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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
resident and have that staff member, client, or client representative complete screening for any contraindication or precautions, and for the client or client representative consent to the vaccination or indicated refusal. This is not a paperwork burden and are covered in the RIA that follows.
3. ICRs Regarding the Education Requirements in 483.460a4ii, iii, and iv At new 483.460a4ii, we require that the ICFIID provide all of its staff with education regarding the benefits and potential risks associated with of the COVID19 vaccine. New 483.460a4iii requires that the ICF
IIF to provide each client or the clients representative education regarding the benefits and risks and potential side effects associated with the vaccine. In addition, new 483.460a4iv requires that the ICFIID, in situations where there is an additional dose of the COVID19 vaccine that was administered, a booster, or any other vaccine needs to be administered, must provide the client, clients representative, and staff member with the current information regarding the benefits and risks and potential side effects for that vaccine, before the facility requests consent for administration of that dose. We believe that all of the education provided by the ICFIID to the client, clients representative and the staff would be virtually identical.
For the initial education, the ICFIID
would be required to develop educational materials by reviewing available resources on COVID19
vaccines. We expect that most if not all ICFsIID will use resources developed by other entities as there is a considerable amount of free information on COVID19 and its vaccines available online. For example, CDC and FDA
provide information on the COVID19
vaccines online.70 71 Finally, we expect that trade publications and other public sources would provide training materials. We believe this educational material would likely be selected by the
RN. The RN would need to review the information available on the vaccines, determine what information needs to be presented to the client, clients representative and staff members, and gather that information as appropriate.
An ICFIID administrator would likely work with the RN and need to approve the final educational material. We estimate that it would initially require 7
hours and thereafter 6 hours annually to review for updates and make those changes to the educational materials for a total of 13 hours for the RN to accomplish these tasks in the first year.
Thus, for each ICFIID, the burden for the RN would require 13 burden hours at an estimated cost of $871 13 $67.
For all 5,772 ICFsIID so the burden for all facilities would be 75,036 burden hours 13 hours 5,772 facilities at an estimated cost of $5,027,412 5,772
hours $871.
For the education required in subsequent years, the RN would need to ensure that the information regarding COVID19 vaccines that is provided to the staff, client and the clients representative before requesting consent for each additional dose of the vaccine is current. We believe that this activity would require the RN to routinely review CDC and FDA websites for updates and make any necessary changes to the education materials used by the ICFIID. We estimate that this would require 6 hours of an IPs time annually. Thus, for each ICFIID to meet this requirement would require 6
burden hours at an estimated cost of $402 $67 6 hours. For all ICFsIID, meeting this requirement would require 34,632 burden hours 6 hours 5,772
facilities at an estimated cost of $2,320,344 5,772 $402. The requirements and burden will be submitted to OMB under OMB control number 0938-New.
4. ICRs Regarding the Documentation Requirements in 483.460a4vi and f At new 483.460a4vi, the ICF
IID must ensure that the clients medical record is documented with, at a
minimum, that the client or clients representative was provided education regarding the benefits and potential risks associated with the COVID19
vaccine and that the resident either received the COVID19 vaccine or did not receive the vaccine due to medical contraindications, or refused the vaccine. This would require that the RN
to retrieve the clients medical record and document the required information.
We estimate that this would require only a few seconds per client 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.
At new 483.460f, the ICFIID is required to, at a minimum, document that their staff were provided education regarding the benefits and potential risks associated with the COVID19
vaccine and that each staff member was offered the vaccine or was provided information on how to obtain it. This would require that a staff person document that these tasks were accomplished. We estimate that this would require one quarter or 0.25 hour per month per facility and that this task would be performed by administrative staff, probably a financial clerk.
According to Table 1 above, the total hourly cost for a financial clerk of $41.
For each ICFIID it would require 3
hours annually 0.25 12 at an estimated cost of $123 $41 3 hours.
For all ICFsIID, the documentation requirements in this IFC this would require 17,316 burden hours 3 hours
5,772 facilities at an estimated cost of $709,956 annually 17,316 hours
$123.
In total, we estimate that information collection burden for all ICFsIID would be about 170,274 hours and $11,425,674
in the first year and 86,580 hours and $5,350,644 in subsequent years.

TABLE 3TOTAL BURDEN FOR COI REQUIREMENTS FOR ALL ICFSIID
First year
Subsequent years
COI requirement Burden hours
Costs
Burden hours
Costs
483.460a4 Developing the policies and procedures
483.460a4ii, iii, and iv Education requirements
483.460a4v and f Documentation requirements

77,922
75,036
17,316

$5,688,306
5,027,412
709,956

34,632
34,632
17,316

$2,320,344
2,320,344
709,956

Totals

170,274

11,425,674

86,580

5,350,644

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