combined synopsis-solicitation 133944 cap and label machine.pdf

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR RFO part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 75F40126Q133944. This solicitation is issued as a Request for Quote (RFQ) for an Automated Vial Capper Machine and Labeler system.

This acquisition is set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul.

The associated North American Industry Classification System (NAICS) Code is- 333993 - Packaging Machinery Manufacturing; the applicable Small Business Size Standard is 600 employees. This requirement is solicited as unrestricted full and open competition, any sized business may submit a quote.

Schedule of Items (all shipping and handling shall be included in the price)

Item Description

QTY

Unit of Measure

Unit Price Extended Price

Automated Vial Capper machine and Labeler system, with installation, IQ/OQ/PQ, and training as specified herein

1 Ea $___________ $___________

Option Year 1: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months

Option Year 2: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months

Option Year 3: Post-Warranty Service Agreement Option Periods (FAR 52.217-9) as specified herein.

12 Months

Grand Total (items 1-4): $ ________________________

Statement of Work:

Purchase of Automated Vial Capper machine and Labeler system

Part I: General Information

A. Objective

Procurement of Automated Vial Capper machine and Labeler system including installation, onsite qualification, training and optional annual onsite preventative maintenance service. This equipment is used for the preparation of Center for Biologics Evaluation and Research (CBER)

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Standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions.

B. Background

Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. This procurement is for the purchase of a replacement Capper and Labeler system to maintain critical production capabilities. These Standards are essential for quantifying the potency of biological drugs and are used by manufacturers during product development and production, as well as by international regulatory agencies and the FDA for mandatory lot-release testing prior to approving biological drugs for public distribution.

The Capper and Labeler system is intended to store CBER Reference Standards and Reagents, specifically for capping and labeling of various sized glass vials containing these critical biological products. The existing equipment has been discontinued by the manufacturer, making a replacement necessary to ensure uninterrupted production of these essential reference standards. Continued production is required to maintain compliance with Code of Federal Regulations 610.60-65 and 812.5. This acquisition supports critical mission of CBER under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act to safeguard the safety, efficacy, and quality of biological products that protect public health.

C. Scope

This procurement is for the purchase of Automated Vial Capper machine and Labeler system for Division of Biological Standards and Quality Control (DBSQC).

Part II: Work Requirements

See technical specifications for automated Vial capping and labeling system.

• Maximum Footprint for Capper Machine and Labeler System: 16 x 5 feet.

The system should maintain high operational reliability and uptime during production periods.

Variable speed control capability must be provided to match production requirements and workflow demands. The equipment must demonstrate consistent capping torque and labeling placement accuracy to ensure product quality and regulatory compliance. Container handling shall be designed for gentle operation to prevent container damage during processing. The system must operate effectively in a temperature-controlled laboratory environment with appropriate humidity levels.

1. Rotary Table

• Construction: Aluminum frame or equivalent durable frame material, with stainless steel external coverings or equivalent cleanable exterior surfaces

• Guide Rails: Stainless steel guide rails and center hub

• Support System: Anti-friction ball bearing supports with stainless steel pads

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• Height Adjustment: Adjustable stainless steel threaded legs, or equivalent leveling mechanism, to support equipment leveling and integration with adjacent equipment;

quoted configuration provides an adjustable height range of 33"–37".

• Cabinet: Integrated stainless-steel cabinet, or equivalent cleanable enclosure, with access panels for maintenance; cabinet shall fit within the overall 16 x 5 system footprint

• Base Frame: 30" with leveling feet

2. Utilities and Controls

• Power Requirements: Compatible with 115-volt, 60 hertz, 1-phase facility power, with adequate motor capacity to operate the integrated capper / labeler line at a minimum of 60 vials per minute for 3 mL and 5 mL vials using 13 mm and 20 mm aluminum crimp caps

• Drive System: Variable speed motor drive system capable of maintaining stable vial handling, capping, and labeling throughput at a minimum of 60 vials per minute, and supporting line start-up, stoppage, and changeover conditions.

