FDA Seeks Comments on Its Plan to Review Existing Regulations
The Food and Drug Administration is requesting comments by June 27, 2011, to help it review its framework for analyzing existing regulations to determine whether they should be modified, streamlined, expanded, or repealed, pursuant to Executive Order 13563, "Improving Regulation and Regulatory Review1."
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
(FDA currently reviews existing regulations when legislative change occurs. Recent legislative changes for which FDA has developed implementing regulations and has taken the opportunity to modify or revoke related regulations as appropriate include the FDA Amendments Act of 2007 (FDAAA), the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009, and the Food Safety Modernization Act (FSMA) in 2011.)
Review to Determine if Regs Can be Made More Effective, Less Burdensome
The goal of this review is to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives in light of current public health needs and to take advantage of and support advances in innovation.
Comments Sought on How FDA Should Revise its Framework of Reviewing Regs
FDA is first seeking comment on how it could revise its existing review framework to develop a plan with a defined method and schedule to expand on those regulations that work and to modify, improve, or rescind those that do not. FDA is particularly interested in how well its current processes for reviewing regulations function and how those processes might be expanded or otherwise adapted to meet the objectives of EO 13563. FDA is further interested in comments about factors that it should consider in selecting rules for review and prioritizing review.
FDA states that comments should address how it can best obtain and consider accurate, objective information and data about the costs, burdens, and benefits of existing regulations and whether there are existing sources of data that FDA can use to evaluate the post-promulgation effects of regulations over time.
Comments Should Focus on Regs that Impede Innovation, Are Deficient
To support its efforts to support innovation, FDA is particularly interested in comments that identify regulations that may be impediments to innovation and suggestions for how they can be improved. Comments should also focus on regulations that have demonstrated deficiencies. The public should focus on rule changes that will achieve a broad public impact, rather than an individual personal or corporate benefit. FDA additionally notes that this review is for published final rules and that the public should not use this process to submit comments on proposed rules.
1EO 13563 directs each federal agency to develop a preliminary plan, consistent with law and its resources and regulatory priorities, under which the agency will periodically review its existing significant regulations to determine whether such regulations should be modified, streamlined, expanded or repealed to make the agency’s regulatory program more effective and or less burdensome in achieving its regulatory objectives. (See ITT’s Online Archives or 01/19/11 news, 11011915, for BP summary.)
(See ITT's Online Archives or 04/27/11 news, 11042721, for BP summary of the Office of Information and Regulatory Affairs offering guidance for agencies on the process of finalizing their regulatory reviews.)
FDA Contact -- Lisa Helmanis (301) 796-9135
(DN FDA-2011-N-0259, FR Pub 04/27/11)