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Table of Contents FDA Programmatic Records Control SchedulesCompliance (Agency-Wide) File Codes: 7000 through 7365 File Code

Prefix: FDA File Code Title of Records Series 7000 Compliance (Agency-wide). 7100 Recall Files. 7110 Recall Action Files. 7111 Records Maintained in Center Program Offices. 7112 Records Maintained in Field Offices. 7113 Records Maintained in the Office of Regulatory Affairs (ORA). 7120 Recall Enterprise System (RES). 7121 Data Files. 7122 Outputs: Periodic Reports and Extracted Recall Data. 7123 Outputs: Reports for Public Access. 7124 Outputs: Ad-hoc Reports. 7125 Electronic Notifications. 7126 System Documentation. 7127 Backups of Files. 7200 Establishment Registration and Product Listing Program. 7210 Registration and Listing Files. 7220 Registration and Listing Systems. 7221 Input Records. 7222 Database Records. 7223 Reports: Output Records. 7224 Monthly Registration and Listing Web Reports: Output Records. 7225 Notifications, Confirmations, Verifications: Output Records. 7226 Systems Documentation. 7300 Establishment Inspections and Compliance Action Files. 7310 BIMO Domestic Inspection and Compliance Action Case Files. 7311 Files with No Action Indicated (NAI). 7312 Files with Voluntary Action Indicated (VAI). 7313 Files with Official Action Indicated (OAI). 7320 OAI Files Resulting in Investigator Disqualification. 7330 BIMO Referral Records maintained in the Referral Office. 7340 GMP Domestic Inspection and Compliance Action Case Files. Page 1 of 16 Updated on 01/06/10

Table of Contents FDA Programmatic Records Control SchedulesCompliance (Agency-Wide) File Codes: 7000 through 7365 File Code Prefix: FDA File Code Title of Records Series 7341 Files with No Action Indicated (NAI). 7342 Files with Voluntary Action Indicated (VAI). 7343 Files with Official Action Indicated (OAI). 7350 International Establishment Inspection and Compliance Action Case Files. 7351 Files with No Action Indicated (NAI). 7352 Files with Voluntary Action Indicated (VAI). 7353 Files with Official Action Indicated (OAI). 7360 Establishment Inspection and Compliance Management Systems. 7361 Input Records. 7362 DQRS Database Records. 7363 Other Database Records. 7364 Reports: Outputs. 7365 Systems Documentation.

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Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code 7000 7100

NARA Approved Citation N1-088-05-1

7110

7111

7112

7113

Compliance (Agency-wide). Recall Files. Supersedes RCS items A2-2 (NC-88-78-1), B-28 (NC 1-8896-3), D-17 (NC 1-88-83-5), F-22 (NC 1-88-78-1), O-6 (NC 188-78-1), R-11 (NC 1-88-79-1), V-5 (NC-88-78-1). Recall Action Files. Materials on each action taken regarding the recalling of unsafe, impure, or mislabeled regulated products from the market for destruction or return initiated by the producer (voluntary) or FDA (involuntary). Includes notifications of action taken, summaries of the extent and effectiveness of the recall, recall inspection reports, labels, sample analysis and photographs of recalled products, distribution information, approvals or denials, summaries of establishment inspection reports, information on consumer complaints, FDA audit checks, status reports, and related correspondence and documentation. Records Maintained in Center Program Offices. Recordkeeping copies of recall related records originated from the center such as health hazard reports/ risk assessment reports, documentation on recall classification, copies of the records originated from the field, tracking information and related records. Disposition: TEMPORARY. Cutoff after action is closed. Transfer to FRC 2 years after cutoff. Destroy/delete 20 years after cutoff. Records Maintained in Field Offices. Recordkeeping copies of recall related materials originated in the field such as audit checks, effectiveness checks, including copies of the records originated from centers, and related records. Disposition: TEMPORARY. Cutoff after action is closed. Transfer to FRC 5 years after cutoff. Destroy/delete 10 years after cutoff. Records Maintained in the Office of Regulatory Affairs (ORA). Memo on Class 1 recall actions and recommendations, Page 3 of 16 Updated on 01/06/10