• Air Supply: Requires clean compressed air utility, with minimum pressure of 30 psi or as specified by the manufacturer. CBER/FDA will provide clean compressed air at the installation site; the contractor/system manufacturer shall identify connection, pressure, and consumption requirements and connect/configure the equipment during installation.

• Control Panel: Capable of supporting labeler configuration with multiple conveyor drives as required by system design

• Interface: A minimum of 4.3" color touchscreen HMI with pushbuttons, or equivalent operator interface, providing clear visibility and manual control during production.

• HMI Mounting: HMI shall be mounted on the conveyor or system frame on the operator side of the equipment, in a location that provides clear visibility and safe, unobstructed access to controls during production; final location shall be confirmed during design or installation

• Production Rate: Minimum of 60 vials per minute

• Conveyor: Low friction chain conveyor with adjustable guide rails, minimum 3¼" wide or as required to accommodate specified containers

• Container Compatibility: Accommodates containers with outer diameter (OD) ranging from 5/8" to 4" and heights up to 6"

• Cap Sizes: Compatible with multiple closure sizes, including 13mm and 20mm

• Sealing Capability: Automated aluminum sealing for all supported cap sizes

• Components: Includes all necessary container handling and sealing components such as star wheel assemblies, cap seats, rollers, and delivery chutes

3. Wrap Labeling System

• Interface: Integrated system HMI/central touchscreen interface for labeling system control. If the labeler uses a separate HMI, it shall provide a 4.3" color touchscreen with push buttons, or equivalent color touchscreen/manual control capability, and be integrated with the overall line controls

• Safety Features: Alarms and warnings for label slippage detection (enhanced with optional alarm package)

• Maintenance Access: Open nip roller for quick correction of labeling problems

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• Label Compatibility: Accommodate multiple label sizes including 0.75" x 1.75" and 1" x 2.625"

• Conveyor System: Chain conveyor, belt conveyor, or other functionally equivalent conveyor system with adjustable guide rails, sized to support stable vial flow, labeling accuracy, and integration with the capper / labeler line

• Application System: Multi-axis label application system with wrap belt assembly of sufficient dimensions to accommodate required label sizes and container configurations

• Labeling Head: Label applicator head configured for side-apply operation with dimensions appropriate to support required label sizes and production throughput

• Drive System: Belt rewind drive system of sufficient width and capacity to support continuous label feed and consistent application

• Peeler: Label peeler of sufficient size and configuration to ensure accurate and consistent label separation during operation

• Brake Unwind: Brake unwind mechanism of sufficient capacity to maintain controlled label tension and feed consistency throughout operation

• Wiper: wiper, 5"

• Applicator: Spring loaded secondary foam roller applicator

• Sensor: Polarized retroreflective sensor with conveyor mount

4. Automatic Tray Loader

• Integration: Seamless integration with the overall capping and labeling system

• Automation: Automatic tray loading capability to support continuous operation

• Flexibility: Downstream accumulation/handling system shall accommodate capped and labeled 3 mL and 5 mL vials after labeling and support manual removal or transfer for subsequent packaging operations

• Conveyor Integration: Compatible with the overall system conveyor design

• System Integration Components

• Conveyor System: Base frame with leveling feet of sufficient dimensions to support system operation and integration

• Guide Rail Assembly: Conveyor guide rail system of sufficient length to support container flow and system integration

• Labeling Head Mount: Multi-axis label head mounting system compatible with the conveyor height and configuration

• Top Hold Down Belt: Hold down belt of sufficient width and length to ensure stable container handling during operation

• Interface Spacer Wheel: Component interface spacer to ensure seamless integration between system elements

Place of Performance

Federal Research Center Building 52/72, Room 5296 (fifth floor) 10903 New Hampshire Avenue Silver Spring, MD 20993

Period of Performance

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Equipment delivery shall be completed within 196 calendar days of contract award. Installation, Qualification and training completion shall be finalized within 226 calendar days of contract award (30 days after delivery).

