Attach_1_SOW_16-223-SOL-00019.docx

Food and Drug Administration

Attachment 1 Statement of Work for the Scientific Computing Support - Indefinite Delivery Indefinite Quantity (IDIQ) FY16

Version 3.0 1 March 2016

Table of Contents

Introduction Background The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation’s public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA also protects and promotes the health and safety of animals by assuring the availability of safe animal drug products and food. FDA decisions must be based on the best available scientific data and use the best tools and methods available in order to ensure products meet the highest quality standards for consumers, while fostering and advancing innovation in the products it regulates.

In support of its regulatory mission, FDA conducts scientific research concerning vaccines, blood products, drug safety, food and food safety, food and color additive review, micro-analytical evaluations, cosmetics, colors certification, veterinary medicine, tobacco products, toxicology, medical devices and radiological products as well as method development and method validation for regulatory laboratories and other scientific research. It also supports new technologies (such as genomics and proteomics) with traditional toxicological data, and it analyzes and visualizes these data to formulate new regulatory standards. Individual FDA Centers often leverage their resources by conducting integrated research programs with other FDA Centers and Offices and through collaborative agreements with government agencies, academia, and industry.

More so than ever before, FDA’s science is data-centric, complex, and collaborative, involving multidisciplinary groups. FDA researchers and other scientists increasingly rely on computationally-intensive methods, high-performance computing (HPC) and cloud- based services for storing, managing, manipulating, and analyzing large datasets.

Scientific computing support is essential to enable the Agency to leverage internal and external knowledge bases, databases, data mining tools, and scientific expertise to inform regulatory decisions. FDA continues to develop and modernize its scientific computing tools and infrastructure in order to keep up with the increasing complexity of FDA‘s regulatory and public health initiatives portfolio.

Recent FDA scientific computing projects include but are not limited to:

· Scientific Enclaves, which are used as a secure web environment for collaboration purposes both within FDA and with external partners outside of FDA or HHS; and,

· Investigating the use of Cloud computing to address some of the Scientific Community’s requirements.

These projects illustrate FDA’s commitment to developing and modernizing its scientific computing environment. FDA requires a contractor that has a deep understanding of both the high-end technologies involved and the scientific efforts, environments, and requirements supported.

Scientific Computing at the FDA Scientific computing is any process dependent directly upon information technology components that results in the generation, access, analysis, storage, or transmittal of scientific data.

FDA scientific computing includes those computing devices, instruments, environments, processes, services, software applications, and specialized configurations that do not fit into the FDA “administrative” computing support model. Typical administrative computing support services are designed around standardized configurations and do not meet the requirements of specialized scientific computing configurations and operations. Scientific computing assets are often non-standard, exceptions, or so specialized that the administrative computing support model is unable to practically support or maintain them.

Some scientific computing assets are located in the data centers and a significant number are in laboratory and office environments. They are non-standard due to the nature of the tasks or functions they are required to perform. For example, they may be vendor- provided, configured and attached to sophisticated laboratory equipment; they may use proprietary software; they may be unique to just one user; they typically include data acquisition and/or analysis and as such they cannot be interrupted by reboots without the agreement of the scientist; and thus they do not fit into the FDA standard, (i.e., the administrative definition.)

Scientific systems may be geared toward computationally-intensive uses, and involve a non-traditional computing environment, e.g., shared computing resources such as grid or cloud, or a Beowulf cluster, focused on statistical modeling systems and computer simulation services. They also often require sophisticated and specialized architecting, computing and analysis techniques. Often, the solution for a particular issue or the data analysis tool to facilitate a particular investigation must be created from scratch. There may not be a standard operating procedure or well-known technique.

Documentation of specialized configurations and standard operating procedures (SOPs) are maintained in accordance with the needs of the specific environment. In the data centers, configurations and change are managed more formally and SOPs are used and maintained. In the laboratory and office environments, documentation and SOPs may or may not be complete or up-to-date. FDA is moving toward more formal management of scientific computing assets outside the data centers.

Computational science is the field of study concerned with constructing mathematical models and quantitative analysis techniques and using computers to analyze and solve scientific problems. In practical use, it involves the application of computer simulation and other forms of computation to solving problems in various scientific disciplines.

Often these models require massive numbers of calculations and are often executed on supercomputers or distributed computing platforms.