N1-088-05-1

N1-088-05-1

N1-088-05-1

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

7120

7121

7122

7123

7124

duplicate copies of the recall related records maintained as working files. Records are filed by center, then recall number and year. Disposition: TEMPORARY. Cutoff after action is closed. Destroy 4 years after cutoff. Recall Enterprise System (RES). Includes data entered to track entire agency-wide recall activities by centers, ORA and field offices. This Oracle database includes the data fields such as field district name, recall number, product name and details, company, recall summary, alert date, recall strategy, recommendation date, audit information, FDA comments, and other data entered to collect, track, and analyze recall information. Maintained by the Office of Enforcement, ORA. Data Files. In addition to the data described above, firm information is directly entered into RES from the Field Accomplishment and Compliance Tracking System (FACTS) or its successor system without creating an input file. Also includes data directly loaded from center tracking systems. Disposition: TEMPORARY. Cutoff after action is closed. Delete 75 years after cutoff. Outputs: Periodic Reports and Extracted Recall Data. Regular reports generated to be part of another records such as Enforcement Report, or to be loaded onto another database. Disposition: File reports and extracted data files in an appropriate subject file. Apply disposition instructions for that file. Outputs: Reports for Public Access. Reports generated from a subset of selected recall data created as public access copies via the RES Internet application. Disposition: TEMPORARY. Destroy/delete when superseded or obsolete, or no longer needed for reference. Outputs: Ad-hoc Reports. Disposition: TEMPORARY. Destroy or delete when no longer needed for administrative or Page 4 of 16 Updated on 01/06/10

N1-088-05-1

N1-088-05-1

N1-088-05-1

N1-088-05-1

N1-088-05-1

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation N1-088-05-1

7125

7126

7127

7200

7210

operational purposes. Electronic Notifications. E-mail notifications to appropriate centers and offices alerting that information has been entered into the system for action. Disposition: TEMPORARY. Delete by recipients within 180 days after dissemination or updating is completed. System Documentation. Systems specifications, file specifications, record layouts, user business rules, input/output specifications, data dictionaries and records relating to system operation. Disposition: TEMPORARY. Destroy/delete when superseded or obsolete, or upon authorized deletion of the related master file or database, whichever is later. Backups of Files. Electronic copy, considered by the agency to be a Federal record, of the master copy of an electronic record or file and retained in case the master file or database is damaged or inadvertently erased. Disposition: TEMPORARY. Delete when the identical records have been deleted, or when replaced by a subsequent backup file. Establishment Registration and Product Listing Program. Per Section 510 of the Federal Food, Drug, and Cosmetic Act, most domestic and foreign firms engaged in the manufacture, preparation, propagation, compounding, processing, or assembling of regulated products that enter interstate commerce are required to register their establishments initially and annually. In most cases, they are also required to provide listings of their products when they initially register and report any new products, certain changes to listed products, and discontinued products periodically or at the time the changes occur. Registration and Listing Files. Includes FDA registration and listing forms or reports for both initial and amended registrations sent directly from an establishment for its annual registration, all applicable correspondence, annual registration reports and supporting Page 5 of 16 Updated on 01/06/10

N1-088-05-1

GRS 20-8b

N1-88-07-2

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

documents. Registration and listing packages may include information on the establishment or facility, contact person, the U.S. agent for foreign establishments, certification statement, cancellation reports, products, product labeling, process information, packaging and other related information. May be used for field inspections, shortages, recalls, import verification and control and other postmarket regulatory actions. Records may be maintained as imaged files, in other electronic format or in paper. Recordkeeping format is determined by Center. Supersedes NC 1-88-83-3: Items, D-24, K-25, K-29; NC 1-8883-5, D-23. Disposition: TEMPORARY. Cutoff after establishment goes out of business, or product is withdrawn or no longer marketed. Delete/destroy 10 years after cutoff. N1-88-07-2 Registration and Listing Systems. Supports premarket, postmarket and compliance activities by providing information about establishments and their regulated products. Registration and Listing data is a primary part of FDA Centers corporate management information systems, and the basis of most Centers database applications that require establishment name, address, or product information. Includes the following systems and their successor systems, but not limited to: Drug Registration and Listing System (DRLS: CDER), Registration and Device Listing System (RDLS: CDRH), Food Facility Registration Module (FFRM: CFSAN), Low Acid/Acidified Canned Foods Registration System (LACF: CFSAN), Voluntary Cosmetic Registration Program System (VCRP: CSFAN). Input Records. Page 6 of 16 Updated on 01/06/10

