FINAL Sol_Doc 75F40123Q00103.pdf

Combined Synopsis/Solicitation: 75F40123Q00103

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 is 75F40123Q00103 and is being issued as a request for quotation RFQ. The NAICS Code for this solicitation is 334516-

Analytical Laboratory Instrument Manufacturing. The small business size standard is 1,000 employees. The requirement will be awarded as Firm-Fixed Price. 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 determine 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 Five (5) year maintenance service agreement for a SyncroPatch 384 system by Nanion

Technologies.

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

A. Background

Electrophysiology is the study of the electrical properties of cells and tissues in the body.

It involves recording voltage signals or current flow resulting from ions moving across ion channel proteins on the cell membrane. Because functions of excitable cells in the heart rely on the cells’ abilities to generate electrical signals, drugs and diseases that affect heart ion channels will alter cardiac functions, thereby disturbing the normal heart rhythm and potentially resulting in death. Electrophysiology method is thus employed in drug development programs to screen drug action on heart ion channels to predict unwanted consequences on the heart.

The Division of Applied Regulatory Science (DARS) has obtained an automated high throughput patch clamp system (HTS) SyncroPatch 384 manufactured by Nanion to characterize drug effects on heart ion channels. Traditionally patch clamp studies are conducted using manual patch clamp systems operated by experienced electrophysiologists. The manual method is low throughput and costly. To increase efficiency and reduce cost, the pharmaceutical industry and large contract research organizations have steadily moved toward using HTS for ion channel screens. Due to the complexity of SyncroPatch 384, maintenance and technical support by the manufacturer are required to keep this equipment functioning properly and operate as needed. This instrument was installed in December 2021 and is currently under warranty for all maintenance and technical support.

https://www.acquisition.gov/far/subpart-12.6#FAR_Subpart_12_6

B. Scope

The requirement is for a five (5) year maintenance service plan including biannual (twice a year) preventive maintenance service, replacement of consumables, twenty-four (24) hour technical support for application and troubleshooting, to include remote diagnostic, and on-site support.

C. Technical Requirements

The service provider shall provide the following:

a) Remote Diagnostics and Support services;

b) 2 preventive maintenance visits per year;

c) Priority callout time - maximum 3 business days;

d) Included spare parts;

e) Included labor and travel time for field service engineers;

f) Included Nanion software upgrades;

g) Refurbishment of one external electrode board;

i) Any additional service discount that can be applied for standard;

j) 24-hours technical support premium application services.

D. Service Records

The Contractor shall, commensurate with the completion of each service call, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment/software being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components repla

1. Delivery Requirements:

Thirty (30) Days After Receipt of Award

2. Period of Performance shall be for a Base Period of one year and 4 one year

Option Periods.

E. Warranty

Shall include a minimum of one (1) year comprehensive parts and labor warranty from the date of installation and acceptance.

F. Delivery and Installation

The installation shall take place at the following location:

The U.S. Food and Drug Administration

White Oak Campus; Building #64, Rm 2073

Attn: TBD

10903 New Hampshire Avenue

Silver Spring, MD 20993

Unless otherwise specified, services shall be rendered at the Service Location specified above, Monday through Friday (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. ET. In case of emergency, and agreement on part of FDA escorting personnel, repairs can occur on federal holidays if essential.

G. Inspection/Acceptance:

FOB: Destination Inspection/Acceptance: Destination

H. Pricing Schedule

The Contractor shall provide the requested services using the pricing schedule as provided below:

Line

Item

Number

Item

Description

QTY List Price

U.S. Dollar

(USD)

Subtotal

(USD)

1 Base

Period

SyncroPatch Premium

Service Plan annually $ $

Option

Period 1

Option

Period 2

Period 3

Period 4

Total Value $

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

All Contract Line Items are firm-fixed price.

I. 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.

J. 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.

K. 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. ***

L. EVALUATION AND AWARD

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

Services (Nov 2021).

Lowest Priced, Technically Acceptable (LPTA)

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 mailto:Iris.Johnson1@fda.hhs.gov later than 21 August 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 25 August 2023, 10:00 a.m.

ET.

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 52.212-3 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 52.222-3 Convict Labor; 52.219-6 Notice of

Total Small Business Set-Aside; 52.219-8 Utilization of Small Business Concerns;

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.

mailto:Iris.Johnson1@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/hhsar

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)—

(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)

52.211-6 Brand Name or Equal (Aug 1999)

52.217-5 Evaluation of Option (July 1990)

52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the award. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor.

The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor before award expiration.

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the

Contractor before expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed _60 months.

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. 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.

1. 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.

2. 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.

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

4. 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).

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

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 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/