Academic literature on the topic 'Approved january'

INTRODUCTION:In the last decade an increasing number of high-priced, new cancer treatments received marketing authorization in Europe. What is actually known about the clinical benefit of those therapies at the time of approval needs to be elucidated in order to inform decisions about the use and reimbursement of these novel treatment options. Thus, the aim of the current analysis was to systematically investigate oncological therapies approved between January 2009 and April 2016. We extracted, as well as quantified the level of knowledge of the clinical benefit at the time of marketing authorization.METHODS:To assess the benefit of new interventions as well as expanded indications, we extracted the median gain of the two study endpoints: progression-free survival (PFS) and overall survival (OS). Information is based on approval documents provided by the European Medicines Agency (EMA) and assessments from the Austrian Horizon Scanning programme (HSO). We included all cancer therapies approved in Europe between 1 January 2009 and 15 April 2016.RESULTS:Cancer drugs for 134 new indications approved since 2009 were identified. In the case of thirty-seven indications (27 percent), no data was available for PFS or for OS. A positive difference in median overall survival was reached by seventy-six licensed indications (55.5 percent); twenty-two (16 percent) of them showed a difference of more than three months. Regarding the study endpoint progression-free survival, an improvement was shown in ninety indications (65.2 percent).CONCLUSIONS:Scarce knowledge regarding the clinical benefit of anti-cancer therapies is available at the time of approval. In addition, the survival benefit of the approved indications is less than three months in the majority of approved therapies.

Laser systems are a new treatment area for onychomycosis. As of January 2012, the US Food and Drug Administration (FDA) has approved four laser systems for the “temporary increase of clear nail in onychomycosis.” The FDA has approved these devices on the basis of “substantial equivalence” to predicate devices with similar technical specifications and applications. Laser therapy appears to be a promising alternative to traditional pharmacotherapy, but these systems have been tested in only limited clinical trials; therefore, it is not possible to compare their efficacy to the oral and topical drugs currently used in the treatment of onychomycosis. (J Am Podiatr Med Assoc 102 (5): 428-430, 2012)

The prevalence of safety-related postmarketing label modifications of medications for hematological malignancies is unknown. We identified 35 new drugs indicated for hematological malignancies approved by the US Food and Drug Administration between January 1999 and December 2014. Characteristics of supporting trials and safety-related label modifications from approval to December 2017 were collected from drug labels. Regulatory review and approval pathways were also collected. New drug approvals were supported by trials with a median of 167 patients (interquartile range 115–316). All drugs were approved based on surrogate endpoints. Twenty-seven drug approvals (77%) were not supported by randomized controlled trials. All drugs received orphan drug designation, and most were granted fast track designation, priority review, and accelerated approval (83, 74, and 60%, respectively). A total of 28 drugs (80%) had postmarketing safety-related label modifications. Additions to black box warnings, contraindications, warnings and precautions, and common adverse reactions were identified in 31, 11, 77, and 46% of drugs, respectively. Five drugs (14%) were permanently or temporarily withdrawn from the US market. Drugs for hematological malignancies are often approved based on limited evidence through expedited regulatory pathways with incomplete safety profiles. Hematologists should be vigilant for unrecognized side effects when prescribing newly approved drugs.

This position paper has been substantially revised by the Canadian Psychiatric Association’s Professional Standards and Practice Committee and approved for republication by the CPA’s Board of Directors on July 26, 2018. The original position paper1 was first approved by the Board of Directors on January 25, 2003. It was subsequently reviewed and approved for republication with minor revisions on June 2, 2009.

Objective: To provide a nontraditional source of data to university policymakers regarding student, faculty, and staff approval of university smoke/tobacco-free policies, as published through campus newspaper articles. Methods: From January to April 2016, a total of 2523 articles were retrieved concerning campus smoking/tobacco at 4-year, public universities. Of these, 54 articles met the inclusion factors, which described 30 surveys about campus approval of tobacco-free policies and 24 surveys about smoke-free policies. Results: In all, the surveys included more than 130 000 respondents. With the exception of 4 surveys, all reported that the most of the respondents approved a tobacco/smoke-free campus policy. Conclusions: Although the study had several limitations, the findings provide a synthesis from a nontraditional data source that is consistent with findings from the peer-reviewed literature, in which most of the students, faculty, and staff on university campuses approve of smoke/tobacco-free campus policies.

