National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table, 68423-68428 [2021-26197]
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[FR Doc. 2021–26143 Filed 12–1–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AB27
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National Vaccine Injury Compensation
Program: Adding the Category of
Vaccines Recommended for Pregnant
Women to the Vaccine Injury Table
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Final rule.
AGENCY:
On April 4, 2018, the
Secretary of Health and Human Services
SUMMARY:
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EPA approval date
*
*
12/2/2021, [Insert citation of publication].
(the Secretary) published in the Federal
Register a notice of proposed
rulemaking (NPRM) to amend the
National Vaccine Injury Compensation
Program (VICP or Program) Vaccine
Injury Table (Table), consistent with the
statutory requirement to include
vaccines recommended by the Centers
for Disease Control and Prevention
(CDC) for routine administration in
pregnant women. Specifically, the
Secretary sought public comment
regarding how the addition of this new
category should be formatted on the
Table. Through this final rule, the
Secretary amends the Table to add
‘‘and/or pregnant women’’ after
‘‘children’’ to the existing language in
Item XVII as proposed in the NPRM.
This change will apply only to petitions
for compensation under the VICP filed
after the effective date of this final rule.
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Explanation
Sfmt 4700
DATES:
*
This rule is effective January 3,
2022.
FOR FURTHER INFORMATION CONTACT:
Tamara Overby, Acting Director,
Division of Injury Compensation
Programs, Healthcare Systems Bureau,
HRSA, 5600 Fishers Lane, Room
8N146B, Rockville, MD 20857, or by
telephone (855) 266–2427. This is a tollfree number.
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.),
established the VICP, a Federal
compensation program for individuals
thought to be injured by certain
vaccines. The statute governing the
VICP has been amended several times
since 1986 and will be hereinafter
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referred to as ‘‘the Vaccine Act.’’
Petitions for compensation under the
VICP 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 gain entitlement to compensation
under this Program, a petitioner must
establish that a vaccine-related injury or
death has occurred, either by proving
that a vaccine actually caused or
significantly aggravated an injury
(causation-in-fact) or by demonstrating
the occurrence of what is 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 the period also
specified in the Table. If so, the injury
is presumed to have been caused by the
vaccination, and the petitioner is
entitled to compensation (assuming that
other Vaccine Act 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)).
Revisions to the Table are authorized
under 42 U.S.C. 300aa–14(c) and (e).
Prior to the 21st Century Cures Act
(Cures Act) (Pub. L. 114–255), the only
vaccines covered under the VICP were
those recommended by the CDC for
routine administration to children (for
example, vaccines that protect against
seasonal influenza), are subject to an
excise tax by Federal law, and added to
the Table by the Secretary. The Table
currently includes 17 vaccine
categories, with 16 categories for
specific vaccines, as well as their
corresponding illness, disability, injury,
or condition covered, and the requisite
time within which the first symptom or
manifestation of onset or significant
aggravation must begin after the vaccine
administration to receive the Table’s
legal presumption of causation. One
category of the Table, ‘‘Item XVII,’’
includes, ‘‘Any new vaccine
recommended by the Centers for Disease
Control and Prevention for routine
administration to children, after
publication by the Secretary of a notice
of coverage.’’ Two injuries—Shoulder
Injury Related to Vaccine
Administration (SIRVA) and vasovagal
syncope—are listed as associated
injuries for this category. Through this
general category, new vaccines
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recommended by the CDC for routine
administration to children and subject
to an excise tax are covered under the
VICP prior to being added to the Table
as a separate vaccine category.
The Cures Act amended 42 U.S.C.
300aa–14(e) to expand the types of
vaccines covered under the VICP. See
section 3093(c)(1) of the Cures Act. The
amended statute requires that the
Secretary revise the Table to include
vaccines recommended by the CDC for
routine administration in pregnant
women (and subject to an excise tax by
Federal law). See 42 U.S.C. 300aa–
14(e)(3). This action does not alter the
current status quo because the CDC has
not recommended any categories of
vaccines for routine administration to
pregnant women that are not also
recommended for routine
administration to children.
Summary of the Final Rule
As discussed in the NPRM (83 FR
14391), Congress enacted a mechanism
for modification of the Table, through
the promulgation of regulatory changes
by the Secretary after consultation with
the Advisory Commission on Childhood
Vaccines (ACCV). The Secretary is
revising the Table to include new
vaccines recommended by the CDC for
routine administration in pregnant
women in Item XVII of the Table. On
September 8, 2017, the Program
consulted the ACCV regarding options
for adding this new category of vaccines
to the Table. The ACCV voted
unanimously to amend the existing
language in Item XVII of the Table to
add ‘‘and/or pregnant women’’ after
‘‘children’’ authorizing coverage under
the VICP of any new vaccine
recommended by CDC for routine
administration in pregnant women (and
subject to an excise tax) after the
publication of a notice of coverage. The
ACCV viewed this option as a simple
approach to revising the Table, rather
than adding a new general Item XVIII to
the Table for vaccines recommended for
routine administration in pregnant
women. Therefore, following the
ACCV’s recommendation, the Secretary
has amended the existing language in
Item XVII of the Table to add ‘‘and/or
pregnant women’’ after ‘‘children.’’ This
amendment allows any new vaccine
recommended by the CDC for routine
administration in pregnant women (and
subject to an excise tax) to be added to
this general category of the Table after
the Secretary publishes a notice of
coverage. The publication of a notice of
coverage reflects the Secretary’s
approval of CDC’s recommendation and
the determination that the statutory
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requirements for coverage under the
VICP have been met.
The Secretary also has retained the
two injuries currently associated with
Item XVII of the Table, SIRVA and
vasovagal syncope, as Table injuries for
vaccines recommended by the CDC for
routine administration in pregnant
women. In its 2012 Report, ‘‘Adverse
Effects of Vaccines: Evidence and
Causality,’’ the Institute of Medicine
considered SIRVA and vasovagal
syncope as mechanistic injuries
resulting from the injection of a vaccine
and not from the contents of a particular
formulation of a vaccine. Thus, these
conditions are listed as Table injuries
for any new vaccine recommended by
the CDC for routine administration to
children (after the imposition of an
excise tax and publication by the
Secretary of a notice of coverage) to
account for any new injected vaccines
that potentially may lead to SIRVA or
vasovagal syncope. Therefore, the
Secretary also has included these
injuries on the Table for new vaccines
recommended by the CDC for routine
administration in pregnant women.
VICP petitions must be filed within
the applicable statutes of limitations.
