SOLICITATION NOTICE
D -- SimCYP® licenses
- Notice Date
- 8/29/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- #511210
— Software Publishers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1185423
- Archive Date
- 9/22/2017
- Point of Contact
- Michele E. Andrews, Phone: 240-402-7522
- E-Mail Address
-
michele.andrews@fda.hhs.gov
(michele.andrews@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Combined Synopsis/Solicitation for Commercial Items prepared in accordance with the format in FAR Subpart 12.6. This is solicitation number FDA-SOL-1185423 and is being issued as a Request for Quotation (RFQ) announcement which constitutes the only solicitation that will be issued; quotes are being requested and a written solicitation will not be issued. This requirement is being solicited as a Brand Name or Equal in accordance with FAR 52.211-6 and the Government contemplates a Firm-Fixed Price Purchase Order will result from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95 dated January 13, 2017. This is a requirement for license renewal for SimCYP® licenses. The associated North American Industry Classification System (NAICS) Code is 511210. It's associated Small Business Size Standard Size in millions of dollars is $38.5. This contract will be awarded with a base year plus one option year. 1.0 Introduction The Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research is requesting an annual license renewal of the SimCYP® software they are currently utilizing. SimCYP is a population-based physiologically-based pharmacokinetic (PBPK) modeling and simulation software, developed by SimCYP Limited. The software provides a user-friendly platform for clinical and non-clinical pharmacologists to readily input data gathered from preclinical and clinical phases. The resulting PBPK model allows users to conduct mechanistic modeling and simulations to address a variety of important clinical and nonclinical pharmacology questions. OCP reviewers have been using and applying the outcomes of this tool for 9 years and it is essential to CDER's projects and review process. These exercises include the use of the software in a dozen IND and NDA submissions by different sponsors and in decision making process by OCP reviewers during review. In addition, OCP reviewers have applied the software to support the update of regulatory guidance documents, such as drug-drug interaction guidance and renal impairment guidance. This request supports the overall drug safety program and critical path initiative of the FDA. More importantly, if the sponsors send submissions using SimCYP®, it will be the only tool the FDA can use to evaluate and make decisions. 2.0 Background CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. Drug companies include reports using SimCYP software in Investigational New Drug and New Drug Applications (INDs and NDAs). Such data must be analyzed/verified by FDA clinical pharmacology reviewers using the same tool, and SimCYP is the only software available for this purpose. Besides its state-of-the-art modeling and simulation capability, the software hosts a comprehensive database on human anatomy and physiology and a library of drug disposition parameters, which are updated annually. This is highly specialized, niche market software with no competition. 3.0 Description and Schedule of Pricing The software renewal needs to include the following: 4 - Simulator Licenses Node 4 - Simulator Licenses Float 20 - Workshop Seats 1 - Paediatric Simulator Licenses Node 1 - Paediatric simulator Licenses Float 1 - CCS Node Licenses Manufacturer Description Quantity Price SimCYP® Base Year: September 21, 2017 to September 20, 2018 4 - Simulator Licenses Node 4 - Simulator Licenses Float 20 - Workshop Seats 1 - Paediatric Simulator Licenses Node 1 - Paediatric simulator Licenses Float 1 - CCS Node Licenses 1 SimCYP® Option Year: September 21, 2018 to September 20, 2019 Renewal of: 4 - Simulator Licenses Node 4 - Simulator Licenses Float 20 - Workshop Seats 1 - Paediatric Simulator Licenses Node 1 - Paediatric simulator Licenses Float 1 - CCS Node Licenses 1 Grand Total 4.0 Salient Characteristics The vendor shall provide software with the following capabilities: • Support strategic decision-making: It provides valuable information relating to clinical trial design and can help obtain clinical trial waivers. • Save time and money: The automated prediction of in vivo outcomes accelerates the assessment of large numbers of compounds. • Optimize drug labels: In recent years, it was used by clients to perform 66 drug-drug interaction (DDI) studies virtually. • Gain access to leading edge R&D: It is the result of more than 12 years of collaboration with a Consortium that now includes leading pharma companies, academia, and major regulatory bodies in an ongoing development program. • Decrease risk to patients: It helps identify individual's whose genetic and physiological characteristics place them at greatest risk of adverse drug reactions. • Easy to use: It has an intuitive user interface. Users gain proficiency quickly through attending training workshops. Functionality includes: • Automated in vitro extrapolation to predict in vivo outcomes, supporting the assessment of large numbers of compounds metabolized by multiple enzymes • Incorporates inter-subject physiological variability • High speed, user-friendly desktop application • Batch processing facility • Transparent algorithms and methodology and easily understood visual outputs through a variety of graphical interfaces • Incorporates leading edge science with continually updated databases • Consortium members guide the development of the Simcyp Simulator and share ‘best practices' • Users are supported by scientific and technical teams Modules included with the Simcyp Simulator are Simcyp pediatric and animal that addresses science of virtual population modeling related to absorption, distribution, drug metabolism, prediction of clearance, prediction of drug-drug Interactions. The Contractor shall provide maintenance and help desk/technical support to ensure the software licenses are functioning as expected. This includes: • Telephone access to technical expertise, Monday through Friday, from 9 - 5 ET. Technical support shall be available either on-line or by telephone. • An account manager to assist with the specific account • Requirements tracking to track any issues that are identified • Upgrades as patches and new versions of the software become available • Access to software and upgrades via the internet • Access to user guides and technical specification via the internet • The tools and license support must also include user support services and the capacity to add users without change in functionality. The Contractor shall provide timely notification of new releases of all tools and provide all updated software, documentation, and training materials in addition to specific management and administrative requirements described. All software keys and other associated deliverables shall be provided to the FDA in electronic form for installation and maintenance. • Escalation procedures that may require on-site Contractor assistance shall be at no cost to the Government. 