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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations state tort remedy for certain avoidable injuries, such as those caused by negligent vaccine administration. Given that the Vaccine Act seeks to replace state tort remedies for the injuries it covers, this reinforces the conclusion that the Act does not reach SIRVA and vasovagal syncope.
Comment: One commenter disagreed with the Departments position that recordkeeping and reporting requirements are woefully inadequate if the Program was designed to compensate for negligence by the provider, since physicians are subject to myriad state laws and regulations governing medical records. The commenter stated that Congress authorized HHS to promulgate additional recordkeeping requirements if need be.
Response: The text and structure of the Vaccine Act show that it was not meant to cover negligent administration of the vaccine. That some state laws and regulations govern medical records is besides the point.
Comment: Many commenters argued that this rule is an unconscionable attempt to alleviate HHSs backlog of pending cases, and that the public would be better served if the Department was to hire additional personal to handle case management.
Response: The Department respectfully disagrees. The Department has set forth a series of legal and policy reasons for this final rule both herein and in the proposed rule.

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III. Statutory Authority The primary statutory authority for this rulemaking is 42 U.S.C. 300aa14.
42 U.S.C 300aa14c1 provides that the Secretary may promulgate regulations to modify in accordance with paragraph 3 the Vaccine Injury Table. In promulgating such regulations, he shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. 42
U.S.C. 300aa14c3, in turn, provides:
A modification of the Vaccine Injury Table under paragraph 1 may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the significant aggravation of any such injury, disability, illness, condition, or death.

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IV. Statutory and Regulatory Requirements A. Executive Orders 12866, 13563, and 13771: Regulatory Planning and Review E.O. 12866 and E.O. 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O. 13563 supplements and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866, which emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are significant because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues require special analysis.
The Department anticipates that the final rule will save limited compensation funds under the National Vaccine Injury Compensation Program.
Specifically, it will reduce the amount of program funds spent on program administration, reduce the amount of funds paid out to those with SIRVA or vasovagal syncope claims, and ensure that funds awarded from the VICP are awarded to individuals whose claims arise from vaccine-related injuries, which is consistent with the original intent of the VICP. Moreover, the Department anticipates that the final rule may result in fewer individuals suffering from SIRVA or vasovagal syncope, because it will better incentivize those administering vaccines to use proper injection technique. If those who administer vaccines can be held liable when a patient suffers from SIRVA or vasovagal syncope as a result of the administration of the vaccine, those who administer vaccines will have greater incentive to use proper injection technique. In addition, the final rule may also limit the ability of those opposed to vaccinations to cite to the high number of SIRVA awards to misleadingly suggest that vaccines are less safe than they truly are.
The Department considered, as an alternative to the proposed rule and this final rule, issuing a notice of proposed
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rulemaking that would revise the definition of SIRVA so that those with true shoulder injuries were able to recover while reducing the number of less appropriate claims. However, the Department concluded that removing SIRVA from the Table is preferable. If SIRVA is removed from the Table, those with actual SIRVA injuries would still be able to recover in state court.
Removal is preferable to redefining SIRVA, because it better addresses the vaccine hesitancy concern, is more in line with the Vaccine Act and Congressional intent, and incentivizes learning and utilizing proper administration technique. Indeed, because Vaccine Act proceedings are generally sealed and not made available to the public, vaccine administrators often are left unaware that they used an improper technique.
The Department also considered, as alternatives to this final rule, not removing one or more of 1 SIRVA, 2
vasovagal syncope, or 3 Item XVII from the Table. For the reasons discussed herein and in the proposed rule, the Department rejected these alternatives.
Section 3f of Executive Order 12866
defines a significant regulatory action as an action that is likely to result in a rule 1 having an annual effect on the economy of $100 million or more in any one year, or adversely or materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities also referred to as economically significant; 2 creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; 3
materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or 4
raising novel legal or policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the Executive Order. A
regulatory impact analysis must be prepared for major rules with economically significant effects $100
million or more in any one year, and a significant regulatory action is subject to Office of Management and Budget OMB review. As discussed below regarding the anticipated effects, these changes are not likely to have economic impacts of $100 million or more in any one year, and therefore do not meet the definition of economically significant under Executive Order 12866. OMB has waived review over this final rule.

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