[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Proposed Rules]
[Pages 43794-43805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15673]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AB24
National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Secretary proposes to amend the Vaccine Injury Table
(Table) by regulation. The proposed regulation will have effect only
for petitions for compensation under the National Vaccine Injury
Compensation Program (VICP) filed after the final regulations become
effective. HHS is seeking public comment on the proposed revisions to
the Table.
DATES: Written comments and related material to this proposed rule must
be received to the online docket via www.regulations.gov on or before
January 12, 2021.
ADDRESSES: Comments must be identified by HHS Docket No. HRSA-2020-
0002. Because of staff and resource limitations, comments must be
submitted electronically to www.regulations.gov. Follow the ``Submit a
comment'' instructions.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including personally identifiable or confidential business information
that is included in a comment. You may wish to consider limiting the
amount of personal information that you provide in any voluntary public
comment submission you make. HHS may withhold information provided in
comments from public viewing that it determines may impact the privacy
of an individual or is offensive. For additional information, please
read the Privacy Act notice that is available via the link in the
footer of http://www.regulations.gov.
Follow the search instructions on that website to view the public
comments.
FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine
Injury Compensation Program's website, https://www.hrsa.gov/vaccinecompensation/, or contact Tamara Overby, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at
[email protected]; or by telephone at (855) 266-2427.
SUPPLEMENTARY INFORMATION: This is a notice of proposed rulemaking by
which HHS proposes to amend the provisions of 42 CFR 100.3 by removing
Shoulder Injury Related to Vaccine Administration, vasovagal syncope,
and Item XVII from the Vaccine Injury Table.
I. Public Participation
All interested parties are invited to participate in this
rulemaking by submitting written views, comments and arguments on all
aspects of this proposed rule, as well as additional data that should
be considered. HHS also invites comments that relate to the economic,
legal, environmental, or federalism effects that might result from this
proposed rule. Comments that will provide the most assistance to HRSA
in implementing these changes will reference a specific portion of the
proposed rule, explain the reason for any recommended change, and
include data, information, or authority that supports such recommended
change.
A public hearing on this proposed rule will be held before the end
of the public comment period. A separate document will be published in
the Federal Register providing details of this hearing. Subject to
consideration of the comments received, the Secretary intends to
publish a final regulation.
Instructions: If you submit a comment, you must include the agency
name and the HHS Docket No. HRSA-2020-0002 for this rulemaking. All
submissions will be posted, without change, to the Federal eRulemaking
Portal at http://www.regulations.gov, and will include any personal
information you provide. Therefore, submitting this information makes
it public. You may wish to consider limiting the amount of personal
information that you provide in any voluntary public comment submission
you make to HHS. HHS may withhold information provided in comments from
public viewing that it determines may impact the privacy of an
individual or is offensive. For additional information, please read the
Privacy Act notice that is available via the link in the footer of
http://www.regulations.gov.
II. Background and Purpose
Vaccination is one of the best ways to protect against potentially
harmful diseases that can be very serious, may require hospitalization,
or even be deadly. Almost all individuals who are vaccinated have no
serious reactions.\1\ Nonetheless, in the 1980s, Congress became
concerned that a small number of children who received immunizations
had serious reactions to them, and it was not always possible to
predict which children would have reactions, or what reactions they
would have.\2\ Claimants alleging vaccine-related injuries in civil
litigation encountered a time-consuming, expensive, and often
inadequate system.\3\ Moreover, increased litigation against vaccine
manufacturers resulted in difficulties in their ability to secure
affordable product liability insurance, stabilize vaccine prices and
supply, and enter the market.\4\
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\1\ National Vaccine Injury Compensation Program, Health
Resources & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/index.html (last reviewed Jan. 2020).
\2\ H.R. Rep. No. 99-908, pt. 1, at 6 (1986). Even though in
rare instances individuals may have adverse reactions to vaccines,
the Centers for Disease Control and Prevention (CDC) recommends that
individuals be vaccinated against a wide range of illnesses and
diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control
& Prevention, https://www.cdc.gov/vaccines/vpd/vaccines-age.html
(last reviewed Nov. 22, 2016).
\3\ H.R. Rep. No. 99-908, at 6.
\4\ See id. at 4-6.
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Therefore, Congress enacted the National Childhood Vaccine Injury
Act of 1986, title III of Public Law 99-660 (42 U.S.C. 300aa-1 et seq.)
(Vaccine Act), which established the National Vaccine Injury
Compensation Program (VICP). The objectives of the VICP are to ensure
an adequate supply of vaccines, stabilize vaccine costs, and establish
and maintain an accessible and efficient forum for individuals found to
be injured by certain vaccines to be federally compensated. Petitions
for compensation under the VICP are filed
[[Page 43795]]
in the United States Court of Federal Claims (Court), rather than the
civil tort system, with a copy served on the Secretary, who is the
Respondent. The U.S. Department of Justice (DOJ) represents HHS in
Court, and the Court, acting through judicial officers called Special
Masters, makes the final decision as to eligibility for, and the type
and 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 what is referred to as a ``Table injury.'' That is, a
petitioner may show that the vaccine recipient (1) received a vaccine
covered under the Act; (2) suffered an injury of the type enumerated in
the regulations at 42 CFR 100.3-the ``Vaccine Injury Table'' (Table)--
corresponding to the vaccination in question; and (3) that the onset of
such injury took place within the time period specified in the Table.
If so, the injury is presumed to have been caused by the vaccine, and
the petitioner is entitled to compensation (assuming that other
requirements are satisfied), unless the respondent affirmatively shows
that the injury was caused by some factor unrelated to the vaccination
(see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-
14(a)).
42 U.S.C. 300aa-14(c) and (e) permit the Secretary to revise the
Table. The Table currently includes 17 vaccine categories, with 16
categories for specific vaccines, as well as the corresponding
illnesses, disabilities, injuries, or conditions covered, and the
requisite time period when the first symptom or manifestation of onset
or of significant aggravation after the vaccine administration must
begin to receive the Table's legal presumption of causation. The final
category of the Table, ``Item XVII,'' includes ``[a]ny new vaccine
recommended by the Centers for Disease Control and Prevention for
routine administration to children, after publication by the Secretary
of a notice of coverage.'' \5\ 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 deemed covered under the VICP
prior to being added to the Table as a separate vaccine category
through Federal rulemaking.
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\5\ 42 CFR 100.3(a).
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On January 19, 2017, the Department issued a final rule amending
the Table (Final Rule) that, among other things, added SIRVA and
vasovagal syncope to the Table. 85 FR 6294. That Final Rule was
scheduled to take effect on February 21, 2017. A notice published in
the Federal Register delayed the effective date until March 21, 2017.
82 FR 11321. The Final Rule followed a 2012 Institute of Medicine (IOM)
\6\ report, ``Adverse Effects of Vaccines: Evidence and Causality;''
the work of nine HHS workgroups that reviewed the IOM findings; and
consideration of the Advisory Commission on Childhood Vaccines' (ACCV)
recommendations.
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\6\ The IOM is now known as the National Academy of Medicine.
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The Department now proposes to remove SIRVA and vasovagal syncope
from the Table found at 42 CFR 100.3(a) and to remove the corresponding
descriptions of those injuries--``Qualifications and Aids to
Interpretation'' (QAI)--from 42 CFR 100.3(c). This proposal is based
upon a review of the relevant statutory provisions and the scientific
literature, as well as the Department's experience since SIRVA and
vasovagal syncope were added to the Table. The Department also proposes
to remove Item XVII from the Table found at 42 CFR 100.3(a), because
the Department has serious concerns that Item XVII is contrary to
applicable law, for the reasons set forth below.
Scientific Literature Concerning SIRVA and Vasovagal Syncope
The scientific literature indicates that SIRVA likely results from
poor vaccination technique, rather than the vaccine or its components
alone. The notice of proposed rulemaking that preceded the Final Rule
characterized SIRVA as an ``adverse event following vaccination thought
to be related to the technique of intramuscular percutaneous injection
(the procedure where access to a muscle is obtained by using a needle
to puncture the skin) into an arm resulting in trauma from the needle
and/or the unintentional injection of a vaccine into tissues and
structures lying underneath the deltoid muscle of the shoulder.'' \7\
The IOM similarly concluded that ``the injection, and not the contents
of the vaccine, contributed to the development of deltoid bursitis.''
