75F40123Q118031.pdf

75F40123Q118031

Document Type: Combined Synopsis/Solicitation

Solicitation Number: 75F40123Q118031

Posted Date: June 6, 2023

Title:

Zebrafish housing, tanks, six-shelf double-sided (“double six”) racks and recirculating water quality filtering, monitoring, and dosing support system, to include one optional year of preventive maintenance

Response Date: June 16, 2023 2:00 PM Central Time

NAICS Code: 333914 – Measuring, Dispensing, and Other Pumping Equipment Manufacturing

Product or Service Code: 6640 – Laboratory Equipment and Supplies

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR Part 13 - Simplified Acquisition Procedures. The solicitation number is 75F40123Q118031. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through are those in effect through Federal Acquisition Circular (FAC) 2023-04 effective June 2, 2023.

The associated North American Industry Classification System (NAICS) code for this acquisition is 333914 – Measuring, Dispensing, and Other Pumping Equipment Manufacturing; the applicable Small Business Size Standard is 750 employees. This requirement is solicited as a small business set-aside.

Only small businesses actively registered as such in SAM.gov my submit a quote.

Schedule of Supplies or Services and Prices/Costs. Pricing shall be inclusive of shipping and handling to NCTR at 3900 NCTR Rd. Jefferson AR 72079.

Line Item 1 IWAKI Zebrafish LAbREED ITS-Z or equal housing system for zebrafish, to include double-six shelf rack, tanks and aquatic support system (pricing shall be firm-fixed pricing inclusive of all shipping, installation, and FDA staff training (if required) and meeting the Minimum Technical Requirements set forth below.

Quantity: 1

Unit: Each

Unit Price: ____________________________

GSA Contract Number (if applicable): ____________________________

Line Item 2 Option Year 1 – 12 consecutive months of preventive maintenance for IWAKI Zebrafish LAbREED ITS-Z or equal housing system system as described in Line Item 1 above, and meeting the Minimum Technical Requirements set forth below.

Quantity: 12

Unit: month

Unit Price: ____________________________

GSA Contract Number (if applicable): ____________________________

GRAND TOTAL (Lines 1-2 above): ____________________________

Background and Requirement

The U.S. Food and Drug Administration’s (FDA), National Center for Toxicological Research (NCTR) requires a zebrafish double-six (double-sided, six shelf) shelf rack, tanks and aquatic support system and one option year of preventive maintenance for the system.

NCTR’s animal facility requires additional housing and recirculating support system for its zebrafish colony. Of paramount importance is the required housing system to integrate with existing Zebrafish housing. This system shall also include primary enclosures of tanks in addition to racks that will support and hold the number of tanks needed for the adult zebrafish used in animal studies at NCTR.

It shall include an aquatic system to manage the water quality and surrounding environment of the fish - including illumination, noise, temperature, and water composition. The system shall include dosage tanks to adjust the chemical composition of the water to adjust the water quality. The standard aquatic system must include first stage mechanical filtration and second stage mechanical filtration for removal of particulate matter. The system must include an oversized moving bed biological filtration capacity for reduction of nitrogenous waste, and an activated carbon filter for absorption of dissolved contaminants. The system must include Stainless steel UV lamp sterilizers for water disinfection. A systemic heater must be included that allows precise control of the systemic water temperature. The system shall also include a storage tank for reverse osmosis water to be used as an available supply when demand cannot be met by the facility’s systemic reverse osmosis production unit or as a back-up supply.

This RFQ is for a “Brand Name or Equal” solution. Components described herein need to meet the technical requirements and salient characteristics listed below to be deemed technically acceptable.

FAR Clause 52.211-6 Brand Name or Equal (Aug 1999) applies to this acquisition.

Minimum Technical Requirements Salient physical, functional, or performance characteristics that "equal" products must meet are as follows:

*System shall integrate seamlessly with an existing IWAKI Zebrafish LAbREED ITS-Z system purchased in 2022. This seamless compatibility extends to all components (tanks, UV lamps, filters, and aquatic support system) as follows:

The breeding and housing tanks must be exact replication of all aspects (material components, size, shape, angle, material thickness, density, color, shade, clarity/transparency, weight, volume) of the existing IWAKI LAbREED ITS-Z system tanks and all components of the tanks (baffles, lids, tanks) and parts of aquatic system. All parts must fit securely into the IWAKI aquatic system with 100% compatibility. All tanks must fit and attach to the existing IWAKI aquatic system securely and function with the recirculating filtration system without modification. Newly purchased parts shall not introduce any new variations in noise, odor, vibration, lighting, light diffusion or alter the environment in a manner that can stress the fish. Stress to fish can result in lowered reproductive performance.

