RFQ FDA-OC-2026-132553.docx

COMBINED SYNOPSIS/SOLICITATION

FOR

One (1) Field-Flow Fractionation Multi-Angle Light Scattering (FFF-MALS) System

SOLICITATION NUMBER: FDA-OC-2026-132553

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR-RFO) format in FAR 12.201-1 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 number is FDA-OC-2026-132553. This requirement is issued as a request for quotation (RFQ).

The solicitation is issued as Full and Open Competition.

The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2026-01, Effective 03/13/2026.

The associated North American Industry Classification System (NAICS) Code 334516 with a small business size standard of 1,000 employees.

The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein. A table list of line item number(s) and items, quantities, and units of measure can be found in the sections listed below in the solicitation.

I. Description of Requirement

1. BACKGROUND

The National Forensic Chemistry Center (NFCC) in the Office of the Chief Scientist, Office of Specialty Laboratories & Enforcement Support, requires the purchase of one (1) Field-flow fractionation Multi-Angle Light Scattering (FFF-MALS) system which includes the ability to perform Size Exclusion Chromatography. The FFF-MALS and Size Exclusion Chromatography Multi-Angle Light Scattering/Refractive Index/Ultraviolet (SEC/MALS/RI/UV) instrument will be utilized to characterize molecules through the determination of molecular mass, hydrodynamic radius, polydispersity, and concentration. Determination of these biophysical properties beyond what is currently possible within the NFCC, would aid in determining sample stability and authenticity. Furthermore, this instrument can be used to characterize proteins, peptides (such as GLP-1), monoclonal antibodies, vaccines, and polymers. SEC/MALS/RI is routinely utilized in the pharmaceutical industry for characterization of biomolecules and vaccines. Acquisition of the MALS/RI/UV detectors would result in the ability to analyze classes of molecules/vaccines, including macromolecules, lipid nanoparticles, proteins, aggregates, and high-molecular-weight polymers, that cannot currently be analyzed at the NFCC and allow the NFCC to implement methodologies currently used in the pharmaceutical industry. It would also expand the capabilities within the NFCC to be more prepared to analyze large molecule therapeutics and biologics. This will not only enable the analysis of forensic and regulatory samples but will also support the development of new methodology for the NFCC and FDA.

2. OBJECTIVE

To procure One (1) Field-flow fractionation Multi-Angle Light Scattering (FFF-MALS) System with Size Exclusion Chromatography Multi-Angle Light Scattering/Refractive Index (SEC/MALS/RI) and variable wavelength Ultraviolet detection capability. The system must meet or exceed the following requirements:

3. SCOPE OF REQUIREMENTS

I. Minimum Performance Requirements/Salient Characteristics

All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the NFCC prior to purchase.

1) The Field-flow fractionation system shall have all new components, include all necessary hardware and electronics for liquid handling, flow control, sample separation, data acquisition and all necessary parts and software to operate with the following specifications:

a) Supports flow rate of at least 5 mL/min.

b) Allows regulation of cross flow in a range of at least 0.03-5 mL/min (i.e., range may go lower than 0.03 mL/min or higher than 5 mL/min, but must cover this range at a minimum).

c) Instrument and channels must be compatible with both aqueous and organic solvents.

d) Ability to regulate temperature of FFF channels.

e) Detector flow rate control with a precision of 0.1% or better.

f) Automated switching mode between FFF and SEC columns between injections.

2) The UV Detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Variable wavelength UV detector.

b) Dual wavelength (2 selectable channels) with a range of at least 190-700 nm.

c) Noise Level ≤5 µAU.

3) The Refractive Index Detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Dynamic Range of at least 12,000,000:1.

b) dRI Range of at least -0047 to +0.0047 RIU.

c) dRI Sensitivity of at least: ±7.5 x10e-10 RIU.

4) The Multi-angle Laser Light scattering detector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) At least 18 unique measurement angles.

b) Molar Mass Range of at least 200 Da to 1 GDa (i.e., range may go lower than 200 Da or higher than 1 GDa, but must cover this range at a minimum).

c) Molecular Size Range of at least 10 nm to 500 nm (i.e., range may go lower than 10 nm or higher than 500 nm, but must cover this range at a minimum).

d) The sensitivity of the MALS instrument must support quantifying the molar mass of an injection of 10 ng of 100 kDa polystyrene in THF mobile phase on standard GPC, to an accuracy of 5% and precision of 2% or better.

e) The MALS instrument must provide, or be field-upgradeable to provide, a Dynamic Light Scattering detection module (DLS is also known as QELS or PCS).

f) The MALS instrument must be equipped with a rear laser monitor that measures the intensity of the laser beam prior to entering the flow cell, in order to calculate any necessary compensation to the scattering signal for laser source intensity fluctuations and drift related to ambient temperature changes, laser device aging, dust or any other mechanism. This rear monitor ensures consistent molar mass measurements over long and short periods.