With the Table change, the general
statutes of limitations applicable to
petitions filed with the VICP, set forth
in 42 U.S.C. 300aa–16(a), continue to
apply. The alternate statute of
limitations afforded by 42 U.S.C. 300aa–
16(b) does not apply to this Table
change. This is because, at present,
there are no vaccines added to the Table
under the revised general category,
since the only vaccines the CDC
currently recommends for routine
administration in pregnant women are
already covered on the Table. In the
future, when any new vaccine, not
already covered under the VICP, is
recommended by the CDC for routine
administration in pregnant women,
subject to an excise tax, and added to
the Table, the alternate statute of
limitations afforded by 42 U.S.C. 300aa–
16(b) would apply if certain
requirements are met.1
II. Responses to Public Comments
The NPRM provided a 180-day
comment period (April 4, 2018–October
1, 2018), and HRSA received 51
comments during that time, including
during a public hearing. There were 48
written comments submitted. The
1 Under 42 U.S.C. 300aa–16(b), the alternate
statute of limitations applies where the effect of the
revision would make an individual, who was not
eligible before the revision, eligible to seek
compensation under the Program or to significantly
increase the individual’s likelihood of obtaining
compensation.
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number and sources of the comments
are as follows: 44 from individuals, two
from pharmaceutical companies, and
two from organizations, with one stating
it represents 12 other entities. In
addition, HRSA held a public hearing
on the NPRM on September 17, 2018,
and a national organization and two
individuals presented oral comments.
While the Secretary only sought
public comment on how best to
implement the statutory amendment to
add vaccines recommended by the CDC
for routine administration in pregnant
women to the Table, many commenters
offered comments beyond the scope of
the request. Nevertheless, the Secretary
carefully considered all 51 comments
received in the development of this final
rule. Below is a summary of the
comments and the Secretary’s response
to them.
Comment: Several comments
supported the addition of vaccines
recommended for routine
administration in pregnant women to
the Table, stating that maternal
immunization will improve the health
of the mother, her unborn child,
newborns, and the overall health of the
nation.
Response: Based on existing evidence
and data trends, the Secretary agrees
that the eradication and reduction of
vaccine-preventable diseases through
immunization has directly increased life
expectancy by reducing mortality.
Pregnant women are at risk for vaccinepreventable disease–related morbidity
and mortality and adverse pregnancy
outcomes, including congenital
anomalies, spontaneous abortion,
preterm birth, and low birth weight. In
addition to providing direct maternal
benefit, vaccination during pregnancy
likely provides direct fetal and infant
benefit through passive immunity
(transplacental transfer of maternal
vaccine-induced antibodies). Among the
vaccines recommended by the CDC for
adults, currently, two are specifically
recommended for routine
administration during pregnancy, and
hepatitis A, hepatitis B, meningococcal
(ACWY), and meningococcal (B) are
recommended in pregnancy based on
additional risk factors.
Comment: A comment supporting the
proposed changes in the NPRM suggests
that the recommendations of the CDC
should be included as additional
language on the Table, supporting the
safe administration of vaccines in
pregnant women.
Response: The Table does not include
language about the safe administration
of vaccines, as the purpose of the Table
is to list and explain injuries and/or
conditions that are presumed to be
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caused by covered vaccines, unless
another cause is proven, for potential
compensation under the VICP.
However, CDC develops best practice
guidance for the safe administration of
vaccines that can be found at https://
www.cdc.gov/vaccines/hcp/acip-recs/
index.html.
Comment: Comments supporting the
proposed changes in the NPRM
indicated that the CDC
recommendations for the administration
of routine vaccination to pregnant
women would result in increased
communication and knowledge around
vaccines recommended for pregnant
women, leading to increased informed
consent and facilitate decision-making
regarding immunizations. In addition,
this may result in the development of
new vaccines for pregnant women.
Response: Recommendations for the
routine use of vaccines in pregnant
women are issued by the CDC and are
harmonized to the greatest extent
possible with recommendations made
by the American College of
Gynecologists and Obstetricians, the
American Academy of Family
Physicians, and the American College of
Physicians. The Advisory Committee on
Immunization Practices, established in
1964 by the Surgeon General of the
United States, is chartered as a Federal
advisory committee to provide expert
external advice and guidance to the
Director of the CDC on the use of
vaccines in the civilian population. The
Advisory Committee on Immunization
Practices makes recommendations to the
Director of the CDC for vaccines
authorized or licensed by the Food and
Drug Administration for the prevention
of diseases. Providing information
regarding whether these
recommendations increase
communication and knowledge around
vaccines recommended for pregnant
women, and facilitating decisionmaking regarding immunizations, is
beyond the scope of this final rule.
Comment: Some comments
supporting the proposed changes in the
NPRM suggested that adding the
category of pregnant women to the
Table would allow the VICP to function
more efficiently and pregnant women
would have recourse should an alleged
injury occur.
Response: The Secretary agrees that
the addition of the category of vaccines
recommended for routine
administration in pregnant women to
the Table will make the VICP function
more efficiently. The addition of such
vaccines to Item XVII of the Table will
allow any new vaccines that in the
future are recommended by the CDC for
routine administration in pregnant
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women (and subject to an excise tax) to
be covered under the VICP after the
Secretary issues a notice of coverage,
without requiring further rulemaking.
In addition, the Table lists covered
vaccines and associated injuries, making
it easier for some people to get
compensation. The Table lists and
explains injuries and/or conditions that
are presumed to be caused by vaccines
unless another cause is proven. The
Table’s Qualification and Aids to
Interpretation define some of the
injuries and/or conditions listed on the
Table. The Table also lists periods in
which the first symptom of these
injuries and/or conditions must occur
after receiving the vaccine to receive the
Table’s presumption of causation. If the
first symptom of an injury and/or
condition listed on the Table occurs
within the listed time, and any
associated definition(s) included in the
Qualification and Aids to Interpretation
are satisfied, it is presumed that the
vaccine was the cause of the injury or
condition unless another cause is
proven.
Comment: Several comments opposed
the proposed changes in the NPRM
because they stated that the
administration of vaccines to pregnant
women and their unborn children
causes injuries, such as miscarriages,
pre-eclampsia, cancer, autism,
neurodevelopmental disorders of
infants, and learning disabilities. Some
opposed the addition of the category of
pregnant women to the Table because
they believe that there is a lack of
vaccine safety testing and studies,
especially regarding the administration
of vaccines in pregnant women. Some
comments suggested there is no
scientific evidence that vaccinating
pregnant women is safe or advantageous
and that there are limited benefits and
increased risks for vaccinating pregnant
women. In addition, some adamantly
opposed all vaccinations.
Response: As noted in the NPRM, a
recent amendment to the Vaccine Act
requires that the Secretary revise the
Table to include vaccines recommended
by the CDC for routine administration in
pregnant women (and subject to an
excise tax by Federal law). See 42 U.S.C.
300aa–14(e)(3).
