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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations all newly hired staff and newly admitted residents have been vaccinated when they start employment or begin residency, turnover is so high that we estimate an excess of two million persons may still need vaccination in the first year after this rule takes effect.
It is critically important that facilities are required to continue to offer vaccination to their residents and staff on an ongoing basis.
Also, we note that some individuals declined the vaccine when it was first offered; approximately 22 percent of LTC facility residents and 62 percent of LTC staff 63 initially declined the vaccine, but provisional CDC data suggest that uptake increased over time as the safety and effectiveness of the vaccines has become better understood, and approaches that ameliorate vaccine hesitancy have been identified. For residents and staff who overcome vaccine hesitancy, it is critical to their health and well-being that they are able to get the vaccine when they are ready to receive it.
All of the concerns that warrant immediate COVID19 vaccination rulemaking for LTC facilities are also applicable to ICFsIID. ICFIID clients continue to be at high risk of serious illness from COVID19 due to their participation in congregate living and must have ongoing access to the vaccine. While there are no data regarding client and staff turnover rates in ICFsIID, it is reasonable to assume that staff turnover rates may be as high as those in LTC facilities see the RIA
section of this preamble.
C. Data for COVID19 Vaccine Reporting: Targeting Resources Our knowledge of the effects of COVID19 vaccination in LTC facilities comes from several sources, including reporting by Partnership pharmacies and voluntary reporting by some facilities through NHSN. Direct voluntary vaccination reporting to NHSN by LTC facilities has been very low, with less than 20 percent of facilities reporting on vaccinations through NHSN. Unfortunately, we are unable to examine the effects of accepting or declining participation in the Pharmacy Partnerships because the data are incomplete for LTC facilities and ICFsIID. Requiring LTC facilities to report on resident and staff vaccination status, in conjunction with the existing COVID19 testing data, would provide the data necessary to identify the outcomes of Pharmacy Partnership participation and determine vaccine 63 https www.cdc.gov/mmwr/volumes/70/wr/
mm7005e2.htm.

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uptake targets. It would also ensure we can identify and address barriers to completing a vaccination series, such as missed or declined second doses.
If this lack of data continues, CDC
will have insufficient information upon which to provide support to or revise COVID19 infection, prevention, and control measures for LTC facilities.
While recommendations for routine staff testing could be linked to vaccination rates in each LTC facility and thus reduce burden on facilities with adequate rates of vaccine coverage, CDC will not have enough data to assess a change in recommendation without full national participation in COVID19
vaccination reporting by CMS-certified LTC facilities.
Declining infection rates in LTC
facilities in early 2021 suggest that vaccination, along with implementation of the full complement of nonpharmaceutical interventions, including engineering and administrative controls, has reduced the risk of illness and death from COVID19 for LTC facility residents. Without the reporting mandate, CMS will have no timely way of monitoring whether LTC facilities are complying with the requirement to offer vaccination. Further, such mandatory reporting allows health care agencies and regulators to better evaluate the impact and importance of vaccination.
Without a reporting requirement, we will have no way to identify those nursing homes with low vaccination rates so that they can be supported by educational outreach and their residents and staff protected by vaccination.
Unfortunately, we have significant data gaps about the effects of COVID19
and vaccination rates among ICFIID
clients, with fewer than 80 ICFsIID
voluntarily reporting vaccination data through NHSN. While we recognize that it is impractical to require ICFsIID to report COVID19 information to NHSN
immediately, we believe that encouraging voluntary reporting is a critical first step in gaining data to help us understand the effects of the pandemic on clients and staff, supporting uptake of COVID19 vaccine in this community.
D. Moving Forward For the reasons discussed above, it is critically important that we implement the policies in this IFC as quickly as possible. As the nation continues to address the health impacts of COVID
19, we find good cause to waive notice and comment rulemaking as we believe it would be impracticable and contrary to the public interest for us to undertake normal notice and comment rulemaking procedures. For the same reasons,
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because we cannot afford sizable delay in effectuating this IFC, we find good cause to waive the 30-day delay in the effective date and, moreover, to make this IFC effective 10 calendar days after this rule is filed for public inspection in the Federal Register.
In this IFC, we follow on policy issued in the September 2, 2020, COVID19 IFC, which revised regulations to strengthen CMS ability to enforce compliance with Medicare and Medicaid LTC facility requirements for reporting information related COVID19
and established a new requirement for LTC facilities for COVID19 testing of facility residents and staff. Since the publication of the September IFC, the FDA has issued EUAs for multiple vaccines developed to prevent the spread of SARS-CoV2.
We anticipate evaluating public input and evolving science before finalizing any requirements.
For this IFC, we believe it would be impractical and contrary to the public interest for us to undertake normal notice and comment procedures and to thereby delay the effective date of this IFC. We find good cause to waive notice of proposed rulemaking under the APA, 5 U.S.C. 553bB, and section 1871b2C of the Act. For those same reasons, we find it is impracticable and contrary to the public interest not to waive the delay in effective date of this IFC under the APA, 5 U.S.C. 553d, section 1871e1Bi of the Act, and the CRA, 5 U.S.C. 801a3. Therefore, we find there is good cause to waive the delay in effective date pursuant to the APA, 5 U.S.C. 553d3, section 1871e1Bii of the Act, and the CRA, 5 U.S.C. 8082.
We are providing a 60-day public comment period.
IV. Collection of Information COI
Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 30day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget OMB for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506c2A of the Paperwork Reduction Act of 1995 PRA requires that we solicit comment on the following issues:
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.

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