Appendix_4_-_FDA_Document_Control_Facilities.xls
XLS spreadsheet 58 KB Posted
- Attached to
- Fully Integrated Records Facility (Offsite Document Control Center) Federal contract opportunity
- Solicitation number
- FDA-Off-Site-RIM-000141
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Appendice 4
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Document Control Facilities
| IDIQ APPENDIX NO. 4: List of Document Control Facilities (DCFs) | ||||||||
| CDER DOCUMENT CONTROL FACILITY INFORMATION | ||||||||
| No. | Document Room | Address | Linear Footage | Supports | Application/File Types | % Box Shelving | % Loose Files | Notes |
| 1 | Central Document Room (CDR): Ammendale A | 5901A Ammendale Road, Beltsville MD | 3643ft | OND | CDER Document Control Facility that is the Central Point of receipt for the following regulatory submissions: DMF, NDA, IND, BLA | n/a | n/a | mailstop |
| 2 | Central Document Room (CDR): Ammendale B | 5901B Ammendale Road, Beltsville MD | 63550ft | OND | CDER Document Control Facility that processes and stores the following regulatory submissions: DMF, NDA, IND, BLA. Storage area for OC compliance inspection reports. | 78 | 22 | |
| 3 | CDR: Ammendale H | 5901H, Ammendale Road, Beltsivlle MD | 23000ft | OND | CDER Document Control Facility: Storage space for the following submission types: NDA, IND | 100 | n/a | |
| 4 | WO22: EDR | White Oak Campus 10903 New Hampshire Avenue, Bldg 22, Silver Spring MD | 9000ft | OND | CDER's central receipt facility that processes the following electronic regulatory submissions: NDA, IND, BLA | n/a | n/a | |
| 5 | WO22: DR1 | White Oak Campus 10903 New Hampshire Avenue, Bldg 22, Silver Spring MD | 57700ft | OND | DCC that processes the following regulatory submissions: NDA, IND, BLA | |||
| 6 | WO22: DR2 | White Oak Campus 10903 New Hampshire Avenue, Bldg 22, Silver Spring MD | 4425ft | OPDP | DCC that processes the following regulatory submissions: NDA/ANDA, 2253, and non-2253 files | 100 | ||
| 7 | Office of Generic Drugs (OGD): MPN2 | 7500 Standish Place, Rockville MD | 11000ft | OGD | Document Control Facility for ANDA chemist and quality reviewers located at MPN2. | 100 | ||
| 8 | OGD: MPN1 | 7520 Standish Place, Rockville MD | 8000ft | OGD | Document Control Facility for ANDA records support, labeling, and micro-biology reviewers located at MPN1. | 100 | ||
| 9 | OGD: MPN7 | 7620 Standish Place, Rockville MD | 33000ft | OGD | Document Control Facility Central Point of Receipt for ANDA submissions | 100 | ||
| 10 | CDER OC | White Oak Campus 10903 New Hampshire Avenue, Bldg 22, Silver Spring MD | Document Control facility: Storage room for OC compliance reports | |||||
| 11 | Montrose Metro 2 (MM2) | Rockville, MD | OGD | Drop-Off location: Submissions review division. (Approximately 100 reviewers) | ||||
| 12 | Hillandale, Silver Spring, MD | FOI | Drop-Off Location: Freedom of Information (FOI) Division | |||||
| CBER DOCUMENT CONTROL FACILITIES | ||||||||
| No. | Document Room | Address | Linear Footage | Support | Application/File Types | % Box Shelving | % Loose Files | |
| 12 | CBER DCC-Woodmont | Woodmont Office Complex I. 1401 Rockville Pike Rockville, MD | 8,000LFT | Submission processing/routing, EDR loading, collection maintenance, mailroom, Document/file requests, RIM support, data abstraction. | IRA collection, Pending marketable submissions, special collections. | 100% | ||
| 13 | CBER DCC-Wilkins | Wikins Building 12100 Parklawn Drive Rockville, MD 20852 | 14,000LFT | Box storage, Accessioning. File/document requests, collection maintenance. | IRA collection. Product files. | 80% | 20% | |
| 14 | CBER DCC-NLRC | Nicholson Lane Research Center (NLRC). 5516 Nicholson Lane Rockville, MD | 4,100LFT | Collection maintenance, File requests, | Approved and completed Product and Licensed files. | 100% | ||
| CFSAN DOCUMENT CONTROL ROOM INFORMATION | ||||||||
| No. | Document Room | Address | Linear Footage | Support | Application/File Types | % Box Shelving | % Loose Files | |
| 15 | Program Offices File Rooms | 5100 Paint Branch Parkway College Park, MD 20740 | app.3,000' LF | Center-Wide Program Office File Rooms | DCC: Administrative,adverse events, contracts, grants, FOIA, precedent, program, research, compliance and research records | 5 | 95 | |
