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[December 13, 2004 (Volume 69, Number 238)]
[Unified Agenda]
 [frwais.access.gpo.gov]


[Page 72651-72890]
 
The Regulatory Plan 



[[page 72651]]
____________________________________________________________________

                <HEAD>INTRODUCTION TO THE FALL 2004 REGULATORY PLAN

                Federal regulation is a fundamental instrument of 
                national policy. It is one of the three major tools -- 
                in addition to spending and taxing -- used to implement 
                policy. It is used to advance numerous public 
                objectives, including homeland security, environmental 
                protection, educational quality, food safety, 
                transportation safety, health care quality, equal 
                employment opportunity, energy security, immigration 
                control, and consumer protection. The Office of 
                Management and Budget's (OMB) Office of Information and 
                Regulatory Affairs (OIRA) is responsible for overseeing 
                and coordinating the Federal Government's regulatory 
                policies.

                The Regulatory Plan is published as part of the fall 
                edition of the Unified Agenda of Federal Regulatory and 
                Deregulatory Actions, and serves as a statement of the 
                Administration's regulatory and deregulatory policies 
                and priorities. The purpose of the Plan is to make the 
                regulatory process more accessible to the public and to 
                ensure that the planning and coordination necessary for 
                a well-functioning regulatory process occurs. The Plan 
                identifies regulatory priorities and contains 
                information about the most significant regulatory 
                actions that agencies expect to undertake in the coming 
                year. An accessible regulatory process enables citizen 
                centered service, which is a vital part of the 
                President's Management Agenda.

                Federal Regulatory Policy

                The Bush Administration supports Federal regulations 
                that are sensible and based on sound science, 
                economics, and the law. Accordingly, the Administration 
                is striving for a regulatory process that adopts new 
                rules when markets fail to serve the public interest, 
                simplifies and modifies existing rules to make them 
                more effective or less costly or less intrusive, and 
                rescinds outmoded rules whose benefits do not justify 
                their costs. In pursuing this agenda, OIRA has adopted 
                an approach based on the principles of regulatory 
                analysis and policy espoused in Executive Order 12866, 
                signed by President Clinton in 1993.

                Effective regulatory policy is not uniformly pro-
                regulation or anti-regulation. It begins with the 
                authority granted under the law. Within the discretion 
                available to the regulating agency by its statutory 
                authority, agencies apply a number of principles 
                articulated in Executive Order 12866 (as well as other 
                orders, such as Executive Order 13211, ``Actions 
                Concerning Regulations That Significantly Affect Energy 
                Supply, Distribution, or Use,'' signed May 18, 2001, 66 
                FR 28355), in order to design regulations that achieve 
                their ends in the most efficient way. This means 
                bringing to bear on the policy problem sound economic 
                principles, the highest quality information, and the 
                best possible science. This is not always an easy task, 
                as sometimes economic and scientific information may 
                point in very different directions, and therefore 
                designing regulations does not mean just the rote 
                application of quantified data to reach policy 
                decisions. In making regulatory decisions, we expect 
                agencies to consider not only benefit and cost items 
                that can be quantified and expressed in monetary units, 
                but also other attributes and factors that cannot be 
                integrated readily in a benefit-cost framework, such as 
                fairness and privacy. However, effective regulation is 
                the result 
                
[[Page 72652]]
                
                of the careful use of all available high-
                quality data, and the application of broad principles 
                established by the President.

                In pursuing this goal of establishing an effective, 
                results-oriented regulatory system, the Bush 
                Administration has increased the level of public 
                involvement and transparency in its review and 
                clearance of new and existing regulations.

                For new rulemakings and programs, OIRA has enhanced the 
                transparency of OMB's regulatory review process. OIRA's 
                website now enables the public to find information on 
                rules that are formally under review at OMB, have 
                recently been cleared, or have been returned to 
                agencies for reconsideration. OIRA has also increased 
                the amount of information available on its website. In 
                addition to information on meetings and correspondence, 
                OIRA makes available communications from the OIRA 
                Administrator to agencies, including ``prompt 
                letters,'' ``return letters,'' and ``post clearance 
                letters,'' as well as the Administrator's memorandum to 
                the President's Management Council (September 20, 2001) 
                on presidential review of agency rulemaking by OIRA.

