Combined Synopsis for Mechnical Qualification of Dissolution.pdf

COMBINED SYNOPSIS/SOLICITATION FOR MECHNICAL QUALIFICATION FOR DISSOLUTION

SOLICITATION NUMBER: FDA-RFQ-24Q1277832

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i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

ii. The solicitation number is FDA-RFQ-24Q1708340. This requirement is issued as Request for Quote (RFQ).

The solicitation is issued as a Full and Open competition.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024.

iv. The associated North American Industry Classification System (NAICS) Code is 334516 with a small business size standard of 1000 employees.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

1. BACKGROUND

The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products in the Office of Regulatory Science, Office of Medical Products and Specialty Laboratory Operations, located at 158-15 Liberty Avenue, Jamaica, NY 11433 (Lead Laboratory for this request). The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The dissolution system is used to evaluate the rate and extent that a compound forms a solution, typically, for drug samples using specific protocols and methods established by USP monographs. Dissolution testing is performed with apparatus described in General Chapter <711> Dissolution.

2. OBJECTIVE

The purpose of this acquisition is to acquire (3) Mechanical Qualification of Dissolution

REQUIREMENTS

All the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government prior to purchase.

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The Contractor shall provide three (3) Mechanical Qualification for Dissolution with the following requirements:

• Mechanical Calibration Device

• Shall include Installation.

The contractor shall provide a system compatible with Industry Dissolution Instrumentation Models:

• VanKel VK7000

• Hanson Research SR8Plus

• Distek 2100C

• Distek 6100

• Distek 7100

• Hanson Research Vision Elite 8

• SOTAX AT MD

The Contractors shall provide a system capable of calibrating Dissolution Apparatus:

• Benchtop level

• Basket depth

• Paddle depth

• Rotational speed

• Shaft wobble

• Shaft verticality

• Basket wobble

• Vessel / shaft centering

• Vessel verticality

• Vessel plate level

• Bath Temperature

• Vessel Temperature

TRADE AND SERVICE SPECS

• The Mechanical Qualification for Dissolution must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

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• The government requires a minimum one-year Original Equipment Manufacturer’s warranty on electronic components which shall include at a minimum: coverage on all non-consumable items and parts supplied and unlimited on-site service visits. All replacement parts, engineer labor and travel costs. The warranty begins on the date of formal government acceptance.

• The Contractor is responsible of doing the actual installation and dispose pallets, empty boxes and any associated garbage off site of FDA facilities the day of the delivery.

• The vendor shall provide to the user documentation of the qualification upon installation.

• The vendor shall demonstrate upon installation that the system meets or exceeds all salient characteristics which have been included in the vendor’s response and/or used are evaluation criteria for award, examples include, but are not limited to mass spectrometer sensitivity specification, mass spectrometer dynamic range, system reproducibility, etc. The instrument shall not be accepted until those characteristics have been met.

• All solutions and accessories for instrument maintenance, calibration and qualification must be provided by vendor at time of installation.

• Contractor shall provide on-site familiarization introductory on-site training for 15 users per site.

• Installation and familiarization shall be performed by a certified and trained engineer.

Contractor to provide any necessary manuals and/or consumables to be used during training.

Repair Service (during warranty period)

• The Service Technician under the service agreement shall repair or replace any part or parts that prove to be defective at no additional charge to the Government.

• The Contractor shall plan for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon time frame.

• All parts replaced will be new replacement parts which meet the original manufacturer's specifications (no refurbished or third-party parts).

• The Service Technician under the service agreement shall agree to unlimited repair service of any part or problem at no additional charge to the Government. This includes replace any part or parts that prove to be defective at no additional charge to the Government and includes upgrading any software etc. so that the system maintains its original functionality and intended purpose.

• Equipment repair and maintenance work is performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts.

The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

• Parts, labor, and travel/per-diem costs for PM and repairs shall be included in the price of the service agreement.

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Records and Reports

The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Packing, 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.

