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D -- Phonetic and Orthographic Computer Analysis (POCA) Operation, Maintenance and Support - Attachment 1 - Technical Questions

Notice Date
Notice Type
Sources Sought
541519 — Other Computer Related Services
Contracting Office
Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code
Solicitation Number
Archive Date
Point of Contact
Christine Rynkiewicz, , Linda Giles,
E-Mail Address
christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov
(christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov)
Small Business Set-Aside
Competitive 8(a)
Technical Questions This Sources Sought Notice/Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its centers. The purpose of this RFI is to help the FDA understand the industry best practices, technical solutions, and sources capable of meeting the FDA's requirements. Specifically, the Government is seeking verification that its requirement is commercially available, determine if there are any questions about the FDA's requirements, determine if industry notes any omissions in the requirements, and information about sources available to meet the FDA's requirements. 8(a) Sources Sought The purpose of this Sources Sought Notice/RFI is to determine the availability and capability of Small Business Administration Certified 8(a) companies. Background The aim is to identify a qualified contractor who can provide operation and maintenance support for an FDA software program called Phonetic and Orthographic Computer Analysis (POCA) system to include project management and customer services. The POCA system is composed of two applications, POCA Search and Rx Studies. The contractor shall also ensure compliance of these systems to meet the FDA's Office of Information Management (OIM) standards for the FDA Contractor Hosted Data Center (CHDC). Other optional services that may be required for the applications during the course of the contract are upgrading of Oracle, Visual Studio and Microsoft.net to the version designated by FDA/OIM. The applications may also require upgrading to ensure full compliance with Section 508 of the Rehabilitation Act of 1973 standards. Additional optional services may include technical support of the FDA's publically available POCA system, adding new data sources to the POCA search engine system, and if needed, updating the Rx Studies software. The POCA Search application improves efficiency of FDA safety evaluators' time. The searchable data includes approved and unapproved proprietary names in the prescription and over-the-counter markets. This application has the capability of searching a wide range of data for look-alike and/or sound-alike names that might increase the probability of medication errors for the proposed proprietary name being reviewed. In addition, the application includes the capability to survey drugs and biologic products with their associated strengths, dosing intervals, dosage forms, and routes of administration. The Rx Studies application allows the OSE Safety Evaluator to design and conduct studies on proposed proprietary names. Handwriting and audio samples are obtained from licensed health professionals. The handwriting samples are scanned and saved as a portable document files (pdf). The audio samples are recorded and saved as audio files. These samples are sent out through the Rx Studies application to volunteer health professionals in the FDA. The volunteers reply to the OSE Safety Evaluator with their interpretations of the proposed proprietary names within the Rx Studies application. Instructions Interested parties shall provide capability-based responses to the following requested information: 1. Project management activities shall include but are not limited to: directing and coordinating Contractor project staff; monitoring the operation and maintenance, and optional task activities through the development of Project and Acceptance Plans; manage software changes including version control of production and development code sources, and help documentation for users; participating in the OSE POCA Change Control Board (CCB) and the OIM CCB meetings and processes as needed; verifying compliance of work activities with the FDA regulations and standards; facilitating a kick-off meeting within 1 week of award and providing kick-off meeting minutes; providing monthly progress reports; and facilitating weekly status meetings. The Contractor shall provide overall Project Management (PM) support. 2. Database administration support shall include the following activities: • Maintenance and operation of the POCA and Rx Studies applications and databases. • Install and upgrade the Oracle server and application tools. • Allocate database storage and plan future storage requirements. • Create the primary database storage structures (table spaces) and primary objects (tables, views, indexes) and modify the database structure as necessary. • Monitor and optimize database performance. • Plan for and perform backup and recovery of database information. • Database administration functions that require changes to the production baseline environment (e.g., install Oracle upgrades, changes to the database structure, etc.). (Note: These are subject to approval by the OSE POCA Change Control Board (CCB) and the OIM CCB). • The current POCA "data sources" which are refreshed on a monthly basis are the "Orange Book", "Drugs at FDA", and Rx Norm. These data sources are available at websites that allow downloading of the data. After some manipulation current updated versions of these data sources shall be loaded into the POCA system and shall be refreshed on a monthly basis. This is called a monthly data refresh. 