The regulatory process

Journal Article Functions From Regulation Get access Timothy Schroeder Timothy Schroeder University of Manitoba Search for other works by this author on: Oxford Academic PubMed Google Scholar The Monist, Volume 87, Issue 1, 1 January 2004, Pages 115–135, https://doi.org/10.5840/monist20048717 Published: 25 November 2014

This paper describes the important regulatory changes underway in the United States (US) that will dramatically affect the design, construction, and operation of offshore terminals for importing liquefied natural gas (LNG). Numerous US oil and gas companies are developing projects to build offshore terminals for importing LNG into the US. As the offshore LNG terminal concept applies new technology, regulatory and technical design rules that will apply to these facilities are rapidly evolving. With the passage of the Maritime Transportation Security Act of 2002, the Deepwater Port Act of 1974 (DWPA) (33 USC 1501-1524) has been amended to include natural gas, fundamentally altering the regulatory process for offshore LNG terminals. Whereas the Federal Energy Regulatory Commission (FERC) and the US Coast Guard (USCG) previously played important roles in permitting and regulating onshore LNG facilities, the USCG and the US Maritime Administration (MARAD) now share the primary responsibility of regulating these facilities offshore, with subsidiary roles played by other federal agencies and the involved states. This paper examines the USCG's new role in offshore LNG terminal development, as well as the major requirements the DWPA imposes on applicants. The USCG will soon publish implementing regulations. DWPA requirements that previously applied to oil, now provide clues regarding the likely environmental review process. Although the USCG will be moving to the Department of Homeland Security, siting and operational oversight for deepwater ports is expected to remain with the Secretary of the Department of Transportation (SECDOT). This paper examines the Deepwater Port regulatory process and describes how these complex licensing requirements could affect the proposed siting, commercial viability, and environmental regulatory review of offshore LNG terminals. This paper also examines current efforts by various classification societies to develop technical guidance regarding the design, construction, and ongoing maintenance of offshore LNG terminals. The ABS Guidance Notes on Building and Classing Offshore LNG Terminals will be presented as an example of classification society efforts to fill the US regulatory void that currently exists for the technical requirements of offshore LNG terminals. In conclusion, this paper proposes a process to combine current regulations with classification society guidance as an effective means of developing appropriate design, construction, and operational requirements for offshore LNG terminals. Such a process may be helpful to US regulators in expediting the regulatory approval process for offshore LNG terminals currently being developed. Finally, this paper assists developers of offshore LNG terminals in understanding the complex US regulatory process and developing effective strategies to expedite critical regulatory approvals. The US Regulatory Scheme for LNG Terminals Prior to the passage of the Maritime Transportation Security Act of 2002 by Congress, and its signing by President Bush on November 25, 2002, FERC had jurisdiction over the siting of LNG import terminals under Section 3 of the Natural Gas Act. FERC asserted that this authority applied to both onshore and offshore LNG terminals.

The Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) has played an important role in the federal regulatory process for many decades. The regulatory review process is multifaceted, and several Executive Orders and laws have been enacted over the years that added various requirements to improve the process. Existing requirements regarding drinking water regulation under the Safe Drinking Water Act (SDWA) are briefly reviewed in this article, including the following: administrative procedures; evaluation of significant regulatory actions; consideration of small entities; paperwork reduction; achieving regulatory flexibility; unfunded mandates reform; input from state and local governments; input from Indian tribal governments; protection of children; actions affecting energy supply, distribution, or use; use of voluntary consensus standards; environmental justice; SDWA consultation provisions; effect on technical, financial, and managerial capacity; congressional review; and, defining a new regulatory process.