Moreover, the United States has a
long-standing vaccine safety program
that closely and constantly monitors the
safety of vaccines. A critical part of the
vaccine safety program is the CDC’s
Immunization Safety Office, which
identifies possible vaccine side effects
and conducts studies to determine
whether health problems are caused by
vaccines. Information regarding vaccine
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safety and current research are available
by conducting literature reviews.
Pregnant women are at risk for
vaccine-preventable disease-related
morbidity and mortality and adverse
pregnancy outcomes, including
congenital anomalies, spontaneous
abortion, preterm birth, and low birth
weight. In addition to providing direct
maternal benefit, vaccination during
pregnancy may provide direct fetal and
infant benefit through passive immunity
(transplacental transfer of maternal
vaccine-induced antibodies).
Existing evidence and data trends
indicate that the eradication and
reduction of vaccine-preventable
diseases through immunization has
directly increased life expectancy by
reducing mortality. In addition,
numerous published and peer-reviewed
scientific studies have found that
neither vaccines nor vaccine ingredients
cause the neurodevelopmental disorders
of autism, Attention-Deficit/
Hyperactivity Disorder, or speech or
language delay.
Comment: Some comments opposing
the proposed changes in the NPRM
stated that pregnant women are often
coerced or forced to be vaccinated
without being given information about
possible vaccine side effects to
themselves and/or their unborn child/
children.
Response: This final rule does not
require vaccines for pregnant women.
However, the CDC and the American
Academy of Pediatrics, as well as other
medical organizations, publish
information regarding the safety of
recommended vaccines. In addition,
Vaccine Information Statements, which
are information sheets produced by the
CDC that explain both the benefits and
risks of VICP-covered vaccines, are
required to be provided to all
individuals, or their legal
representatives, before receiving such
vaccines. However, the decision to
ultimately be vaccinated rests with the
individual or legal representative.
Comment: Some comments opposing
the NPRM stated that by recommending
vaccines to pregnant women, liability
protection is conferred upon vaccine
manufacturers and that this creates a
disincentive to conduct safety research
on vaccines. Some stated a belief that
the addition of pregnant women will
now eliminate the pregnant woman’s
right to sue for damages.
Response: The Vaccine Act created
the VICP, a no-fault alternative to the
traditional tort system. It provides
compensation to people thought to be
injured by vaccines recommended by
the CDC for routine administration to
children and now pregnant women.
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When a vaccine is added to the Vaccine
Injury Table, it is covered under the
VICP. To help ensure a stable vaccine
supply, the VICP generally provides
liability protection for vaccine
manufacturers and health care providers
for injuries caused by VICP-covered
vaccines. Claims alleging injuries or
death from certain vaccines generally
must be filed with the VICP before a
lawsuit can be filed in civil court.
Comment: Some comments opposed
the addition of the category of vaccines
recommended for routine
administration in pregnant women to
the Table, as this would provide vaccine
manufacturers the ability to increase
revenue by having a new population to
target with their products.
Response: As noted previously, the
Secretary is required by statute to revise
the Table to include vaccines
recommended by the CDC for routine
administration in pregnant women (and
subject to an excise tax by Federal law).
See 42 U.S.C. 300aa–14(e)(3).
Comment: Some comments opposing
the change proposed in the NPRM
suggested that the VICP be eliminated.
Response: The Vaccine Act
established the VICP, and Congress
would need to enact legislation to
eliminate the VICP. Eliminating the
Program is beyond the scope of this
final rule.
Comment: Some comments
supporting and opposing the changes
proposed in the NPRM suggested
additional changes to the Table, such as
adding injuries to the Table.
Commenters opposing changes
proposed in the rule stated that vaccines
cause miscarriages and other conditions,
such as chorioamnionitis, encephalitis/
encephalopathy, Guillain-Barre´
Syndrome, and neurodevelopmental
disorders, and can negatively affect the
offspring of pregnant women who have
undiagnosed genetic disorders. Some
commenters requested that the Table be
revised or expanded to include all
vaccines that could be recommended in
pregnancy and their potential
complications, and vaccines
contraindicated during pregnancy,
including statistics of complications.
Response: Consistent with the
statutory requirement, the Secretary is
revising the Table to include new
vaccines recommended by the CDC for
routine administration in pregnant
women. The Secretary is implementing
this change by amending the existing
language in Item XVII of the Table to
include ‘‘and/or pregnant women’’ after
‘‘children.’’ This will add to that general
category of the Table, any new vaccine
recommended by the CDC for routine
administration in pregnant women, after
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imposition of an excise tax and
publication of a notice of coverage by
the Secretary.
As explained above, in its 2012
Report, ‘‘Adverse Effects of Vaccines:
Evidence and Causality,’’ the Institute of
Medicine considered SIRVA and
vasovagal syncope as mechanistic
injuries resulting from the injection of a
vaccine and not from the contents of a
particular formulation of a vaccine.
Thus, these conditions are listed as
Table injuries for any new vaccine
recommended by the CDC for routine
administration to children or pregnant
women (after the imposition of an
excise tax and publication by the
Secretary of a notice of coverage) to
account for any new injected vaccines
that potentially may lead to SIRVA or
vasovagal syncope. In the future, when
specific vaccines recommended for
routine administration in pregnant
women are added to the Table, the
Secretary will review the literature to
determine if other injuries should be
added to the Table for those new
vaccines.
Comment: Comments supporting and
opposing the proposed change in the
NPRM speculated that there is the
potential for increased compensation for
adverse reactions resulting from
increased injury claims, as both the
mother and her unborn child are now
eligible to file a claim for a vaccine
related injury. Commenters expressed
concern with possible abuse in
reporting and compensation,
compounded by the addition of SIRVA
and vasovagal syncope as injuries to the
Table.
Response: The Secretary is required
by statute to revise the Table to include
vaccines recommended by the CDC for
routine administration in pregnant
women (and subject to an excise tax by
Federal law). See 42 U.S.C. 300aa–
14(e)(3). Additionally, with respect to
vaccination of pregnant women, the
Cures Act permits two VICP petitions to
be filed: One on behalf of a woman who
was pregnant when vaccinated and one
on behalf of her live-born child whose
injury(s) was allegedly sustained in
utero. See 42 U.S.C. 300aa–11(b)(2).
Comment: A commenter questioned
who would be the proper petitioner in
the context of maternal immunization
(i.e., would the petitioner be the
pregnant woman, the child born after
his/her pregnant mother was
vaccinated, or both?).
Response: The Cures Act amended the
Vaccine Act to permit VICP claims filed
on behalf of live-born children for
injuries allegedly sustained in utero as
a result of maternal immunizations with
respect to covered vaccines. See 42
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U.S.C. 300aa–11(f). In addition, the
Cures Act modified the Vaccine Act’s
‘‘one petition’’ requirement by allowing
two VICP petitions: One on behalf of a
woman who was pregnant when
vaccinated and one on behalf of her
child whose injury(s) was allegedly
sustained in utero. See 42 U.S.C. 300aa–
11(b)(2).