\8\ Indeed, the primary case series relied upon by the Department in
promulgating the proposed rule and Final Rule found that the medical
literature supports the possibility that SIRVA may result from
inappropriate needle length and/or injection technique.\9\ There is
nearly uniform agreement in the scientific community that SIRVA is
caused by improper vaccine administration, rather than by the vaccine
itself.\10\ Since the Final Rule was promulgated, additional scientific
research concluded that subdeltoid or subacromial bursitis and other
shoulder lesions are ``more likely to be the consequence of a poor
injection technique (site, angle, needle size, and failure to take into
account [a] patient's characteristics, i.e., sex, body weight, and
physical constitution),'' rather than ``antigens or adjuvants contained
in the vaccines that would trigger an immune or inflammatory
response.'' \11\
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\7\ National Vaccine Injury Compensation: Revision to the
Vaccine Injury Table (``2015 Proposed Rule''), 80 FR 45132, 45136
(July 29, 2015) (emphasis supplied); see also Adverse Effects of
Vaccines: Evidence and Causality (``IOM Report''), at 620, available
at https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality.
\8\ IOM Report at 620. SIRVA is a medicolegal term, not a
medical diagnosis, that is meant to capture a broad array of
potential shoulder injuries. However the IOM only made findings
concerning deltoid bursitis.
\9\ Atanasoff S, Ryan T, Lightfoot R, and Johann Liang R, 2010,
Shoulder injury related to vaccine administration (SIRVA), Vaccine
28(51): 8049-52 (recommending that injections avoid the top third of
the deltoid muscle to avoid shoulder injury).
\10\ See Barnes MG, Ledford C, Hogan K. A ``needling'' problem:
Shoulder injury related to vaccine administration. J Am Board Fam
Med. 2012 Nov-Dec; 25(6):919-22; Cross GB, Moghaddas J, Buttery J,
Ayoub S, Korman TM. Don't aim too high: Avoiding shoulder injury
related to vaccine administration. Aust Fam Physician. 2016 May;
45(5):303-6.
\11\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil,
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries
and dysfunctions of the shoulder following vaccinations, Vaccine,
2017; 35: 4870-4876. See also Bancsi A, Houle SKD, Grindrod KA.
Shoulder injury related to vaccine administration and other
injection site events. Can. Fam. Physician. 2019 Jan; 65(1): 40-42
(explaining that SIRVA ``is a preventable occurrence caused by the
injection of a vaccine into the shoulder capsule rather than the
deltoid muscle''); Macomb CV, Evans MO, Dockstater JE, Montgomery
JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections:
A Case Series. Mil Med. 2019 Oct 17 (noting that SIRVA does not
occur unless the vaccine is mistakenly given in the shoulder
capsule). Another recent study reviewed the Vaccine Adverse Event
Reporting System (VAERS) database from July 2010 to June 2017 for
reports of atypical shoulder pain and dysfunction following
injection of inactivated influenza vaccine (IIV). See B. F. Hibbs,
C. S. Ng, O. Museru et al., Reports of atypical shoulder pain and
dysfunction following inactivated influenza vaccine, Vaccine Adverse
Event Reporting System (VAERS), 2010-2017, Vaccine. The review found
that, of the 266 reports where contributing factors for the injury
were reported, 216 (81.2%) described the vaccination as being given
``too high'' on the arm. Other reports described improper or poor
administration technique (e.g., bone strikes, ``administered in
tendon''), uneven position between vaccinator and the patient (e.g.,
vaccinator standing while patient sitting), vaccination needle too
long, and others (e.g., difficulty injecting vaccine). A small
minority of reports also indicated the patient had a history of
thyroid dysfunction or diabetes.
It is possible that certain injuries characterized as SIRVA
occur when an immunologically active substance designed to trigger
an inflammatory response (i.e., the vaccine antigen) is injected
into an area where the inflammatory response can cause joint damage
(i.e., the bursa or tendons) as opposed to an area where the
inflammatory response will not cause joint damage or permanent harm
(i.e., the deltoid muscle). Such injuries are fairly characterized
as resulting from the vaccination technique, since they would not
have occurred if the injection occurred in the proper part of the
body.
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[[Page 43796]]
The scientific literature also indicates that vasovagal syncope
results from the act of injection, rather than the vaccine or its
components. Vasovagal syncope is the loss of consciousness (fainting)
caused by a transient decrease in blood flow to the brain.\12\ In
proposing the addition of vasovagal syncope to the Table, the
Department noted that the IOM found that syncope did not result from
any particular antigen, but instead from the act of the injection.\13\
The scientific literature suggests that those administering vaccines
can take steps to significantly reduce the likelihood of injury from
vasovagal syncope, such as having the patient sit or lie down for the
vaccination, and observing the patient for 15 to 20 minutes after
administering the vaccine.\14\
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\12\ 82 FR 6294-01, 6304 (Jan. 19, 2017).
\13\ 80 FR 45137 (The IOM found that one case report suggested
that ``the injection, and not the contents of the vaccine,
contributed to the development of syncope''). See also IOM Report at
18 (``injection of vaccine, independent of the antigen involved, can
lead to'' syncope).
\14\ Miller, E. and Woo, E.J. 2006 Time to prevent injuries from
postimmunization syncope, Nursing, 36 (12): 20; Braun, M.,
Patriarca, P., and Ellenberg, S. Syncope After Immunization, Arch.
Pediatr. Adolesc. Med. 1997; 151: 255-259.
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Reasons for Removal of SIRVA and Vasovagal Syncope
The Department has concluded that several reasons merit removal of
SIRVA and vasovagal syncope from the Table found at 42 CFR 100.3(a),
and to correspondingly remove the descriptions of those injuries from
the QAI found at 42 CFR 100.3(c).
First, the Department has concluded that the Vaccine Act should be
read as not applying to cover injuries, like SIRVA and vasovagal
syncope, which involve negligence by the vaccine administrator. At
best, the Vaccine Act is ambiguous in how it handles such injuries, and
in the Department's view there are strong reasons to exclude them from
coverage under the Act's compensation scheme.
The Act creates a compensation program ``for a vaccine-related
injury or death.'' 42 U.S.C. 300aa-11(a)(1). Under the Act, ``only . .
. a person who has sustained a vaccine-related injury or death'' can
recover. 42 U.S.C. 300aa-11(a)(9). The Act defines ``[v]accine-related
injury or death'' as ``an illness, injury, condition, or death
associated with one or more of the vaccines set forth in the Vaccine
Injury Table, except that the term does not include an illness, injury,
condition, or death associated with an adulterant or contaminant
intentionally added to such a vaccine.'' 42 U.S.C. 300aa-33(5)
(emphasis added); see also Dean v. HHS, No. 16-1245V, 2018 WL 3104388,
at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018) (defining ``vaccine'' as
```any substance designed to be administered to a human being for the
prevention of 1 or more diseases''') (quoting 26 U.S.C. 4132(a)(2)).
Thus, the compensation program covers injuries ``associated with'' the
vaccine itself.
SIRVA is, of course, not a vaccine, and it is not an injury caused
by a vaccine antigen, but by administration of the vaccine by the
health care provider. The Department does not think the term
``associated with'' was meant to sweep in injuries caused by negligent
administration of the vaccine. Although the Act permits petitioners to
recover for Vaccine Table injuries without demonstrating causation in
individual cases, the term ``associated with'' nevertheless requires
that the injury, in general, be causally related to the vaccine itself.
This is clear both from dictionary definitions of ``associated,'' which
means ``related, connected, or combined together'' (Merriam-Webster.com
Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/associated. Accessed 10 Jul. 2020), and from the text of the
Act itself, see, e.g., 42 U.S.C. 300aa-22(b)(1) (focusing on injuries
that ``resulted'' from vaccine side effects); 42 U.S.C. 300aa-
13(a)(1)(B) & (2)(B) (excluding ``trauma'' that has ``no known relation
to the vaccine involved''). Importantly, in the key operative
provisions discussed above, the phrase ``associated with'' is linked to
the vaccine itself, not to the technique in administering the vaccine.
See Decker v. Nw. Envtl. Def. Ctr., 568 U.S. 597, 611 (2013) (in
interpreting phrase ``associated with industrial activity,'' the key
consideration is the scope of ``industrial activity''; the ``statute
does not foreclose a more specific definition by the agency'' and ``a
reasonable interpretation . . . could . . . require the discharges to
be related in a direct way to operations at `an industrial plant' '');
Chevron, U.S.A., Inc. v. Nat. Resources Def. Council, Inc., 467 U.S.
837, 861 (1984) (``[T]he meaning of a word must be ascertained in the
context of achieving particular objectives, and the words associated
with it may indicate that the true meaning of the series is to convey a
common idea.'').
That basic requirement is not met with SIRVA and vasovagal syncope.
While the act of being vaccinated may be a but-for cause of those
injuries, the injury is not associated with the vaccine itself because,
with proper administration technique, those injuries will not result
from the vaccine. Rather, SIRVA and vasovagal syncope result from the
use of improper--that is, negligent--administration technique.
Furthermore, to the extent there is ambiguity about the scope of
injuries encompassed by the phrase ``associated with,'' this reading,
grounded in tort law principles, better achieves the Act's objectives
for the reasons below.