The Centre for Medicines Research (CMR) in the UK has produced a publication based on its 17th workshop that dealt with quality in the regulatory process [1], which was a logical sequel to the 16th workshop on the clinical dossier [2]. In some ways, it is a companion piece to the recent EMEA/IFAPP conference [3]. As stated in the foreword, the quality of the review process is inseparable from the quality of the submitted dossier and, in turn, the latter depends on the quality of the work performed. However, this simplistic linkage fails to differentiate between the factual basis of the work and of the dossier, on the one hand, and the opinions expressed by experts and the decision-making process in the regulatory review, on the other. After all, the same dossier is reviewed by different regulatory agencies, and the fact that each may identify and/or focus on one or two different issues from the others surprises people in the industry, who have seen this scenario many times. Possible reasons for any divergence was illustrated by the first contribution describing the findings of a CMR International Study. In 1999, the CMR sent a questionnaire to ten major regulatory authorities, of which nine responded. While most agencies provided training for their reviewers and collaborate with each other in training, there was a marked difference in training for external experts and advisory committee members, who make the decisions. Only one agency provided such training. Another difference in practice between authorities was the fact that, in half the cases, Advisory Committees reviewed only selected dossiers, while in the rest all were reviewed. In six authorities, the reviews only covered the assessment reports and only in one was the complete dossier reviewed. Five agencies have extensive contact with sponsors during development and four during the review process. One agency has no contact with the sponsor during development and another has no contact during the review process. A second paper presented an analysis of the outcomes of the European Union Centralized Procedure between 1995 and 1999. The main findings were the rise in the number of negative outcomes, primarily due to withdrawals of the submissions when the applicant received the list of questions, peaking in 1998 (41%) and falling slightly in 1999 (31%). The major negative decisions were based on clinical efficacy, mainly due to their design and the doubtful the robustness of pivotal data, and on clinical safety, where increased mortality and other serious adverse events activated those decisions. There was a positive concordance between the Food and Drug Administration (FDA) and the EMEA on positive decisions, but additionally the FDA approved 35% of applications that had a negative EMEA outcome. The FDA’s recent actions were presented in another paper that described the enhanced performance goals and the Good Review Practice (GRP) initiative. The latter was launched in 1994 and it has examined clinical holds and refusals to file and is setting guidelines in order to achieve consistency and uniformity. It has provided training for Advisory Committee members, although it is not mandatory. The syndicate groups and the workshop discussion addressed the differences in quality assurance methods employed by various national authorities and the impact of them. It also looked at the quality of the dossier on the quality of the review process. The key recommendations included global standards, clarification of questions during the review process, and regulators using review templates. The industry should check the quality of the dossier, provide a ‘road map’ in dossiers to orientate reviewers, and provide early label proposals and supporting studies for them.

