Solicitation_75F40123Q00376.pdf

Combined Synopsis/Solicitation: 75F40123Q00376

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6 with FAR part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is

75F40123Q00376 and is being issued as a request for quotation (RFQ). The NAICS Code for this solicitation is 541714-Research and Development in Nanotechnology (except

Nanobiotechnology). The small business size standard is 1,000 employees. The requirement will be awarded as Firm-Fixed Price and 100% small business set-aside. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov the

Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value to the Government and discussions are not necessary.

The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2023-04.

The Government intends to issue a Firm-Fixed Priced Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to purchase the Zoe module (ZOE-CM2) with an Orb Hub (Orb-HM1) or equal.

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

A. Background

The Office of Biotechnology Products (OBP) in Center for Drug Evaluation and Research

(CDER) regulates therapeutic proteins, such as antibodies, fusion proteins, and enzymes. Within

OBP, the division of biotechnology research and review performs mission-related research to ensure/improve drug safety, quality, and efficacy. This requires the acquisition of new technology that can advance industrial control strategies for drug products. This acquisition is for an instrument that can reliably generate a physiologically relevant organ-on-a chip system that has been validated for reproducibility and repeatability. Currently, OBP does not possess a system that can reliably generate a physiologically relevant organ-on-a-chip model for bioassay development. In this acquisition, FDA is requesting to purchase a compact microfluidic system that can robustly generate physiologically relevant organ-on-a-chip models for bioassays development that can improve monitoring for changes in potency, blood brain penetrance, therapeutic protein clearance, and immunogenicity.

B. Objectives

Restricted in the ability to characterize the penetrance of therapeutic proteins through the blood brain barrier due to the lack of scientific instrumentation that can generate a physiologically relevant blood brain barrier. Current industrial strategies use monolayer cell line studies and protein to protein binding studies to support blood brain barrier penetrance of therapeutic https://www.acquisition.gov/far/subpart-12.6#FAR_Subpart_12_6 proteins, but these do not represent the complex biology that regulates the translocation of therapeutic proteins through the blood brain barrier. Blood brain barrier penetrance can be quantified and qualified for brain-targeted therapeutic proteins. The Zoe-Orb system is a fully automated system the can robustly, repeatably, and reproducibly generate physiologically relevant and validated organ-on-a-chip model of the human blood brain barrier that contains six different cell types and fluidic shear stress. FDA proposes to establish this system for testing the potency and blood brain barrier penetrance of different glycovariants of an experimental fusion protein and drug products.

C. Specifications

FDA requires (1 each) microfluidic system that can culture organ-on-a-chip system for bioassay development. The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

A. The system shall contain two units that control different environmental conditions.

B. A power cable that supply power to the units that is compatible with a standard

Type B, 120 V electrical outlet most common in North America

C. Unit 1: ZOE-CM2 OR EQUAL

1. Overall size to be 7” x 8.6” x 16.9 with a weight less than 25 lbs.

2. House up to 12 different chips in pods that can independently control media or air flow

3. Capable of cyclic stretching with the ability to adjust frequency and strain of stretch

4. Bubble reduction technology to prevent failure in the micro physiological system

5. Operating temperature 10 to 38°C with a 0 to 85% relative humidity

6. Control of low between 0 to 1,000 microliters per hour

7. Stretch range of 0 to 12% and stretch frequency between 0 and 0.4 Hz

8. Vacuum input pressure of 70 kPa minimum

9. Gas input composition of 5% Carbon dioxide with air balance at 276 kPa

D. Unit 2: Orb Hub or EQUAL

1. Overall Size 13” x 13” x 11.75” with a weight less than 17 lbs.

2. Gas input composition 100% Carbon dioxide with a pressure of 10-20 psig

3. Operating temperature at 10-35°C with a relative humidity of 30-80%

4. Storage temperature at -5 to 60°C with a relative humidity of 30 to 90%

5. Gas output composition 5% at a pressure of 275kPa

6. Mix gas flowrate of 130 mL/ min

7. Vacuum output 73 kPa minimum

8. Electrical output for four Zoe or equivalent units.

E. Ability to connect to external networks or memory storage devices via either ethernet or

USB connection.

F. A basic research Kit should be included that contains the chips, pods, a steriflip, and solutions to prepare the 24 chips.

G. A full culture brain chip kit should be included that contains 15 Chips, 12 pods, solutions to prepare the chips, 4 steriflips, seeding media, short-term media, and the following cells: Brain Astrocytes, Brain Pericytes, iPS-derived Glutamatergic neurons, iPS-derived

GABAergic neurons, Brain Microglia, and Human iPSC line (brain endothelium).

H. Delivery Requirements:

Thirty (30) Days After Receipt of Award.

I. Period of Performance:

a. Twelve (12) months from date of award.

D. Warranty

A one (1) year warranty provided by the OEM that begins upon equipment delivery. Warranty shall cover all parts, labor, and service visits for at least 1 year. All replacements shall be

Original Equipment Manufacturer (OEM) parts.

E. Delivery and Installation

FDA White Oak Campus

Bldg 52/72 RM 2244

10903 New Hampshire Ave

Silver Spring, MD 20993

The installation shall be during regular business hours (Monday-Friday) between the time of

9:00 AM – 5:00 PM Eastern Time (ET), excluding Federal Holidays.

A report, in excel or word format, for the instrument performance shall be provided after on-site visit.