BackgroundOptimal drug therapy in children relies on availability of pediatric-specific information. European and American legislative initiatives have resulted in advancement of pediatric pharmacotherapy data. We aim to describe the quality and quantity of pediatric information in drug monographs of New Active Substances (NASs) approved by Health Canada.Design/MethodsCanadian drug monographs of NASs approved by Health Canada, from January 2007 until December 2016, were systematically reviewed for pediatric-specific information. Pediatric-specific information defined as: pediatric indication, dosing, pediatric-friendly dosage forms, and pediatric safety data.ResultsOver the period of the study, Health Canada approved 281 NASs. Of all the non-biologic NASs (205, 74%), 39(19%) were approved for use in pediatric patients. The number of drugs with pediatric approval was lowest in 2008 (1, 8%) and highest in 2016 (8, 32%), following no specific pattern. Neonates had the lowest rate of drug approvals through all pediatric age groups (4, 2%). All drugs with pediatric approval had pediatric-specific dosing information with the majority of them presenting pediatric safety data (79%). Pediatric friendly formulation was only available in 20%(8) of drugs with pediatric approval. Studies in pediatric populations were the source of pediatric information in 59%(23) of drugs with pediatric approval.Conclusion(s)Less than 20% of the NASs approved by Health Canada for use in adults contain pediatric approval. Neonatal populations remain a therapeutic orphan, with severe lack of dosing and safety information. Safe and effective pediatric pharmacotherapy requires well-conducted pediatric research to enhance pediatric drug data. Canadian children are in need for legislative initiatives to promote pediatric drug development.Disclosure(s)Nothing to disclose

Vilazodone was approved by the Food and Drug Administration (FDA) in January of 2011. This article reviews clinically significant aspects of this new drug including: the FDA-approved indications, mechanism of action, administration, drug interactions, adverse effects, clinical trial evidence, innovative properties and place in therapy.

ABSTRACT On January 7, 1994, Regional Response Team VI that covers the Gulf coast approved a plan that allows the federal on-scene coordinator to approve the use of burning three miles or farther off the coasts of Louisiana or Texas. This landmark action is the first preapproval for in-situ burning in the continental U. S. The plan was presented to the response team by the Marine Spill Response Corporation on behalf of the response industry and its clients.

Potassium binders are used for the treatment of and prophylaxis against hyperkalaemia. Already in 1958, the United States Food and Drug Administration (FDA) approved sodium polystyrene sulfonate, a potassium binder exchanging sodium for potassium in the gastrointestinal tract. In 2015, the FDA approved a new potassium binder, patiromer sorbitex calcium (Veltassa^®), exchanging calcium for potassium, and in 2017, it was approved by the European Medicines Agency (EMA). Furthermore, in January 2018 approval by the FDA of another new potassium binder, sodium zirconium cyclosilicate (ZS-9^®), exchanging sodium for potassium, is pending. The clinical pharmacology aspects of potassium binders are reviewed in this chapter.

At its meeting on January 13, 1915, the War Council supposedly authorized an attack at the Dardanelles in order to meet a Russian request for assistance and relieve pressure on the Western Front. This is incorrect. Not only did the government’s interest in the Dardanelles have other sources, but in fact it was leaning at this point toward offensives in Syria and the Balkans rather than Turkey. Churchill, however, continued to push for his Dardanelles operation and in so doing created chaos inside Admiralty, straining his relations with the admirals. On January 20 Asquith approved an offensive in the Balkans, but in so doing underestimated French resistance to the diversion of resources away from the Western Front.

<em>Abstract.</em>—Hurricane Katrina (landfall 29 August 2005) and Hurricane Rita (landfall 24 September 2005) devastated large portions of Louisiana and Mississippi and caused significant impacts to Alabama, Florida, and Texas. Immediately following these storms, the American Fisheries Society (AFS) established the AFS Hurricane Relief Task Force (HRTF). The HRTF was composed of AFS chapter officers from Louisiana and Mississippi as well as state and government agency personnel and university faculty and staff from the impacted region. Because essential members of the HRTF were dealing with personal, professional, and agency needs in the months immediately following these storms, a meeting of the HRTF could not be scheduled until 13 January 2006. This 1-d meeting, held on the campus of Louisiana State University, resulted in the drafting of the AFS Hurricane Relief Initiative Action Plan. During January–February 2006, the HRTF worked primarily through the organizational structure and leadership of the Louisiana and Mississippi chapters and coordinated these activities with the southern division of AFS (SDAFS), and the parent society’s officers, governing board, and executive director. The AFS Hurricane Relief Initiative Action Plan was approved and renamed the AFS Disaster Relief Program by the governing board during its midyear meeting in March 2006. In accordance with the approved program, administration and programmatic responsibility for the initiative were transferred from the HRTF to the SDAFS in June 2006, and funds to support the program were made available to the chapters through the SDAFS.

