View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/HRSA RIN: 0906-AA79 Publication ID: Spring 2010 
Title: ●Countermeasures Injury Compensation Program; Pandemic Influenza Countermeasure Injury Table Amendment for Influenza Vaccines, Antiviral drugs, Respiratory Protection/Support Devices, and Diagnostics 
Abstract: This proposed rule establishes the Pandemic Influenza Countermeasure Injury Table for Influenza Vaccines, Antiviral Medications, Respiratory Protection Devices, Respiratory Support Devices, and Diagnostics for the Countermeasure Injury Compensation Program (CICP). The Public Readiness and Emergency Preparedness Act (PREP Act) authorized the Secretary of HHS to establish the CICP to provide benefits to certain persons who sustain serious physical injury or death as a direct result of the administration or use of covered countermeasures identified by the Secretary in declarations issued under the PREP Act. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as a direct result of covered injuries or their health complications. One way that an individual who was administered or used a covered countermeasure can show that they sustained a covered injury is by demonstrating that they sustained an injury listed on a Countermeasures Injury Table (Table) within the time interval set forth on the Table. This rule will be an amendment to the CICP Administrative Interim Final Rule and will list and explain injuries that, based on compelling, reliable, valid, medical, and scientific evidence, are presumed to be caused by covered Pandemic Influenza Vaccines, Antiviral Medications, Respiratory Protection Devices, Respiratory Support Devices, and Diagnostics, and set forth the time periods in which the onset of these injuries must occur after the administration or use of these covered Pandemic influenza countermeasures. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 110   
Legal Authority: PL109-148    sec 31F-3 and 319F-4 of the PHS Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Vito Caserta
Director, Countermeasures Injury Compensation Program
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-06,
Rockville, MD 20857
Phone:301 443-5287
Fax:301 443-1221
Email: cicp@hrsa.gov