Federal Decisions Research Articles

Roles of Individual Institutions in Achieving Pharmaceutical Sovereignty as Exemplified by the Medical Technology Transfer Centre of the Scientific Centre for Expert Evaluation of Medicinal Products

INTRODUCTION. The strengthening of the health system and the improvement of access to medicines directly depend on the development and marketing authorisation of national innovative medicinal products. Technology transfer is a key tool in bringing medicinal products to market.AIM. This study aimed to evaluate the role of the Medical Technology Transfer Centre of the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) in facilitating the implementation of federal projects in medical science and in achieving of pharmaceutical sovereignty.DISCUSSION. This article is an overview of the main trends in and features of the development of the pharmaceutical industry in the Russian Federation and around the world. The article highlights significant federal decisions made to attain pharmaceutical sovereignty and improve access to medicines for the population. The authors consider documents regulating the work of the Medical Technology Transfer Centre and outline its roles and responsibilities. Additionally, the authors analyse the ability of the Medical Technology Transfer Centre to provide project support throughout the medicinal product development process and to address issues pertaining to efficient pharmaceutical development, patent law, and product commercialisation. The article assesses the role of the Medical Technology Transfer Centre in the development of the pharmaceutical industry in the Russian Federation.CONCLUSIONS. The Medical Technology Transfer Centre supports projects as part of efforts to implement federal projects in human medical science. The Medical Technology Transfer Centre can be considered a driver of effective innovative development in the national pharmaceutical industry.

Prioritizing Indigenous Peoples’ knowledge in federal decision-making: insights from faculty, graduate students, and tribal leaders

In response to the mounting global climate crisis, the Biden administration began developing guidelines for incorporating Indigenous Traditional Ecological Knowledge into US federal decision-making. Though Indigenous Peoples are the original caretakers and stewards of the land, colonization, breached treaties, and false narratives have affected self-determination, treaty rights, and land management. This has negative consequences on the environment, and health of all our relations. When considering the sensitivity of knowledge, information, and data about sacred cultural systems, many Indigenous communities are wary of the high potential of misrepresentation, disrespectful handling, and cooptation. These concerns only deepen with conversations about opening public access to Indigenous Traditional Ecological Knowledge because such policies would allow for the broad sharing of data and its ongoing re-use. We assert that Indigenous Traditional Ecological Knowledge must be incorporated respectfully, knowledge integration must benefit all Indigenous communities, and all Indigenous communities must lead in the process of incorporating Indigenous Traditional Ecological Knowledge into federal decision-making.

U.S. Constitutional Originalism from Transcendence: The Founders’ Methodology

The characteristic that made the U.S. Constitution effective is the transcendence of the concepts it embodies. This essay seeks to define transcendence, its relationship to originalism in Constitutional interpretations, its historic origins, the consequences of rejecting them, and provide a truly originalist standard for Supreme Court decision-making. This transcendence has resulted in the U.S. being the only democracy since the Roman Republics to have been sustained over the long-term. Four specific areas are suggested by the Federalist Papers and many federal decisions over the last 50 years in the areas of civil rights, balance of power, public virtue, and judicial restraint. In civil rights, restoring the Constitutional diversity of this extended Republic would reverse the present “diversity, equity and inclusion” and its destructive policy. The recovery of the free exercise of religion from its “sincere personal belief” status would encourage a moral way of thinking and living by restoring Article I in the Bill of Rights to its proper status.

Understanding the risks of China-made CCTV surveillance cameras in Australia

ABSTRACT In the global interconnected economy, China-made information-collecting technologies such as closed-circuit television (CCTV) surveillance cameras have become popular products for routine video-based surveillance. Hikvision and Dahua are the two largest global suppliers of CCTV cameras, with both companies supplying their products to over 200 countries. Despite their popularity, national security concerns are commonly cited when adopting these cameras, citing manufacturer links with the Communist Party of China (CPC), cybersecurity vulnerabilities, and sales recorded in the Xinjiang region, that has records of human rights violations. This paper is structured in three parts: first, we explore the predominance of China-made information-gathering technologies in Australia; second, we summarise common national security concerns usually associated with China-based technology manufacturers; and third, we propose regulatory measures to regulating China-made CCTV cameras in Australia. The paper suggests that while state and Federal decision-makers are free to remove Chinese CCTV surveillance cameras, they should avoid overt politisation. Overall, a stronger focus should be placed on evaluating cybersecurity risks of Internet of Things (IoT) information-collecting technologies and considering their timely and effective regulation from the perspective of individual and national interests.