g) The MALS instrument must be capable of operating in a cold box or cold room to perform experiments below room temperature.

h) The MALS instrument must be equipped with a forward laser monitor to measure the intensity of light transmitted through the flow cell, in order to correct the scattering signal for absorbance of the laser beam by the sample as well as diagnose the presence of bubbles or large contaminants in the flow cell.

i) The MALS instrument must provide a means of removing particles adhering to the MALS flow cell interior surfaces so as to minimize detector noise due to light scattering from these particles, and to prolong time between manual maintenance.

j) The MALS instrument must be calibrated using a uniform fluid such as toluene, commonly available with high quality and repeatability, rather than calibrated against a molar mass standard, because the latter technique depends on precise knowledge of concentration and refractive index increment of the standard in each specific solvent.

k) The MALS instrument must provide, or be field-upgradeable to provide, a batch operation option whereby one may remove the flow cell and replace it with a cuvette requiring 30 µL or less.

l) The MALS detector must be capable of user-installed upgrades with new firmware releases.

m) The MALS instrument and software must operate so as to provide a laser lifetime of ≥10,000 hours.

n) The MALS instrument must have the ability to adjust its laser intensity.

o) The MALS detector and software must provide a means of accepting external signals from a GPC, FPLC, HPLC, SEC or FFF system in order to utilize autoinject triggers and UV analog signals.

p) The MALS instrument must be field-diagnosable for failures and troubleshooting, and field-serviceable to facilitate rapid, on-site repair in case of failure.

q) The MALS instrument’s flow cell must be field-replaceable without need for optical alignment.

5) The liquid chromatography system shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Pump(s) with high pressure mixing and solvent degasser.

b) Flow rate range of 0.001-5 mL/min and be adjustable in 1 µL /min increments

c) Pressure range up to 400 bar.

d) Flow rate accuracy of ± 1%.

e) Pump pressure ripple less than 1%.

f) Flow rate precision of ≤ 0.075% RSD.

g) Operable pH range of 2-12.

h) Autosampler thermostat controlled with temperature range of at least 4-40ºC.

i) Injection volume range of at least 1 µL to 1000 µL.

ii) Injection precision of ≤1% RSD.

iii) Autosampler thermostat controlled with temperature range of at least 4-40ºC.

i) Column compartment thermostat controlled with temperature range of 20-90ºC (i.e., temperature range may go lower than 20ºC or higher than 90ºC, but must cover this range at a minimum).

6) The Fraction collector shall have all new components, and all necessary parts and software to operate with the following specifications:

a) Thermostat controlled with temperature range of 5-40ºC (i.e., temperature range may go lower than 5ºC or higher than 40ºC, but must cover this range at a minimum).

b) Controlled by system software.

c) Allow for use of 2 x 48 chromatography vials or 2 x 96 well plates as collection vessels.

7) Computer system for running software responsible for instrument tuning, data acquisition, and data storage:

a) The computer system shall have all components necessary to operate the instrument with the following specifications:

a. System salient characteristics:

i. 110 Vac power cord(s).

ii. USB English keyboard.

iii. USB optical mouse.

b. Network salient characteristics:

i. One (1) or more ethernet ports dedicated for network connections.

c. Storage salient characteristics:

i. 1 TB or greater SATA hard drive.

d. Meets or exceeds minimum requirements for instrument system operation.

e. Operating system salient characteristics:

i. Windows 11 Professional 64-bit, or newer.

8) Software responsible for instrument tuning, data acquisition, and data storage:

a) The software must work seamlessly with up to five relevant online detectors.

b) The software must correct the data for interdetector band-broadening such that molar mass is displayed as being uniform across the elution volume of known monodisperse macromolecules.

c) The software must provide for the determination of molar masses and sizes in the eluting macromolecules, stating with each measured value the associated uncertainties (or error bars in graphs).

d) The software must account for changes in all relevant solvent properties, e.g. solvent refractive index or viscosity, due to changes in temperature.

e) The software must be capable of automatically selecting baseline subtraction and peak position parameters.

f) Software must be capable of controlling associated pump modules.

g) The software must be capable of accepting a blank measurement and subtracting it from the sample measurement in order to eliminate gradient baselines.

h) The software must be capable of analyzing binary conjugates such as glycoproteins, PEGylated proteins or copolymers using a three-detector method (MALS-UV-dRI).

i) The software must be capable of calculating critical quality attributes of viral vectors such as an adeno-associated virus (AAV) by both MALS-UV-dRI analyses and MALS + dual-wavelength UV analysis. These quality attributes must include the total number of viral capsid particles, relative capsid content (empty/full ratio) and percent aggregates.

j) Using a three-detector method (MALS-UV-dRI), the software must be capable of analyzing binary nanoconjugates such as LNP-encapsulated RNA, liposomes and polyplexes bearing small-molecule drugs or multi-megaDalton glycoconjugates, that all exhibit inflated UV signals due to scattering in the UV detector, by incorporating a size-dependent UV scattering correction.

k) Software capable of detecting and quantifying nucleic acid in lipid nanoparticles.

l) The software must be capable of analyzing macromolecular conformation by combining two properties such as size/molar mass, intrinsic viscosity/molar mass or rms radius/hydrodynamic radius.

m) The vendor must allow the software to be installed on at least two computers.

