| HHS Privacy Impact Assessment (PIA) Summary |
| FDA: FDA ORA TurboEIR (Turbo) |
| Describe in detail the information the agency will |
| collect, maintain, or disseminate and why and for |
| what purpose the agency will use the information: |
| Turbo EIR Field Agent gathers data on the specific violations |
| observed during the inspection and proceedings that transpire during |
| the course of the inspection. Those data (and the FDA 483 items |
| themselves) are then uploaded to a central database where they are |
| available in the FDA for analysis and trending. The EIRs are also |
| available online. The standardization inherent in Turbo EIR reduces |
| inconsistency and lack of uniformity in the FDA 483 process. |
| Specific personally identifiable information collected by Turbo EIR is |
| names of establishment employees that participated in the FDA |
| inspection. The collection of these names is to identify the most |
| responsible person at the establishment and to note how |
| establishment employees participated in the conduct of the |
| inspection. These names are not used by the Turbo EIR system for |
| data searches. The information is provided voluntarily. |
| Assigned an inspection, the investigator travels to the establishment |
| to perform it. If the investigator observes adverse conditions they are |
| linked to the FDA citation database in Turbo EIR Field Agent. Within |
| Turbo EIR Field Agent the investigator is then able to provide |
| specific information relating to each observation. When all |
| observations and specifics are recorded Turbo EIR Field Agent prints |
| the FDA 483. The investigator then meets with the management of |
| the firm and explains the adverse observations recorded. At this |
| point the firm’s management has an opportunity to have their |
| comments added to the FDA 483. At the end of the management |
| meeting the investigator presents the final FDA 483 (with comments) |
| to the firm’s management and the inspection is complete. Afterwards |
| the investigator using Turbo EIR Field Agent authors the Establish |
| Inspection Report (EIR). An EIR is created for each inspection, even |
| if a FDA 483 is not issued. The EIR is a comprehensive report of the |
| inspection and contains information needed to support the Violation |
| Letter process and of interest to FDA management. The above |
| activites directly support the FDA's responsability to regulate food, |
| drug and devices. |
| Does the website have any information or pages |
| directed at children under the age of thirteen? |
| Are there policies or guidelines in place with regard |
| to the retention and destruction of IIF? |
| The information contained within TurboEIR is protected by several |
| layers of administrative, physical, and technical controls in |
| accordance with policies and regulations from the FDA, NIST, and |
| OMB. All applicable security controls are reviewed on a periodic |
| basis to ensure that they are implemented correctly, operating as |
| intended, and producing the desired result of protecting all |
| information within TurboEIR. |
| PIA-HHS-Form |
| Report Date: 8/13/2007 |
| Page: 95 |
| 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. |