[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Proposed Rules]
[Pages 14567-14570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB24


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of proposed withdrawal; request for comments.

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SUMMARY: HHS proposes rescinding the final rule entitled ``National 
Vaccine Injury Compensation Program: Revisions to the Vaccine Injury 
Table,'' published in the Federal Register on January 21, 2021. That 
final rule, if it were to go into effect, would amend our regulations 
by removing Shoulder Injury Related to Vaccine Administration (SIRVA), 
vasovagal syncope, and the new vaccines category (Item XVII) from the 
Vaccine Injury Table (Table). HHS seeks comments on this proposed 
rescission.

DATES: The final rule published January 21, 2021, at 86 FR 6249, 
delayed February 23, 2021, at 86 FR 10835, is proposed to be withdrawn. 
Written comments and related material to this proposed withdrawal must 
be received on or before April 16, 2021.

ADDRESSES: You may submit written comments electronically by the 
following method: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions on the website for 
submitting comments.
    Instructions. Include the HHS Docket No. HRSA-2021-0001 in your 
comments. All comments received will be posted without change to http://www.regulations.gov. Please do not include any personally identifiable 
or confidential business information you do not want publicly 
disclosed.

FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine 
Injury Compensation Program's website, https://www.hrsa.gov/vaccinecompensation/, or contact Tamara Overby, Acting Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau, 
HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at 
[email protected]; or by telephone at (855) 266-2427.

SUPPLEMENTARY INFORMATION: This is a notice of proposed rulemaking by 
which HHS proposes to rescind the final rule titled ``National Vaccine 
Injury Compensation Program: Revisions to the Vaccine Injury Table,'' 
(final rule), January 21, 2021, 86 FR 6249, delayed February 23, 2021, 
86 FR 10835, which, if it were to go into effect, would amend the 
provisions of 42 CFR 100.3 by removing Shoulder Injury Related to 
Vaccine Administration (SIRVA), vasovagal syncope, and the new vaccines 
category (Item XVII) from the Table.

I. Background and Purpose

    The National Childhood Vaccine Injury Act of 1986, title III of 
Public Law 99-660 (42 U.S.C. 300aa-10 et seq.) (Vaccine Act), 
established the National Vaccine Injury Compensation Program (VICP) to 
ensure an adequate supply of vaccines, stabilize vaccine costs, and 
establish and maintain an accessible and efficient forum for 
individuals found to be injured by certain vaccines to be compensated. 
The Vaccine Act has been amended several times since 1986.
    Petitions for compensation under this Program are filed in the 
United States Court of Federal Claims (Court), with a copy served on 
the Secretary, who is the ``Respondent.'' The Court, acting through 
judicial officers called Special Masters, makes findings as to 
eligibility for, and the amount of, compensation. To be found entitled 
to an award under the VICP, a petitioner must establish a vaccine-
related injury or death, either by proving that a vaccine actually 
caused or significantly aggravated an injury (causation-in-fact) or by 
demonstrating the occurrence of what has been referred to as a Table 
injury. That is, a petitioner may show that the vaccine recipient 
suffered an injury of the type enumerated in the regulations at 42 CFR 
100.3--the Vaccine Injury Table--corresponding to the vaccination in 
question, and that the onset of such injury took place within a time 
period also specified in the Table. The Table is accompanied by, among 
other provisions, the Qualifications and Aids to Interpretation (QAI), 
which defines the injuries and conditions listed on the Table. If these 
criteria are met, the injury is presumed to have been caused by the 
vaccination, and the petitioner is entitled to compensation (assuming 
that other requirements are satisfied), unless the respondent 
affirmatively shows that the injury was caused by some factor other 
than the vaccination (see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-
13(a)(1)(B)), and 300aa-14(a)). Currently, cases are often resolved by 
negotiated settlements between the parties and approved by the Court. 
In such situations, HHS and the Court have not concluded, based upon 
review of the evidence, that the vaccine caused the alleged injury.
    Revisions to the Table are authorized under the Vaccine Act (42 
U.S.C. 300aa-14(c)-(e)). The Vaccine Act prohibits the Secretary of HHS 
from proposing a revision to the Table ``unless the Secretary has first 
provided to the [Advisory] Commission [on Childhood Vaccines] a copy of 
the proposed regulation or revision, requested recommendations and 
comments by the Commission, and afforded the Commission at least 90 
days to make such recommendations'' (42 U.S.C. 300aa-14(d)). Further, 
once the proposed revision is published, the Secretary must afford the 
public at least 180 days of public comment (42 U.S.C. 300aa-14(c)(1)).
    HHS added SIRVA and vasovagal syncope to the Table in March 2017, 
following an extensive, multi-year process that involved nine HHS 
workgroups, including HRSA and the

[[Page 14568]]

Centers for Disease Control and Prevention, and the 2012 Institute of 
Medicine report, ``Adverse Effects of Vaccines: Evidence and 
Causality,'' 82 FR 6294-95. 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 ``[a]ny 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 ``[a]s 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-agenda-march2020.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-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-meeting-minutes.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 ACCV's guiding 
principles for recommending changes to the VICP Table (see https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/reports/accv-recommendation-may-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/HRSA-2020-0002-0373).
    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.
    Both the final rule and the NPRM included the following 
instruction: ``In Sec.  100.3, revise paragraph (a) and remove 
paragraphs (c)(10) and (13) and (e)(8). The revision reads as 
follows:'' Removing paragraphs (c)(10) and (c)(13) would strike the 
definitions of SIRVA and vasovagal syncope, respectively, from the QAI, 
and removing (e)(8) 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/text-idx?SID=f5f03d551be5379a43b4de00614dafaa&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 
President's Chief of Staff sent a memorandum entitled ``Regulatory 
Freeze Pending Review,'' which, among other things, instructed federal 
agencies to, ``[w]ith 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-pending-review/). 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-pending-review/).
    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

[[Page 14569]]

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. 300aa-14(c) and (d), and (2) whether the public 
was properly notified of the entire revised regulation, 42 CFR 
100.3(b)-(e) (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 10835-36).