This chapter details events that occurred in 1819. In the opening days of the year, Jefferson witnessed his life’s last major achievement. After years of preparation, the University of Virginia was approved, its charter passed by the state’s General Assembly on January 25. Officially instituted, Jefferson’s university yet still seemed somewhat aspirational in 1819. Much remained to do down below in Charlottesville. It would take time to attract sufficient students, and the construction of adequate buildings would extend through 1826, the same year that Jefferson died. Overseeing the school’s staggered start, Jefferson ensured that the end of his life also helped to advertise his fledgling university. His memorial, planted on Monticello’s own grounds, would proudly commemorate the college.

This chapter discusses how the government agreed to the commitment of establishing an Arts and Humanities Research Council. Following the achievement, aspiration, and resistance in the early years of the AHRB, Margaret Hodge, who was the Minister of Lifelong Learning and Higher Education in the UK Department of Education and Skills, formulated a Review of Arts and Humanities Research Funding. This review was carried out on behalf of the Ministers responsible for the higher education in England, Northern Ireland, Wales and Scotland. The review aimed to recommend how to enhance support for arts and humanities, including how to encourage government support on such relevant issues. Of the 117 responses from the formal consultations, 114 – 97 per cent – agreed to the need for an organisation dedicated to arts and humanities. The review was subjected to the deliberations and considerations of the Steering Group. The report made by the group was eventually given to the Education Ministers. The Report of the Steering Group lauded the AHRB which despite its provisional start and status made contributions to society and the sciences. Whilst the government made slow progress on the approval of the creation of the AHRB, in January 22, 2003 the government approved the establishment of an Arts and Humanities Research Council which according to the government should be a fully functioning and statutory research council by 2005.

This chapter discusses the existence of support for the AHRB during its struggle for recognition and acceptance. In January 22, 2003, the White Paper on the Future of Higher Education created uproar. This furore over the White Paper was due to concerns over the government's proposal to allow universities to raise fees and to provide deferred loans by which the students might meet those charges. The uproar was also heightened by the government's declared intention to concentrate on research funding. Amidst the din over the AHRB's establishment and the government's intention of giving research funds to research councils, the AHRB found immense support from various groups. Iain Gray, Scotland's Minister For Enterprise and Lifelong Learning, expressed support for the creation of the AHRB. The same warm response to the White Paper and to the prospect of the creation of the AHRB was also expressed by the RCUK Strategy Group which emphasized the importance of arts and humanities as equal to those of engineering, science, and technology. The same response was also accorded by the House of Commons. In addition to the positive responses to the proposal of creating a humanities research council, UK government and political officials were beginning to include the White Paper recommendations into their debates. By mid-summer, widespread support for the AHRB was garnered and on January 27 2004, a second reading of the Higher Education Bill approved the creation of the Arts and Humanities Research Council.

The goal of the author's curriculum is to create a foundational understanding of engineering. Creating this program was a long and bumpy road. The methodology was important. The author has long been a fan of inquiry-based science, and her classes were very often hands-on and discovery aligned. It took a few years, but eventually she ironed out the social setting, the real-world connections, and the hands-on open-ended challenges that allowed students to apply their science information. Originally, the author only intended to use the materials in her own classroom, but when she felt it would be a huge benefit to other educators who were grappling with similar challenges, she began to seek publishers. She went through quite a few false starts—scams, lazy publishers, and rejections—until she decided to self-publish. The author discussed, marketed, strategized, and partnered, and now the curriculum is approved for government funding and will be live in January on global digital platform. For every success, there are a dozen failed attempts. However, she had a great support system that was always ready to help her to the next opportunity. This chapter explores that journey.

<em>Abstract</em>.—Management of blue catfish <em>Ictalurus furcatus</em> populations is an emerging focus for state fish and wildlife agencies as catfish anglers have shown a growing interest in trophy fishing. As blue catfish sampling methodology has improved, management of blue catfish fisheries has become a greater priority in some states. The Oklahoma Department of Wildlife Conservation (ODWC) has collected abundance, age and growth, and mortality data on blue catfish from 14 reservoirs statewide. Electrofishing surveys indicated that blue catfish populations are dominated by slow-growing fish less than 400 mm total length (TL) and average 24% total annual mortality. In addition, relative abundance of ≥762 mm TL blue catfish in the angler creel (8%) greatly exceeds that in population samples (<1%). In 2009, ODWC recommended a statewide regulation limiting harvest of blue catfish greater than 762 mm TL to one fish per day while maintaining the daily limit of 15 fish per day. The proposal met with moderate opposition through the regular regulation review process but was approved by the Oklahoma Wildlife Commission. Legislative opposition to the proposal subsequently developed, and a resolution was introduced to rescind the regulation but ultimately failed. A regulation restricting blue catfish harvest to 15 fish daily with only 1 fish ≥762 mm TL went into effect on January 1, 2010.