A Review of Literature on the Usage of Low-Cost Sensors to Measure Particulate Matter

With advances in technological sciences, individuals can utilize low-cost air monitoring sensors to record air quality at homes, schools, and businesses. Air quality data collected from LCSs are publicly accessible, informing the community of the air quality around them. It is important to measure local and regional particulate matter (PM) concentrations to keep the public involved, especially those with specific health concerns, such as asthma, wheezing, and seasonal allergies. The number of studies involving the use of LCSs to evaluate PM levels is increasing with more manufacturers producing ‘easy to use’ LCSs targeting the public. The goal of this review is to understand and incorporate the findings from studies using LCSs to analyze PM of various sizes, i.e., PM1, PM2.5, PM4, and PM10. This review integrates analyses from 51 different studies in 14 countries, including the U.S. The findings indicate spatial heterogeneity in the PM concentrations across a region. Some of the low-cost sensor manufacturers mentioned in these studies include Plantower, AQMesh, Alpha-sense, PurpleAir, E-MOTEs, and Shinyei. This review emphasizes the importance of LCSs in the field of PM monitoring and its potential to inform the public about their exposure burden, and to aid state and federal decision makers in formulating policies for mitigating the effects of PM pollution in any urban or rural setting.

Impact of Federal Lung Cancer Screening Policy on the Incidence of Early-stage Lung Cancer

BackgroundIn December 2013 the US Preventative Services Task Force (USPSTF) recommended annual lung cancer screening for high-risk patients. The Centers for Medicare & Medicaid Services (CMS) later announced coverage in 2015. The impact of these federal decisions at the population level is unknown. MethodsUsing the Surveillance, Epidemiology, and End Results database, we studied changes in lung cancer incidence by stage and linked to US census data to obtain age-adjusted estimates standardized to the US population. Based on age at diagnosis we stratified patients as age-eligible or age-ineligible for screening. We used difference-in-differences regression to determine the effect of screening on lung cancer incidence by stage. ResultsFor all age groups the incidence of early-stage lung cancer both before and after the USPSTF guidelines remained relatively stable at 12.8 ± 0.52 and 13.5 ± 0.92 per 100,000 patients, respectively (P = .068). However the difference-in-differences analysis estimated an absolute increase in the age-adjusted incidence by 3.4 per 100,000 persons in the age-eligible group after the announcement of the guidelines (P = .007). The effect was even larger after the CMS decision (4.3/100,000 persons, P < .001). Similarly there was a 14.2 per 100,000 persons absolute reduction in the incidence of advanced-stage lung cancer (P < .001). ConclusionsThe 2013 USPSTF lung cancer screening guidelines and CMS coverage decisions were associated with an increased incidence of early-stage lung cancer and decreased incidence of advance-staged lung cancer at the population level.

Women Leadership in Iraq : A Gender study 2021

The study aims at to determine the criteria followed by decision makers to promote women in both the private and public academic sector, to become leaders in top management. It subscribes to the model presented by (Alvesson &amp; Billing, 1997). The participants 70 were divided into 43 male and 27 female managers. The study sample included deans of colleges and their assistants at the University of Basra (public sector) and Shatt Al-Arab College (private sector). The results show that there is no specific model followed by the academic leaders in terms of nominating women for leadership positions. Instead, promotion criteria for women to top positions are decision maker specific. For this reason this study presents a theoretical framework for an Iraqi model. It is called "the personal cumulative Perspectives (Hybrid Model)", which is a combination of two dimensions. First, the personal judgments and Perspectives of decision makers that accumulated over time towards women. Second, the influence of other factors imposed by specific circumstances in some cases. These could include, for example, the government's influences or federal decisions that require fixed share (Quota) for women in leadership positions

