Combined Synopsis Solicitation- Cage and Rack Washer_5.2.2025.pdf

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Acquisition of Brand Name or equal Getinge Cage & Rack Washer
Solicitation number
75N94025Q00053
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About this file

This Combined Synopsis/Solicitation is for the acquisition of a Getinge Cage & Rack Washer for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Laboratory Animal Sciences Section. The solicitation is a 100% small business set-aside for a Firm-Fixed-Price purchase order, with a solicitation number 75N94025Q00053. The requirement is to replace an existing 25-year-old cage and rack washer used for cleaning and sanitizing laboratory animal cages, with specific requirements including 46" W x 85" H x 92" D chamber dimensions, stainless steel construction, and multiple wash cycle functions.

Key submission details include a response date of May 14, 2025 at 10AM EST, with quotations to be submitted via email to the Contract Specialist Trish Matthews and Contracting Officer Airron Wiggins. The anticipated period of performance is May 19, 2025 – May 18, 2026, with delivery and installation required within 12 months of award. The Government will evaluate quotes using Lowest Price Technically Acceptable (LPTA) procedures, with award made to the responsible offeror whose quote is responsive, technically acceptable, and has the lowest evaluated price. The solicitation includes provisions for equipment removal, professional installation, and one operator and supervisor training session during equipment startup.

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COMBINED SYNOPSIS/SOLICITATION

Title: Acquisition of Brand Name or equal Getinge Cage & Rack Washer

Notice ID: 75N94025Q00053

Posted Date: May 2, 2025

Response Date: May 14, 2025 at 10AM EST

Product Service Code: 6515 – MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND

SUPPLIES

NAICS Code: 339113 – Surgical Appliance and Supplies Manufacturing 800 employees

1.0 DESCRIPTION:

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice and shall be processed in accordance with FAR Part 13.5 – Simplified Procedures for Certain Commercial Products and Commercial Services. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued. This solicitation number is 75N94025Q00053 and is issued as a Request for Quotation (RFQ). The solicitation/award will incorporate all applicable provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03 (January 17, 2025). The North American Industry Classification (NAICS) Code is 339112 – Surgical and Medical Instrument Manufacturing and the small business size standard is 1000 employees. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

This solicitation is a 100% set-aside for small businesses.

The Eunice Kennedy Shriver National Institute on Child Health and Human Development (NICHD) in support of the work of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to award a Firm-Fixed-Price purchase order.

STATEMENT OF NEED

2.0 BACKGROUND:

The NIDDK Laboratory Animal Sciences Section (LASS) provides support and guidance to the NIDDK’s intramural researchers for all phases of laboratory animal experimentation. The LASS is responsible for the housing and care of research animals and for enhancing their well-being. This includes managing animal care facilities in order to maximize the use of animals, animal room space, and animal care resources. The Building 8 animal facility is comprised of five rodent housing rooms and 12 holding racks with a capacity of around 1,800 cages. A complete cage setup includes the cage itself, water bottles, water bottle lids, wire bar cage lids, and cage covers. Cages and caging components as well as accessory equipment are sanitized and washed at least weekly in the Building 8 cage and rack washer. Adequate sanitation and washing is required by Federal regulations, accrediting agencies, and NIH policy.

A laboratory rodent cage and rack wash system is crucial for maintaining a clean and healthy environment for laboratory animals. The cage and rack washer is intended for detergent solution washing, clean rinsing and drying of transport carts, cages, racked utensils and bottles used in research animal care laboratories and facilities. This system helps to ensure the cages and racks used to house the animals are thoroughly cleaned and sanitized, which is vital for both animal welfare and scientific accuracy. This cage and rack washer is critical to ensure:

1. Hygiene and Health: Rodents in labs can be sensitive to bacteria, viruses, and other contaminants.

A clean cage and rack system helps prevent the spread of diseases and ensures the animals stay healthy, which is important for the quality of research.

2. Animal Comfort: Just like humans, animals in labs need clean living spaces to thrive. A washing system removes waste, food debris, and other pollutants from the cages, making the environment more comfortable and reducing stress for the animals.

3. Consistency in Research: In scientific research, maintaining a consistent environment is key. If cages are not cleaned properly, it could affect the animals' health and behavior, which in turn could affect the results of experiments. A good wash system ensures that all cages are cleaned to the same high standard.

The cage and rack wash system uses a combination of water, detergent, and disinfectants to clean and sanitize the cages that hold the rodents. Cages are placed into a machine, much like a large dishwasher, which sprays and washes them with high-pressure water to remove dirt, waste, and other contaminants.

The racks that hold multiple cages are also cleaned in this system. Once cleaned, the cages are rinsed thoroughly to ensure no soap or chemicals remain, leaving them ready to be reused.

