19-FDA-SOL-1215586.pdf

COMBINED SYNOPSIS/SOLICITATION FOR Computational whole heart modeling

SOLICITATION NUMBER: 19-FDA-SOL-1215586

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in 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.

The Food and Drug Administration intends to award a sole source firm-fixed price purchase order to Dassault Systemes Solidworks Corp., 175 Wyman St., Waltham, MA 02451-1223, in accordance with FAR part 13.106-1(b)(1)(i). This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13.

ii. The solicitation number is 19-FDA-SOL-1215586.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2019-05, Effective 13 Aug 2019

iv. The associated North American Industry Classification System (NAICS) Code is 541990 All Other Professional, Scientific, and Technical Services; Small Business Size Standard is $16.5 million.

v. The US Food & Drug Administration (FDA) intends to issue a Commercial Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes with the following:

a) Technical approach to complete the scope of work

b) Pricing for all line items utilizing ATTACHMENT B – Schedule.

c) Accessibility Conformance Report (ACR)

Provide information on the proposed solution’s conformance to Section 508 standards delineated in this solicitation. This shall be in the form of an Accessibility Conformance Report (ACR) for the entire solution and any other information that can assist the Government in determining the proposed solution’s conformance to FDA’s accessibility needs. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (VPAT 2.0 or later) provided by the Industry Technology Industry Council (ITIC).

Quoters should note that an ACR, completed to instructions, is required for the reviewing official to complete the technical evaluation. As such, the ACR must be completed and submitted as part of the quote for the Quoter to be considered for award. As part of the technical acceptability determination, the Government will review all information related to 508 submitted by the Quoter. Section 508 conformance of the proposed solution is based upon all information provided by the Quoter relevant to accessibility. The Government will evaluate:

- Submission of an ACR for the solution.

- Quality of the accessibility documentation provided. This includes the submission of an ACR to the instructions, inclusion of all applicable standards, and clarity of the information (including additional or supplementary information beyond the ACR) provided.

Quotes that do not price all line items may be deemed non-responsive.

Period for Acceptance of Offers: The offeror agrees to hold the prices firm for 30 calendar days after quote due date.

vi. Description

See ATTACHMENT A for statement of work (SOW). Appendix A – Project Plan will be provided after award.

ix. The provision at 52.212-2, Evaluation—Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under sections v) and vi) of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable.

A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

x. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov

2017), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

xi. The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Jan 2017), applies to this acquisition with the following addenda:

Invoice Submission:

FDA Three-Way Match Invoicing Procedures

A. 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 Technical Point of Contact (TPOC). The TPOC is indicated in the Government Points of Contact section.

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 -https://www.sam.gov/portal

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 award item number 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 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.

xii. In accordance with interim Rule FAR Case 2018-017 (FAC 2019-05), FAR Clause 52.212-5 Contract

Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Aug 2019), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition:

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.222-3 Convict Labor (June 2003) 52.222-19 Child Labor—Cooperation With Authorities and Remedies (Jan 2018) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2015) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.222-50 Combating Trafficking in Person (Mar 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513) 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008) 52.232-33 Payment by Electronic Funds Transfer— System for Award Management (Jul 2013)

(31 U.S.C. 3332)

xiii. Additional contract requirement(s) or terms and conditions

FAR/HHSAR PROVISIONS

FAR 52.212-1 Instructions to Offerors- Commercial Items (JAN 2017) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

FAR 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/.

https://www.acquisition.gov/

(End of Clause)

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

FAR CLAUSES

FAR 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/ and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html .

(End of Clause)

FAR 52.227-14 & Alt. IV (Dec 2007) Rights in Data – General (May 2014) FAR 52.227-17 Rights in Data -- Special Works (Dec 2007) FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.233-3 Protest after Award (Aug. 1996) FAR 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004)

FAR 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 contract. 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 within one day prior to the end of the period of performance.

(End of Clause)

FAR 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 prior to expiration of term provided that the Government gives the Contractor a preliminary written notice of its intent to extend at any time 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 two (2) years and six (6) months.

(End of Clause)

HHSAR CLAUSES

HHSAR 352.227-70 Publications and Publicity (December 18, 2015)

(a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor shall promptly send a copy of each article submitted for publication to the Contracting Officer’s Representative. The Contractor shall also inform the Contracting Officer’s Representative when the article or other publication is published, and furnish a copy of it as finally published.

https://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(b) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo including Operating Division or Staff Division logos on any publications.

(c) The Contractor shall not reference the product(s) or service(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

(d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract.

(End of clause)

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(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 electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping

Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and

Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

E207 Software E208 Support Documentation and Services E207 Software E208 Support Documentation and Services http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

xiv. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions shall reference solicitation number 19-FDA-SOL-1215586.

Questions must be submitted by September 4, 2019 by 2:00 PM EST to all point of contacts listed below.

All quotes must be submitted via email to the point of contacts listed below on or before September 11, 2019 5:00 PM EST.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

xv. Point of Contacts: Michelle Dacanay at Michelle.Dacanay@fda.hhs.gov.

Phillip Frame at Phillip.Frame@fda.hhs.gov mailto:Michelle.Dacanay@fda.hhs.gov mailto:Phillip.Frame@fda.hhs.gov