There are several indicators in the language and structure of the
Vaccine Act that show it was not meant to cover negligent
administration of the vaccine. First, as the Federal Circuit has
explained, troubling issues arise if the Act were to apply to
``negligence facially unrelated to the vaccine's effects.'' Amendola v.
Sec., Dept. of Health & Human Servs., 989 F.2d 1180, 1187 (Fed. Cir.
1993). It could include, for example, ``the doctor's negligent dropping
of an infant patient'' or use of contaminated equipment. Id. at 1186-
87. The better reading of the statute is that it does not reach this
far.
Second, the definition of vaccine-related injury carves out ``an
adulterant or contaminant intentionally added to such a vaccine. 42
U.S.C. 300aa-33(5) (emphasis added). By excluding from the definition
those injuries associated with an adulterant or contaminant
intentionally added to the vaccine, Congress indicated its intent to
permit suit only where the injury was caused by the components of the
vaccine itself, not individual fault. Relatedly, in the provisions
setting forth the standard for awarding compensation, Congress
specified that an award is not appropriate when injury was ``due to
factors unrelated to the administration of the vaccine,'' and further
defined that phrase to include ``trauma . . . which have no known
relation to the vaccine involved.'' 42 U.S.C. 300aa-13(a)(1)(B) &
(2)(B). In other words, Congress excluded compensation for injuries
that were not related ``to the vaccine involved.''
Third, the statutory scheme requires that the patient ``received a
vaccine set forth in the Vaccine Injury Table,'' 42
[[Page 43797]]
U.S.C. 300aa-11(c)(1)(A), tying compensation to the receipt of a
specific listed vaccine. See 42 U.S.C. 300aa-11(c)(1)(C)(i) (speaking
to an injury aggravated ``in association with the vaccine referred to''
on the Vaccine Injury Table); 42 U.S.C. 300aa-11(c)(1)(C)(ii)(I) (for
conditions not on the Vaccine Injury Table, allowing proof that the
condition ``was caused by a vaccine'' on the Table); 42 U.S.C. 300aa-
11(c)(1)(C)(ii)(II) (same). But negligent administration can occur
without regard to the specific vaccine and, as noted above, can
encompass anything from negligent needle placement to ``the doctor's
negligent dropping of an infant patient.'' Amendola, 989 F.2d at 1186-
87. Congress strongly signaled that it was focused on compensation for
harm caused by the vaccine by requiring that the Table list the
vaccines themselves and the types of injuries the vaccines themselves
would cause.
Fourth, in the provision preempting state tort liability, Congress
protected manufacturers from liability when the injury ``resulted from
side effects that were unavoidable even though the vaccine was properly
prepared. . .'' 42 U.S.C. 300aa-22(b)(1). This language shows Congress
wanted to preserve a state tort remedy for certain avoidable injuries,
such as those caused by negligent vaccine administration. Given that
the Vaccine Act seeks to replace state tort remedies for the injuries
it covers, this reinforces the conclusion that the Act does not reach
SIRVA and vasovagal syncope.
Fifth, Congress provided for health care providers who administer
vaccines to record detailed information about the vaccination,
including the date of administration; the manufacturer; the name of the
provider; and other identifying information. 42 U.S.C. 300aa-25. This
information is well suited to a program designed to compensate for
injuries associated with the vaccine itself, since it provides the key
details about the vaccine provided and when. But this reporting
requirement is woefully inadequate if the Program was designed to
compensate for negligence by the provider, which would require
maintaining careful records regarding the actual administration of the
vaccine.
To be sure, the Vaccine Act does in certain places refer to
``administration of'' or the ``administrator'' of the vaccine. But we
think that those usages were not meant to suggest the Program covers
negligence in the administration of the vaccine, but served other
purposes. At most, these usages render the statute ambiguous with
respect to needle injuries. In Section 300aa-11(a)(2)(A), the statute
precludes suits against ``a vaccine administrator,'' but this reference
does not define the scope of the compensation program--instead, it
protects administrators from suits ``arising from a vaccine-related
injury or death associated with the administration of a vaccine.'' This
language is not entirely clear, as it appears to impose two distinct
qualifications that both must be met but are worded slightly
differently. It may be a belt and suspenders approach to ensure that
vaccine administrators are protected from tort claims like in Amendola,
where the vaccine itself was properly administered and caused the
injury, but the petitioner alleged the administrator was negligent in
deciding to give the vaccine. See 989 F.2d at 1186 (holding Vaccine
Program does not exclude cases of ``negligence in deciding, for
example, whether to administer an otherwise satisfactory vaccine'').
The important point is that the first qualification--``arising from a
vaccine-related injury''--is also included here and, as discussed
above, Congress defined this requirement to include only injuries
associated with the vaccine itself. See also 42 U.S.C. 300aa-
11(b)(1)(A) (referencing individuals who ``died as the result of the
administration of a vaccine'' but only if the individual sustained a
``vaccine-related injury''). In setting up the original Vaccine Injury
Table, Congress referenced conditions ``resulting from the
administration of such vaccines.'' 42 U.S.C. 300a-14(a). But this
phrase was not designed to define the scope of the program or the
Table; instead, Congress directed the Secretary to add conditions to
the Table if they were ``associated with such vaccines.'' 42 U.S.C.
300aa-14(e)(1)(B) & (2)(B). And it is telling that Congress included
nothing similar to SIRVA or other injuries caused by negligent vaccine
administration in the original Table, rather than injuries associated
with the vaccine components themselves. Finally, that Congress asked
the Secretary to ``make or assure improvements'' in the
``administration'' of vaccines, 42 U.S.C. 300aa-27(a)(2), among many
areas of improvement in the vaccination process, does not imply that
the compensation program covers negligent administration.
Perhaps for some or all of these reasons, state courts have found
that injuries arising from negligent administration of a vaccine are
not ``vaccine-related injuries'' under 42 U.S.C. 300aa-33(5), and
therefore are not preempted by the Vaccine Act. See, e.g., Neddeau v.
Rite Aid of Conn., 2015 WL 5133151, at *3 (Super. Ct. Conn. July 28,
2015) (state court action did not allege a ``vaccine-related'' injury
and therefore was not barred by the Vaccine Act, because plaintiff's
allegation that the administrator struck the needle too high was an
allegation that her injuries ``were caused by negligence in the
physical process of injecting the vaccine, not by the effects of the
vaccine''); Nwosu ex rel. Ibrahim v. Adler, 969 So. 2d 516, 519 (Ct.
App. Fla. 2007) (claim arising from a physician's negligent injection
of a vaccine was not a ``vaccine-related injury,'' and adding that
``[i]t is true that had the child not been vaccinated, she would not
have been injured. However, her injury as alleged, does not flow from
the inoculant injected into her body [so] it is not the type of injury
covered under the Act'').
The Table should only include injuries caused by a vaccine or its
components, not the manner in which the vaccine was administered. Thus,
a petitioner must have an injury or death ``associated'' with the
vaccine, not one resulting from poor injection technique or other
improper administration of the vaccine.
Moreover, strong policy considerations support this reading of the
Vaccine Act. It is the Department's belief that Congress intended for
the Vaccine Act's compensation system to be used for unavoidable
injuries and illnesses that cannot be predicted in advance and can
occur without fault. SIRVA and vasovagal syncope are generally not
those types of injuries or illnesses. With proper injection technique,
SIRVA is likely preventable. The scientific literature also suggests
that those administering vaccines can take steps to significantly
reduce the likelihood of vasovagal syncope. However, while the
Department is grateful for the many health care professionals and
pharmacists who improve public health by vaccinating the American
public, and does not believe they would intentionally administer a
vaccine in an improper manner, awarding no-fault compensation from the
VICP to those with SIRVA and vasovagal syncope claims lessens the
incentive to take appropriate precautions. Since Vaccine Act
proceedings are generally sealed and not made available to the public,
vaccine administrators may be left unaware that they used an improper
technique.\15\ If SIRVA and vasovagal
[[Page 43798]]
syncope are included in the Table, petitioners will continue to seek to
recover from the VICP, where they can recover more easily because they
need not prove causation, rather than from those who failed to properly
administer the vaccine.
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\15\ See Jodie Fleischer et al., Half of All New Federal Vaccine
Cases Allege Injury from Shots Given Incorrectly, NBC Washington,
https://www.nbcwashington.com/investigations/Half-of-All-New-Federal-Vaccine-Injury-Cases-Allege-Shots-Given-Incorrectly-481441201.html (explaining that ``the program has no mechanism [due
to privacy laws] to notify the shot-giver of the injury he or she
likely caused,'' and ``[t]hus, they would have no reason to seek
additional training'').
