National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 14567-14570 [2021-05486]
Download as PDF
Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
1999); availability of voluntary
consensus standards pursuant to
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104–
113; tribal implications pursuant to
Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000);
environmental health or safety effects
on children pursuant to Executive Order
13045, entitled Protection of Children
from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23,
1997); energy effects pursuant to
Executive Order 13211, entitled Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001); Paperwork burdens pursuant
to the Paperwork Reduction Act (PRA)
(44 U.S.C. 3501); or human health or
environmental effects on minority or
low-income populations pursuant to
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994). The Agency will
consider such comments during the
development of any subsequent
rulemaking.
List of Subjects in 40 CFR Part 414
Environmental protection, Chemicals,
Plastics materials and synthetics, Waste
treatment and disposal, Water pollution
control.
Jane Nishida,
Acting Administrator.
[FR Doc. 2021–05402 Filed 3–16–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AB24
National Vaccine Injury Compensation
Program: Revisions to the Vaccine
Injury Table
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed withdrawal;
request for comments.
jbell on DSKJLSW7X2PROD with PROPOSALS
AGENCY:
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
SUMMARY:
VerDate Sep<11>2014
17:42 Mar 16, 2021
Jkt 253001
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.
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: https://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 https://
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
vaccinecompensation@hrsa.gov; 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.
DATES:
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
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
14567
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
E:\FR\FM\17MRP1.SGM
17MRP1
jbell on DSKJLSW7X2PROD with PROPOSALS
14568
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 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-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-
VerDate Sep<11>2014
17:42 Mar 16, 2021
Jkt 253001
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 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-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.
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
Both the final rule and the NPRM
included the following instruction: ‘‘In
§ 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/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 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-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
E:\FR\FM\17MRP1.SGM
17MRP1
Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS
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
VerDate Sep<11>2014
17:42 Mar 16, 2021
Jkt 253001
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-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
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
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.
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
14569
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
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-pharmacyprogram//). 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/remarksby-president-biden-to-nationalinstitutes-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
E:\FR\FM\17MRP1.SGM
17MRP1
14570
Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS
optimize the manufacture, distribution,
and administration of COVID–19 and
other critical vaccinations.’’ (see https://
www.regulations.gov/comment/HRSA2021-0001-0022). 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
VerDate Sep<11>2014
17:42 Mar 16, 2021
Jkt 253001
availability thus leading to poorer
public health outcomes.’’ (see https://
www.regulations.gov/comment/HRSA2021-0001-0004).
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
PO 00000
Frm 00020
Fmt 4702
Sfmt 9990
(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
E:\FR\FM\17MRP1.SGM
17MRP1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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:
---------------------------------------------------------------------------
\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
---------------------------------------------------------------------------
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//). 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