National Vaccine Injury Compensation Program: Rescission of Revisions to the Vaccine Injury Table, 21209-21213 [2021-08478]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 76 (Thursday, April 22, 2021)]
[Rules and Regulations]
[Pages 21209-21213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08478]



[[Page 21209]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB24


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

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

ACTION: Final rule; withdrawal.

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SUMMARY: This action rescinds in its entirety the rule entitled 
``National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table,'' published in the Federal Register on January 
21, 2021 (January 21, 2021 Final Rule).

DATES: As of April 22, 2021, the January 21, 2021 Final Rule, published 
in the Federal Register at 86 FR 6249, which was delayed at 86 FR 10835 
on February 23, 2021, is withdrawn.

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:

I. Background

    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 it was first 
enacted in 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 of Health and Human Services (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 
\1\ (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),\2\ 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 reached a conclusion, based upon 
review of the evidence, whether the vaccine caused the alleged injury.
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    \1\ https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf.
    \2\ These requirements generally include that: (1) The person 
bringing the petition qualifies as a petitioner under the Vaccine 
Act; (2) the petitioner filed the petition within the statute of 
limitations; (3) the individual who sustained the vaccine-related 
injury has not collected a prior award or settlement of a civil 
action for the vaccine-related injury (or no prior award or 
settlement of a civil action was made on their behalf); (4) the 
vaccine was administered within the United States or its trust 
territories; and, (5) the individual who sustained the vaccine-
related injury suffered the residual effects or complications of the 
injury for more than six months, died, or was hospitalized and 
underwent surgical intervention in response to the vaccine-related 
injury. See generally 42 U.S.C. 300aa-11(b)-(c), 300aa-16(a)-(b).
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    Revisions to the Table are authorized under the Vaccine Act (42 
U.S.C. 300aa-14(c)-(e)). The Vaccine Act prohibits the Secretary from 
proposing a revision to the Table's list of injuries, disabilities, 
illnesses, conditions, and deaths for which compensation may be 
provided, or to the time periods for the first symptom or manifestation 
of the onset or the significant aggravation of any such injury, 
disability, illness, condition, or death, ``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)). The 
Advisory Commission on Childhood Vaccines (ACCV) advises and makes 
recommendations to the Secretary on issues relating to the operation of 
the VICP (see generally 42 U.S.C. 300aa-19). Further, once the proposed 
revision is published, the Vaccine Act requires the Secretary to 
provide for a public hearing and at least 180 days of public comment 
(42 U.S.C. 300aa-14(c)(1)). To add a new category of vaccines to the 
Table, that category also must be recommended for routine 
administration to children or pregnant women by the Centers for Disease 
Control and Prevention (CDC), be made subject to an excise tax by 
Federal law, and be added to the VICP by the Secretary within two years 
of the CDC's recommendation (42 U.S.C. 300aa-14(e)).
    HHS added Shoulder Injury Related to Vaccine Administration (SIRVA) 
and vasovagal syncope to the Table in March 2017, following an 
extensive, multi-year process that involved nine HHS workgroups 
comprising HRSA and CDC medical staff reviewing the 2012 Institute of 
Medicine report, ``Adverse Effects of Vaccines: Evidence and 
Causality,'' \3\ as well as other then-newly published scientific 
literature not contained in the report (82 FR 6294-95). The ACCV 
considered the proposed changes to add SIRVA and vasovagal syncope to 
the Table in its meetings on March 8, 2012, September 5, 2013, December 
5, 2013, June 5, 2014, and September 4, 2014 (80 FR 45134). On July 29, 
2015, a notice of proposed rulemaking (NPRM) was published (80 FR 
45132), which provided a 180-day public comment period that resulted in 
the receipt of 14 written comments; 13 from individuals and one from a 
national organization (82 FR 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, on January 19, 2017, HHS issued the final rule that added 
SIRVA and vasovagal syncope to the Table, with an effective date of 
February 21, 2017 (Id. at 6294). Pursuant to a January 20, 2017 
memorandum from the Assistant to the President and Chief of Staff, 
titled ``Regulatory Freeze Pending Review,'' the effective date of the 
final rule adding SIRVA and vasovagal syncope to the

