Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 45655 

PART 9—OMB APPROVALS UNDER 

THE PAPERWORK REDUCTION ACT 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g-1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, amend the table by adding 

entries for §§ 721.11556 through 

721.11558 in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB control 

No. 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.11556 ............................. 2070–0012 

721.11557 ............................. 2070–0012 

721.11558 ............................. 2070–0012 

* * * * * 

* * * * * 

PART 721— SIGNIFICANT NEW USES 

OF CHEMICAL SUBSTANCES 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add §§ 721.11556 through 

721.11558 to subpart E to read as 

follows: 

Subpart E Significant New Uses for 

Specific Chemical Substances 

* * * * * 

Sec. 

721.11556 Rosin adduct ester, polymer with 

polyols, compd. with ethanolamine 

(generic). 

721.11557 Rosin adduct ester, polymer with 

polyols, potassium salt (generic). 

721.11558 1,3-Propanediol, 2,2-dimethyl-, 

1,3-diacetate. 

* * * * * 

§ 721. 11556 Rosin adduct ester, polymer 

with polyols, compd. with ethanolamine 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as rosin adduct ester, 

polymer with polyols, compd. with 

ethanolamine (PMN P–18–399) is 

subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture an annual 

production volume greater than the 

confidential production volume 

identified in the PMN. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

§ 721. 11557 Rosin adduct ester, polymer 

with polyols, potassium salt (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as rosin adduct ester, 

polymer with polyols, potassium salt 

(PMN P–18–400) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. It is a significant 

new use to manufacture an annual 

production volume greater than the 

confidential production volume 

identified in the PMN. 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

§ 721.11558 1,3-Propanediol, 2,2-dimethyl-, 

1,3-diacetate. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified as 

1,3-propanediol, 2,2-dimethyl-, 1,3- 

diacetate (PMN P–20–68, CAS No. 

13431–57–7) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(j). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph (b). 

(1) Recordkeeping. Recordkeeping 

requirements as specified in 

§ 721.125(a) through (c) and (i) are 

applicable to manufacturers and 

processors of this substance. 

(2) Limitation or revocation of certain 

notification requirements. The 

provisions of § 721.185 apply to this 

section. 

(3) Determining whether a specific use 

is subject to this section. The provisions 

of § 721.1725(b)(1) apply to paragraph 

(a)(2)(i) of this section. 

[FR Doc. 2021–17389 Filed 8–13–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 110 

RIN 0906–AB22 

Countermeasures Injury 

Compensation Program: Smallpox 

Countermeasures Injury Table 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: HHS is establishing the 

Smallpox Countermeasures Injury Table 

(Table) as authorized by the Public 

Readiness and Emergency Preparedness 

Act of 2005 (PREP Act). Through this 

final rule, the Secretary of the U.S. 

Department of Health and Human 

Services (Secretary) adds the Smallpox 

Countermeasures Injury Table to the 

agency’s regulations. The Table includes 

a list of covered smallpox 

countermeasures, required time 


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45656 Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 

1See Department of Defense, Emergency 

Supplemental Appropriation to Address Hurricanes 

in the Gulf of Mexico, and Pandemic Influenza Act 

of 2006, Part C (Pub. L. 109–148); 42. U.S.C. 247d– 

6e. 

2 42 U.S.C. 247d–6e (b)(5)(A). 

3 42 CFR 110.3(g). 

4 Id. 

5 42 CFR 110.3(z). 

6 42 CFR 110.20(c). 

7 Id. 

8 Id. 

9 80 FR 76546 (Dec. 9, 2015). 

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) 266–2427. 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 

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 Table’s requirements. 

The CICP’s regulations, which detail 

the Program’s requirements, are found at 

42 CFR part 110. The provision at 42 

CFR 110.20(a) 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 

Secretary’s 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 

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 110.42(f), 

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 Table’s 

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 Table’s 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 

100.42(a) (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 (d)(6) 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 (d)(9) 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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changes made to the final rule are to 

paragraphs (d)(6) and (9) for clarity. 