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Furthermore, the Department has found that SIRVA petitions are
likely to unnecessarily risk reductions in the funding available for
children and others who sustained an unavoidable vaccine-related injury
or death that did not result from improper technique or negligent
administration. In the VICP's early years, the overwhelming majority of
cases brought, and compensation awarded, involved injuries to
children.\16\ However, over 99.2% of SIRVA cases (3,034 out of 3,057)
filed since FY 2010 were filed by adults. From FY 2016 through FY 2019,
approximately $119,154,985 has been paid out of the Vaccine Injury
Compensation Trust Fund (Trust Fund) to compensate SIRVA petitioners,
who are overwhelmingly adults. The sheer prevalence of shoulder
injuries in the country's adult population and the low burden of proof
placed on petitioners have made it attractive to file SIRVA petitions,
even when such claims are dubious.\17\ Petitioners in such cases often
prevail because of the low burden of proof and because it is not
necessary to prove causation. If SIRVA and vasovagal syncope were
removed from the Table, individuals could still file SIRVA and
vasovagal syncope claims in state court \18\ where they would be
required to prove causation between the manner of administration and
the claimed injury. Requiring plaintiffs to prove causation in state
court would mitigate the filing of frivolous claims in the VICP that
are diminishing the Trust Fund.
---------------------------------------------------------------------------
\16\ Peter H. Meyers, Fixing the Flaws in the Federal Vaccine
Injury Compensation Program, 63 Admin. L. Rev. 785, 795 (2011).
\17\ See also B.F. Hibbs, C.S. Ng, O. Museru et al., Reports of
atypical shoulder pain and dysfunction following inactivated
influenza vaccine, Vaccine Adverse Event Reporting System (VAERS),
2010-2017, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.023
(reports of atypical shoulder pain following IIV are uncommon and
the level of reporting has remained fairly constant in recent years,
``in contrast to the substantial increase in SIRVA claims filed with
the VICP for IIV during the same time period'').
\18\ Or Federal district court if they satisfy the requirements
of 28 U.S.C. 1332 or 28 U.S.C. 1367.
---------------------------------------------------------------------------
The removal of SIRVA and vasovagal syncope from the Table is
intended to also preclude VICP claims for SIRVA or vasovagal syncope
based on causation in fact, given that they are not injuries associated
with vaccines or their components, nor are they unavoidable injuries or
illnesses that cannot be predicted in advance, or that can occur
without fault. While only eight and nine vasovagal syncope claims were
filed in FY 18 and FY 19 respectively, the number of SIRVA claims has
increased since the agency began suggesting that SIRVA could be a Table
injury, and increased dramatically after SIRVA was in fact added to the
Table in FY 17:
------------------------------------------------------------------------
Total number
Fiscal year of SIRVA
claims filed
------------------------------------------------------------------------
FY 2010................................................. 5
FY 2011................................................. 10
FY 2012................................................. 20
FY 2013................................................. 34
FY 2014................................................. 116
FY 2015................................................. 225
FY 2016................................................. 433
FY 2017................................................. 605
FY 2018................................................. 671
FY 2019................................................. 711
FY 2020................................................. 227
---------------
Totals................................................ 3,057
------------------------------------------------------------------------
Prior to SIRVA's addition to the Table, SIRVA claims were sometimes
awarded due to a combination of the government resolving the claims
without litigating them to conclusion, and public statements by the
Department suggesting SIRVA was a cognizable injury. The proposal to
add SIRVA to the Table was in the works for several years before the
2015 notice of proposed rulemaking was published, and there was a great
deal of public discussion about it at the ACCV and at the Court of
Federal Claims' annual judicial conference. The Department has in the
past not always contested cases alleging injuries that have been
proposed for addition to the Table if the case as pleaded fulfilled the
criteria for entitlement to compensation. However, for the reasons
discussed in this notice of proposed rulemaking, including the
Department's review of the statute and more recent scientific
literature, the Department no longer believes such claims should be
included on the Table or can be based on causation in fact, because
they are not injuries associated with vaccines or their components, nor
are they unavoidable injuries or illnesses that cannot be predicted in
advance, or that can occur without fault.
In addition, DOJ informs the Department that, out of 2,214 SIRVA
claims filed since 2017, DOJ has identified 27 cases in which altered
medical records have been filed, some of which involved changes to the
site of vaccination. 2,214 SIRVA claims have been filed in this time
period. Additionally, the median award for SIRVA claims is far higher
than the damages awarded for comparable injuries in the civil tort
system. See Memo re: Damages for Shoulder Injuries Outside of the
Vaccine Program, Dep't of Justice (Sept. 21, 2018) (indicating the
median award for SIRVA claims resolved by stipulation, which ostensibly
include a litigative risk discount, is $71,355.26, but is $22,530 for
comparable claims awarded either by settlement or judgment in the civil
tort system in 2015-2018); see also Bossenbroek v. HHS, 2020 WL
2510454, Appendix 2 (Fed. Cl. Spec. Mstr. Apr. 3, 2020) (citing the DOJ
memo). The Department is concerned that the alteration of records and
excessive awards to petitioners seen in SIRVA cases threaten the
integrity of the VICP.
In FY 10, SIRVA claims made up 5 (1.1%) of the 448 claims filed in
the VICP. However, for FY17-FY19, SIRVA claims made up 52.6% of all
claims filed in the VICP. Thus, indications that SIRVA claims were
cognizable and then adding SIRVA to the Table dramatically increased
the number of claims filed in the VICP. Such claims, which are not
associated with vaccines or their components, therefore erroneously
suggest that vaccines are less safe than they in fact are. For example,
if no SIRVA claims were filed, the number of claims filed in FY 19
would have fallen from 1,282 to 575. Thus, reductions in VICP
petitions, particularly those claiming SIRVA, will support the
overwhelming scientific understanding that vaccines are both safe and
effective.
Item XVII
As discussed in further detail below, the Department also proposes
to remove Item XVII from the Table found at 42 CFR 100.3(a), and to
remove 42 CFR 100.3(e)(8), which describes the mechanism for adding new
vaccines to Item XVII. The Department proposes these changes because it
has serious concerns that Item XVII is contrary to law, including the
procedures described in the Vaccine Act for amending the Table.
Specifically, to the extent that Item XVII provides a unilateral
mechanism for adding injuries and vaccines to the Table, it may be
inconsistent with the Vaccine Act, as discussed in more detail below.
SIRVA and vasovagal syncope are the only illnesses, disabilities,
injuries, or conditions listed for Item XVII.
[[Page 43799]]
Guiding Principles for Recommending Changes to the Vaccine Injury Table
In 2006, the ACCV established ``Guiding Principles for Recommending
Changes to the Vaccine Injury Table'' (Guiding Principles) to assist
the ACCV in evaluating proposed Table revisions and determining whether
to recommend changes to the Table to the Secretary. The Guiding
Principles consist of two overarching principles: (1) The Table should
be scientifically and medically credible, and (2) where there is
credible scientific and medical evidence both to support and to reject
a proposed change (addition or deletion) to the Table, the change
should, whenever possible, be made to the benefit of petitioners. The
Guiding Principles also state, among other factors, that ``[t]o the
extent that the [IOM] has studied the possible association between a
vaccine and an adverse effect, the conclusions of the IOM should be
considered by the ACCV and deemed credible but those conclusions should
not limit the deliberations of the ACCV.'' As part of its mandate under
the Act, the ACCV considered the proposed changes set forth in this
NPRM on March 6, 2020 and May 18, 2020.\19\ Four members of the ACCV
also held a workgroup meeting on April 3, 2020 to discuss the proposed
changes. For each proposed change by the Secretary, the ACCV voted for
one of three options:
---------------------------------------------------------------------------
\19\ The Department first provided the proposed revisions to the
Table and requested recommendations and comments by the ACCV on or
about February 15, 2020.
---------------------------------------------------------------------------
1. ACCV concurs with the proposed change(s) to the Table and would
like the Secretary to move forward (with or without comments);
2. ACCV does not concur with the proposed change(s) to the Table
and would not like the Secretary to move forward; or
3. ACCV would like to defer a recommendation on the proposed
change(s) to the Table pending further review at a future ACCV meeting.
The Guiding Principles are not binding on the Secretary. The ACCV's
findings and recommendations are discussed at page 26-31.
Findings
In prior Table revisions, the Secretary determined that the
appropriate framework for making changes to the Table is to make
specific findings as to the illnesses or conditions that can reasonably
be determined in some circumstances to be caused or significantly
aggravated by the vaccines under review and the circumstances under
which such causation or aggravation can reasonably be determined to
occur. The Secretary continues this approach, and finds that the
scientific literature does not provide a sufficient association between
either SIRVA or vasovagal syncope and any vaccine component alone so as
to support including SIRVA or vasovagal syncope in the Table.
Accordingly, the Secretary proposes to remove SIRVA and vasovagal
syncope from the Table and from the QAI found at 42 CFR 100.3(c) for
the reasons discussed in this NPRM. The Secretary also has serious
concerns that Item XVII does not comport with applicable law, and
therefore also recommends removal of Item XVII from the Table and the
removal of 42 CFR 100.3(e)(8) for the reasons discussed in this NPRM.