Barriers and opportunities to incorporating environmental justice in the National Environmental Policy act

Environmental justice, which seeks to achieve equity in the process and outcomes of environmental policy and decision-making, is a broadly recognized policy objective. As a foundational environmental regulation and opportunity for public engagement with federal decision-making, the United States' National Environmental Policy Act (NEPA) is frequently considered a promising venue for addressing environmental justice. While environmental justice has been a recognized consideration within the NEPA process since the 1990s, it is by no means a streamlined process. Understanding the barriers and opportunities to better incorporation of EJ principles in NEPA review processes is critical for understanding how to move from EJ as a concept to actual implementation. Drawing on interviews with federal agencies, project developers, nongovernmental organizations, and other organizations who contributed to NEPA reviews for projects across the US, this paper explores how environmental justice–specifically procedural, distributive, and recognition justice–is currently addressed in the preparation of Environmental Impact Statements and identifies barriers and opportunities for better inclusion. We find that many NEPA practitioners see NEPA as a valuable tool for achieving procedural and distributive justice. However, a number of institutional and organizational barriers exist, most prominently a structure that hinders opportunities for meaningful public engagement, ambiguity in how distributive justice is defined and implemented, and a lack of substantive requirements for potential distributional inequities to be addressed.

Universal Child Care as a Policy to Prevent Child Maltreatment.

Universal Child Care as a Policy to Prevent Child Maltreatment.

The financing of innovation policies in Brazil between 1999 and 2016: political economy, institutions and financial cycles

ABSTRACT The main objective of the present paper is to provide the reasons behind the rise and fall of resources for innovation policies in Brazil between 1999 and 2016. The paper also intends to provide a broad map of the financial relations between funding sources and financial agents in the Brazilian National System of Innovation (NSI). In order to do that, the paper uses mixed methods: a historical approach to cover the motivations of the political economy; principles of network analyses to map the institutional relations between funding sources and financial agents; and economic theory to understand the determinants of the cash flows that finance science, technology and innovation (STI) policies. The institutional arrangement of the Brazilian NSI led the financial cycle to rely, on a general level, on GDP dynamism; the strategy of selected public bodies; on the federal budget decision process; and on the external economic cycle. Between 2003 and 2014, political struggles led to economic policies that favoured GDP growth and public spending, while the opposite occurred from 2015 onwards. In general, institutions were not equipped to protect the financial resources from the political changes of the mid-2010s.

Evidence-Based Recommendations for Improving National Environmental Policy Act Implementation

The National Environmental Policy Act requires federal agencies to consider environmental impacts before acting. NEPA is the Magna Carta of U.S. environmental law, a topic of intense debate, and the subject of ongoing rulemaking efforts. Prior NEPA scholarship focuses almost exclusively on Environmental Impact Statements, which account for just 1% of all NEPA decisions. Little is known about the length of time required to complete the other 99% of agency decisions, which involve a more streamlined review. This is a critical gap in the literature because NEPA compliance involves an estimated 50,000 federal decisions annually. NEPA reform, we believe, should begin with a careful understanding of NEPA practice at all levels of review. &#x0D; To help advance effective NEPA reform, we studied over 41,000 NEPA decisions completed by the U.S. Forest Service between 2004 and 2020. Using this data, we conducted a multivariate statistical analysis of the length of time required to complete the NEPA process at each level of review. We then investigated factors associated with longer decisionmaking times. Our model accounts for interactions between 3 levels of NEPA analysis, 43 activities involved in these decisions, 9 geographic regions, and the year of project initiation. Contrary to widely held assumptions, we found that a less rigorous level of analysis often fails to deliver faster decisions. Delays, we found, are often caused by factors only tangentially related to the Act, like inadequate agency budgets, staff turnover, delays receiving information from permit applicants, and compliance with other laws. Improving NEPA efficacy, we argue, should therefore focus on improving agency capacity. This approach, we believe, would improve the NEPA process and advance NEPA’s mandate to engage with key stakeholders and carefully consider environmental impacts before making decisions.

