[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10835-10837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03747]


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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; Delay of Effective Date

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

ACTION: Final rule; delay of effective date.

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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 delays 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 (January 21, 2021 Final Rule).

DATES: As of February 22, 2021, the effective date of the January 21, 
2021 Final Rule, published in the Federal Register at 86 FR 6249, is 
delayed for 60 days, from February 22, 2021 to April 23, 2021.

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: 

I. Background

    HHS published a notice of proposed rulemaking on July 20, 2020 (85 
FR 43794), and a final rule on January 21, 2021 (86 FR 6249). The 
January 20, 2021 Final Rule amended the provisions of 42 CFR 100.3 by 
removing Shoulder Injury Related to Vaccine Administration (SIRVA), 
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.
    On February 12, 2021, HHS published a notice of proposed 
rulemaking, proposing, after a brief public comment period, to delay 
the effective date of the January 21, 2021 Final Rule for 60 days, from 
February 22, 2021, to April 23, 2021. HHS did so to determine whether 
the January 21, 2021 Final Rule's promulgation raises any legal issues, 
including but not limited to (1) whether the Advisory Commission on 
Childhood Vaccines (ACCV) was properly notified of the proposed rule 
pursuant to 42

[[Page 10836]]

U.S.C. 300aa-14(c) and (d), 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 received 29 comments on the notice of proposed rulemaking, most 
in support of the delay of the effective date to April 23, 2021, with 
only two anonymous comments against. After careful consideration of the 
comments received, HHS has decided to delay the January 21, 2021 Final 
Rule's effective date to April 23, 2021. HHS continues to believe that 
the delay is reasonable and will not be disruptive because the 
underlying rule has not yet been implemented or taken effect.
    Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 
551 et seq.) requires that Federal agencies provide at least 30 days 
after publication of a final rule in the Federal Register before making 
it effective, unless good cause can be found not to do so. HHS finds 
that there is good cause for making this final rule effective less than 
30 days after publication in the Federal Register given that failure to 
do so would result in the January 21, 2021 Final Rule going into effect 
before it can be reviewed by the new Administration pursuant to the 
Regulatory Freeze Memorandum and OMB M-21-14, and because the majority 
of public comments received support the delay and HHS's plans to more 
closely review the January 21, 2021 Final Rule's promulgation for both 
procedural and policy reasons.

II. Analysis and Responses to Public Comments

    In the notice of proposed rulemaking, HHS solicited comments 
regarding whether to delay the January 21, 2021 Final Rule's effective 
date for 60 days, from February 22, 2021, to April 23, 2021. We 
received 29 comments. The 27 comments in support of the delay of the 
effective date of the January 21, 2021 Final Rule to April 23, 2021, 
were from a broad range of patients, vaccine attorneys and legal 
clinics, biotech trade associations, pharmacist and drug store 
associations, and non-profit organizations. HHS only received two 
anonymous comments opposing the delay of the effective date of the 
January 21, 2021 Final Rule. HHS took into consideration comments on 
the underlying rule to the extent they shed light on the reasons 
commenters were for or against the delay; other comments that raised 
issues beyond the scope of the proposed rule delaying the effective 
date are not addressed here, but will be considered by the agency in 
determining future actions related to the underlying rule. We have 
summarized the relevant comments received and provided our answers 
below.
    Eight commenters, including the Biotechnology Innovation 
Organization, American Association for Justice, Walgreens, and the 
National Association of Chain Drug Stores, support delaying the January 
21, 2021 Final Rule because they believe that the rule contravenes the 
purpose of the National Childhood Vaccine Injury Act. Thirteen 
commenters, including the National Community Pharmacists Association, 
the Vaccine Injured Petitioners Bar Association, the American 
Pharmacists Association, the National Alliance of State Pharmacy 
Associations, and various petitioners' attorneys, support the delay of 
the final rule because they believe the final rule did not adequately 
take into account the recommendations of the ACCV or the public. Four 
commenters, including a petitioner's attorney, supported the delay so 
that, pursuant to the Regulatory Freeze memorandum, the new 
Administration may review the rule and the comments submitted during 
that rulemaking process. Another commenter expressed concern with the 
promulgation of the final rule, specifically that the contents of the 
November 9, 2020 hearing have not been made publicly available, and as 
such supported the delay. Many commenters who said they had their own 
SIRVA injuries supported the delay. Finally, four commenters stated 
that the January 21, 2021 Final Rule contravenes the science 
surrounding SIRVA. HHS agrees that delaying the effective date of the 
final rule would provide the agency time to ensure the rule was 
properly promulgated and consider the other issues surrounding the 
rule.
    Two anonymous commenters opposed the delay of the final rule. One 
anonymous commenter stated the final rule should go into effect without 
delay for the reasons stated in the Department of Justice's (DOJ) May 
15, 2020 letter. See https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/hunt-letter-sirva.pdf. That letter 
outlines DOJ's views with respect to the July 20, 2020 notice of 
proposed rulemaking (NPRM) (85 FR 43794), specifically the view that 
SIRVA should not be a compensable injury under the VICP, but does not 
discuss why the commenter opposes delaying the effective date of the 
final rule. As such, HHS is unable to respond to this comment as it 
does not state why the commenter does not support the delay.
    The other anonymous commenter asserted, without indicating the 
factual basis for the assertion, that the ACCV had been properly 
notified about the NPRM to remove SIRVA, vasovagal syncope, and Item 
XVII from the Table. Furthermore, the anonymous commenter pointed out 
that ``HHS says it needs time to determine whether the ACCV `was 
properly notified of the proposed rule pursuant to 42 U.S.C. 300aa-
14(c).' 86 FR 9308, 9309 (Feb. 12, 2021) (the notice refers to 42 
U.S.C. 300aa-14(c), but presumably it meant to refer to 300aa-
14(d).).'' HHS disagrees with this commenter's views about the ACCV and 
is concerned that the ACCV may not have been properly notified. We also 
note that 300aa-14(c) discusses the process for promulgating 
regulations to revise the Table, but agree that section that 300aa-
14(d) discusses the role of the ACCV in the regulation process more 
specifically. That subsection states the ``Secretary may not propose a 
regulation under subsection (c) or any revision thereof, unless the 
Secretary has first provided to the Commission 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.'' [emphasis added] Per the March 6, 2020 ACCV meeting 
minutes, found at https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/meetings/2020/accv-march-meeting-minutes.pdf, ACCV members said during the March meeting that, because 
the NPRM was marked as ``privileged and confidential'' and was not on 
the agenda for the meeting, they were uncertain whether they were 
allowed to discuss the NPRM at the ACCV meeting as a group. The fact 
that ACCV members were uncertain as to whether the ACCV as a group 
could discuss the NPRM at that meeting raises the issue about whether 
the ACCV as a whole actually was provided with the statutorily-required 
90 days to provide its comments and recommendations on the NPRM. This 
sentiment was echoed in the May 18, 2020 meeting minutes, found at 
https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/meetings/2020/accv-may-meeting-minutes.pdf, where, for an 
example, an ACCV member raised the issue that ``ACCV commissioners 
received this draft VICP NPRM in February of 2020, at that time 
commissioners were told it was