For any vaccine adverse event pairs for which future scientific
evidence develops to support a finding of a causal relationship, the
Secretary will consider future rulemaking to revise the Table
accordingly.
In support of his proposals, and notwithstanding the
recommendations of the ACCV, the Secretary makes the following
findings:
Findings That Result in Removals From the Table Because the Evidence
Favors Rejection of a Causal Relationship
1. The scientific evidence does not adequately support a causal
relationship between any specific vaccine's antigen or other component
and SIRVA. For reasons detailed below, the Secretary proposes removing
SIRVA from the Table.
2. The scientific evidence does not adequately support a causal
relationship between any specific vaccine's antigen or other components
and vasovagal syncope. For reasons detailed below, the Secretary
proposes removing vasovagal syncope from the Table.
Findings That Result in Removals From the Table for Procedural Reasons
1. Item XVII in the Table may not comport with applicable law. For
reasons detailed below, the Secretary proposes removing Item XVII from
the Table.
III. Discussion of Proposed Rule
The Secretary has examined the relevant statutory provisions, the
scientific literature, the Department's experience since SIRVA and
vasovagal syncope were added to the Table, and the recommendations of
the ACCV and proposes that the Table set forth at 42 CFR 100.3(a) be
revised to remove SIRVA, vasovagal syncope, and Item XVII, as described
below. Due to these amendments, the Secretary also proposes making the
corresponding changes of removing 42 CFR 100.3(c)(10), 42 CFR
100.3(c)(13), and 42 CFR 100.3(e)(8), which describe the injuries or
items that the Secretary proposes to remove from the Table. Following
each proposed removal from the Table, as applicable, there is a
discussion of the 2017 addition of each injury to the Table, the IOM's
2012 conclusions about that injury cited by HHS in its 2015 Proposed
Rule, and other relevant research and conclusions, as well as the
Department's proposal. Each of the changes proposed by the Department
and the rationale for the proposal is described in detail.
As provided in 42 U.S.C. 300aa-14(c)(4), the modified Table will
apply only to petitions filed under the Program after the effective
date of the final regulation. Petitions must also be filed within the
applicable statute of limitations. The general statute of limitations
applicable to petitions filed with the VICP, set forth in 42 U.S.C.
300aa-16(a), continues to apply. In addition, the statute identifies a
specific exception to this statute of limitations that applies when the
effect of a revision to the Table makes a previously ineligible person
eligible to receive compensation or when an eligible person's
likelihood of obtaining compensation significantly increases.
Under 42 U.S.C. 300aa-16(b), an individual who may be eligible to
file a petition based on the revised Table may file the petition for
compensation not later than 2 years after the effective date of the
revision if the injury or death occurred not more than 8 years before
the effective date of the revision of the Table. This is true even if
such individual previously filed a petition for compensation, and is
thus an exception to the ``one petition per injury'' limitation of 42
U.S.C. 300aa-11(b)(2).
Based on the requirements of the Administrative Procedure Act, the
Department publishes a Notice of Proposed Rulemaking in the Federal
Register before a regulation is promulgated. The public is invited to
submit comments on the proposed rule. In addition, a public hearing
will be held for this proposed rule.
After the public comment period has expired, the comments received
and the Department's responses to the comments will be addressed in the
preamble to the final regulation. The Department will publish the final
rule in the Federal Register.
In the following sections, background information on different
injuries and Item XVII, as well as the Secretary's rationale for the
proposed Table changes, is provided.
[[Page 43800]]
1. Shoulder Injury Related to Vaccination
SIRVA is an adverse event following vaccination thought to be
related to the technique of intramuscular percutaneous injection (the
procedure where access to a muscle is obtained by using a needle to
puncture the skin) into an arm resulting in trauma from the needle and/
or the unintentional injection of a vaccine into tissues and structures
lying underneath the deltoid muscle of the shoulder.
On March 21, 2017, HHS adopted the Final Rule adding SIRVA to the
Table. As defined in the Final Rule, SIRVA is an injury related to the
intramuscular injection of a vaccine. Since the addition of SIRVA to
the Table, SIRVA has become the predominant claim under the National
Vaccine Injury Compensation Program. In Fiscal Year 2018, of the 1,238
claims filed, 671 were SIRVA claims (54.2%). In Fiscal Year 2019, of
the 1,282 claims filed, 711 were SIRVA claims (55.4%). Thus, the number
of SIRVA claims have increased dramatically, having comprised only 5
(1.1%) of the 448 claims filed in Fiscal Year 2010 and 10 (2.6%) of the
386 claims filed in Fiscal Year 2011.
By definition, a Table injury of SIRVA results from the injection
technique. For that reason, the Department did not include SIRVA as an
injury on the 2017 revised Table for vaccines that are not administered
by intramuscular injection, including oral polio and rotavirus;
subcutaneous MMR, MMRV, varicella, and meningococcal-polysaccharide;
and intranasal influenza. In addition, the Department did not add a
SIRVA injury to the revised 2017 Table for vaccines administered via a
needleless jet device. Similarly, the Department found that a SIRVA
injury would not apply to formulations of influenza vaccine where the
route of administration was intradermal, such as those delivered
through a needle that was only 1.5 millimeters long, because the
``needle is not long enough to enter the deltoid bursa or any other
structure in the shoulder related to the development of SIRVA.'' \20\
---------------------------------------------------------------------------
\20\ 80 FR 45144.
---------------------------------------------------------------------------
In addition, in the 2012 IOM review of medical and scientific
literature related to SIRVA cited by the Department in the 2015
Proposed Rule, the IOM found a causal connection between the injury of
deltoid bursitis and vaccine injection with a needle only.\21\ The IOM
did not find a causal connection between the injury of deltoid bursitis
and the components of the vaccine itself.
---------------------------------------------------------------------------
\21\ 80 FR 45136. See also IOM Report.
---------------------------------------------------------------------------
Since the final rule was promulgated, additional scientific
research has concluded that subdeltoid or subacromial bursitis and
other shoulder lesions are ``more likely to be the consequence of a
poor injection technique (site, angle, needle size, and failure to take
into account patient's characteristics, i.e., sex, body weight, and
physical constitution),'' rather than ``antigens or adjuvants contained
in the vaccines that would trigger an immune or inflammatory
response.'' \22\ The evidence is thus insufficient to support an
adequate causal connection between the contents of any vaccine by
themselves and SIRVA.
---------------------------------------------------------------------------
\22\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil,
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries
and dysfunctions of the shoulder following vaccinations, Vaccine,
2017 35:4870-4876; Bancsi A, Houle SKD, Grindrod KA. Shoulder injury
related to vaccine administration and other injection site events.
Can. Fam. Physician. 2019 Jan; 65(1):40-42 (explaining that SIRVA
``is a preventable occurrence caused by the injection of a vaccine
into the shoulder capsule rather than the deltoid muscle''); Macomb
CV, Evans MO, Dockstater JE, Montgomery JR, Beakes DE. Treating
SIRVA Early With Corticosteroid Injections: A Case Series. Mil Med.
2019 Oct 17 (noting that SIRVA does not occur unless the vaccine is
mistakenly given in the shoulder capsule).
---------------------------------------------------------------------------
As discussed above, it is the Department's belief that SIRVA is not
a ``vaccine-related injury'' and therefore should not be included on
the Table or compensable under the VICP.\23\ Moreover, as discussed in
the Background section, the Department has concluded that there are
strong policy reasons for removing SIRVA from the Table. Accordingly,
the Secretary recommends removing SIRVA altogether from the Table.
---------------------------------------------------------------------------
\23\ 42 U.S.C. 300aa-11, 300aa-14(e).
---------------------------------------------------------------------------
2. Vasovagal Syncope
Vasovagal syncope is the loss of consciousness (fainting) caused by
a transient decrease in blood flow to the brain. Vasovagal syncope is
usually a benign condition but may result in falling and injury.
On January 19, 2017, the Department adopted the Final Rule adding
vasovagal syncope to the Table. 82 FR 6294; 82 FR 11321. In making that
revision, the Department relied on the IOM's 2012 review of medical and
scientific literature concerning a possible link between the injection
of a vaccine and syncope. The IOM found insufficient epidemiologic
evidence of an association between the injection of a vaccine and
syncope, but it found sufficient mechanistic evidence supporting the
conclusion that syncope is ``directly related to vaccine
administration.'' \24\ The IOM explained that evidence it examined as
part of its review suggested ``that the injection, and not the contents
of the vaccine, contributed to the development of syncope.'' \25\ In
addition, because syncope is an injury related solely to the injection
of a vaccine, the Department did not add syncope to the 2017 revisions
to the Table as an injury for vaccines that are not administered by
injection, such as oral polio and rotavirus vaccine.
