Federal Register - January 21, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations responsibilities among the various levels of government.
PART 100VACCINE INJURY
COMPENSATION
B. Collection of Information
The Paperwork Reduction Act of 1995
44 U.S.C. 3507d PRA requires that OMB approve all collections of information by a federal agency from the public before they can be implemented.
This final rule is projected to have no impact on current reporting and recordkeeping burden, as the amendments finalized 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.
Accordingly, 42 CFR part 100 is amended as set forth below:
1. The authority citation for 42 CFR
part 100 continues to read as follows:
Authority: Secs. 312 and 313 of Public Law 99660 42 U.S.C. 300aa1 note; 42 U.S.C.
300aa10 to 300aa34; 26 U.S.C. 4132a; and sec. 13632a3 of Public Law 10366.
2. In 100.3, revise paragraph a and remove paragraphs c10 and 13 and e8. The revision reads as follows:
100.3
Vaccine injury table.
a In accordance with section 312b of the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99660, 100 Stat. 3779 42 U.S.C.
300aa1 note and section 2114c of the Public Health Service Act, as amended PHS Act 42 U.S.C. 300aa14c, the following is a table of vaccines, the injuries, disabilities, illnesses,
6267
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 PARAGRAPH aVACCINE INJURY TABLE
Illness, disability, injury or condition covered
I. Vaccines containing tetanus toxoid e.g., DTaP, DTP, DT, Td, or TT.
A. Anaphylaxis
4 hours.
B. Brachial Neuritis
A. Anaphylaxis
228 days not less than 2 days and not more than 28 days.
4 hours.
B. Encephalopathy or encephalitis
A. Anaphylaxis
72 hours.
4 hours.
B. Encephalopathy or encephalitis
515 days not less than 5 days and not more than 15 days.
742 days not less than 7 days and not more than 42 days.
730 days not less than 7 days and not more than 30 days.
II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigens e.g., DTP, DTaP, P, DTP-Hib.
III. Vaccines containing measles, mumps, and rubella virus or any of its components e.g., MMR, MM, MMRV.
IV. Vaccines containing rubella virus e.g., MMR, MMRV.
V. Vaccines containing measles virus e.g., MMR, MM, MMRV.
VI. Vaccines containing polio live virus OPV.
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Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
Vaccine
VII. Vaccines containing polio inactivated virus e.g., IPV.
VIII. Hepatitis B vaccines
IX. Haemophilus influenzae type b Hib vaccines.
X. Varicella vaccines
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A. Chronic arthritis
A. Thrombocytopenic purpura
B. Vaccine-Strain Measles Viral Disease in an immunodeficient recipient.
Vaccine-strain virus identified
If strain determination is not done or if laboratory testing is inconclusive.
A. Paralytic Polio.
Not applicable.
12 months.
in a non-immunodeficient recipient
in an immunodeficient recipient
in a vaccine associated community case
B. Vaccine-Strain Polio Viral Infection.
in a non-immunodeficient recipient
in an immunodeficient recipient
in a vaccine associated community case
A. Anaphylaxis
30 days.
6 months.
Not applicable.
A. Anaphylaxis
No Condition Specified.
4 hours.
Not applicable.
A. Anaphylaxis
B. Disseminated varicella vaccine-strain viral disease.
Vaccine-strain virus identified
4 hours.
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30 days.
6 months.
Not applicable.
4 hours.
Not applicable.
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