[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Proposed Rules]
[Pages 9308-9309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB24


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table; Notice of Proposed Rulemaking; Public Comment 
Period; Delay of Effective Date

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking; proposed delay of effective 
date; request for comments.

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SUMMARY: In accordance with the Presidential directive as expressed in 
the memorandum of January 20, 2021, from the Assistant to the President 
and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this 
action proposes, following a brief public comment period, to further 
delay until April 23, 2021, the effective date of the 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 is scheduled to take effect on February 22, 
2021. HHS seeks comments on this proposed delay, which would allow it 
additional opportunity for review and consideration of the new rule.

DATES: Written comments and related material to this proposed rule must 
be received to the online docket via https://www.regulations.gov on or 
before February 16, 2021.

ADDRESSES: You may submit written comments electronically by the

[[Page 9309]]

following method: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions on the website for 
submitting comments.
    Instructions. Include the HHS Docket No. HRSA-2021-0001 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 Program's 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 
[email protected]; or by telephone at (855) 266-2427.

SUPPLEMENTARY INFORMATION: HHS published a notice of proposed 
rulemaking on July 20, 2020 (85 FR 43794), and final rule on January 
21, 2021 (86 FR 6249). That final rule amended the provisions of 42 CFR 
100.3 by removing Shoulder Injury Related to Vaccine Administration, 
vasovagal syncope, and Item XVII from the Vaccine Injury Table. The 
January 20, 2021, memorandum from the Assistant to the President and 
Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' 
instructed federal agencies to consider delaying the effective date of 
rules published in the Federal Register, but which have not yet taken 
effect, for a period of 60 days so that the new Administration may 
review recently published rules for ``any questions of fact, law, and 
policy the rule may raise.'' The memorandum notes certain exceptions 
that do not apply here. On January 20, 2021, the Office of Management 
and Budget (OMB) also published OMB Memorandum M-21-14, Implementation 
of Memorandum Concerning Regulatory Freeze Pending Review, which 
provides guidance regarding the Regulatory Freeze Memorandum. See OMB 
M-21-14, Implementation of Memorandum Concerning Regulatory Freeze 
Pending Review, https://www.whitehouse.gov/wp-content/uploads/2021/01/M-21-14-Regulatory-Review.pdf. OMB M-21-14 explains that pursuant to 
the Regulatory Freeze Memorandum, agencies ``should consider postponing 
the effective dates for 60 days and reopening the rulemaking process'' 
for ``rules that have not yet taken effect and about which questions 
involving law, fact, or policy have been raised.'' Id. In accordance 
with the Regulatory Freeze Memorandum and OMB M-21-14, HHS proposes to 
delay the effective date of the final rule revising the Vaccine Injury 
Table to April 23, 2021, which would be 60 days beyond its original 
effective date. HHS needs to extend the effective date of the 
underlying rule by 60 days to determine whether its promulgation raises 
any legal issues, including but not limited to (1) whether the Advisory 
Commission on Childhood Vaccines was properly notified of the proposed 
rule pursuant to 42 U.S.C. 300aa-14(c), and (2) whether the public was 
properly notified of the entire revised regulation, 42 CFR 100.3(b)-(e) 
(including the qualifications and aids to interpretation and the 
coverage provisions), given that both the proposed and final rules 
published in the Federal Register included only the revised Vaccine 
Injury Table itself, but not the entire revised regulation. HHS 
believes that the proposed delay is reasonable, would allow HHS time to 
receive public comments, and would not be disruptive since the 
underlying rule has not yet taken effect and the agency has not yet 
implemented the rule.
    HHS seeks comment on the proposed delay, including the proposed 
delay's impact on any legal, factual, or policy issues raised by the 
underlying rule and whether further review of those issues warrants 
such a delay. All other comments on the underlying rule will be 
considered to be outside the scope of this rulemaking. HHS therefore 
seeks comment by February 16, 2021 on its proposal to extend the 
effective date by 60 days to April 23, 2021.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-03069 Filed 2-11-21; 8:45 am]
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