[[Page 10837]]

privileged, confidential document that could not be discussed. It was 
not on the agenda for the March 6, 2020 meeting.'' While the member 
acknowledged a brief discussion did occur, it remains clear that not 
all ACCV members believed they could discuss the NPRM during the March 
meeting. In a letter to the Secretary of HHS dated May 20, 2020, with 
the recommendation to oppose the proposed changes to the Table, the 
ACCV again expressed dissatisfaction with the ACCV recommendation 
process, stating, ``During its March 6 Meeting, the Commission briefly 
discussed this draft NPRM; however, no representative from HHS was 
present to address questions from ACCV members, and discussion of the 
draft NPRM was not an agenda item. Therefore, ACCV members requested, 
among other things, a meeting with an HHS official to respond to their 
questions about the NPRM. Thus, the May 18, 2020 meeting was scheduled, 
but an HHS official who could respond to the ACCV's questions did not 
attend.'' (See https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/reports/accv-recommendation-may-2020.pdf.)
    That anonymous commenter also stated that the public was made aware 
of the entire revised regulation, including the qualifications and aids 
to interpretation and coverage provisions, because ``the NPRM and the 
Final Rule provide: `In 100.3, revise paragraph (a) and remove 
paragraphs (c)(10) and (13) and (e)(8).' 85 FR 43,804; 86 FR 6249, 6267 
(Jan. 21, 2021).'' The anonymous commenter said he or she believes it 
is sufficient to refer solely to the paragraphs being removed, and not 
spell out the entire revised regulation. However, the final rule says, 
``In Sec.  100.3, revise paragraph (a) and remove paragraphs (c)(10) 
and (13) and (e)(8). The revision reads as follows . . .'' After the 
``as follows,'' the only text that is included is the Table itself, and 
not the revised qualifications and aids to interpretation and coverage 
provisions. Therefore, the language in the proposed and final rules is 
ambiguous because it implies that the entirety of the revised 
regulation is included, but then only includes the Table itself. 
Furthermore, the version of the Vaccine Injury Table that is currently 
displayed on the eCFR includes a link titled ``Link to an amendment 
published at 86 FR 6267, Jan. 21, 2021.'' This link displays only the 
Vaccine Injury Table that was published in the final rule, and this 
delay will permit HHS to clarify these seemingly conflicting 
instructions concerning 42 CFR 100.3(b)-(e).

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 
3(f) of Executive Order 12866.
    HHS has determined that no resources are required to implement the 
requirements in this rule because compensation will continue to be made 
consistent with the status quo. Therefore, in accordance with the 
Regulatory Flexibility Act of 1980 (RFA), and the Small Business 
Regulatory Enforcement Act of 1996, which amended the RFA, HHS 
certifies that this rule will not have a significant impact on a 
substantial number of small entities.
    HHS has also determined that this rule does not meet the criteria 
for a major rule under the Congressional Review Act or Executive Order 
12866 and would have no major effect on the economy or Federal 
expenditures. Similarly, it will not have effects on State, local, and 
tribal governments and on the private sector such as to require 
consultation under the Unfunded Mandates Reform Act of 1995. Nor on the 
basis of family well-being will the provisions of this rule 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 654(c) of the Treasury and General Government Appropriations 
Act of 1999.

Impact of the New Rule

    This rule extends the effective date of the final rule titled 
``National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table'' until April 23, 2021, to determine whether that 
rule's promulgation raises any legal issues. This delay is reasonable 
and will not be disruptive because the underlying rule has not yet been 
implemented or taken effect.

Paperwork Reduction Act of 1995

    This rule has no information collection requirements.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-03747 Filed 2-19-21; 11:15 am]
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