IV. Regulatory Impact Analysis 

HHS examined the impact of this final 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Congressional Review Act (5 

U.S.C. 804(2)), the Regulatory Flexibility 

Act (RFA) (September 19, 1980, Pub. L. 

96–354), section 202 of the Unfunded 

Mandates Reform Act of 1995 (March 2, 

1995; Pub. L. 104–4), section 654(c) of 

the Treasury and General Government 

Appropriations Act of 1999, and 

Executive Order 13132 on Federalism 

(August 4, 1999). 

Executive Orders 12866 and 13563 

Executive Order 12866 requires all 

regulations reflect consideration of 

alternatives, costs, benefits, incentives, 

equity, and 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. 

In 2011, President Obama supplemented 

and reaffirmed Executive Order 12866. 

Executive Order 13563 provides that, 

to the extent feasible and permitted by 

law, the public must be given a 

meaningful opportunity to comment on 

any proposed regulations, with at least 

a 60-day comment period. In addition, 

to the extent feasible and permitted by 

law, agencies must provide timely 

online access to both proposed and final 

rules of the rulemaking docket on 

https://www.regulations.gov/, including 

relevant scientific and technical 

findings, in an open format that can be 

searched and downloaded. Federal 

agencies must consider approaches to 

maintain the freedom of choice and 

flexibility, including disclosure of 

relevant information to the public. 

Objective scientific evidence guides 

regulations and should be easy to 

understand, consistent, and written in 

plain language. Furthermore, Federal 

agencies must attempt to coordinate, 

simplify, and harmonize regulations to 

reduce costs and promote certainty for 

the public. 

Summary of Impacts 

In this final rule, the Secretary 

establishes a Table identifying serious 

physical injuries that are presumed to 

result from the administration or use of 

certain covered countermeasures, 

required definitions of those injuries, 

and the time interval in which the onset 

of the first symptom or manifestation of 

each injury must manifest for the 

presumption of causation to apply. The 

Table establishes a presumption of 

causation for requesters meeting the 

Table’s requirements and relieves 

requesters of the burden of 

demonstrating causation. However, this 

presumption is rebuttable if, based on 

the Secretary’s review of the evidence, 

a source other than the countermeasure 

is found to be the more likely cause of 

the injury. The publication of this Table 

may afford some requesters a new filing 

deadline. 

The Secretary has determined that 

minimal staff and funding resources are 

required to implement the provisions 

included in this final rule. Therefore, in 

accordance with the Regulatory 

Flexibility Act of 1980 (RFA) and the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, which amended 

the RFA, the Secretary certifies that this 

final rule will not have a significant 

impact on a substantial number of small 

entities. 

The Secretary has determined that 

this final rule does not meet the criteria 

for an ‘‘economically significant’’ 

regulatory action as defined by 

Executive Order 12866 and would have 

no major effect on the economy or 

Federal expenditures. The Secretary 

also has determined that this final rule 

is not a ‘‘major rule’’ within the 

meaning of the statute providing for 

Congressional Review of Agency 

Rulemaking, 5 U.S.C. 801. The Office of 

Information and Regulatory Affairs 

within the Office of Management and 

Budget has determined that this rule is 

not a ‘‘significant regulatory action’’ 

within the meaning of section 3(f) of the 

Executive order. 

Unfunded Mandates Reform Act of 1995 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any 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 $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $158 million, 

using the most current (2020) Implicit 

Price Deflator for the Gross Domestic 

Product. This final rule would not result 

in an expenditure in any year that meets 

or exceeds this amount. 

Executive Order 13132—Federalism 

The Secretary also reviewed this final 

rule in accordance with Executive Order 

13132 regarding federalism and has 

determined that it does not have 

‘‘federalism implications.’’ This final 

rule will 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.’’ 

Paperwork Reduction Act of 1995 

This final rule has no information 

collection requirements. 

List of Subjects in 42 CFR Part 110 

Biologics, Immunization. 

Dated: August 9, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

PART 110—COUNTERMEASURES 

INJURY COMPENSATION PROGRAM 

■ 1. The authority citation for part 110 

continues to read as follows: 

Authority: 42 U.S.C. 247d–6e. 