Estimated dates below:

Contract Award Date: 09/01/2026 Equipment Delivery (200 days after award): 03/20/2027 Installation, Qualification & Training Completion (230 days after award): 04/19/2027 Manufacturer's Warranty Period (12 consecutive months): 04/20/2027 – 04/19/2028 Option Year 1: 04/20/2028 – 04/19/2029 Option Year 2: 04/20/2029 – 04/19/2030 Option Year 3: 04/20/2030 – 04/19/2031

The period of performance for the Option years in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the warranty offered. If/when Option Year 1 Post-Warranty Service/ maintenance is exercised, the periods of performance for all post-warranty Options will be firmed via unilateral modification.

Part III: Supporting Information

A. Security

The contractor Technicians / Customer Service Representatives are required to use White Oak campus parking lot and are required to follow government security procedures. Once the contractors enter the Security Desk at Bldg. WO75 Atrium or Bldg. 52/72 Loading Dock, FDA employees must escort the contractor Technicians and/or Customer Service Representatives during their presence in the building.

B. Packaging and Shipping Requirements

Advance notification at least 48 hours prior to delivery must be coordinated with FDA facility management. Deliveries to made between 9 AM – 3 PM. All shipping and delivery activities must comply with FDA security protocols. Installation is included with no separate shipping charges.

C. Installation and Setup Visual inspection for shipping damage and completeness shall be conducted upon delivery.

Performance testing verification of all operational parameters is required. Government acceptance shall occur within 30 days of successful qualification.

The contractor should provide guidance and full support for any site preparation in collaboration with FDA counterparts.

D. Set-up and Configuration

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Complete system assembly and integration of all components shall be performed by the contractor. Software installation and configuration of control systems is required. Initial system optimization and performance verification must be completed.

E. Testing and Calibration procedures Factory Acceptance Testing (FAT) prior to shipment must be conducted to verify equipment performance and specifications at the manufacturer's facility before delivery.

Installation Qualification (IQ) and Operation Qualification protocols shall be provided by the contractor to FDA for review and approval. The contractor shall address any comments/suggestions from FDA staff. The contractor shall execute only approved protocols.

Installation Qualification (IQ) protocol determines the site preparation and installation of all equipment components according to manufacturer specifications to satisfy FDA requirements.

Operational Qualification (OQ) performance verification must be conducted to demonstrate that the system operates as intended within specified parameters.

Performance Qualification (PQ) validation using actual production parameters and materials shall be performed to validate system performance under routine operating conditions.

Replicate analyses must be performed to verify consistency. Complete testing of all system functions is required. Testing design must be presented in the protocols. Verification of all safety systems and interlocks must be completed

Qualification (IQ/OQ):

1. Provide qualification protocol for FDA review and address any comments / suggestions

2. Execute qualification based on FDA approved protocol

3. Prepare qualification report with data and any deviations

4. Provide qualification report for FDA review and address any comments / suggestions.

F. Training and Manuals Comprehensive on-site training for FDA personnel should be provided. Operation, basic maintenance and troubleshooting training is required. Control system operation and parameter adjustment training must be included. Written training materials and certificates of completion shall be provided to all trained personnel.

Complete operation and maintenance manuals shall be provided (1 printed copies, 1 electronic).

Software user guides and technical specifications must be included. Safety data sheets for all consumables and materials shall be provided.

G. Warranty and Maintenance

A minimum of twelve (12) months’ warranty from acceptance shall be provided. Complete coverage including parts, labor, travel and subsistence for all warranty repairs at no charge to the Government is required. The vendor shall provide response and repair services in accordance with their standard warranty terms and conditions. The vendor should provide one onsite preventative maintenance service and unlimited phone trouble shooting guidance.