In 2006, the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community.1-5 Much of the funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research.”4 Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific key functions to advance the consortium goals. These required key functions are (1) expertise in Biomedical Informatics, (2) a program in Research Education, Training, and Career Development, (3) a program in Community Engagement and Research, (4) an Evaluation component, (5) Pilot Projects in Translational and Clinical Studies, and (6) a Regulatory Knowledge and Support component. Optional CTSA key functions include (1) support of the Development of Novel Clinical and Translational Methodologies, (2) components or cores to support Research Design, Epidemiology, Biostatistics, and Clinical Research Ethics, (3) Clinical Research Resources and Facilities, and (4) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these key functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution. After receiving a CTSA award in 2007, the University of Michigan (U-M) conducted a strategic assessment of the translational research enterprise through over 100 extensive interviews of faculty and staff providing the infrastructure for translational research, as well as the investigators conducting that research. The institution then conducted a survey of research team members involved in human subject research to identify and describe the current challenges facing translational research—specifically, the administrative processes associated with its planning and execution. In addition to identifying the issues, the team rated the technical and cultural/political levels of difficulty in implementing the solutions, as well as the corresponding impact each solution would potentially bring. These were then graphically mapped on a three-dimensional bubble chart (Figure 1). This stratification assisted in the planning, design, and prioritization of solutions, offering insights that guide the refinement efforts of a clinical research enterprise’s organization, business, and information technology (IT) processes. Bubble chart of implementation complexity. The chart orders tasks by level of execution difficulty—both technical and fiscal execution difficulty—as well as organizational and cultural complexity. The bubble size represents impact such that the bigger the bubble, the bigger the impact the change will have on improving translational research. For instance, enhancing study coordinator programs is relatively easy both technically and from an institutional buy-in perspective and was judged to provide a relatively large impact. Creating integrated informational technology systems involves significant investment, is more technically complex, requiring buy-in from multiple parties within the institution but is pivotal for achieving the goal of doing more effective translational research. The visual mapping provides context and definition to the challenge of enhancing the efficiency and effectiveness of translational research not only at the University of Michigan but all of the CTSAs. IT = Information Technology, CTSU = Clinical Trials Support Unit. Eight areas were identified as solution categories. The topics include organizational, procedural, financial, structural, educational, technological, and cultural elements. Transform and expedite study and contract approval process. The contract approval process, especially in regard to industry protocols, was recognized by the faculty as their number one area of discontent. The approval process was not clear to research team members and varied widely by unit and department as well as by type of sponsor. Educational and process improvement opportunities were identified. To address these issues, U-M has set a goal to expedite study approval process so that the contract and regulatory processes are executed within 60 days from submission for all studies and 45 days for industry-sponsored studies. The primary strategy to accomplish this aggressive goal was to create a team consisting of members of the units involved and to reengineer processes and conduct a demonstration project for feasibility within 1 year. Secondary strategies included increasing the transparency of contracting within the system to allow better tracking of proposals by the faculty and study teams, publishing desirable contract terms on a website for faculty and staff to use as protocols are developed, and to create an interactive, web-based research road map to guide faculty and staff through the necessary administrative steps to conduct translational research.6 Establish a clinical research support unit with best practice tools. The current translational research enterprise consists of multiple units with redundant functions of varying quality. The primary strategy was to create a leveraging of the resources of the CTSA to develop a franchisable model built on best practice modules that could then be easily adopted by other units throughout the university. Develop a customer friendly, transparent financial system that spans clinical trial budget creation to account reconciliation and study close out. The lack of transparent and integrated financial systems to track costs and other financial aspects of clinical research including budgeting and billing remains a challenge for study team members. The University of Michigan Office of Research has created the Calendar Review and Analysis Office (CRAO) to assist researchers with this process and is currently implementing a clinical study budget tool, eThority, to create standard billing calenders and processes across the organization. CRAO will also champion the evaluation of financial feasibility prior to proposal initiation; provide more assistance to