2025-07-07 Amendment 1 RFQ 75F40125Q00182 Laser Diffraction System.pdf

Request for Quotation (RFQ) No. 75F40125Q00182, Amendment 1 Center for Drug Evaluation and Research (CDER)

Office of Pharmaceutical Quality (OPQ) Laser Diffraction System

1. DESCRIPTION/COMMERICAL PRODUCTS AND COMMERCIAL SERVICES

PROCUREMENT

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 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 separate written solicitation will not be issued.

This is Request for Quotation (RFQ) no. 75F40125Q00182 for commercial products and commercial services in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Part 13- Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) code is 334516 - Analytical Laboratory Instrument Manufacturing. The associated small business size standard is 1,000 employees.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-04, effective June 11, 2025.

The FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov

The Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 7, Statement of Work, for a full description of the products and services to be acquired.

4. ORDER TYPE

The Government anticipates awarding one (1) Firm-Fixed Price (FFP) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance consists of one (1), 12-month base year and no option periods.

http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

6. PRICING

Anticipated Period of Performance: Base Year (September 2, 2025, through September 1, 2026) Item Description (Brand Name or Equal)

Quantity Unit Unit Price

Extended Price

STD LAB SYST 950mm BENCH, 300mm LENS) (STP5311): Short bench Spraytec laboratory system with a 950mm optical bench and a 300mm lens.

1 EA $ $

Electronic Records and Signatures (ER/ES) Feature Key for Spraytec (CPS0037) 1 EA $ $

Spraytec Regulated Environment Compliance Test

(CFR2021) 1 EA $ $

Spraytec Extraction System (115V 60Hz) (STP2499):

Spraytec Extraction System (100V variant) for the extraction of low volume spray systems such as domestic aerosols, nasal sprays and personal products.

1 EA $ $

Electronic Switching Box (STP2400): Electronic switching box to synchronize mains-operated external devices such as extraction and vacuum pump systems with the Spraytec measurement.

1 EA $ $

Trigger Cables for Spraytec - Set of 2 (STP2401): Set of 2 trigger cables for use with the input and output triggers on the Spraytec system.

1 EA $ $

SPRAYTEC WET CELL & DISPERSION UNIT

(STP2520): Wet sample dispersion unit for the Spraytec system.

1 EA $ $

SPRAYTEC AIR PURGE SYSTEM (STP2501): Provides a compressed air purge to prevent optics fouling during the measurement of large volume spray plumes.

1 EA $ $

AIR FLOW CONTROL SYSTEM (STP2502): Air Flow Control System, providing a means of controlling the air flow passing through the Spraytec purge system.

1 EA $ $

NSS Nasal Spray Support for Vereo NSx (STP2213):

Spraytec NSS Nasal Spray Support. 1 EA $ $

Windows 10/11 Pro PC PACKAGE – US (CPH3170US):

Includes: Base unit; PC monitor; US keyboard; 2 x kits of mains cables straight Euro+UK+USA+China.

1 EA $ $

Diff System-IQOQ-Bronze Level Service (SER010007):

Diffraction Product Line - Bronze Service Level. This is a fixed price service to perform an Installation Qualification (IQ) and an Operational Qualification (OQ).

1 EA $ $

Initial System Operational Overview (ATS0000): This comprises a brief basic operational overview of the system and how to maintain the hardware and would be delivered during the time the installer is visiting.

1 EA $ $

Classroom Training Included - 1 Seat (CTI2000): A voucher for a single seat at one of our regularly scheduled training courses are included with your system purchase.

1 EA $ $

2000mm OPTICAL BENCH ASSEMBLY (STP2532):

Spraytec 2000mm optical bench providing a measurement zone width of 1350mm.

