Regulations Development - Background
Regulations are generally implemented using a two step process. First, the agency publishes a Notice of Proposed Rulemaking (NPRM) in the Federal Register and the public is given a specified period of time to comment on the rule. After the comments are reviewed and analyzed, the agency publishes the final rule. If FDA determines that circumstances have changed significantly since the publication of a proposed rule, FDA may reopen the comment period to allow the public to submit additional comments before finalizing the proposed rule.
Pursuant to Executive Order 12866, FDA must publish a regulatory agenda that contains regulations under development or review at the agency. Regulations that the agency plans to work on during the next 12 months are included in the agenda. This includes any plans to publish an Advance Notice of Proposed Rulemaking (ANPRM), a NPRM, or a final rule. For each planned regulation, FDA provides in its regulatory agenda, among other things:
- brief summary of the action,
- legal authority for the action,
- projected date for completion of at least the next step for the regulatory action (dates for all past steps are included),
- statutory deadlines, if any, and
- the agency’s priority for the regulation.
Any actions or reviews of regulations that have been completed or withdrawn since the last regulatory agenda was published are also included.
Twice a year, the federal government issues the Unified Agenda of Federal Regulatory and Deregulatory Actions, a compilation of regulatory agendas published by federal agencies.
An informal survey of the projected dates for regulatory action included in regulatory agendas published by FDA since May 2005 indicates that FDA should work with the Department of Health and Human Services and the Office of Management and Budget to better manage the regulations development process so that the projected timetables are more accurate. A review of 68 proposed regulations included in FDA’s regulatory agenda during this time period reveal that only 7 regulations were published by the date projected in the regulatory agenda. Six regulations were published within 6 months of the projected date, but the vast majority of the regulations were published two years or more after the projected date (some of these regulations are yet to be published).
FDA hosts training workshops for industry to explain agency procedures. FDA employees also frequently participate in educational events hosted by others. These events occur as the need arises, and oftentimes occur during the implementation of final rules.