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HHS/HRSA RIN: 0906-AB00 Publication ID: Fall 2015 
Title: Vaccine Injury Table: Rotavirus Vaccine Within the National Vaccine Injury Compensation Program 

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: Completed Actions 
Major: No  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 U.S.C. 300ea-14(e)(2)    sec 13632(a)(3) of the Family Preservation and Support Services Program Act of 1993    Pub. L. 103-66    42 U.S.C. 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  06/23/2015  80 FR 35848   
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