Appendix_C_-_CFSAN_Systems_and_Tools_-Dec_17-2013.xls
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Appendix C - Systems and Tools
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CFSAN Systems and Tools
| CFSAN System Abbreviation | CFSAN System Name | CFSAN System Description | CFSAN Submission Types (e.g.,FAPs, CAPs, FCNs, GRNs, etc.) and Numbering Format | Submission Formats (e.g., ESG, paper, CD, etc.) | Associated CFRs, Statutory Acts, Mandates | CCB Information | System Interfaces | User Information | System Support Information | 508 Testing Information | ||||||||
| CCB Name | CCB Meets (Frequency) | CFSAN System Provides Data to Which Other CFSAN Systems? | CFSAN System Retrieves Data from Which Other CFSAN Systems? | CFSAN System Provides Data to Which Other non-CFSAN (external) Systems? | CFSAN System Retrieves Data from Which Other non-CFSAN (external) Systems? | User Information | User Types | CFSAN Offices | System Status (Current) | System Status | ||||||||
| (Planned) | Currently Supported By | Historical Average Number of Planned Releases per Year | Historical Average Number of Defects (bug fixes) per Release | Historical Average Number of Enhancements per Release | Historical Average Number of Data Corrections per Month | Historical Average Number of User Support Requests per Month | Historical LOE per Release (# hours for Development, Testing, and Documentation) | Primary Technologies | Environment Locations | Approximate Storage Size - Database (Mb) | Approximate # of Database Views | Approximate # of Forms (if applicable) | Approximate # of Reports (if applicable) | Approximate # of JSP/Java Pages (if applicable) | Approximate # of Menus (if applicable) | Section 508 Tested (Y/N) | Section 508 Compliant (Y/N or N/A or Don't know) | |
| FARM | Food Applications Regulatory Management | FARM is an electronic information management system designed to support electronic processing, review, maintenance, and reporting for food ingredient submissions.The FARM system is available to CFSAN reviewers to access and review industry submissions and conduct analyses with regards to chemical, toxicological, and environmental and other issues, regarding specific substances. Specifically, this system supports CFSAN’s Office of Food Additive Safety (OFAS) and the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in the review of a wide variety of submissions and petitions submitted by regulated industry. | FAPs, CAPs, FCNs, BNF, NPC, FALNs and FALPs, IFN, NDI, Correspondence, Citizen Petitions, and EFOIA | Paper, electronic via physical media (e.g CD-ROMs,DVD, etc,) and ESG | FDC&A, FALCPA, Federal Information Security Management Act (FISMA) |
Appendix III to OMB Circular No. A-130 FARM CCB Monthly CERES, SRS TMS SRS SRS 200 users Business Owners, System Owners, CSOs, Scientific reviewers OFAS, ONLDS, OCAC, ORS Steady State Migrate to Oracle 10g to 11g Contractor 4 20 10 10 25 1600 Oracle 10g: DB, OAS, Portal; Appian BPM WSDC WODC: Dev/Test
| CHDC: Pre-prod/Prod | 500GB | 5000 | N/A | approximately 55 | N/A | 0 | Y | Yes | ||||||||||||||||||||||||||
| TMS | Terminology Management System | TMS module provides Indexing support for FARM and controlled vocabulary to standardize terminologies across systems such as CAERS and CERES (old PAFA) and produce a CFSAN Lexicon. | ||||||||||||||||||||||||||||||||
| Currently contains 5 dictionaries: MeDRA, HOC, HOC2, CTFA and PCPC. | TBD | N/A | N/A | N/A | N/A | Steady State | Current: Government | |||||||||||||||||||||||||||
| Planned: Contractor/ Government | N/A | N/A | N/A | N/A | N/A | WODC: Prod | N/A | N/A | N/A | N/A | N/A | N/A | y | yes | ||||||||||||||||||||