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Table was delayed until March 21, 2017 (82 FR 11321).
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    \3\ https://www.ncbi.nlm.nih.gov/books/NBK190024/.
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    On July 20, 2020, HHS published an NPRM proposing to amend the 
Table by removing SIRVA, vasovagal syncope, and the new vaccines 
category, Item XVII (85 FR 43794). A final rule amending the Table was 
published on January 21, 2021 (86 FR 6249). Pursuant to the Regulatory 
Freeze Memorandum dated January 20, 2021, and after a brief public 
comment period, effective February 22, 2021, HHS delayed the effective 
date of the January 21, 2021 Final Rule until 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 January 21, 2021 Final Rule to determine 
whether its promulgation raised any legal issues, including but not 
limited to (1) whether the 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 QAI 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). On March 17, 2021, HHS 
published an NPRM to rescind the January 21, 2021 Final Rule (86 FR 
14567).

Summary of the Final Rule

    This final rule rescinds the January 21, 2021 Final Rule entitled 
``National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table'' (86 FR 6249), which, if it were to go into 
effect, would amend the provisions of 42 CFR 100.3 by removing SIRVA, 
vasovagal syncope, and the new vaccines category (Item XVII) from the 
Table.
    HHS is rescinding the January 21, 2021 Final Rule for both 
procedural and policy reasons. HHS had already been alerted, and 
commenters to the March 17, 2021 NPRM reiterated, that members of the 
public believe that the promulgation of the January 21, 2021 Final Rule 
was irregular in its haste, and that HHS did not fully engage with 
either the ACCV or the public regarding its rationale behind the July 
20, 2020 NPRM and its proposed amendments to the Table. The 
promulgation of the January 21, 2021 Final Rule stands in contrast to 
the extensive, multi-year process HHS followed to add SIRVA and 
vasovagal syncope to the Table in March 2017.
    Specifically, the July 20, 2020 NPRM stated that HHS provided its 
proposal to remove SIRVA, vasovagal syncope, and Item XVII from the 
Table to the 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'' (85 FR 43799 & n. 19). However, the draft 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). In the past, when HHS has proposed a revision to 
the Table, it has sent 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 
Notification that a hearing on the July 20, 2020 NPRM would be held on 
November 9, 2020 (85 FR 68540). Unfortunately, that Federal Register 
Notification 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 (Id.). 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 
notification issues, 26 individuals spoke at the public hearing; all 
were opposed to the NPRM (see https://www.regulations.gov/document/HRSA-2020-0002-0373).
    Both the January 21, 2021 Final Rule and the July 20, 2020 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 (13) would strike 
the definitions of SIRVA and vasovagal syncope, respectively, from the 
QAI, and removing paragraph (e)(8) would strike the new vaccines 
category (Item XVII of the Table) from the Coverage Provisions section 
of the regulation. What followed the instruction was paragraph (a) and 
the Table itself. The rest of the regulation, including the revised 
paragraph (c) QAI and paragraph (e) Coverage Provisions, which are a 
critical part of the regulation (86 FR 6267; 85 FR 43804), were not 
included in the instruction and therefore were not included in the 
revised regulations set out following the instruction. 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 January 21, 2021 Final Rule (see https://www.ecfr.gov/cgi-bin/text-idx?SID=f5f03d551be5379a43b4de00614dafaa&mc=true&node=20210121y1.4). It 
also does not include paragraph (b) Provisions that apply to all 
conditions listed, paragraph (c) QAI, paragraph (d) Glossary for 
purposes of paragraph (c), and/or paragraph (e) Coverage Provisions 
sections of the Table, because those revisions were not included in the 
instruction and therefore were not included in the