1 EA $ $

TOTAL FIRM-FIXED PRICE (FFP) $

Center for Drug Evaluation and Research (CDER)

7. STATEMENT OF WORK

U.S. Food and Drug Administration (FDA)

Title: Laser Diffraction System for characterizing Over-the-Counter (OTC) spray drug products

BACKGROUND

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality, Office of Pharmaceutical Quality Research – St. Louis (OPQR – STL) has been providing laboratory testing and research support to test nonprescription spray drug products and has been working with the Office of New Drugs (OND)/Office of Non-Prescription Drugs (ONPD)/Division of Nonprescription Drugs I (DNDP I). The research is to evaluate the particle size distribution of over-the-counter (OTC) spray drug products emitted after actuation to support proposed guidance and update information in the OTC monographs that allow for spray/aerosol dosage forms.

OPQR – STL requires a new laser diffraction system to support testing and research on nonprescription spray drug products. The laser diffraction system shall be able to analyze aerosol particles with a wide variety of sizes from 0.1 μm to 900 μm. A wider bench with spatial working distance between lens and detectors will be used to test dermal spray drug products that have a much larger spray plume. The existing laser diffraction system has a narrow working distance that restricts our research to only nasal and inhalation drugs having smaller plumes due to no concern of lens contamination. Therefore, a new laser diffraction system is required to measure particle size of longer and wider plumes without contaminating the lens and detector windows providing accurate measurements.

OBJECTIVE

The objective of this Purchase Order is to acquire a laser diffraction system to enhance CDER/OPQ/OPQR – STL’s capability in characterizing nonprescription spray drug products, and evaluating particle size distribution and mass concentration of respirable particles from the products.

SCOPE OF WORK

This statement of work covers the delivery, installation, training, and instrument familiarization on a new laser diffraction system. Upon installation, operation of the instrument and performance qualification shall be demonstrated.

Center for Drug Evaluation and Research (CDER)

SALIENT CHARACTERISTICS (BRAND NAME OR EQUAL)

The salient characteristics are based upon the Spraytec system manufactured by MALVERN PANALYTICAL INC (UEI: YYDEKQG2AR67). The proposed acquisition package should include the laser diffraction system, Installation Qualification (IQ)/Operational Qualification (OQ), computers, and vendor provided instrument and software familiarization. To be considered brand name or equal, the system must be capable of, and include the following:

Parameters Descriptions

Systems

1) A laser diffraction system with an optical bench for at least 1350mm wide measurement zone and a 300mm lens or equal covering a size range at least from 0.1 to 900 microns (Dv50: 0.5 to 600 microns)

2) Workstation (at least Windows 10/11 Pro PC) with Control and Data Acquisition Software and full Adobe Acrobat application installed.

3) An extraction system (at least 100V variant) includes spray collector assembly, tubing, HEPA filter unit and a synchronization switching box

4) Wet sample dispersion unit for the laser diffraction system for the dispersion of particles in liquids

5) Compressed air purge system to prevent optics fouling during the measurement of large volume spray plumes, with air flow control

6) Must be compatible with Proveris Scientific Vereo NSx nasal spray actuator currently used in the lab

Software Must provide Control and Data Acquisition Software configured with the instrument, preinstalled on a workstation. Must ensure compliance with 21 CFR Part 11.

Performance

1) 300mm Fourier lens system or equal, covering a size range at least from 0.1 to 900 microns (Dv50: 0.5 to 600 microns).

2) Optical configuration provides a maximum working distance of 150mm at 0.5 microns, increasing to greater than 1000mm above 5 microns.

3) At least 2000mm optical bench providing a measurement zone width of at least 1350mm.

4) Optical models include Mie Theory and Fraunhofer Approximation.

5) Capable of high concentration (Multiple Scattering) analysis

6) Maximum acquisition rate - Continuous Mode: 1Hz / Rapid Mode

(Standard): 2.5kHz or equal

7) Automatic rapid optical alignment system, Minimum acceptable transmission 5% (95% obscuration) Powder Requirements 100 to 120VAC 50/60Hz 3.0A (360W) max

Laser Class 3R laser; Maximum output power <5mW; Beam diameter (measurement zone) 10mm (1/e²); Beam wavelength 632.8nm.

