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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations changes made to the final rule are to paragraphs d6 and 9 for clarity.
IV. Regulatory Impact Analysis HHS examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review September 30, 1993, Executive Order 13563 on Improving Regulation and Regulatory Review January 18, 2011, the Congressional Review Act 5
U.S.C. 8042, the Regulatory Flexibility Act RFA September 19, 1980, Pub. L.
96354, section 202 of the Unfunded Mandates Reform Act of 1995 March 2, 1995; Pub. L. 1044, section 654c of the Treasury and General Government Appropriations Act of 1999, and Executive Order 13132 on Federalism August 4, 1999.

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Executive Orders 12866 and 13563
Executive Order 12866 requires all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and 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.
In 2011, President Obama supplemented and reaffirmed Executive Order 12866.
Executive Order 13563 provides that, to the extent feasible and permitted by law, the public must be given a meaningful opportunity to comment on any proposed regulations, with at least a 60-day comment period. In addition, to the extent feasible and permitted by law, agencies must provide timely online access to both proposed and final rules of the rulemaking docket on https www.regulations.gov/, including relevant scientific and technical findings, in an open format that can be searched and downloaded. Federal agencies must consider approaches to maintain the freedom of choice and flexibility, including disclosure of relevant information to the public.
Objective scientific evidence guides regulations and should be easy to understand, consistent, and written in plain language. Furthermore, Federal agencies must attempt to coordinate, simplify, and harmonize regulations to reduce costs and promote certainty for the public.

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Summary of Impacts In this final rule, the Secretary establishes a Table identifying serious physical injuries that are presumed to result from the administration or use of certain covered countermeasures, required definitions of those injuries, and the time interval in which the onset of the first symptom or manifestation of each injury must manifest for the presumption of causation to apply. The Table establishes a presumption of causation for requesters meeting the Tables requirements and relieves requesters of the burden of demonstrating causation. However, this presumption is rebuttable if, based on the Secretarys review of the evidence, a source other than the countermeasure is found to be the more likely cause of the injury. The publication of this Table may afford some requesters a new filing deadline.
The Secretary has determined that minimal staff and funding resources are required to implement the provisions included in this final rule. Therefore, in accordance with the Regulatory Flexibility Act of 1980 RFA and the Small Business Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the Secretary certifies that this final rule will not have a significant impact on a substantial number of small entities.
The Secretary has determined that this final rule does not meet the criteria for an economically significant regulatory action as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. The Secretary also has determined that this final rule is not a major rule within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. The Office of Information and Regulatory Affairs within the Office of Management and Budget has determined that this rule is not a significant regulatory action within the meaning of section 3f of the Executive order.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 section 202a requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing any rule that includes any Federal mandate that may result in the
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expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any one year. The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
Executive Order 13132Federalism The Secretary also reviewed this final rule in accordance with Executive Order 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 responsibilities among the various levels of government.
Paperwork Reduction Act of 1995
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 110
Biologics, Immunization.
Dated: August 9, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.

PART 110COUNTERMEASURES
INJURY COMPENSATION PROGRAM
1. The authority citation for part 110
continues to read as follows:

Authority: 42 U.S.C. 247d6e.

2. Amend 110.100 by revising paragraph b introductory text and paragraph c and adding paragraph d to read as follows:

110.100

Injury Tables.

b Qualifications and aids to interpretation table definitions and requirements. The following definitions and requirements shall apply to the Table set forth in paragraph a of this section and only apply for purposes of this subpart.

c Smallpox countermeasures injury table.

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