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
substantial additional administrative
and compensation resources are
required to implement the requirements
in this rule. Compensation will be made
in the same manner. As in all other
VICP cases, to be found entitled to
compensation, petitioners will need to
prove by a preponderance of the
evidence either that they meet the
requirements of the Table or that their
injury was caused by the vaccine unless
the respondent affirmatively shows that
the injury was caused by some factor
other than the vaccination. Therefore, in
accordance with the Regulatory
Flexibility Act of 1980 (RFA), and the
Small Business Regulatory Enforcement
Act of 1996, which amended the RFA,
the Secretary certifies that this rule will
not have a significant impact on a
substantial number of small entities.
The National Vaccine Injury
Compensation Program: Adding the
Category of Vaccines Recommended for
Pregnant Women to the Vaccine Injury
Table Final Rule is ‘‘not significant’’
because no substantial resources are
required to implement the requirements
in this rule. This rule adds ‘‘and/or
pregnant women’’ to the new vaccines
category (Item XVII) on the Table.
Currently, the only vaccines
recommended for routine
administration in pregnant women are
already on the Table because they are
recommended for routine
administration to children and have an
excise tax imposed on them. Therefore,
this final rule does not have a
significant impact on a substantial
number of small entities. Additionally,
this rule does not meet the criteria for
a major rule as defined by Executive
Order 12866 and would have no major
effect on the economy or Federal
expenditures. We have determined that
the final rule is not a ‘‘major rule’’
within the meaning of the statute
providing for Congressional Review of
Agency Rulemaking, 5 U.S.C. 801.
Similarly, it will not have effects on
state, local, and tribal governments and
on the private sector such as requiring
consultation under the Unfunded
Mandates Reform Act of 1995.
The provisions of this final rule do
not, on the basis of family well-being,
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.
This final rule is not being treated as
a ‘‘significant regulatory action’’ as
defined under section 3(f) of Executive
Order 12866. As stated above, this final
rule will modify the Table based on
legal authority.
Impact of the New Rule
This final rule will allow any vaccines
that in the future are recommended by
the CDC for routine administration to
pregnant women and subject to an
excise tax to be covered under the VICP
after the Secretary issues a notice of
coverage, without requiring further
rulemaking. In addition, this final rule
will have the effect of making it easier
for future petitioners alleging injuries
that meet the criteria in the Vaccine
Injury Table to receive the Table’s
presumption of causation, which
relieves them of having to prove that the
vaccine actually caused or significantly
aggravated their injury.
Paperwork Reduction Act of 1995
This final rule has no information
collection requirements.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance,
Immunization.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
Accordingly, 42 CFR part 100 is
amended as set forth below:
PART 100—VACCINE INJURY
COMPENSATION
1. The authority citation for 42 CFR
part 100 continues to read as follows:
■
Authority: Secs. 312 and 313 of Public
Law 99–660 (42 U.S.C. 300aa–1 note); 42
U.S.C. 300aa–10 to 300aa–34; 26 U.S.C.
4132(a); and sec. 13632(a)(3) of Public Law
103–66.
2. In § 100.3, amend the Table in
paragraph (a) by revising entry ‘‘XVII’’
to read as follows:
■
§ 100.3
Vaccine injury table.
(a) * * *
lotter on DSK11XQN23PROD with RULES1
VACCINE INJURY TABLE
Vaccine
Illness, disability,
injury, or condition
covered
*
*
*
*
XVII. Any new vaccine recommended by the Centers for Disease Control and
Prevention for routine administration to children and/or pregnant women,
after publication by the Secretary of a notice of coverage.
*
*
A. Shoulder Injury Related to Vaccine
Administration.
B. Vasovagal syncope ..........................
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Time period for
first symptom or
manifestation of
onset or of significant
aggravation
after vaccine
administration
≤48 hours.
≤1 hour.
*
68428
*
*
Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
*
*
Supplemental Final Regulatory
Flexibility Analysis (Supplemental
FRFA) of the possible significant impact
on small entities of the Standard
Questions and procedures addressed in
this Second Report and Order.
*
[FR Doc. 2021–26197 Filed 12–1–21; 8:45 am]
BILLING CODE 4150–28–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1 and 63
[IB Docket No. 16–155; FCC 21–104]
Process Reform for Executive Branch
Review of Certain FCC Applications
and Petitions Involving Foreign
Ownership
Federal Communications
Commission.
ACTION: Final action.
AGENCY:
This document summarizes
the Federal Communications
Commission’s (Commission) decision in
the Second Report and Order in the
Process Reform for Executive Branch
Review of Certain FCC Applications and
Petitions Involving Foreign Ownership
proceeding, in which the Commission
adopted Standard Questions that certain
applicants with reportable foreign
ownership will be required to answer as
part of the Executive Branch review
process of their applications.
DATES: The Commission adopted the
Standard Questions on September 30,
2021.
SUMMARY:
lotter on DSK11XQN23PROD with RULES1
FOR FURTHER INFORMATION CONTACT:
Jocelyn Jezierny, International Bureau,
Telecommunications and Analysis
Division, at (202) 418–0887 or
Jocelyn.Jezierny@fcc.gov. For
information regarding the PRA
information collection requirements
contained in the PRA, contact Cathy
Williams, Office of the Managing
Director, at (202) 418–2918 or Cathy.
Williams@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Second
Report and Order, FCC 21–104, adopted
on September 30, 2021, and released on
October 1, 2021. The full text of this
document is available on the
Commission’s website at https://
docs.fcc.gov/public/attachments/FCC21-104A1.pdf. To request materials in
accessible formats for people with
disabilities, send an email to FCC504@
fcc.gov or call the Consumer &
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Supplemental Final Regulatory
Flexibility Analysis
As required by the Regulatory
Flexibility Act of 1980, as amended
(RFA), the Commission has prepared a
VerDate Sep<11>2014
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Congressional Review Act
The Commission will include a copy
of this Second Report and Order in a
report to be sent to Congress and the
Government Accountability Office
pursuant to the Congressional Review
Act, 5 U.S.C. 801(a)(1)(A).