                For existing rulemakings, OIRA has initiated a modest 
                series of calls for reform nominations in 2001, 2002, 
                and 2004. In the draft 2001 annual Report to Congress 
                on the Costs and Benefits of Federal Regulation, OMB 
                asked for suggestions from the public about specific 
                regulations that should be modified in order to 
                increase net benefits to the public. We received 
                suggestions regarding 71 regulations, 23 of which OMB 
                designated as high priorities. After a similar call for 
                reforms in the 2002 draft Report, OMB received 
                recommendations on 316 distinct rules, guidance 
                documents, and paperwork requirements from over 1,700 
                commenters. Of the 156 reform nominations that OMB 
                determined were ripe for consideration by Cabinet-level 
                agencies and the Environmental Protection Agency, 
                agencies have decided to pursue 34 rules and 11 
                guidance documents for reform, are undecided about 26 
                rules and 4 guidance documents, and have decided not to 
                pursue reform of 62 rules and 19 guidance documents at 
                this time. Finally, in the 2004 draft Report, OMB 
                requested public nominations of promising regulatory 
                reforms relevant to the manufacturing sector. In 
                particular, commenters were asked to suggest specific 
                reforms to rules, guidance documents, or paperwork 
                requirements that would improve manufacturing 
                regulation by reducing unnecessary costs, increasing 
                effectiveness, enhancing competitiveness, reducing 
                uncertainty, and increasing flexibility. With the 
                publication of the final 2004 Report, OMB will discuss 
                the next steps in these regulatory reform initiatives 
                and will work closely with the agencies to ensure a 
                robust reform process. For further information, all of 
                these Reports are available on OIRA's website at http:/
                /www.whitehouse.gov/omb/inforeg/regpol.html.

                The Bush Administration has also moved aggressively to 
                establish basic quality performance goals for all 
                information disseminated by Federal agencies, including 
                information disseminated in support of proposed and 
                final regulations. The Federal agencies issued 
                guidelines on October 1, 2002 under the Information 
                Quality Act to ensure the ``quality, objectivity, 
                utility, and integrity'' of all information 
                disseminated by Federal agencies. Under these 
                guidelines, Federal agencies are taking appropriate 
                steps to incorporate the information quality 
                performance standards into agency information 
                dissemination practices, and developing pre-
                dissemination review procedures to substantiate the 
                quality of information before it is disseminated. Under 
                the agency information quality guidelines, ``affected 
                persons'' can request that the agencies correct 
                information if they believe that scientific, technical, 
                economic, statistical or other information disseminated 
                does not meet the agency and OMB standards. If the 
                requestor is dissatisfied with the initial agency 
                response to a correction request, an appeal opportunity 
                is provided 
                
[[Page 72653]]
                
                by the agencies. To date, agencies have 
                received and responded to approximately 30 complaints 
                that appear to be stimulated by the Information Quality 
                Law. Although we are still in the early phases of 
                implementation, agencies are aware that ensuring the 
                high quality of government information disseminations 
                is a high priority of the Administration. Further 
                information on OIRA's activities implementing the 
                Information Quality Act is available on OIRA's website 
                at http://www.whitehouse.gov/omb/inforeg/
                infopoltech.html.

                As part of its efforts to improve the quality, 
                objectivity, utility, and integrity of information 
                disseminated by the Federal agencies, OMB has proposed 
                guidance to realize the benefits of meaningful peer 
                review of the most important science disseminated by 
                the Federal government. The Bulletin on Peer Review 
                establishes minimum standards for when peer review is 
                required and how intensive the peer review should be 
                for different information. The Bulletin requires the 
                most rigorous form of peer review for highly 
                influential scientific assessments. Further information 
                on peer review is available on OIRA's website at http:/
                /www.whitehouse.gov/omb/inforeg/infopoltech.html.