Bioinformatics derives knowledge from computerized analysis of biological data. Examples include analysis of human DNA sequences to look for genetic variation that can affect an individual's disease status, susceptibility to adverse events, and ability to metabolize drugs. FDA is also using genetic analysis of foodborne pathogens to aid in identification of outbreak clusters and to help identify the source of the contamination. Research in bioinformatics includes method development for storage, retrieval, and analysis of the data, and often involves sharing vast amounts of data with external collaborators, i.e., data transfer of huge datasets. Bioinformatics is highly interdisciplinary, using techniques and concepts from informatics, statistics, mathematics, chemistry, biochemistry, molecular biology and genetics, physics, and linguistics. It has many practical applications in different areas of biology, and medicine, and public health.

High Performance Computing (HPC) refers to the type of computing performed on large, sophisticated computing systems requiring very fast or specially arrayed processors, high-speed networks, large-capacity storage systems, large quantities of memory, or all of these components.

An Enclave is a network area that is securely partitioned from the main FDA regulatory network and is designed to enable and foster collaboration and research replication, two lynchpins of scientific discovery.

Network infrastructure refers to the conceptual and physical parts of FDA’s network which supports scientific computing both for regulatory and research purposes.

Objectives As a direct result of Contract performance, the scientific community at FDA expects to achieve the following outcomes:

· Enhance its ability to manipulate, process, store, and transmit relevant scientific data and maintain and augment its analytical, visualization, and computational tools, techniques, and approaches.

· Enable FDA scientists to securely collaborate with scientists worldwide, and perform cutting-edge research and analysis that supports the scientific mission of FDA.

· Expedite connection of laboratory instrumentation to the FDA network and making data and computed results available to internal and external "stakeholders".

· Support and develop procedures that are effective in supporting Scientific program goals and flexible enough to accommodate rapidly changing laboratory procedures, instrumentation, hardware and software.

· Incorporate innovative and emerging technologies that will meet the needs of the FDA scientific community as its requirements evolve.

· Encourage collaboration between and achieve synergy within, and between, the FDA organizational elements and scientific activities.

· Enable faster, better-informed regulatory decisions.

Scientific Computing Technical Environment FDA Scientific Computing Systems FDA scientific computing systems include equipment in both laboratory and office environments. Scientific computing systems are workstations, servers, appliances, and other systems that use a variety of operating systems such as, but not limited to:

· Microsoft Windows Operating Systems;

· Apple Macintosh Operating Systems;

· UNIX and UNIX-Like Operating Systems (e.g., Linux Distributions, Solaris, HP-UX, IRIX, AIX, etc.);

· Proprietary operating environments;

· Embedded Software Solutions;

· Proprietary instrumental embedded computers that interface with the control workstation to operate the instrument and send data and results to the external workstation; and

· Networks in collaboration with OIM personnel and other contractors.

Of the approximately 2100 managed scientific computing workstations, more than 80% are Windows PC-based. Others include Apple Macintosh Computers, and Linux Computers such as Ubuntu, Scientific Linux, Fedora, etc. Approximately 200-250 Scientific Computing Workstations are added to the total every year, which must be supported in the Agency.

Scientific computing systems are individual workstations or clustered systems that may or may not be attached to a Local Area Network (LAN). LANs are either physical or virtual and may be attached to the FDA LAN, or another network environment. Network connectivity to a variety of FDA and DHHS networks is involved. The LAN’s may connect to Internet 2 interfaces and well as separate fiber optic networks which parallel non-fiber optic networks.

The majority of workstations are high-end Dells and HP's, in a variety of models, but there are also some laptops, and a considerable number of Macintosh computers. There are also workstations that are supplied by vendors of scientific equipment. For example, a mass spectrometer vendor might supply its own workstation with its own image/configuration and proprietary software. Other examples of specialized instruments include Nuclear Magnetic Resonance (NMR) systems, flow cytometers, High Performance Liquid Chromatography systems, Protein and Nucleic Acid systems, Spectrophotometers, Mass Spectrometers, imaging systems, Pulse Field Gel Electrophoresis (PFGE) and other electrophoretic methodologies, automated DNA extraction and sequencing equipment and other scientific equipment that require information systems technology integration.

Server Applications are hosted on Windows, Macintosh and UNIX platforms, both physical servers (including blade servers) and virtual servers.

