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HHS/HRSA RIN: 0906-AA74 Publication ID: Fall 2010 
Title: National Vaccine Injury Compensation Program; Separate Category for Hepatitis A, Influenza, Meningococcal, Human Papillomavirus Vaccines 
Abstract: This notice of proposed rulemaking proposes to change the Vaccine Injury Table (Table) to create separate categories for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus (HPV) vaccines. When a vaccine is recommended for routine administration to children by the Centers for Disease Control and Prevention (CDC), and after an excise tax is imposed on it by Congress, a vaccine is added to the Table under the new vaccines category (Category XIII). These four vaccines have been recommended for routine administration to children by the CDC and have had an excise tax imposed on them. Notices were published informing the public that these four vaccines have been added to the Table under Category XIII. The next step is that new vaccines are added as their own separate categories, with associated injuries/conditions, including the time periods in which the first symptoms or significant aggravation of such injuries/conditions must occur, if applicable, once the Secretary goes through the rulemaking process. In the past, such injuries/conditions have been added based on extensive scientific reviews of medical literature for adverse events following vaccination. Because reviews for these vaccines are not expected until 2011 at the earliest, we are proceeding with rulemaking to add these four vaccines as their own separate categories in order to make clear the four vaccines are covered by the National Vaccine Injury Compensation Program. Once results of the scientific reviews are published, additional rulemaking may be necessary, if certain conditions are viewed by the Department as appropriate for inclusion on the Table, including the relevant time periods of onset. 
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: 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 300ea-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
NPRM  12/00/2010    
NPRM Comment Period End  03/00/2011    
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
Director, Division of Vaccine Injury Compensation, Healthcare Systems Bureau
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: gevans@hrsa.gov