---------------------------------------------------------------------------
\24\ 80 FR 45137.
\25\ 80 FR 45137. See also IOM Report.
---------------------------------------------------------------------------
Other scientific and medical literature support the conclusion that
syncope may be caused by the act of vaccination, but not its
contents.\26\ The evidence is thus insufficient to support a causal
connection between the contents of any vaccine and vasovagal syncope.
---------------------------------------------------------------------------
\26\ 80 FR 45137 (The IOM found that one case report suggested
that ``the injection, and not the contents of the vaccine,
contributed to the development of syncope''). See also IOM Report at
18 (``injection of vaccine, independent of the antigen involved, can
lead to'' syncope); Miller, E. and Woo, E.J. Time to prevent
injuries from postimmunization syncope, Nursing, 2006 36 (12): 20.
---------------------------------------------------------------------------
As discussed above, it is the Department's belief that vasovagal
syncope is not a ``vaccine-related injury'' and therefore should not be
included on the Table or compensable under the VICP.\27\ Moreover, as
discussed in the Background section, the Department has concluded that
there are strong policy reasons for removing vasovagal syncope from the
Table. Accordingly, the Secretary recommends removing vasovagal syncope
from the Table.
---------------------------------------------------------------------------
\27\ 42 U.S.C. 300aa-11, 300aa-14(e).
---------------------------------------------------------------------------
3. Category for 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
Item XVII of the current Table includes ``[a]ny new vaccine
recommended by the CDC for routine administration to children, after
publication by the Secretary of a notice of coverage.'' \28\ Through
this general category, new vaccines recommended by the CDC for routine
administration to children and subject to an excise tax are deemed
covered under the VICP prior to being added to the Table as a separate
vaccine category through Federal rulemaking. SIRVA and vasovagal
syncope are the only illnesses, disabilities, injuries, or conditions
listed in Item XVII of the Table.
---------------------------------------------------------------------------
\28\ 42 CFR 100.3(a).
---------------------------------------------------------------------------
[[Page 43801]]
The Department has serious concerns that Item XVII is contrary to
law. The Vaccine Act provides a method for adding new vaccines to the
Table, and it is far from clear that the approach in Item XVII complies
with that method. The Vaccine Act provides that the Secretary may
promulgate regulations to modify the Table, but in doing so, he ``shall
provide for notice and opportunity for a public hearing and at least
180 days of public comment.'' \29\ Moreover, the Table cannot be
revised unless ``the Secretary has first provided to the [ACCV] a copy
of the proposed regulation or revision, requested recommendations and
comments by the [ACCV], and afforded the [ACCV] at least 90 days to
make such recommendations.'' \30\ Item XVII, by contrast, suggests that
vaccines are added to the Table once the CDC recommends them for
routine administration to children and an excise tax is imposed, even
prior to notice and public comment or comments from the ACCV.\31\ This
may be inconsistent with the rulemaking requirements of the
Administrative Procedure Act 5 U.S.C. 553, the Regulatory Flexibility
Act, 5 U.S.C. 601 et seq., various Executive Orders that cabin
rulemaking (see, e.g., Executive Order 12866), and the Vaccine Act.
---------------------------------------------------------------------------
\29\ 42 U.S.C. 300aa-14(c)(1).
\30\ 42 U.S.C. 300aa-14(d).
\31\ The language in Item XVII also raises Constitutional
concerns. Item XVII in effect allows CDC to add vaccines to the
Table so long as the Secretary publishes notice of coverage. The
Office of Legal Counsel has previously opined that a statute that
sought to authorize the CDC director to take certain action
unilaterally was inconsistent with the Executive Powers Clause.
(Statute Limiting The President's Authority To Supervise The
Director Of The Centers For Disease Control In The Distribution Of
An AIDS Pamphlet, 12 U.S. Op. Off. Legal Counsel 47, 48, 1988 WL
390999, at * 1). For the same reasons, it is not clear that the CDC
director, as an inferior officer, has the authority to unilaterally
add vaccines to the Table without the approval of the Secretary.
---------------------------------------------------------------------------
Further, SIRVA and vasovagal syncope are the only illnesses,
disabilities, injuries, or conditions listed for Item XVII.
4. The ACCV's Recommendations and Comments
More than 90 days after it received the Department's proposed
changes to the Table, on May 20, 2020 the ACCV sent a letter to the
Secretary (May 20 Letter) explaining why it opposed the proposed
changes.\32\ The Department is grateful to the ACCV for its time spent
considering the proposed changes and for providing its comments.
---------------------------------------------------------------------------
\32\ https://www.hrsa.gov/advisory-committees/vaccines/reports-recommendations.html.
---------------------------------------------------------------------------
However, the Department found the ACCV's comments not adequately
persuasive, and for the reasons stated above has decided to issue this
notice of proposed rulemaking and provide for public comment and notice
and opportunity for a public hearing. The May 20 Letter stated that,
although rare, SIRVA and vasovagal syncope are injuries that can be
caused by vaccination, so they should be eligible for compensation from
the VICP. However, for the reasons stated herein, only ``vaccine-
related injuries or deaths,'' as defined in the statute, are eligible
for compensation. The May 20 Letter also stated that one intent of the
VICP is to provide liability protection to vaccine manufacturers and
administrators, and that removing SIRVA or vasovagal syncope could (1)
result in higher malpractice premiums for those who administer vaccines
and (2) disincentivize administering vaccines, thereby resulting in
lower vaccination rates. However, the May 20 Letter failed to cite any
evidence that these issues were problematic in the United States before
SIRVA and vasovagal syncope were added to the Table in 2017, and the
Department has been unable to locate any evidence that premiums have
materially declined due to the addition of SIRVA and vasovagal syncope
to the Table. Moreover, the vaccination rate has gone down slightly
since SIRVA and vasovagal syncope were added to the Table.\33\ The
Department is grateful for the many health care professionals and
pharmacists who improve public health by vaccinating the American
public, and does not believe they would intentionally administer a
vaccine in an improper manner, but the Department also wants to
incentivize those who administer vaccines to do so properly. Doing so
will improve public confidence in vaccinations.
---------------------------------------------------------------------------
\33\ See, e.g., https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates.htm; https://www.cdc.gov/nchs/data/hus/2018/031.pdf.
---------------------------------------------------------------------------
The May 20 Letter also stated that the Vaccine Act has a
subrogation clause which permits the Federal government to seek
recompense if the VICP compensates a claim, but determines later that a
health care professional was negligent in administering a vaccine.
Thus, injury claims resulting from the administration of vaccines
should still be eligible for VICP compensation. However, this
subrogation provision does not properly incentivize the vaccine
administrator, since it is unlikely that the Federal government would
assert many claims against administrators, given the burden and expense
compared to the relatively small potential recovery for the Federal
government. Individuals would have a greater incentive to assert such
claims if the administrator were negligent.
The May 2020 Letter further stated that the explanations in the
proposal that the Department submitted to the ACCV do not meet the
tenets of the ACCV's Guiding Principles. As noted above, the Guiding
Principles state: ``When recommending changes to the Vaccine Injury
Table (``the Table''), members of the Advisory Commission on Childhood
Vaccines (ACCV) shall utilize the following overarching guiding
principles:
The Table should be scientifically and medically credible;
and
Where there is credible scientific and medical evidence
both to support and to reject a proposed change (addition or deletion)
to the Table, the change should, whenever possible, be made to the
benefit of petitioners.''
The Guiding Principles are not binding on the Secretary.\34\
Nonetheless, the Department believes that credible scientific and
medical evidence supports removing SIRVA and vasovagal syncope from the
Table. In addition, the Secretary must consider what will benefit the
public, not only petitioners. Furthermore, in determining whether a
proposed change benefits petitioners, it is important to consider all
petitioners. The inclusion of SIRVA has harmed the petitioners with
injuries that the VICP was primarily designed to compensate, including
children, because the high number of SIRVA claims has significantly
slowed down the adjudication process. The Vaccine Act established a
compensation program that was ``designed to work faster and with
greater ease than the civil tort system.'' Bruesewitz v. Wyeth, 562
U.S. 223, 228 (2011) (quoting Shalala v. Whitecotton, 514 U.S. 268,
269, (1995)). However, since 2017, the average amount of time for a
case to finally resolve has increased significantly (from 575 days to
751 days). As of March 2020, 926 petitions awaited initial review,
including 530 that had been filed in FY 2019.\35\ Prior to FY 2014,
there generally were not even 530 total petitions filed per year. Non-
SIRVA cases, including those filed on behalf of children, are adversely
affected as resources are stretched or diverted to litigate SIRVA
cases. Because SIRVA claims are lucrative to pursue and simpler to
prosecute than childhood vaccine injuries, there is little reason to
[[Page 43802]]
believe this is a temporary phenomenon.