Scientific computing also includes the specialized software applications used on scientific workstations, servers, or other equipment such as software used to control the attached laboratory equipment; specialized data analysis software; and interfaces to a variety of specialized scientific and lab equipment. These applications include such “routine” items such as Microsoft Office and Adobe Acrobat as well as hundreds of different versions of lab instrument or data analysis software. A small sample of which is provided in the table below:

Support for networks may require the use of software tools such as:

· Wireshark

· Bandwidth Monitor

· Compass

Use of this software must be done in coordination with OIM Network Staff and OIM Security personnel.

Scientific instruments and their host computers are not static; they are updated and/or replaced, sometimes on a frequent basis. New instruments or data analysis technology may be brought into the laboratory for evaluation. The ability to integrate new computing platforms (e.g. Linux) into the scientific network is essential to scientific instrument integration. Maintaining these integrated systems is complex. It can be even more so because some instruments and their data interface systems are kept in service for long periods of time. Replacements of the older systems may not be available, and when they can be replaced, the updated data systems may not be certified by the instrument manufacturer.

Scientific computing systems typically include data acquisition and/or analysis and as such they cannot be interrupted by reboots without the agreement of the scientist.

Representative activities include, but are not limited to, the following:

· Data gathering that occurs on dedicated equipment connected to a computer that controls an experiment, and subsequently transfers the acquired data for analysis elsewhere;

· Data assimilation from a variety of electronic sources and data analysis which may occur on a single computer or on an array of computers.

Scientific computing systems are often involved with data sharing with internal and external collaborators, sometimes involving vast quantities of data.

Also included are centralized scientific computing storage systems supporting scientific data capture, analysis, and backup. Data storage requirements are growing rapidly and require continuous expansion.

FDA Scientific Monitoring Systems Monitoring of scientific equipment (such as freezer temperature monitoring systems, device operating information) are facilitated using wired and wireless sensors and measurement devices to collect device performance data. Support is required to integrate these devices with the FDA network.

SAS

SAS is the most widely used statistical package at the FDA and as such requires a high level of support. FDA needs SAS administration expertise in:

· SAS depot management

· Workstation installation in MS Windows and Linux environments

· SAS Client/Server architectures such as Visual Analytics and Enterprise Miner

FDA Scientific Computing Web Systems Scientific Computing Web systems include HTTP and FTP servers, and services that support FDA scientific processes (Intranet and Extranet), including mechanisms for secure data sharing with external collaborators. These collaborations systems are expanding and will require support in developing engineering solutions, incorporating emerging technologies and adapting existing systems to leverage the collaboration systems to best serve the FDA Enterprise.

FDA Geographic Information Systems (GIS) Systems FDA analysts use GIS tools to track public health indicators, identify disease clusters, explore sites of environmental risk, and identify spatial patterns and relationships. GIS integrates and spatially enables FDA data. GIS technology provides FDA decision makers with a tool to devise strategies and target resources to efficiently and effectively respond to food related incidents and outbreaks.

Scientific Enclaves FDA is currently implementing enclaves into its infrastructure to enable and foster collaboration and research replication, two lynchpins of scientific discovery.

FDA Scientific Computational Science, Bioinformatics, Statistical Computing and Modeling Systems The FDA scientific computing systems include high performance computing (HPC) facilities and infrastructure, such as Grid Computing; statistical analysis computing assets located on a centralized server, cluster, or array; computational science and bioinformatics tools and systems; computer simulation services; and the statistical analysis of product safety data.

Scientific Computing and Internet 2 The Internet 2 is an important development in the evolution of the Internet. Internet 2 connects today’s leaders in research, academia, industry and government to create one community worldwide. FDA will require Internet 2 advanced layer 2 service (AL2S) with Internet2 Research and Education Internet Protocol (R&E IP) and Internet 2 Commercial Internet Peering Service (TR-CPS) delivered to the WSDC and Ashburn. This will provide a robust and readily available information processing system to support the mission critical applications of FDA. The IDIQ contractor will need to have the expertise to assist in the support of scientific computing’s full productive use of this resource.

Software Defined Network (SDN) Software-defined networking (SDN) is an architecture purporting to be dynamic, manageable, cost-effective, and adaptable, seeking to be suitable for the high-bandwidth, dynamic nature of today's applications. SDN architectures decouple network control and forwarding functions, enabling network control to become directly programmable and the underlying infrastructure to be abstracted from applications and network services. The IDIQ contractor will need to have expertise in this arena of technology to assist in the support of scientific computing’s full productive use of this resource.