Dismantling The Professional Student Political Speech Minefield: Rejecting The Proliferation of Conduct Standards That Restrict Political Expression

Universities have discarded their role as institutions dedicated to the marketplace of ideas and the freedom of expression. The desire to shield students from ideas that make them uncomfortable has unfortunately spread to professional programs, as administrators have constructed student conduct policies that limit political speech. Although recent federal circuit decisions have permitted professional programs more discretion to punish speech than undergraduate or graduate students, courts have only applied those decisions to situations where student conduct clearly violates established professional standards. While professional programs possess a legitimate pedagogical purpose in preparing its students to enter a licensed profession, that purpose is not absolute and is limited by the First Amendment when applied to political speech. Courts should find that professional programs violate its students’ First Amendment rights when student conduct policies punish political speech that does not violate any written code of conduct or established professional standard. When a university punishes a professional student’s political speech without reference to existing professional standards, student discipline may become a pretext for discrimination against political beliefs. Accordingly, courts should hold that an administrator’s application of a student conduct policy against political speech is void for vagueness and overbreadth and risks viewpoint discrimination. When students are unaware of what political speech their universities may sanction, they may avoid engaging in frank discussions of politics over the fear of discipline. Professional students are the emerging leaders of our country, and their program administrations should not chill them from freely expressing their opinions on matters of public concern as the price of admission into the program. This article will take a novel approach to reject limitations on professional student political speech, using the Tenth Circuit’s analysis in Hunt v. Board of Regents of the University of New Mexico to demonstrate the threat of students’ First Amendment rights.

School Nutrition Director Perceptions of Flexible Regulations for School Nutrition Programs in One Southeastern State.

Schools are a promising site for influencing the dietary intake of children and adolescents. The US Department of Agriculture recently released flexibilities to requirements for whole-grains, sodium, and low-fat milk in schools who demonstrated difficulty meeting nutrition standards for school meal programs. The support of School Nutrition Directors (SNDs) is vital to the success of school food environment changes; however, few studies have explored SNDs perceptions to changes in nutrition standards. Experiences and perspectives toward nutrition standards of 10 SNDs, and their satisfaction with flexibilities for whole-grains, sodium, and low-fat milk were explored using a semi-structured interview. Responses were analyzed using an inductive approach with thematic analysis. Three broad categories emerged challenges with the Healthy, Hunger-Free Kids Act, food preferences and acceptability, and support and representation. A greater need for internal and external support, assistance in equipment and staff, procurement of foods compliant with regulations and acceptable to students, and more input on federal decisions and policies were perceived as important. Results provide critical insight into the implementation of nutrition standards. Future research and changes to school nutrition programs should consider these challenges as they strive to meet the needs of this important population.

Federalism and the management of the COVID-19 crisis: centralisation, decentralisation and (non-)coordination

The ability of federal states to manage the COVID-19 pandemic has created much debate. Federations differ considerably in the way they have been tackling the crisis, however. To shed light on how European federations (Austria, Germany, Switzerland) managed COVID-19, this paper distinguishes two dimensions of federal decision making: centralised/decentralised and unilateral/coordinated decision making. Drawing on official government documents and press reports, it examines decisions on the introduction of containment measures and their subsequent easing during the first wave. While Austria and Switzerland adopted a centralised approach, decentralised decision making prevailed in Germany. However, most decisions were coordinated between the governments at the federal and constituent unit level in Austria and Germany, in contrast to Switzerland where unilateralism prevailed. This difference in approaches can partly be explained by the distribution of powers. Political and economic factors also influenced the choice of crisis management strategies.