*Rack systems shall not require facility renovations, including alterations to the building HVAC or major alterations to systemic plumbing system, to accommodate their use;

*The equipment shall provide an environment that shall meet or exceed the housing specifications listed in the Guide for the Care and Use of Laboratory Animals, 8th edition (http://qrants.nih.gov/qrants/olaw/Guide-for-the-care-and-use-of-laboratorv-animals.pdf).

*The zebrafish racks and caging components shall be constructed of high quality and corrosion resistant stainless steel or powder-coated aluminum and durable plastic/rubber/silicone materials that shall be repeatedly washed with detergents or bleach;

*Racks shall be a two-sided, six shelf configurations designed to hold at least 16 two-liter tanks per row in a side-by-side rack positioning. A minimum total of 192 two-liter tanks shall be supported by this system. A minimum of 192 two-liter zebrafish housing tanks shall be included with this system.

The racks shall have the ability to hold alternate size tanks, such as 4.5 liter and 9-liter tanks if needed for future studies. The rack dimensions shall not exceed 61” wide X 26.25” deep X 92” total height when assembled. The racks shall be multi-piece or able to be moved through a door measuring 43¾” wide x 85½” inches tall and assembled in room 53C 106 of NCTR zebrafish housing vivarium. This facility room does not have floor drains:

*Tanks, Iwaki Aquatic LAbREED 2 Liter Molded Plastic Tank Kit (Part Number AQT2LBC) or equal shall be rectangular shape and composed of clear polycarbonate material that is cage washable (82.2° C) and autoclavable (121° C). The tank shall include a 3-piece tank assembly design of lid, baffle, and tank. The tank form and baffle shall fit to provide self-cleaning flow design for removal of settleable solids. The tanks shall be designed with minimal recesses for ease of cleaning. The tanks shall also have locking lids to prevent fish escape if a tank is tipped over. This will prevent competing tanks’ lids from falling off when tipped over resulting in escaping fish and unwanted fish crossings resulting in poor research results. Dosing tanks with viewing windows shall be included, in addition to housing tanks for control of pH and conductivity; tanks shall be free of sharp edges and/or projections that could cause injury;

*Tank components - Baffles: Iwaki Aquatic LAbREED 2 Liter Molded Tank Adult Baffle (IWAKI part AQT2LB) or equal, Tank cover/lid: Iwaki Aquatic LAbREED 2 Liter Molded Tank Cover (IWAKI part AQT 2LC) or equal;

*Iwaki Zebrafish breeding tank set (Iwaki part number AQ10055): 8”X4”3” polycarbonate tank inserts lid and divider. 750 ml volume or equal;

*UV Lamp H/PLUS, PRO20 professional UV Systems, Viqua H Series Replacement UV Lamp (Iwaki part # AQ 1604), UV quartz sleeve compatible with H/PLUS, PRO20 professional UV Systems.

(IWAKI part AQ 1605) or equal;

http://qrants.nih.gov/qrants/olaw/Guide-for-the-care-and-use-of-laboratorv-animals.pdf

*Filters: 1. Alita air pump external porous filter (Iwaki part AQ 1604) or equal; 2. Pleated mechanical filter cartridge for use in Iwaki ITS-X, ITS-Z standalone systems, (Iwaki part AQ1091) or equal; 4.5 “diameter, 9 3/4” tall, 50-micron pore size. 3. Filter cartridge, pleated mechanical filter cartridge for use in AHab / Pentair GHab (glass tank system) or equal;, and ZHab Duo (double-sided standalone) systems or equal; Cartridge features a 50-micron pore size,4.5” diameter by 19 3/4” tall, Mechanical filter (Hydronix part SPC-45-2050) or equal;

*Filter housing (Iwaki part AQ 10085) or equal; Hydronix HF3 2.5" x 10"Filter housing, Keystone filter housing, clear, 20” (IWAKI part AQ1905) or equal;

*pH electrodes and calibration systems: Walchem’s WEL Series pH electrodes (IWAKI part WEL- PHF-NN) or equal;

*Components of the aquatic system shall be constructed of nontoxic materials that do not leach toxicants or chemicals into the aquatic environment;

*Filtration systems shall include at minimum: first stage mechanical filtration (300-micron filter bag), second-stage mechanical filtration (250-micron filters), a moving bed biological filtration with oversized filtration capacity for removal of particulate matter and nitrogenous waste. An activated carbon filter must be present for filtration of toxins;

*Stainless steel enclosed UV disinfection lights of minimal 100ml/cm2 shall be included in the system;

*Systemic controller with systemic maintenance, pH, water level, and conductivity dosing package shall be included;

*Pump shut-off with alarm indicator shall be included in the system in event of low water level condition;

*System shall offer constant flow technology, a recirculating multiple pump system that shall provide multiple pumps and a speed-controlled pumping system. The system of pumps shall be speed controlled based on a pressure feedback loop to maintain flow over time to the zebrafish tanks, even if filters clog. Since the pumps function to speed up if pressure increases inside the filters to maintain constant flow, this feature reduces the amount of labor required to maintain a recirculating zebrafish housing system;