■ 2. Amend § 110.100 by revising 

paragraph (b) introductory text and 

paragraph (c) and adding paragraph (d) 

to read as follows: 

§ 110.100 Injury Tables. 

* * * * * 

(b) Qualifications and aids to 

interpretation (table definitions and 

requirements). The following definitions 

and requirements shall apply to the 

Table set forth in paragraph (a) of this 

section and only apply for purposes of 

this subpart. 

* * * * * 

(c) Smallpox countermeasures injury 

table. 


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45658 Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 

TABLE 2 TO PARAGRAPH (c) 

Covered countermeasures under declarations Serious physical injury 

(illness, disability, injury, or condition) 1

Time interval 

(for first symptom or manifestation of onset of 

injury after administration or use of covered 

countermeasure, unless otherwise specified) 

I. Smallpox Vaccines Replication-Deficient ....... A. Anaphylaxis ..................................................

B. Vasovagal Syncope .....................................

A. 0–4 hours. 

B. 0–1 hour. 

II. Smallpox Vaccines Replication-Competent .. A. Anaphylaxis ..................................................

B. Vasovagal Syncope .....................................

A. 0–4 hours. 

B. 0–1 hour. 

C. Significant Local Skin Reaction ................... C. 1–21 days. 

D. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis.D. 4–28 days. 

E. Inadvertent Autoinoculation ......................... E. 1–21 days. 

F. Generalized Vaccinia ................................... F. 6–9 days. 

G. Eczema Vaccinatum .................................... G. 3–21 days. 

H. Progressive Vaccinia ................................... H. 3–21 days. 

I. Post-vaccinial Encephalopathy, Encephalitis 

or Encephalomyelitis (PVEM).

I. 5–14 days. 

J. Vaccinial Myocarditis, Pericarditis, or 

Myopericarditis (MP).

J. 0–21 days. 

III. Vaccinia Immunoglobulin Intravenous 

(VIGIV).

A. Anaphylaxis ..................................................

B. Transfusion-Related Acute Lung Injury 

(TRALI).

A. 0–4 hours. 

B. 0–72 hours. 

C. Acute Renal Failure (ARF) .......................... C. 0–10 days. 

D. Drug-Induced Aseptic Meningitis (DIAM) .... D. Within 48 hours after the first dose and up 

to 48 hours after the last dose of VIGIV. 

E. Hemolysis .................................................... E. 12 hours to 14 days. 

IV. Cidofovir ....................................................... A. No Condition Covered 2 ............................... A. Not Applicable. 

V. Tecovirimat .................................................... A. No Condition Covered 2 ............................... A. Not Applicable. 

VI. Brincidofovir ................................................. A. No Condition Covered 2 ............................... A. Not Applicable. 

VII. Smallpox Infection Diagnostic Testing Devices.A. No Condition Covered 2 ............................... A. Not Applicable. 

1Serious physical injury as defined in § 110.3(z). 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 will be considered serious physical injuries. 2The use of ‘‘No condition covered’’ in this Table 2 reflects that the Secretary evaluated the countermeasure, but at this time does not find 

compelling, reliable, valid, medical, and scientific evidence to support that any serious injury is presumed to be caused by the associated covered countermeasure. For injuries alleged to be due to covered countermeasures for which there is no associated Table 2 injury, requesters 

must demonstrate that the injury occurred as the direct result of the administration or use of the covered countermeasure. See § 110.20(b) and 

(c). 

(d) Qualifications and aids to 

interpretation (table definitions and 

requirements). The following definitions 

and requirements shall apply to the 

Table set forth in paragraph (c) of this 

section and only apply for purposes of 

this subpart. 

(1) Anaphylaxis. Anaphylaxis is an 

acute, severe, and potentially lethal 

systemic reaction that occurs as a single 

discrete event with simultaneous 

involvement of two or more organ 

systems. Most cases resolve without 

sequelae. Signs and symptoms begin 

within minutes to a few hours after 

exposure. Death, if it occurs, usually 

results from airway obstruction caused 

by laryngeal edema or bronchospasm 

and may be associated with 

cardiovascular collapse. Other 

significant clinical signs and symptoms 

may include the following: Cyanosis, 

hypotension, bradycardia, tachycardia, 

arrhythmia, edema of the pharynx and/ 

or trachea and/or larynx with stridor 

and dyspnea. There are no specific 

pathological findings to confirm a 

diagnosis of anaphylaxis. 