PIs and research team members with study budgets, through increased training on best practices, budget negotiators, and standardized internal budget; and generate a new reconciliation report that will make study account statements more easily understood by research teams. Improve regulatory approval process and reduce Institutional Review Board (IRB) turn-around time. Significant gains have been made, resulting in a 40% improvement in IRB cycle time. Study teams will be advantaged by continuous improvements to the process. Embedded within the goal to expedite study approval is the goal to reduce IRB turnaround time (TAT) to 21 days for full convened board approval, including ancillary committees, and reduce no more than minimal risk studies to 5 days TAT. U-M is investigating strategies for greater IRB board participation of faculty, instituting another IRB board specifically for industry-based studies, as well as dedicating a board to minimal risk studies. The CTSA is also identifying various research teams to extract best practices. The CTSA has created an IND/IDE consultation and support team for researchers that have already helped over 100 investigators with IND/IDE applications. Create a home for study coordinators to promote education and sharing of best practices. A strong research team, anchored by a solid study coordinator, is critical to clinical research success. Study coordinator turnover was noted to be 18% a year. Of all study coordinators, 75% have been at U-M less than 3 years, compared to 44% of the rest of U-M staff and 56% of study coordinators nationally. Study coordinators noted that there was no coherent program or “home” for them within the system. Several strategies have been developed and are being enacted to address this problem. The CTSA created a virtual, web-based site for study coordinator support that will eventually include standardized resources such as workflow steps, templates, forms, and answers to common questions. A monthly study coordinator forum has been enacted to share challenges and best practices. Human resources has been engaged to develop uniform study coordinator job descriptions and to mentor the coordinators to develop a meaningful career path. Increase patient participation (enrollment) in research. The institution has set an ambitious goal to double patient participation in research in 5 years, while decreasing the number of studies that do not enroll a subject to 5%. A primary strategy to accomplish this was the creation of a web-based participant registry (UMclinicalstudies.org) to help match interested patients and volunteers with open studies. Currently, over 7,000 participants are registered. U-M is also investing in an electronic medical record system that better enables queries and “flags” potentially eligible patients. Further investigation by a study team is necessary to determine the underlying reasons for poor accrual to studies, whether due to missed competitive enrollment periods, rare disease studies that inherently will be challenged to accrue, registry studies with open enrollment, lack of ability to find enough patients within the patient population, or unwillingness to ask patients to participate. Understanding and addressing the underlying issues provides an opportunity for the CTSA to improve the quality, and potentially reduce “waste,” in the proposal and regulatory systems. Achieve efficiencies through integration of multiple, fragmented IT systems. More than 30 IT systems, as well as paper records, were identified that are currently utilized by investigators to perform clinical and translational research. Moreover, multiple IT service providers exist across the institution with poorly defined roles, responsibilities, and accountability. Alignment of key IT systems and personnel that support clinical and translational research is imperative. The CTSA is playing a central role in developing and leading a cohesive strategy that integrates IT for researchers’ benefits. For example, the institution is investing in a system-wide approach to develop an overall architecture that will create a clinical data repository. Evolve the culture of U-M to be more supportive and enthusiastic of clinical research. Like many academic institutions, the University of Michigan has struggled to value clinical research to the same extent as the basic sciences. In interviews and surveys, many faculty noted that choosing a career in clinical research can be seen as “falling between the cracks” or not as respected as a career in basic research. While improving infrastructure demonstrates value to these researchers, it is not enough. The CTSA has advocated to create a working group to make recommendations to University leadership to increase recognition for excellence in clinical research, to refine promotion and incentive criteria to value scholarly clinical activity and emphasize collaboration and innovation across all disciplines (team science). Furthermore, a plan is being developed to expand training programs to support training of those who want to become clinical and translational researchers, beyond the few slots that the CTSA (K and T programs) can currently support. The mission of the CTSA to enhance an investigator’s ability to conduct translational research at the University of Michigan has resulted in concrete organizational plans and investments to improve infrastructure of translational research and increase the satisfaction of participants, faculty, and staff who are engaged in these activities.7 Similar changes are occurring at CTSA institutions all over the country, validating the vision of Dr. Zerhouni and the investment in these vehicles of change by the NIH. Supported by UL 1RR024986 NIH/NCRR—Clinical and Translation Science Award.

