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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Proposed Rules 1999; availability of voluntary consensus standards pursuant to Section 12d of the National Technology Transfer and Advancement Act of 1995 NTTAA, Public Law 104
113; tribal implications pursuant to Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments 65 FR
67249, November 6, 2000;
environmental health or safety effects on children pursuant to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997; energy effects pursuant to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use 66 FR 28355, May 22, 2001; Paperwork burdens pursuant to the Paperwork Reduction Act PRA
44 U.S.C. 3501; or human health or environmental effects on minority or low-income populations pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994. The Agency will consider such comments during the development of any subsequent rulemaking.
List of Subjects in 40 CFR Part 414
Environmental protection, Chemicals, Plastics materials and synthetics, Waste treatment and disposal, Water pollution control.
Jane Nishida, Acting Administrator.
FR Doc. 202105402 Filed 31621; 8:45 am BILLING CODE 656050P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906AB24

National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table Health Resources and Services Administration HRSA, Department of Health and Human Services HHS.
ACTION: Notice of proposed withdrawal;
request for comments.
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AGENCY:

HHS proposes rescinding the final rule entitled National Vaccine Injury Compensation Program:
Revisions to the Vaccine Injury Table, published in the Federal Register on January 21, 2021. That final rule, if it were to go into effect, would amend our
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regulations by removing Shoulder Injury Related to Vaccine Administration SIRVA, vasovagal syncope, and the new vaccines category Item XVII from the Vaccine Injury Table Table. HHS
seeks comments on this proposed rescission.
The final rule published January 21, 2021, at 86 FR 6249, delayed February 23, 2021, at 86 FR 10835, is proposed to be withdrawn. Written comments and related material to this proposed withdrawal must be received on or before April 16, 2021.
ADDRESSES: You may submit written comments electronically by the following method: Federal eRulemaking Portal: http www.regulations.gov.
Follow the instructions on the website for submitting comments.
Instructions. Include the HHS Docket No. HRSA20210001 in your comments. All comments received will be posted without change to http
www.regulations.gov. Please do not include any personally identifiable or confidential business information you do not want publicly disclosed.
FOR FURTHER INFORMATION CONTACT:
Please visit the National Vaccine Injury Compensation Programs website, https www.hrsa.gov/
vaccinecompensation/, or contact Tamara Overby, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at vaccinecompensation@hrsa.gov; or by telephone at 855 2662427.
SUPPLEMENTARY INFORMATION: This is a notice of proposed rulemaking by which HHS proposes to rescind the final rule titled National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, final rule, January 21, 2021, 86 FR 6249, delayed February 23, 2021, 86 FR 10835, which, if it were to go into effect, would amend the provisions of 42 CFR 100.3 by removing Shoulder Injury Related to Vaccine Administration SIRVA, vasovagal syncope, and the new vaccines category Item XVII from the Table.
DATES:

I. Background and Purpose The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99660 42 U.S.C. 300aa10 et seq.
Vaccine Act, established the National Vaccine Injury Compensation Program VICP to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines
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to be compensated. The Vaccine Act has been amended several times since 1986.
Petitions for compensation under this Program 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 be found entitled to an award under the VICP, a petitioner must establish a vaccine-related injury or death, either by proving that a vaccine actually caused or significantly aggravated an injury causation-in-fact or by demonstrating the occurrence of what has been 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 Tablecorresponding to the vaccination in question, and that the onset of such injury took place within a time period also specified in the Table. The Table is accompanied by, among other provisions, the Qualifications and Aids to Interpretation QAI, which defines the injuries and conditions listed on the Table. If these criteria are met, the injury is presumed to have been caused by the vaccination, and the petitioner is entitled to compensation assuming that other 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.
300aa11c1Ci, 300aa13a1B, and 300aa14a. Currently, cases are often resolved by negotiated settlements between the parties and approved by the Court. In such situations, HHS and the Court have not concluded, based upon review of the evidence, that the vaccine caused the alleged injury.
Revisions to the Table are authorized under the Vaccine Act 42 U.S.C. 300aa 14ce. The Vaccine Act prohibits the Secretary of HHS from proposing a revision to the Table unless the Secretary has first provided to the Advisory Commission on Childhood Vaccines a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations 42 U.S.C.
300aa14d. Further, once the proposed revision is published, the Secretary must afford the public at least 180 days of public comment 42 U.S.C.
300aa14c1.
HHS added SIRVA and vasovagal syncope to the Table in March 2017, following an extensive, multi-year process that involved nine HHS
workgroups, including HRSA and the
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