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HHS/HRSA RIN: 0906-AB00 Publication ID: Fall 2014 
Title: Vaccine Injury Table: Rotavirus Vaccine Within the National Vaccine Injury Compensation Program 
Abstract: This final rule adds 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 amends 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: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
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) of the Family Preservation and Support Services Program Act of 1993    PL 103-66, 42 USC 100.3(c)(5)   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/24/2013  78 FR 44512   
NPRM Comment Period End  01/21/2014 
Final Action  07/00/2015 
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. Avril Melissa Houston
Acting Director, Countermeasures Injury Compensation Program
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane,
Rockville, MD 20857
Phone:301 443-6593