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On February 2, 2011, President Barack Obama issued Executive Order (E.O.) 13563, “Improving Regulation and Regulatory Review.” One of the provisions in the new Executive order is the affirmation of retrospective reviews of existing significant regulations. FDA already has several processes in place to ensure periodic review of its existing regulations, including those that are significant, and will continue to enhance these efforts. Under E.O. 13563, FDA is reviewing this framework for retrospective review of regulations and, through this notice, is soliciting comments on ways to make this program more effective.
FDA is responsible for protecting the public health by: (1) Ensuring the safety and efficacy of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety and security of our nation's food supply, products that emit radiation, cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. FDA also promotes the public health by striving to foster innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
Currently, FDA has three main mechanisms that trigger a retrospective review of an existing regulation. First, a retrospective review may occur when there is a significant change in circumstances, such as advances in technology, new data or other information, or legislative change. Second, whenever FDA is revising an existing regulation, it reviews that regulation to determine if the underlying science and policy are still valid and whether the regulations should be updated based on current science, policy, data, or technology. The third mechanism is FDA's Citizen Petition process. Under 21 CFR 10.30, FDA provides a mechanism for the public to request the Commissioner of Food and Drugs to issue, amend, or revoke a regulation by submitting a Citizen Petition.
Other ongoing mechanisms that FDA uses to target specific audiences are biannual letters to State and Local government officials and small business entities, which are also posted on FDA's Web site. These letters highlight upcoming regulations that FDA believes may have an impact on these two groups. In addition, FDA uses the Federal Government's biannual Unified Agenda of Federal Regulations (Unified Agenda) to announce reviews conducted under section 610(c) of the Regulatory Flexibility Act (RFA). In section 610(c), Federal Agencies are required within 10 years of the effective date of regulations that have a significant economic impact on a substantial number of small entities to review the regulation and seek public input on the continued need for the regulation or on possible changes to the regulation.
Since the 1980s, FDA has participated in a variety of reviews to streamline and improve its regulatory processes. For example, as previously mentioned, section 610(c) of the RFA requires Agencies to review their regulations to determine whether the rules should be continued without change, amended, or rescinded to minimize any significant economic impact on a substantial number of small entities. These reviews are announced in the Unified Agenda.
In the 1990s, FDA participated in the “Reinventing Government” initiative and met 95 percent of its goal for eliminating outdated or unnecessary regulations, and 89 percent of its goal for revising regulations. Following that initiative, FDA has undertaken other reviews of its regulations and regulatory processes including implementing new efficiencies such as withdrawing outdated proposed rules that were never finalized. The most recent withdrawal was in 2008 (73 FR 75625, December 12, 2008). We currently conduct this review of pending proposed rules about every 5 years.
Over the past 15 years, there have also been major legislative changes that have significantly reformed major program areas within FDA and added to the Agency's responsibilities. When FDA develops implementing regulations for these legislative mandates, FDA also takes the opportunity to modify or revoke related regulations as appropriate, and streamline various regulatory processes.
The Food and Drug Administration Modernization Act of 1997 and, 10 years later, the Food and Drug Administration Amendments Act of 2007 (FDAAA) both modernized certain FDA programs and created new ones, mandating numerous regulations to implement those programs. FDAAA also expanded FDA's user fee authority and charged FDA with encouraging more research and development for treatments specifically for children. In 2009, FDA saw a significant increase in its authorities with enactment of the Family Smoking Prevention and Tobacco Control Act of 2009. Finally, earlier this year, the FDA Food Safety Modernization Act was signed into law by President Obama and, when fully implemented, will enable FDA to better protect public health by helping to ensure the safety and security of the food supply.
FDA is first seeking comment on how the Agency could revise its existing review framework to meet the objectives of E.O. 13563 regarding the development of a plan with a defined method and schedule for identifying certain significant rules that may be obsolete, unnecessary, unjustified, excessively burdensome, or counterproductive. Comments should address how best to evaluate and analyze regulations to expand on those that work and to modify, improve, or rescind those that do not. To be useful, comments should address how FDA 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. 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 E.O. 13563. FDA is further interested in comments about factors that it should consider in selecting rules for review and prioritizing review.
Due to limited resources, FDA generally focuses its retrospective review efforts on: (1) Regulations that have a significant public health impact, (2) regulations that impose a significant burden on the Agency and/or industry, and (3) regulations that impose no significant burden on the Agency and/or industry. FDA welcomes comments
In addition, FDA is seeking public comment on which, if any, regulations should be reviewed at this time. Please identify any regulation that should be modified, expanded, streamlined, or repealed to make our regulatory program more effective and less burdensome. Please be as specific as possible in your comments. 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 focus on regulations that have demonstrated deficiencies. Comments that reiterate previously submitted arguments relating to recently issued rules will be less useful. Furthermore, the public should focus on rule changes that will achieve a broad public impact, rather than an individual personal or corporate benefit. Comments should reference a specific regulation by the Code of Federal Regulations (CFR) cite, and provide specific information on what needs fixing and why. Lastly, FDA stresses that this review is for published final rules; the public should not use this process to submit comments on proposed rules.
The most useful comments will include which specific regulations need to be changed, strengthened or clarified, or revoked. It will be most helpful to include the specific reasons explaining why the change or revocation is necessary or desired, and to provide specific ways to improve the regulation, particularly any specific language modifications.
The Agency will be able to more efficiently review and consider comments that are submitted in the format shown in table 1 of this document:
Interested persons may submit to the Division of Dockets Management (see