Solicitation 75F40126Q00415 .docx

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS AND GRANTS SERVICES (OAGS)

REQUEST FOR QUOTATION (RFQ)

SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

SECTION A - SUPPLIES OR SERVICES AND PRICES / COSTS

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format prescribed in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued separately.

This solicitation is issued as a Request for Quotation (RFQ) under the simplified acquisition procedures of FAR Part 12 (Commercial Products and Services). The Government contemplates award of a single, firm-fixed-price purchase order for the items listed below.

This acquisition is conducted on a BRAND NAME OR EQUAL basis in accordance with FAR 52.211-6. The brand name item identified in CLIN 0001 (ChemiDoc MP Imaging System, Bio-Rad Laboratories, Inc.) is referenced to describe the minimum acceptable level of quality and performance. Offerors may propose the brand name item or an equal item that meets or exceeds all mandatory technical specifications set forth in Section C.3.

See Section C for mandatory technical specifications.

SECTION B - CONTRACT CLAUSES AND APPLICABLE REGULATIONS

This acquisition is conducted under FAR Part 12 (Acquisition of Commercial Products and Commercial Services). The following FAR provisions and clauses apply to this solicitation and any resultant order. Clauses incorporated by reference have the same force and effect as if set forth in full text. Full text of all FAR clauses may be found at https://www.acquisition.gov/far/.

B.1 FAR Provisions (Solicitation) FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (SEP 2023) Quotes shall be submitted electronically to the Contracting Officer no later than the response due date and time shown on the cover page. Quotes must include: (1) completed SF-1449 or equivalent quote form; (2) technical specifications confirming compliance with all requirements in Section C; (3) price for each CLIN; (4) proposed delivery schedule; (5) company name, DUNS/UEI, CAGE code, and SAM.gov registration confirmation; and (6) any proposed exceptions or deviations. Offerors proposing an equal item must include a compliance matrix as specified in Section I (Factor 1).

FAR 52.211-6 Brand Name or Equal (AUG 1999)

(a) If an item in this solicitation is identified as 'brand name or equal,' the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that equal products must meet are specified in Section C.3.

(b) To be considered for award, the offeror must submit, with its offer, descriptive material (e.g., illustrations, drawings, or brochures) that clearly shows that the product offered will meet the salient characteristics of the brand name item. The contracting officer shall evaluate such material and determine whether the proposed item meets the salient characteristics.

(c) Unless the offeror clearly indicates in its offer that it is proposing the brand name product, the offer will be evaluated as if it were proposing an equal product.

FAR 52.212-3 Offeror Representations and Certifications - Commercial Products and Commercial Services (FEB 2024) The offeror shall complete and submit this provision with their quote, or confirm active registration in SAM.gov with representations current.

FAR 52.213-1 Fast Payment Procedure (MAY 2006) Applicable where payment is made prior to Government verification of delivery.

B.2 FAR Clauses (Contract) FAR 52.212-4 Contract Terms and Conditions - Commercial Products and Commercial Services (NOV 2023) Incorporated by reference. Governs inspection, acceptance, payment, changes, disputes, and other standard commercial terms.

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (MAR 2024) The following clauses within 52.212-5 are checked as applicable:

(b)(4) FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (b)(8) FAR 52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (b)(18) FAR 52.219-8, Utilization of Small Business Concerns (b)(25) FAR 52.222-3, Convict Labor (b)(26) FAR 52.222-19, Child Labor (b)(27) FAR 52.222-21, Prohibition of Segregated Facilities (b)(28) FAR 52.222-26, Equal Opportunity (b)(40) FAR 52.225-13, Restrictions on Certain Foreign Purchases (b)(55) FAR 52.232-33, Payment by Electronic Funds Transfer - System for Award Management FAR 52.204-7 System for Award Management (OCT 2018) FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) FAR 52.211-6 Brand Name or Equal (AUG 1999) FAR 52.232-18 Availability of Funds (APR 1984) FAR 52.232-25 Prompt Payment (JAN 2017) FAR 52.246-1 Contractor Inspection Requirements (APR 1984) FAR 52.246-16 Responsibility for Supplies (APR 1984) FAR 52.247-34 F.O.B. Destination (NOV 1991) FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

SECTION C - STATEMENT OF WORK / DESCRIPTION / SPECIFICATIONS

C.1 Purpose and Background The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) requires the purchase of one (1) Image Analyzer - ChemiDoc MP Imaging System manufactured by Bio-Rad Laboratories, Inc. - OR AN APPROVED EQUAL meeting all mandatory technical specifications stated herein.

