[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]


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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 
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 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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[FR Doc. 2021-26197 Filed 12-1-21; 8:45 am]
BILLING CODE 4150-28-P