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HHS/HRSA RIN: 0906-AB00 Publication ID: Fall 2013 
Title: Vaccine Injury Table: Rotavirus Vaccine Within the National Vaccine Injury Compensation Program 
Abstract: This proposed rule would add intussusception to the Vaccine Injury Table under the category of rotavirus vaccines. The National Vaccine Injury Compensation Program allows a family of a child, a person, or their estate to receive monetary compensation if they experience a vaccine-related injury or death after receiving a covered vaccine. Currently, no adverse event is listed on the Vaccine Injury Table for rotavirus vaccines. However, recent data point to a small risk of intussusception, and the rule would amend the Vaccine Injury Table to provide for this adverse event. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 100.3(C)(5) 
Legal Authority: sec 2114(e) of the Public Health Service Act; 42 USC 300ea-14(e)(2); sec 13632(a)(3); PL 103-66, 42 USC 100.3(c)(5) 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/24/2013  78 FR 44512 
NPRM Comment Period End  01/21/2014   
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. 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
Email: cicp@hrsa.gov

 
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