CBER regulates protein therapeutics used to treat patients with abnormal hemostasis, including deficiencies in blood coagulation factors, and conducts supporting research under Program #05010: 'Towards more efficient Factor VIII drug products to improve the treatment of Hemophilia A.' Research activities include: (i) studying structure and functions of Factor VIII (FVIII) related to plasma clearance and development of longer-acting drug products; (ii) investigating FVIII potency assay discrepancies; and (iii) characterizing product-related impurities (structurally altered FVIII) in therapeutic FVIII products. These studies directly support the FDA mission to promote and protect public health.

C.2 Scope of Work The contractor shall furnish, deliver, and, if applicable, install one (1) multi-channel gel and blot documentation imaging system - brand name (ChemiDoc MP Imaging System, Bio-Rad Laboratories, Inc.) or equal - meeting or exceeding all mandatory technical specifications in Section C.3. The contractor shall also provide applicable software, documentation, and operator training as specified herein.

C.3 Mandatory Technical Specifications (Salient Characteristics) The following specifications define the minimum salient physical, functional, and performance characteristics that any proposed item (brand name or equal) must meet. These characteristics are derived from the ChemiDoc MP Imaging System (Bio-Rad Laboratories, Inc.) and represent the Government's minimum requirements. Offerors proposing an equal item must demonstrate compliance with each specification below via a compliance matrix (see Section I, Factor 1).

C.3.1 Critical / Salient Characteristics (Mandatory) Stain-Free Western Blotting capability using UV-activated stain-free technology to rapidly assess electrophoresis and blot transfer quality prior to blot processing and to perform total protein normalization. Stain-free protein gel imaging must complete in less than 2 minutes, eliminating the need for Coomassie blue staining (approximately 1.5 hours with significant chemical waste).

Minimum five (5) fluorescent channels, including a channel suitable for GFP/Cy2 detection, to support multiplex fluorescence imaging and in-cell Westerns.

Mechanical zoom capability that maintains optical resolution over any field of view without compromising sensitivity, including physical movement of the camera (equivalent to U.S. Patent 9,618,733 or demonstrated equal performance).

Multi-stack optical filtration design with optimized flat black coatings within the lens and instrument interior to prevent stray, scattered, and reflected excitation light from entering the sensor (equivalent to U.S. Patent 9,841,378 or demonstrated equal performance).

Compatibility with high-performance fluorophores comparable in brightness to StarBright 520 and StarBright 700 (or equivalent fluorophores of equal or greater performance available for use with the proposed system).

C.3.2 Additional Technical Parameters Automation Capabilities:

Automatic tray recognition with automatic adjustment of imaging parameters and software options (equivalent to U.S. Patent 8,913,127 or demonstrated equal performance).

Autofocus Auto-exposure Dynamic image flat fielding: pre-calibrated and optimized for each application.

Optical Features:

Baffled epi cooling unit or equivalent that controls excitation light direction and ensures temperature stability of LEDs to maximize output power without wavelength drift, enabling output uniformity and faster acquisition times.

Low autofluorescence and solarization-resistant interior materials.

Hardware:

Touch screen: minimum 2-touch capability, minimum 12.1" display.

Minimum image area: 21 x 16.8 cm (W x H).

Detector: Cooled CCD, minimum 6.05 megapixel (2,750 H x 2,200 V pixels); pixel size of 4.54 um square.

Quantum efficiency: >= 70% at 425 nm; maximum >= 75% at 525 nm; 75-50% across 525-800 nm.

Low read noise: <= 6e-.

Low dark current: <= 0.002 e-/p/s at -15 degrees C.

Peltier cooling to -15 degrees C.

f/0.95 fast lens (or faster).

Dynamic range: > 4 orders of magnitude.