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revised regulations set out following the instruction.
    As a policy matter, HHS is rescinding the January 21, 2021 Final 
Rule because it is concerned that it would have a negative impact on 
vaccine administrators, which would be at odds with the Federal 
Government's efforts to increase confidence in vaccinations in the 
United States, particularly in light of efforts to respond to the 
Coronavirus Disease 2019 (COVID-19) pandemic, as detailed in the March 
17, 2021 NPRM. On March 16, 2021, the then-Acting Secretary issued a 
Seventh Amendment to the Public Readiness and Emergency Preparedness 
(PREP) Act Declaration to, among other things, add additional 
categories of qualified people authorized to prescribe, dispense, and 
administer COVID-19 vaccines authorized by the U.S. Food and Drug 
Administration, including dentists, EMTs, midwives, optometrists, 
paramedics, physician assistants, podiatrists, respiratory therapists, 
and veterinarians (86 FR 14462).
    Given this unprecedented vaccination effort and the concern that 
the January 21, 2021 Final Rule's revisions to the Table could 
negatively impact the COVID-19 vaccination campaign, as well as other 
campaigns such as annual influenza vaccination efforts, and the January 
21, 2021 Final Rule's associated procedural issues, HHS is rescinding 
that rule.
    Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 
551 et seq.) requires that Federal agencies provide at least 30 days 
after publication of a final rule in the Federal Register before making 
it effective, unless good cause can be found not to do so. HHS finds 
that there is good cause for making this final rule effective less than 
30 days after publication in the Federal Register given that failure to 
do so would result in the removal of SIRVA and vasovagal syncope from 
the Table for 30 days, which would result in logistical and legal 
uncertainty regarding injuries allegedly received, petitions filed, and 
petitions adjudicated during that 30-day period. That same uncertainty 
also applies to the status of 42 CFR 100.3(b)-(e) during such period, 
given the January 21, 2021 Final Rule's conflicting instructions 
regarding these provisions. For these reasons, HHS finds there is good 
cause to make this final rule effective before the January 21, 2021 
Final Rule goes into effect on April 23, 2021.

II. Analysis and Responses to Public Comments

    The March 17, 2021 NPRM provided a 30-day comment period, and HRSA 
received 121 comments during that time, none of which supported the 
January 21, 2021 Final Rule. HRSA received comments from: Nurses and 
patients; law and other graduate school students; petitioners' 
attorneys (including a former member of the ACCV), law firms, and a bar 
association; a Member of Congress; a biotech trade association; 
pharmacist and drug store associations; a national drug store chain; 
non-profit organizations; and other individuals. While the Secretary 
only sought public comment on rescinding the January 21, 2021 Final 
Rule, many commenters offered comments beyond the scope of the request. 
We have summarized the relevant comments received, all of which support 
rescinding the January 21, 2021 Final Rule, and provided our responses 
below.
    Comment: Several commenters supported the rescission of the January 
21, 2021 Final Rule because they believe that rule did not adequately 
consider the recommendations of the ACCV or the public, or because they 
had other concerns regarding the January 21, 2021 Final Rule's 
promulgation. Several commenters pointed out irregularities in how HHS 
consulted with the ACCV as required by 42 U.S.C. 300aa-14(d). For 
example, then-ACCV Vice Chair raised concerns about the fact that the 
draft NPRM he received was marked privileged and confidential, and that 
he had ``never been given permission by anyone from HHS or anywhere 
else to talk about that document prior to the March 2020 meeting.'' He 
went on to state ``a discussion about the Proposed Rule was not on the 
agenda, and we [the ACCV] had absolutely zero notice that the Proposed 
Rule was going to be a topic of [consideration], even if the privileges 
and confidentiality had been waived by HHS.''
    In addition, some commenters noted that HHS received more than 760 
comments, the vast majority of which were opposed to the July 20, 2020 
NPRM, and that more than 150 of those comments were posted on the last 
day of the comment period. These commenters contended that HHS did not 
address various substantive comments in the January 21, 2021 Final 
Rule. For example, one commenter pointed to six specific comments 
(three from petitioners' attorneys, one from an orthopedic surgeon, one 
from a commercial pharmacy, and one from a biotechnology trade 
association) that ``were substantial and challenged key premises of the 
[July 20, 2020] NPRM'' to which the January 21, 2021 Final Rule did not 
adequately respond.
    Response: HHS agrees that there were irregularities in how HHS 
consulted with the ACCV, and there is a legitimate question as to 
whether the ACCV received the full 90 days to make recommendations. HHS 
also shares the commenters' other concerns related to the January 21, 
2021 Final Rule's promulgation, as detailed above, including whether 
all public comments were adequately considered and addressed as 
required by the APA. Given the numerous concerns that have already been 
raised and the questions that surround the January 21, 2021 Final 
Rule's promulgation, HHS agrees that rescinding that rule is proper.\4\
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    \4\ One commenter expressed concern regarding the following 
sentence in the March 17, 2021 NPRM: ``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.'' HHS wants to 
clarify that the quoted sentence was intended merely to be a 
hypothetical statement.
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    Comment: Many patients and individuals supported the rescission of 
the January 21, 2021 Final Rule because they stated they had suffered 
SIRVA or other injuries related to vaccinations and wanted others to be 
able to submit petitions for their own alleged SIRVA injuries. Some 
individuals raised concerns about COVID-19 vaccines and expressed their 
view that any potential vaccine-related injuries from that vaccination 
should be covered by the Program.
    Response: The VICP was created in the 1980s, after lawsuits against 
vaccine companies and health care providers threatened to cause vaccine 
shortages and reduce U.S. vaccination rates, which could have caused a 
resurgence of vaccine preventable diseases. HHS understands the 
important role the VICP plays by allowing any individual, of any age, 
who received a covered vaccine and believes he or she was injured as a 
result, to seek compensation. HHS regrets that it is unable to comment 
on individual pending or potential claims for compensation. Further, 
HHS notes that COVID-19 vaccines are covered countermeasures under the 
Countermeasures Injury Compensation Program (CICP),\5\ not the VICP. As 
long as Item XVII is included on the Table, for a new category of 
vaccines to be

