Rule2021-26197
National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
Primary source
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Published
December 2, 2021
Effective
January 3, 2022
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 229 (Thursday, December 2, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26197]
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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.
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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\
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\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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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
<a href="https://www.cdc.gov/vaccines/hcp/acip-recs/index.html">https://www.cdc.gov/vaccines/hcp/acip-recs/index.html</a>.
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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.