FDA may consider whether to add specific search criteria (e.g., those that  would enable product-specific or violation-specific searches) to its  inspections database to make it user-friendly and improve data analysis. The  idea was included in a list of eight 

 for increasing transparency that the agency published on Oct.  3, 2011. FDA also proposed introducing sophisticated search capability, such as  predictive name searches.

  Other draft proposals in the list aim to improve data quality and facilitate  timely data disclosure. The agency may consider adopting various tools, including  new technologies for investigators, process improvements, or administrative  incentives. These tools would be intended to expedite data entry and expedite  inspection review and classification. FDA also proposed to examine how  frequently data should be updated for it to be useful to stakeholders.

  Another draft proposal would provide context for compliance and enforcement  data to help ensure that the data are not misinterpreted or misused. The  proposal document gives the following examples of appropriate contextual  information:

Information regarding how frequently data are updated

Information regarding the reliability of the data

Information regarding the average lapse of time between  an inspection and the posting of inspection-classification information

Definitions of inspection classification types

A statement explaining that the website’s lack of  information regarding a particular facility does not imply compliance or  noncompliance.

Other draft proposals relate to FDA’s presentation of compliance and  enforcement data. For example, the agency may consider how to present the data  graphically and better use mobile web applications to attract users and  encourage data analysis. FDA also proposes to explore ways to better use social  media, agency-sponsored webinars, and automatic email notifications to better  communicate with the public.

  The agency’s draft proposals are part of its response to President Obama’s  Memorandum on Regulatory Compliance of Jan. 18, 2011, which requires federal  agencies to make public compliance information easily accessible, downloadable,  and searchable online. FDA examined the ways that the Environmental Protection  Agency and the Department of Labor disclose compliance and enforcement  information before creating its list of draft proposals.

  FDA is soliciting public comment on the draft proposals for 60 days. Comment  may be submitted at 

. After comments have been received, the  agency’s Transparency Task Force will recommend specific draft proposals to the  commissioner, who will determine whether to adopt them by Jan. 31, 2012.

News

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.