Synopsis
I. Introduction
1. In this Second Report and Order,
we adopt a set of standardized national
security and law enforcement questions
(Standard Questions) that certain
applicants and petitioners (together,
‘‘applicants’’) with reportable foreign
ownership will be required to answer as
part of the Executive Branch review
process of their applications and
petitions (together, ‘‘applications’’). In
the Executive Branch Review Order, the
Commission adopted rules and
procedures to facilitate a more
streamlined and transparent review
process for coordinating applications
with the Executive Branch agencies (the
Departments of Justice, Homeland
Security, Defense, State, and Commerce,
as well as the United States Trade
Representative) for their views on any
national security, law enforcement,
foreign policy, or trade policy issues
associated with the foreign ownership of
the applicants. The Executive Branch
Review Order also established firm time
frames for the Executive Branch
agencies to complete their review
consistent with Executive Order 13913,
which established the Committee for the
Assessment of Foreign Participation in
the United States Telecommunications
Services Sector (the Committee).1 To
expedite the national security and law
enforcement review of such
applications, applicants must provide
1 Executive Order No. 13913 of April 4, 2020,
Establishing the Committee for the Assessment of
Foreign Participation in the United States
Telecommunications Services Sector, 85 FR 19643,
19643 through 44 (Apr. 8, 2020) (Executive Order
13913) (establishing the ‘‘Committee,’’ composed of
the Secretary of Defense, the Secretary of Homeland
Security, and the Attorney General of the
Department of Justice, who serves as the Chair, and
the head of another executive department or
agency, or any Assistant to the President, as the
President determines appropriate (Members), and
also providing for Advisors, including the Secretary
of State, the Secretary of Commerce, and the United
States Trade Representative); id. (stating that, ‘‘[t]he
security, integrity, and availability of United States
telecommunications networks are vital to United
States national security and law enforcement
interests’’).
PO 00000
Frm 00040
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their answers to the Standard Questions
directly to the Committee prior to or at
the same time they file their
applications with the Commission. This
process would replace the current
practice of the Executive Branch seeking
such threshold information directly
from the applicants after the
Commission refers the applications.
II. Background
2. For over 20 years, the Commission
has referred certain applications that
have reportable foreign ownership to the
Executive Branch agencies for their
review.2 In the Executive Branch Review
Order, the Commission formalized the
review process and established firm
time frames for the Executive Branch
national security and law enforcement
agencies to complete their review,
consistent with Executive Order 13913
that established the Committee in 2020.
The types of applications the
Commission generally refers include
applications for international section
214 authorizations and submarine cable
landing licenses and applications to
assign, transfer control or modify such
authorizations and licenses where the
applicant has reportable foreign
ownership, and all petitions for section
310(b) foreign ownership rulings.3
2 In adopting rules for foreign carrier entry into
the U.S. telecommunications market over two
decades ago in its Foreign Participation Order, the
Commission affirmed that it would consider
national security, law enforcement, foreign policy,
and trade policy concerns in its public interest
review of applications for international section 214
authorizations and submarine cable landing
licenses and petitions for declaratory ruling under
section 310(b) of the Act. Rules and Policies on
Foreign Participation in the U.S.
Telecommunications Market; Market Entry and
Regulation of Foreign-Affiliated Entities, IB Docket
Nos. 97–142 and 95–22, Report and Order and
Order on Reconsideration, 12 FCC Rcd 23891,
23919, paragraph 63 (1997) (Foreign Participation
Order), recon. denied, 15 FCC Rcd 18158 (2000).
3 Process Reform for Executive Branch Review of
Certain FCC Applications and Petitions Involving
Foreign Ownership, IB Docket No. 16–155, Report
and Order, 85 FR 76360 (Nov. 27, 2020), 35 FCC
Rcd 10927, 10935–38, paragraphs 24 through 28
(2020) (Executive Branch Review Order) (setting out
which types of applications will generally be
referred to the Executive Branch, but noting the
Commission has the discretion to refer additional
types of applications if we find that the specific
circumstances of an application require the input of
the Executive Branch); see also Erratum (Appendix
B—Final Rules), DA 20–1404 (OMD/IB rel. Nov. 27,
2020), 47 CFR 1.40001(a)(1); Numbering Policies for
Modern Communications, WC Docket No. 13–97;
Telephone Number Requirements for IP-Enabled
Service Providers, WC Docket No. 07–243;
Implementation of TRACED Act Section 6(a)—
Knowledge of Customers by Entities with Access to
Numbering Resources, WC Docket No. 20–67;
Process Reform for Executive Branch Review of
Certain FCC Applications and Petitions Involving
Foreign Ownership, IB Docket No. 16–155, Further
Notice of Proposed Rulemaking, FCC 21 through 94,
paragraphs 23 through 29 (2021) (seeking comment
on referring certain numbering applications to the
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]]>Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68423-68428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26197]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AB27
National Vaccine Injury Compensation Program: Adding the Category
of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On April 4, 2018, the Secretary of Health and Human Services
(the Secretary) published in the Federal Register a notice of proposed
rulemaking (NPRM) to amend the National Vaccine Injury Compensation
Program (VICP or Program) Vaccine Injury Table (Table), consistent with
the statutory requirement to include vaccines recommended by the
Centers for Disease Control and Prevention (CDC) for routine
administration in pregnant women. Specifically, the Secretary sought
public comment regarding how the addition of this new category should
be formatted on the Table. Through this final rule, the Secretary
amends the Table to add ``and/or pregnant women'' after ``children'' to
the existing language in Item XVII as proposed in the NPRM. This change
will apply only to petitions for compensation under the VICP filed
after the effective date of this final rule.
DATES: This rule is effective January 3, 2022.
FOR FURTHER INFORMATION CONTACT: Tamara Overby, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, 5600 Fishers Lane, Room 8N146B, Rockville, MD 20857, or by
telephone (855) 266-2427. This is a toll-free number.
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.), established the VICP, a
Federal compensation program for individuals thought to be injured by
certain vaccines. The statute governing the VICP has been amended
several times since 1986 and will be hereinafter
[[Page 68424]]
referred to as ``the Vaccine Act.'' Petitions for compensation under
the VICP 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 gain entitlement to compensation under this Program, a
petitioner must establish that a vaccine-related injury or death has
occurred, either by proving that a vaccine actually caused or
significantly aggravated an injury (causation-in-fact) or by
demonstrating the occurrence of what is 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 the
period also specified in the Table. If so, the injury is presumed to
have been caused by the vaccination, and the petitioner is entitled to
compensation (assuming that other Vaccine Act 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)).
Revisions to the Table are authorized under 42 U.S.C. 300aa-14(c)
and (e). Prior to the 21st Century Cures Act (Cures Act) (Pub. L. 114-
255), the only vaccines covered under the VICP were those recommended
by the CDC for routine administration to children (for example,
vaccines that protect against seasonal influenza), are subject to an
excise tax by Federal law, and added to the Table by the Secretary. The
Table currently includes 17 vaccine categories, with 16 categories for
specific vaccines, as well as their corresponding illness, disability,
injury, or condition covered, and the requisite time within which the
first symptom or manifestation of onset or significant aggravation must
begin after the vaccine administration to receive the Table's legal
presumption of causation. One category of the Table, ``Item XVII,''
includes, ``Any new vaccine recommended by the Centers for Disease
Control and Prevention for routine administration to children, after
publication by the Secretary of a notice of coverage.'' Two injuries--
Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal
syncope--are listed as associated injuries for this category. Through
this general category, new vaccines recommended by the CDC for routine
administration to children and subject to an excise tax are covered
under the VICP prior to being added to the Table as a separate vaccine
category.