3. INSPECTION/ACCEPTANCE CRITERIA

The Project Officer will perform inspection and acceptance of equipment, installation and services to be provided. The Project Officer (to be identified upon contract award) is the authorized representative of the Contracting Officer.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the Government to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within 1 business day of task being completed. The Government will provide written notification of acceptance or rejection within 2 business days. Inspection will include review of the deliverables to ensure adequacy.

The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

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The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within two 2-business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within 1 day via email.

4. CONTRACT TYPE

This is firm fixed price.

5. PERIOD OF PERFORMANCE

Deliverable Quantity Due Date Mechanical Qualification for Dissolution 3 Within 60 days from award

Installation 3 Within two weeks after Government acceptance of delivered item

Training 15 users Within two weeks after IQ/OQ/PQ

Service Reports As Needed At time of installation or immediately thereafter and only during months when warranty work is performed

One-year manufacturer’s warranty 3 Begins at Government acceptance of delivered item

The period of performance (POP) is 60 days from award.

6. PLACE OF DELIVERY AND PERFORMANCE

Delivery must be coordinated with the New York Medical Products Laboratory at least 48 hours in advance:

U.S. Food and Drug Administration New York Laboratory Medical Products 158-15 Liberty Avenue Jamaica, NY 11433 POC: POC to be identified at time of the award.

U.S. Food and Drug Administration Detroit Laboratory Medical Products 300 River Place Dr., Suite 6th Floor Detroit, MI 48207 POC: POC to be identified at time of award.

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U.S. Food and Drug Administration Irvine Laboratories 19701 Fairchild Irvine, CA 92612-2506 POC: POC to be identified at time of award.

HOURS OF OPERATION

Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays.

FEDERAL HOLIDAYS

The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/.

• New Year's Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

GOVERNMENT CLOSURES

Government operating statuses for offices nationwide can be found on https://www.opm.gov/.

Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level.

https://www.opm.gov/ https://www.opm.gov/

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In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO.

8. GOVERNMENT POINTS OF CONTACT

9. CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price.

The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

10. INVOICING INSTRUCTIONS

Instructions for invoicing are indicated below.

Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone: 301-796-7376 Email: warren.jackson@fda.hhs.gov

Contracting Officer’s Representative/Technical Point of Contact (TPOC) To be determine after award.

mailto:warren.jackson@fda.hhs.gov

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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.

i. 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.

ii. 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.

iii. 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.

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

v. 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.

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

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• 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;

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

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

• 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;

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

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

• 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

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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.

viii. The provision at 52.212-1 (SEP 2023), Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition and with the addenda below.

Submission of offers: The quoter shall submit all quotes to the point(s) of contact listed below by the due date and time indicated in the solicitation.

Period for Acceptance of Quotes: The quoter agrees to hold the prices firm for 90 calendar days after quote due date.

Quote Submission: All quotes shall be submitted with the following –

a) Pricing for all line items with the total price

b) The time specified in the solicitation for receipt of offers

c) The name, address, and telephone number of the offeror

Quotes that do not provide pricing for all line items may be deemed non-responsive.

The quoter shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an quoter to correct the document submission and the Government will not inform the quoter that their submission is non-responsive prior to award. It is the quoter’s responsibility to ensure all electronic documents are submitted without the use of macros.

ix. The provision at 52.212-2, Evaluation—Commercial Items (NOV 2021), is applicable to this requirement.

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The government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the requirements listed under the solicitation and is the lowest priced received in response to this solicitation. Therefore, award will be made to quoter is determined to be Lowest Price Technically Acceptable.

x. The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2023), applies to this acquisition with the addenda for INVOICING provided under HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) and invoicing instructions section.

xi. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (May 2024), The additional FAR clauses cited in the clause that apply under this acquisition are indicated below.