One application of SDN is the infrastructure as a service (IaaS). This extension means that SDN virtual networking combined with virtual compute (VMs) and virtual storage can emulate elastic resource allocation as if each such enterprise application was written like a Google or Facebook application. In the vast majority of these applications resource allocation is statically mapped in inter process communication (IPC). However, if such mapping can be expanded or reduced to large (many cores) or small VMs the behavior would be much like one of the purpose built large Internet applications.

Organizational Background The Contractor will work with various FDA scientific community organizations including the FDA Centers. The FDA Scientific Computing Board (SCB) is the primary sponsor of the contract; the Office of Information Management (OIM) is the principal IT operations organization. The Contractor will coordinate with OIM, the SCB, and the scientific community throughout the course of the contract.

Links to FDA organization structure and related information:

· http://www.fda.gov/AboutFDA/CentersOffices/default.htm

· http://www.fda.gov/AboutFDA/ContactFDA/default.htm

Links to FDA Science and research pages:

· http://www.fda.gov/ScienceResearch/default.htm

· http://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/default.htm

Purpose This Statement of Work (SOW) conveys the current FDA Scientific Computing environment, business objectives, constraints, applicable scope, and task areas. Individual task orders will be issued to obtain specific services.

The purpose of the resulting contract is to provide FDA with scientific computing services that extend beyond the typical computing services and applications provided within the FDA’s administrative environment and make available the type of specialized, science- facing IT support services, allowing FDA scientists the ability to leverage currently available and emerging technologies and advance the FDA regulatory mission. The FDA does not anticipate using the contract as a vehicle to purchase data or access to data; acquire OEM support services for equipment and software; purchase significant amounts of equipment or software; or develop enterprise, non-scientific or large-scale databases or other systems.

Constraints Technical Standards and Guidelines Current standards and guidelines that must be considered in the execution of this contract include:

1. FDA Tailored Enterprise Performance Life Cycle (EPLC). Refer to the attachment “EPLC Overview for Contracts” for more information.

2. FDA Approved Technologies List - The FDA Master Approved Technology (MAT) List contains a list of approved and not approved technologies including applications (software), infrastructure and peripherals (hardware), and scientific software and devices.

3. FDA Security Authorization Process - Security Authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information resources have adequate security to protect the Confidentiality, Integrity and Availability of information collected, processed, transmitted, stored, or disseminated by the agency. For further information see: FDA Security Authorization Toolkit (see attachment entitled Security Authorization Toolkit) SP 800-37 Rev. 1: Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach.

4. National Institute of Standards and Technology (NIST) SP800-53 - This publication was developed by the Joint Task Force Transformation Initiative Interagency Working Group with representatives from the Civil, Defense, and Intelligence Communities in an ongoing effort to produce a unified information security framework for the federal government— including a consistent process for selecting and specifying safeguards and countermeasures (i.e., security controls) for federal information systems . SP 800-53 Rev. 3: Recommended Security Controls for Federal Information Systems and Organizations.

5. Federal Information Security Management Act (FISMA)—The E-Government Act (Public Law 107-347), passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of FISMA requires each federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. Federal Information Security Management Act (FISMA).

6. NIST The E-Government Act [Public Law 107-347] passed by the 107th Congress and signed into law by the President in December 2002 recognized the importance of information security to the economic and national security interests of the United States. Title III of the E-Government Act, entitled the Federal Information Security Management Act of 2002 (FISMA), included duties and responsibilities for the Computer Security Division in Section 303 of the National Institute of Standards and Technology document: NIST: Computer Security Division - Computer Security Resource Center.

7. FDA 3250 series of Staff Manual Guide (SMG) policies, as well as HHS security policies. Note: SMG 3251.4 Outsourcing and Third Party Arrangements - The FDA Staff Manual Guides (SMGs) are the Agency directives that document organizations and functions; delegations of authority; and administrative and program policies, responsibilities and procedures.

8. FDA Security Program: Contractor Oversight Guide - Section 2, Defining Contractor Systems and Related Security Requirements - Information systems subject to Departmental and Federal requirements are predominantly maintained by Department personnel within HHS facilities; however, there exist a substantial number of contractor-run systems. This section clarifies security requirements for these contractor-based systems as well as defines the related roles of contractors and Departmental personnel.

