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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations
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
100.3the 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 11c1Ci, 300aa13a1B, and 300aa14a.
Revisions to the Table are authorized under 42 U.S.C. 300aa14c and e.
Prior to the 21st Century Cures Act Cures Act Pub. L. 114255, 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 Tables 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 injuriesShoulder Injury Related to Vaccine Administration SIRVA and vasovagal syncopeare listed as associated injuries for this category. Through this general category, new vaccines
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recommended by the CDC for routine administration to children and subject to an excise tax are covered under the VICP prior to being added to the Table as a separate vaccine category.
The Cures Act amended 42 U.S.C.
300aa14e to expand the types of vaccines covered under the VICP. See section 3093c1 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 14e3. 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 ACCVs 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 Secretarys approval of CDCs recommendation and the determination that the statutory
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requirements for coverage under the VICP have been met.
The Secretary also has retained the two injuries currently associated with Item XVII of the Table, SIRVA and vasovagal syncope, as Table injuries for vaccines recommended by the CDC for routine administration in pregnant women. In its 2012 Report, Adverse Effects of Vaccines: Evidence and Causality, the Institute of Medicine considered SIRVA and vasovagal syncope as mechanistic injuries resulting from the injection of a vaccine and not from the contents of a particular formulation of a vaccine. Thus, these conditions are listed as Table injuries for any new vaccine recommended by the CDC for routine administration to children after the imposition of an excise tax and publication by the Secretary of a notice of coverage to account for any new injected vaccines that potentially may lead to SIRVA or vasovagal syncope. Therefore, the Secretary also has included these injuries on the Table for new vaccines recommended by the CDC for routine administration in pregnant women.
VICP petitions must be filed within the applicable statutes of limitations.
With the Table change, the general statutes of limitations applicable to petitions filed with the VICP, set forth in 42 U.S.C. 300aa16a, continue to apply. The alternate statute of limitations afforded by 42 U.S.C. 300aa 16b 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 16b would apply if certain requirements are met.1
II. Responses to Public Comments The NPRM provided a 180-day comment period April 4, 2018October 1, 2018, and HRSA received 51
comments during that time, including during a public hearing. There were 48
written comments submitted. The 1 Under 42 U.S.C. 300aa16b, 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 individuals likelihood of obtaining compensation.

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