7220

7221

GRS 20-2a, 2b

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

Includes FDA registration and listing forms submitted electronically or on paper by establishments to FDA Centers, U.S. agent letters, correspondence and related materials (see 6.1 for disposition of recordkeeping copy of registration and listing forms). Also includes electronic records transmitted via a gateway application referred to as FDA Unified Registration and Listing System (FURLS). Disposition: TEMPORARY. Destroy after the information has been converted to an electronic medium and verified, or when no longer needed to support the reconstruction of, or serve as the back up to, the master file, whichever is later. N1-88-07-2 Database Records. Includes data fields such as establishment name and address, production site information, type of ownership or establishment, registration number, reason for update, date of updated annual registration report, submitters data and other firm related information. Product listings may include information such as product proprietary name, common name, firm name and address, product classification number, reason for submission, product type, establishment identifier, and other related information. Supersedes NC 1-88-79-2, Item F-69. Disposition: TEMPORARY. Cutoff after establishment goes out of business or product is not commercially marketed. Delete/destroy 10 years after cutoff or when no longer needed for legal, research, historical or reference purposes, whichever is the latest. If data are migrated into a new system or replaced by a successor system, delete/destroy after the verification of successful data migration. Reports: Output Records. GRS 20-4, 5, 6, Includes ad-hoc reports generated for reference use and 7, 12, 16 routine reports produced at an application level that are used for reports such as annual registration reports. For extracted data automatically loaded into other systems, apply disposition authorized for appropriate corresponding Page 7 of 16 Updated on 01/06/10

7222

7223

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

systems. Disposition: TEMPORARY. Delete when the agency determines that they are no longer needed for administrative, legal, audit, or other operational purposes. Monthly Registration and Listing Web Reports: Output Records. Releasable registration and listing information under the Freedom of Information Act posted monthly on the web for public access. Disposition: TEMPORARY. Delete/destroy when no longer needed for public access. Notifications, Confirmations, Verifications: Output Records. Letters of notifications, confirmations and verification regarding status and issues relating to facility registration submissions. Disposition: TEMPORARY. Delete/destroy when no longer needed for administrative or reference purposes. Systems Documentation. Includes systems operations manuals, user manuals, data dictionary, requirements documents and other systems related materials. Disposition: TEMPORARY. Destroy/delete upon authorized deletion of the related electronic records or upon the destruction of the output of the system if the output is needed to protect legal rights, whichever is later. Establishment Inspections and Compliance Action Files. Records copies of the domestic establishment inspection reports and related compliance files are maintained by ORA District Offices. Files are also known as Establishment Files (EF) in the Field. Records copies of the international establishment inspection Page 8 of 16 Updated on 01/06/10

7224

N1-88-07-2

7225

N1-88-07-2

7226

GRS 20-11a(1)

7300

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

reports and related compliance files are maintained by the assigning Center. 7310 BIMO Domestic Inspection and Compliance Action Case Files. Under the Bio-Research Monitoring (BIMO) Program, FDA inspects clinical investigators, sponsors, monitors, contract research organizations (CROs), Institutional Review Boards (IRBs), non-clinical (GLP) laboratory facilities, and bioequivalence facilities. Inspections of establishments that conduct studies of products intended for final use in humans but which are initially being tested in animals are also covered under this program. BIMO Domestic Inspection Files: Include Establishment Inspection Reports (EIR) for domestic firms including any attachments or exhibits related to the inspection; postinspection correspondence to and from the inspected firm; memos, summaries of conference calls, e-mails, and other internal documents related to the inspection; summary database reports; referral records; and other related materials. BIMO Compliance Action Case Files: Include records on compliance actions (e.g., regulatory or legal actions) and supporting materials that are maintained by FDA Centers. May include correspondence related to the pre-approval and/or post-marketing inspections and reviews of the firms and facilities; copies of establishment inspection reports, exhibits, attachments, and investigation records; sample collection reports; complaints; copies of field laboratory test records; regulatory/enforcement letters (such as warning letters, untitled letters, cyber letters, Notices of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOEs)); warrants; precedents; reports on final actions and action items; legal interpretations; and records related to the compliance history of regulated products and establishments. Reference materials from public sources such as the Federal Register may be included. Page 9 of 16 Updated on 01/06/10 N1-088-09-1

