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Public Readiness And Emergency Preparedness Act
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of ), is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The part of PREPA that actually affords such protection is now codified at . The act specifically affords to drug makers immunity from actions related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic ...
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United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washington, D.C. Senators and representatives are chosen through direct election, though vacancies in the Senate may be filled by a governor's appointment. Congress has 535 voting members: 100 senators and 435 representatives. The U.S. vice president has a vote in the Senate only when senators are evenly divided. The House of Representatives has six non-voting members. The sitting of a Congress is for a two-year term, at present, beginning every other January. Elections are held every even-numbered year on Election Day. The members of the House of Representatives are elected for the two-year term of a Congress. The Reapportionment Act of 1929 establishes that there be 435 representatives and the Uniform Congressional Redistricting Act requires ...
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Bill Frist
William Harrison Frist (born February 22, 1952) is an American physician, businessman, and politician who served as a United States Senator from Tennessee from 1995 to 2007. A member of the Republican Party, he also served as Senate Majority Leader from 2003 to 2007. Born in Nashville, Tennessee, Frist studied health care policy at Princeton University and interned for U.S. Representative Joe L. Evins. Rather than going directly into politics, Frist earned a Doctor of Medicine degree from Harvard Medical School, becoming a surgeon at Massachusetts General Hospital and several other hospitals. In the 1994 Republican Wave, he defeated incumbent Democratic Senator Jim Sasser; he pledged to only serve two terms. After serving as Chairman of the National Republican Senatorial Committee, Frist succeeded Tom Daschle as the Senate Majority Leader. Frist helped pass several parts of President George W. Bush's domestic agenda, including the Jobs and Growth Tax Relief Reconciliation Act ...
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Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ...
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Bioterrorism
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, insects, fungi, and/or toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism. Definition Bioterrorism is the deliberate release of viruses, bacteria, toxins or other harmful agents to cause illness or death in people, animals, or plants. These agents are typically found in nature, but could be mutated or altered to increase their ability to cause disease, make them resistant to current medicines, or to increase their ability to be spread into the environment. Biological agents can be spread through the air, water, or in food. Bi ...
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Complaint
In legal terminology, a complaint is any formal legal document that sets out the facts and legal reasons (see: cause of action) that the filing party or parties (the plaintiff(s)) believes are sufficient to support a claim against the party or parties against whom the claim is brought (the defendant(s)) that entitles the plaintiff(s) to a remedy (either money damages or injunctive relief). For example, the Federal Rules of Civil Procedure (FRCP) that govern civil litigation in United States courts provide that a civil action is commenced with the filing or service of a pleading called a complaint. Civil court rules in states that have incorporated the Federal Rules of Civil Procedure use the same term for the same pleading. In Civil Law, a “complaint” is the first formal action taken to officially begin a lawsuit. This written document contains the allegations against the defense, the specific laws violated, the facts that led to the dispute, and any demands made by the ...
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United States District Court For The District Of Columbia
The United States District Court for the District of Columbia (in case citations, D.D.C.) is a federal district court in the District of Columbia. It also occasionally handles (jointly with the United States District Court for the District of Hawaii and the High Court of American Samoa) federal issues that arise in the territory of American Samoa American Samoa ( sm, Amerika Sāmoa, ; also ' or ') is an unincorporated territory of the United States located in the South Pacific Ocean, southeast of the island country of Samoa. Its location is centered on . It is east of the Internationa ..., which has no local federal court or United States territorial court, territorial court.https://www.gao.gov/products/GAO-08-1124T U.S. Government Accountability Office. AMERICAN SAMOA: Issues Associated with Some Federal Court Options. September 18, 2008. Retrieved September 7, 2019. Appeals from the District are taken to the United States Court of Appeals for the District of Columbia C ...
