ not passing certification

• Note that any necessary repair services will be paid for outside of the scope of this contract. Repair services are not included in the scope of this contract.

D. The contractor shall ensure performance of calibration for at least 90 days post-calibration.

If a unit fails due to calibration within 90 days, the contractor er shall return to the site, at no additional cost to FDA, to recalibrate the unit(s) that failed. The Contractor shall return to the site within 15 calendar days of notification to perform the re-calibration on the failed units.

E. Documentation

a. The contractor shall provide copies of test reports and calibration certificates to the

COR or COR designee for each instrument upon completion of service. The contractor shall ensure the documents include the following information per ISO/IEC 17025:2017 requirements:

• A title (e.g. “Calibration Certificate”);

• The name and address of the laboratory;

• Unique identification of the calibration certificate (serial number);

• Inclusion on each page an identification in order to ensure that the page is recognized as a part of the calibration certificate (i.e. page 1 of 3), and a clear identification of the end of the calibration certificate;

• The name and address of the local Government POC;

• Identification of the method used;

• A description of, the condition of, and unambiguous identification of the item(s) tested or calibrated;

• Date of performance of the calibration;

• Reference to the sampling plan and procedures used by the Contractor where these are relevant to the validity or application of the results;

• The calibration results (“as found data” and “as left data”) with the units of measurement;

• The name, function and signature or equivalent identification of those authorizing the calibration certificate;

• A statement to the effect that the results relate only to the items calibrated;

• The conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results;

• Evidence that the measurements are traceable;

• The uncertainty of measurement (and/or statement of compliance with a specification)

b. The contractor shall ensure upon completion of the certification that each analytical and precision balance instrument receives calibration status sticker affixed to unit, showing date of calibration, serial number, technician’s initials, and next calibration due date.

Task Deliverables

• The contractor shall provide Test Reports and Calibrations certificates for each instrument serviced, each time it is serviced to the COR and COR designee within 7 working days after service is performed.

• Evidence of ISO/IEC 17025 accreditation (as required per task order) shall be required at throughout performance period of contract order.

Deliverable Description of Deliverable Due Date

1 Calibrated lab balances As required by the task order

Test reports, certificates of calibration, calibration status sticker for each instrument serviced, and estimate of repairs

As required by the task order

Period of Performance- 3/1/2023-2/29/2028.

Date of Delivery- To be provided in the Task Order.

Places of Performance: (note: specific location will be provided with the order)

LAB Address

WEAC

Winchester Engineering Analytical Center 109 Holton Street Winchester, MA 01890

IRVLHAF/IRVLMP

Irvine Human and Animal Feed/Medical Products Laboratory 19701 Fairchild Irvine, CA 92612

ARLHAF

Arkansas Human and Animal Food Laboratory 3900 NCTR Road Jefferson, AR 72079

DETLMP

Detroit Medical Products Laboratory Suite 6700 300 River Place Drive Detroit, MI 48207

NYLHAF/NYLMP

New York Human and Animal/Medical Products Laboratory 158-15 Liberty Avenue Jamaica, NY 11433

SJNLMP

San Juan Medical Products Laboratory 466 Fernandez Juncos Avenue San Juan, PR 00901

FCC

Forensic Chemistry Center 6751 Steger Drive Cincinnati, OH 45237

ATLHAF/TPL

Atlanta Human and Animal Food Laboratory/Tobacco Products Laboratory Annex II - 60 Eighth St NE Atlanta, GA 30309

DENLHAF

Denver Human and Animal Food Laboratory DFC Bldg. 20 W. 6th Ave. & Kipling Street Lakewood, CO 80225

SANLHAF

San Francisco Human and Animal Food Laboratory 1201 Harbor Bay Parkway Alameda, CA 94502

KCLHAF

Kansas City Human and Animal Food Laboratory 10749 W 84th Terrace Lenexa, KS 66214

Contract Ceiling and Guaranteed Minimum

The contract’s guaranteed minimum is the first task order upon award of the IDIQ. The contract’s estimated ceiling is $600,000.00 over a five (5) year ordering period

Contract Type Single Award IDIQ with firm fixed price orders

Ordering All orders placed against this IDIQ are subject to the terms and conditions of the IDIQ. In the event of a conflict between the clauses of a resulting Order and IDIQ. the IDIQ will take precedence.

Ordering Procedures

Orders shall be placed in accordance with FAR 52.216-19. Any authorized FDA Contracting Officer can place orders under this IDIQ in accordance with the following procedures:

The Contracting Officer will provide an RFQ order to include the following information:

1. A requirements document that includes one or more of the SOW Section 3 (ie quantity, service location, period of performance, COR and Laboratory Point of Contact)

2. A statement if FDA requires a firm fixed price (FFP) quote.

3. Any terms or conditions unique to the order (e.g., Government furnished information, special delivery requirements)

Order Limitations (a)Maximum Order - The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $600,000.00;

(2) Any order with a minimum of $10,000.00

(2) Any order for a combination of items in excess of $600,000.00; or

(3) A series of orders from the same ordering office within 2 days that together call for quantities exceeding the limitation in paragraph (a)(1) or (2) of this section.