The National Environmental Policy Act (NEPA) was approved unanimously in the Senate and with near unanimity in the House of Representatives in December 1969. President Nixon signed the act into law on January 1, 1970. The new statute was both brief and farsighted. In fewer than 3,500 words the congressional authors of NEPA articulated for the first time a national policy on the environment, set in motion an innovative regulatory process centered on environmental impact statements, institutionalized public participation in federal environmental decision making, and introduced the requirement that the president report annually to Congress on the nation’s environmental status and trends. NEPA also included a provision that established a new agency, the Council on Environmental Quality (CEQ), in the Executive Office of the President. The CEQ’s assigned statutory role was to implement the environmental impact statement process, prepare the president’s annual environmental report on the condition of the environment, develop policy proposals for solving environmental problems, and coordinate efforts across the federal government to address environmental concerns. As stated in the law, NEPA is designed to “encourage productive and enjoyable harmony between man and his environment”; to “promote efforts which will prevent or eliminate damage to the environment and biosphere and stimulate the health and welfare of man”; and to “fulfill the responsibilities of each generation as trustee of the environment for succeeding generations.” The references to promoting harmony between people and the environment, protecting the biosphere, and affirming the nation’s responsibility for environmental stewardship illustrate an understanding of the scope, scale, and significance of environmental matters that was significantly ahead of its time. The language in NEPA quoted above anticipated by twenty years the concern for the Earth’s biosphere and the concept of environmental sustainability that would become more widely articulated in the run-up to the 1992 Earth Summit in Rio de Janeiro. Moreover, NEPA has had an enduring global impact. By the law’s fortieth anniversary, a majority of U.S. states had established their own environmental impact statement requirements and more than 160 nations worldwide had adopted similar legislation.

The Charite III artificial disc replacement was approved for use in the United States in October of 2004 by the FDA. Another similarly designed lumbar disc replacement called the ProDisc II was also approved by the FDA a year later in January of 2006. The purpose of this study was to retrospectively review 29 patients with either the Charite III or the Prodisc II disc replacement surgery and complications.

Code Case 2564 for the design of impulsively loaded vessels was approved in January 2008. In 2010 the US Army Non-Stockpile Chemical Materiel Program, with support from Sandia National Laboratories, procured a vessel per this Code Case for use on the Explosive Destruction System (EDS). The vessel was delivered to the Army in August of 2010 and approved for use by the DoD Explosives Safety Board in 2012. Although others have used the methodology and design limits of the Code Case to analyze vessels, to our knowledge, this was the first vessel to receive an ASME explosive rating with a U3 stamp. This paper discusses lessons learned in the process. Of particular interest were issues related to defining the design basis in the User Design Specification and explosive qualification testing required for regulatory approval. Specifying and testing an impulsively loaded vessel is more complicated than a static pressure vessel because the loads depend on the size, shape, and location of the explosive charges in the vessel and on the kind of explosives used and the point of detonation. Historically the US Department of Defense and Department of Energy have required an explosive test. Currently the Code Case does not address testing requirements, but it would be beneficial if it did since having vetted, third party standards for explosive qualification testing would simplify the process for regulatory approval.

Smooth Running Pumps have been an Industry issue since 1988. This caused many nuclear plants to obtain a Relief Request to use alternative requirements than those specified in the tables in subsections ISTB or ISTF of the ASME OM Code. Code Case OMN-22, Smooth Running Pumps, was approved in January 2017 for pumps with very low reference value vibration levels. This Code Case specifies the alternative requirements that may be used in lieu of the applicable Code subsections. Paper published with permission.

In January, 2003, Enbridge Midcoast Energy, L.P., a subsidiary of Enbridge Energy Partners, L.P., implemented a comprehensive direct assessment development and validation project for its Natural Gas Business segment; a project intended to demonstrate the validity of External Corrosion and Internal Corrosion Direct Assessment (ECDA and ICDA). The work began in January 2003 and was concluded in June 2003. The primary goal of the project was to demonstrate that External Corrosion Direct Assessment and Internal Corrosion Direct Assessment as performed in compliance with the NACE and INGAA methodologies could be used to effectively verify and manage the integrity of non-piggable and non-interruptible natural gas pipeline segments. The programs were validated by in-line inspection (ILI) using high-resolution magnetic flux leakage tools and field verification digs. The objective of the project was to receive approval from the Texas Railroad Commission to use direct assessment (“DA”), where demonstrated to be appropriate, for integrity verification and management of pipeline systems that are not verifiable through other approved means. The Enbridge DA Validation Project was successfully completed and is considered to be one of the leading DA validation projects undertaken to date in the U.S. A total of 12,000 manhours and over $1MM was expended in performing the pre-assessment to identify a candidate pipeline, develop detailed procedures for DA execution and implementation, perform indirect surveys, modify pipe and complete cleaning pig runs, gauge pig runs, dummy pig runs, intelligent pig runs, perform detailed direct examinations and perform detailed analysis of the results including the preparation of the final report. This paper is intended to describe the steps that Enbridge took in validating DA.

