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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
B. Economic and Regulatory Impact In accordance with the Regulatory Flexibility Act of 1980 RFA, and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.
Between FY 2017 and FY 2019, the VICP on average paid out $30,893,481.90 per year to petitioners alleging SIRVA claims. The VICP on average paid out $124,489.56 per year to petitioners alleging vasovagal syncope claims. When this final rule goes into effect, the Department anticipates that small entities will not actually pay these amounts, because fewer SIRVA and vasovagal syncope claims would be filed if petitioners had to prove causation. In addition, vaccines are often administered by non-small entities, so even if total amounts paid approximated the amounts paid on average between FY 2017 and FY 2019, claims against small entities would be less. It is the Departments belief that should the amounts paid equal the amounts annually paid out of the VICP
between FY 2017 and FY 2019, and such claims are paid in full by small entities, these amounts will not constitute a significant impact on a substantial number of small entities for purposes of the RFA.
Section 202 of the Unfunded Mandates Reform Act of 1995
Unfunded Mandates Act 2 U.S.C.
1532 requires that covered agencies prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $154 million. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires covered agencies to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. The Department has determined that this final rule will not result in expenditures by State, local, and tribal governments, or by the private sector, of $154 million or more in any one year. Accordingly, the Department has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.
The provisions of this rule will also not negatively affect family well-being or the following family elements: family safety; family stability; marital commitment; parental rights in the
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education, nurture and supervision of their children; family functioning;
disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654c of the Treasury and General Government Appropriations Act of 1999.
On January 30, 2017, the White House issued Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs. Section 2a of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation.
In furtherance of this requirement, section 2c of Executive Order 13771
requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. This final rule partially repeals prior regulations and is not expected to increase incremental costs, so it is not anticipated to be a regulatory or deregulatory action under Executive Order 13771.
As stated above, this final rule modifies the Vaccine Injury Table to ensure that the Table complies with applicable law, the Table is consistent with medical and scientific literature, those administering vaccines have additional incentive to use proper injection technique, and the VICP has sufficient funds to adequately compensate those injured by vaccines listed in the Table.
C. Executive Order 12988: Civil Justice Reform The agency has reviewed this rule under Executive Order 12988 on Civil Justice Reform and has determined that this final rule complies with this Executive Order.
V. Summary of Impacts This final rule has the effect of removing injuries from the Table that are not encompassed by the provisions of the Vaccine Act and that are reducing the pool of funds available to those injured by vaccines or vaccine components. It therefore aligns the Table with the Departments understanding of Congress intent and public policy in favor of compensating those harmed by injuries associated with the vaccine or vaccine components, and particularly children who have suffered such harm. The rule also has the effect of ensuring that the limited compensation resources available under the National Vaccine
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Injury Compensation Program are provided to those with vaccine-related injuries or deaths. In addition, because of the large volume of SIRVA claims, removing SIRVA from the Table will reduce the amount of program funds spent on program administration and ensure that funds awarded from the VICP are awarded to individuals whose claims arise from vaccine-related injuries, which is consistent with the Departments interpretation of the original intent of the VICP.
The final rule also better incentivizes those who administer vaccines to use proper injection technique. It may also help correct misleading and erroneous suggestions that vaccines are not safe.
Because COVID19 and the COVID19
vaccines are not currently on the Table, the Department does not believe this rule will have an impact on patients with COVID19 or the COVID19
vaccines.
Moreover, the rule is unlikely to unduly burden the civil tort system. The Department conducted a search in the WestLaw legal database for cases in state court that contained both the terms SIRVA and vaccine, and found only 20 hits, at least two of which were cases involving an entity named SIRVA
and not the injury.54 It is possible that some additional cases were filed in federal district court. Nonetheless, the Department believes based on this data that any additional burden on the civil tort system, which will be dispersed across States and not concentrated in any one or few States, from removing SIRVA and vasovagal syncope from the Table and reverting to the status quo as of January 2017 will be minimal.
A. Executive Order 13132Federalism HHS has reviewed this final rule in accordance with E.O. 13132 regarding federalism and has determined that it does not have federalism implications. This final rule will not have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and 54 https 1.next.westlaw.com/Search/
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