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Number of Congressional correspondence and information or briefing requests received that month

Dictionary: Congressional requests as tracked by the AIMS system including 1) general information requests, 2) constituent related requests, 3) requests for technical assistance on legislation, 4) review and comment on letters produced by OL, 5) letters expressing concerns from Congress, 6) questions for the record related to hearings, 7) briefing requests, and 8) document requests. AIMS tracks formal written letters, as well as verbal requests for information that are conveyed in email from the Office of Legislation (OL).

These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

• FY 2010
• FY 2011
• FY 2012
• All

Number of ongoing Government Accountability Office (GAO) and Office of the Inspector General (OIG) assessments and investigations managed that month

Dictionary: OEP considers a GAO or OIG study to be open when we receive the request from the agency GAO/OIG liaison. OEP considers a GAO or OIG study to be closed when OEP receives notice from the agency GAO/OIG liaison that the final report has been posted, or, if no report is to be posted, the agency liaison notifies OEP that GAO or OIG considers the study to be closed. OEP tracks these notifications in AIMS and also in an internal database. The total number of open studies for a month is equal to the number of ongoing studies plus the number of newly opened studies that month minus the number of studies closed that month.

Number of International inquiries that month

Dictionary: International requests as tracked by the AIMS system including 1) general information requests, 2) teleconference requests, 3) document requests, 4) visit requests, 5) documents for review and comment, 6) information provided by international regulatory counterparts to the FDA (FYI), and 7) FDA requests for information from international regulatory counterparts. AIMS tracks formal written requests as well as verbal and email requests.