Some companies seek ISO 9000 registration for competitive reasons or because customers require it. PETRONAS Gas Bhd, pipeline division company TOD or Transmission Operations Division, seek ISO 9000 registrations purely for the benefits since the management believes that a well designed and well implemented quality system has a process which tends to be lean, sensitive to customers needs, highly reactive and efficient. This paper informs how TOD sets out to put ISO 9002 international quality system to work in its operations. A Quality Steering Council was formed in Feb. 1994 and the HSE and Quality Management Manager was appointed as management representative. The current working system was first assessed. Next, an implementation plan was prepared. Training was provided and the quality manual prepared followed by all the necessary work procedures and instructions. Finally there was trial implementation and actual “live” implementation. In January 1995 TOD ISO 9002 registration was approved.

The nuclear industry is preparing for the licensing and construction of new nuclear power plants in the United States. Several new designs have been developed and approved, including the “traditional” reactor designs, the passive safe shutdown designs and the small modular reactors (SMRs). The American Society of Mechanical Engineers (ASME) provides specific Codes used to perform preservice inspection/testing and inservice inspection/testing for many of the components used in the new reactor designs. The U.S. Nuclear Regulatory Commission (NRC) reviews information provided by applicants related to inservice testing (IST) programs for Design Certifications and Combined Licenses (COLs) under Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” in Title 10 of the Code of Federal Regulations (10 CFR Part 52) (Reference 1). The 2012 Edition of the ASME OM Code defines a post-2000 plant as a nuclear power plant that was issued (or will be issued) its construction permit, or combined license for construction and operation, by the applicable regulatory authority on or following January 1, 2000. The New Reactors OM Code (NROMC) Task Group (TG) of the ASME Code for Operation and Maintenance of Nuclear Power Plants (NROMC TG) is assigned the task of ensuring that the preservice testing (PST) and IST provisions in the ASME OM Code to address pumps, valves, and dynamic restraints (snubbers) in post-2000 nuclear power plants are adequate to provide reasonable assurance that the components will operate as needed when called upon. Currently, the NROMC TG is preparing proposed guidance for the treatment of active pumps, valves, and dynamic restraints with high safety significance in non-safety systems in passive post-2000 reactors including SMRs.

Nowadays, social media platforms are frequently being used on the Internet. When the users create an account for these platforms, they are required to accept the data privacy policy. With the approval of the data policy, major problems may arise such as observing every activity of users on the platform, violations of security and protection of personal data, and sharing user data with third parties for commercial purposes. In this regard, it is significant to examine the privacy policies of social media platforms in detail. In this research, we examined the privacy policies of the five most popular free applications on the communication section of the Google Play Store on January 30th, 2021. The privacy policies of these applications were analyzed with the content analysis method, and the research aims to reveal the area of utilization of the data that the users provide, with or without the permission of the user.

Since the approval of hydrogen peroxide as a package sterilant by the Food and Drug Administration in January 1981, aseptic processing has exploded onto the U.S. marketplace. In fact, during the summer of 1989, an expert panel from the Institute of Food Technologists voted aseptic technology as the food industry’s top innovation of the past 50 years. The major commercial success to date has been the aseptic processing of high acid fruit juices and fruit drinks, particularly when packaged in the 250 ml, single serve, laminated paper box. (Slide 2) Over three billion unit volumes were sold in 1989. This represents greater than a 12% increase over 1988 and means aseptic packaging has captured a larger unit volume than any other food packaging technology has ever done in so short a time. This paper will look at the technologies involved as they relate to citrus juices, the precautions which should be taken to optimize the product, and the promises which the future holds. Paper published with permission.

National Agency for Radioactive Waste — ANDRAD — is in Romania, by law, the competent authority for the disposal administration of spent nuclear fuel and radioactive waste and for the coordination of the predisposal management of spent nuclear fuel and radioactive waste, inclusive decommissioning of nuclear facilities. Government Ordinance (GO) No. 11/January 30, 2003 and Government Decision (GD) No. 1601/December 23, 2003 established the ANDRAD’s foundation and organization. In accordance with GO No. 11/2003, republished, on the safe management of the radioactive waste, ANDRAD has the responsibility to endorse the decommissioning documentation issued by the main radioactive waste generators (nuclear installations and other major radiological installations: radioactive waste treatment plants, radioactive waste storage facilities, post irradiation examination laboratories, centres for radioisotopes production etc.). ANDRAD receives for endorsement some of the documentation for decommissioning that is provided by enforced norms for each type of nuclear facility. There are presented the nuclear facilities that must have decommissioning documentation endorsed by ANDRAD, the type of documents submitted by license holder to ANDRAD and the procedure of endorsement in relation with the regulatory body (CNCAN) approval of the decommissioning documents.