| FDA Appian | FDA Appian BPM Suite | The Appian BPM Suite provides a way to manage business processes, work automations, and social collaboration across the enterprise for employees, customers, and systems. The FARM workflows are developed using Appian BPM. | See above for FARM submission types | N/A | N/A | Infrastructure Change Control Board (CCB) | Every Tuesday | N/A | N/A | Centers: CVM & FACTRS --- Web Services: CDMS & STARS | Centers: CVM & FACTRS --- Web Services: CDMS & STARS | CFSAN: 166 Users, CVM: 300 Users, FACTRS: 24 | Basic End Users | OFAS, ONLDS, OCAC, ORS | Steady State | Appian 7.3 | Contractor | N/A | N/A | N/A | N/A | 30 - 45 Requests per Month | N/A | Appian BPM Suite, Apache Web Server, JBOSS Application Server, mySQL Database, LDAP and external data storage technologies | CDHC & WODC | SAN Storage Allocation (Dev, Test, Pre-Prod, Prod): 250 GB --- For database size information, contact DBA team | Contact DBA Team | N/A | N/A | N/A | N/A | Y | Yes | |
| FARM IA | FARM InputAccel | Provides support for image capture, document classification, data recognition, export, and indexing support for FARM System submissions. | Ad-hoc | N/A | APS | N/A | N/A | Business Owners, System Owners, CSOs, Scientific reviewers | OFAS, ONLDS, OCAC, ORS | Steady State | IA version 7.0 | Contractor | 1 | 5 | 2 | 2 | 3 | 40 | EMC | WODC: Dev/Test | ||||||||||||||
| CHDC: Pre-prod/Prod | y | yes | ||||||||||||||||||||||||||||||||
| FDA BO | FDA Business Objects | Business Intelligence reporting tool supports many investments including FARM, FDA OC User Fee and Finanical Reporting System Exhibit 300 Major Investment. FARM develops many dashboard, canned and Ad-hoc reports | Monthly | N/A | N/A | N/A | Business Owners, System Owners, CSOs, Scientific reviewers | Steady State | BI 4.0 | FDA | SAP | WODC: Prod | y | yes | ||||||||||||||||||||
| FDA ESG | FDA Electronic Submissions Gateway | The FDA ESG enables the receipt of guidance-compliant electronic submissions over the Internet and directs these submissions to the appropriate business units within the Agency. FARM receives submissions through the ESG. | Steady State | FDA | Y | Yes | ||||||||||||||||||||||||||||
| FDA SRS/ID | FDA Substance Registration/Ingredient Dictionary | SRS/ID integrates application, product and activity information available at FDA and from external reference sources for the substances present in regulated products. SRS/ID provides FARM access to internal and external data sources and lexicons | Steady State | Global Ingredient Archival System (GinAS | FDA | Y | Yes |
&CCBER Systems Detail &L&D &T&RPage &P of &N
Definition of Terms
| Term | Definition |
| Initial Release | Scheduled release for a new system development effort. |
| Major Release (DME) | Scheduled release to include defect corrections, technology upgrades, major enhancements, and/or redesigns |
| Minor Release (O&M) | Scheduled release to include defect corrections and/or minor enhancements |
| Emergency/Patch Release (Defect) | Unscheduled release to correct a problem with the FARM system that is negatively impacting OFAS Business and requires immediate resolution. |
| ESG | The Electronic Submission Gateway is CFSAN's electronic regulatory submission |
| ONLDS | Office of Nutrition, Labeling and Dietary Supplements |
| OFAS | Office of Food Additive Safety |
| NDI | New Dietary Ingredient |
| FAP, CAP | Food and Color Additive Petitions (FAPs and CAPs) |
| GRN | Generally Recognized As Safe Notices |
| FCN | Food Contact Notifications |
| BNF | Biotechnology Consultations |
| NPC | New Protein Consultations |
| IFN | Infant Formula Notifications |
| FALCPA | Food Allergen Labeling and Consumer Protection Act (FALCPA) notifications |
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