Environmental Requirements Temperature 10-35℃; Humidity 35% - 80%, non-condensing

Center for Drug Evaluation and Research (CDER)

TASKS

The vendor shall perform the following tasks:

• The vendor shall perform and document Installation Qualification (IQ) and Operational Qualification (OQ).

• The vendor shall provide software / hardware familiarization for analysts at the place of instrument performance (OPQR – STL).

• The vendor shall provide free unlimited technical support for the life of the instrument: phone AND internet contacts.

• A standard warranty shall apply, including at least one (1) year for parts, travel, and labor from the date of IQ/OQ completion.

• The vendor shall provide service agreement option consisting of at least one (1) annual preventative maintenance (PM) for three (3), 1-year periods following warranty end. Option for comprehensive maintenance plan, if available and in best interest of government, may be considered. The vendor shall also be capable of servicing the instrument through the extended warranty or service contract. This information shall not obligate FDA to purchase an extended warranty.

Trade and Service Specifications

• The instrument shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. CDER shall be able to reasonably expect service and technical support from the vendor during its lifecycle.

• The entire system shall be warranted for parts and labor for twelve (12) months from the date of installation.

DELIVERABLES

Deliverables are specified in Table 1 below.

Table 1: Deliverables/Schedule

Deliverable

Number Description Quantity Date Completed

1 Delivery of the laser diffraction system 1 90 days after award

2 Installation and instrument qualification 1 90 days after award

3 User familiarization 1

During qualification or 60 days after installation

Center for Drug Evaluation and Research (CDER)

8. SHIPPING DESTINATION

CDER/OPQ/OPQR – St. Louis 645 S. Newstead Ave.

Saint Louis, MO 63110

9. REPORTING REQUIREMENTS AND DELIVERABLES

The contractor shall provide 30-day notice prior to shipping. All reports for installation and qualification shall be provided (electronic format preferred). Acceptance will be made by the government within 30 days following completion of instrument installation and qualification.

10. SECURITY REQUIREMENTS

Supervision of install engineer upon arrival at OPQR – STL will be required. All software required must be approved on FDA’s Master Approved Technology (MAT) list and comply with OIMT requirements.

Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award.

11. PERIOD OF PERFORMANCE (POP)

The Period of Performance (PoP) is the 12-month period following the date of award, anticipated to commence on September 2, 2025. The actual PoP will be determined at time of award.

The anticipated period of performance is twelve (12) months from award date. The delivery of the entire system with accessories as outlined in the SOW should be completed within ninety (90) days of award.

Instrument installation and qualification should be completed within ninety (90) days of award.

Instrument familiarization and training should be completed during qualification or within sixty (60) days after installation. Warranty of one (1) year will start at the time of instrument IQ/OQ completion.

12. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO)

• Name and Position: Nicholas Bisher, Lead Contract Specialist

• Phone: (240) 402-2773

• Email: Nicholas.Bisher@fda.hhs.gov

Contract Specialist (CS)

• Name and Position: Melinda Kim, Contract Specialist

• Phone: (301) 796-0607

• Email: Melinda.Kim@fda.hhs.gov

Contracting Officer’s Representative (COR)

• Name and Position: Changning Guo, Supervisory Pharmaceutical Scientist

• Phone: (314) 539-3852

• Email: Changning.Guo@fda.hhs.gov

Technical Point of Contact (TPOC)

• Name and Position: Xiaofei Liu, Research Scientist

• Phone: (314) 539-3794

• Email: xiaofei.liu@fda.hhs.gov mailto:Nicholas.Bisher@fda.hhs.gov mailto:Melinda.Kim@fda.hhs.gov mailto:Changning.Guo@fda.hhs.gov mailto:xiaofei.liu@fda.hhs.gov

Center for Drug Evaluation and Research (CDER)

13. CONTRACTING OFFICER’S AUTHORITY

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting, ensuring compliance with the terms of the Purchase Order, and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this Purchase Order and is the only person authorized to approve changes to any of the requirements under this Purchase Order;

notwithstanding any provision contained elsewhere in this Purchase Order, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the CO, shall be interpreted as modifying the terms and conditions of the Purchase Order. 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 Purchase Order. The Government will not reimburse the Contractor for any work not authorized by the CO.