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covered under the VICP, the following three things must happen: (1) 
Congress must enact an excise tax on the vaccine, (2) the CDC must 
recommend it for routine administration to children or pregnant women, 
and (3) the Secretary must publish a notice of coverage in the Federal 
Register (see 42 CFR 100.3(a), (e)(8)).
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    \5\ The Public Readiness and Emergency Preparedness Act (PREP 
Act) authorizes the CICP to provide benefits to certain individuals 
or estates of individuals who sustain a covered serious physical 
injury as the direct result of the administration or use of covered 
countermeasures identified in and administered or used under a PREP 
Act declaration.
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    Comment: Many commenters supported the rescission of the January 
21, 2021 Final Rule because they believe it contravenes the science 
surrounding SIRVA. For example, a group of registered nurses stated: 
``Shoulder injury related to vaccine [administration] (SIRVA) and 
vasovagal syncope are legitimate vaccine-related injuries that should 
remain on the Vaccine Injury Table. The 2011 Institute of Medicine 
Report provided convincing evidence through extensive literature 
reviews that vaccine administration had a causal relationship with both 
SIRVA and vasovagal syncope. It is necessary that the Vaccine Injury 
Table [retain] injuries proven by evidence that have the potential to 
adversely affect American lives.''
    Response: HHS is rescinding the January 21, 2021 Final Rule before 
it goes into effect in part so that the agency can have sufficient time 
to carefully and methodically consider the state of the science 
regarding SIRVA since it last completed its comprehensive review of the 
literature before adding SIRVA to the Table in March of 2017.
    Comment: Various commenters supported the rescission of the January 
21, 2021 Final Rule because they disagreed with the policy and legal 
rationales outlined in that rule. For example, some commenters argued 
that the cited financial considerations in the July 20, 2020 NPRM and 
the January 21, 2021 Final Rule did not support the removal of SIRVA 
and vasovagal syncope from the Table because these two injuries have 
minimal impact on the compensation funds available. Further, some 
commenters posited that the stated legal basis for removing SIRVA and 
vasovagal syncope from the Table, i.e., that the VICP only covers 
injuries attributable to the contents of a vaccine, and for removing 
Item XVII from the Table, i.e., that the item was contrary to law, 
represented changes in HHS's interpretation of the Vaccine Act that HHS 
did not adequately explain.
    Response: HHS agrees that compensation paid for SIRVA and syncope 
claims under the VICP are not currently threatening the solvency of the 
Vaccine Injury Compensation Trust Fund.\6\ Additionally, HHS agrees 
that the legal interpretation outlined in the January 21, 2021 Final 
Rule represented a change from HHS's historical interpretation of the 
Vaccine Act.\7\ Such a change in interpretation would deserve a more 
thorough review and public discussion by HHS with the ACCV and the 
general public than occurred during the development of the January 21, 
2021 Final Rule.
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    \6\ The Vaccine Injury Compensation Trust Fund provides funding 
for the VICP to compensate vaccine-related injury or death petitions 
for covered vaccines administered on or after October 1, 1988. 
Funded by a $.75 excise tax on vaccines recommended by the CDC for 
routine administration to children or pregnant women, the excise tax 
is imposed on each dose of a vaccine.
    \7\ Prior to the addition of SIRVA to the Table, SIRVA was a 
recognized vaccine injury in the VICP, with the Court of Federal 
Claims awarding compensation to petitioners based on a finding of 
causation in fact. See, e.g., Vessey v. Secretary of HHS, No. 14-
556V, 2014 WL 5408975 (Fed. Cl. Sept. 26, 2014); Grant v. Secretary 
of HHS, No. 13-743V, 2013 WL 6913004 (Fed. Cl. Dec. 11, 2013); 
Simpson v. Secretary of HHS, No. 13-068V, 2013 WL 2454365 (Fed. Cl. 
May 9, 2013); Godlewski v. Secretary of HHS, No. 12-396V, 2012 WL 
6830374 (Fed. Cl. Dec. 17, 2012); Gainey v. Secretary of HHS, No. 
09-597V, 2010 WL 2483748 (Fed. Cl. May 12, 2010); Ali v. Secretary 