---------------------------------------------------------------------------
\34\ 80 FR 45134.
\35\ https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/meetings/2020/03062020-dicp-update.pdf.
---------------------------------------------------------------------------
The May 20 Letter also stated that since enactment of the Vaccine
Act and the inception of the program, claims resulting from the
administration of a vaccine have been filed and some have been
compensated. The May 20 Letter added that the ACCV was not presented
with any new peer-reviewed medical or scientific literature on SIRVA or
syncope. Thus, since no new medical and scientific literature has been
published about the proposed changes, HHS should not be proposing any
changes to the Table. However, the proposal that the Department
provided to the ACCV, as well as this notice of proposed rulemaking,
includes the findings of additional studies concluded since SIRVA and
vasovagal syncope were added to the Table. The Department has also
learned from its experience since SIRVA and vasovagal syncope were
added to the Table, and believes this experience supports the proposed
changes. Additionally, the Department believes the changes are
supported by the IOM, which found that (1) ``the injection, and not the
contents of the vaccine, contributed to the development of deltoid
bursitis'' \36\ and (2) ``the injection, and not the contents of the
vaccine, contributed to the development of syncope.'' \37\ Thus, there
was insufficient scientific evidence to support adding SIRVA and
vasovagal syncope in the first place, as there was insufficient
evidence that either are vaccine-related injuries.
---------------------------------------------------------------------------
\36\ IOM Report at 620.
\37\ 80 FR 45137. See also IOM Report.
---------------------------------------------------------------------------
The May 20 Letter added that the Trust Fund has a balance of over
$4 billion, so funds are available to pay valid claims resulting from
the administration of vaccines. However, it is the Department's belief
that the availability of funds at this moment does not justify their
dispersal for claims that are not associated with vaccines or vaccine
components. Lastly, the May 20 Letter also recommended that the
Secretary support an increase in the number of Special Masters and
staffing and funding resources for the VICP in order to reduce the
backlog caused by SIRVA claims. It is Congress's decision whether to
increase funding and the number of Special Masters. Moreover, any
increase in staffing or funding by Congress would only address one of
the several issues identified above.
The May 20 Letter did not provide any reasons why it opposed the
Department's proposal to remove Item XVII from the Table.\38\
---------------------------------------------------------------------------
\38\ The May 20 Letter also stated that the ACCV wished it could
have heard from an HHS official who could provide the evidence and
reasoning to support the proposal and to explain and discuss the
original basis for the inclusion of SIRVA and vasovagal syncope on
the Table. While perhaps an understandable concern, the proposal,
which synthesized the views of many within the Department, was the
Department's best explanation for why it was proposing the changes
to the Table.
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One member of the ACCV sent a letter to the Secretary on May 26,
2020. The letter stated that the member was concerned that the large
number of SIRVA claims has clogged the VICP, resulting in delayed
resolution of claims; the large amount paid annually from the Trust
Fund has reinforced vaccine hesitancy among some who incorrectly
believe this figure reflects lack of vaccine safety; and the number of
awards for SIRVA are in excess of the true number of cases. This member
recommended revising the definition of SIRVA so that those with true
shoulder injuries are able to recover while reducing the number of
``inappropriate claims.'' The Department believes the concerns
expressed in this letter can best be accomplished by removing SIRVA
from the Table. If SIRVA is removed from the Table, those with SIRVA
injuries would still be able to recover in state court. Removal is
preferable to redefining SIRVA, because it better addresses the vaccine
hesitancy concern, is more in line with the Vaccine Act and
Congressional intent, and incentivizes learning proper administration
technique. Indeed, because Vaccine Act proceedings are generally sealed
and not made available to the public, vaccine administrators often are
left unaware that they used an improper technique.
IV. Statutory Authority
The primary statutory authority for this rulemaking is 42 U.S.C.
300aa-14. 42 U.S.C. 300aa-14(c)(1) provides that the ``Secretary may
promulgate regulations to modify in accordance with paragraph (3) the
Vaccine Injury Table. In promulgating such regulations, he shall
provide for notice and opportunity for a public hearing and at least
180 days of public comment.'' 42 U.S.C. 300aa-14(c)(3), in turn,
provides: ``A modification of the Vaccine Injury Table under paragraph
(1) may add to, or delete from, the list of injuries, disabilities,
illnesses, conditions, and deaths for which compensation may be
provided or may change the time periods for the first symptom or
manifestation of the onset or the significant aggravation of any such
injury, disability, illness, condition, or death.''
V. Request for Comment
HHS and HRSA request comment on all aspects of this proposed rule,
including its likely costs and benefits and the impacts that it is
likely to have on the public health, as compared to the current
requirements under 42 CFR 100.3.
VI. Statutory and Regulatory Requirements
A. Executive Orders 12866, 13563, and 13771: Regulatory Planning and
Review
E.O. 12866 and E.O. 13563 direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). E.O. 13563 supplements and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866, which emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of incentives, of
equity, and of available information. Regulations must meet certain
standards, such as avoiding an unnecessary burden. Regulations that are
``significant'' because of cost, adverse effects on the economy,
inconsistency with other agency actions, effects on the budget, or
novel legal or policy issues require special analysis. The Department
anticipates that the proposed rule would save limited compensation
funds under the National Vaccine Injury Compensation Program.
Specifically, it will reduce the amount of program funds spent on
program administration, reduce the amount of funds paid out to those
with SIRVA or vasovagal syncope claims, and ensure that funds awarded
from the VICP are awarded to individuals whose claims arise from
vaccine-related injuries, which is consistent with the original intent
of the VICP. Moreover, the Department anticipates that the proposed
rule may result in fewer individuals suffering from SIRVA or vasovagal
syncope, because it will better incentivize those administering
vaccines to use proper injection technique. If those who administer
vaccines can be held liable when a patient suffers from SIRVA or
vasovagal syncope as a result of the administration
[[Page 43803]]
of the vaccine, those who administer vaccines will have greater
incentive to use proper injection technique. In addition, the proposed
rule may also limit the ability of those opposed to vaccinations to
cite to the high number of SIRVA awards to misleadingly suggest that
vaccines are less safe than they truly are.
The Department considered, as an alternative to this NPRM, issuing
a NPRM that would revise the definition of SIRVA so that those with
true shoulder injuries were able to recover while reducing the number
of less appropriate claims. However, the Department concluded that
removing SIRVA from the Table is preferable. If SIRVA is removed from
the Table, those with actual SIRVA injuries would still be able to
recover in state court. Removal is preferable to redefining SIRVA,
because it better addresses the vaccine hesitancy concern, is more in
line with the Vaccine Act and Congressional intent, and incentivizes
learning and utilizing proper administration technique. Indeed, because
Vaccine Act proceedings are generally sealed and not made available to
the public, vaccine administrators often are left unaware that they
used an improper technique.
The Department also considered, as alternatives to this NPRM, not
removing one or more of (1) SIRVA, (2) vasovagal syncope, or (3) Item
XVII from the Table. For the reasons discussed herein, the Department
rejected these alternatives.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a rule (1)
having an annual effect on the economy of $100 million or more in any
one year, or adversely or materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. A regulatory impact
analysis bust be prepared for major rules with economically significant
effects ($100 million or more in any one year), and a ``significant''
regulatory action is subject to Office of Management and Budget (OMB)
review. As discussed below regarding the anticipated effects, these
proposals are not likely to have economic impacts of $100 million or
more in any one year, and therefore do not meet the definition of
``economically significant'' under Executive Order 12866. OMB has
determined, however, that the actions are significant within the
meaning of section 3(f)(4) of the Executive Order. Accordingly, this
rule has been reviewed by OMB.
B. Economic and Regulatory Impact
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. Between
FY 2017 and FY 2019, the VICP on average paid out $30,893,481.90 per
year to petitioners alleging SIRVA claims. The VICP on average paid out
$124,489.56 per year to petitioners alleging vasovagal syncope claims.
If this proposed rule went into effect, the Department anticipates that
small entities would not actually pay these amounts, because fewer
SIRVA and vasovagal syncope claims would be filed if petitioners had to
prove causation. In addition, vaccines are often administered by non-
small entities, so even if total amounts paid approximated the amounts
paid on average between FY 2017 and FY 2019, claims against small
entities would be less. Should this rule be finalized as proposed, it
is the Department's belief that should the amounts paid equal the
amounts annually paid out of the VICP between FY 2017 and FY 2019, and
such claims were paid in full by small entities, these amounts would
not constitute a significant impact on a substantial number of small
entities for purposes of the RFA.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a
budgetary impact statement before promulgating a rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million in 1995 dollars, updated annually for inflation. Currently,
that threshold is approximately $154 million. If a budgetary impact
statement is required, section 205 of the Unfunded Mandates Act also
requires covered agencies to identify and consider a reasonable number
of regulatory alternatives before promulgating a rule. The Department
has determined that this proposed rule will not result in expenditures
by State, local, and tribal governments, or by the private sector, of
$154 million or more in any one year. Accordingly, the Department has
not prepared a budgetary impact statement or specifically addressed the
regulatory alternatives considered.
