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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
understand. Thus, we expect that this required education would be in a language that the resident or the resident representative understands.
Language translations for residents may be available in many facilities from staff, and are virtually always available on demand through services, such as Language Line. LTC facilities are already required to provide information in an alternative format or language the resident or resident representative understands. Any additional costs are minor and are discussed in more detail in the RIA below. At 483.80d3iv, we require that the LTC facility must provide to the staff, resident, or the resident representative, in situation where the vaccination process requires one or more doses of vaccine, up-to-date information regarding the vaccine, including any changes in the benefits or risks and potential side effects associated with the COVID19 vaccine, before requesting consent for administration of each additional vaccinations. This would require that the IP remains up-to-date on information regarding COVID19
vaccines and ensures the information provided to the resident and the resident representative before requesting consent for the administration of each additional dose of vaccine includes current information on the benefits and potential risks associated with the vaccine. We believe that this activity would require that the IP routinely review CDC and FDA websites for updates and make any necessary changes to the education materials used by the LTC facility. We estimate that this would require 6 hours of an IPs time annually. Thus, for each LTC
facility to meet this requirement would require 6 burden hours at an estimated cost of $402 6 $67. For all LTC
facilities, the annual burden would be 93,600 6 hours 15,600 hours at an estimated cost of $6,271,200 $402
15,600. We estimate that the burden to the LTC facilities will be similar in subsequent years due to the large turnover in these facilities. The requirements and burden will be submitted to OMB under OMB control number 09381363 Expiration Date 6/30/2022.

4. ICRs Regarding the Documentation Requirements in 483.80d3vi and vii At 483.80d3vi, we require that the facility ensure that the residents medical record is documented with, at a minimum, that the resident or resident representative was provided education regarding the benefits and potential risks associated with the COVID19
vaccine and that the resident either received the COVID19 vaccine, did not receive the vaccine due to medical contraindications, or refused the vaccine. This would require that a health care provider, probably a licensed nurse, would retrieve the residents medical record and document that the education was provided and whether the resident or resident representative had consented or refused the vaccine or whether the vaccine was contraindicated. We estimate that this would require only a few seconds per resident, but estimate no costs as maintaining a medical record is a usual and customary business practice.
Therefore, this activity is exempt from the PRA in accordance with 5 CFR
1320.3b2.
As discussed above in section II.A. of this rule, the LTC facility would also be required to document that the required education was provided to its staff that must include the benefits and potential risks associated with of the COVID19
vaccine as set forth in 483.80d3ii.
Section 483.80d3vii sets forth that the LTC facility must maintain documentation on its staff regarding the education provided; that the staff person was offered the COVID19 vaccine or information on obtaining the vaccine, and his or her vaccine status and related information indicated by the NSHN.
This would require that a staff person document the required information in the staff persons record. We estimate that this would require one half-hour per month per facility. According to Table 1 above, the total hourly cost of a financial clerk is $41. For each LTC
facility, we estimate that the burden for this activity would be 6 hours at an estimated cost of $246 $41 12 .5.
For all LTC facilities, this would require 93,600 12 .5 15,600 burden hours at an estimated cost of $3,837,600 $41

12 .5 15,600. We estimate that the burden to the LTC facilities will be similar in subsequent years due to the large turnover in these facilities. The requirements and burden will be submitted to OMB under OMB control number 09381363.
5. ICRs Regarding the Reporting Requirements to CMS and CDC NSHN
483.80g1viii and ix Section 483.80g1viii requires LTC
facilities to electronically report information about COVID19 in a standardized format to the NHSN about the COVID19 vaccine status of residents and staff, including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID19
vaccine received, COVID19
vaccination adverse events. The LTC
facility must also report the therapeutics administered to residents for treatment of COVID19.
We believe the IP would do this weekly reporting to the NHSN, because this reporting would require information on the therapeutics that were administered to resident for treatment of COVID19. We believe this additional reporting would require about 30 minutes or .5 hour each week for the IP. Thus, for each LTC facility, this burden would be 26 hours .5 52
weeks at an estimated cost of $1,742
$67 26 annually. For all LTC
facilities, the burden would be 405,600
hours 26 15,600 at an estimated cost of $27,175,200 $1,742 15,600
annually.
Thus, the total annual burden for all LTC facilities to comply with the requirements in this IFC in the first year is 1,107,600 452,400 + 62,400 + 93,600
+ 93,600 + 405,600 hours at an estimated cost of $79,825,200
$38,360,400 + $4,180,800 + $6,271,200
+ $3,837,600 + $27,175,200. In subsequent years, the burden would be 780,000 hours 187,200 + 93,600 +
93,600 + 405,600 at an estimated cost of $49,826,400 $12,542,400 +
$6,271,200 + $3,837,600 + $27,175,200.
See Table 2 below. The requirements and burden will be submitted to OMB
under OMB control number 09381363.

TABLE 2TOTAL COST FOR COI REQUIREMENTS FOR ALL LTC FACILITIES
First year
Subsequent years
COI requirements Burden hours 483.80d3 Developing Policies and Procedures
483.80d3ii & iii Developing education materials for staff members and residents and residents Representatives

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Costs
Burden hours
Costs
452,400

$38,360,400

187,200

$12,542,400

62,400

4,180,800

N/A

N/A

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