of HHS, No. 09-660V, 2010 WL 1010027 (Fed. Cl. Feb. 26, 2010).
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    Comment: Some commenters supported the rescission of the January 
21, 2021 Final Rule because removing Item XVII from the Table would 
significantly lengthen the process of adding any new vaccine in the 
future--such as COVID-19 vaccines--to the Table for coverage under the 
VICP. Other commenters supported moving coverage for COVID-19 vaccines 
to the VICP from the CICP.
    Response: HHS agrees that, without Item XVII on the Table, the 
process for adding a vaccine to the Table could be more drawn out. With 
Item XVII in place, if HHS were to want to add a vaccine to the Table, 
it could do so if (1) Congress enacts an excise tax on the vaccine, (2) 
the CDC recommends it for routine administration to children or 
pregnant women, and (3) the Secretary publishes a notice of coverage in 
the Federal Register (see 42 CFR 100.3(a), (e)(8)). The January 21, 
2021 Final Rule stated incorrectly that, if Item XVII were removed from 
the Table, notice and comment rulemaking to add a new vaccine to the 
VICP would require that any proposed addition of a new vaccine to the 
Table be presented to the ACCV for its consideration for 90 days prior 
to publication of an NPRM, with a 180-day comment period for the NPRM, 
and a public hearing.\8\
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    \8\ Specifically, the January 21, 2021 Final Rule states: ``This 
final rule has zero impact on inclusion of the COVID-19 vaccine on 
the Table. The COVID-19 vaccine can separately be added to the 
Table, but the Department needs to follow the process specified in 
42 U.S.C. 300aa-14(c)--(d) to do so. This includes that the ACCV 
recommend that the COVID-19 vaccine be added, or opine on the 
Department's recommendation to add the COVID-19 vaccine to the 
Table'' (86 FR 6251).
    However, the process described in 42 U.S.C. 300aa-14(c)--(d) 
does not apply to adding vaccines to the Table; rather, it only 
applies to Table modifications that ``add to, or delete from, the 
list of injuries, disabilities, illnesses, conditions, and deaths 
for which compensation may be provided or [ ] change the time 
periods for the first symptom or manifestation of the onset or the 
significant aggravation of any such injury, disability, illness, 
condition, or death.'' 42 U.S.C. 300aa-14(c)(3). Subsection 300aa-
14(e)(2)--(3), by contrast, provides the process for adding new 
vaccines to the Table.
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    As stated above, COVID-19 vaccines are covered countermeasures 
under the CICP, not the VICP. For COVID-19 vaccines to be covered under 
the VICP, the process described above would have to occur.
    Comment: Many commenters supported the rescission of the January 
21, 2021 Final Rule because they are concerned that it would be 
particularly detrimental to vaccine administrators, which would be at 
odds with the Federal Government's efforts to increase COVID-19 
vaccinations, influenza vaccinations, and routine childhood 
vaccinations, the latter of which have significantly dropped during the 
pandemic. For example, the American Pharmacists Association and the 
National Alliance of State Pharmacy Associations commented that 
``during a pandemic is not the time to make changes to the Vaccine 
Injury Table, when we are working as a nation to implement the 
Administration's National Strategy for the COVID-19 Response and 
Pandemic Preparedness, including optimizing the manufacture, 
distribution, and administration of COVID-19 and other critical 
vaccinations.'' Another comment pointed out that many states are 
already suffering from nursing shortages, and increasing nurses' risk 
of liability for vaccine administration could exacerbate that shortage. 
Commenters also expressed concern that removing SIRVA and vasovagal 
syncope may increase vaccine hesitancy as individuals who already 
distrust vaccinations may decide to avoid being vaccinated if they 
believe they will not be compensated for SIRVA or vasovagal syncope 
injuries.
    Response: Although the COVID-19 vaccine is not covered under the 
VICP, HHS recognizes that any action taken that concerns administration 
of other vaccines could impact the Federal Government's efforts to 
combat COVID-19.\9\ For example, as discussed above,