The provisions of this rule will also not negatively affect family
well-being or 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.
On January 30, 2017, the White House issued Executive Order 13771
on Reducing Regulation and Controlling Regulatory Costs. Section 2(a)
of Executive Order 13771 requires an agency, unless prohibited by law,
to identify at least two existing regulations to be repealed when the
agency publicly proposes for notice and comment or otherwise
promulgates a new regulation. In furtherance of this requirement,
section 2(c) of Executive Order 13771 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with at
least two prior regulations. This proposed rule would partially repeal
prior regulations and is not expected to increase incremental costs, so
it is not anticipated to be a regulatory or deregulatory action under
Executive Order 13771. Public comments will inform the ultimate
designation of this rule.
As stated above, this proposed rule would modify the Vaccine Injury
Table to ensure that the Table complies with applicable law, the Table
is consistent with medical and scientific literature, those
administering vaccines have additional incentive to use proper
injection technique, and the VICP has sufficient funds to adequately
compensate those injured by vaccines listed in the Table.
Summary of Impacts
This proposed rule will have the effect of removing injuries from
the Table that are not encompassed by the provisions of the Vaccine Act
and that are reducing the pool of funds available to those injured by
vaccines or vaccine components. It will therefore align the Table with
the Department's understanding of Congress' intent and
[[Page 43804]]
public policy in favor of compensating those harmed by injuries
associated with the vaccine or vaccine components, and particularly
children who have suffered such harm. The rule will also have the
effect of ensuring that the limited compensation resources available
under the National Vaccine Injury Compensation Program are provided to
those with vaccine-related injuries or deaths. In addition, because of
the large volume of SIRVA claims, removing SIRVA from the Table will
reduce the amount of program funds spent on program administration and
ensure that funds awarded from the VICP are awarded to individuals
whose claims arise from vaccine-related injuries, which is consistent
with the Department's interpretation of the original intent of the
VICP.
The rule will also better incentivize those who administer vaccines
to use proper injection technique. It may also help correct misleading
and erroneous suggestions that vaccines are not safe. Because COVID-19
and a potential COVID-19 vaccine are not currently on the Table, the
Department does not believe this rule would have an impact on patients
with COVID-19 or a COVID-19 vaccine. However, HHS requests public
comment on this determination.
Moreover, the rule is unlikely to unduly burden the civil tort
system. The Department conducted a search in the WestLaw legal database
for cases in state court that contained both the terms ``SIRVA'' and
``vaccine,'' and found only 20 hits, at least two of which were cases
involving an entity named SIRVA and not the injury.\39\ It is possible
that some additional cases were filed in federal district court.
Nonetheless, the Department believes based on this data that any
additional burden on the civil tort system, which would be dispersed
across States and not concentrated in any one or few States, from
removing SIRVA and vasovagal syncope from the Table and reverting to
the status quo as of January 2017 will be minimal.
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\39\ https://1.next.westlaw.com/Search/Results.html?query=%22sirva%22%20%26%20%22vaccine%22&jurisdiction=ALLSTATES&saveJuris=False&contentType=CASE&querySubmissionGuid=i0ad6ad3f000001733a44933a7bf4372d&startIndex=1&searchId=i0ad6ad3f000001733a44933a7bf4372d&kmSearchIdRequested=False&simpleSearch=False&isAdvancedSearchTemplatePage=False&skipSpellCheck=False&isTrDiscoverSearch=False&thesaurusSearch=False&thesaurusTermsApplied=False&ancillaryChargesAccepted=False&proviewEligible=False&eventingTypeOfSearch=FRM&transitionType=Search&contextData=%28sc.Search%29.
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A. Executive Order 13132--Federalism
HHS has reviewed this proposed rule in accordance with E.O. 13132
regarding federalism and has determined that it does not have
``federalism implications.'' This proposed rule would not ``have
substantial direct effects on the States, or on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
B. Collection of Information
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA)
requires that OMB approve all collections of information by a federal
agency from the public before they can be implemented. This proposed
rule is projected to have no impact on current reporting and
recordkeeping burden, as the amendments proposed in this rule will not
impose any data collection requirements under the PRA.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
Dated: June 22, 2020.
Thomas J. Engels,
Administrator, Health Resources and Services Administration.
Approved: July 9, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
Accordingly, 42 CFR part 100 is proposed to be 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, revise paragraph (a) and remove paragraphs (c)(10)
and (13) and (e)(8).
The revision reads as follows:
Sec. 100.3 Vaccine injury table.
(a) In accordance with section 312(b) of the National Childhood
Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat.
3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health
Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the
following is a table of vaccines, the injuries, disabilities,
illnesses, conditions, and deaths resulting from the administration of
such vaccines, and the time period in which the first symptom or
manifestation of onset or of the significant aggravation of such
injuries, disabilities, illnesses, conditions, and deaths is to occur
after vaccine administration for purposes of receiving compensation
under the Program. Paragraph (b) of this section sets forth additional
provisions that are not separately listed in this Table but that
constitute part of it. Paragraph (c) of this section sets forth the
Qualifications and Aids to Interpretation for the terms used in the
Table. Conditions and injuries that do not meet the terms of the
Qualifications and Aids to Interpretation are not within the Table.
Paragraph (d) of this section sets forth a glossary of terms used in
paragraph (c).
Table 1 to Sec. 100.3(a)--Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation after
vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing A. Anaphylaxis...... <=4 hours.
tetanus toxoid (e.g., DTaP, B. Brachial Neuritis 2-28 days (not less
DTP, DT, Td, or TT). than 2 days and not
more than 28 days).
II. Vaccines containing A. Anaphylaxis...... <=4 hours.
whole cell pertussis B. Encephalopathy or <=72 hours.
bacteria, extracted or encephalitis.
partial cell pertussis
bacteria, or specific
pertussis antigen(s) (e.g.,
DTP, DTaP, P, DTP-Hib).
III. Vaccines containing A. Anaphylaxis...... <=4 hours.
measles, mumps, and rubella B. Encephalopathy or 5-15 days (not less
virus or any of its encephalitis. than 5 days and not
components (e.g., MMR, MM, more than 15 days).
MMRV).
[[Page 43805]]
IV. Vaccines containing A. Chronic arthritis 7-42 days (not less
rubella virus (e.g., MMR, than 7 days and not
MMRV). more than 42 days).
V. Vaccines containing A. Thrombocytopenic 7-30 days (not less
measles virus (e.g., MMR, purpura. than 7 days and not
MM, MMRV). more than 30 days).
B. Vaccine-Strain
Measles Viral
Disease in an
immunodeficient
recipient.
--Vaccine-strain Not applicable.
virus identified.
--If strain <=12 months.
determination is
not done or if
laboratory testing
is inconclusive.
VI. Vaccines containing A. Paralytic Polio..
polio live virus (OPV).
--in a non- <=30 days.
immunodeficient
recipient.
--in an <=6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain ....................
Polio Viral
Infection.
--in a non- <=30 days.
immunodeficient
recipient.
--in an <=6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
VII. Vaccines containing A. Anaphylaxis...... <=4 hours.
polio inactivated virus
(e.g., IPV).
VIII. Hepatitis B vaccines.. A. Anaphylaxis...... <=4 hours.
IX. Haemophilus influenzae No Condition Not applicable.
type b (Hib) vaccines. Specified.
X. Varicella vaccines....... A. Anaphylaxis...... <=4 hours.
B. Disseminated
varicella vaccine-
strain viral
disease.
--Vaccine-strain Not applicable.
virus identified.
--If strain 7-42 days (not less
determination is than 7 days and not
not done or if more than 42 days).
laboratory testing
is inconclusive.
C. Varicella vaccine- Not applicable.
strain viral
reactivation.
XI. Rotavirus vaccines...... A. Intussusception.. 1-21 days (not less
than 1 day and not
more than 21 days).
XII. Pneumococcal conjugate No Condition Not applicable.
vaccines. Specified.
XIII. Hepatitis A vaccines.. No Condition Not applicable.
Specified.
XIV. Seasonal influenza A. Anaphylaxis...... <=4 hours.
vaccines.
B. Guillain- 3-42 days (not less
Barr[egrave] than 3 days and not
Syndrome. more than 42 days).
XV. Meningococcal vaccines.. A. Anaphylaxis...... <=4 hours.
XVI. Human papillomavirus A. Anaphylaxis...... <=4 hours.
(HPV) vaccines.
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-15673 Filed 7-16-20; 4:15 pm]
BILLING CODE 4165-15-P