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

May include duplicate copies of litigation case files and other related records for which the records copies are maintained by the Office of Chief Counsel. Certain records may contain personal information that cannot be publicly disclosed; disclosure is subject to the Freedom of Information Act, the Trade Secrets Act, the Privacy Act, and restrictions in other statutes and FDA's implementing regulations. 7311 Files with No Action Indicated (NAI). Supersedes NC1-88-78-1, items A2-1a, A2-1b, A2-3, X-7, V-9, V-10; NC1-88-83-4, item X-14; NC1-88-83-5, Items 3 and 10; N1-88-03-3, Item 1. Disposition: TEMPORARY. Cutoff at the end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. Files with Voluntary Action Indicated (VAI). Supersedes NC1-88-78-1, items A2-1a, A2-1b, A2-3, X-7, V9, V-10; NC1-88-83-4, item X-14; NC1-88-83-5, Items 3 and 10; N1-88-03-3, Item 1. Disposition: TEMPORARY. Cutoff at the end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. Files with Official Action Indicated (OAI). Supersedes NC1-88-78-1, items A2-1a, A2-1b, A2-3, X-7, V9, V-10; NC1-88-83-4, item X-14; NC1-88-83-5, Items 3 and 10; N1-88-03-3, and Item 1. Disposition: TEMPORARY. Cutoff at the end of the fiscal year after the case is closed. Transfer paper records to the Federal Records Center (FRC) 5 years after cutoff. Delete/destroy 30 years after cutoff. N1-088-09-1 OAI Files Resulting in Investigator Disqualification. Files relating to clinical investigator disqualification pursuant Page 10 of 16 Updated on 01/06/10

7312

7313

7320

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

to a Part 16 Regulatory Hearing process. Used as legal opinion precedent files for application throughout FDA. Included are Presiding Officer Reports, Commissioners Decisions, legal opinions, directly related memorandums, copies of laws, and related documents. Certain records may contain personal information that cannot be publicly disclosed; disclosure is subject to the Freedom of Information Act, the Trade Secrets Act, the Privacy Act, and restrictions in other statutes and FDA's implementing regulations. Disposition: TEMPORARY. Cutoff at end of the fiscal year after the final action. Delete/destroy 75 years after cutoff, or when no longer needed for administrative, legal, or reference purposes, whichever is the latest. BIMO Referral Records maintained in the Referral Office. Includes duplicate copies of correspondence from and responses to various organizations (e.g., the HHS Office for Human Research Protections; IRBs that have terminated or suspended research; clinical investigators or others who file complaints about the conduct of clinical research) that are referred to a responsible Center for information or follow-up. Records copies are maintained by Centers as part of the BIMO inspection files. Disposition: TEMPORARY. Cutoff at end of the fiscal year either when the correspondence was received or when a response was sent, whichever is later. Delete/destroy 3 years after cutoff. 7340 GMP Domestic Inspection and Compliance Action Case Files. Under the Current Good Manufacturing Practices (CGMP) inspection program which includes routine surveillance, preapproval (NDA/BLA), and for-cause inspections, FDA Page 11 of 16 Updated on 01/06/10

7330

N1-088-09-1

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

inspects manufacturing and testing establishments. Includes Establishment Inspection Reports (EIR) for domestic firms including any attachments or exhibits related to the inspection and other inspection related records originated by the Field. Also includes post inspection communications such as VAI letters and approval memos for administrative/legal actions that are originated by Centers. Certain records may contain personal information that cannot be publicly disclosed; disclosure is subject to the Freedom of Information Act, the Trade Secrets Act, the Privacy Act, and restrictions in other statutes and FDA's implementing regulations. N1-088-09-1 Files with No Action Indicated (NAI). Disposition: TEMPORARY Cutoff at end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. N1-088-09-1 Files with Voluntary Action Indicated (VAI). Disposition: TEMPORARY Cutoff at end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. N1-088-09-1 Files with Official Action Indicated (OAI). Disposition: TEMPORARY. Cutoff at end of the fiscal year after the case is closed. Transfer paper records to the Federal Records Center (FRC) 5 years after cutoff. Delete/destroy 30 years after cutoff. International Establishment Inspection and Compliance Action Case Files. Includes records of the complete files covering both GMP and BIMO foreign inspections that are maintained by the assigning center. Includes signed original international inspection files, including exhibits and related correspondence such as responses from the investigated firms and corrective action plans. Certain records may contain personal information that cannot Page 12 of 16 Updated on 01/06/10

7341

7342

7343

7350

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

be publicly disclosed; disclosure is subject to the Freedom of Information Act, the Trade Secrets Act, the Privacy Act, and restrictions in other statutes and FDA's implementing regulations. Supersedes NC1-88-78-1, item O-11; NC1-88-79-1, item R-9. N1-088-09-1 Files with No Action Indicated (NAI). Disposition: TEMPORARY. Cutoff at end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. 7352 Files with Voluntary Action Indicated (VAI). N1-088-09-1