This paper seeks to contribute to the broader debate on how to promote ‘better regulation’ by examining the origins and influence of different regulatory styles. More particularly it examines the extent to which economic theories of cooperation can help to explain the presence of the cooperative regulatory style that has long been associated with the implementation of environmental regulations in the United Kingdom. After reporting the results of empirical research that focused on these issues, it concludes that cooperative regulatory styles are likely to depend upon: (a) the presence of inter-dependencies between regulators and firms; and either (b) the presence of trust amongst stakeholders; or (c) the effective exclusion of those stakeholders from influence in the regulatory decisionmaking process. Highlighting the importance of recent changes in each of these three areas in the United Kingdom, it explains the factors that have led to a shift away from a purely cooperative approach towards what has been termed a more ‘responsive’ or ‘risk-based’ approach. Recognising that such changes have been driven by a desire to enhance the efficacy and the efficiency of environmental regulation, and by concerns about the lack of transparency and accountability in the regulatory process, it concludes that such evolutions represent an important contribution to the debate on regulation and its reform.

As regulatory reporting involves loosely defined processes, it is a considerable challenge for data scientists and academics to extract instances of such processes from event records and analyse their characteristics e.g. whether they satisfy certain process compliance requirements. This paper proposes a software framework based on a semantic data model that helps in deriving and analysing regulatory reporting processes from event repositories. The key idea is in using business-like templates for expressing commonly used constraints associated with the definition of regulatory reporting processes and mapping these templates with those provided by an existing process definition language. A case study investigates the efficacy of the proposed solution in the case of an “Off-market bid” regulatory process. The results demonstrate the capability of the architecture in deriving process instances from a repository of Australian Company Announcements provided by the Australian Securities Exchange.

In its ambitious Communication “A stronger European-based pharmaceutical industry for the benefit of the patient”, the European Commission set out clear priorities and put patients at the very centre of the agenda. When presenting the Communication to the European Parliament on 1 July 2003, Commissioner Liikkanen underlined that benefits to patients constituted the heart of this new Commission initiative and stressed that the Commission would “Look at ways of improving patient information on medicines, strengthening the role of patients in public health decision-making, reviewing national approaches to cost and clinical effectiveness of medicines and strengthening European supervision of medicines once they are on the market”. The role of patients has changed fundamentally in the last years. They are no longer just passive recipients of healthcare, but are fully involved in all decisions affecting their lives, their treatment and care. Similarly, patients do no longer just blindly follow the advice of their prescribing doctor, but are engaged in an active dialogue where treatment, non-treatment and other medical decisions are arrived at jointly. The Communication thus recognises the change in the role of patients and accords them an active role in policy and regulatory decisions and processes. A first important step for patient involvement in the regulatory process was achieved through the adoption of the orphan drugs regulation with patient representatives becoming full members of the newly created Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA). The review of the pharmaceutical legislation in 2004 similarly opened the doors for patient representation in the EMEA Management Board where two patient representatives are now able to ensure that the patient’s voice is heard. The involvement of patients’ organisations in EMEA activities predates the review of the European pharmaceutical legislation and as early as 2002, the agency organised a workshop with patient organisations to discuss issues of concern to both patients and regulatory authorities. As a result of the workshop, an ad hoc working group

This chapter studies the pharmaceutical regulatory approval process. It begins by looking at how the Therapeutic Goods Administration (TGA) has adopted the European Union’s approach to the regulatory approval process, making only those changes necessary for Australia’s own individual needs. Stringent testing must be undergone to receive Australian Register of Therapeutic Goods (ARTG) listing for pharmaceutical products and manufacturing practices are continually monitored. For all pharmaceuticals, a pre-market evaluation and approval process is undergone to ensure safety. The chapter then considers the regulatory approval process governed by the Food and Drug Act and its accompanying Regulations in Canada; the pharmaceutical regulatory approval process in China and in Japan; and the Drugs and Cosmetics Rules, 1945, in India. It also discusses the regulatory approval process for both innovator and generic drugs, for prescription or OTC use, under the US Food and Drug Administration. Finally, the chapter examines the regulatory approval process in France, Germany, Italy, the Netherlands, and the United Kingdom, explaining how a marketing authorization is required before a medicinal product can be placed on a market in any Member State of the European Community.

The question this paper addresses is whether knowledge of variation of individual human response to toxicants introduces elements into the regulatory process that, in some sense, are radically different, thereby forcing major changes into the regulatory process. In this paper I will examine the regulatory process as I perceive it, i.e., the views presented here do not bear the nihil obstat or imprimatur of any agency or instrumentality of the U.S. Government. The views will also perforce reflect the fact that virtually all the regulatory processes I have observed have been those of the U.S. Environmental Protection Agency. However I hope by examining the workings of the regulatory process to see where and to what extent information on individual response will effect the regulatory process.KeywordsRegulatory ProcessLegal ProcessExposure StandardIncremental RiskLegal ForceThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

