National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table, 14391-14395 [2018-06770]
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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules
hearings prior to adoption and submittal
of this rule, in accordance with the
requirements of CAA sections 110(a)(2)
and 110(l).
We are also approving Rules 130, 220,
and 230 because we have determined
these rules satisfy all of the statutory
and regulatory requirements for an NSR
permit program (including the PSD
program) as set forth in the applicable
provisions of part C of title I of the Act
and in 40 CFR 51.165 and 40 CFR
51.307. The revisions to these rules also
resolve the limited disapproval issues
from the October 2016 action.
Our TSD, which can be found in the
docket for this rule, contains a more
detailed discussion of the approval
criteria.
C. Public Comment and Proposed
Action
As authorized in section 110(k)(3) of
the Act, the EPA proposes to fully
approve the submitted rules because
they fulfill all relevant requirements.
We will accept comments from the
public on this proposal until May 4,
2018. If we take final action to approve
the submitted rules, our final action will
incorporate these rules into the federally
enforceable SIP.
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III. Incorporation by Reference
In this rule, the EPA is proposing to
include in a final EPA rule regulatory
text that includes incorporation by
reference. In accordance with
requirements of 1 CFR 51.5, the EPA is
proposing to incorporate by reference
the NSCAPCD rules described in Table
1 of this preamble. The EPA has made,
and will continue to make, these
materials available through
www.regulations.gov and at the EPA
Region IX Office (please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section of this
preamble for more information).
IV. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, the EPA’s role is to
approve state choices, provided that
they meet the criteria of the Clean Air
Act. Accordingly, this action merely
approves state law as meeting Federal
requirements and does not impose
additional requirements beyond those
imposed by state law. For that reason,
this action:
• Is not a significant regulatory action
subject to review by the Office of
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Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866.
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
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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. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by June 4, 2018.
Filing a petition for reconsideration by
the Administrator of this final rule does
not affect the finality of this action for
the purposes of judicial review nor does
it extend the time within which a
petition for judicial review may be filed,
and shall not postpone the effectiveness
of such rule or action. This action may
not be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
New Source Review, Particulate matter,
Reporting and recordkeeping
requirements.
Authority: 42 U.S.C. 7401 et seq.
Dated: March 26, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2018–06878 Filed 4–3–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 100
RIN 0906–AB14
National Vaccine Injury Compensation
Program: Adding the Category of
Vaccines Recommended for Pregnant
Women to the Vaccine Injury Table
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
As required by a recent
amendment to the VICP’s authorizing
statute, the Secretary of the Department
of Health and Human Services
(Secretary) proposes to amend the
National Vaccine Injury Compensation
Program (VICP) Vaccine Injury Table
(Table) to include vaccines
recommended by the Centers for Disease
Control and Prevention (CDC) for
routine administration in pregnant
SUMMARY:
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women. Thus, the Secretary is only
seeking public comment on how the
addition of this new category is
proposed to be formatted on the Table.
DATES: Written comments must be
submitted on or before October 1, 2018.
ADDRESSES: You may submit comments,
identified by the Regulatory Information
Number (RIN) 0906–AB14 in one of
three ways, as listed below. The first is
the preferred method. Please submit
your comments in only one of these
ways to minimize the receipt of
duplicate submissions.
1. Federal eRulemaking Portal. You
may submit comments electronically to
https://www.regulations.gov. Click on the
link ‘‘Submit electronic comments’’ on
HRSA regulations with an open
comment period. You may submit
attachments to your comments in any
file format accepted by Regulations.gov.
2. Regular, express, or overnight mail.
You may mail written comments to the
following address only: Health
Resources and Services Administration,
Department of Health and Human
Services, Attention: HRSA Regulations
Officer, 5600 Fishers Lane, Room
13N82, Rockville, MD 20857. Please
allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. Delivery by hand (in person or by
courier). If you prefer, you may deliver
your written comments before the close
of the comment period to the same
address, 5600 Fishers Lane, Room
13N82, Rockville, MD 20857. Please call
one of our HRSA Regulations Office
staff members at telephone number
(301) 443–1785 in advance to schedule
your arrival. This is not a toll-free
number.
Because of staffing and resource
limitations, and to ensure that no
comments are misplaced, the program
cannot accept comments by facsimile
(FAX) transmission. When commenting,
by any of the above methods, please
refer to file code (#HRSA–0906–AB14).
