National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective Date, 10835-10837 [2021-03747]
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Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
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Agency consideration of voluntary
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12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
X. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
VerDate Sep<11>2014
21:28 Feb 22, 2021
Jkt 253001
Dated: December 23, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1381 to subpart D to read
as follows:
■
§ 180.1381 Oxalic Acid; exemption from
the requirement of a tolerance.
Residues of oxalic acid in or on honey
and honeycomb are exempted from the
requirement of a tolerance when oxalic
acid is used as a miticide in honeybee
hives.
[FR Doc. 2021–03256 Filed 2–22–21; 8:45 am]
BILLING CODE 6560–50–P
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Final rule; delay of effective
date.
AGENCY:
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/
SUMMARY:
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10835
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) 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-21-14Regulatory-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
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Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
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
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Jkt 253001
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,
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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-meetingminutes.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 statutorilyrequired 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-maymeeting-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
E:\FR\FM\23FER1.SGM
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Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
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/advisorycommittees/vaccines/reports/accvrecommendation-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 § 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).
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Jkt 253001
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
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10837
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]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2021–0003; Internal
Agency Docket No. FEMA–8667]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur.
Information identifying the current
participation status of a community can
be obtained from FEMA’s CSB available
at www.fema.gov/flood-insurance/workwith-nfip/community-status-book.
Please note that per Revisions to
Publication Requirements for
Community Eligibility Status
Information Under the National Flood
Insurance Program, notices such as this
one for scheduled suspension will no
longer be published in the Federal
Register as of June 2021 but will be
available at National Flood Insurance
Community Status and Public
Notification | FEMA.gov. Individuals
without internet access will be able to
contact their local floodplain
management official and/or State NFIP
Coordinating Office directly for
assistance.
SUMMARY:
E:\FR\FM\23FER1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4165-15-P