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 rule's 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 ACCV's recommendations, HHS acknowledges 
the ACCV's valid complaints that it was not able to fully engage in the 
process, which arguably runs counter to the ACCV's 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 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 rule's 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 government's 
efforts to increase vaccinations in the United States to respond to the 
Coronavirus Disease 2019 (COVID-19) pandemic, as well as to make up for 
observed delays in routine vaccinations that have occurred during the 
pandemic.
    The COVID-19 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 COVID-19 
Response and Pandemic Preparedness (see https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf) (National Strategy). Goal 2 of the 
National Strategy is to ``Mount a safe, effective, comprehensive 
vaccination campaign,'' and provides:
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    \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/covid19-07Jan2021.aspx.

    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 governments--and improved line of sight into supply--to 
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 vaccination 
and communicates the importance of maintaining public health 
measures such as masking, physical distancing, testing, and contact 
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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 COVID-19 
Vaccination to provide COVID-19 vaccinations in more locations through 
various non-federal partners (see https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/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, ``We're now allowing retired 
doctors and nurses to come back and administer shots. We're 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/remarks-by-president-biden-to-national-institutes-of-health-staff/). Although 
the COVID-19 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 Strategy's goals and affect the 
federal government's efforts to combat COVID-19. It is partially due to 
this unprecedented vaccination effort and the concern that the final 
rule's 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 COVID-19 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

[[Page 14570]]

optimize the manufacture, distribution, and administration of COVID-19 
and other critical vaccinations.'' (see https://www.regulations.gov/comment/HRSA-2021-0001-0022). These organizations further explained 
they opposed the ``removal of SIRVA and syncope from the Table because 
such a move would put a significant damper on vaccine research and 
development, the willingness of healthcare providers, including 
pharmacists, to administer vaccines, as well as the public's 
willingness to get vaccinated without the protections provided by the 
National Vaccine Injury Compensation Program (VICP).'' (Id.) 
Furthermore they stated, ``Removing [SIRVA and syncope] might 
discourage providers from vaccinating if they are concerned about being 
sued in court for these vaccine injuries.'' (Id.)
    The National Association of Chain Drug Stores (NACDS) also 
supported delaying the final rule, and urged HHS to withdraw it, 
claiming it contained ``policies that will serve to inhibit vaccine 
availability thus leading to poorer public health outcomes.'' (see 
https://www.regulations.gov/comment/HRSA-2021-0001-0017).
    Another commenter stated, ``The proposed Amendment to the Vaccine 
Injury Compensation Table is contrary to the purpose of the Act. It 
exposes doctors, nurses, health care workers and pharmacies to civil 
tort liability for administering a vaccine, which causes arm or 
shoulder injuries. The result will be more obstacles to the 
administration of vaccines as well as ultimately less Americans 
receiving vaccines availability thus leading to poorer public health 
outcomes.'' (see https://www.regulations.gov/comment/HRSA-2021-0001-0004).
    HHS seeks comment by April 16, 2021 on the proposed rescission of 
the final rule, including on the issues raised above related to the 
final rule's promulgation and the impact the final rule could have on 
vaccine administrators.

III. Regulatory Impact Analysis

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive, and equity effects). In addition, under 
the Regulatory Flexibility Act, if a rule has a significant economic 
effect on a substantial number of small entities, HHS must specifically 
consider the economic effect of a rule on small entities and analyze 
regulatory options that could lessen the impact of the rule.
    The Office of Information and Regulatory Affairs has determined 
that this rule is not a ``significant regulatory action'' under section 
3(f) of Executive Order 12866.
    HHS has determined that no resources are required to implement the 
requirements in this rule because compensation will continue to be made 
consistent with the status quo. Therefore, in accordance with the 
Regulatory Flexibility Act of 1980 (RFA), and the Small Business 
Regulatory Enforcement Act of 1996, which amended the RFA, HHS 
certifies that this rule will not have a significant impact on a 
substantial number of small entities.
    HHS has also determined that this rule does not meet the criteria 
for a major rule under the Congressional Review Act or Executive Order 
12866 and would have no major effect on the economy or Federal 
expenditures. Similarly, it will not have effects on State, local, and 
tribal governments and on the private sector such as to require 
consultation under the Unfunded Mandates Reform Act of 1995. Nor on the 
basis of family well-being will the provisions of this rule affect the 
following family elements: Family safety; family stability; marital 
commitment; parental rights in the education, nurture and supervision 
of their children; family functioning; disposable income or poverty; or 
the behavior and personal responsibility of youth, as determined under 
section 654(c) of the Treasury and General Government Appropriations 
Act of 1999.

Paperwork Reduction Act of 1995

    This rule has no information collection requirements.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-05486 Filed 3-12-21; 4:15 pm]
BILLING CODE 4165-15-P