In summary, this system is essential for creating a clean, safe, and comfortable space for laboratory animals, which helps ensure the success of scientific studies and the wellbeing of the animals involved.

The cage and rack washer is required to replace the existing cage and rack washer which has been in use for over 25 years and is at the end of its productive lifecycle. The replacement must fit into the space dedicated to the existing washer without major renovation of the area, and without modification of building steam sources, water sources, or electrical sources.

3.0 OBJECTIVE:

The objective of this requirement is to procure a cage and rack washer for the NIDDK LASS.

4.0 CONTRACTOR REQUIREMENTS

See requirements as detailed below:

4.1 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The following product features/characteristics are required for this requirement:

Chamber Dimensions: 46” W x 85” H x 92” D, pit mounted 10” depth, free standing with right hand service access and control, Washer Sump/Base Frame.

The interior walls are American Iron and Steel Institute(AISI) 304 stainless steel with a #3 finish for long lasting durability. Exterior panels are AISI 304 stainless steel with a #3 finish.

Interior of double pane chamber ceiling, wall panels, and doors are insulated with two-inch (2", 50 mm) thick, compressed Fiberglas™ Batt insulation

Process piping, valves, inline heat exchanger, steam coils, manifold tubes, sump base, removable filter screens and chamber floor are made of 304 stainless steel

Cycle Functions: Prewash, Detergent Wash, Acid Wash, Acid Soak, Neutralization, First Rinse, Final Rinse / Disinfection, and Exhaust Phases

Automatic Seven Phase Treatment Cycle, Reciprocating Jet-Spray Manifold, pH Neutralization

A stainless steel heat exchanger is provided to raise the temperature of the incoming water by ~80°F (27°C).

Existing Equipment Removal with Off-Site Disposal

4.2 TRAINING

Vendor shall provide one operator & supervisor training session during equipment startup.

Training will cover equipment operation, Human Machine Interface (HMI) navigation, and common equipment questions for up to 6 people.

Vendor personnel shall be onsite during normal working hours (please see Attachment 1 for the pre-registration process for visitors requiring access to NIH facilities).

5.0 PURCHASE ORDER TYPE

The Government anticipates a Firm-Fixed-Price Purchase Order.

6.0 ANTICIPATED PERIOD OF PERFORMANCE:

The anticipated period of performance is May 19, 2025 – May 18, 2026.

7.0 DELIVERY / INSTALLATION:

Inspection and acceptance will be performed at the National Institutes of Health, NIDDK, Building 8 Room B1-07/B01-11 animal facility cage wash area, 9000 Rockville Pike, Bethesda, MD 20892.

The item shall be delivered and installed within 12 months of award. The onsite training will also take place during this time.

Existing Equipment Removal with Off-Site Disposal to be completed during same visit as installation

Includes equipment dis-assembly, rigging to loading dock, and removal from customer site Remove associated debris to customer provided receptacle Professional Installation includes:

Transporting equipment upon arrival to site Receiving and unloading of equipment on site, uncrating at the installation area Final set in place Equipment leveling and assembly Perform equipment startup

8.0 PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this Purchase Order:

Project Officer: TBD

The Project Officer 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 Purchase Order; 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 Purchase Order. 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 Purchase Order; or (5) otherwise change any terms and conditions of this Purchase Order.

CONTRACT CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

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

FEDERAL ACQUISITION REGULATION (FAR) – CLAUSES INCORPORATED BY

REFERENCE:

Clause No. Title

FAR 52.203-17 Contractor Employee Whistleblower Rights (NOV 2023) FAR 52.204-7 System for Award Management (OCT 2018) FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.211-6 Brand Name or Equal (AUG 1999) FAR 52.212-3 Offeror Representations and Certifications – Commercial Products and

Commercial Services (MAY 2024) [(DEVIATION FEB 2025)] FAR 52.212-4 Contract Terms and Conditions- Commercial Products and Services (NOV 2023) FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive

Orders—Commercial Products and Commercial Services (JAN 2025)

[DEVIATION FEB 2025)]

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) – CLAUSES

INCORPORATED BY REFERENCE:

Clause No. Title

HHSAR 352.203-70 Anti-Lobbying (DEC 2015)

(END OF CONTRACT CLAUSES)

SOLICITATION PROVISIONS

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(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.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known).

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020).

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

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(c)

(1) Representation. The Offeror represents that it □ does, □ does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(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 any equipment, system, or service that uses covered telecommunications equipment or services.