9. FDA’s Project Management (PM) processes include a variety of project management methodologies which may be employed in the task orders released under this contract including, but not limited to, the Project Management Body of Knowledge (PMBOK).

10. The Contractor may, as directed, be required to perform in accordance with the practices and procedures defined in Good Laboratory Practice for Non-clinical Laboratory Studies, 21 CFR, part 58, in addition to 21 CFR, part 11 (E-records and E-signatures). ORA laboratories utilize ISO 17025 standards and protocols.

http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm

Data Quality Standards

1. Compliance with FDA standards.

The Contractor shall comply with all FDA data standards for consistency, standardization, and the FDA Office of Information Management (OIM) Data and Information Standards and Technology (DIST) group’s guidelines.

2. Support for Evidentiary Requirements.

The activities performed in the FDA Scientific Computing environment must conform to the rules that govern proceedings in the courts of the United States. The results produced must be consistent in both process and data so as to be submitted as evidence in both civil and criminal cases. Please refer to USC Title 28 Part V - Procedure, Chapter 115 :Evidence, Documentary, sections 1732 & 1733 and Federal Rules of Evidence, Article IX, Rules 901-903 (in particular 901(b)9.

3. Additional Data Quality Standards may be required in the individual Task Orders.

FDA Standardized Development Environment (SDE) The Contractor, shall, where applicable, conform to the FDA SDE. A truncated guide to the SDE is included in the attachment entitled “FDA SDE.”

Information Technology Investment Management (ITIM) FDA has instituted the ITIM process in order to track technologies across the agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor may be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion. FDA Center IT Investment Review Boards may need to be included in a coordinated review process.

Scientific Exception of FDCC Requirements FDCC requirements are not applicable to special purpose (e.g., scientific, medical, process control, and experimental systems) computers.

http://nvd.nist.gov/fdcc/fdcc_faq.cfm

The primary targets of FDCC are general-purpose systems such as managed desktops and laptops. Embedded computers, process control systems, specialized scientific or experimental systems, and similar systems using Windows XP or Vista (and others) are out of the scope of FDCC. Of course, such systems still require appropriate protection and application of sound risk management principles.

FDA Scientific Computing includes those devices and processes dependent directly upon information technology components that results in the generation, access, analysis, storage, or transmittal of scientific data and information that is not, cannot, or should not be supported by FDA’s administrative computing infrastructure. Therefore FDA scientific systems are managed to assure compliance with appropriate OMB standards and security best practices, but this management is supported by scientifically-trained Staff and engineers who are familiar with such environments and with specialized laboratory equipment and techniques and who understand the unique needs of the scientists.

FDA Data Centers FDA has three primary data centers. These are the White Oak Data Center (WODC), the Ashburn Data Center (ADC), and the Scientific Data Center (SDC). WODC is used primarily for Development and Test environments. ADC is used for Pre-Production and Production environments. The Contractor may be required to use these four environments in the performance of its support. The SDC in College Park, in the Wiley Building, is currently in use for hosting some scientific environments. Contractor support services will be required in all three data centers.

Scope The scope of this contract is the complete range of scientific computing services necessary to support FDA scientists and research programs and achieve the objectives in Section 1.3 of this SOW. The task areas include broad support activities in the following categories: project management, system engineering, computational science and bioinformatics support, security, operations and maintenance, technical support, and transition out.

All of the FDA Centers and Offices may require scientific computing services. The scientific computing systems may reside on the physical FDA local area network, virtual FDA local area networks, dedicated FDA scientific computing networks or external networks such as the National Institutes of Health (NIH) local area network. Alternatively, the scientific computing systems may be completely isolated from any network.

The task orders to be issued under this contract are anticipated to include the development of analytical tools, statistical packages, prototypes, data analysis solutions and other scientific computing endeavors. They will not be used for enterprise, non-scientific or large- scale database or system development efforts.

