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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations The total burden estimate for the information collection burden in both LTC facilities and ICFsIID in the first year is 1,277,874 hours 1,107,600 +
170,274 at an estimated cost of
$91,250,874 $79,825,200 +
$11,425,674 and in subsequent years the burden is estimated at 866,580 hours 780,000 + 86,580 at a cost of $55,177,044 $49,826,400 + $5,350,644.

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The requirements and burden will be submitted to OMB under OMB control number 09381363 for the LTC facilities and 0938-New for the ICFsIID.

TABLE 4TOTAL COI BURDEN FOR LTC FACILITIES AND ICFSIID IN THIS IFC
First year
Subsequent years
Type of facility Burden hours
Costs
Burden hours
Costs
LTC Facility
ICFsIID

1,107,600
170,274

$79,825,200
11,425,674

780,000
86,580

$49,826,400
5,350,644

Totals

1,277,874

91,250,874

866,580

55,177,044

If you comment on this information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the ADDRESSES section of this interim final rule.
Comments must be received on/by June 14, 2021.
V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
VII. Regulatory Impact Analysis A. Statement of Need The COVID19 pandemic has precipitated the greatest economic crisis since the Great Depression, and one of the greatest health crises since the 1918
Influenza pandemic. Of the approximately 540,000 Americans estimated to have died from COVID19
through March 2021,72 over one-third are estimated to have died during or after a nursing home stay.73 The development and large-scale utilization of vaccines to prevent COVID19 cases and have the potential to end future COVID19-related nursing home deaths.
But this huge achievement depends critically on success in vaccination of nursing home residents and staff. This interim final rule will close a gap in 72 https covid.cdc.gov/covid-data-tracker/
datatracker-home.
73 For updated data, see CDC daily updates of total deaths at https www.cdc.gov/nchs/nvss/vsrr/
COVID19/index.htm, and the Kaiser Family Foundation weekly updates on nursing home deaths at https www.kff.org/coronavirus-covid-19/
issue-brief/state-covid-19-data-and-policy-actions/, among other sources.

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current regulations, which are silent on the subject of vaccination to prevent COVID19.
B. Overall Impact We have examined the impacts of this 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 Regulatory Flexibility Act RFA September 19, 1980, Pub. L. 96
354, section 1102b of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
March 22, 1995; Pub. L. 1044, Executive Order 13132 on Federalism August 4, 1999 and the Congressional Review Act 5 U.S.C. 8042.
Executive Orders 12866 and 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. 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 1 year, or adversely and 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
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the principles set forth in the Executive order.
A regulatory impact analysis RIA
must be prepared for major rules with economically significant effects $100
million or more in any 1 year. We estimate that this rulemaking is economically significant as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared an RIA that, taken together with COI section and other sections of the preamble, presents to the best of our ability the costs and benefits of the rulemaking.
This RIA focuses on the overall costs and benefits of the rule, taking into account vaccination progress to date or anticipated over the next year that is not due to this rule, and estimating the likely additional effects of this rule. We analyze both the costs of the required actions and the payment of those costs.
As intended under these requirements, this RIAs estimates cover only those costs and benefits that are likely to be the effects of this rule. In the case of the COVID19 PHE, there is rapid and massive improvement through vaccination, social distancing, treatment, and other efforts already underway, and this rule would have relatively small effects compared to these other efforts, past, present, and future. There are also a number of unknowns that may affect current progress or this rule or both. There are many unknowns for example, whether vaccine protection lasts only one year rather than 3 years or more, and the possibility of variants that reduce the effectiveness of currently approved vaccines and we cannot estimate the effects of each of the possible interactions among them, but throughout the analysis we point out some of the most important assumptions we have made and the possible effects of alternatives to those assumptions.

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