Regulatory Information
-
-
Privacy Act
FDA is pleased to provide the following materials regarding the Agency's privacy program.
-
Privacy Program Resources
Privacy Act of 1974 - FDA Privacy Act Regulations - 21 CFR, Part 21
HHS Privacy Act Regulations Privacy Act Issuances (National Archives and Records Administration compilations from 1995-forward) DOJ Privacy Act Overview 2010 - FDA Privacy Impact Assessment (PIAs) for Information Systems published Feb. 13, 2012
FDA Privacy Impact Assessment (PIAs) for Information Systems published May 23, 2012 FDA Third-Party Website and Application Use PIAs
-
The following Systems of Records Notices (SORNs) are specific to systems maintained by FDA.
-
Privacy Act Systems of Records Notices (SORNs)
- 09-10-0002 Regulated Industry Employee Enforcement Records, HHS/FDA/OC
09-10-0003 FDA Credential Holder File, HHS/FDA/OC 09-10-0004 Communications (Oral and Written) With the Public, HHS/FDA/OC - 09-10-0005 State Food and Drug Official File, HHS/FDA/ORA
09-10-0007 Science Advisor Research Associate Program (SARAP), HHS/FDA/ORA 09-10-0008 Radiation Protection Program Personnel Monitoring System, HHS/FDA/CDRH 09-10-0009 Special Studies and Surveys on FDA-Regulated Products, HHS/FDA/OM 09-10-0010 Bioresearch Monitoring Information System, HHS/FDA 09-10-0011 Certified Retort Operators, HHS/FDA/CFSAN 09-10-0013 Employee Conduct Investigative Records, HHS/FDA/OM 09-10-0017 Epidemiological Research Studies of the Center for Devices and Radiological Health, HHS/FDA/CDRH 09-10-0018 Employee Identification Card Information Records, HHS/FDA/OC 09-10-0019 Mammography Quality Standards Act (MQSA) Training Records, HHS/FDA/CDRH 09–10–0020 FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC 09-10-0021 FDA User Fee System, HHS/FDA
-
The following FDA Privacy Act systems are associated with one or more SORNs. The applicable FDA, HHS and/or Government-wide SORNs are identified by number following the system name. The Privacy Impact Assessments (PIAs) noted above under Privacy Program Resources contain descriptions of the systems.
-
FDA Systems Associated With Other SORNs
- Agency Information Management System (FDA/OC): 09-10-0004 Communications (Oral and Written) With the Public, HHS/FDA/OC
- Agency Information Management System (FDA/OC): 09-90-0008 Conflict of Interest Records, HHS/OS/ASPER
- Agency Information Management System (FDA/OC): 09-90-0058 Freedom of Information Case Files and Correspondence Control Log, HHS/OS/ASPA/FOIA
- Agency Information Management System (FDA/OC): OGE-1 Executive Branch Personnel Public Financial Disclosure Reports and Other Name-Retrieved Ethics Program Records
- Agency Information Management System (FDA/OC): OGE-2 Executive Branch Confidential Financial Disclosure Reports
- Agency Information Management System (FDA/OC): OPM/Central-9 Personnel Investigations Records
- Enterprise Administrative Support Environment System (FDA/OC): 09-90-0018 Personnel Records in Operating Offices, HHS/OS/ASPER
- Mission Accomplishment and Regulatory Compliance System - Compliance Management Services (FDA/ORA): 09-10-0010 Bioresearch Monitoring Information System, HHS/FDA
- Mission Accomplishment and Regulatory Compliance System Domestic – Field Accomplishments and Compliance Tracking System (FDA/ORA): 09-10-0010 Bioresearch Monitoring Information System, HHS/FDA
- Turbo Establishment Inspection Reports (FDA/ORA): 09-10-0002 Regulated Industry Employee Enforcement Records, HHS/FDA/OC
- Turbo Establishment Inspection Reports (FDA/ORA): 09-10-0010 Bioresearch Monitoring Information System, HHS/FDA
- Hewlett Packard (HP) Service Manager 9.30 System (FDA/OC): 09-90-0018 Personnel Records in Operating Offices, HHS/OS/ASPER
- Hewlett Packard (HP) Service Manager 9.30 System (FDA/OC: 09-90-0777 Facility and Resource Access Control Records
- Hewlett Packard (HP) Service Manager 9.30 System (FDA/OC): 09-90-0024 Financial Transactions of HHS Accounting and Finance Offices
- Hewlett Packard (HP) Service Manager 9.30 System (FDA/OC): OPM/GOVT-1 General Personnel Records
- Physical Security System (FDA/OC): 09-90-0018 Personnel Records in Operating Offices, HHS/OS/ASPER
- Physical Security System (FDA/OC): 09-90-0777 Facility and Resource Access Control Records
- Records Management Training System (FDA/OC): 09-90-0018 Personnel Records in Operating Offices, HHS/OS/ASPER
-
-
-