The Cures Act amended 42 U.S.C. 300aa-14(e) to expand the types of
vaccines covered under the VICP. See section 3093(c)(1) of the Cures
Act. The amended statute requires that the Secretary revise the Table
to include vaccines recommended by the CDC for routine administration
in pregnant women (and subject to an excise tax by Federal law). See 42
U.S.C. 300aa-14(e)(3). This action does not alter the current status
quo because the CDC has not recommended any categories of vaccines for
routine administration to pregnant women that are not also recommended
for routine administration to children.
Summary of the Final Rule
As discussed in the NPRM (83 FR 14391), Congress enacted a
mechanism for modification of the Table, through the promulgation of
regulatory changes by the Secretary after consultation with the
Advisory Commission on Childhood Vaccines (ACCV). The Secretary is
revising the Table to include new vaccines recommended by the CDC for
routine administration in pregnant women in Item XVII of the Table. On
September 8, 2017, the Program consulted the ACCV regarding options for
adding this new category of vaccines to the Table. The ACCV voted
unanimously to amend the existing language in Item XVII of the Table to
add ``and/or pregnant women'' after ``children'' authorizing coverage
under the VICP of any new vaccine recommended by CDC for routine
administration in pregnant women (and subject to an excise tax) after
the publication of a notice of coverage. The ACCV viewed this option as
a simple approach to revising the Table, rather than adding a new
general Item XVIII to the Table for vaccines recommended for routine
administration in pregnant women. Therefore, following the ACCV's
recommendation, the Secretary has amended the existing language in Item
XVII of the Table to add ``and/or pregnant women'' after ``children.''
This amendment allows any new vaccine recommended by the CDC for
routine administration in pregnant women (and subject to an excise tax)
to be added to this general category of the Table after the Secretary
publishes a notice of coverage. The publication of a notice of coverage
reflects the Secretary's approval of CDC's recommendation and the
determination that the statutory requirements for coverage under the
VICP have been met.
The Secretary also has retained the two injuries currently
associated with Item XVII of the Table, SIRVA and vasovagal syncope, as
Table injuries for vaccines recommended by the CDC for routine
administration in pregnant women. In its 2012 Report, ``Adverse Effects
of Vaccines: Evidence and Causality,'' the Institute of Medicine
considered SIRVA and vasovagal syncope as mechanistic injuries
resulting from the injection of a vaccine and not from the contents of
a particular formulation of a vaccine. Thus, these conditions are
listed as Table injuries for any new vaccine recommended by the CDC for
routine administration to children (after the imposition of an excise
tax and publication by the Secretary of a notice of coverage) to
account for any new injected vaccines that potentially may lead to
SIRVA or vasovagal syncope. Therefore, the Secretary also has included
these injuries on the Table for new vaccines recommended by the CDC for
routine administration in pregnant women.
VICP petitions must be filed within the applicable statutes of
limitations. With the Table change, the general statutes of limitations
applicable to petitions filed with the VICP, set forth in 42 U.S.C.
300aa-16(a), continue to apply. The alternate statute of limitations
afforded by 42 U.S.C. 300aa-16(b) does not apply to this Table change.
This is because, at present, there are no vaccines added to the Table
under the revised general category, since the only vaccines the CDC
currently recommends for routine administration in pregnant women are
already covered on the Table. In the future, when any new vaccine, not
already covered under the VICP, is recommended by the CDC for routine
administration in pregnant women, subject to an excise tax, and added
to the Table, the alternate statute of limitations afforded by 42
U.S.C. 300aa-16(b) would apply if certain requirements are met.\1\
---------------------------------------------------------------------------
\1\ Under 42 U.S.C. 300aa-16(b), the alternate statute of
limitations applies where the effect of the revision would make an
individual, who was not eligible before the revision, eligible to
seek compensation under the Program or to significantly increase the
individual's likelihood of obtaining compensation.
---------------------------------------------------------------------------
II. Responses to Public Comments
The NPRM provided a 180-day comment period (April 4, 2018-October
1, 2018), and HRSA received 51 comments during that time, including
during a public hearing. There were 48 written comments submitted. The
[[Page 68425]]
number and sources of the comments are as follows: 44 from individuals,
two from pharmaceutical companies, and two from organizations, with one
stating it represents 12 other entities. In addition, HRSA held a
public hearing on the NPRM on September 17, 2018, and a national
organization and two individuals presented oral comments.
While the Secretary only sought public comment on how best to
implement the statutory amendment to add vaccines recommended by the
CDC for routine administration in pregnant women to the Table, many
commenters offered comments beyond the scope of the request.
Nevertheless, the Secretary carefully considered all 51 comments
received in the development of this final rule. Below is a summary of
the comments and the Secretary's response to them.
Comment: Several comments supported the addition of vaccines
recommended for routine administration in pregnant women to the Table,
stating that maternal immunization will improve the health of the
mother, her unborn child, newborns, and the overall health of the
nation.
Response: Based on existing evidence and data trends, the Secretary
agrees that the eradication and reduction of vaccine-preventable
diseases through immunization has directly increased life expectancy by
reducing mortality. Pregnant women are at risk for vaccine-preventable
disease-related morbidity and mortality and adverse pregnancy outcomes,
including congenital anomalies, spontaneous abortion, preterm birth,
and low birth weight. In addition to providing direct maternal benefit,
vaccination during pregnancy likely provides direct fetal and infant
benefit through passive immunity (transplacental transfer of maternal
vaccine-induced antibodies). Among the vaccines recommended by the CDC
for adults, currently, two are specifically recommended for routine
administration during pregnancy, and hepatitis A, hepatitis B,
meningococcal (ACWY), and meningococcal (B) are recommended in
pregnancy based on additional risk factors.
Comment: A comment supporting the proposed changes in the NPRM
suggests that the recommendations of the CDC should be included as
additional language on the Table, supporting the safe administration of
vaccines in pregnant women.
Response: The Table does not include language about the safe
administration of vaccines, as the purpose of the Table is to list and
explain injuries and/or conditions that are presumed to be caused by
covered vaccines, unless another cause is proven, for potential
compensation under the VICP. However, CDC develops best practice
guidance for the safe administration of vaccines that can be found at
https://www.cdc.gov/vaccines/hcp/acip-recs/.