Comments received on a timely basis
will be available for public inspection
online at www.regulations.gov or in
person at the Health Resources and
Services Administration’s offices, 5600
Fishers Lane, Room 13N82, Rockville,
MD, Monday through Friday of each
week from 8:30 a.m. to 5:00 p.m.
FOR FURTHER INFORMATION CONTACT:
Please visit the National Vaccine Injury
Compensation Program’s website,
https://www.hrsa.gov/vaccinecompensation/, or contact Dr. Narayan
Nair, Director, Division of Injury
Compensation Programs, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
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Lane, Room 08N146B, Rockville, MD
20857. Phone calls can be directed to
(855) 266–2427. This is a toll-free
number.
The
Department of Health and Human
Services (HHS) urges all interested
parties to examine this regulatory
proposal carefully and to share your
views with us, including any supporting
data. We must consider all relevant
written comments received during the
comment period before issuing a final
rule. Subject to consideration of the
comments received, the Secretary
intends to publish a final regulation.
If you are a person with a disability
and/or a user of assistive technology
who has difficulty accessing this
document, please see the ‘‘For Further
Information’’ box above for the names
and contact information to obtain this
information in an accessible format.
Please visit https://www.HHS.gov/
regulations for more information on
HHS rulemaking and opportunities to
comment on proposed and existing
rules.
SUPPLEMENTARY INFORMATION:
Background
The National Childhood Vaccine
Injury Act of 1986, title III of Public Law
99–660 (42 U.S.C. 300aa-10 et seq.),
established the VICP as a no-fault
alternative to the traditional legal
system for resolving vaccine injury
petitions and to provide compensation
for individuals thought to be injured by
certain vaccines. Congress has amended
the statute governing the VICP 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 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 is
referred to as a Table injury. That is, a
petitioner may show that the vaccine
recipient received a covered vaccine
and suffered an injury of the type listed
for that vaccine in the regulations at 42
CFR 100.3—the Table—and that the
onset of such injury took place within
the time period specified in 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
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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.
300aa–11(c)(1)(C)(i), 300aa–13(a)(1)(B)),
and 300aa–14(a)). Currently, cases are
often resolved by negotiated settlements
between the parties and approved by the
Court. In negotiated settlements, 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 subsections 2114(c) and (e) of the
Public Health Service (PHS) Act (42
U.S.C. 300aa–14(c) and (e)). Prior to the
21st Century Cures Act (Pub. L. 114–
255), the only vaccines covered under
the VICP were those recommended for
routine administration to children by
the CDC (for example, vaccines that
protect against seasonal influenza),
subject to an excise tax by Federal law,
and added to the Program by the
Secretary. The Table currently includes
17 vaccine categories, with 16 categories
for specific vaccines, as well as the
corresponding illness, disability, injury,
or condition covered; and the requisite
time period when the first symptom or
manifestation of onset or of significant
aggravation after the vaccine
administration must begin to receive the
Table’s legal presumption of causation.
One category of the Table, ‘‘Item XVII,’’
includes ‘‘Any new vaccine
recommended by the Centers for Disease
Control and Prevention for routine
administration to children, after
publication by the Secretary of a notice
of coverage.’’ Two injuries—Shoulder
Injury Related to Vaccine
Administration (SIRVA) and vasovagal
syncope—are listed as associated
injuries for this category. Through this
general category, new vaccines
recommended by the CDC for routine
administration to children and subject
to an excise tax are covered under the
VICP prior to being added to the Table
as a separate vaccine category through
Federal rulemaking.
The 21st Century Cures Act amended
section 2114(e) of the PHS Act (42
U.S.C. 300aa–14(e)) to expand the types
of vaccines covered under the VICP. See
section 3093(c)(1) of the 21st Century
Cures Act. The revised statute requires
that the Secretary revise the Table to
include vaccines recommended by the
CDC for routine administration in
pregnant women (and subject to an
excise tax by Federal law). See section
2114(e)(3) of the PHS Act (42 U.S.C.
300aa–14(e)(3)). Currently, the CDC
recommends only two vaccines for
routine administration in pregnant
women: (1) The tetanus, diphtheria, and
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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules
acellular pertussis vaccine,1 and (2) the
seasonal influenza vaccine.2 These
categories of vaccines are already
covered under the VICP, as the CDC
recommends them for routine
administration to children and they are
subject to an excise tax.