(b) Notwithstanding paragraph (a) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (a), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

Contract Points of Contact

Contract Specialist (Primary POC) Nina Montgomery 4041 Powder Mill Road Beltsville, MD

Nina.Montgomery@fda.hhs.gov

Contracting Officer Representative (COR)

TO BE PROVIDED AT TIME OF AWARD

Contracting Officer’s Authority:

The Contracting Officer (CO) is the only individual who has the authority to enter into, administer, or terminate this IDIQ and is the only person authorized to approve changes to any of the requirements under this IDIQ and resulting orders, and notwithstanding any provision contained elsewhere in this IDIQ, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this IDIQ. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the IDIQ. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the IDIQ.

Contracting Officer’s Representative:

a. The Contracting Officer may designate other Government personnel (known as the Contracting Officer’s Representative, or COR) to act as his or her authorized representative for IDIQ administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the IDIQ or resulting orders. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the IDIQ. Such designation will not contain authority to sign contractual documents, order changes, modify terms, or create any commitment or liability on the part of the Government different from that set forth in the IDIQ. The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this IDIQ.

b. For each IDIQ Order, a Contracting Officer’s Representative (COR) will be assigned. The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluations as required; (4) performing technical inspections and acceptances required by this IDIQ; (5) assisting in the resolution of technical problems encountered during performance; and (6) reviewing invoices/vouchers.

c. The Government may unilaterally change its COR designation.

d. Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances as required by this performance; and (5) reviewing invoices/vouchers.

Visitor Access Requirements

All visitors must be pre-approved through the onsite POC listed in each task order. To pre-approve a visitor, send an email to the POC at least 24 business hours (5 days for foreign visitors), prior to the visitor’s arrival. The email shall state the visitor’s name, make/model of vehicle, and when the visitor is expected to arrive. Visitors must be escorted at all times, are not allowed in areas that would pose a risk to safety (including laboratories and the fitness center) and are prohibited from accessing FDA IT equipment.

All visitors are required to the security entry point and present a valid Government issued photo ID. The visitor(s) must sign the visitor logbook and be screened via the metal detector.

All the visitor’s possessions will also be screened. Food items, video/audio tapes, computer equipment, disks and other magnetic media are not affected by the x-ray machine and will be scanned. The guards will then issue a visitor badge and contact the escort identified in the email. The visitor will turn in their visitor badge and sign-out on the logbook upon exiting the security entry point building.

Access to the facility shall not be granted if the visitor(s) refuses to cooperate with these security measures or fail to provide required information for building access as determined by security.

Government Holidays

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov closure due to inclement weather.

January (New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) June (Juneteenth) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day)

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 IDIQ 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 shall be submitted via the CPARS within 14 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.

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.

Invoicing

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA 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.

Contractor Advertising of Award The Contractor shall not refer to the product or service awarded under this IDIQ or any Orders in commercial advertising, as defined in FAR 31.205–1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

Solicitation Contract Clauses:

52.212-4 Contract Terms and Conditions-Commercial Items (NOV 2021) This clause is incorporated by reference (refer to SF1449 block 27a) The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (NOV 2021)

FAR 52.212-4 Alternate I (Nov 2021) will apply to any task orders issued on a time and material or labor-hour basis.

Additional Clauses Incorporated by Reference This solicitation incorporates one or more FAR and HHSAR clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/browse/index/far and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Clause 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011) FAR Clause 52.204-13 System for Award Management and Maintenance (Oct 2018)

FAR Clause 52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) FAR Clause 52.216-18 Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from effective date of award through and including the last date of the contract period of performance.

FAR Clause 52.216-19 Ordering Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $10,000.00 the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor-

(1) Any order for a single item in excess of $600.000.00;

(2) Any order for a combination of items in excess of $600,000.00; or

(3) A series of orders from the same ordering office within 30 calendar days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216- 21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five (5) calendar days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons.

Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR Clause 52.216-22 Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after the date of final payment under this contract.

The below clause may be included in and is applicable to Task Orders. FAR Clause 52.217-8 Option to Extend Services (NOV 1999)

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

The below clause may be included in and is applicable to Task Orders.

(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 anytime 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 IDIQ contract is five (5) years with a five (5) year ordering period.

HHSAR Clauses:

HHSAR Clause 352.203-70 Anti-Lobbying (Dec 2015) HHSAR Clause 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR Clause 352.223-70 Safety and Health (Dec 2015) HHSAR Clause 352.224-71 Confidential Information (Dec 2015) HHSAR Clause 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

Paragraph (c). The Section 508 standards applicable to this contract are:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

Reporting Matters Involving Fraud, Waste and Abuse Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector Generals Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W. Washington, D.C. 20201

Information regarding procedural matters is contained on the HHS/OIG website at http://oig.hhs.gov/hotline.html

Organizational Conflict of Interest

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

d. All contractor personnel involved in this requirement shall abide by the FDA’s Form FDA 3398 – Commitment to Protect Non-Public Information Employee Agreement included at Attachment 3.

