CB SYN_SOL 1228325 05112020.pdf

75F40120Q00049 PHOTON COUNTING CdTe COUNTING X-RAY DETECTOR

This is a combined synopsis/solicitation for commercial supplies prepared in accordance with the Federal Acquisition Regulation (FAR) format Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-06.

***************************BRAND NAME OR EQUAL**************************

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F4012Q00049 and is being issued as a Request for Quote (RFQ). The solicitation is being issued in conjunction with FAR PART 13.106. The associated North American Industry Classification System (NAICS) Code for this solicitation is 334519, Other Measuring and Controlling Device Manufacturing. This requirement is Full and Open Competition with no set-aside. Prospective Offerors are responsible for downloading the solicitation and any amendments. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary.

Contract Type-Commercial Supply– Firm Fixed Price

The U. S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) requires the following:

A. BACKGROUND:

The breast imaging laboratory in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH) has a custom-built imaging simulator (benchtop system) emulating mammography, digital breast tomosynthesis (DBT), and breast computed tomography (bCT) imaging systems.

The FDA previously purchased the XCounter Actaeon FX5 photon counting detector with Cadmium Telluride (CdTe) sensor from XCounter. A custom-built benchtop CT system was vault to accommodate x-ray imaging with this detector. This detector was of size 2 cm x 5 cm.

Because of its small size, it was not capable for adequately imaging of the breast. Thus, the FDA requires a larger active area but otherwise compatible photon counting detector x-ray detector to appropriately perform breast imaging.

Images of basic physical phantoms, as well as an anthropomorphic breast phantom, will be acquired with both the photon counting detector and a standard energy integrating detector.

Performance with this photon counting detector will be compared to that with a conventional energy integrating detector. The detector shall be used for testing and development of material decomposition algorithms to provide new biomarkers for breast lesion analysis.

B. STATEMENT OF WORK

1. OBJECTIVE

The objective is to purchase a large area Cadmium Telluride photon (CdTe) counting x-ray detector.

2. SALIENT CHARACTERISTICS

The 1 each (ea) Photon Counting X-Ray Detector shall possess the following qualities

a. Cadmium Telluride sensor material, 75 microns thick

b. Active area of at a minimum 5 cm x 30 cm

c. Capability of counting individual x-rays at high count-rates up to 200 million counts per second (MCPS) per squared millimeter

d. Includes at a minimum two x-ray energy discrimination windows

e. Includes anti-coincidence technology to reduce charge sharing

f. Detector pixel size between 80 - 120 microns

g. Readout protocol shall be the same as with Direct Conversion Actaeon FX5 detector

h. The Vendor shall accept trade-in of currently owned Direct Conversion Actaeon

FX5 detector

a. Existing Conditions: Currently have a small area (2 cm x 5 cm ) Direct Conversion Actaeon FX5 photon counting x-ray detector connected to a custom built benchtop acquisition system with in-house custom data acquisition software.

b. Trade-In: Direct Conversion 2 cm x 5 cm Actaeon FX5 photon counting x-ray detector, SN:

4325966.

c. Software: No software is required, plug and play detector only.

d. Installation: No installation is required, plug and play detector only.

e. Capabilities:

a. Photon counting x-ray detector capable of counting individual x-rays at high count-rates of up to 200 million counts per second (Mcps) per squared millimeter

b. Photon counting x-ray detector capable of human breast imaging and with a

Cadmium Telluride sensor material having an active area of at a minimum 5 cm x 30 cm and a detector pixel size between 80 - 120 microns.

c. Photon counting x-ray detector capable of use in development/testing material decomposition algorithms for breast lesion analysis and with at a minimum two x-ray energy windows.

d. Photon counting x-ray detector readout protocol same as that of the Direct Conversion’s Actaeon FX5 detector such that it can be directly integrated into current acquisition platform.

3. DELIVERY REQUIREMENT/Delivery

Item Quantity Delivery Method/Inspection & Acceptance

PHOTON COUNTING

CdTe COUNTING X-RAY

DETECTOR

1 each FOB Destination and 90 Days After Award/ 100% Inspection and Acceptance

Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Attn: TBD Building WO62 RM310Z 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:TBD Email: TBD

4. WARRANTY AND MAINTENANCE

Manufacturer warranty applies.

5. POINTS OF CONTACT

Contracting Officer:

Name: Monifa Coleman Email Address: Monifa.Coleman@fda.hhs.gov

Contract Specialist:

Name: Patricia Natividad Email Address: Patricia.Natividad@fda.hhs.gov

Technical Point of Contact Name: tbd Telephone Number: tbd Email Address: tbd mailto:Monifa.Coleman@fda.hhs.gov mailto:Patricia.Natividad@fda.hhs.gov

C. LINE ITEM AND PRICES:

Table 2 Line Items and Prices

Description Quantity Price

Line Item 1 350mm Wide CdTe Detector

1 each $

Total:

Provide a fixed price quote in accordance with the Statement of Work identified and Section C (Table 2) for Pricing Schedule. Ensure to include the trade-in as a credit for this item.

D. GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

E. EVALUATION AND AWARD:

Lowest Priced, Technically Acceptable (LPTA)

F. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (MAR 2020)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Patricia.Natividad@fda.hhs.gov no later than May 19, 2020, 10:00 a.m. Eastern Standard Time.

Please include the company name, FDA solicitation number, and “Question(s)” in the subject line. 75F40120Q00049 PHOTON COUNTING CdTe COUNTING X-RAY DETECTOR

PROPOSAL DUE: All Volumes for the quotes are due, electronically through email to patricia.natividad@fda.hhs.gov, no later than May 26, 2020, 10:00 a.m. Eastern Standard Time.

Ensure the email subject line annotates the solicitation number and description:

G. FAR CLAUSES AND PROVISIONS AND HHSAR CLAUSES AND PROVISIONS

FAR clauses referenced in this RFQ can be found on the following website:

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

HHSAR clauses referenced in this RFQ can be found on the following website:

https://www.acquisition.gov/hhsar.

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; FAR 52.203-6, Restrictions on mailto:Patricia.Natividad@fda.hhs.gov mailto:patricia.natividad@fda.hhs.gov http://www.acquisition.gov/far/index.html

Subcontractor Sales to the Government; FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights; FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor-Cooperation with Authorities and Remedies; FAR 52.222- 21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-37, Employment Reports on Veterans, FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act; FAR 52.222-50, Combating Trafficking in Persons; FAR 52.225- 5, Trade Agreements;;FAR 52.225-13, Restrictions on Certain Foreign Purchases; FAR 52.232- 40, Providing Accelerated Payments to Small Business Subcontractors.

FAR 52.212-3 Offeror Representations and Certifications—Commercial Items (MAR 2020)

HHSAR Clauses and Provisions by Reference:

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigation

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice

HHSAR 353.239.74 Electronic and Information Technology Accessibility

H. INVOICE SUBMISSION REQUIREMENTS

A. FDA Three-Way Match Invoicing Procedures (Three-Way Match)

The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (TBD)

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.beta.sam.gov/ http://www.beta.sam.gov/