Sol_Doc.docx

FDA-RFQ-20-1227081 Annual Maintenance of Lhasa Nexus (Derek, Meteor, and Sarah), Vitic, and Zeneth

OR EQUAL

COMBINED SYNOPSIS/SOLICITATION

Date: May 26, 2020

Product or Service Code: 7030, Information Technology Software

Subject: Lhasa Knowledge Suite Nexus (Lhasa Membership, Derek, Meteor, Vitic, Sarah Nexus, and Zeneth, Unlimited number of PC’s) Brand Name or Equal Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-20-1227081

Quotes Due By: Thursday, May 28, 2020 at 10:00 AM Eastern Time (ET) via email to Michele.Andrews@fda.hhs.gov.

Government Point of Contact: Michele Andrews Contract Specialist Michele.Andrews@fda.hhs.gov Phone calls not accepted

Set-Aside Status: This requirement is not being set-aside for small business.

Description:

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, 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.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97 / 01-24-2018.

This requirement is not being set-aside for small business. The NAICS code for this requirement is 511210, Software Publishers Small Business size standard: $38.5 million

Items required:

Full Membership of Lhasa Knowledge Suite Nexus (Derek, Meteor, Vitic, Sarah Nexus, and Zeneth, Unlimited number of PC’s) OR EQUAL with software maintenance, technical support, and 4 option year license subscription renewal with software maintenance and technical support.

Description of required items:

Background

The Center for Tobacco Products (CTP), Office of Science (OS), Division of Regulatory Science Informatics (DRSI) on behalf of OS is interested in evaluating the toxicological effects of thousands of chemical components found in tobacco products. Within OS, the Division of Noncinical Sciences (DNCS) is the primary end user of this software. Given the paucity of in vitro and in vivo data for these chemicals, DNCS has turned to in silico, or computational, methods to analyze the related toxicological endpoints. The analyses of these chemicals must include: identification of structure-activity relationships (SAR) between different compounds and related substructures, quantitative predictions of the toxicological endpoints for those SAR, identification of metabolite and degradative products, and incorporation of a high-quality expert-knowledge base to ensure an accurate and statistically robust computational model. Lhasa Limited, a not-for-profit organization, provides a variety of chemoinformatic software that represents a consortium of knowledge between public sources and data supplied through private, member organizations that are not available through other software companies. The Lhasa Limited Nexus suite (DEREK, Meteor, and SARAH) of software products provides an expert knowledge-based decision-support system all integrated and compared to competitor products the most rigorously validated in the scientific literature for performing predictions on the toxicity from parent, metabolite and forced degradation compounds, while also complementing the expert-based process with statistical (Q)SAR predictive outcomes. This generated internal data is then stored in an internal database for ease of future use. Unlike other predictive toxicity software, this software suite provides the user with the unique ability to edit the knowledge base to reflect the chemistry being analyzed (i.e. tobacco constituents), providing more targeted and specific analyses of substructures or pattern attributes to ensure more accurate computational prediction. Additionally, Lhasa Limited’s Zeneth software is the only commercially available software system that predicts forced degradation products. As the products evaluated by DNCS will be heated to temperatures capable of catalyzing forced thermal degradation, this software is imperative in determining chemical products of these reactions that can affect toxicological outcomes. Vitic is a toxicity knowledge base that is developed through data and knowledge contributions from the members of Lhasa Ltd.’s consortium. As such, it contains higher quality toxicity data than what is publicly available or available from other vendor’s software that is not developed from scientific data sharing on a pre-competitive basis as is the Lhasa product. The pairing of expert knowledge with validated, quantitative toxicity predictions of parent, metabolite and forced degradative compounds through these software is critical for CTP/OS/DNCS for data mining and to integrate the expert knowledge available from Lhasa Ltd.’s products in order to support assessments on the complex toxicological effects from the thousands of chemicals used in tobacco products.

Objective

CTP’s objective is to provide annual maintenance of Lhasa Knowledge Suite Nexus (Derek, Meteor, Vitic, Sarah, and Zeneth), or equivalent, to enhance the CTP/OS/ DNCS capability in toxicology data mining and assessment of potential toxicity of chemicals used in tobacco products for which no or only limited toxicology data is available.