We need to take a fresh look at the regulatory process. In recent years, we have been offered many criticisms of the administrative agencies, some suggested changes, and a few defenses. However, much of the discussion is so repetitive that it seems like an exercise in pouring old beer into new steins-producing a stale, flat potion. In the main, these deliberations do not encourage affirmative analysis of the more pressing problems of government regulation. Nor do they offer a firm basis for imaginative inquiry into the substance of public policy, rather than the form. The discussions have reflected a familiar preoccupation with limited procedural technicalities, rather than an active interest in the practical problems of administrative regulation and its results. Semantic tags have been employed widely, if not wisely. The dichotomy of rule-making and adjudication has been employed to describe the total regulatory process. Meanwhile, the important processes of policy formulation, negotiation, and administration have been overlooked. Attention has been riveted on the independent commissions. Accordingly, the equally important regulatory functions of the executive departments have escaped notice. In the almost ritualistic procession of critical moves and defensive countermoves, consideration has been confined largely to peripheral issues of procedure and organization. Substantial policy issues have been swept under the rug. The objectives of the regulations, together with their achievements, or failures, have been virtually disregarded in the search for changes in administrative form. Most importantly, government regulation has been treated as an insulated, technical activity of government. Much of the discussion has been founded on the implication-stronger because unstated-that regulation is a legal function that can be protected from the contamination of other government activities. This academic assumption has been so imbedded that most of the debating gambits have overlooked three significant features of the regulatory process: first, it is inherently a political activity that is a substantial element in modern economies; second, the regulatory functions are too intertwined with a host of other government activities to be set as a class apart; and third, while procedural problems are important, they are subsidiary to the objectives and accomplishments of the regulatory functions. Adequate consideration of the policy issues that are inherent in the regulatory process will depend upon a continuing awareness of our traditional anxiety about

Chapter 84 - The regulatory process from concept to market

The influence of patient advocates on FDA regulatory decision making has increased. Despite enhanced engagement with FDA, there remain challenges to achieving the regulatory goals of patients within FDA's regulatory framework. Gaps exist between patient advocates' knowledge of the agency's processes and FDA's need for rigorous, clinically meaningful patient experience data. This study examined the policy process in which patient experience data are collected by patient advocates and provided to FDA for regulatory decision making. Semistructured, narrative interviews were conducted with 14 professionals working in patient advocacy or at FDA. The purpose was to examine, in depth, participants' perceptions and experiences regarding this new regulatory process. Interviews were coded and examined for themes. The use of patient experience data by FDA is an evolving regulatory process. Participants identified a number of barriers and contributors to regulatory success. Well-organized and sophisticated patient advocacy groups with access to scientific and policy expertise are more likely to find success meeting FDA's patient experience data requirements. A conceptual model of this regulatory process was developed. Use of patient experience data by FDA has the potential to positively influence the regulation of medical products in the United States. Success within this new regulatory process will depend on clear guidance from FDA regarding the collection, analysis, and use of patient experience data. Patient advocacy groups must enhance internal capacity and expertise while engaging in substantive collaborations with FDA and other stakeholders in order to meaningfully contribute to the regulatory review of new therapeutics.

A cognitive regulatory control model of schizophrenia

The primary goal of this study was to explore the changes that four Korean university students made in their regulation of cognition during reading processes. The students were trained using explicit reading strategy instruction based on the CALLA model. To this end, first, metacognition was framed and categorized by the definition from Baker and Brown (1984) and, second, a scoring scale for measuring the readers’ regulation of cognition was developed based on the study by Block (1992) to examine and trace any changes in their regulation processes. For data analyses, the participants’ think-aloud protocols were used. The results indicate that there were marked changes in the frequencies of their regulation processes over time. Specifically, the students’ overt strategic and regulatory behaviors in a regulation process showed more flexibility and organization toward the end of the strategy training. This study suggests that students would benefit from being provided with sufficient time for practice in order to build effective regulation of cognition in reading processes and that the teacher should understand the complex nature of the regulation processes that students go through. In addition, think-aloud procedures as an instructional tool for effective strategy training was shown to be a worthwhile technique in the classroom.