Key Message Accelerating the rollout of Ontario’s COVID-19 vaccine such that all LTC residents receive the first dose of a COVID-19 vaccine by January 31, 2021, would prevent a projected 600 COVID-19 cases and 115 deaths by March 31, 2021 when compared with the province’s current plan to vaccinate all LTC residents by February 15, 2021. Projections indicate that further acceleration of the rollout would prevent even more COVID-19 cases and deaths. If vaccine supply is limited, the early provision of first doses of a COVID-19 vaccine to LTC home residents is likely to be more beneficial than the on-schedule provision of second doses to health care workers outside of LTC homes. All LTC residents should receive the second dose according to approved vaccination schedules.

1.1 Macroeconomic summary Economic recovery has consistently outperformed the technical staff’s expectations following a steep decline in activity in the second quarter of 2020. At the same time, total and core inflation rates have fallen and remain at low levels, suggesting that a significant element of the reactivation of Colombia’s economy has been related to recovery in potential GDP. This would support the technical staff’s diagnosis of weak aggregate demand and ample excess capacity. The most recently available data on 2020 growth suggests a contraction in economic activity of 6.8%, lower than estimates from January’s Monetary Policy Report (-7.2%). High-frequency indicators suggest that economic performance was significantly more dynamic than expected in January, despite mobility restrictions and quarantine measures. This has also come amid declines in total and core inflation, the latter of which was below January projections if controlling for certain relative price changes. This suggests that the unexpected strength of recent growth contains elements of demand, and that excess capacity, while significant, could be lower than previously estimated. Nevertheless, uncertainty over the measurement of excess capacity continues to be unusually high and marked both by variations in the way different economic sectors and spending components have been affected by the pandemic, and by uneven price behavior. The size of excess capacity, and in particular the evolution of the pandemic in forthcoming quarters, constitute substantial risks to the macroeconomic forecast presented in this report. Despite the unexpected strength of the recovery, the technical staff continues to project ample excess capacity that is expected to remain on the forecast horizon, alongside core inflation that will likely remain below the target. Domestic demand remains below 2019 levels amid unusually significant uncertainty over the size of excess capacity in the economy. High national unemployment (14.6% for February 2021) reflects a loose labor market, while observed total and core inflation continue to be below 2%. Inflationary pressures from the exchange rate are expected to continue to be low, with relatively little pass-through on inflation. This would be compatible with a negative output gap. Excess productive capacity and the expectation of core inflation below the 3% target on the forecast horizon provide a basis for an expansive monetary policy posture. The technical staff’s assessment of certain shocks and their expected effects on the economy, as well as the presence of several sources of uncertainty and related assumptions about their potential macroeconomic impacts, remain a feature of this report. The coronavirus pandemic, in particular, continues to affect the public health environment, and the reopening of Colombia’s economy remains incomplete. The technical staff’s assessment is that the COVID-19 shock has affected both aggregate demand and supply, but that the impact on demand has been deeper and more persistent. Given this persistence, the central forecast accounts for a gradual tightening of the output gap in the absence of new waves of contagion, and as vaccination campaigns progress. The central forecast continues to include an expected increase of total and core inflation rates in the second quarter of 2021, alongside the lapse of the temporary price relief measures put in place in 2020. Additional COVID-19 outbreaks (of uncertain duration and intensity) represent a significant risk factor that could affect these projections. Additionally, the forecast continues to include an upward trend in sovereign risk premiums, reflected by higher levels of public debt that in the wake of the pandemic are likely to persist on the forecast horizon, even in the context of a fiscal adjustment. At the same time, the projection accounts for the shortterm effects on private domestic demand from a fiscal adjustment along the lines of the one currently being proposed by the national government. This would be compatible with a gradual recovery of private domestic demand in 2022. The size and characteristics of the fiscal adjustment that is ultimately implemented, as well as the corresponding market response, represent another source of forecast uncertainty. Newly available information offers evidence of the potential for significant changes to the macroeconomic scenario, though without altering the general diagnosis described above. The most recent data on inflation, growth, fiscal policy, and international financial conditions suggests a more dynamic economy than previously expected. However, a third wave of the pandemic has delayed the re-opening of Colombia’s economy and brought with it a deceleration in economic activity. Detailed descriptions of these considerations and subsequent changes to the macroeconomic forecast are presented below. The expected annual decline in GDP (-0.3%) in the first quarter of 2021 appears to have been less pronounced than projected in January (-4.8%). Partial closures in January to address a second wave of COVID-19 appear to have had a less significant negative impact on the economy than previously estimated. This is reflected in figures related to mobility, energy