Comment: Comments supporting the proposed changes in the NPRM
indicated that the CDC recommendations for the administration of
routine vaccination to pregnant women would result in increased
communication and knowledge around vaccines recommended for pregnant
women, leading to increased informed consent and facilitate decision-
making regarding immunizations. In addition, this may result in the
development of new vaccines for pregnant women.
Response: Recommendations for the routine use of vaccines in
pregnant women are issued by the CDC and are harmonized to the greatest
extent possible with recommendations made by the American College of
Gynecologists and Obstetricians, the American Academy of Family
Physicians, and the American College of Physicians. The Advisory
Committee on Immunization Practices, established in 1964 by the Surgeon
General of the United States, is chartered as a Federal advisory
committee to provide expert external advice and guidance to the
Director of the CDC on the use of vaccines in the civilian population.
The Advisory Committee on Immunization Practices makes recommendations
to the Director of the CDC for vaccines authorized or licensed by the
Food and Drug Administration for the prevention of diseases. Providing
information regarding whether these recommendations increase
communication and knowledge around vaccines recommended for pregnant
women, and facilitating decision-making regarding immunizations, is
beyond the scope of this final rule.
Comment: Some comments supporting the proposed changes in the NPRM
suggested that adding the category of pregnant women to the Table would
allow the VICP to function more efficiently and pregnant women would
have recourse should an alleged injury occur.
Response: The Secretary agrees that the addition of the category of
vaccines recommended for routine administration in pregnant women to
the Table will make the VICP function more efficiently. The addition of
such vaccines to Item XVII of the Table will allow any new vaccines
that in the future are recommended by the CDC for routine
administration in pregnant women (and subject to an excise tax) to be
covered under the VICP after the Secretary issues a notice of coverage,
without requiring further rulemaking.
In addition, the Table lists covered vaccines and associated
injuries, making it easier for some people to get compensation. The
Table lists and explains injuries and/or conditions that are presumed
to be caused by vaccines unless another cause is proven. The Table's
Qualification and Aids to Interpretation define some of the injuries
and/or conditions listed on the Table. The Table also lists periods in
which the first symptom of these injuries and/or conditions must occur
after receiving the vaccine to receive the Table's presumption of
causation. If the first symptom of an injury and/or condition listed on
the Table occurs within the listed time, and any associated
definition(s) included in the Qualification and Aids to Interpretation
are satisfied, it is presumed that the vaccine was the cause of the
injury or condition unless another cause is proven.
Comment: Several comments opposed the proposed changes in the NPRM
because they stated that the administration of vaccines to pregnant
women and their unborn children causes injuries, such as miscarriages,
pre-eclampsia, cancer, autism, neurodevelopmental disorders of infants,
and learning disabilities. Some opposed the addition of the category of
pregnant women to the Table because they believe that there is a lack
of vaccine safety testing and studies, especially regarding the
administration of vaccines in pregnant women. Some comments suggested
there is no scientific evidence that vaccinating pregnant women is safe
or advantageous and that there are limited benefits and increased risks
for vaccinating pregnant women. In addition, some adamantly opposed all
vaccinations.
Response: As noted in the NPRM, a recent amendment to the Vaccine
Act requires that the Secretary revise the Table to include vaccines
recommended by the CDC for routine administration in pregnant women
(and subject to an excise tax by Federal law). See 42 U.S.C. 300aa-
14(e)(3).
Moreover, the United States has a long-standing vaccine safety
program that closely and constantly monitors the safety of vaccines. A
critical part of the vaccine safety program is the CDC's Immunization
Safety Office, which identifies possible vaccine side effects and
conducts studies to determine whether health problems are caused by
vaccines. Information regarding vaccine
[[Page 68426]]
safety and current research are available by conducting literature
reviews.
Pregnant women are at risk for vaccine-preventable disease-related
morbidity and mortality and adverse pregnancy outcomes, including
congenital anomalies, spontaneous abortion, preterm birth, and low
birth weight. In addition to providing direct maternal benefit,
vaccination during pregnancy may provide direct fetal and infant
benefit through passive immunity (transplacental transfer of maternal
vaccine-induced antibodies).
Existing evidence and data trends indicate that the eradication and
reduction of vaccine-preventable diseases through immunization has
directly increased life expectancy by reducing mortality. In addition,
numerous published and peer-reviewed scientific studies have found that
neither vaccines nor vaccine ingredients cause the neurodevelopmental
disorders of autism, Attention-Deficit/Hyperactivity Disorder, or
speech or language delay.
Comment: Some comments opposing the proposed changes in the NPRM
stated that pregnant women are often coerced or forced to be vaccinated
without being given information about possible vaccine side effects to
themselves and/or their unborn child/children.
Response: This final rule does not require vaccines for pregnant
women. However, the CDC and the American Academy of Pediatrics, as well
as other medical organizations, publish information regarding the
safety of recommended vaccines. In addition, Vaccine Information
Statements, which are information sheets produced by the CDC that
explain both the benefits and risks of VICP-covered vaccines, are
required to be provided to all individuals, or their legal
representatives, before receiving such vaccines. However, the decision
to ultimately be vaccinated rests with the individual or legal
representative.
Comment: Some comments opposing the NPRM stated that by
recommending vaccines to pregnant women, liability protection is
conferred upon vaccine manufacturers and that this creates a
disincentive to conduct safety research on vaccines. Some stated a
belief that the addition of pregnant women will now eliminate the
pregnant woman's right to sue for damages.
Response: The Vaccine Act created the VICP, a no-fault alternative
to the traditional tort system. It provides compensation to people
thought to be injured by vaccines recommended by the CDC for routine
administration to children and now pregnant women. When a vaccine is
added to the Vaccine Injury Table, it is covered under the VICP. To
help ensure a stable vaccine supply, the VICP generally provides
liability protection for vaccine manufacturers and health care
providers for injuries caused by VICP-covered vaccines. Claims alleging
injuries or death from certain vaccines generally must be filed with
the VICP before a lawsuit can be filed in civil court.
Comment: Some comments opposed the addition of the category of
vaccines recommended for routine administration in pregnant women to
the Table, as this would provide vaccine manufacturers the ability to
increase revenue by having a new population to target with their
products.
Response: As noted previously, the Secretary is required by statute
to revise the Table to include vaccines recommended by the CDC for
routine administration in pregnant women (and subject to an excise tax
by Federal law). See 42 U.S.C. 300aa-14(e)(3).
Comment: Some comments opposing the change proposed in the NPRM
suggested that the VICP be eliminated.
Response: The Vaccine Act established the VICP, and Congress would
need to enact legislation to eliminate the VICP. Eliminating the
Program is beyond the scope of this final rule.