The Blueprint for Dred Scott: United States v. Dow and the Multi-Racial Jurisprudence of White Supremacy

Chief Justice Taney’s 1857 opinion in Dred Scott v. Sandford is justly infamous for its holdings that African Americans could never be citizens, that Congress was powerless to prohibit slavery in the territories, and for its proclamation that persons of African ancestry “had no rights which the white man was bound to respect.” For all of the interest in and attention to Dred Scott, however, no scholar has previously analyzed United States v. Dow, an 1840 decision of Chief Justice Taney in a Circuit Court trial which is apparently the first federal decision to articulate a broad theoretical basis for White supremacy. Dow identified Whites as the “master” race, and it explained that only those of European origin were either welcomed or allowed to be members of the political community in the colonies. Non-Whites such as members of Dow’s race, Taney explained, could be reduced to slavery, and therefore their rights continued to be subject to absolute legislative discretion. Dow, however, was not a person of African descent, he was Malay, from the Philippines. Chief Justice Taney’s employment in Dow of legal reasoning which he would later apply in Dred Scott suggests that Dred Scott should be regarded as pertinent to all people of color, not only African Americans. This understanding of Dred Scott helps explain the revival of Taney’s reputation during the Jim Crow era after Reconstruction. Courts declined to invalidate restrictions with respect to a broad range of civil rights on citizens and immigrants of African, Indian, Asian, and Mexican ancestry to which Whites were not subject. Indeed, Whites could not be subject to them, unless it is conceivable that under the U.S. Constitution, the law could provide, for example, that all races would be ineligible to testify or vote because of their race. Accordingly, even after Reconstruction, just as Dred Scott and Dow contemplated, the White race remained the master race, in the sense that they were the exclusive holder of truly inalienable rights.

Repercussions of Poor Broadband Connectivity for Students in Rural and Small Town Michigan

This paper examines the repercussions of discrepancies in Internet connectivity for high school students in rural and small-town locations in Michigan. It provides detailed analyses of the interrelations between broadband connectivity, educational outcomes, digital skills, and broader life outcomes. While the disadvantages of insufficient Internet access are well established, existing research has not fully investigated the extent of student performance gaps resulting from varying levels of home connectivity. Our research uses a granular, yet fully de-identified original data set focused on rural broadband access that allows assessing the effects of discrepancies in connectivity on several measures of educational achievement, including grades, standardized test scores, and educational aspirations. With the help of intermediate school districts and Merit Network, we collected and combined information from three sources: a detailed survey of middle and high school students from 173 classrooms in 15 predominately rural Michigan school districts, SAT/PSAT standardized test scores, and home speed tests. This approach resulted in unique original data set of 3,258 observations. This data includes many households that are either cell phone dependent or cannot get broadband access at home (see Hampton et al., 2020). The paper explores the relations among infrastructure, sociodemographic variables, and student achievement outcomes, using multiple statistical approaches, including hierarchical linear models to address the nested structure of the relationships and path analysis. We find that students who do not have access to the Internet from home or are dependent on a cell phone only for access, perform lower on a range of metrics, including digital skills, homework completion, and grades. Students lacking home Internet, and those dependent on a cell phone, are also less likely to consider post-secondary education. A deficit in digital skills compounds inequalities in access, contributing to lower standardized test scores and less interest in STEM careers. Consequently, lack of broadband access not only impacts school performance, but also has broader repercussions for career choice, life income, and the ability to adapt to emerging demands of the workforce. We believe the findings are generalizable to rural America. Our analysis suggests that infrastructure availability and sociodemographic factors affect outcomes. Unlike most sociodemographic factors, access affects outcomes in indirect paths, particularly through its effects on digital skill. Based on these findings we offer policy considerations and practical recommendations for narrowing and eliminating these digital inequalities. Our analysis suggests a multi-pronged, polycentric policy approach. Whereas it is important to mobilize local creativity and initiatives, effective measures require the collaboration of local, state and federal decision-makers across traditional boundaries and jurisdictions.