3. Customer support shall include the following activities: • Customer support involves helping FDA COR with application-related issues, responding to telephone and e-mail messages, and assisting users with specific POCA System problems. • Answering questions that are more complex that require program or system expertise to troubleshoot and diagnose a more complicated POCA software problem. • Maintain an electronic software based problem tracking systems (e.g. JIRA) which creates a log of requests for technical assistance that includes: name of the requestor, request date, description of the request, and description what and how the assistance was provided, and date the assistance was completed. • Update existing technical user and help documentation for all changes made to the system. • Host and maintain an Intel based server with current software and versions of the POCA System and Rx Studies. (Note: FDA shall provide the small stand-alone Intel based server which will be a test/development resource that is outside of the Computer Hosted Data Center (CHDC). 4. The Contractor shall develop an Acceptance Plan and provide continued technical support to the Rx Study community, which consists solely of FDA users. 5. The Contractor shall maintain compliance with all FDA OIM, FDA CHDC and FISMA standards listed below: a. Must conform to ICT-21 Architecture. b. Must comply with FDA approved technologies list. c. Must comply with and supply a resource to assist with the FDA Security Authorization process, which closely resembles NIST SP800-37. d. Security controls must comply with NIST SP800-53. e. Must comply with all FISMA, NIST and OMB requirements. f. Must comply with FDA 3250 series of SMG policies, as well as HHS security policies. Note: SMG 3251.4 Outsourcing and Third Party Arrangements. g. Must comply with HHS information Security Program: Contractor Oversight Guide - Section 2, Defining Contractor Systems and Related Security Requirements. Security Management Act of 2002, (FISMA) links: http://www.govexec.com/basics/FISMA.htm http://csrc.nist.gov/groups/SMA/fisma/index.html 6. Optional services to include: a. Upgrade POCA and Rx Studies databases to the current FDA Oracle CHDC standards. b. Upgrade POCA and Rx Studies applications from the existing version of Visual Studio and Microsoft.net to the current standard version. c. Modify all new versions of POCA and Rx Studies applications to be fully compliant with current Section 508 standards. Additional information on Section 508 standards can be found at the following link: http://www.accessboard.gov/sec508/guide d. Provide technical support for the publically released source code. e. Add potential new data sources to the POCA search engine and present analysis on advantages of possible new data sources. f. Implement new requirements that enhance the functionality or POCA or Rx Studies applications. Responses Responses to this notice shall be limited to ten pages (excluding marketing literature and/or technical data sheets), and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated technical capabilities identified in the responses. 3. Commercial pricing list or other pricing information. 4. Customary practices, including warranty, discounts, contract type under which commercial sales of the products or services are made. 5. Any questions concerning the FDA's requirements for the POCA and Rx Studies applications with graphical display. Omissions from the requirements information that are needed to meet the Government's need; such as what services may be required in subsequent years for hosting, operations, maintenance and training. 6. Business size and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned small business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned small business (must be listed in the VetBiz Vendor Information Pages). 7. For small businesses, please provide a detailed capability statement, focusing on your firm's proven ability to provide the range of requirements. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 8. DUNS number, CAGE Code, Tax Identification Number, and company structure (corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at https://www.bpn.gov/ccr/) to be considered as potential sources. 9. Identification of the available contract vehicles; such as GSA Federal Supply Schedules (schedule/contract number and appropriate Special Item Numbers) or other GWAC vehicles by agency and contract number. 10. Responses to Attachment 1 - Technical Questions. Additonal Information Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. However, FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, if issued. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Any questions regarding this notice must be submitted by e-mail only to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov. Respondents must submit a capability statement by e-mail to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov no later than May 14, 2012 at 12:00PM Eastern Standard Time for consideration. Attachments Attachment 1 - Technical Questions
Web Link
FBO.gov Permalink
Place of Performance
Address: The US Food and Drug Administration, 10903 New Hampshire Ave., White Oak Campus, Building 66, Silver Spring, Maryland, 20993, United States
Zip Code: 20993
SN02731921-W 20120428/120426235211-a25d62772948dfa54ccd8207b2e6b938 (fbodaily.com)
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