| 16 | CFSAN Document Room | 5901I Ammendale Road, Beltsville MD | app. 12,000' LF | Center-Wide | DCC: Contracts, IAG, , procurement, travel, HR, IAG, GMP, IF, FOIA, Corsp., Seafood, EIR, Compliance & Enforcement, Advisory Cmte, Int'l MOU, CODEX | 25 | 75 | |
| CVM DOCUMENT CONTROL ROOM INFORMATION | ||||||||
| No. | Document Room | Address | Linear Footage | Support | Application/File Types | % Box Shelving | % Loose Files | |
| 17 | MPN2 | 7500 Standish Place Rockville, MD 20855 | 4757 | All CVM Offices | DCC: NADA, VOL 0, INAD, JINAD, MIF | 100 | ||
| 18 | MPN4 | 7519 Standish Place Rockville, MD 20855 | 3192 | All CVM Offices | DCC: ANADA, FAP, GRAS, IFA, GC, DER, VMF, PMF | 100 | ||
| CTP DOCUMENT CONTROL ROOM INFORMATION | ||||||||
| No. | Document Room | Address | Linear Footage | Support | Application/File Types | % Box Shelving | % Loose Files | |
| 19 | 9200 Corporate Blvd. Rockville, MD 20850 | 248 ft | Entire CTP | DCC: Adverse Event; Executive Correspondence; Grandfatheredealth Document; Harmful Constituents; Investigation Use Modified Risk; Other Media; Required / Requested Documents; Rotational Warning Plan; Substantial equivalence, general correspondence, Tobacco Ingredients; Tobacco Establishment Registration; Tobacco Inspection Management System TIMs (States Program) | App 10 ft. (9%) of the total is currently stored in boxes. All remaining files are in shelving units. | App 12 ft.(5%) Are currently loose as the folders are in various stages of processing |
Records Syst. Software
| Records System Supporting Software | |
| Document Control Support | |
| eCopies Loader | Electronic copies for premarket submissions. An eCopy is an exact duplicate of a paper submission submitted on a CD, DVD, or flash drive. The eCopy is submitted with a hard copy of the cover letter. An electronic copy is not an electronic submission. |
| CD Loader | Provides a web-based interface for OIR and RadHealth CD-based electronic submissions to be processed and loaded into IMAGE. |
| CEntry and APPS | These are the two applications used for data entry of premarket submissions incoming to DCC, as well as for storing interim and final decisions. Premarket submission reporting is primarily linked to the data captured in these 2 applications, along with our Center Tracking System (CTS). |
| Scanning Support (InputAccel) | The backend scanning application performs and supports the indexing, OCRing, and the QC of scanned in documents as they are loaded into the CDRH electronic document repository. Uses InputAccel and PrimeOCR for the scanning applications and Visual Basic for the user interface and DLLs to support scanning processes for ODE, OSB, and RH. |
| Barcode Application | Used by the ODE group for generating cover sheets and separator sheets for indexing and scanning. |
| MDR Barcode Application | Used by the MDR group for generating cover sheets and separator sheets for indexing and scanning. |
| SIS – Submission Inventory System | Used to track documents loaded into IMAGE via the eCopies Loader. Also used by DCC to box documents to send to the off-site scanner; SIS tracks all steps through to completion of the loading into IMAGE step. |
| Radiological Health Processing | |
| RadHealth Processor (RH Pro) | The Radiological Health Processor (RH Pro) allows for the viewing and data entry of metadata (e.g., manufacture, submitter, product information) to be captured in a relational database and acknowledging receipt of individual regulatory submissions, replacing the legacy M204 system. In addition, RH Pro automates the loading of all incoming electronic Rad Health Submission into an electronic Repository. |
| CD Loader | See above. |
| e2579 | E2579 is used for purposes of entering content of FDA Form 2579, Report of Assembly for Diagnostic X-ray Systems and Components. |
| MARCS-Case Management System (CMS) | The Case Management System (CMS) is used for purposes of entering metadata and uploading electronic submissions requiring coordination with FDA Office of Regulatory Affairs (ORA) and field offices. This system serves as both a data entry and review interface for staff. |
| Adverse Event Processing | |
| eMDR | The Electronic Medical Device Reports system facilitates the data entry workflow of the MedWatch 3500A forms for medical device reports. |
| Document Management | |
