75F40126Q133508.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 75F40126Q133508. This solicitation is issued as a Request for Quote (RFQ) for bioMerieux or equal consumables (API Listeria Strips, API 20 E Strips, SX2 Broth 20 Tubes, etc.) required for existing FDA bioMerieux instruments, specifically its VIDAS Immunoassay and VITEK systems.

This acquisition is not 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- 334519 - Other Measuring and Controlling Device Manufacturing, Small Business Size Standard of 600 employees. This requirement is solicited as unrestricted full and open competition; any sized business may submit a quote.

Background The U.S. Food and Drug Administration (FDA) is a regulatory agency with responsibility for the safety of food for humans and animals and the safety and efficacy of drug, devices and other medical products.

Within the FDA, The Office of Regulatory Testing and Surveillance (ORTS) laboratory network performs scientific testing on products which are regulated by the FDA. The BioMérieux VIDAS Immunoassay and VITEK Automated Microbiology instrument systems are the approved standardized instruments currently in use in FDA laboratories to aid in the screening and identification of micro-organisms isolated from regulatory samples. These instruments use consumable strips, cards, tube media and slides to identify these contaminants in food and environmental samples.

In support of this regulatory mission, the bioMerieux VIDAS and VITEK instruments require proprietary reagents, slides, strips and cards. These consumables are used in accordance with the manufacturer’s recommendations to achieve the goals of screening and identification confirmation of isolates associated with outbreaks. The use of these specific consumables in identifying organisms significantly reduces the time it takes to perform the identification which allows for quicker results and reduced costs to perform these tests.

Consistent with this current infrastructure is the use of “brand name or equal” when describing each consumable and their salient performance characteristics in this solicitation. This is a brand name or equal requirement for bioMerieux or equal consumables designed to seamlessly integrate with VITEK and VIDAS instrument systems. Where an offeror submits an equal product, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements.

The salient characteristics that any and all equal consumables shall meet are as follows for the specified bioMerieux or equal consumables for multiple VIDAS and VITEK instrument systems across multiple FDA delivery points:

https://www.acquisition.gov/far-overhaul

*API 20 E Strips or equal, Catalog #20160 Box shall contain 100 individually wrapped strips and incubation chambers; strips shall include the following biochemical reactions:

o ONPG for beta-galactosidase activity o Alcohol dehydrogenase o Lysine decarboxylase o Ornithine decarboxylase o Citrate o Hydrogen Sulfide o Urea o Tryptophan decarboxylase o Indole o Voges Proskauer o Gel o Glucose o Mannose o Inositol o Sorbitol o Rhamnose o Saccharose o Melibiose o Amygdaline o Arabinose o Nitrate reduction o Nitrogen

*API Listeria Strips or equal, Catalog #10300 Box shall contain 10 individually wrapped strips, media vials and incubation chambers; strips shall have the ability to differentiate Listeria species using the following biochemical reactions:

o Presence of Arylamidase o Esculin hydrolysis o alpha-Mannosidase o Acidification of

D-Arabitol D-Xylose L-Rhamnose Alpha-Methyl-D-glucoside D-Ribose Glucose-1 phosphate D-Tagatose

*SX2 Broth 20 Tubes or equal, Catalog #42121 Selective medium inhibiting the growth of organisms except for Salmonella species to be screened via VIDAS

VIDAS Strips:

*Salmonella 60T or equal, Catalog #30702;

*Listeria 60T or equal, Catalog #30700;

*VIDAS SET2 (Staph Enterotoxin II) or equal, 30TCatalog #30705;

*QVC VIDAS 60T (Quality Control Test) or equal, Catalog #30706.

• Test strips shall be compatible with existing VIDAS instrumentation;

• Test strips shall be ready-to-use Solid Phase Receptacle (SPR) coated with antibodies against Salmonella, and Listeria specific antigens;

• Test strips shall have a minimum shelf-life of at least 6 months;

• Each shipment of strips will be of the same lot number;

• Assay strips shall contain 10 wells, be foil-sealed and labeled.

o Labels shall contain a barcode that identifies assay code, kit lot number and expiration date o Strip Well 1 shall be empty for sample, control or standard introduction and have perforated foil for ease of sample introduction o Strip well 2 shall contain 400 µL of prewash solution o Strip wells 3-5 and 7-9 shall contain 600 µL of wash buffer o Strip well 6 shall contain 400 µL of conjugate o Strip well 10 shall contain a cuvette with substrate in which a fluorometric reading can be performed

• Strips shall contain:

o Assay standard and controls containing purified and inactivated organism specific antigen + preservative + protein stabilizer o Assay positive controls o Assay specific confidence interval o Assay negative control containing TRIS with buffered saline and tween, pH

7.6 o Specification sheet containing the factory master calibration data required for test calibration on the instrument used for pathogen detection

• Strips shall allow assay interpretation using existing VIDAS automated readers and store all pertinent lot and reagent information within the reader

VITEK 2 Cards *VITEK 2 ANC or equal, Catalog #21347;

*VITEK 2 BCL or equal, Catalog #21345;

*VITEK 2 GN or equal, Catalog #21341;

*VITEK 2 GP or equal, Catalog #21342.