Description of Task Areas All tasks shall be performed in a manner that meets the highest level of professional and technical standards and adheres to industry leading practices such as the PMBOK and CMMI level 2 or higher. All Contractor personnel shall be considered fully proficient in the areas in which they work. All Contractor personnel are expected to routinely:

· Keep current with advances in technology and share this knowledge with the FDA scientific computing community;

· Act in a consultative manner, proactively searching for creative solutions and strategies;

· Respond promptly, professionally and courteously to requests for assistance;

· Freely provide knowledge transfer of work products and technology expertise associated with contracted tasks;

· Provide and maintain required documentation to a standard that allows FDA personnel and appropriate third parties to install, maintain, support and independently test the products of contracted tasks.

Project Management For the task orders released under this contract, the Contractor shall provide task order level project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones are met. For each task order, the Contractor shall prepare a Task Order Management Plan describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task order execution.

The Contractor shall provide monthly status reports on all awarded tasks and their progress to the Task Order Contracting Officer Representative (COR). Within the first 30 days after contract award, the Government and the Contractor will design and agree upon a standard reporting format that includes the following information at a minimum:

· Status and progress of tasks;

· Cost and schedule variances;

· Significant risks to scheduled deliverables and plans to mitigate them;

· Progress against task order service level metrics; and,

· Recommendations for changes or additional activities to ensure that the tasks support progress on the overall scientific computing objectives.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA staff, or other contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

As an integral part of its task order management, the Contractor may be tasked to prepare materials for and participate in program/project reviews, stage gate reviews, management briefings, SCB sessions, stakeholder presentations, cross-agency information exchanges, and other similar meetings.

Technical Coordination For all awarded tasks, the Contractor shall coordinate activities with the SCB, OIM, the Center or Office requesting support, other service providers and contractors, and the scientific community as required by specific task orders. The Contractor shall maintain ownership over assigned projects and reported issues until they are successfully implemented, resolved or a coordinated transfer of the issue is accomplished with the cognizant FDA authority under the specific task order, keeping all stakeholders fully up to date.

Documentation For tasks areas that are governed by the FDA EPLC, the Contractor shall ensure that all system documentation (see Attachment titled EPLC Overview for Contracts) is complete and up-to-date as required by specific task orders. The Contractor may be tasked to support FDA processes such as the ITIM process and Center ITIRB process, including writing and submitting ITIM requests and tracking them from inception through completion. An FDA IT PM may be assigned, as available, to assist in compliance with HHS EPLC processes and requirements.

System Engineering for Scientific Computing Requirements The Contractor shall work closely with the FDA scientific community, performing a wide range of engineering services necessary to enable FDA to identify and leverage emerging technologies and tools and provide the necessary processing, storage, and connectivity support needed to achieve FDA’s scientific computing objectives. This work may include tasks such as working with researchers and other scientific computing customers to facilitate, validate, and document scientific computing related requirements; system analysis and design activities; identifying, benchmarking and evaluating new technologies; assisting in the development of technical standards, shared approaches and tools, assist with interoperability and collaboration; and, developing proofs-of–concept and prototypes, including working with OIM to set up and configure “sandboxes” and other environments to integrate all required components, facilities, equipment, software, and data resources to permit demonstration of a solution’s capabilities. Components will be Government-furnished.

If the Contractor’s analysis of the researchers’ analysis requirements indicates that there may be commercially available solutions, the Contractor may be tasked to research and evaluate such commercial solutions and develop technical specifications. Following Government acquisition of the solutions or components, the Contractor may be tasked to work with OIM and the Centers to integrate, install, configure, and customize them and provide training, documentation, and ongoing support. Scientific Computing solutions often require configuration to accommodate different workflow processes and lab instruments particular to individual FDA environments and may require integration with other FDA systems. Configuration, customization or modification of COTS applications is also expected.

Representative activities may include:

· Engineering, troubleshooting, devising connections between scientific workstations and specialized scientific hardware and software, data acquisition, network, and/or analysis equipment;

· Working with other FDA organizations and contractors to support integration efforts between scientific computing assets and other FDA assets such as the laboratory information system (LIMS);

· Implementing scientific computing solutions so the data produced by the systems will provide data elements that can be utilized by other systems at FDA. FDA is working towards developing standards. While existing standards should be used where reasonable, scientific computing may be a source for development of new standards. The FDA standards can be found at, http://www.fda.gov/forindustry/datastandards/default.html;

· Analyzing and reporting on the impact of infrastructure, connectivity, bandwidth, throughput, capacity and other changes to the scientific computing environment;

· Reviewing available technologies and providing recommendations and engineering support for issues such as storage solutions for large amounts of data; advanced networking technologies; 10 Gb/s networks both fiber optic and copper; and high data throughput parallel computing techniques;

· Providing consultative support to personnel maintaining high performance computing facilities such as Raven, Betsy, FDA’s HPC or other Beowulf cluster of computers; and,

· Developing and prototyping solutions for the support of mobile devices such as smart phones and tablets.