*System shall include a minimum of 600-watt titanium heaters;

*Shall include OEM specified annual software updates as well as a tool for remote monitoring and control through its water management software;

*System shall include a sump tank for collection of water drainage from the system;

*System shall include a 100-gallon reverse osmosis water storage tank;

*System shall include all plumbing, hoses, pumps, O-rings, connections, and manifolds, and flow valves required to assemble functioning system and connect system to existing facility reverse osmosis system and sink drainage. The system shall include quality shut-off valves/unions in all system plumbing connections to allow for a decreased repair rate and disassembly for all servicing or replacement;

*First year of all consumable accessories shall be provided as part of the system cost, to include filter cartridges, O-rings, larval baffles, salt mix, calibration solutions, spare UV lamp, activated carbon, and sodium bicarbonate;

*Pricing shall include a separate line item for one option year of annual preventive system maintenance;

*Shipping, installation and training shall be included;

*System shall include 2-year warranty which shall commence from date of FDA acceptance of system.

Installation, Training and Additional System Requirements:

*System shall be warranted for not less than two (2) years from FDA acceptance, to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of two (2) years;

*Components and equipment shall be a newly manufactured, not used or refurbished, or previously used for demonstration;

*System shall be delivered with all necessary supplies and accessories required for installation and start-up;

*System and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format;

*Shall include contractor guidance on pre-installation site requirements;

*Contractor shall provide installation and setup;

*Contractor shall provide onsite training on the system.

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

Minimum Performance Requirements for Post-warranty Preventive Maintenance:

*Post warranty maintenance service contract shall include one (1) on-site PM (preventive maintenance) visit per year, including unlimited free OEM system software updates, and parts, labor and travel;

*Service shall include inspection and testing the function of manufactured parts, components, and equipment composing the installed equipment of the zebrafish aquatic system. (This includes the racks, PVC piping, tanks, pumps, filters, valves, and tank components). The aquatics systems is a complex husbandry system functioning to maintain strict water quality parameters. Preventative maintenance shall include servicing, calibration and checking the function of components, including:

overall system status valusues, UV sterilizer, Filter service, pump service, Heating service, Chem Feed Dosing service, General Rack Service. Replacement of expired consumables shall be performed by experienced technicians for the UV Replacement Lamp, Filtration components, testing, dosing and monitoring components, and O-rings;

*All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers. All repairs and/or PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.);

*Service contract shall include unlimited technical support; contractor shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.).

Deliverables: Service Records and Reports: The Contractor shall, commensurate with the completion of each maintenance service visit, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR or Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Preventive maintenance or repair visits 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 Christmas Day Independence Day

Delivery Terms: FOB Destination within 90 days after receipt of award.

Anticipated Dates for the Option year based on the date of the actual award and actual warranty date: anticipated dates are as follows:

Warranty Period: 08/01/2023 – 07/31/2025 Option Year Service: 08/01/2025 – 07/31/2026

Contract Type: Commercial Product-Firm Fixed Price

Place of Delivery/Performance

U.S. Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079-9501 POC: Will be provided at time of award

Solicitation Provisions

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR Provisions 52.204-7 System for Award Management (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-17 Ownership or Control of Offeror (Aug 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) (fill-in appropriate boxes below):

(d) Representation. The Offeror represents that—

(1) It ☐ will, ☐ will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It ☐ does, ☐ does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

HHSAR Provisions 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

Shall meet the level of conformance of the delivered service/items to the 508 standards identified in HHSAR Clause 352.239-74(c) herein.

FAR FULL TEXT PROVISIONS

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

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (Mar 2023) applies to this solicitation. The following addenda apply:

(b)(4). As to Technical Acceptability (see also FAR 52.212-2 Evaluation-Commercial Items (Nov 2021) below), Offerors shall provide sufficient technical information necessary for the government to conclusively determine that the offered Zebrafish housing system meets all the technical requirements herein, to include descriptive material, literature, brochures and other information corresponding to each required item, which demonstrates the capabilities of the offeror.

Offerors shall also demonstrate that the proposed Zebrafish housing system functions and accomplishes the required results as indicated in the Background and Minimum Technical Requirements. To be considered for award, quotes of “equal” products, 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 offer meets each salient/performance characteristics as well. Quotes for “equal” products shall demonstrate compatibility/ prior use of offered products with an existing IWAKI LAbREED ITS-Z system.

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 service records and reports and 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 quote; however, the Government reserves the right to obtain information for use in the evaluation from any sources including sources outside of the Government. The Government also reserves the right to request additional information at any time.