• Cards shall be compatible with existing VITEK 2 instrumentation;

• Cards shall be individually wrapped, with the filling tube;

• Cards shall be ready-to-use for the identification of:

o Gram negative bacteria o Gram positive bacteria o Bacillus species o Yeast and yeast-like organisms o Anaerobic bacteria

• Cards shall have a minimum shelf-life of at least 6 months;

• Each shipment of cards will be of the same lot number.

VITEK MS Slides and Reagent *VITEK MS DS or equal, Catalog #410893;

*VITEK MS CHCA or equal, Catalog #411071;

*VITEK 2 YST or equal, Catalog #21343.

Each target slide shall be compatible with existing VITEK MS instrument; reagent must be able to absorb energy and transfer it to micro-organisms to allow ionization for identification.

Periods of Performance (PoP)s; Estimated Value; Pricing Schedule

Type of Agreement & Value This is a Single-Award IDIQ with a total estimated ceiling of $1,500,000 over five (5) years.

Individual Delivery Orders issued against this IDIQ will be Firm-Fixed-Price (FFP).

Scope of Work The FDA seeks a single-award IDIQ contract for bioMerieux strips, cards, tube media and slides to identify these contaminants in food and environmental samples.

It is expected over the life of the contract that items may be phased/aged out, and that new items may be added to this list. These additional products, prices and descriptions of the products will be negotiated on a case-by-case basis. The additional categories, prices and descriptions quoted, upon determination by the Government, that they are necessary for performance and are both fair and reasonable, can be added to a given Delivery Order. New consumables will be incorporated by bilateral modification into the Schedule of Items tables of this contract.

All prices, both in response to this solicitation and on all delivery orders, shall be firm-fixed-price.

The Contractor shall maintain a log of all consumables purchased under this Contract and shall supply a copy to the FDA upon request.

Immediately upon shipping consumables, Contractor shall provide all tracking information to the FDA Contracting Officer’s Representative (COR) who will be identified at time of contract award.

Delivery Points (FOB Destination) Delivery orders under the IDIQ ordering periods shall be shipped directly to multiple FDA laboratory facilities – all within the contiguous United States. Other FDA centers and locations may also receive deliveries when required to meet the mission of the FDA and will be identified at the Delivery Order level. The Contractor shall arrange direct shipment of bioMerieux or equal consumables as follows:

Shipment-to-Delivery Cadence Domestic FDA Office/Laboratory: 7 days from ARO Emergency Overnight Delivery; only when required.

Shipping Destinations: The contractor may deliver to the following locations as specified by the delivery order. Other FDA locations may receive orders that will be identified on the specific delivery order.

U.S. Food & Drug Administration Arkansas Human and Animal Food Laboratory (ARLHAFL) 3900 NCTR Road, Bldg. 26 Jefferson, AR 72079

U.S. Food & Drug Administration Atlanta Human and Animal Food Laboratory (ATLHAFL) 1777 Hardee Ave, Atlanta, GA. 30310

U.S. Food & Drug Administration Denver Human and Animal Food Laboratory (DENHAFL) 1 Denver Federal Center 6th Ave and Kipling St., Bldg. 20, Entrance W10 Denver, CO 80225

U.S. Food & Drug Administration Irvine Human and Animal Food Laboratory (IRVHAFL) 19701 Fairchild, Irvine, CA 92612 U.S. Food & Drug Administration

San Francisco Human and Animal Food Laboratory (SANHAFL) 1201 Harbor Bay Pkwy Alameda, CA 94502

U.S. Food & Drug Administration Seattle Human and Animal Food Laboratory (SEAHAFL) 22201 23rd Dr. SE Bothell, WA 98021

U.S. Food & Drug Administration New York Human and Animal Food Laboratory (NYHAFL) 158-15 Liberty Ave.

Jamaica, NY 11433

Minimum and Maximum Quantities The guaranteed contract minimum will be $100,000. Funding for this minimum guarantee will be obligated against the base contract award. If the FDA requires a delivery order under the IDIQ, then that delivery order amount will be reduced by the minimum guarantee obligated on the IDIQ contract.