“We Take EVERYONE”: Perceptions of External Assessment and Accountability at the Community College

ABSTRACT Assessment, accountability, and transparency represent a greater focus than ever in higher education. Community colleges are not exempt from these requirements, though they are overlooked in the creation of state and national assessment instruments. Therefore, we designed and distributed the Perceptions of Community College Assessment (PCCA) survey, a national mixed methods survey of the perceptions of community college employees (N = 198) who administer or assist in the administration of state and federal community college assessments. Respondents reported low confidence in the accuracy of existing assessment measures used at the state (e.g., performance-based funding measures) and federal (e.g., the College Scorecard) levels. Respondents believed much of the work of community colleges is not captured in existing external assessments which can lead to inaccurate educational data overall. Based on our findings, we recommend that existing federal and state assessment measures be reevaluated, and the classifications of community colleges be expanded to reflect the realities and complexities of modern day community colleges. We further recommend that community college leaders be provided an opportunity to actively assist in the creation of new measures and classifications based on their in the field expertise. Through this research, we seek to educate state and federal decision makers and to provide a tool for community college leaders to advocate for policy and practical changes in the accountability systems used to assess community colleges.

Failure to lead on COVID-19: what went wrong with the United States?

PurposeThe purpose of this paper is to review the federal decisions to coronavirus disease 2019 (COVID-19) response in the United States and consider the different approaches employed by the California state government.Design/methodology/approachThis paper focuses on COVID-19-related issues, responses and implications in federal countries, and largely draws comparisons between the Trump Administration and California state.FindingsThe slow response of the federal government could have been avoided, had there been a current and tested national plan. The defunding of the Office of Pandemics and Emerging Threats, and the lack of coordination between the Trump Administration and the states have contributed to its ranking as the country with the highest COVID-19 infection and fatality rates worldwide. California state oversaw an effective initial pandemic response, which was ultimately undermined by a lack of national support and the refusal of some citizens to comply with the restrictions.Research limitations/implicationsThe paper draws upon open-source information published on government websites and news media.Originality/valueAs the COVID-19 pandemic in the United States is currently ongoing, information about the federal governance and state response is still evolving. The authors examine California as a state exemplar, since it is the largest such jurisdiction by populace and the first state to issue statewide mandatory lockdown measures. This comparison offers insights as to the decisive initiatives that could have occurred at the federal level. The “lessons learned” highlight the critical role of crisis leadership in societal and public health preparedness for future pandemic events.

Safeguarding Science from Attack: Data and Trends from the Trump Administration and How to Strengthen the Role of Science-Based Decisionmaking

Background/Aim: Protecting the environment and public health often depends on the effective incorporation of science into the federal decisionmaking process. However, the Trump administration has undermined these safeguards such that environmental hazards like air pollution and harmful chemicals are increasingly affecting communities across the US. It is worth analyzing how science is being attacked by the Trump administration and how to strengthen the role of science in the decisionmaking process. Methods: We created a searchable public database to track and analyze attacks on science that have occurred since the inauguration of the Trump administration. A rigorous and systematic set of criteria were used to assess what constitutes an attack on science and how to categorize the attack. Results: Over one hundred attacks on science have been carried out by dozens of federal agencies that follow six trends: anti-science rules, censoring scientists, manipulating studies, making data inaccessible or halting its collection, politicizing funding, sidelining scientific advisory committees, and restricting conference attendance. Conclusions: Our analysis suggests that attacks on science follow a set of patterns that future presidential administrations can guard against. By analyzing data and trends associated with the Trump administration’s attacks on science, we offer specific policy recommendations to combat them, including restoring the role of scientific experts in policymaking, bolstering scientific integrity, improving public access to government research, strengthening conflicts of interest policies, restoring protections for government scientists, encouraging public engagement in the rulemaking process, and safeguarding fundamental processes of a healthy democracy.

Managing Interdependencies in Federal Systems: Intergovernmental Councils and the Making of Public PolicyJohannaSchnabelCham, Palgrave Macmillan (2020), 286 p., ISBN 978‐3‐030‐35460‐2

Managing Interdependencies in Federal Systems: Intergovernmental Councils and the Making of Public PolicyJohannaSchnabelCham, Palgrave Macmillan (2020), 286 p., ISBN 978‐3‐030‐35460‐2