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Discussion of Proposed Table Changes
Congress enacted a mechanism for
modification of the statutory Table,
through the promulgation of regulatory
changes by the Secretary, after
consultation with the Advisory
Commission on Childhood Vaccines
(ACCV). As required by statute, the
Secretary is proposing to revise the
Table to include new vaccines
recommended by the CDC for routine
administration in pregnant women, and
seeks comment on the means of
effectuating this revision. The Secretary
also proposes retaining the two injuries
currently associated with Item XVII of
the Table, SIRVA and vasovagal
syncope, as Table injuries for vaccines
recommended by the CDC for routine
administration in pregnant women. In
its 2012 Report, ‘‘Adverse Effects of
Vaccines: Evidence and Causality,’’ the
Institute of Medicine considered SIRVA
and vasovagal syncope as mechanistic
injuries resulting from the injection of a
vaccine and not from the contents of a
particular formulation of a vaccine.
Thus, these conditions are listed as
Table injuries for any new vaccine
recommended by the CDC for routine
administration to children (after the
imposition of an excise tax and
publication by the Secretary of a notice
of coverage) to account for any newly
developed injected vaccines that
potentially may lead to SIRVA or
syncope. Therefore, the Secretary
proposes including these injuries on the
Table for new vaccines recommended
by the CDC for routine administration in
pregnant women.
On September 8, 2017, the Program
consulted the ACCV regarding options
for adding this new category of vaccines
to the Table. The ACCV voted
unanimously to amend the existing
language in Item XVII of the Table to
include ‘‘and/or pregnant women’’ after
‘‘children’’ permitting coverage under
the VICP of any new vaccine
recommended by CDC for routine
administration in pregnant women and
1 Centers for Disease Control and Prevention.
MMWR Morbid Mortal Wkly Rep. 2011 Oct
21:60(41); 1424–26. Available from: https://
www.cdc.gov/mmwr/preview/mmwrhtml/
mm6041a4.htm.
2 Centers for Disease Control and Prevention.
Pregnancy and vaccination: Guidelines for
vaccinating pregnant women. Last updated Aug
2016. Website: https://www.cdc.gov/vaccines/
pregnancy/hcp/guidelines.html#flu1.
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subject to an excise tax after publication
by the Secretary of a notice of coverage.
They viewed this option as a simple
approach to revising the Table, rather
than adding a new general Item XVII to
the Table for vaccines recommended for
routine administration in pregnant
women. Therefore, the Secretary is
proposing to amend the existing
language in Item XVII of the Table to
include ‘‘and/or pregnant women’’ after
‘‘children’’ in accordance with the
ACCV’s recommendation which would
add to that general category of the Table,
any new vaccine recommended by the
CDC for routine administration in
pregnant women, after imposition of an
excise tax and publication of a notice of
coverage.
HHS seeks comments regarding the
proposed method of revising the Table,
that is, to amend the existing language
in Item XVII to include ‘‘and/or
pregnant women’’ after ‘‘children’’
which would add to that general
category of the Table any new vaccine
recommended by the CDC for routine
administration in pregnant women after
imposition of an excise tax and
publication of a notice of coverage. HHS
notes that an important consideration in
proposing changes to the Table is the
clarity of such changes.
Petitions must be filed within the
applicable statute of limitations. With
the proposed change, the general statute
of limitations applicable to petitions
filed with the VICP, set forth in 42
U.S.C. 300aa–16(a) continue to apply.
Specifically, in the case of an injury, the
claim must be filed within 36 months
after the first symptoms appeared. In the
case of a death, the claim must be filed
within 24 months of the death and
within 48 months after the onset of the
vaccine-related injury from which the
death occurred.
In addition, 42 U.S.C. 300aa–16(b)
allows petitioners an alternative statute
of limitations of 2 years from the date
of the Table change for injuries or
deaths that occurred up to 8 years before
the Table change if the revision makes
a petitioner eligible to seek
compensation or significantly increases
the likelihood of a petitioner obtaining
compensation. However, the alternate
statute of limitations afforded by 42
U.S.C. 300aa–16(b) is not applicable at
this time for this proposed Table
change. At present, there are no
vaccines to add to the Table under the
revised general category because the
only vaccines the CDC recommends for
routine administration in pregnant
women are already covered on the
Table—(1) the diphtheria, tetanus, and
pertussis vaccine and (2) the seasonal
influenza vaccine—because they are
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also recommended by the CDC for
routine administration to children, are
subject to an excise tax. However, in the
future, when any new vaccine not
already covered under the VICP is
recommended by the CDC for routine
administration in pregnant women,
subject to an excise tax, and added to
the Table (and/or any additional
associated injury), the alternate statute
of limitations afforded by 42 U.S.C.