(End of provision)

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

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

www.acquisition.gov/browse/index/far

(End of provision)

FEDERAL ACQUISITION REGULATION (FAR) – PROVISIONS INCORPORATED BY

REFERENCE:

Provision No. Title

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (JAN 2017)

FAR 52.204-7 System for Award Management (NOV 2024) FAR 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.204-22 Alternative Line Item Proposal (JAN 2017) FAR 52.212-1 Instructions to Offerors – Commercial Products and Commercial Services

(SEP 2023)

FAR 52.212-2 Evaluation – Commercial Products and Commercial Services (NOV 2021) FAR 52.212-3 Offeror Representations and Certifications-Commercial Products and

Commercial Services (MAY 2024)

(END OF PROVISIONS)

SUBMISSION & GENERAL INSTRUCTIONS

This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file. The Government is not responsible for locating or securing any information which is not identified in the quote.

Quotes must contain a statement to the effect that offer is valid for a period of at least 30 days from the date of receipt thereof by the Government.

Quote submittal must also include/address the following:

All submittals must include a completed FAR Provision 52.204-24, 52.204-26 and 52.213-3 unless already completed in the System for Award Management (SAM). If already provided in the vendors SAM.gov profile, and do not conflict with the requirements as stated in this solicitation please provide a statement to the effect of “Provisions 52.204-24, 52.204-26 and 52.212-3 are complete and accurate per our SAM.gov registration dated 00/00/00.”

All attachments must be in MS Word or Adobe Portable Format (PDF).

All correspondence must have the Notice ID “75N94025Q00053” included in the subject line.

SOLICITATION QUESTIONS

If there are questions regarding this requirement, please submit your inquiries immediately via email but no later than 9:00 AM EST on May 8, 2025 to the points of contact listed below:

Name: Ms. Trish Matthews Contract Specialist Email: trish.matthews@nih.gov

Name: Mr. Airron Wiggins Contracting Officer Email: airron.wiggins@nih.gov

Note: Questions submitted by a method other than email will not be accepted. Any questions received after the specified cut-off time and date above will not be accepted or answered unless at the Contracting Officers discretion is deemed necessary. All email inquiries must have the Solicitation number “75N94025Q00053” included in the subject line.

QUOTATION SUBMITTAL

Quotations submitted in response to this solicitation must be submitted via email no later than May 8, 2025 by 9:00 AM Eastern Standard Time to the points of contacts listed below:

Name: Trish Matthews Contract Specialist Email: trish.matthews@nih.gov

Name: Airron Wiggins Contracting Officer Email: airron.wiggins@nih.gov

Note: It’s the Offeror’s responsibility to read the RFQ and all related documents carefully. Additionally, it is the Offeror’s responsibility to ensure/verify the Government receives its submission on or before the date/time specified. The Government reserves the right to not accept any late quotes. Please do not wait until the deadline to submit your quotation.

BASIS FOR AWARD AND EVALUATION

Evaluation of quotes will be conducted in accordance with FAR 13.106-2 (b)(3) procedures. The Government intends to award a Firm-Fixed-Priced Purchase Order from this solicitation to the responsible offeror, using Lowest Price Technically Acceptable (LPTA) procedures.

The Government may reject any quote that is evaluated to be non-compliant with the solicitation requirements, unreasonably high or low in price, or reflects a failure to comprehend the complexity and risks of the work to be performed. The Government intends to make award selection without clarifications/discussions but may determine after evaluating the quotes submitted that clarifications/discussions are necessary and conduct them as appropriate with all, some, or none of the firms’ submitting quotations in response to this RFQ. The Government reserves the right to make no award if quotes do not meet the requirements of this solicitation.

Award will be made to the responsible offeror whose quote is responsive to the solicitation, technically acceptable, and has the lowest evaluated price among all proposals meeting or exceeding the specified technical acceptability standards.

LIST OF ATTACHMENTS

Attachment 1 – Visit NIH Vendor Memo Attachment 2 – FAR 52.212-3 (MAY 2024) [(DEVIATION FEB 2025)] Attachment 3 – FAR 52.212-5 (JAN 2025) [(DEVIATION FEB 2025)] Attachment 4 – FAR 52.223-23 (MAY 2024) [(DEVIATION FEB 2025)] Attachment 5 – NIH Invoicing Instructions with IPP (MAR 2023)

Controlled Unclassified Information

Controlled Unclassified Information

M a r c h 1 1 , 2 0 2 5

Vis i tN IH Vendor Memo Overview:

NIH recently implemented a pre-registration process for visitors coming to the Bethesda Main Campus, as well as the satellite facilities listed below, in alignment with the HHS Foreign National Access Management Policy

(FNAMP). In accordance with the NIH Non-U.S. Person Visitor Access Policy and Federal Acquisitions

Regulation (FAR) Clause 52.241-5, this memo serves to notify NIH vendors and contractors of the related changes described below.

New Requirements:

Pre-registration is required for access to applicable NIH facilities for non-U.S. persons (those who are not U.S.

citizens or permanent residents with a Green Card) who do not possess a valid NIH Identification Badge. Pre-registration requests must be initiated by NIH staff, and it is recommended that pre-registration be completed

30 days in advance of the visit to allow enough time for vetting and information verification.