14. COMPLIANCES

Contractor Compliance The Contractor shall be responsible for knowledge of, and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: https://www.cio.gov/. HHS documents are found at: https://www.hhs.gov/.

15. GOVERNMENT CLOSURES AND FEDERAL HOLIDAYS

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, D.C. area:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday

Memorial Day Juneteenth National Independence Day Independence Day

Labor Day Columbus Day

Veterans Day Thanksgiving Day

Christmas Day

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management (OPM) or other such official for late arrivals due to inclement weather (unless otherwise specified in the Purchase Order).

In the event the Federal Government is closed by order of the President of the United States or OPM for any reason, or the agency, the Center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by the COR or Contracting Officer concerning reporting for

Center for Drug Evaluation and Research (CDER) work. In the event of early closings, the Contractor may be approved to leave early at the discretion of the COR and/or local policy.

16. INVOICING INSTRUCTIONS AND REQUIREMENTS

Health and Human Services Acquisition Regulation (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)

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

Center for Drug Evaluation and Research (CDER) 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:

• 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 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.

Center for Drug Evaluation and Research (CDER)

17. CONTRACTOR ADVERTISING OF CONTRACT AWARD (SEP 2012)

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies the U.S. 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.

18. NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENTAL FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the Federal Government and are not eligible for entitlement to benefits given Federal employees.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration, or control over personnel or personnel of other Government contractors or become a part of the Government organization.

• Be used in administration or supervision of procurement activities.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of the contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

Center for Drug Evaluation and Research (CDER)

19. 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 General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-8164, TTY 1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

20. NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

21. PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this contract prior to being assigned to the awarded contract.

22. GOVERNMENT-FURNISHED DATA AND MATERIALS

The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data.

These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

23. TRANSITION

The Contractor shall provide all management, administrative, clerical, and supervisory functions required for the effective and efficient performance of this contract.

A smooth and orderly transition between the Contractor and a predecessor or successor Contractor is necessary to ensure minimum disruption to vital Government business. The Contractor shall cooperate fully in the transition.

The Contractor shall adhere to the same professional and ethical standards of conduct required of Government personnel. The Contractor shall NOT:

• Discuss with unauthorized persons any information obtained in the performance of work under this contract;

• Conduct business not directly related to this contract on Government premises;

• Use computer systems and/or other Government facilities for company or personal business other than work related to this contract; or mailto:hhstips@oig.hhs.gov

Center for Drug Evaluation and Research (CDER)

• Recruit on Government premises or otherwise act to disrupt official Government business.

It is the Government’s intention to perform closeout procedures on an individual contract basis. The Contractor agrees to perform those internal functions necessary to support this process in a timely manner. The contract closeout will occur as soon as possible after required audit and establishment of final rates, as applicable.

24. INSURANCE REQUIREMENTS

The Contractor shall maintain the types of insurance and coverage required in FAR 28.307-2.

25. 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): http://www.acquisition.gov/comp/far/index.html.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) PROVISIONS:

NUMBER TITLE DATE

52.203-11 CERTIFICATION AND DISCLOSURE REGARDING SEP 2024

PAYMENTS TO INFLUENCE CERTAIN FEDERAL

TRANSACTIONS

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT JAN 2017

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS - REPRESENTATION

52.204-7 SYSTEM FOR AWARD MANAGEMENT NOV 2024

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

REPORTING

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR AUG 2020

52.204-24 REPRESENTATION REGARDING CERTAIN NOV 2021

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OCT 2020

OR SERVICES-REPRESENTATION

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

DOMESTIC CORPORATIONS-REPRESENTATION

52.211-6 BRAND NAME OR EQUAL AUG 1999

52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS SEP 2023

AND COMMERCIAL SERVICES

Please note: System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations, including 52.223-22, http://www.acquisition.gov/comp/far/index.html.