(2) Vasovagal syncope. Vasovagal 

syncope (also sometimes called 

neurocardiogenic syncope) means loss 

of consciousness (fainting) and loss of 

postural tone caused by a transient 

decrease in blood flow to the brain 

occurring after the administration of an 

injected countermeasure. Vasovagal 

syncope is usually a benign condition, 

but may result in falling and injury with 

significant sequelae. Vasovagal syncope 

may be preceded by symptoms, such as 

nausea, lightheadedness, diaphoresis 

(sweating), and/or pallor. Vasovagal 

syncope may be associated with 

transient seizure-like activity, but 

recovery of orientation and 

consciousness generally occurs 

simultaneously. Loss of consciousness 

resulting from the following conditions 

will not be considered vasovagal 

syncope: Organic heart disease, cardiac 

arrhythmias, transient ischemic attacks, 

hyperventilation, metabolic conditions, 

neurological conditions, psychiatric 

conditions, seizures, trauma, and 

situational as can occur with urination, 

defecation, or cough. This list is not 

complete as other conditions that are 

not associated with the vaccine also 

may cause loss of consciousness. 

Episodes of recurrent syncope occurring 

after the applicable timeframe are not 

considered to be sequelae of an episode 

of syncope meeting the Table 2 

requirements. 

(3) Significant local skin reaction. 

Significant local skin reaction is an 

unexpected and extreme response at the 

vaccination or inoculation site that 

results in a significant scar that is 

serious enough to require surgical 

intervention. The onset of this injury is 

the initial skin lesion at the vaccination 

site that generally occurs with 

replication-competent smallpox 

vaccinations. Minor scarring or minor 

local reactions do not constitute a Table 

2 injury. A robust take, defined as an 

area of redness at the vaccination site 

that exceeds 7.5 cm in diameter with 

associated swelling, warmth and pain, is 

generally considered an expected 

response to the vaccination or 

inoculation. A robust take, in itself, does 

not constitute a Table 2 injury, even 

when the redness and swelling involves 

the entire upper arm with associated 

enlargement and tenderness of the 

glands (lymph nodes) in the underarm 

(axilla). 


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(4) Stevens-Johnson syndrome/Toxic 

epidermal necrolysis (SJS/TEN). SJS/ 

TEN is a spectrum of acute 

hypersensitivity reactions that affects 

skin, mucous membranes, and 

sometimes, internal organs (systemic 

toxicity) associated with the use or 

administration of replication- competent 

smallpox vaccines. For purposes of 

Table 2, both skin and mucous 

membrane rash or lesions must be 

present. Rash or lesion distribution 

must be widespread. Rash must not 

have a symmetric acral distribution 

(affecting arms, hands, legs or feet). Two 

or more mucosal sites must be involved. 

Mucosal lesions generally manifest as 

painful lesions in sites, such as the 

mouth or eyes. Skin rash or lesions in 

SJS/TEN usually consist of red or purple 

raised areas (erythematous macules), 

blisters, and ulcerations. 

(5) Inadvertent autoinoculation (IA). 

IA is the spread of vaccinia virus from 

an existing vaccination site to a second 

location usually by scratching the 

vaccination site and subsequently 

spreading the virus, which produces a 

new vaccinial lesion on the same person 

who received the vaccination. IA is the 

most common adverse event associated 

with the replication-competent 

smallpox vaccine. 

(6) Generalized vaccinia (GV). GV is 

a vaccinial infection that occurs from 

the spread of vaccinia from an existing 

vaccination or inoculation site, with the 

use or administration of a replicationcompetent smallpox vaccine, to 

otherwise normal skin, resulting in 

multiple new areas of vaccinial rash or 

lesions. The vaccinia is believed to be 

spread through the blood. The rash or 

lesions, characterized by multiple 

blisters (vesicles or pustules), generally 

evolve in a similar sequence or manner 

as the original vaccination site. 

