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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
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TABLE 2TOTAL COST FOR COI REQUIREMENTS FOR ALL LTC FACILITIESContinued First year
Subsequent years
COI requirements Burden hours
Costs
Burden hours
Costs
483.80d3iv Keeping vaccine information up-to-date and Making necessary changes
483.80d3vi and vii Documentation requirements
483.83d3viii and ix NHSN Reporting

93,600
93,600
405,600

6,271,200
3,837,600
27,175,200

93,600
93,600
405,600

6,271,200
3,837,600
27,175,200

Totals

1,107,600

79,825,200

780,000

49,826,400

B. Intermediate Care Facilities for Individuals With Intellectual Disabilities ICFIIDs 1. ICRs Regarding the Development of Policies and Procedures for 483.460a4
At new 483.460a4, we require that ICFsIID develop policies and procedures to ensure that each client or clients representative and staff member is educated about the COVID19
vaccine. Specifically, before offering the COVID19 vaccine, all staff members and clients or client 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 client and staff member is offered COVID19 vaccine unless the immunization is medically contraindicated or the client 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 client, client representative, and staff member must be provided with the current information regarding the benefits and risks and potential side effects for that vaccine, before the ICFIID requests consent for administration of that dose.
The client, clients 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 clients medical record must include documentation that indicates, at a minimum, that the client or clients representative was provided education regarding the benefits and risks and potential side effects of the COVID19
vaccine and each does of the COVID19
vaccine administered to the client or if the client did not receive a dose due to medical contraindications or refusal.
We believe that developing these policies and procedures would require a RN to gather the necessary information and materials and draft the policies and procedures. The facility must also ensure that these materials are in an
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accessible format for the client and his or her representative. It must be in a language that they understand and in a format that is accessible to them, such as Braille or large print for a person who is visually-impaired or in American Sign Language for a person who is hearing-impaired. The RN would need to work with an ICFIID administrator who would likely provide input and guidance in developing the policies and procedures and would need to approve them before they go before the governing body for approval. For the RN, we estimate that this would require 5 hours initially, and 30 minutes or .5
hour a month thereafter to review for updated information to determine if any changes need to be made to the policies or procedures and then make any necessary changes. According to Table 1
above, the total hourly cost for an RN is $67. We estimate that for each ICFIID, the burden would be 10.5 hours 5
hours initially + 5.5 11 .5 for the RN
during the first year at an estimated cost of $704 $67 10.5 hours. Assuming 5,772 ICFsIID, for the first year the burden for all facilities would be 60,606
burden hours 10.5 5,772 facilities at an estimated cost of $4,060,602 10.5
$67 5,772. In subsequent years, the burden for this activity for each facility would be 6 hours .5 hour 12 months at an estimated cost of $402 6 $67.
In subsequent years the burden for all facilities would be 34,632 6 5,772
burden hours at an estimated cost of $2,320,344 6 $67 5,772.
For the ICFIID administrator, we believe it would require 3 hours to work with the RN in developing the policies and procedures and give final approval before taking the policies and procedures to the governing body for approval. We believe that the administrator would likely make a salary similar to that of a manager in the LTC setting, like that for the DON salary as discussed above. Therefore, we estimate that an ICFIID administrators hourly mean salary is about $94. Thus, for each ICFIID, the burden hours for the administrator would be 3 hours at an estimated cost of $282 3 $94. For
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all 5,772 ICFsIID, the total burden for the administrator would be 17,316
hours 3 5,772 facilities at an estimated cost of $1,627,704 $282
5,772 facilities.
As discussed above, the ICFIID
administrator would need to obtain approval from the ICFIIDs governing board for the policies and procedures.
Since the review and approval of policies and procedures should be encompassed within the governing boards responsibilities, this activity would be usual and customary and exempt from the information collection estimate. In addition, in subsequent years the ICFIID administrator might need to spend time reviewing or attending a meeting to discuss any updates to the policies and procedures;
however, that would also be a usual and customary business practice. Therefore, this activity is exempt from the PRA in accordance to 5 CFR 1320.3b2.
Therefore, for all ICFsIID, the total annual burden in the first year for the required policies and procedures would be 77,922 burden hours 60,606 +
17,316 at an estimated cost of $5,688,306 $4,060,602 + $1,627,704. In subsequent years, the burden would only be for the RN and it would be 34,632 burden hours at an estimated cost of $2,320,344. The requirements and burden will be submitted to OMB
under OMB control number 0938-New.
2. ICRs Regarding the ICFsIID Offering the Vaccine and Obtaining and Documenting Consent in 483.460a4i At new 483.460a4i, we require that the ICFIID offer the COVID19
vaccine to each staff member and client, when the vaccination is available to the facility, unless the vaccine is medically contraindicated, the client has already been vaccinated, or the client or the client representative has already refused the vaccine. We believe that the ICFIID
will offer the vaccine to the client or the client representative at the same time the facility provides the education required by new 483.460a4ii. This activity would require that the ICFIID
offer the vaccine to the staff member or
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