Center for Drug Evaluation and Research (CDER)

Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

FAR 52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services (MAY 2024) (DEVIATION FEB 2025)

• This provision applies to this solicitation. Offerors shall provide the required data with their quotations in accordance with FAR 52.212-3. (Please include completed representations and certifications, not already completed in SAM.gov.)

26. FAR PROVISIONS INCORPORATED BY FULL TEXT:

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of a Firm-Fixed-Price (FFP) type Purchase Order resulting from this solicitation.

Center for Drug Evaluation and Research (CDER)

27. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/browse/index/far.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES:

NUMBER TITLE DATE

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN JUN 2020

FEDERAL TRANSACTIONS

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR JAN 2011

PERSONNEL

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

MAINTENANCE

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS DEC 2014

AND CERTIFICATIONS

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL NOV 2023

PRODUCTS AND COMMERCIAL SERVICES

52.227-14 RIGHTS IN DATA – GENERAL MAY 2014

52.232-1 PAYMENTS APR 1984

52.232-23 ASSIGNMENT OF CLAIMS MAY 2014

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL MAR 2023

BUSINESS SUBCONTRACTORS

52.233-1 DISPUTES MAY 2014

52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM OCT 2004

52.237-3 CONTINUITY OF SERVICES JAN 1991

52.242-15 STOP-WORK ORDER AUG 1989

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

52.243-1 CHANGES-FIXED-PRICE AUG 1987

52.243-1 CHANGES-FIXED-PRICE, ALT I APR 1984

52.246-4 INSPECTION OF SERVICES—FIXED-PRICE AUG 1996

52.246-25 LIMITATION OF LIABILITY-SERVICES FEB 1997

52.249-1 TERMINATION FOR CONVENIENCE OF THE APR 1984

GOVERNMENT (FIXED-PRICE) (SHORT FORM)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025)

• The additional FAR clauses cited in this clause that have an “X” next to them are applicable to this solicitation. Full text of this clause is provided in (Attachment A).

Center for Drug Evaluation and Research (CDER)

28. FAR CLAUSES IN FULL TEXT:

FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(a) Definitions. As used in this clause-

Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with 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) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

Center for Drug Evaluation and Research (CDER)

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

(a) Definitions. As used in this clause— Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information ( 44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

Center for Drug Evaluation and Research (CDER) unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the Order. 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 six (6) months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the Order expires.

FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

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

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

(c) The total duration of this Order, including the exercise of any options under this clause, shall not exceed one (1) year and six (6) months.

29. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR) (48 CFR CHAPTER 3) CLAUSES INCORPORATED BY REFERENCE:

HHSAR Clauses can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR Clause # Clause Title Date 352.211-3 Paperwork Reduction Act Dec 2015 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

Center for Drug Evaluation and Research (CDER)

30. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR) (48 CFR CHAPTER 3) PROVISIONS AND CLAUSES IN FULL TEXT:

HHSAR Provisions and Clauses can be viewed in full text at:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR 352.209-1 CONTRACTOR COMPLIANCE WITH DEFENDING WOMEN AND

PROTECTING CHILDREN REQUIREMENTS – CERTIFICATION (MARCH 2025)

(DEVIATION)

(a) Certification. By submission of this offer and during performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor certifies that: [Offeror shall check each item.]

___ (1) It is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Contractor will remain compliant for the duration of the contract.

___ (2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

___ (3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

___ (4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

____ (5) Submitting a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of provision)

HHSAR 352.209-2 CONTRACTOR COMPLIANCE WITH DEFENDING WOMEN AND

PROTECTING CHILDREN REQUIREMENTS (MARCH 2025) (DEVIATION)

(a) During performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor agrees that:

(1) It must remain compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of 177 the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq.

(2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

Center for Drug Evaluation and Research (CDER)

(3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

(4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

(5) Submission of a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) The Contractor must include the provisions of this clause in all subcontract…