The contract maximum of all orders issued over five (5) year ordering periods and awarded under this contract is estimated not to exceed $1,500,000 including any shipping costs, though this ceiling can be increased via mutual agreement of the parties. The estimated maximum anticipated under this contract is not intended to imply that it is an estimate of the total products that will be required.

The maximum amount in no way guarantees that the volume of purchases through this IDIQ will be higher or lower than the said estimate over the term of the IDIQ. The Government is obligated only for the contract minimum funded for the base year.

Ordering Procedures/Delivery Schedule Ordering under this contract shall be accomplished by the issuance of written Delivery orders. The only individual authorized to process Delivery orders for the FDA is an Office of Acquisitions & Grants Services (OAGS) Contracting Officer.

All delivery orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any delivery order. The general process for individual delivery orders is as follows:

a) For each delivery order, the FDA will prepare a Statement of Work (SOW). The SOW will include, at a minimum, the following elements:

1. Description of products required and quantity;

2. Delivery location;

3. delivery schedule and Performance Period. Each DO may have multiple shipment dates;

4. Anything else necessary for the delivery order.

b) The FDA will confirm pricing with the contractor.

c) The Contractor shall prepare and submit a price proposal if needed addressing all areas of the requirement. The Contractor shall submit the Task Order proposal within the time period specified in the request and adhere to the product ceiling rates established in the contract. Other direct costs such as shipping shall be clearly identified, explained, and substantiated. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a Delivery Order proposal. The Government will evaluate Delivery Order proposals as specified in the notice.

d) The FDA Contracting Officer placing the delivery order shall issue either an OF347, SF1449 or other designated form to the Contractor. Period of Performance for individual delivery orders may extend beyond the five-year ordering period provided the task order was issued prior to ordering period five year expiration date, and requested up to and not longer than one (1) year prior to the expiration date of the final ordering period.

Delivery orders issued against this contract vehicle will be Firm-Fixed-Price (FFP).

Specific delivery details will be provided in the delivery order, such as the delivery address, point of contact information, the consumables required, delivery schedule, and any specific local delivery requirements for security or loading dock delivery. Changes to the delivery schedule may occur after issuance of the delivery order at the request of the FDA as long as adequate notice (minimum of two weeks) is given to the contractor and as long as the changes are within the period of performance of the delivery order. Any changes that fall outside the period of performance of the delivery order will require the Contracting Officer to modify the delivery order. No one other than the Contracting Officer is authorized to change the terms and conditions of a delivery order.

Contract Period of Performance The period of performance for this IDIQ contract shall consist of five (5), one-year ordering periods estimated to be:

Ordering period 1: September 15, 2026, through September 14, 2027 Ordering Period 2: September 15, 2027 through September 14, 2028 Ordering Period 3: September 15, 2028 through September 14, 2029 Ordering period 4: September 15, 2029 through September 14, 2030 Ordering period 5: September 15, 2030 through September 14, 2031

Delivery orders may be issued up to the final day of this contract inclusive of any extensions thereto, and the contract shall remain in force to allow for the completion of all delivery orders issued. Delivery order performance periods may go up to one year past the IDIQ Ordering Period end date and products prices shall remain at the last ordering period rates.

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

Deliveries 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 Alt I, 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) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(DEVIATION) (RFO NOV 2025)

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

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

NOV 2025)

52.219-4, Notice of Price Evaluation preference for HUBZone Small Business Concerns

(DEVIATION) (RFO SEP 2025)

52.219-8, Utilization of Small Business Concerns (DEVIATION) (RFO SEP 2025) 52.219-9, Small Business Subcontracting Plan (DEVIATION) (RFO SEP 2025) Alt II, (DEVIATION) (RFO SEP 2025)

52.219-16, Liquidated Damages-Subcontracting Plan (DEVIATION) (RFO SEP 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 Sep 2025) 52.222-36, Equal Opportunity for Workers with Disabilities (Deviation) (RFO Sep 2025) 52.222-37, Employment Reports on Veterans (Deviation) (RFO Sep 2025) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEVIATION) (RFO SEP 2025)

52.222-50, Combating Trafficking in Persons (Deviation) (RFO Sep 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) 52.225-5, Trade Agreements (Nov 2023) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) 52.229-12, Tax on Certain Foreign Procurements—Notice and Representation (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:

52.216-18 Ordering (Aug 2020)

(a) “ … from effective date of contract award through and including the last date of the contract including any extensions thereto.”

FAR Clause 52.216-19 Order Limitations (Oct 1995)

(a) “…$1,000.00 per Delivery order, …”

(b) (1) “… in excess of $1,000,000.00;”

(b) (2) “… in excess of $1,000,000.00;”

(b) (3) “… within five (5) calendar days…”

(d) “… within five (5) calendar days…”

FAR Clause 52.216-22 Indefinite Quantity (Deviation) (RFO Sep 2025)

(d) “…after three (3) years from date of contract expiration.”