300aa–16(b) would apply, if the effect of
the revision would be to make an
individual, who was not eligible before
the revision, eligible to seek
compensation under the Program or to
significantly increase the individual’s
likelihood of obtaining compensation.
Based on the requirements of the
Administrative Procedure Act, HHS
publishes an NPRM in the Federal
Register before a regulation is
promulgated. The public is invited to
submit comments on this proposed rule.
HHS specifically requests the public’s
views on the proposed option for adding
new vaccines recommended by the CDC
for routine administration in pregnant
women to the Table. In addition, a
public hearing will be held for this
proposed rule. After the 180-day public
comment period has ended, the
comments received and HHS’s
responses to the comments will be
addressed in the preamble of the final
rule. HHS will publish the final rule in
the Federal Register.
Additional VICP Provisions in the 21st
Century Cures Act
While not seeking comment on these
changes in response to this NPRM, the
Secretary notes that the 21st Century
Cures Act included additional
amendments to the Vaccine Act. The
21st Century Cures Act also amended
section 2111 of the PHS Act (42 U.S.C.
300aa–11) to permit both a woman who
received a covered vaccine while
pregnant and any live-born child who
was in utero at the time such woman
received the vaccine to be considered
persons to whom the covered vaccine
was administered. See section
3093(c)(2) of the 21st Century Cures Act,
adding 42 U.S.C. 300aa–11(f). The
amendments to this section also provide
that a covered vaccine administered to
a pregnant woman constitutes more
than one vaccine administration—one to
the mother and one to each live-born
child who was in utero at the time such
woman was administered the vaccine.
See section 3093(c)(3) of the 21st
Century Cures Act, amending 42 U.S.C.
300aa–11(b)(2). These provisions do not
require regulatory actions to implement.
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Economic and Regulatory Impact
HHS has examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(September 19, 1980), section 1102(b) of
the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of
1995 (March 22, 1995), Executive Order
13132 on Federalism (August 4, 1999),
the Congressional Review Act, and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
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Executive Orders 12866, 13563, and
13771
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). As
discussed below, HHS estimates that
this proposed rulemaking is not
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence not a major rule under the
Congressional Review Act.
The Secretary has determined that no
substantial additional administrative
and compensation resources are
required to implement the requirements
in this proposed rule. Compensation
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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 actually 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 Notice of Proposed Rulemaking 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:
(1) The tetanus, diphtheria, and
acellular pertussis vaccine; and (2) the
seasonal influenza vaccine. These
vaccines are already on the Table
because they are recommended for
routine administration to children and
have an excise tax imposed on them.
Therefore, this 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 to require
consultation under the Unfunded
Mandates Reform Act of 1995.
The provisions of this proposed rule
do not, on the basis of family wellbeing, 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.
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This proposed rule is not being
treated as a ‘‘significant regulatory
action’’ as defined under section 3(f) of
Executive Order 12866. As stated above,
this proposed rule will modify the Table
based on legal authority.
Executive Order 13771, titled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017. It has been
determined that this proposed rule is a
not significant and thus is exempt from
regulatory or deregulatory action for the
purposes of Executive Order 13771.
Impact of the New Rule
This proposed rule will allow any
new vaccines that in the future are
recommended by the CDC for routine
administration in pregnant women and
subject to a Federal excise tax to be
covered under the VICP after the
Secretary issues a notice of coverage,
without requiring further rulemaking. In
addition, this proposed 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 Table’s 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 proposed rule has no
information collection requirements.
Dated: March 16, 2018.
George Sigounas,
Administrator, Health Resources and Services
Administration.
Approved: March 28, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
Accordingly, 42 CFR part 100 is
proposed to be amended as set forth
below:
PART 100—VACCINE INJURY
COMPENSATION
1. The authority citation for 42 CFR
part 100 continues to read as follows:
■
Authority: Secs. 312 and 313 of Public
Law 99–660 (42 U.S.C. 300aa–1 note); 42
U.S.C. 300aa–10 to 300aa–34; 26 U.S.C.
4132(a); and sec. 13632(a)(3) of Public Law
103–66.
2. In § 100.3 amend the Table in
paragraph (a) by adding ‘‘and/or
pregnant women’’ after ‘‘children’’ to
the existing language in Item XVII of the
Table as follows:
■
§ 100.3
Vaccine injury table.
(a) * * *
E:\FR\FM\04APP1.SGM
04APP1
14395
Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules
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 ...........................