demand, industry and retail sales, foreign trade, commercial transactions from selected banks, and the national statistics agency’s (DANE) economic tracking indicator (ISE). Output is now expected to have declined annually in the first quarter by 0.3%. Private consumption likely continued to recover, registering levels somewhat above those from the previous year, while public consumption likely increased significantly. While a recovery in investment in both housing and in other buildings and structures is expected, overall investment levels in this case likely continued to be low, and gross fixed capital formation is expected to continue to show significant annual declines. Imports likely recovered to again outpace exports, though both are expected to register significant annual declines. Economic activity that outpaced projections, an increase in oil prices and other export products, and an expected increase in public spending this year account for the upward revision to the 2021 growth forecast (from 4.6% with a range between 2% and 6% in January, to 6.0% with a range between 3% and 7% in April). As a result, the output gap is expected to be smaller and to tighten more rapidly than projected in the previous report, though it is still expected to remain in negative territory on the forecast horizon. Wide forecast intervals reflect the fact that the future evolution of the COVID-19 pandemic remains a significant source of uncertainty on these projections. The delay in the recovery of economic activity as a result of the resurgence of COVID-19 in the first quarter appears to have been less significant than projected in the January report. The central forecast scenario expects this improved performance to continue in 2021 alongside increased consumer and business confidence. Low real interest rates and an active credit supply would also support this dynamic, and the overall conditions would be expected to spur a recovery in consumption and investment. Increased growth in public spending and public works based on the national government’s spending plan (Plan Financiero del Gobierno) are other factors to consider. Additionally, an expected recovery in global demand and higher projected prices for oil and coffee would further contribute to improved external revenues and would favor investment, in particular in the oil sector. Given the above, the technical staff’s 2021 growth forecast has been revised upward from 4.6% in January (range from 2% to 6%) to 6.0% in April (range from 3% to 7%). These projections account for the potential for the third wave of COVID-19 to have a larger and more persistent effect on the economy than the previous wave, while also supposing that there will not be any additional significant waves of the pandemic and that mobility restrictions will be relaxed as a result. Economic growth in 2022 is expected to be 3%, with a range between 1% and 5%. This figure would be lower than projected in the January report (3.6% with a range between 2% and 6%), due to a higher base of comparison given the upward revision to expected GDP in 2021. This forecast also takes into account the likely effects on private demand of a fiscal adjustment of the size currently being proposed by the national government, and which would come into effect in 2022. Excess in productive capacity is now expected to be lower than estimated in January but continues to be significant and affected by high levels of uncertainty, as reflected in the wide forecast intervals. The possibility of new waves of the virus (of uncertain intensity and duration) represents a significant downward risk to projected GDP growth, and is signaled by the lower limits of the ranges provided in this report. Inflation (1.51%) and inflation excluding food and regulated items (0.94%) declined in March compared to December, continuing below the 3% target. The decline in inflation in this period was below projections, explained in large part by unanticipated increases in the costs of certain foods (3.92%) and regulated items (1.52%). An increase in international food and shipping prices, increased foreign demand for beef, and specific upward pressures on perishable food supplies appear to explain a lower-than-expected deceleration in the consumer price index (CPI) for foods. An unexpected increase in regulated items prices came amid unanticipated increases in international fuel prices, on some utilities rates, and for regulated education prices. The decline in annual inflation excluding food and regulated items between December and March was in line with projections from January, though this included downward pressure from a significant reduction in telecommunications rates due to the imminent entry of a new operator. When controlling for the effects of this relative price change, inflation excluding food and regulated items exceeds levels forecast in the previous report. Within this indicator of core inflation, the CPI for goods (1.05%) accelerated due to a reversion of the effects of the VAT-free day in November, which was largely accounted for in February, and possibly by the transmission of a recent depreciation of the peso on domestic prices for certain items (electric and household appliances). For their part, services prices decelerated and showed the lowest rate of annual growth (0.89%) among the large consumer baskets in the CPI. Within the services basket, the annual change in rental prices continued to decline, while those services that continue to experience the most significant restrictions on returning to normal operations (tourism, cinemas, nightlife, etc.) continued to register significant price declines. As previously mentioned, telephone rates also fell significantly due to increased competition in the market. Total inflation is expected to continue to be affected by ample excesses in productive capacity for the remainder of 2021 and 2022, though less so than projected in January. As a result, convergence to the inflation target is now expected to be somewhat faster than