FDA Data Disclosure Procedures

Dissemination, Publication and Distribution of Information Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor’s right to use data or information obtained from a non-restrictive source. Any questions concerning “privileged information” shall be referred to the Contracting Officer.

Any questions about use or release of the data or information or handling of material under this contract shall be referred to the COR who must render a written determination to the Contracting Officer (CO). The COR’s determination will reflect the results of internal coordination with appropriate program and legal officials. After receipt of the COR’s written determination, the CO will make a final decision authorizing the release of information.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (Deviation 2017-02, Jun 2017) (Deviation APR 2020) (DEVIATION 2020-05 Oct 2020)

(b) 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 products and commercial services:

(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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(6) 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)).

(c) 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 products and commercial services: [Contracting Officer check as appropriate.] X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Jun 2020) (Deviation 2017-02) (41 U.S.C. 4712) relating to whistleblower protections)

X (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

(6) [Reserved].

(7) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

(8) 52.204-15, Service Contract Reporting Requirements for Indefinite- Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

X(9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

X (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) ( 41 U.S.C. 2313).

(11) [Reserved].

(12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (SEP 2021) ( 15 U.S.C.

657a).

(13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

(14) [Reserved]

(15) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

(ii) Alternate I (MAR 2020) of 52.219-6.

(16) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

(ii) Alternate I (MAR 2020) of 52.219-7.

(17) 52.219-8, Utilization of Small Business Concerns (OCT 2018) ( 15 U.S.C. 637(d)(2) and (3)).

(18) (i) 52.219-9, Small Business Subcontracting Plan (NOV 2021) ( 15 U.S.C. 637(d)(4)).

(ii) Alternate I (NOV 2016) of 52.219-9.

(iii) Alternate II (NOV 2016) of 52.219-9.

(iv) Alternate III (JUN 2020) of 52.219-9.

(v) Alternate IV (SEP 2021) of 52.219-9.

(19) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

(ii) Alternate I (MAR 2020) of 52.219-13.

X (20) 52.219-14, Limitations on Subcontracting (SEP 2021) ( 15 U.S.C. 637s).

(21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C.

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

(22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (SEP 2021) ( 15 U.S.C. 657f).

(23) (i) 52.219-28, Post Award Small Business Program Rerepresentation (SEP 2021) ( 15 U.S.C. 632(a)(2)).

(ii) Alternate I (MAR 2020) of 52.219-28.

(24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (SEP 2021) ( 15 U.S.C. 637(m)).

(25) 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 (SEP 2021) ( 15 U.S.C. 637(m)).

(26) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ( 15 U.S.C. 644(r)).

(27) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)). X (28) 52.222- 3, Convict Labor (JUN 2003) (E.O.11755).

X (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2022) (E.O.13126).

X (30) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

X (31) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

(ii) Alternate I (FEB 1999) of 52.222-26.

X (32) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

(ii) Alternate I (JUL 2014) of 52.222-35.

X (33) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ( 29 U.S.C. 793).

(ii) Alternate I (JUL 2014) of 52.222-36.

X (34) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

X (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

X (36) (i) 52.222-50, Combating Trafficking in Persons (NOV 2021) ( 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).

X (37) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

(38) (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.)

(39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

(40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(41) (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.

(42) (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.

(43) 52.223-15, Energy Efficiency in Energy- Consuming Products (MAY 2020) ( 42 U.S.C.

8259b).

(44) (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 (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

(46) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

(47) 52.223-21, Foams (Jun2016) (E.O. 13693).

(48) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

(ii) Alternate I (JAN 2017) of 52.224-3.

(49) 52.225-1, Buy American-Supplies (NOV 2021) ( 41 U.S.C. chapter 83).

(50) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV2021) ( 41 U.S.C.chapter83, 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 (JAN 2021) of 52.225-3.

(iii) Alternate II (JAN 2021) of 52.225-3.

(iv) (i[ii]) Alternate III (JAN 2021) of 52.225-3.

(51) 52.225-5, Trade Agreements (OCT 2019) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (52) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(53) 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. 2302Note).

(54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C.

5150).

(55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

(56) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

(57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

(58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management

(OCT2018) ( 31 U.S.C. 3332).

(60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

(61) 52.232-36, Payment by Third Party (MAY 2014) ( 31 U.S.C. 3332).

(62) [52.232-40, Providing Accelerated Payments to Small Business Subcontractors (NOV 2021)(DEVIATION APR 2020)(31 U.S.C. 3903 and 10 U.S.C. 2307).

(63) 52.239-1, Privacy or Security Safeguards (AUG 1996) ( 5 U.S.C. 552a).

(64) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ( 15 U.S.C.

637(d)(13)).

(65) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

(ii) Alternate I (APR 2003) of 52.247-64.

(iii) Alternate II (NOV 2021) of 52.247-64.

(d) 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 products and commercial services:

[Contracting Officer check as appropriate.]

(1) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter67).

(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) ( 29 U.S.C. 206 and 41 U.S.C.

chapter 67).

X (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards- Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for…