| Image 2000+ | Image2000 the central repository and official records management system for CDRH. The repository includes the document management activities for premarket, compliance, post market and administrative business processes. |
| Registration and Listing | |
| FDA Unified Registration and Listing System (FURLS) | Electronic registration and listing system used to collect and store registration and listing information for medical device establishments. |
| Once a firm enters registration and listing information into FURLS/DRLM, FURLS/DRLM pulls data for non-exempt listings from CEntry/APPS into the listing. | |
| CEntry/Apps | This application stores the premarket submission data. We use this application to verify premarket submission numbers and to pull information associated with the premarket submission numbers into the listing record in FURLS. |
| Gov Delivery | This application is used to send emails to medical device establishments. |
| Express Click Yes | This is used to send queued e-mail blasts |
| MS Visual Studio Express | This is used to rename/merge/split PDF files using a script. |
| Mozilla Firefox | This is used to access GovDelivery. |
| GovDelivery | This is used to send blast general emails to industry. |
| Beyond Compare | This software is used for backing up all of the local files to the server in case of emergency. |
Tracking Systems and Repository
| TRACKING SYSTEMS AND REPOSITORIES BY CENTER | |||
| CDER | |||
| Document Archiving Reporting and Regulatory Tracking System (DAARTS) - Primary Tracking System for INDs, ANDAs, BLA, DMF, NDAs, Title 8 Forms, Medical Gas Certificates, 2253 Submissions, Non-2253 Submissions, and Patent Declarations. | |||
| LXMain is a legacy system stores information for INVAS, BrMIS, User Fees, DPRF, and others. | |||
| IND and NDA Volume Accountability System (INVAS) | |||
| MedWatch: The FDA Safety Information and Adverse Event Reporting Program | |||
| Bioresearch Monitoring Information System (BRMIS) | |||
| iCERTs Tracking System | |||
| Federal Adverse Event Tracking System (FAERs) | |||
| Compliance Management System (CMS) | |||
| Documentum Enterprise Content Management System (ECMS) | |||
| CBER | |||
| Document Accountability and Tracking System (DATS) - Primary Database for capturing a variety of information related to CBER Submissions | |||
| Document Tracking System (DTS) | |||
| Electronic Document Room (EDR) - Repository for all CBER electronic submissions | |||
| Lot Release System | (LRS) | ||
| Regulaotory Management System - Bilogics License Application (RMS-BLA): Used to track and report on BLAs using assigned Submissions | |||
| Tracking Numbers (STNs) | |||
| Biologics IND and Related Applications Management System (BIRAMS) | |||
| Animal, Biologics, Chemical database -- data abstraction database | |||
| Blood Logging and Tracking - tracks CBER device applications | |||
| CDRH | |||
| Systems Inventory System (SIS) Oracle Apex Based Application | |||
| CFSAN | |||
| CFSAN Electronic Document Room (CeDR) | and Records Management Application (RMA) | ||
| Food Applications Regulatory Management System (FARM) | |||
| Low Acid Canned Food System (LACF) | |||
| CVM | |||
| CVM Electronic Submission System (CVM ESS) | |||
| eSubmitter tool | |||
| WebTrader or AS2 connections | |||
| Safety Reporting Portal | |||
| Submission Tracking and Reporting System (STARs) | |||
| Drug Experience Reporting System (DERs) | |||
| Minor Species Indexing Filing System (MIFs) | |||
| Corporate Document Management System (CDMS) | |||
| Office of Commissioner (OC) | |||
| Field Accomplishments and Compliance Tracking System | |||
| CTP DCC Tracking & Data Entry Tools | |||
| iTrac | |||
| eSubmitter | |||
| PreLoader | |||
| Compliance Management System (CMS) | |||
| CTP Data Repository | |||
| Image 2000 | |||
| Tobacco Database | |||
| CTP/DCC Internal Tracking Tools | |||
| Incoming Submissions Log | |||
| Outgoing Documents Log | |||
| Change Request Log | |||
| Image Corrections Log | |||
| iTRAC Status Update Log | |||
| Tobacco Inspection Management System (TIMS) Response Log | |||
| CTP/DCC Mailroom Internal Tracking Tools | |||
| Courier Log | |||
| Package Count Log | |||
| Mail Count by Super Office Log | |||
| Submissions Delivered to DCC Log | |||
| Misdirected Mail Log | |||
| Misrouted Mail Log | |||
| Undeliverable Mail Log |
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