Beginning on March 31, 2025, non-U.S. person visitors who do not complete the VisitNIH pre-registration process, or who does so but is not approved, will not be permitted access to the NIH facilities listed below.

Beginning April 28, 2025, non-U.S. person visitors will be required to have an escort who is an NIH staff member and U.S. person. These escort requirements will apply to the NIH facilities listed below.

Applicability:

Pre-registration and escort requirements apply to the following NIH facilities. Additional NIH facilities will implement these requirements at a later date to be determined.

• Bethesda Main Campus

• 5601 Fishers Lane

• Shady Grove (9609 Medical Center Dr.)

• Biomedical Research Center-Bayview

• NIH Animal Center at Poolesville

• Ft. Detrick

• Rocky Mountain Laboratories (MT)

Who to Contact:

Please review the information on the security.nih.gov visitor site, including FAQs, or contact your NIH

Contracting Officer’s Representative (COR) for more information.

If there are any concerns about identification requirements or urgent needs for access, hosts and visitors should contact the NIH Police at NIHPoliceSpecialEvents@mail.nih.gov.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acquisition.gov%2Ffar%2F52.241-5&data=05%7C02%7Cphillip.osborne%40nih.gov%7Ccd21c4823d37441408b108dd3c9eb303%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638733374481655927%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mETKSENW%2F8OzVFK%2F5J1CvFe0GLFdUHziFYBsGyndi0Q%3D&reserved=0 https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acquisition.gov%2Ffar%2F52.241-5&data=05%7C02%7Cphillip.osborne%40nih.gov%7Ccd21c4823d37441408b108dd3c9eb303%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638733374481655927%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mETKSENW%2F8OzVFK%2F5J1CvFe0GLFdUHziFYBsGyndi0Q%3D&reserved=0 https://security.nih.gov/visitors/Pages/default.aspx mailto:NIHPoliceSpecialEvents@mail.nih.gov

52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services. [(DEVIATION FEB 2025)]

Offeror Representations and Certifications—Commercial Products and Commercial Services (May

2024) [(DEVIATION FEB 2025)]

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 https://www.sam.gov/ https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/section-127.300 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).

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 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 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 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 (SDVOSB) concern means a small business concern—

(1)

(i) Not less than 51 percent of which is owned and controlled 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; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, 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), and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that—

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

Service-disabled veteran-owned small business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title50-section1702(b)(3)&num=0&edition=prelim https://www.acquisition.gov/far/subpart-19.14#FAR_Subpart_19_14 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 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

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 with 13 CFR 124.1001, 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 the threshold at 13 CFR 124.104(c)(2) 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 and controlled 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 business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women

Women-owned small business concern means a small business concern— https://www.ecfr.gov/current/title-13/part-121 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101(2)&num=0&edition=prelim

(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.

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—

(i) It □ is, □ is not a small business concern; or

(ii) It □ is, □ is not a small business joint venture that complies with the requirements of 13 CFR 121.103(h) and 13 CFR 125.8(a) and (b). [ The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(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) SDVOSB 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 that it □ is, □ is not https://www.ecfr.gov/current/title-13/part-127 https://www.ecfr.gov/current/title-13/section-127.300 http://www.sam.gov https://www.acquisition.gov/far/4.1201#FAR_4_1201 https://www.acquisition.gov/far/part-19#FAR_Part_19 https://www.acquisition.gov/far/19.000#FAR_19_000 https://www.ecfr.gov/current/title-13/section-121.103#p-121.103(h) https://www.ecfr.gov/current/title-13/section-121.103#p-121.103(h) https://www.ecfr.gov/current/title-13/section-125.8#p-125.8(a) https://www.ecfr.gov/current/title-13/section-125.8#p-125.8(b) an SDVOSB concern.

(4) SDVOSB concern joint venture eligible under the SDVOSB Program. The offeror represents that it □ is, □ is not an SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [Complete only if the offeror represented itself as an SDVOSB concern in paragraph (c)(3) of this provision.] [The offeror shall enter the name and unique entity identifier of each party to the joint venture: ____________.]

(5) 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 CFR 124.1001.

(6) 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.

(7) 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:

(8) 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: ____________.]

Note to paragraphs (c)(9) and (10): Complete paragraphs (c)(9) and (10) only if this solicitation is expected to exceed the simplified acquisition threshold.

(9) 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.

(10) 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:____________

(11) 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.

https://www.ecfr.gov/current/title-13/section-124.1001 https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(c) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(a) https://www.ecfr.gov/current/title-13/section-127.506#p-127.506(c) https://www.ecfr.gov/current/title-13/section-126.200 https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(a) https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(a) https://www.ecfr.gov/current/title-13/section-126.616#p-126.616(c)

(d) [Reserved] Representations required to implement provisions of Executive Order 11246

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

(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…

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