Illumination Sources:

Trans-UV, 302 nm excitation Epi-white Trans-white (requires White Sample Tray) Trans-blue, 450-490 nm excitation (requires Blue Sample Tray) Epi-blue, 460-490 nm excitation Epi-green, 520-545 nm excitation Epi-red, 625-650 nm excitation Epi-far red, 650-675 nm excitation Epi-near IR, 755-777 nm excitation Filters and Applications:

590/110 nm standard filter for protein and DNA gel/blot imaging and chemiluminescence 518-546 nm filter for blue-excitable fluorophores and stains 577-613 nm filter for green-excitable fluorophores and stains 675-725 nm filter for red-excitable fluorophores and stains 700-730 nm filter for far red-excitable fluorophores and stains 813-860 nm filter for near IR-excitable fluorophores and stains Data Output:

16-bit or 8-bit output: SCN, TIFF, and JPEG file formats.

Minimum four (4) USB ports.

Physical and Environmental:

Instrument weight: <= 35 kg (78 lb).

Instrument size (L x W x H): <= 61 x 51 x 53 cm.

Operating voltage: 100-250 V.

Operating temperature: 10-28 degrees C.

Operating humidity: 10-85% relative humidity (non-condensing).

Software:

Standalone image analysis software compatible with PC and Mac for image viewing and 1-D analysis (e.g., Image Lab Software or equivalent).

C.4 Training The contractor shall provide operator training for FDA personnel on the operation, maintenance, and software use of the delivered system. Training shall be coordinated with the Contracting Officer's Representative (COR) and shall occur on-site at the delivery location or via remote/virtual means acceptable to the COR. Training materials (user manuals, quick-start guides) shall be provided in English.

C.5 Warranty The contractor shall provide a minimum one (1) year manufacturer's warranty covering defects in materials and workmanship. The warranty period shall commence upon Government acceptance. The contractor shall repair or replace any defective components at no additional cost to the Government during the warranty period.

SECTION D - PACKAGING AND MARKING

All items shall be packaged in accordance with the manufacturer's standard commercial packaging practices sufficient to prevent damage during transportation and delivery. Each package shall be clearly marked with the purchase order number, item description, quantity, and delivery address. Equipment shall include all original manufacturer's documentation, cables, and accessories.

SECTION E - INSPECTION AND ACCEPTANCE

Inspection and acceptance shall be performed at destination by the designated Contracting Officer's Representative (COR). Acceptance will be based on:

Physical delivery of the complete system with all components, accessories, and documentation.

Verification that the delivered item meets all mandatory technical specifications listed in Section C.3.

Successful power-on and functional demonstration by the contractor.

Completion of operator training (CLIN 0002, if applicable).

The Government reserves the right to reject any item that does not conform to the specifications in this solicitation. Rejected items shall be removed and replaced by the contractor at no cost to the Government within a timeframe agreed upon with the COR.

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Delivery Schedule Delivery shall occur within thirty (30) calendar days after contract award.

F.2 Delivery Address U.S. Food and Drug Administration 10903 New Hampshire Avenue Building 52/72, Room 4256 Silver Spring, MD 20993

POC: TBD

IMPORTANT: Delivery must be coordinated with the Point of Contact (POC) at least 72 hours in advance. The contractor shall contact the POC to schedule a delivery appointment before dispatching equipment. Unscheduled deliveries may be refused.

Federal Holidays and Government Closures The Contractor is not required to provide on-site services on the following Federal holidays or any other day designated as a Federal holiday for the Washington, DC area:

New Year's Day Martin Luther King Jr. Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day In the event of inclement weather when the Federal Government is closed, the Contractor is not required to provide on-site service. The Contractor shall follow all directives issued by the U.S. Office of Personnel Management for late arrivals due to inclement weather unless otherwise specified in the contract.

SECTION G - CONTRACT ADMINISTRATION DATA

The Contracting Officer (CO) is the only individual authorized to make changes to or modify this contract. Any changes made by any other individual are void.

