Quiero saber acerca de...

68427

Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations U.S.C. 300aa11f. In addition, the Cures Act modified the Vaccine Acts one petition requirement by allowing two VICP petitions: One on behalf of a woman who was pregnant when vaccinated and one on behalf of her child whose injurys was allegedly sustained in utero. See 42 U.S.C. 300aa 11b2.
III. Regulatory Impact Analysis Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits including potential economic, environmental, public health, safety, distributive, and equity effects.
In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, HHS must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.
The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under section 3f of Executive Order 12866.
HHS has determined that no substantial additional administrative and compensation resources are required to implement the requirements in this rule. Compensation will be made in the same manner. As in all other VICP cases, to be found entitled to compensation, petitioners will need to prove by a preponderance of the evidence either that they meet the requirements of the Table or that their injury was caused by the vaccine unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination. Therefore, 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.
The National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table Final Rule is not significant because no substantial resources are required to implement the requirements in this rule. This rule adds and/or pregnant women to the new vaccines category Item XVII on the Table.
Currently, the only vaccines recommended for routine administration in pregnant women are already on the Table because they are recommended for routine administration to children and have an excise tax imposed on them. Therefore, this final rule does not have a significant impact on a substantial number of small entities. Additionally, this rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the 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.
Similarly, it will not have effects on state, local, and tribal governments and on the private sector such as requiring consultation under the Unfunded Mandates Reform Act of 1995.
The provisions of this final rule do not, on the basis of family well-being, affect 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 654c of the Treasury and General Government Appropriations Act of 1999.
This final rule is not being treated as a significant regulatory action as defined under section 3f of Executive
Order 12866. As stated above, this final rule will modify the Table based on legal authority.
Impact of the New Rule This final rule will allow any vaccines that in the future are recommended by the CDC for routine administration to pregnant women and subject to an excise tax to be covered under the VICP
after the Secretary issues a notice of coverage, without requiring further rulemaking. In addition, this final rule will have the effect of making it easier for future petitioners alleging injuries that meet the criteria in the Vaccine Injury Table to receive the Tables presumption of causation, which relieves them of having to prove that the vaccine actually caused or significantly aggravated their injury.
Paperwork Reduction Act of 1995
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
Xavier Becerra, Secretary, Department of Health and Human Services.

Accordingly, 42 CFR part 100 is amended as set forth below:
PART 100VACCINE INJURY
COMPENSATION
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, amend the Table in paragraph a by revising entry XVII
to read as follows:

100.3

Vaccine injury table.

a

lotter on DSK11XQN23PROD with RULES1

VACCINE INJURY TABLE

Vaccine
Illness, disability, injury, or condition covered

XVII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children and/or pregnant women, after publication by the Secretary of a notice of coverage.

A. Shoulder Injury Related to Vaccine Administration.
B. Vasovagal syncope

VerDate Sep<11>2014

16:00 Dec 01, 2021

Jkt 256001

PO 00000

Frm 00039

Fmt 4700

Sfmt 4700

E:FRFM02DER1.SGM

02DER1

Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration
48 hours.
1 hour.