(7) Eczema vaccinatum (EV). EV is the 

transmission or the spread of vaccinia 

virus from a vaccination site, after the 

use or administration of a replicationcompetent smallpox vaccine, to skin 

that has been affected by, or is currently 

affected with, eczema or atopic 

dermatitis. EV is characterized by 

lesions that include multiple blisters 

(vesicles or pustules), which generally 

evolve in a similar sequence or manner 

as the original vaccination site. The 

lesions may come together to form larger 

lesions. Lesions may also spread to 

patches of skin that have never been 

involved with eczema or atopic 

dermatitis. The new lesions, if cultured, 

will be positive for vaccinia virus. A 

person with EV may become severely ill 

with signs and symptoms that involve 

the whole body (systemic illness), such 

as fever, malaise, or enlarged glands 

(lymph nodes). 

(8) Progressive vaccinia (PV). PV is 

the failure to initiate the healing process 

in an initial vaccination or inoculation 

site, after the use or administration of a 

replication-competent smallpox 

vaccine, by 21 days after exposure to 

vaccinia, with progressive ulceration or 

necrosis at the vaccination site leading 

to a large destructive ulcer. PV is seen 

in people who are 

immunocompromised (have an 

impaired immune system) and is 

characterized by a complete or near 

complete lack of inflammation or 

absence of inflammatory cells in the 

dermis of the skin at the vaccination 

site. The diagnosis of PV may be made 

before 21 days after exposure, especially 

in a known immunocompromised 

individual who develops a lesion at the 

vaccination site. PV may spread through 

the blood to any location in the body. 

No one who experiences a significant 

healing process of the vaccination site 

within 21 days after receipt of the 

replication-competent smallpox vaccine 

or exposure to vaccinia has PV. 

(9) Post-vaccinial encephalopathy, 

encephalitis, and encephalomyelitis 

(PVEM). PVEM is a spectrum of 

overlapping conditions that includes 

post-vaccinial encephalopathy, 

encephalitis, and encephalomyelitis, 

and, for the purposes of Table 2, is 

treated as one injury. For the purposes 

of Table 2, PVEM is an autoimmune 

central nervous system injury that 

occurs after the use or administration of 

a replication-competent smallpox 

vaccine. In rare cases, the vaccinia virus 

is isolated from the central nervous 

system. Manifestations usually occur 

abruptly and may include fever, 

vomiting, loss of appetite (anorexia), 

headache, general malaise, impaired 

consciousness, confusion, 

disorientation, delirium, drowsiness, 

seizures, language difficulties (aphasia), 

coma, muscular incoordination (ataxia), 

urinary incontinence, urinary retention, 

and clinical signs consistent with 

inflammation of the spinal cord 

(myelitis), such as paralysis or 

meningismus (meningeal irritation). 

Long-term central nervous system 

impairments, such as paralysis, seizure 

disorders, or developmental delays are 

known to occur as sequelae of the acute 

PVEM. No clinical criteria, radiographic 

findings, or laboratory tests are specific 

for the diagnosis of PVEM. Symptoms 

that occur before 5 days or more than 14 

days after receiving the smallpox 

vaccine should not be attributed to it. In 

addition, encephalopathy caused by an 

infection, a toxin, a metabolic 

disturbance, a structural lesion, a 

genetic disorder, or trauma would not 

meet the Table 2 definition. 

(10) Vaccinial myocarditis, 

pericarditis, or myopericarditis (MP). 

For purposes of Table 2, MP is vaccinial 

myocarditis, pericarditis, or 

myopericarditis. Vaccinial myocarditis 

is defined as an inflammation of the 

heart muscle (myocardium) because of 

receiving the replication-competent 

smallpox vaccine. Vaccinial pericarditis 

is defined as an inflammation of the 

covering of the heart (pericardium) 

because of receiving the smallpox 

vaccine. Vaccinial myopericarditis is 

defined as an inflammation of both the 

heart muscle and its covering because of 

receiving the smallpox vaccine. The 

inflammation associated with MP may 

range in severity from very mild 

(subclinical) to life threatening. In many 

mild cases, myocarditis is diagnosed 

solely by transient electrocardiographic 

(EKG) abnormalities (e.g., ST segment 

and T wave changes), increased cardiac 

enzymes, or mild echocardiographic 

abnormalities. Arrhythmias, abnormal 

heart sounds, heart failure, and death 

may occur in more severe cases. 