Salient Characteristics and Functional Specifications

3.1 Software

The contractor shall provide software licenses required to perform all of the following salient functional characteristics:

· Make predictions for various toxicological endpoints with an expert rule or knowledge-based computer software system that uses pre-built chemical structure-activity relationships (SAR), and in addition, another system that predicts mutagenicity using pre-built statistical quantitative structure-activity relationships (QSAR) models of chemicals with fragment-based methodology providing a confidence score. The knowledge-base for the SAR system and training sets for the QSAR model system need to be based on expert-curated data and consistent with the principals of the Organization of Economic Cooperation and Development for QSAR validation http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2007)2

· Make predictions of toxicity using non-quantitative SARs for the following endpoints.

· Carcinogenicity

· Mutagenicity

· Genotoxicity

· Skin Sensitization

· Teratogenicity

· Irritation

· Respiratory Sensitization

· Reproductive Toxicity

· Negative predictions for SAR relationships of mutagenicity and skin sensitization for chemicals with a verifiable scientific rationale.

· SAR predictions of chemical toxicity need to show the specific structural toxicity alerts as a 2-dimensional chemical structure, the rationale for the predictions and literature references to support the toxicity alert.

· Ability to build a hierarchy of statistical QSAR models

· Prediction of metabolic fates of chemicals covering both phase I and phase II reactions based on a knowledge base and reasoning methodology, and provide graphics for visualizing the data (e.g., metabolic trees), and the ability to perform toxicity predictions of the generated metabolites seamlessly within the same graphical user interface.

· Ability to make predictions of forced degradation pathways of organic compounds based on chemical structure and chemistry reactions under varying temperature conditions

· Toxicity data searching of a large chemical database that contains at least 300,000 toxicity data records for at least 20,000 structures curated and updated by experts using peer-review practices at least once a year.

· Provide technical training and scientific support on use, and interpretation of the how the predictions are generated by the software programs.

3.2 Compatibility: The computational models of the software to be purchased should be compatible to in-house data for custom-model building through use of a knowledge editor. It must also be compatible with existing installation of Lhasa products in use by DNCS users in CTP/OS.

3.3 License type: Should allow unlimited users located at one primary site.

3.4 Maintenance: 12 months standard maintenance is included with the software license.

Delivery

The Contractor shall deliver the software licenses electronically via secure e-mail to the COR (TBD at award) with license activation code within 72 hours of purchase.

Inspection and Acceptance Criteria

The COR/designee will load the software and licensing to verify that the software is functioning properly. The COR/designee will inspect and verify that the software is operational, functional and compatible with FDA server and software. The COR/designee will provide written notification of acceptance or rejection within 10 days of receipt. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR/designee of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

Period of Performance for the Software Maintenance and Technical Support

Software technical support and maintenance shall be for 12 months from award.

The option year period of performance shall be 12 months from option exercise, which is expected to be on or about the date of base year expiration.

Contract Type

Firm fixed price Government Points of Contact

Contracting Officer:

Michele Andrews Michele.Andrews@fda.hhs.gov

Contracting Officer’s Representative:

To be Provided at time of award.

Period of Performance

Base: 05/29/2020 – 05/28/2021 Option Period 1: 05/29/2021 – 05/28/2022 Option Period 2: 05/29/2022 – 05/28/2023 Option Period 3: 05/29/2023 – 05/28/2024 Option Period 4: 05/29/2024 – 05/28/2025

Clauses

The following clauses apply to this acquisition. For instructions regarding requirements of the clauses as part of the quoter’s submission, see Section 11.

1.1 FAR Clauses

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):

FAR: https://www.acquisition.gov/?q=browsefar HHSAR: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Jul 2019)

52.212-4, Contract Terms and Conditions -- Commercial Items. (Jan 2017) 52.225-5, Trade Agreements (Oct 2016) 52.232-40, Providing Accelerated Payments to Small Business subcontractors (Dec 2013)

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items. (Aug 2019)

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

_X_ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

_X_ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

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 within 1 day of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 3 days 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 24 months.