Comment: Some comments supporting and opposing the changes proposed
in the NPRM suggested additional changes to the Table, such as adding
injuries to the Table. Commenters opposing changes proposed in the rule
stated that vaccines cause miscarriages and other conditions, such as
chorioamnionitis, encephalitis/encephalopathy, Guillain-Barr[eacute]
Syndrome, and neurodevelopmental disorders, and can negatively affect
the offspring of pregnant women who have undiagnosed genetic disorders.
Some commenters requested that the Table be revised or expanded to
include all vaccines that could be recommended in pregnancy and their
potential complications, and vaccines contraindicated during pregnancy,
including statistics of complications.
Response: Consistent with the statutory requirement, the Secretary
is revising the Table to include new vaccines recommended by the CDC
for routine administration in pregnant women. The Secretary is
implementing this change by amending the existing language in Item XVII
of the Table to include ``and/or pregnant women'' after ``children.''
This will add to that general category of the Table, any new vaccine
recommended by the CDC for routine administration in pregnant women,
after imposition of an excise tax and publication of a notice of
coverage by the Secretary.
As explained above, in its 2012 Report, ``Adverse Effects of
Vaccines: Evidence and Causality,'' the Institute of Medicine
considered SIRVA and vasovagal syncope as mechanistic injuries
resulting from the injection of a vaccine and not from the contents of
a particular formulation of a vaccine. Thus, these conditions are
listed as Table injuries for any new vaccine recommended by the CDC for
routine administration to children or pregnant women (after the
imposition of an excise tax and publication by the Secretary of a
notice of coverage) to account for any new injected vaccines that
potentially may lead to SIRVA or vasovagal syncope. In the future, when
specific vaccines recommended for routine administration in pregnant
women are added to the Table, the Secretary will review the literature
to determine if other injuries should be added to the Table for those
new vaccines.
Comment: Comments supporting and opposing the proposed change in
the NPRM speculated that there is the potential for increased
compensation for adverse reactions resulting from increased injury
claims, as both the mother and her unborn child are now eligible to
file a claim for a vaccine related injury. Commenters expressed concern
with possible abuse in reporting and compensation, compounded by the
addition of SIRVA and vasovagal syncope as injuries to the Table.
Response: The Secretary is required by statute to revise the Table
to include vaccines recommended by the CDC for routine administration
in pregnant women (and subject to an excise tax by Federal law). See 42
U.S.C. 300aa-14(e)(3). Additionally, with respect to vaccination of
pregnant women, the Cures Act permits two VICP petitions to be filed:
One on behalf of a woman who was pregnant when vaccinated and one on
behalf of her live-born child whose injury(s) was allegedly sustained
in utero. See 42 U.S.C. 300aa-11(b)(2).
Comment: A commenter questioned who would be the proper petitioner
in the context of maternal immunization (i.e., would the petitioner be
the pregnant woman, the child born after his/her pregnant mother was
vaccinated, or both?).
Response: The Cures Act amended the Vaccine Act to permit VICP
claims filed on behalf of live-born children for injuries allegedly
sustained in utero as a result of maternal immunizations with respect
to covered vaccines. See 42
[[Page 68427]]
U.S.C. 300aa-11(f). In addition, the Cures Act modified the Vaccine
Act's ``one petition'' requirement by allowing two VICP petitions: One
on behalf of a woman who was pregnant when vaccinated and one on behalf
of her child whose injury(s) was allegedly sustained in utero. See 42
U.S.C. 300aa-11(b)(2).
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 substantial additional administrative
and compensation resources are required to implement the requirements
in this rule. Compensation will be made in the same manner. As in all
other VICP cases, to be found entitled to compensation, petitioners
will need to prove by a preponderance of the evidence either that they
meet the requirements of the Table or that their injury was caused by
the vaccine unless the respondent affirmatively shows that the injury
was caused by some factor other than the vaccination. Therefore, in
accordance with the Regulatory Flexibility Act of 1980 (RFA), and the
Small Business Regulatory Enforcement Act of 1996, which amended the
RFA, the Secretary certifies that this rule will not have a significant
impact on a substantial number of small entities.
The National Vaccine Injury Compensation Program: Adding the
Category of Vaccines Recommended for Pregnant Women to the Vaccine
Injury Table Final Rule is ``not significant'' because no substantial
resources are required to implement the requirements in this rule. This
rule adds ``and/or pregnant women'' to the new vaccines category (Item
XVII) on the Table. Currently, the only vaccines recommended for
routine administration in pregnant women are already on the Table
because they are recommended for routine administration to children and
have an excise tax imposed on them. Therefore, this final rule does not
have a significant impact on a substantial number of small entities.
Additionally, this rule does not meet the criteria for a major rule as
defined by Executive Order 12866 and would have no major effect on the
economy or Federal expenditures. We have determined that the final rule
is not a ``major rule'' within the meaning of the statute providing for
Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it
will not have effects on state, local, and tribal governments and on
the private sector such as requiring consultation under the Unfunded
Mandates Reform Act of 1995.
The provisions of this final rule do not, on the basis of family
well-being, 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.
This final rule is not being treated as a ``significant regulatory
action'' as defined under section 3(f) of Executive Order 12866. As
stated above, this final rule will modify the Table based on legal
authority.
Impact of the New Rule
This final rule will allow any vaccines that in the future are
recommended by the CDC for routine administration to pregnant women and
subject to an excise tax to be covered under the VICP after the
Secretary issues a notice of coverage, without requiring further
rulemaking. In addition, this final rule will have the effect of making
it easier for future petitioners alleging injuries that meet the
criteria in the Vaccine Injury Table to receive the Table's presumption
of causation, which relieves them of having to prove that the vaccine
actually caused or significantly aggravated their injury.
Paperwork Reduction Act of 1995
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
Xavier Becerra,
Secretary, Department of Health and Human Services.
Accordingly, 42 CFR part 100 is amended as set forth below:
PART 100--VACCINE INJURY COMPENSATION
0
1. The authority citation for 42 CFR part 100 continues to read as
follows:
Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C.
300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a);
and sec. 13632(a)(3) of Public Law 103-66.
0
2. In Sec. 100.3, amend the Table in paragraph (a) by revising entry
``XVII'' to read as follows:
Sec. 100.3 Vaccine injury table.
(a) * * *
Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
Time period for first symptom or
Illness, disability, manifestation of onset or of
Vaccine injury, or condition significant aggravation after vaccine
covered administration
----------------------------------------------------------------------------------------------------------------
* * * * * * *
XVII. Any new vaccine recommended by the A. Shoulder Injury Related <=48 hours.
Centers for Disease Control and Prevention to Vaccine Administration. ......................................
for routine administration to children and/ B. Vasovagal syncope....... <=1 hour.
or pregnant women, after publication by
the Secretary of a notice of coverage.
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[[Page 68428]]
* * * * *
[FR Doc. 2021-26197 Filed 12-1-21; 8:45 am]
BILLING CODE 4150-28-P