[FR Doc. 2018–06770 Filed 4–3–18; 8:45 am]
BILLING CODE 4150–28–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[GN Docket No. 18–22; FCC 18–18]
Encouraging the Provision of New
Technologies and Services to the
Public
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Commission is committed to improving
the process for enabling the
introduction of new technologies and
services that serve the public interest
and made available to the public on a
timely basis. Therefore, the Commission
proposes guidelines and procedures to
implement.
SUMMARY:
Comments are due May 4, 2018.
Reply comments are due May 21, 2018.
FOR FURTHER INFORMATION CONTACT: Paul
Murray, Office of Engineering and
Technology, 202–418–0688,
Paul.Murray@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Notice of
Proposed Rulemaking, GN Docket No.
18–22, FCC 18–18, adopted February 22,
2018, and released February 23, 2018.
The full text of this document is
available for inspection and copying
during normal business hours in the
FCC Reference Center (Room CY–A257),
445 12th Street SW, Washington, DC
20554. The full text may also be
downloaded at: https://
transition.fcc.gov/Daily_Releases/Daily_
Business/2018/db0223/FCC-1818A1.pdf. People with Disabilities: To
request materials in accessible formats
for people with disabilities (braille,
large print, electronic files, audio
format), send an email to fcc504@fcc.gov
or call the Consumer & Governmental
Affairs Bureau at 202–418–0530 (voice),
202–418–0432 (tty).
amozie on DSK30RV082PROD with PROPOSALS
DATES:
VerDate Sep<11>2014
17:08 Apr 03, 2018
Jkt 244001
Synopsis
1. Background. Section 7, entitled
‘‘New Technologies and Services,’’
reads in its entirety as follows:
(a) It shall be the policy of the United
States to encourage the provision of new
technologies and services to the public.
Any person or party (other than the
Commission) who opposes a new
technology or service proposed to be
permitted under this Act shall have the
burden to demonstrate that such
proposal is inconsistent with the public
interest.
(b) The Commission shall determine
whether any new technology or service
proposed in a petition or application is
in the public interest within one year
after such petition or application is
filed. If the Commission initiates its
own proceeding for a new technology or
service, such proceeding shall be
completed within 12 months after it is
initiated.
2. Discussion. In this NPRM, the
Commission proposes to adopt rules
describing guidelines and procedures to
implement the stated policy goal of
section 7 ‘‘to encourage the provision of
new technologies and services to the
public.’’ Although the forces of
competition and technological growth
work together to enable the
development and deployment of many
new technologies and services to the
public, the Commission has at times
been slow to identify and take action to
ensure that important new technologies
or services are made available as quickly
as possible. The Commission has sought
to overcome these impediments by
streamlining many of its processes, but
all too often regulatory delays can
adversely impact newly proposed
technologies or services.
3. Section 7 reflects clear
Congressional intent to encourage and
expedite provision of technological
innovation that would serve the public
interest. To better align purpose and
practice, the Commission propose a set
of rules that will allow the Commission
to effectively breathe life into section 7.
As noted above, this law applies to new
technologies or services proposed to be
permitted in a petition or application, as
well as to Commission-initiated
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
Time period for first
symptom or manifestation of onset or
of significant aggravation after vaccine
administration
≤48 hours.
≤1 hour.
proceedings for new technologies and
services.
4. By its terms, § 7 could apply to any
petition or application that includes a
proposal involving the use of new
technologies and services. Accordingly,
the Commission proposes to interpret
§ 7 to include petitions for rulemaking
or waiver of the Commission’s rules as
well as applications for authorization of
any type of technology or service within
the Commission’s statutory purview,
whether radio-based, wired, or
otherwise. The Commission also
proposes to interpret § 7 to apply to any
petitions or applications that properly
could be resolved either by the
Commission or by any Bureau or Office
pursuant to delegated authority.
Whether the Commission itself, or a
particular Bureau or Office acting on
delegated authority, would address the
§ 7-related issue would depend on the
particular filing, the nature of the
request, and the kind of decision(s) and
course(s) of action regarding the
proposed new technology or service that
may be deemed appropriate under the
circumstances.
