SOURCES SOUGHT
D -- Food Application Regulatory Management System Maintenance and Technical Support
- Notice Date
- 11/20/2008
- Notice Type
- Sources Sought
- NAICS
- 541512
— Computer Systems Design 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
- 20857-0001
- Solicitation Number
- 1045070
- Archive Date
- 12/16/2008
- Point of Contact
- Linda Giles,, Phone: 301-827-7048, Ted L Weitzman,, Phone: 301-827-7178
- E-Mail Address
-
linda.alexander-giles@fda.hhs.gov, ted.weitzman@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small businesses (including certified 8(a), Small Disadvantaged, HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide support for the FARM system front-end scanning, image capture, enhancement and export submissions in electronic format. The FARM System includes document management custom workflow, tracking, and reporting functionalities. Office of Food Additive Safety (OFAS) is responsible for the review of industry submissions of food and color additive petitions (FAPs and CAPs), and generally recognized as safe (GRAS) notices, food contact notifications (FCNs), and Biotechnology Consultations (BNFs). The Food Application Regulatory Management (FARM) System supports the review and safety decisions for the above cited submissions and the New Dietary Ingredient 75 Day Notices, and 30 Day Structure Function Label Notices for the Office of Nutrition, Labeling and Dietary Supplements (ONLDS). The FARM System supports petitions and notifications submitted under the Food Allergen Labeling and Consumer Protection Act (FALCPA).These submissions address chemical, toxicological, environmental and other issues, regarding specific ingredients, and are the basis for the OFAS regulatory safety decisions. The System supports certificates of free sale requests, correspondence, and Electronic Freedom of Information (EFOI) requests for FDA. The FARM System is one of FDA’s primary applications that supports the Center’s need for end-to-end electronic receipt, processing, accessing, searching, and reviewing of industry applications and expedites the safety decision-making process. During the past few years, FDA has upgraded the system to a current FARM 5 version. While the FARM system is in full production, certain modules require enhancements and ongoing support and maintenance is essential to the continued use of the system. Desired capabilities of the FARM system include such functionality as electronic submission, improved indexing, data/document accessibility, more flexible document searching and adherence to FDA Data Standards Council Guidelines and Health Level 7 (HL7) standards. Continued support and maintenance including performance improvement is desired. The objective is to administer, monitor, and update the FARM System’s Windows 2000 InputAccel Module server; to develop, administer, and update the FARM System automatic indexing module’s Dispatcher software; to update and maintain the InputAccelModule’s workflow files; to configure and administer the CFSAN E-Submission Gateway (CESG) and its connection and data transmission to the FARM InputAccel Module. The contractor shall perform the following tasks; Task 1 Administer Windows 2000 InputAccel Module and CFSAN E-Submission Gateway. (1) Maintain ImputAccel server software used for scanning, capture, indexing using Dispatcher software, and quality control (2) Monitor and troubleshoot Windows 2000 InputAccel Module (3) Maintain user accounts in the Windows 2000 Server system (4) Modify and maintain process workflow files as required based on submission type; (5) Support the Dispatcher indexing module; and (6) Support, monitor, troubleshoot problems and maintain the CFSAN E-Submission Gateway (CESG) to implement the Regulated Products Submission (RPS). Task 2 Configuring, upgrading, and testing the Dispatcher indexing module as needed for processing scanned paper documents and electronic submissions. The contractor ensures that the technical operation of the Dispatcher indexing module is set and functions to verify that indexing is done correctly for both scanned and electronically uploaded documents, while monitoring and troubleshooting the module as needed. Creating a Dispatcher indexing workflow plan that includes the route of submission, submission types, database fields for each submission type, data search and retrieval process, test scripts, and user access screens, for the on-line electronic submissions to be provided to the Government (FARM Project Officer) before the start of the Electronic Submission Task. The Project Officer will approve the plan within 5 working days of the contractor’s submission based on FDA’s Data Standards Council guidelines and standards. Specific tasks includes; (a) Designing, creating, and testing dynamic section 508 compliant forms for capturing data submitted in electronic and paper formats for use on the World Wide Web in compliance with FDA and Health Level 7 Regulated Product Submission (RPS) criteria and standards for the OFAS, FALCPA and ONLDS applications; (b) Configuring Dispatcher Module to accommodate application parameters for OFAS, FALCPA and ONLDS; (c) Coding, testing, capturing and validating data fields from standardized submission forms; (d) Generating indexing values from submission forms captured by the InputAccel module; (e) Exporting/uploading InputAccel indexing (IDX) values, XML indexes and submission files/documents; Monitoring and troubleshooting the indexing module as needed; (f) Producing planning, testing, and production tasks documentation; (g) Implementing FDA E-Submission Gateway protocol and the linking the CESG to the FDA ESG and the InputAccel module; (h) Incorporating Electronic Signatures capabilities into the electronic submission forms; (i) Making use of web based tools (excluding e-mail attachments); (j) Supporting the FARM database system and currently available application development and searching tools (XML, HTML, XQuery, and PLSQL); (k) Developing and implementing the Health Level 7 (HL7) Implementation Plan for System Regulated Product Submissions (RPS) for FARM. Task 3 Yearly Upgrade the FARM InputAccel workflow modules. (1) Upgrade user interface software and DCC InputAccel workflow for all workflows listed in Task I. (2) Monitor, troubleshoot, and maintain other InputAccel modules upon requests. Task 4 Configure, test, and monitor the CFSAN E-Submission Gateway Server (CESG) to allow it to accept and route submissions in electronic format that are submitted by industry to the FARM System InputAccel Module. (1) Set up the notification process for FARM staff and extract and upload the electronic submissions from the CESG into the InputAccel Module. (2) Set up the notification process to allow two-way communication with industry submitters to implement RPS. (3) Develop, test, implement, and monitor the CFSAN RPS Implementation Guide for HL7 Messaging. Task 5 Perform tasks that cover additional orders by the Government to implement newly issued or separate functionalities standards, and guidance required for the FARM System that require resources such as Adobe LiveCycle server, dynamic electronic forms, digital signatures, automatic bar codes, HL7 Regulated Product Submission Release 2, and FDA Bioinformatics and the FDA Electronic Submission Gateway upgrades that are to be determined. The NAICS Code is 541512. The small business size standard is 23M. Interested small business must provide a capability statement demonstrating their experience, skills and capability to fulfill the Government requirement that is stated above. However, be advised that generic capability statements & brochures are not sufficient to evaluate your capability statement effectively. Information submitted must be in sufficient detail to permit the government to determine whether your organization possesses the skills capabilities and experience need to perform the type of work contain within. This notice is for planning purposes only, and does not constitute a Request for Quotation. This request is not to be construed as a commitment on the part of the Government to award a purchase order or 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. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit via email copies of their capability statement, addressing the areas above. Capability statements must identify the business status of the organization. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Ted Weitzman and Linda Alexander Giles at ted.weitzman@fda.hhs.gov and linda.alexander-giles@fda.hhs.gov, no later than December 1, 2008 at 9:00 AM Eastern Time for consideration.
- Web Link
-
FedBizOpps Complete View
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- Place of Performance
- Address: USA, United States
- Record
- SN01707841-W 20081122/081120215442-b82c4a82ef5a46a1d839382e3f671911 (fbodaily.com)
- Source
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