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HHS/HRSA RIN: 0906-AB14 Publication ID: Fall 2017 
Title: ●National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table  
Abstract:

This proposed rule would revise the Vaccine Injury Table to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women.  The addition of this category of vaccines to the Vaccine Injury Table is necessary to allow related injury claims to be eligible for adjudication through the Vaccine Injury Compensation Program.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 100   
Legal Authority: 21st Century Cures Act    FR 114-255   
Legal Deadline:  None

Statement of Need:

This statutorily required regulation revises the Vaccine Injury Table to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women. This category of vaccines must be added to the Table for such injury claims to be eligible for adjudication through the Vaccine Injury Compensation Program.

Summary of the Legal Basis:

This rule would implement provisions of the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended.

Alternatives:

None. This rule implements statutory requirements.

Anticipated Costs and Benefits:

An estimate of costs of this regulation is not available at this time.  There are no anticipated costs to this regulation.

Risks:

This category of vaccines must be added to the Table for such injury claims to be eligible for adjudication through the Vaccine Injury Compensation Program.

Timetable:
Action Date FR Cite
NPRM  09/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Tamara Overby
Deputy Director, Division of Injury Compensation Programs
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, 08N142,
Rockville, MD 20857
Phone:301 443-3766
Email: toverby@hrsa.gov