5.0 Deliverables Vendor will provide license renewal, as well as annual maintenance and support. Delivery method is via download. The contractor shall provide the licenses as specified in 3.0 Description and Schedule of Pricing. 6.0 Inspection and Acceptance The COR will perform inspection and acceptance of all products. The performance criteria for these products shall be timely delivery of all deliverables listed above and within the established Period of Performance. 7.0 Period of Performance The period of performance shall be: Base Year: September 21, 2017 through September 20, 2018 Option Year: September 21, 2018 through September 20, 2019 8.0 Contracting Officer's Representative (COR) The COR will be designated by the Contracting Officer at award. 9.0 Provisions and Clauses Provisions: 352.239-73 - Electronic Information and Technology Accessibility Notice (DEC 2015) 52.211-6 - Brand Name or Equal (Aug 1999) The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply. HHSAR Clauses can be viewed in full text at: http://www.hhs.gov/policies/hhsar/subpart352.html#subpart352.1-- InstructionsforUsingProvisionsandClauses 352.203-70 - Anti-Lobbying (DEC 2015) 352.222-70 - Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015) 352.239-74 - Electronic Information and Technology Accessibility (DEC 2015) The below Federal Acquisition Regulation (FAR) Clauses apply. FAR Clauses can be viewed in full text at: http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482 52.212-4 -- Contract Terms and Conditions -- Commercial Items (May 2015) 52.227-19 - Commercial Computer Software License (Dec 2007) 52.232-39 - Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 -- Providing Accelerated Payment to Small Business Subcontractors (Dec 2013) 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the additional FAR clauses cited are applicable to the acquisition: 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2016); 52.204-14, Service Contract Reporting Requirements (Oct 2016); 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015); 52.219-28, Post Award Small Business Program Representation (Jul 2013); 52.222-3, Convict Labor (June 2003); 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Oct 2016); 52.222-21, Prohibition of Segregated Facilities (Apr 2015); 52.222-26, Equal Opportunity (Sep 2016);52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014); 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) ; 52.222-50, Combating Trafficking in Persons (Mar 2015); 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011); 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014); 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008); 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013). 10.0 Invoicing Invoicing instructions will be provided at time of award. 11.0 Section 508 Compliance Requirements Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR). Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 FR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products. The following Section 508 provisions apply to the content identified in this SOW: § 1194.21 - Software applications and operating systems § 1194.22 - Web-based intranet and internet information and applications § 1194.41 - Information, documentation, and support 12.0 Order of Precedence The Contractor shall following the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor's document, the Order of Precedence shall be as specified in FAR Clause 52.212-4, dated May 2015. Any governing law language appearing in any Contractor terms or conditions shall be treated as null, void and stricken. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order (not the Schedule). The Contractor shall provide all terms and conditions with their quotations as attachments, appendixes, etc. In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence. 13.0 Instructions to Quoters Respondents are responsible for delivery via email before 3:00 PM EST on September 7, 2017 to Michele Andrews at michele.andrews@fda.hhs.gov. Questions shall be emailed to Michele Andrews by 3:00 PM EST, August 31, 2017. Quoter shall certify their quotes to be valid for 60 days. Incomplete pricing or pricing with omissions may not be considered for award. All quotes will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. FDA anticipates that this contract will be firm fixed price. Quoters shall submit one (1) copy of their quotation with pricing information. Equal to quotes must meet all the salient characteristics in order to be considered technically acceptable. If the part numbers are different from the vendors' part numbers, Quoters shall map their part numbers to the vendor's part numbers. Compatibility: FDA is purchasing this equipment on a "Brand Name or Equal" basis. In order to be considered an "equal" solution, an alternative solution must be compatible with the equipment already owned by FDA.Maintenance provided shall not void any warranties, usage terms and conditions of the FDA's perpetual licenses. For the purposes of this RFQ, FDA defines compatible as meaning that there will be no communication, performance, maintainability issues in the interconnection of solutions with different configurations. Equal to quotes must submit a separate Technical quote with detailed point-by-point description of how the equal to product meets all the salient characteristics of this SOW. Quotes with the specified Oracle Software license and maintenance service meeting all the salient characteristics of this SOW is not required to submit a separate Technical Quote. Technical quotes shall not contain pricing information. All Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits. Quoters shall submit Product Accessibility Templates (PAT) in full text with their quotations. Quoters providing quotations must clearly state the overall cost to the Government. Quoters shall submit all assumptions in their quotation. The Quoter shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the Original Equipment Manufacturer (OEM). Quoters are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deemed as technically unacceptable and as such not be considered for award. Quoters shall submit the terms and conditions in full text with their quote. Quoters are advised to provide their best prices in their quotation. The Government does not intend to have communications to allow revision of the quotation. But the Government reserves the right to communicate with Quoters should the Government determined it is necessary for quotation revisions prior to award. 14.0 Award Determination All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made To the lowest price quoter that demonstrates they can meet all the requirements of this solicitation. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. Incomplete quotations will not be considered for award.
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