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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
Centers for Disease Control and Prevention, and the 2012 Institute of Medicine report, Adverse Effects of Vaccines: Evidence and Causality, 82
FR 629495. The notice of proposed rulemaking NPRM provided a 180-day comment period that resulted in the receipt of 14 written comments; 13 from individuals and one from a national organization Id. at 6296. In addition, a public hearing on the proposed rule was held on January 14, 2016 Id.. Almost a year after considering the 14 written comments and the remarks at the public hearing, HHS issued the final rule that added SIRVA and vasovagal syncope to the Table Id. at 6294.
On July 20, 2020, HHS published an NPRM proposing to amend the Table by removing SIRVA, vasovagal syncope, and new vaccines category Item XVII, 85 FR 43794. Item XVII includes any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage.
SIRVA and vasovagal syncope are also listed as associated injuries for this category. That NPRM stated that HHS
provided its proposed revisions to the Advisory Commission on Childhood Vaccines ACCV for its comments on or about February 15, 2020, and that as part of its mandate under the Vaccine Act, the ACCV considered the proposed changes set forth in this NPRM on March 6, 2020, and May 18, 2020 Id. at 43799 & n. 19. However, the NPRM was not officially provided to the ACCV as a group in mid-February 2020, and, while the statute requires the Secretary to request recommendations and comments by the Commission, instead the draft NPRM was mailed in hard copy to each of the ACCV
members, marked privileged and confidential, with a request for comments from the individual members. Although the then-Chair started the first brief discussion of the draft NPRM at the ACCV meeting on March 6, 2020, the draft NPRM was not on the agenda see https
www.hrsa.gov/sites/default/files/hrsa/
advisory-committees/vaccines/
meetings/2020/accv-agendamarch2020.pdf, and no members of the ACCV other than the then-Chair knew in advance that it would be discussed.
One ACCV member commented at the meeting that she thought that the members were not permitted to discuss the draft NPRM. Several members stated that they had questions about the draft NPRM and wished to have further discussion see https www.hrsa.gov/
sites/default/files/hrsa/advisory-

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committees/vaccines/meetings/2020/
accv-march-meeting-minutes.pdf.
At the May 18, 2020, ACCV meeting, three ACCV members expressed their concern that no HHS representative was present to explain the draft NPRM, provide scientific evidence in support, or discuss the recommendations with the ACCV members see https
www.hrsa.gov/sites/default/files/hrsa/
advisory-committees/vaccines/
meetings/2020/accv-may-meetingminutes.pdf. It was highly unusual for HHS to propose a revision to the Table without sending an agency representative to discuss the proposal with the ACCV. The ACCV
unanimously voted to oppose the proposed changes to the Table, and sent a recommendation to the Secretary opposing the draft NPRM for many reasons including: 1 No representative from HHS was made available to provide the evidence and reasoning behind the draft NPRM; 2 SIRVA and vasovagal syncope, though rare, are injuries caused by vaccines; 3
exposing vaccine administrators to civil liability could be a disincentive to vaccine administration and result in lower vaccination rates; and 4 the explanation in the draft NPRM did not meet the ACCVs guiding principles for recommending changes to the VICP
Table see https www.hrsa.gov/sites/
default/files/hrsa/advisory-committees/
vaccines/reports/accv-recommendationmay-2020.pdf.
On October 29, 2020, HHS published in the Federal Register a Notice that a hearing on the NPRM would be held on November 9, 2020, 85 FR 68540.
Unfortunately, that Federal Register Notice incorrectly gave a deadline of October 26, 2020 three days earlier than the Notice was published for individuals to register to speak at the hearing, 85 FR 68540. A correction extending the deadline to November 5, 2020, was published in the Federal Register on November 6, 2020 one day after the deadline, 85 FR 71046. Despite these notice issues, 26 individuals spoke at the public hearing; all were opposed to the NPRM see https
www.regulations.gov/document/HRSA2020-0002-0373.
The comment period for the NPRM
closed on January 12, 2021, at 11:59
p.m. HHS received over 760 comments.
Over 150 of those comments, more than 20 percent, were posted on the last day of the comment period or the next day, since some comments were received after normal business hours. Four business days later, on January 19, 2021, the Federal Register posted for public inspection the final rule amending the Table.

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Both the final rule and the NPRM
included the following instruction: In 100.3, revise paragraph a and remove paragraphs c10 and 13 and e8.
The revision reads as follows:
Removing paragraphs c10 and c13
would strike the definitions of SIRVA
and vasovagal syncope, respectively, from the QAI, and removing e8
would strike the new vaccines category Item XVII of the Table from the Coverage Provisions section of the regulation. However, what followed the instruction was only subsection a and the Table itself, but not the rest of the regulation, including the revised c QAI
and e Coverage Provisions, which are a critical part of the regulation, 86 FR
6267; 85 FR 43804. Furthermore, the version of the Vaccine Injury Table that is currently displayed on the eCFR
includes a link titled Link to an amendment published at 86 FR 6267, Jan. 21, 2021. This link displays only the Vaccine Injury Table that was published in the final rule see https
www.ecfr.gov/cgi-bin/textidx?SID=f5f03d551be5379a43b 4de00614dafaa&mc =true&node=20210121y1.4. However, it does not include the b Provisions that apply to all conditions listed, c QAI, d Glossary for purposes of paragraph c, and/or e Coverage Provisions sections of the Table.
On January 20, 2021, the first day of the new Administration, the Presidents Chief of Staff sent a memorandum entitled Regulatory Freeze Pending Review, which, among other things, instructed federal agencies to, with respect to rules that have been sent to the OFR but not published in the Federal Register, immediately withdraw them from the OFR for review and approval https www.whitehouse.gov/
briefing-room/presidential-actions/
2021/01/20/regulatory-freeze-pendingreview/. The final rule was published in the Federal Register on January 21, 2021, with an effective date of February 22, 2021, 86 FR 6249.
The Regulatory Freeze Memorandum also instructed federal agencies to consider delaying the effective date of rules published in the Federal Register, but which have not yet taken effect, for a period of 60 days so that the new Administration may review recently published rules for any questions of fact, law, and policy the rule may raise see https www.whitehouse.gov/
briefing-room/presidential-actions/
2021/01/20/regulatory-freeze-pendingreview/.
Pursuant to that direction, and after a brief public comment period, effective February 22, 2021, HHS delayed the effective date of the final rule until
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