Drug Quality Security Act (DQSA) Support and Implementation Services

The purpose of amendment no. 1 is to edit the instructions to interested vendors and extend the due date. THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response. The objectives of this Sources Sought notice are to: a. Obtain additional Drug Quality Security Act (DQSA)/Pharmaceutical/FDA specific information regarding potential vendor capabilities b. Determine the need for and extent of potential teaming c. Determine extent of small business expertise in the marketplace d. Determine the appropriate acquisition contract vehicle for the DQSA requirement. Specifically, Food and Drug Administration (FDA) seeks to acquire contractor support for policy development regulatory, pharmaceutical supply chain, data management, modeling and simulation, data science, technical, communications and training experience to evaluate the impact of DQSA on existing programs and processes, identify new processes and/or systems required to implement the provisions of DQSA. The Contractor shall provide technical support in the following areas: 1. Policy/Regulatory Support 2. Pharmaceutical Supply Chain Assessments/Pilots 3. Regulatory Business Process Development 4. Modeling and Track and Trace 5. Systems Support 6. Training 7. Communications BACKGROUND On November 27th, 2013, the President signed H.R. 3204, the DQSA into law to grant the Food and Drug Administration (FDA) more authority to regulate and monitor the manufacturing of compounded drugs and provisions to secure the drug supply chain as they are distributed in the United States. The regulatory responsibilities of the FDA are outlined in Title I - Drug Compounding and Title II - Drug Supply Chain Security. The provisions within the titles need to be fully implemented by 2023 and are ordinarily the responsibility of the Center for Drug Evaluation and Research (CDER) to define, implement and regulate with the assistance of the Center for Biologics Evaluation and Research (CBER), the Office of the Commissioner (OC) and the Office of Regulatory Affairs (ORA ). The specific subsections of each title are summarized below: Title I - Drug Compounding: Title I requires certain compounding facilities to register, undergo inspections, submit adverse event reports, and pay user fees. Compounding facilities that elect to register as an outsourcing facility must do so annually. FDA must make available on the public internet the names of all registered outsourcing facilities, which state they are located in, whether they compound from bulk substances and if they are for sterile or non-sterile drugs. In addition, each outsourcing facility must provide a report to FDA electronically twice annually identifying the drugs compounded during the six-month period. Outsourcing facilities will be inspected at least every four years utilizing a risk-based schedule that will consider the compliance history of the facility, recalls linked to a facility and the inherent risk of the drugs compounded. Also, outsourcing facilities must submit adverse events reports as defined by FDA for DQSA or existing regulations. Finally, beginning in fiscal year 2015 and every subsequent year, outsourcing facilities must pay an establishment fee and re-inspection fees as determined under DQSA and all fees assessed by FDA must be reported to Congress within 120 days after each fiscal year. Lastly, FDA must communicate with State Boards of Pharmacy including receiving submissions submitted by State boards of pharmacy and notifying State boards of pharmacy if FDA determines a pharmacy is not compliant with FDA regulatory requirements. Title II - Drug Supply Chain Security: Title II contains provisions to help secure the drug supply chain and requires FDA to define and regulate a framework for identifying certain prescription drugs and tracing their transaction history as these products move throughout the supply chain from the manufacturer to dispensers. To operationalize such a framework will require FDA to develop data exchange standards, industry guidance, regulations, execute pilots, and implement licensing programs. In addition, FDA is required to hold at least five public meetings, solicit and respond to public comments and define other processes for waivers, exceptions and exemptions to support an effective implementation of the law. The law defines timelines and requirements for lot based tracing and serialized product handling. In 2015 manufacturers must implement lot level traceability (either paper or electronic); in 2017 manufacturers must provide electronic lot level tracing, manufacturers must serialize all trade products and manufacturers must be able to verify suspect & saleable returns; in 2020 wholesalers must accept only serialized products and wholesalers must verify suspect or saleable returned products; by 2023 Section 203 of Title II requires Enhanced Drug Distribution Security be operational, which includes the interoperable, electronic tracing of a product at the package level by all participants of the supply chain, unless they are granted a waiver, exception or exemption. Implementing all the requirements of DQSA by 2023 is very complicated. It will require detailed