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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comments on each of these issues for the following sections of this document that contain
information collection requirements ICRs:
For the estimated costs contained in the analysis below, we used data from the United States Bureau of Labor Statistics to determine the mean hourly wage for the positions used in this analysis. For the total hourly cost, we doubled the mean hourly wage for a 100
percent increase to cover overhead and
fringe benefits, according to standard HHS estimating procedures. If the total cost after doubling resulted in .50 or more, the cost was rounded up to the next dollar. If it was .49 or below, the total cost was rounded down to the next dollar. The total costs used in this analysis are indicated in the chart below.

TABLE 1TOTAL HOURLY COSTS BY POSITION
Mean hourly wage
Position LTC and ICFIID: RN/IP
LTC: Director of Nursing & ICFIID: Administrator
LTC: Medical Director
LTC: Financial Clerk

A. Long-Term Care Facilities 1. ICRs Regarding the Development of Policies and Procedures for 483.80d3
At 483.80d3, we require that LTC
facilities develop policies and procedures to ensure that each resident and staff member is educated about the COVID19 vaccine. Specifically, before offering the COVID19 vaccine, all staff members and residents or resident representatives must be provided with education regarding the benefits and risks and potential side effects associated with the vaccine. When the vaccine is available to the facility, each resident and staff member is offered COVID19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized. If an additional dose of the COVID19
vaccine that was administered, a booster, or any other vaccine needs to be administered, the resident, resident representative, and staff member must be provided with the current 64 Bureau of Labor Statistics. Occupational Employment and Wages, May 2019. 291141
Registered Nurses. Accessed at https www.bls.gov/
oes/current/oes291141.htm. Accessed on March 18, 2021.
65 Bureau of Labor Statistics. Occupational Employment and Wages, May 2019. 119111
Medical and Health Services Managers. Nursing Care Facilities Skilled Nursing Facilities.
Accessed at https www.bls.gov/oes/current/
oes119111.htm. Accessed on February 17, 2021.
66 Bureau of Labor Statistics. Occupational Employment and Wages, May 2019. 291228
Physicians, All Other; and Ophthalmologists, Except Pediatric. General Medical and Surgical Hospitals. Accessed at https www.bls.gov/oes/
current/oes291228.htm5. Accessed on February 17, 2021.
67 Bureau of Labor Statistics. Occupational Employment and Wages, May 2019. 433099
Financial Clerks, All Others. Accessed at https
www.bls.gov/oes/current/oes433099.htm. Accessed on March 23, 2021.

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information regarding the benefits and risks and potential side effects for that vaccine, before the LTC facility requests consent for administration of that dose.
The resident, resident representative, and staff member must be provided the opportunity to refuse the vaccine and change their decision if they decide to take the vaccine. Finally, the residents medical record includes documentation that indicates, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential risk associated with the COVID19 vaccine, and that the resident either received the complete COVID19 vaccine series or single dose or did not receive the vaccine due to medical contraindications or refusal. The estimates that follow are largely based on upon our experience with LTC
facilities. However, given the uncertainty and rapidly changing nature of the pandemic, we acknowledge that there will likely need to be significant revisions over time as LTC facilities gain experience with these requirements. As previously discussed, we do not have current reporting data on facility compliance with COVID19 vaccination best practices of the kinds established in this rule. We welcome comments that might improve these estimates.
Based upon our experience with LTC
facilities, we believe that some of these facilities have already developed the required policies and procedures.
However, since we do not have any reliable method to make an estimate of how many or what percentage of LTC
facilities have done so, we will base our estimate for this ICR on all 15,600 LTC
facilities needing to develop new policies and procedures in order to comply with this requirement. These facilities also need to review the
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64 $33.53
65 46.78
66 84.57
67 20.40

Total cost $67
94
169
41

policies and procedures to ensure they are up-to-date and make any necessary changes. We believe these activities would be performed by the infection preventionist IP, director of nursing DON, and medical director in the first year and the IP in subsequent years as analyzed below.
In the first year, the IP would need to develop the policies and procedures by conducting research and obtaining the necessary information and materials to draft the policies and procedures. The IP would need to work with the medical director and DON to develop and finalize the policies and procedures. For the IP, we estimate that this would require 10 hours initially to develop the policies and procedures, and one hour a month thereafter to review and make changes or updates as needed, for a total of 21 hours 10 hours initially and 1
hour for the 11 months thereafter.
According to Table 1 above, the IPs total hourly cost is $67. Thus, for each LTC facility the burden for the IP would be 21 hours at a cost of $1,407 21 hours $67. For the IPs in all 15,600 LTC
facilities, the burden would be 327,600
hours 21 hours 15,600 facilities at an estimated cost of $21,949,200 $1,407
15,600. For subsequent years, the IP
would need to review the policies and procedures and make any updates or changes to them. Hence, we estimate that the IP would need 12 hours annually 1 hour 12 months at a cost of $804 12 hours $67. For all LTC
facilities, the annual burden would be 187,200 hours 12 15,600 at a cost of $12,542,400 15,600 $804.
As discussed above, the development and approval of these policies and procedures would also require activities by the medical director and the DON.
Both the medical director and the DON
would need to have meetings with the
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