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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
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optimize the manufacture, distribution, and administration of COVID19 and other critical vaccinations. see https
www.regulations.gov/comment/HRSA2021-0001-0022. These organizations further explained they opposed the removal of SIRVA and syncope from the Table because such a move would put a significant damper on vaccine research and development, the willingness of healthcare providers, including pharmacists, to administer vaccines, as well as the publics willingness to get vaccinated without the protections provided by the National Vaccine Injury Compensation Program VICP. Id. Furthermore they stated, Removing SIRVA and syncope might discourage providers from vaccinating if they are concerned about being sued in court for these vaccine injuries. Id.
The National Association of Chain Drug Stores NACDS also supported delaying the final rule, and urged HHS
to withdraw it, claiming it contained policies that will serve to inhibit vaccine availability thus leading to poorer public health outcomes. see https www.regulations.gov/comment/
HRSA-2021-0001-0017.
Another commenter stated, The proposed Amendment to the Vaccine Injury Compensation Table is contrary to the purpose of the Act. It exposes doctors, nurses, health care workers and pharmacies to civil tort liability for administering a vaccine, which causes arm or shoulder injuries. The result will be more obstacles to the administration of vaccines as well as ultimately less Americans receiving vaccines
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availability thus leading to poorer public health outcomes. see https
www.regulations.gov/comment/HRSA2021-0001-0004.
HHS seeks comment by April 16, 2021 on the proposed rescission of the final rule, including on the issues raised above related to the final rules promulgation and the impact the final rule could have on vaccine administrators.
III. Regulatory Impact Analysis Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits including potential economic, environmental, public health, safety, distributive, and equity effects.
In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, HHS must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.
The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under section 3f of Executive Order 12866.
HHS has determined that no resources are required to implement the requirements in this rule because compensation will continue to be made consistent with the status quo.
Therefore, in accordance with the Regulatory Flexibility Act of 1980

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RFA, and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, HHS certifies that this rule will not have a significant impact on a substantial number of small entities.
HHS has also determined that this rule does not meet the criteria for a major rule under the Congressional Review Act or Executive Order 12866
and would have no major effect on the economy or Federal expenditures.
Similarly, it will not have effects on State, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. Nor on the basis of family well-being will the provisions of this rule affect the following family elements: Family safety; family stability; marital commitment; parental rights in the 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.
Paperwork Reduction Act of 1995
This rule has no information collection requirements.
Norris Cochran, Acting Secretary, Department of Health and Human Services.
FR Doc. 202105486 Filed 31221; 4:15 pm BILLING CODE 416515P

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