F. Inspection/Acceptance:

FOB: Destination

Inspection/Acceptance: Destination

G. Pricing Schedule

Line Item is as follows:

Item Service and Supply Description Quantity

(Qty)

Unit List Price

U.S. Dollar

(USD)

Subtotal

1 Zoe Culture Module 2 (Zoe-

CM2)

1 EA $ $

2 Orb Hub Module 1 (Orb-HM1) 1 EA $ $

3 Basic Research Kit 24 pack 1 EA $ $

4 Cortical Brain Chip Kit 12 pack 1 EA $ $

5 Warranty $

6 Shipping $

Total $

Note: The Contractor shall complete the pricing table above to be considered responsive. All

Contract Line Items are firm-fixed price.

H. Government Holidays

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

(1) New Year's Day (7) Labor Day

(2) Martin Luther King's Birthday (8) Columbus Day

(3) President’s Day (9) Veterans' Day

(4) Memorial Day

(5) Juneteenth (10) Thanksgiving Day

(6) Independence Day (11) 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.

I. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

The provision at 52.212-1, Instructions to Offerors—Commercial Products and Commercial

Services (Mar 2023), applies to this acquisition.

J. 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. Please follow the volume instructions or your quote may be considered non-responsive. ***

The technical volume shall provide the specifications of the equipment and the warranty. 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 Offeror shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e.

email blocks, quarantine). If the Offeror submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an Offeror to correct the document submission and the

Government will not inform the Offeror that the submission is non-responsive prior to award.

It is the Offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine).

Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

***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. ***

K. EVALUATION AND AWARD

The provision at 52.212-2, Evaluation—Commercial Products and Commercial

Services (Nov 2021).

Lowest Priced, Technically Acceptable (LPTA)

L. Instructions to Offeror(s)

Pricing shall include shipping and installation cost:

Site Preparation Information: Offerors shall include in their proposal any, and all site preparation information required for proper system operation and maintenance, including physical space, ventilation, and IT/network requirements.

Information Technology (IT) Purchasing Requirements:

NOTE to Contractor: Before a purchase order is awarded under this SOW, the FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA

Chief Information Officer (CIO). All software required must be approved on FDA’s Master

Approved Technology (MAT) list and comply with Office of Information Management and

Technology (OIMT) requirements. Software not already on the FDA MAT list may be considered but must be approved on MAT list prior to award. For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware (rack, network cables, power supplies/cords, etc.). This will require the applicable vendor to provide a complete list of hardware and/or software-firmware-freeware that the Vendor will use in fulfilling this order.

This list must include the following:

IT hardware: manufacturer, nomenclature and model number

Software (all types): manufacturer, nomenclature and version number

IT Accessibility and Section 508 Compliance

M. QUESTIONS DEADLINE:

Questions Deadlines: Interested Offerors shall submit questions electronically to Contract

Specialist (CS) Iris Johnson electronically to Iris.Johnson1@fda.hhs.gov no later than August

22,2023, 10:00 a.m. Eastern Time (ET). Please include the company name, FDA Solicitation number, and “Question(s)” in the subject line. No Phone Calls Will Be Accepted.

Quotes Due: Interested Offerors shall submit their RFQ to Iris Johnson (CS) electronically to

Iris.Johnson1@fda.hhs.gov no later than August 25, 2023, 10:00 a.m. ET.

mailto:Iris.Johnson1@fda.hhs.gov mailto:Iris.Johnson1@fda.hhs.gov

N. Provisions and Clauses

FAR 52.252‐2 Solicitation Provisions 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 and https://www.acquisition.gov/hhsar.

HHSAR

352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec

2015)

352.211-3 Paperwork Reduction Act (Dec 2015)

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec

2015)

352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

FAR

The following provisions and clauses apply: FAR 52.204-19 Incorporation by Reference of

Representations and Certifications; FAR 52.204-24 Representation Regarding Certain

Telecommunications and Video Surveillance Services or Equipment; FAR 52.204-25

Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or

Equipment; FAR 52.204-26 Covered Telecommunications Equipment or Services-

Representation; FAR 52.212-1 Instructions to Offerors Commercial Items; FAR 52.212-2

Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-

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 52.219-6 Notice of Total Small Business Set-Aside; FAR 52.222-3

Convict Labor; FAR 52.222-19 Child Labor--Cooperation with Authorities and Remedies; FAR

52.223-18 Encouraging Contractor policies to Ban Text Messaging While Driving; FAR 52.222-

21 Prohibition of Segregated Facilities; FAR 52.222-26 Equal Opportunity; FAR 52.222-36

Affirmative Action for Workers with Disabilities; FAR 52.232-33 Payment by Electronic Funds

Transfer—System for Award Management.

52.204-27 Prohibition on ByteDance Covered Application (Jun 2023)

(a) Definitions. As used in this clause—

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by

ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)— https://www.acquisition.gov/far https://www.acquisition.gov/hhsar

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a

Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023

(Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause)

O. FDA Invoice Submission Instructions

352.232-71 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.

P. 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. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, 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, or the clause 52.212-4

Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector

Account for submitting invoice requests for payment. The Contractor Government

Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to

IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

1. Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

2. Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other

Indirects)- show rate, base and total amount;

3. Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

4. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

5. Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

6. Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

7. Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the

Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of

God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC)

Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at

ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now

Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

***NOTE TO VENDOR***

Parties responding to this solicitation may submit their offer in accordance with the company’s 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) Unique Entity Identifier 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 FAR 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. A company may register by going to www.sam.gov.

http://www.sam.gov/