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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations IP to discuss the development, evaluation, and approval of the policies and procedures. We estimate that this would require 4 hours for both the medical director and DON. According to Table 1 above, the total hourly cost for a medical director is $169. For each LTC
facility, this would require 4 hours for the medical director during the first year at an estimated cost of $676 4 hours
$169. For the first year, the burden would be 62,400 4 15,600 at an estimated cost of $10,545,600 $676
15,600. For subsequent years, the medical director might need to spend time reviewing or attending meetings to discuss any updates or changes to the policies and procedures; however, that would be a usual and customary business practice. Therefore, these activities for the medical director associated with updating or changing the policies and procedures are exempt from the PRA in accordance with 5 CFR
1320.3b2.
For the DON, we have estimated that the development of policies and procedures would also require 4 hours.
According to the chart above, the total hourly cost for the DON is $94. The burden in the first year for the DON in each LTC facility would be 4 hours at an estimated cost of $376 4 hours
$94. The first year burden would be 62,400 hours 4 15,600 at an estimated cost of $5,865,600 $376
15,600. For subsequent years, the DON
would likely need to spend time reviewing or attending meetings to discuss any updates or changes to the policies and procedures; however, that would be a usual and customary business practice. Therefore, these activities for the DON associated with updating or changing the policies and procedures are exempt from the PRA in accordance with 5 CFR 1320.3b2.
Therefore, for all 15,600 LTC facilities in the first year, the estimated burden for this ICR would be 452,400 hours 327,600 + 62,400 + 62,400 at a cost of $38,360,400 $21,949,200 + $10,545,600
+ $5,865,600.
In subsequent years, all 15,600 LTC
facilities would have the same burden.
The burden for each LTC facility would be 12 hours at an estimated cost of $804
12 hours $67 for the IP. Hence, for all 15,600 LTC facilities, the burden would be 187,200 12 15,600 at an estimated cost of $12,542,400 $804
15,600. The requirements and burden will be submitted to OMB under OMB
control number 09381363 Expiration Date 06/30/2022.

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2. ICRs Regarding LTC Facilities Offering the COVID19 Vaccine and Obtaining and Documenting Consent for 483.80d3ii Through iv At 483.80d3i, we require that the facility offer the COVID19 vaccine to each staff member and resident, when the vaccination is available to the facility, unless the vaccine is medically contraindicated, the resident has already been vaccinated, or the resident or the resident representative has already refused the vaccine. We believe that the LTC facility will offer the vaccine to the staff or resident at the same time the facility provides the education required by 483.80d3ii and iii. We note that for LTC facilities contracted with the Pharmacy Partnership, the education and offering of the vaccine are being done by the participating pharmacy. We assume that this cost is about the same as the preceding estimates, so that the first year costs would be about the same whether performed entirely in-house by facility staff or by pharmacy staff who visit the facility.
We note that the LTC facility or the pharmacy would also have to offer the vaccine to the staff member or resident and have that staff member, resident, or resident representative, complete screening for any contraindication or precautions, and for the resident to consent to the vaccination or indicate refusal. These costs are not paperwork burden and are covered in the RIA that follows.
As indicated in the next section, the facility must also ensure that the provision of the education and the residents decision must be documented in the residents medical record. If there is a contraindication to the resident having the vaccination, the appropriate documentation must be made in the residents chart. Documentation regarding a residents medical care is a usual and customary business practice for a health care provider. Therefore, this activity is exempt from the PRA in accordance with 5 CFR 1320.3b2.
3. ICRs Regarding Staff Education Requirements in 483.80d3ii Through iv At 483.80d3ii, we require that the LTC facility provide all of its staff with education regarding the benefits and potential risks of the COVID19
vaccine. This would require that the LTC facility develop or choose educational materials for this staff training. We expect that most if not all LTC facilities will use resources developed by other entities as there is a considerable amount of free
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information on COVID19 and vaccines available online. The CMS Nursing Home COVID19 training program has five modules designed for the frontline clinical staff and ten modules for nursing home management staff building maintenance staff and other support staff would not take these particular courses. The training is online, at http QSEP.cms.gov, and is summarized in a CMS press release that can be found at https www.cms.gov/
newsroom/press-releases/cms-releasesnursing-home-covid-19-training-dataurgent-call-action. In addition, both CDC and FDA provide information on the COVID19 vaccines online.68 69
Finally, we expect that trade publications and other public sources would provide training materials that might complement or substitute for the CMS materials. We believe this educational material would likely be selected by the IP. The IP would need to review the information available on the vaccines, determine what information needs to be presented to staff, and gather that information as appropriate for their facilitys staff. We estimate that it would take an average of 4 hours for the IP to accomplish these tasks. Thus, for each LTC facility to meet this requirement would require 4
burden hours at an estimated cost of $268 4 $67. For all 15,600 LTC
facilities, the burden would be 62,400
burden hours 4 15,600 at an estimated cost of $4,180,800 4 $67
15,600 facilities.
At 483.80d3iii, we require that LTC facilities provide their residents or resident representatives with education regarding the benefits and risks and potential side effects associated with the COVID19 vaccine. We believe that the education provided to staff and residents or resident representatives will be identical or virtually the same.
Hence, we believe that it will not require any additional time or burden to develop the educational materials for the residents and resident representatives. According to 483.10g3, the facility must ensure that information is provided to each resident in a form and manner the resident can access and understand, including in an alternative format or in a language that the resident can 68 CDC. Communication Resources for COVID19
Vaccines. Access at https www.cdc.gov/
coronavirus/2019-ncov/vaccines/resourcecenter.html. Updated March 16, 2021. Accessed on March 23, 2021.
69 FDA. COVID19 Vaccines. Access at https
www.fda.gov/emergency-preparedness-andresponse/coronavirus-disease-2019-covid-19/covid19-vaccines. Updated March 18, 2021. Accessed on March 23, 2021.

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