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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1

intervals for the first symptom or manifestation of onset of injuries, and the accompanying Qualifications and Aids to Interpretation QAI, which set forth definitions and other requirements necessary to establish Table injuries.
DATES: This rule is effective September 15, 2021.
FOR FURTHER INFORMATION CONTACT:
Tamara Overby, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, 8N146B, Rockville, MD 20857, or by telephone 855 2662427. This is a toll-free number.
SUPPLEMENTARY INFORMATION: On October 15, 2020, HHS published a notice of proposed rulemaking NPRM
in the Federal Register 85 FR 65311
proposing to add the Table for designated covered smallpox countermeasures identified in the Smallpox Medical Countermeasures PREP Act declaration. The Table includes a list of smallpox countermeasures, proposed time intervals for the first symptom or manifestation of onset of injury, and Qualifications and Aids to Interpretation which set forth the definitions and requirements necessary to establish the Table injuries. The NPRM provided a 60-day comment period, and HHS received one out-ofscope comment.
I. Background and Purpose The PREP Act authorizes the Countermeasures Injury Compensation Program CICP to provide compensation to certain individuals who develop serious physical injuries or to certain survivors of individuals who die as a direct result of the administration or use of a covered countermeasure identified in a PREP
Act declaration.1 In carrying out the CICP, the PREP Act directs the Secretary to establish, through regulation, a Covered Countermeasures Injury Table Table identifying serious physical injuries that are presumed to be directly caused by the administration or use of covered countermeasures identified in PREP Act declarations issued by the Secretary. The Secretary may only add to a Table injuries that are directly caused by the administration or use of the covered countermeasure based on compelling, reliable, valid, medical and scientific evidence. 2 The Table 1 See Department of Defense, Emergency Supplemental Appropriation to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006, Part C Pub. L. 109148; 42. U.S.C. 247d 6e.
2 42 U.S.C. 247d6e b5A.

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informs the public about serious physical injuries known to be directly caused by covered countermeasures and creates a rebuttable presumption of causation for eligible individuals whose injuries are listed on the Table and meet the Tables requirements.
The CICPs regulations, which detail the Programs requirements, are found at 42 CFR part 110. The provision at 42
CFR 110.20a states that individuals must establish that a covered injury occurred to be eligible for benefits under the Program. A covered injury is death or a serious injury determined by the Secretary to be: 1 An injury meeting the requirements of a Table, which is presumed to be the direct result of the administration or use of a covered countermeasure unless the Secretary determines there is another more likely cause; or 2 an injury or its health complications that is the direct result of the administration or use of a covered countermeasure.3 This includes a covered countermeasure causing a serious aggravation of a pre-existing condition.4 In general, only injuries that warranted hospitalization whether or not the person was actually hospitalized, or injuries that led to a significant loss of function or disability are considered serious injuries.5
Individuals with injuries not meeting the requirements of the Table may still pursue their claims as non-Table injuries under the Program.6 In that instance, the requester does not receive the presumption of causation for a Table injury and must demonstrate that the administration or use of the covered countermeasure directly caused the injury.7 Proof of a causal association for the non-Table injury must be based on compelling, reliable, valid, medical and scientific evidence.8
II. Summary of the Final Rule Through this final rule, the Secretary adds the Smallpox Countermeasures Injury Table to subpart K of 42 CFR part 110. The Table established in this final rule is limited to smallpox covered countermeasures identified in the Secretarys PREP Act Declaration for Smallpox Medical Countermeasures.9
The Smallpox Countermeasures Injury Table lists several smallpox covered countermeasures and serious physical injuries that, based on compelling, reliable, valid, medical and 3 42

CFR 110.3g.

4 Id.
5 42
6 42

CFR 110.3z.
CFR 110.20c.

7 Id.
8 Id.
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scientific evidence, are directly caused by the administration or use of the associated covered countermeasures.
The Table provides the serious injuries associated with a specific countermeasure and the time interval within which the first symptom or manifestation of onset of injury must appear. The QAI, which accompany the Table, are definitions included to further explain the requirements for each covered injury and the level of severity necessary to qualify as a Table injury. The Secretary will stay informed of updates in the scientific and medical field concerning potential new information about causal associations between injuries and covered countermeasures and update the Table as needed.
In accordance with 42 CFR 110.42f, in addition to the standard filing deadline, with the publication of this new Table, certain eligible requesters have one year from the effective date of the publication of the Table to file claims for injuries that meet the Tables requirements. Individuals who sustained injuries that are not included on the Table or that do not meet all of the requirements for a Table injury, but who may prove causation of the injury through other means, are not eligible for the additional one-year filing deadline based on the Tables publication.
Because the new Table would not enable such individuals to establish a Table injury, they would be subject to the standard filing deadline in 42 CFR
100.42a i.e., one year from the date of administration or use of the covered countermeasure.
In this final rule, the Secretary has made the following change from what was proposed in the NPRM for the purposes of clarity.
a. Changed paragraph d6 by adding a comma after pustules and before generally to the second sentence. The revised sentence states, The rash or lesions, characterized by multiple blisters vesicles or pustules, generally evolve in a similar sequence or manner as the original vaccination site.
b. Changed paragraph d9 by adding to after attributed and before it to the seventh sentence. The revised sentence states, Symptoms that occur before 5 days or more than 14 days after receiving the smallpox vaccine should not be attributed to it.
III. Comments and Responses The NPRM set forth a 60-day public comment period, which ended on December 14, 2020. During the comment period, HHS received one comment that was not relevant to the NPRM. As noted above, the only
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