☐ 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN2020), with Alternate (NOV 2021)

☒ 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ☒ 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) ☒ 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) ☐ 52.204-14, Service Contract Reporting Requirements (OCT 2016) ☐ 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) ☒ 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) ☐ 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) ☐ 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (DEC 2023) ☐ Alternate I (DEC 2023) of 52.204–30.

☒ 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ☐ 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ☒ 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ☐ 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) ☐ 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ☐ Alternate I (MAR 2020) of 52.219-6.

☐ 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ☐ Alternate I (MAR 2020) of 52.219-7.

☒ 52.219-8, Utilization of Small Business Concerns (FEB 2024) ☐ 52.219-9, Small Business Subcontracting Plan (SEP 2023)

☐ Alternate I (NOV 2016) of 52.219-9.

https://www.acquisition.gov/far/part-52#FAR_52_203_6 https://www.acquisition.gov/far/part-52#FAR_52_203_13 https://www.acquisition.gov/far/part-52#FAR_52_203_17 https://www.acquisition.gov/far/part-52#FAR_52_204_10 https://www.acquisition.gov/far/part-52#FAR_52_204_14 https://www.acquisition.gov/far/part-52#FAR_52_204_15 https://www.acquisition.gov/far/part-52#FAR_52_204_27 https://www.acquisition.gov/far/part-52#FAR_52_204_28 https://www.acquisition.gov/far/part-52#FAR_52_204_30 https://www.acquisition.gov/far/part-52#FAR_52_209_6 https://www.acquisition.gov/far/part-52#FAR_52_209_9 https://www.acquisition.gov/far/part-52#FAR_52_219_3 https://www.acquisition.gov/far/part-52#FAR_52_219_4 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_6 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_7 https://www.acquisition.gov/far/part-52#FAR_52_219_8 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9

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

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

☐ Alternate IV (SEP 2023) of 52.219-9.

☐ 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ☐ Alternate I (MAR 2020) of 52.219-13.

☐ 52.219-14, Limitations on Subcontracting (OCT 2022) ☐ 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ☐ 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned

Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (FEB 2024) ☒ 52.219-28, Post Award Small Business Program Representation (FEB 2024) ☐ Alternate I (MAR 2020) of 52.219-28.

☐ 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged

Women-Owned Small Business Concerns (OCT 2022) ☐ 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 (OCT 2022) ☐ 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) ☐ 52.219-33, Nonmanufacturer Rule (SEP 2021) ☒ 52.222-3, Convict Labor (JUN 2003) ☐ 52.222-19, Child Labor-Cooperation with Authorities and Remedies ☒ 52.222-21, Prohibition of Segregated Facilities ☐ 52.222-26, Equal Opportunity (SEP 2016) ☐ Alternate I (FEB 1999) of 52.222-26.

☒ 52.222-35, Equal Opportunity for Veterans (JUN 2020) ☐ Alternate I (JUL 2014) of 52.222-35.

☒ 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) ☐ Alternate I (JUL 2014) of 52.222-36.

☐ 52.222-37, Employment Reports on Veterans (JUN 2020) ☒ 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) ☒ 52.222-50, Combating Trafficking in Persons (NOV 2021) ☐ Alternate I (MAR 2015) of 52.222-50 ☒ 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) ☐ 52.224-3 Privacy Training (JAN 2017) ☐ Alternate I (JAN 2017) of 52.224-3.

☐ 52.225-1, Buy American-Supplies (OCT 2022) ☐ Alternate I (OCT 2022) of 52.225-1.

