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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
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April 23, 2021, so that the new Administration could review the final rule for any questions of fact, law, and policy the rule may raise 86 FR
10835. Specifically, HHS delayed the final rule to determine whether its promulgation raised any legal issues, including but not limited to 1 whether ACCV was properly notified of the proposed rule pursuant to 42 U.S.C.
300aa14c and d, and 2 whether the public was properly notified of the entire revised regulation, 42 CFR
100.3be including the qualifications and aids to interpretation and the coverage provisions, given that both the proposed and final rules published in the Federal Register included only the revised Vaccine Injury Table itself, but not the entire revised regulation Id. at 1083536.
II. Discussion of Proposed Rescission HHS proposes to rescind the final rule published on January 21, 2021, for both procedural and policy reasons. HHS has already been alerted to the fact that members of the public believe that the promulgation of the final rule was irregular in its haste, which stands in contrast to the extensive, multi-year process HHS followed to add SIRVA
and vasovagal syncope to the Table in March 2017, and that HHS did not fully engage with either the ACCV or the public regarding its rationale behind the NPRM to subsequently remove these conditions from the Table. HHS agrees that the rules promulgation further raises problematic issues related to the perceived procedural defects. Members of the public have raised concern that this Table modification was highly unusual because HHS failed to appear before the ACCV to discuss its proposed modification to the Table, and modified the Table over the opposition of the ACCV. Although HHS is not legally required to appear before the ACCV or accept the ACCVs recommendations, HHS acknowledges the ACCVs valid complaints that it was not able to fully engage in the process, which arguably runs counter to the ACCVs statutory purpose. Commenters and the ACCV
itself pointed out that the method of transmittal of the NPRM to the ACCV
and the manner in which it was introduced at the March 6, 2020 ACCV
meeting raises concerns regarding whether the ACCV as a body had the full 90 days to make recommendations, as required by the Vaccine Act. HHS
agrees that there is a legitimate question as to whether the ACCV received the full 90 days to make recommendations.
Moreover, the paucity of time between the close of the comment period and the posting of the final rule for public
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inspection the day before the change in administration, with publication the day after, has raised doubts from the public regarding whether all public comments were sufficiently reviewed, considered, and responded to under Administrative Procedure Act APA standards. Given the numerous concerns that have already been raised and the questions that surround the final rules promulgation, HHS proposes rescinding the final rule so that, if it chooses to proceed with removing SIRVA, vasovagal syncope, and the new vaccines category Item XVII from the Table, it does so with sufficient time to carefully and methodically review the policy, science, and law regarding these items and creates a transparent record of the process that clearly complies with all Vaccine Act and APA requirements.
As a policy matter, HHS also is proposing to rescind the final rule because it is concerned that it could have a negative impact on vaccine administrators, which would be at odds with the federal governments efforts to increase vaccinations in the United States to respond to the Coronavirus Disease 2019 COVID19 pandemic, as well as to make up for observed delays in routine vaccinations that have occurred during the pandemic.
The COVID19 public health emergency was first declared on January 27, 2020, and continues to impact the nation.1 On January 21, 2021, the White House published the National Strategy for the COVID19 Response and Pandemic Preparedness see https
www.whitehouse.gov/wp-content/
uploads/2021/01/National-Strategy-forthe-COVID-19-Response-and-PandemicPreparedness.pdf National Strategy.
Goal 2 of the National Strategy is to Mount a safe, effective, comprehensive vaccination campaign, and provides:
The United States will spare no effort to ensure Americans can get vaccinated quickly, effectively, and equitably. The federal government will execute an aggressive vaccination strategy, focusing on the immediate actions necessary to convert vaccines into vaccinations, including improving allocation, distribution, administration, and tracking. Central to this effort will be additional support and funding for state, local, Tribal, and territorial governmentsand improved line of sight into supplyto ensure that they are best prepared to mount local vaccination programs. At the same time, the federal government will mount an unprecedented public campaign that builds trust around 1 See Renewal of Determination That A Public Health Emergency Exists, which was first declared on January 27, 2020 and was last renewed on January 21, 2021, at https www.phe.gov/
emergency/news/healthactions/phe/Pages/covid1907Jan2021.aspx.

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vaccination and communicates the importance of maintaining public health measures such as masking, physical distancing, testing, and contact tracing even as people receive safe and effective vaccinations.

Id. at 8.
In carrying out the National Strategy, the federal government has taken a number of recent actions. It has increased access to vaccines by creating the Federal Retail Pharmacy Program for COVID19 Vaccination to provide COVID19 vaccinations in more locations through various non-federal partners see https www.cdc.gov/
vaccines/covid-19/retail-pharmacyprogram/index.html/. It is also taking steps to increase the number of vaccine administrators. As President Biden stated to NIH Staff on February 11, 2021, Were now allowing retired doctors and nurses to come back and administer shots. Were deploying federal vaccinators, and over the last three weeks, we put hundreds of new vaccinators in the field and are lining up thousands more. These include medical personnel from our Commissioned Corps at the Department of Health and Human Services, as well as personnel from FEMA, the Defense Department, and more departments to come. see https
www.whitehouse.gov/briefing-room/
speeches-remarks/2021/02/11/remarksby-president-biden-to-nationalinstitutes-of-health-staff/. Although the COVID19 vaccine is not part of the VICP, HHS is cognizant of the fact that any action taken that concerns administration of other vaccines could impact the National Strategys goals and affect the federal governments efforts to combat COVID19. It is partially due to this unprecedented vaccination effort and the concern that the final rules revisions to the Table could negatively impact the vaccine administrators carrying out this massive campaign that HHS proposes to rescind the final rule.
HHS received comments in response to the February 12, 2021, NPRM that proposed to delay the effective date of the final rule that raised concerns from the public and interested organizations that the changes to the Table in the final rule would be particularly detrimental to vaccine administrators during the COVID19 pandemic. For example, the American Pharmacists Association APhA and the National Alliance of State Pharmacy Associations NASPA
supported delaying the final rule, and urged HHS to rescind it. APhA and NASPA stressed that, During a pandemic is not the time to make changes to the Vaccine Injury Table, when we are working as a nation to
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