(End of clause)

1.2 HHSAR Clauses

352.203-70 Anti-Lobbying (December 18, 2015) 352.208-70 Printing and Duplication (December 18, 2015) 352.211-3 Paperwork Reduction Act (December 18, 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) 352.224-70 Privacy Act (December 18, 2015) 352.224-71 Confidential Information (December 18, 2015) 352.227-70 Publications and Publicity (December 18, 2015)

352.239-74 Electronic and Information Technology Accessibility (December 18, 2015) For this clause, the phrase “information and communication technology (ICT”) shall be substituted for “electronic and information technology (EIT)”.

(c) The Section 508 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 (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

Appropriate Technical Performance and Technical Requirement from Appendix C

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

Per 339.203-70 Contract Clauses for Electronic and Information Technology (EIT) Acquisitions

(a) The contracting officer shall insert the provision at 352.239-73, Electronic and Information Technology Accessibility Notice, in all solicitations.

(b) The contracting officer shall insert the clause at 353.239-74, Electronic and Information Technology Accessibility, in all contracts and orders.

The following provisions apply to this acquisition. For instructions regarding requirements of the provisions as part of the quoter’s submission, see Section 11.

10.3 FAR Provisions

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):

FAR: https://www.acquisition.gov/?q=browsefar HHSAR: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation (Jan 2017) 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) 52.204-26 Covered Telecommunications Equipment or Services-Representation (Dec 2019) 52.211-6, Brand Name or Equal (Aug 1999) 52.212-3, Offeror Representations and Certifications -- Commercial Items. (Nov 2017) 52.217-5, Evaluation of Options (July 1990) 52.212-1, Instructions to Offerors -- Commercial Items (Jan 2017)

1. HHSAR Provisions

352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015) For this provision, the phrase “information and communication technology (ICT”) shall be substituted for “electronic and information technology (EIT)”.

Instructions to Quoters

The quoter shall follow the instructions below in order to be considered for award (See Section 10, Clauses and Provisions, for reference):

1) Follow instructions at FAR 52.212-1.

2) Submit a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items, with their quote.

3) Ensure the submitted quote meets all technical requirements of the solicitation and contains the best terms from a price standpoint. Equal to Quotes MUST submit a detailed point-by-point description of how the equal to product meets EACH of the salient characteristics of this solicitation. Quoters submitting brand name items identical to those identified in this solicitation need not identify each salient characteristic.

4) Submit pricing for each item requested, including the discount offered to FDA and total final price. Quotes shall clearly state the overall cost to the Government, including options. Quotes shall identify unit item pricing for each item identified in Section 3 of this solicitation.

5) Submit a written Accessibility Conformance Report (ACR) for each ICT item (software and electronic documentation, as applicable) addressing the level of conformance of the delivered items to the 508 standards identified in Section 9.2, 352.239-74) (c). The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). To be considered for award, the ACR must be complete, and submitted according to the instructions provided by ITIC.

NOTE: Submission of the ACR is required for documentation purposes. In accordance with agency purchasing procedures, solutions which do not conform fully to the applicable 508 standards may still be purchased by FDA if the FDA Requiring Office obtains the appropriate approval. In order to obtain approval, the FDA must have an ACR from the vendor documenting the level of conformance of the items being purchased.

6) Submit all assumptions in the quotation including all applicable terms and conditions.

The FDA intends to evaluate quotes and award without communications. However, the government reserves the right to conduct communications if later determined by the Contracting Officer to be necessary. Incomplete pricing or pricing with omissions may not be considered for award.

Basis of Award

The FDA will evaluate all quotes received in response to this RFQ by using the lowest-price-technically-acceptable (LPTA) methodology. FDA will issue the award to the Quoter whose proposed solution meets all technical requirements, including the Terms and Conditions identified within the solicitation, and whose overall price is lowest. Quotes must meet all requirements of this solicitation in order to be considered technically acceptable, and the submitted ACR must be complete and submitted according to the instructions provided by ITIC. “Equal to” quotes must demonstrate a detailed point-by-point analysis of equivalence to each salient characteristic identified in order to be deemed technically acceptable. Quoters are advised that additional terms and conditions submitted with their quotation that are in conflict of the terms and conditions of this solicitation may be deemed technically unacceptable and may not be considered for award. The Quoter shall be an authorized reseller and/or servicing agent of the software manufacturer while performing on this contract. Past performance will not be evaluated.

The Quoter shall be an authorized reseller and/or servicing agent of the software manufacturer while performing on this contract.

The government intends to award a single purchase order to one vendor.