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

HHSAR Clause 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.

(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, http://www.ipp.gov/ https://www.access-board.gov/ict/ https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.itic.org/policy/accessibility/vpat 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 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

a. Contracting Specialist

Tim Walbert, Contract Specialist Phone: 301-796-1768 Email: timothy.walbert@fda.hhs.gov

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

(To be completed at time of award) Name:

Phone:

Email:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html mailto:nick.sartain@fda.hhs.gov mailto:timothy.walbert@fda.hhs.gov

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 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.

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

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

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

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

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

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

• 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 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.

Notice Regarding the Use of Macros in Submitted Documents 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.

Designation of Task Order/Delivery Order Ombudsman In accordance with HHSAR 316.505(b)(8), the Director, Office of Acquisitions and Grants Services, has been designated as the FDA Ombudsman for Task Order and Delivery Order contracts:

Leonard Grant Three White Flint North

11601 Landsdown Street Rockville MD 20852 Phone: 240-402-7584 Email: Leonard.Grant@fda.hhs.gov (End of Clause)

Contract Administration

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.

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 mailto:Leonard.Grant@fda.hhs.gov https://www.cpars.gov/ https://www.cpars.gov/ https://www.cpars.gov/lc.htm https://www.acquisition.gov/far-overhaul

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) 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products (FEB 2021) 52.225-6 Trade Agreements-Certificate (FEB 2021) 52.229-11 Tax on Certain Foreign Procurements—Notice and Representation (DEVIATION)

(RFO SEP 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, 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 https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibilitychecklists/index.html 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).

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO Aug 2025) applies to this solicitation. The following addenda apply:

Technical Acceptability. Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered consumables meet all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each minimum technical requirement which demonstrates the capabilities of the offered system.

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.

Price proposed must be detailed and shall represent the offeror’s response to the schedule of supplies/services above. Pricing must be valid through September 30, 2026.

Pricing Periods The specific calendar timelines, operational windows, and base/option periods governing this requirement are detailed in full under the Periods of Performance listed on page 7. Offerors must enter corresponding firm-fixed unit pricing into Attachment 1 – Pricing Tables for the appropriate ordering periods.

https://section508.gov/ https://section508.gov/

Attachment 1 - Pricing Tables Respondents are required to enter unit pricing for each Line Item and ordering period as illustrated in Attachment 1 – Pricing Tables. Offerors must quote all line items to be considered for award.

NOTE: Quantity for all systems for all ordering periods in Attachment 1 is defaulted to "1" to evaluate unit pricing only and does not represent actual order quantities for any period of performance. Offerors must complete all columns (I, U, AG, AS, BE) highlighted in blue in Attachment 1.

Small Business Subcontracting Plan If the Offeror determines that there will not be subcontracting opportunities, the Offeror shall still submit a subcontracting plan and include a statement of circumstances supporting this determination. Failure to submit and then negotiate an acceptable subcontracting plan within the time specified by the Contracting Officer (CO) when the CO notifies the offeror of issues and concerns with the subcontracting plan will render the offeror, notwithstanding any other decision made from the above-listed criteria, ineligible for award. The resulting subcontracting plan will be made a part of the resulting contract and the Contractor shall comply with the reporting requirements of FAR Clause 52.219-9(I). Small businesses are exempt from this requirement.

*Note: If offeror already has an approved Commercial Plan, submit that in lieu of Attachment 2.

In accordance with FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and price proposals. An offeror’s subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to contract award. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at:

https://osdbu.hhs.gov/subcontracting/fc0e3e95-9abc-47bd-9d97-b8ee6c379943. The offeror shall follow the instructions outlined in the SBCX Industry Guide to successfully submit their subcontracting plan by the proposal submission deadline.

(https://sbcm-acqtools.s3.amazonaws.com/SBCX+Industry+Subcontracting+Guide.pdf)

The official point of receipt for determining timely submission of an offeror’s subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission.

If an offeror’s subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

Accessibility Conformance Report (ACR) 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 https://osdbu.hhs.gov/subcontracting/fc0e3e95-9abc-47bd-9d97-b8ee6c379943 https://sbcm-acqtools.s3.amazonaws.com/SBCX+Industry+Subcontracting+Guide.pdf

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.

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.

Line Item No. Country of Origin http://www.itic.org/policy/accessibility

The provision at FAR 52.212-2 Evaluation-Commercial Items (Deviation) (RFO Aug 2025) .

The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In this case, the Government intends to award a Firm‐Fixed‐Price IDIQ contract resulting from this solicitation to the lowest-priced technically acceptable and responsible offeror. Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first.