[[Page 21213]]

on March 16, 2021, the then-Acting Secretary issued a Seventh Amendment 
to the Public Readiness and Emergency Preparedness (PREP) Act 
Declaration to, among other things, add additional categories of 
qualified people authorized to prescribe, dispense, and administer 
COVID-19 vaccines authorized by the U.S. Food and Drug Administration. 
HHS has determined it is not appropriate to remove categories of 
vaccines and types of injuries from the Table in the midst of the 
pandemic, especially in light of the Federal Government's unprecedented 
vaccination effort and data showing lower rates of routine 
immunizations during this period.\10\ In addition, HHS agrees that the 
January 21, 2021 Final Rule's revisions to the Table could negatively 
impact the vaccine administrators carrying out this massive COVID-19 
vaccination campaign by increasing their exposure to liability for 
administering non-COVID vaccines, without ample opportunity for vaccine 
administrators to engage in dialogue with HHS about their concerns. HHS 
agrees that removing compensable Table injuries, like SIRVA and 
vasovagal syncope, might run counter to public health goals and 
increase vaccine hesitancy because doing so could remove the 
possibility of an accessible and efficient forum for compensation for 
these injuries.
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    \9\ See National Strategy for the COVID-19 Response and Pandemic 
Preparedness (Jan. 2021), available at https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf.
    \10\ Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the 
COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and 
Administration -- United States, 2020. MMWR Morb Mortal Wkly Rep 
2020;69:591-593. DOI: https://dx.doi.org/10.15585/mmwr.mm6919e2.
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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.

Impact of the New Rule

    This rule rescinds the final rule titled ``National Vaccine Injury 
Compensation Program: Revisions to the Vaccine Injury Table.'' This 
rescission is reasonable and will not be disruptive because the 
underlying rule has not yet been implemented or taken effect.

Paperwork Reduction Act of 1995

    This rule has no information collection requirements.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-08478 Filed 4-21-21; 8:45 am]
BILLING CODE 4165-15-P