Post-Warranty Service Agreement Option Periods

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• The Contractor shall provide one (1) scheduled on-site (hardware and software) planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays).

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

k. Contractor Personnel Requirements The contractor’s technicians shall have a Real ID, or a USA government issued passport to enter the FDA laboratories. White Oak campus parking lot access is required for all contractor personnel. Compliance with security desk procedures at Building WO75 Atrium or Loading Dock at Building 52/72 is mandatory. FDA employee escorts are required during all contractor presence in the building. Adherence to all FDA security protocols is required without exception.

Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.

2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, software, and that otherwise required to meet these specifications and the FDA’s stated need.

3. Systems/equipment shall be warranted for not less than one (1) year from FDA acceptance of the system(s), to include on-site training. Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one

(1) year.

FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

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Service/Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Labor Day Martin Luther King, Jr.’s Birthday Columbus Day Washington’s Birthday Veterans Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

Contract clauses- 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/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Required:

52.212-4, Contract Terms and Conditions-Commercial Items (Deviation SEP 2025) Applicable:

52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020) Alternate I (Nov 2021) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-13 System for Award Management and Maintenance (Deviation) (RFO Aug 2025) 52.209-6, Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Deviation) (RFO

NOV 2025)

52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Deviation) (RFO

NOV 2025)

52.219-6, Notice of Total Small Business Set-Aside (DEVIATION) (RFO SEP 2025) 52.219-8, Utilization of Small Business Concerns (DEVIATION) (RFO SEP 2025) 52.219-14, Limitations on Subcontracting (DEVIATION)(RFO Nov 2025) 52.222-3, Convict Labor (DEVIATION) (RFO SEP 2025) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Deviation) (RFO Sep 2025) 52.222-35, Equal Opportunity for Veterans (DEVIATION)(RFO Nov 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (Deviation) (RFO Sep 2025) 52.222-37, Employment Reports on Veterans (DEVIATION)(RFO Nov 2025) 52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 2025) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (DEVIATION) (RFO

SEP 2025)

52.222-54, Employment Eligibility Verification (DEVIATION)(RFO Nov 2025) 52.222-90, Addressing DEI Discrimination by Federal Contractors (DEVIATION) (RFO APR 2026) 52.223-23, Sustainable Products and Services (Deviation) (RFO Sep 2025)

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52.225-1, Buy American-Supplies (DEVIATION) (RFO NOV 2025) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.229-12, Tax on Certain Foreign Procurements (DEVIATION) (RFO SEP 2025) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-3, Protest After Award (Deviation) (RFO Aug 2025) 52.233-4, Applicable Law for Breach of Contract Claim (Deviation) (RFO Aug 2025) 52.240-91 Security Prohibitions and Exclusions (Deviation) (RFO Aug 2025) 52.244-6, Subcontracts for Commercial Products and Commercial Services (Deviation) (RFO Sep 2025)

Other applicable Clauses:

52.217-9, Option to Extend the Term of the Contract (Mar 2000)

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

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

(c)The total duration of this contract, including the exercise of any options under this clause, shall not exceed three (3) years exclusive of the time set forth for delivery, installation, training and warranty.

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):

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

HHSAR Clauses 352.203-70 Anti-Lobbying JUN 2026 (RFO DEVIATION) 352.208-70 Printing and Duplication Feb 2026 (RFO Deviation) 352.232-71 Electronic Submission of Payment Requests (Apr 2026) (RFO DEVIATION)

(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 in FAR 32.905(b) and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must 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) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

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

(END OF CLAUSE)

HHSAR Clause 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(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 information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the

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Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)]

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer’s Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

Contract Administration

a. Contracting Officer/Contract Administrator Nick Sartain, Contracting Officer Phone: 301-796-1988 Email: nick.sartain@fda.hhs.gov

b. COR – The following COR will represent the Government for the purpose of this contract:

(To be completed at time of award) Name:

Phone:

Email:

The COR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

Payments

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Payment terms Net 30 days after government acceptance. No advance payments will be made.