7351

7353

Disposition: TEMPORARY. Cutoff at end of the fiscal year when the final classification of inspection occurs. Delete/destroy 10 years after cutoff. N1-088-09-1 Files with Official Action Indicated (OAI). Disposition: TEMPORARY. Cutoff at end of the fiscal year after the case is closed. Transfer paper records to the Federal Records Center (FRC) 5 years after cutoff. Delete/destroy 30 years after cutoff. Establishment Inspection and Compliance Management Systems. Provides case management and tracking functionality for domestic and international inspections, compliance and regulatory activities. Includes tracking data on inspection and compliance status, assignment, completion date, date received, date forwarded, date response sent and other related information. Includes the following systems or their successor systems maintained by lead Center offices, but not limited to: Establishment Evaluation System (EES: CDER): Tracks the progress and results of the inspections in support of CDERs drug approval activities; Drug Quality Reporting System (DQRS: CDER): Maintains the information received from a field alert reporting process, Page 13 of 16 Updated on 01/06/10

7360

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

post market studies and compliance related activities to help determine if problems are a result of drug quality issues and to help resolve the problems; Bio-Research Monitoring System (BRMS: CDRH): Provides tracking functionality for CDRH Bio-Research Monitoring Program (BIMO) records; Foreign Inspection Tracking Systems (FITS: Centers): FITS tracks compliance, pre- and post-market inspections, and review of inspection documents of foreign firms. FITS captures inspection assignment and inspection summary reports and internal work processes. For records maintained as part of the Mission Accomplishment and Regulatory Compliance Services/Compliance Management System (MARC/CMS), follow records retention instructions for that series. Certain records may contain personal information that cannot be publicly disclosed; disclosure is subject to the Freedom of Information Act, the Trade Secrets Act, the Privacy Act, and restrictions in other statutes and FDA's implementing regulations. GRS 20 Item Input Records. In addition to data electronically entered from the ORAs 2a4 compliance tracking systems such as Field Accomplishments and Compliance Tracking System (FACTS) or its successor system, records are manually input from various documents from domestic and international inspection and compliance action case files. Disposition: TEMPORARY. Apply disposition schedule authorized for appropriate subject case files. If records are used for input or scanning only, destroy after the information has been converted to an electronic medium and verified, when no longer needed for legal or audit purposes or to support the reconstruction of, or serve as a backup to, the electronic records, or 60 days after NARA has been provided the notification required by 36 CFR 1228.31(b)(1)(i), whichever is later. Page 14 of 16 Updated on 01/06/10

7361

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code 7362

DQRS Database Records. Includes product name, lot and expiration date of drug product, nature of problem, tracking code and other related data.

NARA Approved Citation N1-088-09-1

7363

Disposition: TEMPORARY. Cutoff after last system update or reference query. Delete data 30 years after cutoff or when no longer needed for reference, whichever is later. If data are migrated onto a new system, delete/destroy after the verification of successful data migration. N1-088-9-1 Other Database Records. Includes data fields such as action type, fiscal year, country of origin, submitting District, submitter, firm, industry code, product code, sample number, date/time received, date entered into system and other related data. Supersedes NC1-88-83-5, Item 24. Disposition: TEMPORARY. Cutoff records at the end of the calendar year after the case is closed. Destroy 20 years after cutoff or when no longer needed for reference, whichever is later. If data are migrated onto a new system, delete/destroy after the verification of successful data migration. GRS 20 Items Reports: Outputs. Includes routine status, statistical or ad-hoc reports generated 4, 5, 6, 7, 12, 16 by users. Disposition: TEMPORARY. Delete/destroy when obsolete or superseded. If reports are maintained with other records described in another records series, apply disposition authorized for that series. Systems Documentation. Includes systems operations manuals, user manuals, data dictionary, requirements documents, and other systems related materials. Disposition: TEMPORARY. Destroy/delete when superseded or obsolete, or upon Page 15 of 16 Updated on 01/06/10

7364

7365

GRS 20 Item 11a1

Programmatic Records Schedules-Compliance (Agency-wide) File Codes: 7000 through 7365 File Code Prefix: FDA Records Description and Authorized Disposition

File Code

NARA Approved Citation

authorized deletion of the related master file or database, or upon the destruction of the output if the output is needed to protect legal rights, whichever is latest.

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