☐ 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ☐ Alternate I [Reserved].

https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_9 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_13 https://www.acquisition.gov/far/part-52#FAR_52_219_14 https://www.acquisition.gov/far/part-52#FAR_52_219_16 https://www.acquisition.gov/far/part-52#FAR_52_219_27 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_28 https://www.acquisition.gov/far/part-52#FAR_52_219_29 https://www.acquisition.gov/far/part-52#FAR_52_219_30 https://www.acquisition.gov/far/part-52#FAR_52_219_32 https://www.acquisition.gov/far/part-52#FAR_52_219_33 https://www.acquisition.gov/far/part-52#FAR_52_222_3 https://www.acquisition.gov/far/part-52#FAR_52_222_19 https://www.acquisition.gov/far/part-52#FAR_52_222_21 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_26 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_35 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_36 https://www.acquisition.gov/far/part-52#FAR_52_222_37 https://www.acquisition.gov/far/part-52#FAR_52_222_40 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_222_50 https://www.acquisition.gov/far/part-52#FAR_52_223_18 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_224_3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-52#FAR_52_225_3

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☐ Alternate II (DEC 2022) of 52.225-3.

☐ Alternate III (NOV 2023) of 52.225-3.

☐ Alternate IV (Oct 2022) of 52.225-3.

☐ 52.225-5, Trade Agreements (NOV 2023) ☒ 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) ☐ 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) ☐ 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ☐ 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

☒ 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT2018) ☒ 52.239-1, Privacy or Security Safeguards (AUG 1996) ☐ 52.242-5, Payments to Small Business Subcontractors (JAN 2017) ☐ 52.222-41, Service Contract Labor Standards (AUG 2018) ☐ 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) ☐ 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment

(Multiple Year and Option Contracts) (AUG 2018) ☐ 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment

(May 2014) ☒ 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) ☒ 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for

Certain Services-Requirements (MAY 2014) ☐ 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022) ☐ 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) ☐ 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)

xii. Additional contract requirement(s) or terms and conditions

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://www.acquisition.gov/.

(End of Clause) https://www.acquisition.gov/far/part-52#FAR_52_225_3 https://www.acquisition.gov/far/part-52#FAR_52_225_5 https://www.acquisition.gov/far/part-52#FAR_52_225_13 https://www.acquisition.gov/far/part-52#FAR_52_225_26 https://www.acquisition.gov/far/part-52#FAR_52_226_5 https://www.acquisition.gov/far/part-52#FAR_52_229_12 https://www.acquisition.gov/far/part-52#FAR_52_232_33 https://www.acquisition.gov/far/part-52#FAR_52_239_1 https://www.acquisition.gov/far/part-52#FAR_52_242_5 https://www.acquisition.gov/far/part-52#FAR_52_222_41 https://www.acquisition.gov/far/part-52#FAR_52_222_42 https://www.acquisition.gov/far/part-52#FAR_52_222_43 https://www.acquisition.gov/far/part-52#FAR_52_222_44 https://www.acquisition.gov/far/part-52#FAR_52_222_51 https://www.acquisition.gov/far/part-52#FAR_52_222_53 https://www.acquisition.gov/far/part-52#FAR_52_222_55 https://www.acquisition.gov/far/part-52#FAR_52_222_62 https://www.acquisition.gov/far/part-52#FAR_52_226_6 https://www.acquisition.gov/

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HHSAR CLAUSES

HHSAR

CLAUSE NO.

DESCRIPTION DATE

352.203-70 Anti-Lobbying DEC 2015 352.208-70 Printing and Duplication DEC 2015 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.227-70 Publications and Publicity DEC 2015 352.231-70 Salary Rate Limitation DEC 2015

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

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide

15 | P a g e any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility 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.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services

16 | P a g e provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

FDA CONDITION Regarding Macros

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

(End of Condition)

FAR/HHSAR PROVISIONS

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/.

(End of Provision)

FAR/HHSAR

PROVISION NO.

DESCRIPTION DATE

52.217-5 Evaluation of Options JULY 1990 HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice DEC 2015

xiii. The Defense Priorities and Allocations System (DPAS) is not applicable.

xiv. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions submitted shall reference the solicitation number and name.

https://www.acquisition.gov/

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Quote Due Date & Time: August 1, 2024; 12:00 pm EST

Quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

xv. Point(s) of Contacts: Warren Jackson at warren.jackson@fda.hhs.gov mailto:warren.jackson@fda.hhs.gov