Invoice Submission

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

75F40126Q133944 12 of 20 http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ 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 delivery 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

75F40126Q133944 13 of 20 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.

CPARS Registration and Access The FDA utilizes the Contractor Performance Assessment Reporting System (CPARS), located at https://www.cpars.gov, to process mandatory performance reviews in accordance with RFO FAR 42.1103. Upon receipt of the names and email addresses of two (2) designated individuals serving as the Contractor’s primary and alternate contacts, the FDA will register the firm in the system. Registered contacts will receive an automated system email containing unique User IDs and password setup.

• Primary contact name/email:

• Alternate contact name/email:

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 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the https://www.cpars.gov/ system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/lc.htm . There is no fee for registration or use of the CPARS.

Notice Regarding the Use of Macros in Submitted Documents

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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.

Solicitation provisions Contract Type: Commercial Item-Firm Fixed Price.

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

FAR Provisions.

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2024) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-7 System for Award Management (Deviation) (RFO Aug 2025) 52.219-1 Small Business Program Representations (DEVIATION)(RFO Nov 2025) 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (FEB 2021) 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate Alt II

(DEVIATION) (RFO SEP 2025)

52.229-11 Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 2025)

52.240-90 Security Prohibitions and Exclusions Representations and Certifications

(DEVIATION) (RFO AUG 2025)

HHSAR Provisions 352.239-73[8] Electronic Information and [Communication] Technology Accessibility Notice (Dec 2015[Feb 2024]) [(Deviation)]

(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, 75F40126Q133944 15 of 20 https://www.acquisition.gov/far-overhaul https://www.hhs.gov/web/section-508/index.html information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://section508.gov/.

(e) In order to facilitate the Government's determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(g) Items delivered as electronic content must be accessible to HHS acceptance criteria.

Checklist for various formats are available at https://section508.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(END OF PROVISION).

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The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (Deviation) (RFO Aug 2025) The following addenda have been added to this provision:

Technical Capability: Will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered products meet or exceed the technical requirements identified above. In addition to identifying manufacturer or distributor of quoted products, it is incumbent of quoters that they unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications. it is incumbent that quoters unequivocally demonstrate that quoted products meet the requirements herein through the submission of technical specifications, descriptive material, scientific literature, brochures, and/or scientific publications where proposed solution has been used for same or similar purposes, and other information which demonstrates the capability of the quoted equipment. Quoters shall address the technical requirements identified above, as well as provide detailed information on the item(s) in this RFQ/solicitation.

To be considered for award, quotes of “equal” products, including “equal” products of the manufacturer shall meet the salient physical, functional, or performance characteristic specified in this solicitation; clearly identify the item by brand name, if any; and make or model number. “Equal” quotes shall include a narrative describing how the offered product(s) meet(s) each salient characteristic as well as a demonstration of how each salient characteristic is fully met.

Any proprietary information shall be marked as such.

Price: The price(s) proposed must be detailed and shall represent the quoter’s response to the schedule of supplies/services above. Quoters are also encouraged to submit a vendor quote with this document. Offerors shall include their SAM Unique Entity ID (UEI) with the quotation.

The Quoter shall submit a written Accessibility Conformance Report (ACR) for each item not in compliance with 508 standards identified in clause 352.239-74, describing how the item(s) will fully address the accessibility requirements outlined in the solicitation; and a description of the evaluation methods the offeror will use to validate for conformance to the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). For this requirement we anticipate only invoices to be applicable to the requirement

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

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The government is not responsible for locating or securing any information, which is not identified in the proposal however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. The Government reserves the right to request additional information from a quoter at any time.

Microsoft Suite Documents Containing Macros The offeror or applicant 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 offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

Buy American Act and Executive Order 14005 If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required.