Regulatory Information
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Privacy Act
FDA is pleased to provide the following materials regarding the Agency's privacy program.
The following Systems of Records Notices (SORNs) are specific to systems maintained by FDA.
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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
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The following Systems of Records Notices (SORNs) are specific to systems maintained by 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.
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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
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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.
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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
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