II. Trade and Service Specifications

· The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

· A minimum of one-year warranty is required with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including the base instrument and any sampling accessories.

· Onsite installation and training. 3-day onsite installation and familiarization installing and testing the system and detectors. Four-day onsite training course at customer facility for up to three people including all training materials, all handouts, MALS training, hands-on training on software and hardware, sample analysis, data processing, system maintenance, and system troubleshooting.

· Unlimited free telephone, e-mail, and/or FAX technical support for one year.

4. CONTRACT TYPE

Firm Fixed price

5. PERIOD OF PERFORMANCE

The Period of Performance begins on the date of formal government acceptance and continues through the end of the manufacturer’s warranty period. Equipment shall be delivered no later than 90 days after contract award.

6. PLACE OF DELIVERY AND PERFORMANCE

The place of performance will be at the Government site(s) indicated below:

U.S. Food and Drug Administration National Forensic Chemistry Center 6751 Steger Dr.

Cincinnati, OH 45237

HOURS OF OPERATION

Work shall typically be performed during normal business hours of 8:00 A.M. to 4:00 P.M. local standard time, Monday through Friday.

7. INSPECTION/ACCEPTANCE CRITERIA

Inspection and acceptance shall be in accordance with the FAR-RFO clause 52.212-4(b). All items specified in this Statement of Work to be delivered under this order are subject to final inspection and acceptance by an authorized representative for the Government. The technical point of contact and Contracting Officer Representative (TPOC/COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

8. DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall perform all services as set forth below:

9. GOVERNMENT POINTS OF CONTACT

Contract Specialist

Andrea Howard U.S. Food and Drug Administration Office of Acquisitions and Grants Services 11601 Landsdown Street North Bethesda, MD 20852 Phone: 240-402-7197 Email: Andrea.howard1@fda.hhs.gov

Contracting Officer’s Representative/ (TPOC)

Mark Burton (COR) Phone: 214-253-4909 Email: Mark.burton@fda.hhs.gov

10. CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms, or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

11. CLAUSES AND PROVISIONS

FAR PROVISIONS Incorporated by Reference (IBR)

FAR CLAUSES Incorporated by Reference (IBR)

FAR PROVISIONS Incorporated by Full-Text

FAR 52.219-1 – SMALL BUSINESS PROGRAM REPRESENTATIONS (DEVIATION) (APR 2026)

(a) Definitions. As used in this provision- 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 concern eligible under the WOSB Program.

HUBZone small business concern means a small business concern that meets the requirements described in 13 CFR 126.200, is certified by the Small Business Administration (SBA) and designated by SBA as a HUBZone small business concern in the Small Business Search (SBS) ( 13 CFR 126.103).

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300.

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 the size standard in paragraph (b) of this provision.

(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 means a small business concern that-

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by one or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States, 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 paragraph (1) of this definition.

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) The North American Industry Classification System (NAICS) code for this acquisition is 334516.

(2) The small business size standard is 1,000 employees.

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce (i.e., nonmanufacturer), is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(c) Representations.

(1) 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) [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 disadvantage business concern.

(3) Women-owned small business (WOSB) joint venture eligible under the WOSB Program. The offeror represents as part of its offer 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: __.]

(4) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents as part of its offer 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: __.]

(5) SDVOSB joint venture eligible under the SDVOSB Program. [Complete only if the offeror is certified as a SDVOSB concern]. The offeror represents as part of its offer that it □ is, □ is not a SDVOSB joint venture eligible under the SDVOSB Program that complies with the requirements of 13 CFR 128.402. [ The offeror shall enter the name and unique entity identifier of each party to the joint venture:__.]

(6) HUBZone joint venture eligible under the HUBZone Program. [Complete only if the offeror is a HUBZone small business concern.] The offeror represents, as part of its offer, that 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 must be certified as a HUBZone concern.

(d) Notice. Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, will be—

(1) Punished by imposition of fine, imprisonment, or both;

(2) Subject to administrative remedies, including suspension and debarment; and

(3) Ineligible for participation in programs conducted under the authority of the Act.

(End of provision)

52.225-2 Buy American Certificate.