The price(s) proposed must be detailed and shall represent the offeror’s response to the schedule of supplies/services above. Pricing shall be detailed and supported by an itemized but practical list of all items required for system operation. NOTE: Offerors shall fill in the schedule of items above and provide a detailed quote in their own format.

Proprietary and/or confidential information shall be clearly marked. Respondent’s SAM Unique Entity Identifier (UEI) number shall be included with quote.

Paragraph (c) Period for Acceptance of Offerors. FAR Clause 52.232-18 applies to this acquisition.

Pricing shall remain valid through September 30, 2023.

https://www.itic.org/policy/accessibility/vpat http://www.itic.org/policy/accessibility

The option year service agreement periods will not be funded at time of award. If exercised, funding will be obligated individually each year for the option period exercised via contract modification; the option period shall be priced accordingly.

The Contractor’s quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48 (see below).

NOTE: This solicitation is being issued under the premise that the offeror will certify that the combination of equipment maintenance/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If the Contractor certifies that the company is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will be applicable to the resulting order. In the event that a contractor does not make this certification, the traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 2015-5121 (Rev. 20) dated 12/27/2022. The applicable Wage Determination can also be accessed at the following link:

https://sam.gov/wage-determination/2015-5121/20.

The provision at FAR 52.222-48 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) applies as follows:

(a) The offeror shall check the following certification:

CERTIFICATION

The offeror [ ] does [ ] does not certify that—

(1) The items of equipment to be serviced under this contract are used regularly for other than Government purposes, and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontractor) in substantial quantities to the general public in the course of normal business operations;

(2) The services will be furnished at prices which are, or are based on, established catalog or market prices for the maintenance, calibration, or repair of equipment.

(i) An “established catalog price” is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public.

(ii) An “established market price” is a current price, established in the usual course of trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror; and

(3) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract are the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(c)(3) that the Service Contract Act—

(1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or https://sam.gov/wage-determination/2015-5121/20

(2) Will apply to this offeror, then the clause at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Requirements, in this solicitation will not be included in any resultant contract awarded to this offeror, and the offeror may be provided an opportunity to submit a new offer on that basis.

(c) If the offeror does not certify to the conditions in paragraph (a) of this provision—

(1) The clause in this solicitation at 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements, will not be included in any resultant contract awarded to this offeror; and

(2) The offeror shall notify the Contracting Officer as soon as possible, if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation.

(d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.

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 country (or countries) of origin for the products and/or services offered in response to this solicitation, and shall include any other applicable information to enable review and analysis pursuant 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.

The provision at 52.212-2 Evaluation-Commercial Items (Nov 2021) is applicable to this solicitation. The following addenda apply:

(a) The Government intends to award a contract resulting from this solicitation to the lowest priced technically acceptable responsible offeror. Offers will be evaluated on their ability to meet the requirements provided herein. The lowest priced offer will be evaluated first. If the lowest priced offeror is not technically acceptable, the next lowest priced offer will be evaluated and so on until a technically acceptable offer is determined.

Technical acceptability will be determined and evaluated by review of information submitted by the offeror, which must provide sufficient technical information necessary for the Government to conclusively determine that the offered product(s) and/or services meet the technical requirements identified above.

The Government's determination of technical acceptability in no way relinquishes the Awardee's contractual obligation to ensure the supplies meet the FDA’s stated need.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Dec 2022) applies to this acquisition.

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204- 25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25 https://www.acquisition.gov/far/part-52#FAR_52_204_25 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174).

Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended. "Sensitive technology"— Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3)of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern— https://www.acquisition.gov/far/part-52#FAR_52_204_25

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C.

101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300.

(b)(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a women-owned small business concern.

(6) WOSB joint venture eligible under the WOSB Program. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(7) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents that it □ is, □ is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.]

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is a women-owned business concern.

http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:____________________________________

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

(i) It [ ] is, [ ] is not a HUBZone small business concern listed, on the date of this representation, as having been certified by SBA as a HUBZone small business concern in the Dynamic Small Business Search and SAM, and will attempt to maintain an employment rate of HUBZone residents of 35 percent of its employees during performance of a HUBZone contract (see 13 CFR 126.200(e)(1)); and

(ii) It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: __.] Each HUBZone small business concern participating in the HUBZone joint venture shall provide representation of its HUBZone status.

(d) Representations required to implement provisions of Executive Order11246-

(1) Previous contracts and compliance. The offeror represents that-

(i) It [ ] has, [ ] has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It [ ] has, [ ] has not filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that-

(i) It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or

(ii) It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 http://uscode.house.gov/ U.S.C. 1352).

(Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225- 1, Buy American-Supplies, is included in this solicitation.)

(1) (i) The Offeror certifies that each end product and that each domestic end product listed in paragraph (f)(3) of this provision contains a critical component, except those listed in paragraph (f)(2) of this provision, is a domestic end product.

(ii) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(iii) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see…