Support for Computational Science/Bioinformatics FDA engages in computational science research and develops bioinformatics tools for use throughout the agency. As tasked, the Contractor shall work collaboratively with scientists from FDA Centers and Offices to identify and elicit requirements, develop, maintain, and further extend the bioinformatics tools and infrastructure at the FDA. Data used for computational science may originate from various sources such as FDA internal research, FDA sponsored research, regulatory submissions, and data in the public domain or other sources. Novel data architecture may be required to structure data for meaningful computational analysis. Typical tasks may include providing support for the following scientific endeavors: computational science analytics; data warehousing, data analysis, data mining, data architecture, data curation and data management, modeling and simulation, and data display and visualization.

The Contractor shall also support the identification, elaboration and management of scientific requirements and specifications for the installation, configuration and customization of tools and other assets; and operations and maintenance services in support of existing bioinformatics assets.

Statistical computing support requirements generally arise as specific requests from principal investigators for assistance with protocol development, data analysis, or statistical support for FDA experiments and projects. As tasked, the Contractor shall support the use of statistical packages, such as SAS, Python (SciPy/NumPy), and R, including providing programming support for statistical analysis and modeling, and providing technical support for the systems supporting them. Support tasks could involve developing a complete SAS application or supporting an existing SAS application on FDA systems. Support may also include providing assistance with the statistical aspects of experimental design and advising the FDA scientific community on new developments and innovations in statistical computing. While SAS is in common usage, there are a number of other approved statistical tools in use, and new ones are constantly added to the list.

While it is anticipated that the task orders issued under this task area will include the development of analytical tools, statistical packages, and data management solutions, they will not be used for large-scale or system development efforts.

Representative activities may include:

· Support for users of computer simulation systems - a computer simulation system may be located on workstations or on central server systems and support major simulation techniques such as Markov Chain and the Monte Carlo method;

· Creating, demonstrating, and prototyping approaches for data architecture, data management, and data normalization solutions in support of FDA scientific data analyses, including activities such as database design, data acquisition, capture of metadata, and capacity planning;

· Providing computing support for the analysis of large data sets and databases such as DNA sequence and protein databases;

· Support for data storage and archiving tasks including assistance with creating, testing, and restoration from reliable and accessible backups;

· Working with Subject Matter Experts (SMEs) to populate and curate databases and laboratory information systems (LIMs) containing sample, experiment, and project meta-data;

· Providing support for text mining and natural language processing;

· Developing, documenting, maintaining and supporting data analytics and techniques;

· Configuring, deploying, and maintaining scientific collaboration tools such as shared web sites, FTP sites, and share point sites;

· Providing support for data safety and integrity tasks;

· Providing recommendations of data analysis tools that can handle large quantities of data; deliver solid conclusions; permit easy data visualization; maximize productivity with automation; and provide quick accurate graph plotting with the option of customizing graphs and charts;

· Providing support for users of statistical analysis systems-- a statistical analysis system may include workstations utilizing statistical software or a system with software located on a central scientific computing server, cluster or array;

· Providing support for users of statistical analysis systems-- a statistical analysis system may include workstations utilizing statistical software or a system with software located on a central scientific computing server, cluster or array;

· Coding and scripting to customize, modify, deploy, document, and support the investigator’s use of available scientific analysis software. A representative example includes supporting FDA collaboration efforts on the national MIDAS project which required installation of C++ development tools and coding in C++;

· Creating, documenting, and maintaining SAS, R, and Python packages and scripts including optimizing existing statistical models for use with scientific workstations or in a high performance computing environment.

Scientific Computing Security Services Modern science depends on the ability to capture, store, manage, access, and most importantly, share data and collaborate with others within the scientific community. Increased security awareness and resulting constraints can create significant impediments to these activities, inhibiting on-line collaboration and access to data in an effort to protect sensitive information. As tasked, the Contractor shall work closely with the FDA scientific community, OIM, and other stakeholders to provide and maintain the secure access required in accordance with the specifics of each task order.

