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HHS/HRSA RIN: 0906-AA79 Publication ID: Spring 2013 
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 would establish 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) as authorized under the Public Readiness and Emergency Preparedness Act (PREP Act). The rule would 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: Info./Admin./Other 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 110 
Legal Authority: PL 109-148,; sec 31F-3 and 319F-4 of the PHS Act  
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2013   
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

 
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