Contracting Officer (CO): Janice Heard; email: Janice.Heard@fda.hhs.gov Contracting Officer's Representative (COR): TBD FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All invoice submissions for goods and/or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. To constitute a proper invoice, the payment request must comply with FAR 32.905(b) and the applicable Payment clause. The IPP website address is: https://www.ipp.gov

c. The Agency will enroll Contractors new to IPP. The Contractor Government Business POC (as listed in SAM) will receive a Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3-5 business days of contract award. Registration emails are sent from ipp.noreply@mail.eroc.twai.gov. IPP Helpdesk: IPPCustomerSupport@fiscal.treasury.gov or (866) 973-3131. Temporary password must be used within 30 days of receipt.

d. Invoices that include time-and-materials or labor-hour line items must include supporting documentation to substantiate labor hours and material costs incurred.

e. Contractor is required to attach an invoice log addendum to each invoice which shall include: (1) list of all invoices submitted to date; (2) total payments received to date; and (3) for definitized contracts, total estimated amounts yet to be invoiced.

f. Payment will be made upon Government acceptance of the entire task or tangible product deliverable(s) invoiced, based on certification of satisfactory services.

g. If services are rejected for failure to conform to technical requirements, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

h. Questions regarding invoice payments should be directed to the FDA ERIC Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); email: ERIC@fda.hhs.gov.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 Security and Site Access Contractor personnel performing delivery and installation at FDA facilities must comply with all applicable FDA physical security requirements. The contractor shall coordinate with the COR to obtain visitor access badges and escort arrangements prior to entering the facility. Government-issued photo identification will be required for all contractor personnel.

H.2 Biosafety Compliance Delivery personnel entering Building 52/72 must comply with all applicable biosafety protocols for FDA research facilities. The COR will provide specific instructions and access routes to the delivery location. Contractor personnel shall not access restricted laboratory areas beyond the loading dock unless specifically authorized by the COR.

SECTION I - EVALUATION CRITERIA AND BASIS FOR AWARD

Award will be made to the responsible offeror whose quote represents the best value to the Government. For this acquisition, price will be the primary basis for award, provided all mandatory technical requirements in Section C are met.

Factor 1 - Technical Acceptability:

The quote must demonstrate compliance with ALL mandatory technical specifications in Section C.3. Quotes that fail to meet any mandatory specification will be deemed technically unacceptable and will not be evaluated further.

Offerors proposing the brand name item (ChemiDoc MP Imaging System, Bio-Rad Laboratories, Inc.) should clearly state the brand name and model in their quote. No further technical documentation is required beyond confirmation of brand name and model number.

Offerors proposing an equal item must provide a compliance matrix cross-referencing each mandatory salient characteristic in Section C.3.1 and each additional technical parameter in Section C.3.2 with the proposed product's published specifications. The compliance matrix must include: (1) the specification requirement; (2) the proposed product's corresponding specification or feature; and (3) supporting documentation (e.g., manufacturer's published data sheets, brochures, or test data). Offerors that do not clearly indicate they are proposing the brand name item will be evaluated as proposing an equal item.

Factor 2 - Price:

All technically acceptable quotes will be evaluated on price (CLIN 0001 + CLIN 0002, if applicable). Award will be made to the technically acceptable offeror offering the lowest total evaluated price. The Government reserves the right to make award without discussions.

SECTION J - INSTRUCTIONS TO OFFERORS

Quotations shall be submitted electronically by the date and time specified on the cover page. Each quotation shall include the following:

Completed Price Schedule (Section A) with firm-fixed unit and total prices.

For brand name offerors: confirmation of the brand name (ChemiDoc MP Imaging System, Bio-Rad Laboratories, Inc.) and model number.

For equal item offerors: completed compliance matrix as specified in Section I, Factor 1, with supporting manufacturer's documentation (data sheets, brochures, or equivalent) for each salient characteristic and technical parameter in Section C.3.

Proof of active registration in SAM.gov with current representations and certifications.

Any additional terms, conditions, or service agreement documentation the Offeror proposes.

Quotations submitted after the deadline may not be considered. The Government reserves the right to make no award, to award without discussions, or to cancel this solicitation at any time.

Quotations shall be submitted to the Contracting Officer via the contact information provided in the solicitation transmittal. Offerors with questions must submit them in writing no later than three (3) business days prior to the quotation due date.