| HHS Privacy Impact Assessment (PIA) Summary |
| FDA: FDA ORA TurboEIR (Turbo) |
| Summary of PIA Required Questions |
| The following required questions represent the information necessary to complete the PIA Summary for transmission to the Office of Management and |
| Budget. Note: If a question or its response is not applicable, please answer “No” to that question. |
1
System:
FDA ORA TurboEIR (Turbo)
2
Is this a new PIA?
No
3
| If this is an existing PIA, please provide a reason |
| for revision: |
PIA Validation
4
Date of this Submission:
Aug 10, 2007
5
OPDIV Name:
FDA
6
Unique Project Identifier (UPI) Number:
009-10-01-02-02-1070-00-110-246
7
Privacy Act System of Records (SOR) Number:
09-10-0002
8
OMB Information Collection Approval Number:
N/A
9
Other Identifying Number(s):
N/A
10
System Name:
FDA ORA Turbo Establishment Inspection Report (EIR)
11
| System Point of Contact (POC). The System POC |
| is the person to whom questions about the system |
| and the responses to this PIA may be addressed: |
Agnes Kivuvani
12
Provide an overview of the system:
| The Turbo EIR Field Agent application provides a standardized |
| database of citations, and assists the investigator in preparation of |
| the FDA Form 483 and the Establishment Inspection Report (EIR). |
| FDA field investigators annually conduct approximately 17,000 |
| establishment inspections. A Food Drug and Cosmetic Act |
| requirement of the inspectional process is to report (in writing) certain |
| types of adverse observations to the management of the inspected |
| firm at the conclusion of the inspection. About forty percent of all |
| inspections result in the issuance of an FDA 483. The FDA 483 is the |
| written report listing the adverse observations observed by the |
| investigator. |
| The investigators must also generate a comprehensive narrative for |
| each inspection. These narratives are known as Establishment |
| Inspection Reports (EIRs) and are commonly prepared with word |
| processing software. Turbo EIR Field Agent provides onscreen |
| guidance to the investigator for preparation of the EIR. Turbo on the |
| Web is a web browser-based application that allows FDA users to |
| retrieve FDA 483 and EIR documents via the FDA intranet. |
13
| Indicate if the system is new or an existing one |
| being modified: |
Existing
14
| Does/Will the system collect, maintain (store), |
| disseminate and/or pass through IIF within any |
| database(s), record(s), file(s) or website(s) hosted |
| by this system? |
Yes
15
Is the system subject to the Privacy Act?
Yes
16
| If the system shares or discloses IIF please specify |
| with whom and for what purpose(s): |
| The information is shared with various compliance/management |
| operational divisions (such as Center for Biologics Evaluation and |
| Research, Center for Drug Evaluation and Research, Center for |
| Food Safety and Applied Nutrition, Center for Devices and |
| Radiological Health, Center for Veterinary Medicine) in the FDA that |
| perform enforcement, analysis, and trending. |
| Note on IIF: Any question about IIF seeks to identify any, and all, personal information associated with the system. This includes any IIF, whether or not it |
| is subject to the Privacy Act, whether the individuals are employees, the public, research subjects, or business partners, and whether provided voluntarily |
| or collected by mandate. Later questions will try to understand the character of the data and its applicability to the requirements under the Privacy Act or |
| other legislation. Note: If no IIF is contained in the system, please answer the remaining required questions, then promote the PIA to the Sr. Privacy |
| Official who will authorize the PIA. Note: If this system contains IIF, all remaining questions on the PIA Form Tabs must be completed prior to signature |
| and promotion. |