Pericarditis generally manifests with 

chest pain, abnormal heart sounds 

(pericardial friction rub), EKG 

abnormalities (e.g., ST segment and T 

wave changes), and/or increased fluid 

accumulation around the heart. A Table 

2 injury of MP requires sufficient 

evidence in the medical records of the 

occurrence of acute MP. 

(11) Transfusion-related acute lung 

injury (TRALI). TRALI is defined as the 

onset of respiratory distress within 6 

hours in non-critically ill patients, and 

72 hours in critically ill patients, after 

receipt of blood products containing 

plasma, in this case, VIGIV. The relative 

level of illness will be determined on a 

case-by-case basis after reviewing the 

medical records and the medical 

history. The respiratory distress is the 

result of receiving a plasma containing 

transfusion (VIGIV) and subsequently 

developing pulmonary edema, 

respiratory distress, and hypoxia. TRALI 

occurs as the result of an antibody 

response in the host to the donor 

antibodies within the plasma product. 

Pulmonary edema is non-cardiac in 

nature and does not occur more than 72 

hours after receiving VIGIV. Pulmonary 

edema occurring more than 72 hours 

after receiving a blood product 

containing plasma (VIGIV) or associated 

with cardiac dysfunction is not TRALI 

and is excluded as a countermeasurerelated injury. TRALI has been 

identified as a major cause of mortality 

in those individual receiving plasmacontaining transfusions. A Table 2 

injury for TRALI has occurred in a 


lotter on DSK11XQN23PROD with RULES1
45660 Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 

1 Disaster Recovery Reform Act of 2018, Public 

Law 115–254, 132 Stat. 3186 (Oct. 5, 2018), 42 

U.S.C. 5189a. 

recipient if there is sufficient evidence 

in the medical record of an occurrence 

of TRALI and the pulmonary edema is 

not caused by cardiac dysfunction or 

other causes and occurs within 72 of 

receiving a blood product containing 

plasma, in this case VIGIV. 

(12) Acute renal failure (ARF). ARF is 

the sudden loss of the kidneys’ ability 

to perform their main function of 

eliminating excess fluids and 

electrolytes (salts), as well as waste 

material from the blood. ARF, which is 

also called acute kidney injury, 

develops rapidly over a few hours or a 

few days. ARF can be fatal and requires 

intensive treatment; however, ARF may 

be reversible. ARF may cause 

permanent loss of kidney function, or 

end-stage renal disease necessitating 

dialysis or transplant. A Table 2 injury 

for ARF has occurred if there is 

sufficient evidence in the medical 

record of an occurrence of ARF within 

the identified timeframe and the 

individual received the associated 

countermeasure (VIGIV). 

(13) Drug-induced aseptic meningitis 

(DIAM). (i) DIAM is an inflammation of 

the meninges (linings of the brain) that 

is not caused by a bacteria or virus, but 

is caused by a drug or medication. The 

symptoms of meningitis include severe 

headache, nuchal (neck) rigidity, 

drowsiness, fever, photophobia (light 

sensitivity), painful eye movements, 

nausea, and vomiting. Discontinuation 

of the medication leads to a resolution 

of the symptoms. DIAM is thought to 

occur because of an immunological 

hypersensitivity reaction to a specific 

medication. In the case of 

immunoglobulins, DIAM may be 

precipitated by the immunologically 

active components within the plasma or 

because of the stabilizers used within 

the product. The symptoms of DIAM 

may reoccur with another exposure to 

the offending agent. 

(ii) A Table 2 injury for DIAM has 

occurred in a recipient if there is 

sufficient evidence in the medical 

record of an occurrence of DIAM within 

the identified timeframe and the 

individual received the associated 

countermeasure (VIGIV). DIAM 

occurring in the absence of the use of 

VIGIV, or DIAM occurring with the use 

of VIGIV outside the established 

timeframe of onset, which is any time 

after the first dose and up to 48 hours 

after the last dose of this medication, is 

not a Table 2 injury. 