As prescribed in 25.601(a)(2), insert the following provision:

Buy American Certificate (Oct 2022) (a)

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

(2) 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”.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

(b) Foreign End Products:

(b)[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No. ___ [List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision)

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/far-overhaul/far-part-deviation-guide https://www.acquisition.gov/hhsar

(End of provision)

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/far-overhaul/far-part-deviation-guide https://www.acquisition.gov/hhsar

FAR CLAUSES INCORPORATED by FULL TEXT

52.219-28 POSTAWARD SMALL BUSINESS PROGRAM REREPRESENTATION (DEVIATION RFO) (APR 2026)

(a) Definitions. As used in this clause— Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

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 the size standard in paragraph (c) of this clause.

(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.

(b) If the Contractor represented that it was a small business concern, a small disadvantaged business concern, or a joint venture that was any of the small business concerns identified in 19.000(a)(3) prior to award of this contract, the Contractor shall rerepresent its size and socioeconomic status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon occurrence of any of the following:

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3) For long-term contracts-

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

(c) The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of this rerepresentation that corresponds to the North American Industry Classification System (NAICS) code(s) assigned to this contract. The small business size standard corresponding to this NAICS code(s) can be found at https://www.sba.gov/document/support--table-size-standards.

(d) The small business size standard for a Contractor providing an end item that it does not manufacture, process, or produce itself, for a contract other than a construction or service contract, is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(1) Was set aside for small business and has a value above the simplified acquisition threshold;

(2) Used the HUBZone price evaluation preference regardless of dollar value, unless the Contractor waived the price evaluation preference; or

(3) Was an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation(s) required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting officer in writing within the timeframes specified in paragraph (b) of this clause, that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

(1) The Contractor represents that it □ is, □ is not a small business concern under NAICS Code 334516 assigned to contract number_________________________.

(2) [Complete only if the Contractor represented itself as a small business concern in paragraph (g)(1) of this clause.] The Contractor represents that it □ is, □ is not, a small disadvantaged business concern as defined in 13 CFR 124.1001.

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

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

(5) Service-disabled veteran-owned small business (SDVOSB) joint venture eligible under the SDVOSB Program. The Contractor 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. [ The Contractor shall enter the name and unique entity identifier of each party to the joint venture: __.]

(6) HUBZone joint venture eligible under the HUBZone Program.[ Complete only if the offeror is a HUBZone small business concern. ] The offeror represents, as part of its offer, that It □ is, □ is not a HUBZone joint venture that complies with the requirements of 13 CFR 126.616(a) through (c). [ The Contractor 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 must be certified as a HUBZone concern. [ Contractor to sign and date and insert authorized signer's name and title.______________________ ] (End of clause)

52.246-20 WARRANTY OF SERVICES (MAY 2001)

(a) Definition.

"Acceptance," as used in this clause, means the act of an authorized representative of the Government by which the Government assumes for itself, or as an agent of another, ownership of existing and identified supplies, or approves specific services, as partial or complete performance of the contract.

(b) Notwithstanding inspection and acceptance by the Government or any provision concerning the conclusiveness thereof, the Contractor warrants that all services performed under this contract will, at the time of acceptance, be free from defects in workmanship and conform to the requirements of this contract. The Contracting Officer shall give written notice of any defect or nonconformance to the Contractor 45 days after the discovery of the defect. This notice shall state either (1) that the Contractor shall correct or reperform any defective or nonconforming services, or (2) that the Government does not require correction or reperformance.

(c) If the Contractor is required to correct or reperform, it shall be at no cost to the Government, and any services corrected or reperformed by the Contractor shall be subject to this clause to the same extent as work initially performed. If the Contractor fails or refuses to correct or reperform, the Contracting Officer may, by contract or otherwise, correct or replace with similar services and charge to the Contractor the cost occasioned to the Government thereby, or make an equitable adjustment in the contract price.

(d) If the Government does not require correction or reperformance, the Contracting Officer shall make an equitable adjustment in the contract price.

(End of clause)

HHSAR CLAUSES/PROVISIONS

HHSAR 352.223-70 Safety and Health (DEC 2015)

a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

(i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafety/publications/index.htm.

(ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street NW., Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication is available at http://www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-anddisposal-of-chemicals.

(b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer's Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures result in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable “Changes” clause set forth in this contract.

(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor.

(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

(End of clause)

HHSAR 352.232-71 Electronic Submission of Payment Requests (APR 2026)

As prescribed in HHSAR 332.7003, use the following clause:

Electronic Submission of Payment Requests

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

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

(End of clause)

HHSAR 352.239-78 Information and Communication Technology Accessibility Notice (DEVIATION) (FEB 2024)

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

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

Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.

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

(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.

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

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

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

Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.

(End of provision)

HHSAR 352.239-79 Information and Communication Technology Accessibility (DEVIATION) (FEB 2024)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

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

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR)…