estimated in the previous report, assuming the absence of significant additional outbreaks of COVID-19. The technical staff’s year-end inflation projections for 2021 and 2022 have increased, suggesting figures around 3% due largely to variation in food and regulated items prices. The projection for inflation excluding food and regulated items also increased, but remains below 3%. Price relief measures on indirect taxes implemented in 2020 are expected to lapse in the second quarter of 2021, generating a one-off effect on prices and temporarily affecting inflation excluding food and regulated items. However, indexation to low levels of past inflation, weak demand, and ample excess productive capacity are expected to keep core inflation below the target, near 2.3% at the end of 2021 (previously 2.1%). The reversion in 2021 of the effects of some price relief measures on utility rates from 2020 should lead to an increase in the CPI for regulated items in the second half of this year. Annual price changes are now expected to be higher than estimated in the January report due to an increased expected path for fuel prices and unanticipated increases in regulated education prices. The projection for the CPI for foods has increased compared to the previous report, taking into account certain factors that were not anticipated in January (a less favorable agricultural cycle, increased pressure from international prices, and transport costs). Given the above, year-end annual inflation for 2021 and 2022 is now expected to be 3% and 2.8%, respectively, which would be above projections from January (2.3% and 2,7%). For its part, expected inflation based on analyst surveys suggests year-end inflation in 2021 and 2022 of 2.8% and 3.1%, respectively. There remains significant uncertainty surrounding the inflation forecasts included in this report due to several factors: 1) the evolution of the pandemic; 2) the difficulty in evaluating the size and persistence of excess productive capacity; 3) the timing and manner in which price relief measures will lapse; and 4) the future behavior of food prices. Projected 2021 growth in foreign demand (4.4% to 5.2%) and the supposed average oil price (USD 53 to USD 61 per Brent benchmark barrel) were both revised upward. An increase in long-term international interest rates has been reflected in a depreciation of the peso and could result in relatively tighter external financial conditions for emerging market economies, including Colombia. Average growth among Colombia’s trade partners was greater than expected in the fourth quarter of 2020. This, together with a sizable fiscal stimulus approved in the United States and the onset of a massive global vaccination campaign, largely explains the projected increase in foreign demand growth in 2021. The resilience of the goods market in the face of global crisis and an expected normalization in international trade are additional factors. These considerations and the expected continuation of a gradual reduction of mobility restrictions abroad suggest that Colombia’s trade partners could grow on average by 5.2% in 2021 and around 3.4% in 2022. The improved prospects for global economic growth have led to an increase in current and expected oil prices. Production interruptions due to a heavy winter, reduced inventories, and increased supply restrictions instituted by producing countries have also contributed to the increase. Meanwhile, market forecasts and recent Federal Reserve pronouncements suggest that the benchmark interest rate in the U.S. will remain stable for the next two years. Nevertheless, a significant increase in public spending in the country has fostered expectations for greater growth and inflation, as well as increased uncertainty over the moment in which a normalization of monetary policy might begin. This has been reflected in an increase in long-term interest rates. In this context, emerging market economies in the region, including Colombia, have registered increases in sovereign risk premiums and long-term domestic interest rates, and a depreciation of local currencies against the dollar. Recent outbreaks of COVID-19 in several of these economies; limits on vaccine supply and the slow pace of immunization campaigns in some countries; a significant increase in public debt; and tensions between the United States and China, among other factors, all add to a high level of uncertainty surrounding interest rate spreads, external financing conditions, and the future performance of risk premiums. The impact that this environment could have on the exchange rate and on domestic financing conditions represent risks to the macroeconomic and monetary policy forecasts. Domestic financial conditions continue to favor recovery in economic activity. The transmission of reductions to the policy interest rate on credit rates has been significant. The banking portfolio continues to recover amid circumstances that have affected both the supply and demand for loans, and in which some credit risks have materialized. Preferential and ordinary commercial interest rates have fallen to a similar degree as the benchmark interest rate. As is generally the case, this transmission has come at a slower pace for consumer credit rates, and has been further delayed in the case of mortgage rates. Commercial credit levels stabilized above pre-pandemic levels in March, following an increase resulting from significant liquidity requirements for businesses in the second quarter of 2020. The consumer credit portfolio continued to recover and has now surpassed February 2020 levels, though overall growth in the portfolio remains low. At the same time, portfolio projections and default indicators have increased, and credit establishment earnings have come down. Despite this, credit disbursements continue to recover and solvency indicators remain well above regulatory minimums. 1.2 Monetary policy decision In its meetings in March and April the BDBR left the benchmark interest rate unchanged at 1.75%.