(14) Hemolysis. Hemolysis is the 

physical breakdown of red blood cells 

(RBCs) either through natural attrition 

or as caused by external factors. The 

RBC’s function is to transport oxygen 

throughout the body in the hemoglobin 

contained within the RBC. Additionally, 

the RBCs contain the majority of the 

body’s potassium stores. With 

hemolysis, the body is unable to 

transport oxygen effectively, and the 

person develops hypoxia. Additionally, 

the rapid breakdown of the cell releases 

large amounts of potassium into the 

blood stream, which can cause 

abnormal heart rhythms and cardiac 

arrest. In severe cases of hemolysis, a 

blood transfusion may be required to 

correct the resulting anemia. A Table 2 

injury for hemolysis has occurred if 

there is sufficient evidence in the 

medical record of an occurrence of 

hemolysis, and the patient received the 

associated countermeasure (VIGIV). 

Hemolysis occurring in the absence of 

the use of VIGIV and outside of the 

timeframe of 12 hours to 14 days after 

receiving VIGIV is not a Table 2 injury. 

Hemolysis occurring from a more likely 

alternative diagnosis, such as infections, 

toxins, poisons, hemodialysis, or 

medications, is not a Table 2 injury. 

This list of conditions that can cause 

hemolysis, not associated with VIGIV, is 

not exhaustive, and all additional 

diagnoses within the medical 

documentation will be evaluated. 

[FR Doc. 2021–17216 Filed 8–13–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 206 

[Docket ID: FEMA–2019–0012] 

RIN 1660–AB00 

Public Assistance Appeals and 

Arbitrations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This final rule implements 

the new right of arbitration authorized 

by the Disaster Recovery Reform Act of 

2018 (DRRA) and revises the Federal 

Emergency Management Agency’s 

regulations regarding first and second 

Public Assistance appeals. 

DATES: This rule is effective on January 

1, 2022. Proposed information 

collection comments must be submitted 

on or before September 15, 2021. 

ADDRESSES: The docket for this 

rulemaking is available for inspection 

using the Federal eRulemaking Portal: 

http://www.regulations.gov and can be 

viewed by following that website’s 

instructions. 

Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Shabnaum Amjad, Deputy Associate 

Chief Counsel, Regulatory Affairs, Office 

of Chief Counsel, Federal Emergency 

Management Agency, 500 C Street SW, 

Washington, DC 20472. Phone: 202– 

212–2398 or email: Shabnaum.Amjad@

fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Proposed Rule 

On August 31, 2020, the Federal 

Emergency Management Agency 

(FEMA) published a Notice of Proposed 

Rulemaking (NPRM) (85 FR 53725) 

proposing to revise its current Public 

Assistance (PA) appeals regulation at 44 

CFR 206.206 to add in the new right to 

arbitration under the Disaster Recovery 

Reform Act of 2018 (DRRA),1 in 

conjunction with some revisions to the 

current appeals process. The DRRA 

adds arbitration as a permanent 

alternative to a second appeal under the 

PA Program. Additionally, applicants 

that have had a first appeal pending 

with FEMA for more than 180 calendar 

days may withdraw such appeal and 

submit a request for arbitration. In both 

cases, the amount in dispute must be 

greater than $500,000, or greater than 

$100,000 for an applicant for assistance 

in a rural area. The other major 

proposed revisions to 44 CFR 206.206 

included adding definitions; adding 

subparagraphs to clarify what actions 

FEMA may take and will not take while 

an appeal is pending and stating that 

FEMA may issue separate guidance as 

necessary, similar to current 44 CFR 

206.209(m); adding a finality of decision 

paragraph; requiring electronic 

submission for appeals and arbitrations 

documents; and clarifying overall time 

limits for first and second appeals. 

These proposed rules for arbitration 

are separate and distinct from the 

arbitration provisions located in 44 CFR 

206.209. Under § 206.209, applicants 

may request arbitration to resolve 

disputed PA applications under major 

disaster declarations for Hurricanes 

Katrina and Rita, pursuant to the 


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