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Countermeasures Injury Compensation Program: Smallpox Countermeasures Injury Table
The Department of Health and Human Services (HHS) proposes adding a Smallpox Countermeasures Injury Table (Table) for designated covered smallpox countermeasures identified in a declaration. The proposed Smallpox Countermeasures Injury Table includes a list of smallpox countermeasures, proposed time intervals for the first symptom or...
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
The Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. The proposed regulation will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. HHS is seeking public comment on the proposed revisions to the Table.
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Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
In the regulation of health care, the United States has a long history of providing conscience-based protections for individuals and entities with objections to certain activities based on religious belief and moral convictions. Multiple such statutory protections apply to the Department of Health and Human Services (HHS, or the Department) and...
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
The Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will have effect only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the...
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Countermeasures Injury Compensation Program: Pandemic Influenza Countermeasures Injury Table
The Public Readiness and Emergency Preparedness Act (PREP Act) directs the Secretary of Health and Human Services (the Secretary), to establish a Countermeasures Injury Compensation Program (the Program) to provide ``timely, uniform, and adequate compensation'' to eligible individuals who sustain serious physical injuries or to certain survivors...
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National Vaccine Injury Compensation Program
The Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for...
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Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act
The Food and Drug Administration (FDA or Agency) is proposing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and...
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table
Through this proposed rule, the Secretary proposes to change the Vaccine Injury Table (Table) to create distinct and separate listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus (HPV) vaccines. The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP...
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National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine Injury Table
The Secretary has made findings as to a condition that can reasonably be determined in some circumstances to be caused by vaccines containing live, oral, rhesus-based rotavirus. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by adding to the Table vaccines containing live, oral, rhesus-based rotavirus...