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University Of Minnesota
The University of Minnesota, formally the University of Minnesota, Twin Cities, (UMN Twin Cities, the U of M, or Minnesota) is a public university, public Land-grant university, land-grant research university in the Minneapolis–Saint Paul, Twin Cities of Minneapolis and Saint Paul, Minnesota, United States. The Twin Cities campus comprises locations in Minneapolis and Falcon Heights, Minnesota, Falcon Heights, a suburb of St. Paul, approximately apart. The Twin Cities campus is the oldest and largest in the University of Minnesota system and has the List of United States university campuses by enrollment, ninth-largest main campus student body in the United States, with 52,376 students at the start of the 2021–22 academic year. It is the Flagship#Colleges and universities in the United States, flagship institution of the University of Minnesota System, and is organized into 19 colleges, schools, and other major academic units. The Minnesota Territorial Legislature drafted a ...
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Center For Infectious Disease Research And Policy
The Center for Infectious Disease Research and Policy (CIDRAP) is a center within the University of Minnesota that focuses on addressing public health preparedness and emerging infectious disease response. It was founded in 2001 by Dr. Michael Osterholm, in order to "prevent illness and death from infectious diseases through epidemiological research and rapid translation of scientific information into real-world practical applications and solutions". It is not part of the Center for Disease Control or National Institute of Health. History Michael Osterholm founded Center for Infectious Disease Research and Policy (CIDRAP) in 2001. In 2019, the CIDR (Center for Infectious Disease Research in Seattle) was absorbed by the Seattle Children's Research Institute but the CIDRAP is not the same organization. Primary activities News publishing CIDRAP's news publishing division writes news stories and maintains information on influenza, bioterrorism, and new hot topics. The CIDRAP n ...
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Epidemic
An epidemic (from Ancient Greek, Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of patients among a given population within an area in a short period of time. Epidemics of infectious diseases are generally caused by several factors including a significant change in the ecology of the areal population (e.g., increased stress maybe additional reason or increase in the density of a vector species), the introduction of an emerging pathogen to an areal population (by movement of pathogen or host) or an unexpected genetic change that is in the pathogen reservoir. Generally, epidemics concerns with the patterns of infectious disease spread. An epidemic may occur when host immunity to either an established pathogen or newly emerging novel pathogen is suddenly reduced below that found in the endemic equilibrium and the transmission threshold is exceeded. For example, in meningococcal infections, an attack rate in ...
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Vaccine Injury
A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI). AEFIs can be related to the vaccine itself (product or quality defects), to the vaccination process (administration error or stress related reactions) or can occur independently from vaccination (coincidental). Most vaccine adverse events are mild. Serious injuries and deaths caused by vaccines are very rare, and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO. Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who attribute their children's autism to vaccine injury, despite the fact that vaccines do not cause autism. Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th century. Some families ...
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Appropriations Bill (United States)
In the United States Congress, an appropriations bill is legislation to appropriate federal funds to specific federal government departments, agencies and programs. The money provides funding for operations, personnel, equipment and activities. Regular appropriations bills are passed annually, with the funding they provide covering one fiscal year. The ''fiscal year'' is the accounting period of the federal government, which runs from October 1 to September 30 of the following year. Appropriations bills are under the jurisdiction of the United States House Committee on Appropriations and the United States Senate Committee on Appropriations. Both Committees have twelve matching subcommittees, each tasked with working on one of the twelve annual regular appropriations bills. There are three types of appropriations bills: regular appropriations bills, continuing resolutions, and supplemental appropriations bills. Regular appropriations bills are the twelve standard bills that cove ...
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Conference Report
In the United States Congress, a conference report refers to the final version of a bill that is negotiated between the House of Representatives and the Senate via conference committee. It is printed and submitted to each chamber for its consideration, such as approval or disapproval. It contains the "statement of managers," a section-by-section explanation of the agreement.{{cite web, url = http://www.c-span.org/guide/congress/glossary/confrepo.htm, url-status = dead, archive-url = https://web.archive.org/web/20000111035721/http://www.c-span.org/guide/congress/glossary/confrepo.htm, archive-date = 2000-01-11, title = CONFERENCE REPORT Publication procedure An amendment to Rule XXVIII of the Standing Rules of the United States Senate states: ::9(a)(1) It shall not be in order to vote on the adoption of a report of a committee of conference unless such report has been available to Members and to the general public for at least 48 hours before such vote. If a point of order is ...
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