3.9 Public Notice
FDA Public Posting and Availability of Comments Submitted to FDA Dockets
In the past, FDA generally did not publicly post on the www.regulations.gov docket comments individuals submitted in their individual capacities out of concern that individuals, when submitting their comments, may not have realized that their names, addresses, and identifying information would be publicly viewable. In 2010, part of its Transparency Initiative, FDA proposed changing this practice “so that comments submitted at http://www.regulations.gov from people self-identified as individual consumers are posted on that website in the same manner as other comments.” On September 18, 2015, FDA implemented this draft proposal by announcing that it will generally post comments from people self-identified as individual consumers as it posts other comments on that website.
This practice will increase the transparency and public utility of FDA’s public dockets, thereby better enabling its public dockets to meets their intended functions of sharing information and encouraging an open exchange of ideas. FDA will include new information and standard instructions for submitting comments in all Federal Register documents requesting or providing for the submission of comments. The instructions will explain how to submit comments to the docket on that particular document via electronic means and also will explain the process for submission of comments, in written/paper format, that the commenter wishes to mark as confidential.
FDA Office of Regulatory Affairs (ORA) Enforcement Report using internet RES (iRES)
The iRES system was launched in March 2016 and fully automates the posting of recall data to the Enforcement Report (Title 21 CFR Part 7.50) by eliminating many of the manual aspects of previous methods and allowing records to be available to the public sooner. In mid-2012, FDA began using iRES, which utilizes a database that is populated directly from FDA’s internal Recall Enterprise System (RES), to make available to the public weekly reports of classified recalls and to allow for searching and displaying of all recall records in the database. Recall data are propagated to this database when Centers identify that a recall is ready to be posted to the internet. iRES allows for newly classified recalls and for updates or corrections to recalls already published in the Enforcement Report to be made more readily available to the public. Future enhancements to iRES (which are slated for October 2016) improve searching ability in the weekly Enforcement Report and allow manipulation of the dataset returned in a query, as well as improve support for using the Enforcement Report on mobile devices.
Enforcement Report recall data can also be queried using the iRES application programming interface (API) which allows IT systems to query recall data, minimizing the need for the manual review, download, and data entry steps needed to enter recall data into other systems. Printable views of the weekly Enforcement Report and exporting to .csv format are also available in order to provide as many options as possible for the public to view recall records.
FDA Inspections Database
The Inspections Database, first published in mid-2011, is an online database providing the public with access to a central repository of FDA conducted inspections. The database displays inspection information such as firm name and location, Inspection End Date, Program Area, and final inspection classification (i.e., NAI, VAI, and OAI) and is updated twice a year. Posting the final inspection classification provides the public with rationale for FDA’s enforcement actions, seeks to promote informed marketplace choices made by the public and industry, helps to encourage compliance, and improves the public’s understanding of how FDA works to protect the nation’s health. Future enhancements include streamlining publishing updates to the web and increasing the frequency of the updates.
FDA Data Dashboard
The FDA Data Dashboard, launched September 2014, provides the public a cloud-based, dynamic tool to access FDA transparency data using data visualizations and an enhanced user experience. The Data Dashboard presents FDA data pertaining to inspections, compliance and recalls in easily understood graphical formats, enables drill-down capability from graphs to view the underlying data and filtering on underlying data to limit results, and allows export of both graphs and underlying data. In addition, the Data Dashboard builds relationships between the various datasets that are ingested and displays compiled information all in one location. Future enhancements to the Dashboard, scheduled for 2017, consist of increasing the amount and diversity of the data available through the Dashboard to include imports (i.e., Refusals, import lines, etc.) and developing dashboards related to programs in the Food Safety and Modernization Act.
FDA Filer Evaluations Outcome Report
Commonly known as the filer report on FDA’s external website, the FDA Filer Evaluations Outcome Report was established several years ago to provide trade statuses of Filers that import regulated products into the United States. The report provides what is known as the status to the public on a dedicated webpage along with any explanations and displays information demonstrating whether a Filer has had any issues. With this report, the public can see whether the Filer is new to importing FDA-regulated products or obtain the history of the latest evaluation conducted on the Filer. The report is updated on a monthly basis to help provide the most current information available.
FDA Import Web Project
The project is designed to update FDA’s web presence to provide clear and understandable information to the public about FDA’s import coverage and operations. Over the past two years, the Division of Import Operations and Office of Communications have developed content and posted more than 40 webpages covering all aspects of FDA’s import operations, describing the entry process and FDA field operations, enforcement actions taken by FDA, import data systems, points of contact throughout the Agency, and resource links for the importing community. The final pages were posted in July 2016 and are currently available on FDA.gov. FDA will formally announce this new web presence via internal and external communications in September 2016. The new webpages provide transparency into FDA’s import program and will provide better understanding of FDA’s import operations to the regulated import community and to the public.
FDA Food Safety Modernization Act – High Risk and Non-Risk Inspections
The Food Safety Modernization Act established a mandated inspection frequency for food facilities that must register under the Bioterrorism Act that is risk-based in part. All “high-risk” domestic facilities must be inspected within five years of FSMA enactment and no less than every three years thereafter. All “non high-risk” domestic facilities must be inspected within seven years of enactment and no less than five years thereafter. FDA will make publicly available the criteria used in defining “high risk” and “non high-risk” domestic food facilities. In addition, at the end of each fiscal year, the agency will make available the number of high risk and non-high risk inspections for each state.