planning to identify all the tasks, interdependencies among them and the technical, legal and privacy requirements that will need to be addressed. DQSA will require many deliverables across the spectrum of new regulatory processes, technical assistance, data standards and interoperability, enhancements to existing and new systems and databases, information exchange with the states, communication and outreach to all stakeholders, e.g. manufacturer, wholesalers, re-packagers, third party logistic providers, dispensers, states, foreign regulators, etc. In addition, FDA will need to provide accurate and complete data to the public and reports to Congress. Furthermore, it requires FDA to implement and verify new user fees, develop risk-based schedules for inspections and be to track and trace products throughout the supply chain using electronic transaction data to identify supply chain vulnerabilities and take action on suspect or illegitimate products. To meet this broad spectrum of requirements will require specific activities to be performed with resources that possess program management, policy development, regulatory, pharmaceutical supply chain, data management, modeling and simulation, data science, technical, communications and training experience. CDER is currently developing and implementing a comprehensive suite of strategic capabilities aimed at streamlining and enhancing the Center's regulatory, surveillance, compliance, and enforcement oversight of drugs and biological therapeutics. This is being accomplished through a single platform with four (4) strategic capabilities. The four (4) strategic capabilities include: Electronic Submissions: The goal of this capability is to improve and streamline the electronic submission process to provide CDER reviewers with valid submission content and data. Systems and business processes are enforced in this area to ensure the secure submission and processing of electronic submissions. Integrated Data Management (Integrity): The objective of this capability is to establish a single source of regulatory data and act as the foundation upon which the master data is managed and distributed for all regulatory and compliance decision-making purposes. The key role is to provide a single source of master data to be used across all of CDER's business domains (e.g., facilities, sponsors, products, applications) to improve the overall quality, accuracy and consistency of data across CDER's systems. Integrated Work Management (Panorama): The goal of this capability is to improve the way cross-functional teams manage measure, execute, track, and report on work commitments throughout the Center to help achieve business strategies. The capability provides CDER users a seamless user experience by leveraging single user interfaces through which they can access CDER's strategic capabilities and supporting tools. Business Intelligence and Publishing (Mercado): The objective of this capability is to help CDER make data driven decisions, meet organizational goals and respond to congressional requirements. The Mercado capability offers an integrated marketplace for regulatory data that provides business intelligence to various CDER offices. This capability is comprised of a data warehouse with powerful analytics tools e.g. flexible querying, reporting and analysis. Each strategic capability is comprised of a number of "functions" supported by the following enabling COTS tools: - Web Layer: Oracle HTTP Server 11g. Oracle HTTP Server 12c, Citrix management, IBM Web Sphere Portal - Application Layer: Oracle WebLogic Server 11g, (v.10.3.6), Oracle WebLogic Server 12c, (v.12.1.3), Informatica PowerCenter 9.6.1, Informatica PowerCenter 10.1, Informatica Multi-Domain MDM 9.7.1, Informatica Multi-Domain MDM 10.2, Informatica Data Quality 9.6.1, Informatica Data Quality 10.1, RedHat Drools 5.4, Guvnor 5.4, Tomcat Application Server 7.0.26, WorkFront H4, Address Doctor 5.6, Duns & Bradstreet Direct 2.0, SequeLink 6.0, Solr 4.0.7, Solr 6.1, Tableau 9.1, Tableau 10.1, Oracle OBIEE 12c, Oracle WebLogic Server 12c, (v.12.1.3), Exalytics X-4-4: Oracle OBIEE 11.x, ZooKeeper, Tomcat Application Server 7.x, IBM Operational Decision Manager (ODM) 8.6, RedHat Drools 5.4, Guvnor 5.4 - Integration: IBM Message Broker, IBM Datapower, API Management - Data Layer: Oracle ExaData: X5-2 Quarter Rack EF 1.6TB ,, X5-2 Half Rack EF 1.6TB,, Oracle RDBMS 11g, version 11.2.0.4 , Oracle Client 11.2.0.4, Exalytics Timesten database 11.2.2.7.8, Oracle RDBMS 12c. Please note: In an effort to satisfy this DQSA requirement, vendors will be required to work and / or configure these tools to become compliant with the standards set forth in the Act. INSTRUCTIONS FOR INTERESTED VENDORS 1. Interested vendors shall fill out information in the attached MS Excel Spreadsheet. 2. Interested parties having the capabilities to perform the stated requirements in the Excel Spreadsheet may submit supporting information further demonstrating their capabilities. Responses shall be limited to 15 pages. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses must be received no later than April 3, 2017, 4:30 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Jody OKash at Jody.OKash@fda.hhs.gov.