                In addition, the Administration is currently increasing 
                the impact of OMB's analytical perspective. The OIRA 
                Administrator is using the ``prompt letter'' to 
                agencies as a new way to suggest promising regulatory 
                priorities, and highlight issues that may warrant 
                regulatory attention. Though not meant to have legal 
                authority, these prompt letters are designed to bring 
                issues to the attention of agencies in a transparent 
                manner that permits public scrutiny and debate. Prompt 
                letters may highlight regulations that should be 
                pursued, rescinded, revised, or further investigated. 
                For example, OIRA's first set of prompts has suggested 
                lifesaving opportunities at FDA, NHTSA, OSHA and EPA. 
                In a letter to FDA, OIRA suggested that priority be 
                given to completing a promising rulemaking (started in 
                the previous Administration), to require that food 
                labels report the trans-fatty acid content of foods. 
                (Trans-fats are now recognized as a significant 
                contributor to coronary heart disease.) FDA has now 
                issued a final rule that will require the disclosure of 
                trans-fat content in food labels. Similarly, OSHA has 
                responded to an OIRA prompt letter by notifying each 
                employer in the country of the lifesaving effects and 
                cost-effectiveness of automatic defibrillators, a 
                lifesaving technology designed to save lives during 
                sudden cardiac arrest. A list of all of the prompt 
                letters is available at OIRA's website at http://
                www.whitehouse.gov/omb/inforeg/prompt--letter.html.

                In addition to increasing the level of public 
                involvement and transparency in its review of 
                regulations, the Bush Administration has sought to 
                enhance the role of analysis in the development of 
                effective regulations. On September 17, 2003, OMB 
                issued revised guidance to agencies on regulatory 
                analysis.\1\ Key features of the revised guidance 
                include more emphasis on cost-effectiveness, more 
                careful evaluation of qualitative and intangible 
                values, and a greater emphasis on considering the 
                uncertainty inherent in estimates of impact. OIRA was 
                very interested in updating the guidance in light of 
                these and other innovations now commonplace in the 
                research community. The 2004 Regulatory Plan continues 
                OIRA's effort to ensure coordination across Federal 
                agencies in pursuing analytically sound regulatory 
                policies.

                The Administration's 2004 Regulatory Priorities

                With regard to Federal regulation, the Bush 
                Administration's objective is quality, not quantity. 
                Those rules that are adopted promise to be more 
                effective, less intrusive, and more cost-effective in 
                achieving national objectives while demonstrating 
                greater durability in the face of political and legal 
                attack. The Regulatory Plan is integral to enhancing 
                the quality of 
                
[[Page 72654]]                
                
                Federal regulations, and OMB seeks to 
                ensure that the public is provided with the information 
                needed to understand and comment on the Federal 
                regulatory agenda. Accordingly, the 2004 Regulatory 
                Plan highlights the following themes:

                        <bullet> Regulations that are particularly good 
                            examples of the Administration's ``smart'' 
                            regulation agenda to streamline regulations 
                            and reporting requirements, which is a key 
                            part of the President's economic plan.

                        <bullet> Regulations that are of particular 
                            concern to small businesses.

                        <bullet> Regulations that respond to public 
                            nominations submitted to OMB in 2001 or 
                            2002.

                Conclusion

                Smarter regulatory policies, created through public 
                participation, transparency, and cooperation across 
                Federal agencies, are a key Administration objective. 
                The following department and agency plans provide 
                further information on regulatory priorities. All 
                agencies' plans are a reflection of the 
                Administration's Federal Regulatory Policy objectives, 
                which aim at implementing an effective and results-
                oriented regulatory system.

                ------------

                \1\ See Circular A-4, ``Regulatory Analysis,'' 
                published as part of OMB's 2003 Report to Congress on 
                the Costs and Benefits of Federal Regulations. The 
                report is available on OMB's website at: http://
                www.whitehouse.gov/omb/inforeg/2003--cost-ben--final--
                rpt.pdf

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