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HHS/HRSA RIN: 0906-AA75 Publication ID: Fall 2008 
Title: National Vaccine Injury Compensation Program; Removal of Separate Category for Vaccines Containing Live, Oral, Rhesus-Based Rotavirus From the Vaccine Injury 
Abstract: The Secretary of the Department of Health and Human Services plans to make a technical change to the Vaccine lnjury Table (Table) by removing vaccines containing live, oral, rhesus-based rotavirus from the Table. Because the manufacturer of this vaccine voluntarily ceased distribution of it in July 1999, and because the CDC recommended that this vaccine no longer be routinely administered to children in the United States in October 1999, the Secretary concluded that it was unlikely that potential claims for this vaccine would arise after the rule's publication. Furthermore, the applicable statute of limitations requires petitioners to file claims within three years of the injury's first symptom or manifestation of onset (or four years from such onset and two years from the date of death, in death cases). Therefore, the Secretary believes that any person with a potential Vaccine Injury Table claim for this vaccine would be time-barred. See attached document for more information. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 100.3(c)(5)   
Legal Authority: sec 2114(e)(2) of the Public Health Service Act, 42 USC 300aa-14(e)(2)    sec 13632(a)(3) PL 103-66, 42 USC CFR 100.3(c)(5)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  10/09/2008  73 FR 59528   
Interim Final Rule Effective  11/10/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Geoffrey S. Evans
Acting Director, Division of Vaccine Injury Compensation
Department of Health and Human Services
Health Resources and Services Administration
Room 11C-26, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 443-6593
Fax:301 443-8196
Email: gevansr@hrsa.gov