Representative activities may include:

· Collaborating with OIM to enable secure customer access to needed data, collaboration resources and network partitions both within and outside the FDA;

· Managing security controls for scientific workstations, servers, the HPC infrastructure, and cloud computing resources;

· Collaborating with OIM to provide firewall support for Scientific Computing Local Area Networks (LAN), including the Center for Biologics Evaluation and Research (CBER) Local Area Network (physical) 10 Gb/s fiber optic network, and the Center for Devices and Radiological Health (CDRH) Local Area Network (virtual) on the FDA Local Area Network;

· Installing, monitoring and administering Anti-virus software on appropriate scientific computing workstations and equipment;

· Patch management. Management of security and software patches on scientific computing equipment differs from that of non-scientific computing equipment in that reboots for installation of software without the agreement of the scientist are not acceptable as they result in interruption of data acquisition and long term computation processes;

· Performing periodic reports and technical reviews, and compiling summaries from workstation audits. Developing additional methods, and adapting existing methods, to acquire and compile audit data. Such auditing and detailed reviews are critical to the security, and “health” and performance of scientific IT devices used by FDA scientists. These reviews may also be required in response to Agency, department or government-wide audits or requests;

· Performing analyses of audit data and proposing recommendations for methods to address deficiencies;

· Supporting the implementation of HSPD-12 on appropriate scientific computing workstations and equipment;

· Assisting with response to other mandated security tasks, e.g., development of security authorization documentation.

Operations and Maintenance of Scientific Computing Environments and Systems Operations and maintenance activities focus on maintaining the functionality, reliability, availability, performance, stability, sustainability and security of scientific computing environments and systems including FDA scientific computing software, configurations, integrated services and interfaces, customizations, and components. Task orders may encompass the complete set of activities required for operations and maintenance (O&M) including but not limited to issue identification, tracking, analysis, and resolution; code generation, testing, and documentation; maintenance of data analysis tools, custom code, specialized configurations, customizations, connectivity to laboratory instrumentation, and process automation such as scripts, templates, and workflows; and, coordination of hardware and software maintenance with the manufacturers of instruments. The contract will not include the provision of OEM maintenance.

O&M related tasks may also include activities such as system administration for all scientific computing related environments; performance monitoring; change management; user account management; configuration management; performance tuning; and, other typical Administrator duties necessary to ensure that FDA scientific computing systems, scientific monitoring systems, and equipment perform their intended functions. In the event that task orders specify O&M support for obsolete technologies, the Contractor’s responsibility shall be limited to best effort.

As tasked, the Contractor shall provide O&M services for FDA scientific computing systems, environments, tools, and supporting infrastructure in accordance with the specifics of each task order including:

· Scientific Computing Workstations including maintaining the connectivity to laboratory instrumentation;

· Scientific Computing Servers and services to support FDA scientific internal and external Web presences;

· HPC Infrastructure assets deployed in support of scientific computing endeavors.

· Any version of Linux that is approved by the Request for Quality IT Services (RQST).

· Cloud Computing Services that may be deployed in the scientific computing environment, must minimally meet FedRamp requirements and FDA Information Security Services requirements.

Representative activities may include:

· Linux administration activities such as administration of user accounts, quotas and backups; Linux management; Linux-based authentication and authorization management; dynamic resource management; elastic cloud configuration and management; and, CLI based administration;

· File system management for HPC environments;

· HPC compute cluster support including support for remote activities and HPC networking management;

· Coordinating with other FDA infrastructure support teams to resolve issues such as network maintenance, firewall administration, active directory maintenance;

· System backup and archiving tasks including assistance with creating and testing scripts; testing and restoration of data from backups; and, documentation of procedures;

· Testing, integrating, and deploying new releases, upgrades, technology refreshes, and new modules, and incorporating changes (e.g., updates, patches, service packs);

· Developing, testing, and applying disaster recovery (DR) and Continuity of Operations (COOP) procedures to scientific computing assets and environments.

Technical Support for Scientific Computing Environments and Systems As tasked, the Contractor shall provide technical support to the researchers and other scientific computing customers in their use of the scientific computing systems, HPC and cloud resources, supporting infrastructure, and network resources within the scientific computing environment. Support services may consist of tasks typical for Tiers 2 and 3 of a standard 3-tier technical support model.