5. The Commission proposes adopting
a new subpart in part 1 that sets forth
specific procedures and timetables for
action with respect to requests in
petitions or applications for § 7
consideration. These procedures and
timetables are designed to ensure that
the Commission or Bureau/Office
identifies and moves swiftly to promote
new technologies and services that are
in the public interest. These new rules
would not replace or substitute for the
Commission’s existing rules for
processing petitions and applications
(e.g., the part 1 rules for rulemaking
proceedings and for applications
involving common carriers or wireless
radio services, the part 25 rules for
satellite service applications, the part 73
and 74 rules for broadcast service
applications, among many other rule
parts dealing with applications).
Instead, they would specify additional
steps to ensure that timely decisions are
made on § 7 requests suited to serve the
public interest.
6. Section 7 establishes a timeline by
which the Commission must determine
E:\FR\FM\04APP1.SGM
04APP1
Agencies
[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Proposed Rules]
[Pages 14391-14395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06770]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AB14
National Vaccine Injury Compensation Program: Adding the Category
of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of proposed rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: As required by a recent amendment to the VICP's authorizing
statute, the Secretary of the Department of Health and Human Services
(Secretary) proposes to amend the National Vaccine Injury Compensation
Program (VICP) Vaccine Injury Table (Table) to include vaccines
recommended by the Centers for Disease Control and Prevention (CDC) for
routine administration in pregnant
[[Page 14392]]
women. Thus, the Secretary is only seeking public comment on how the
addition of this new category is proposed to be formatted on the Table.
DATES: Written comments must be submitted on or before October 1, 2018.
ADDRESSES: You may submit comments, identified by the Regulatory
Information Number (RIN) 0906-AB14 in one of three ways, as listed
below. The first is the preferred method. Please submit your comments
in only one of these ways to minimize the receipt of duplicate
submissions.
1. Federal eRulemaking Portal. You may submit comments
electronically to https://www.regulations.gov. Click on the link
``Submit electronic comments'' on HRSA regulations with an open comment
period. You may submit attachments to your comments in any file format
accepted by Regulations.gov.
2. Regular, express, or overnight mail. You may mail written
comments to the following address only: Health Resources and Services
Administration, Department of Health and Human Services, Attention:
HRSA Regulations Officer, 5600 Fishers Lane, Room 13N82, Rockville, MD
20857. Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. Delivery by hand (in person or by courier). If you prefer, you
may deliver your written comments before the close of the comment
period to the same address, 5600 Fishers Lane, Room 13N82, Rockville,
MD 20857. Please call one of our HRSA Regulations Office staff members
at telephone number (301) 443-1785 in advance to schedule your arrival.
This is not a toll-free number.
Because of staffing and resource limitations, and to ensure that no
comments are misplaced, the program cannot accept comments by facsimile
(FAX) transmission. When commenting, by any of the above methods,
please refer to file code (#HRSA-0906-AB14). Comments received on a
timely basis will be available for public inspection online at
www.regulations.gov or in person at the Health Resources and Services
Administration's offices, 5600 Fishers Lane, Room 13N82, Rockville, MD,
Monday through Friday of each week from 8:30 a.m. to 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine
Injury Compensation Program's website, https://www.hrsa.gov/vaccine-compensation/, or contact Dr. Narayan Nair, Director, Division of
Injury Compensation Programs, Healthcare Systems Bureau, Health
Resources and Services Administration, 5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857. Phone calls can be directed to (855) 266-2427.
This is a toll-free number.
SUPPLEMENTARY INFORMATION: The Department of Health and Human Services
(HHS) urges all interested parties to examine this regulatory proposal
carefully and to share your views with us, including any supporting
data. We must consider all relevant written comments received during
the comment period before issuing a final rule. Subject to
consideration of the comments received, the Secretary intends to
publish a final regulation.
If you are a person with a disability and/or a user of assistive
technology who has difficulty accessing this document, please see the
``For Further Information'' box above for the names and contact
information to obtain this information in an accessible format. Please
visit https://www.HHS.gov/regulations for more information on HHS
rulemaking and opportunities to comment on proposed and existing rules.
Background
The National Childhood Vaccine Injury Act of 1986, title III of
Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established the VICP as
a no-fault alternative to the traditional legal system for resolving
vaccine injury petitions and to provide compensation for individuals
thought to be injured by certain vaccines. Congress has amended the
statute governing the VICP 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 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 is
referred to as a Table injury. That is, a petitioner may show that the
vaccine recipient received a covered vaccine and suffered an injury of
the type listed for that vaccine in the regulations at 42 CFR 100.3--
the Table--and that the onset of such injury took place within the time
period specified in 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.
300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B)), and 300aa-14(a)). Currently,
cases are often resolved by negotiated settlements between the parties
and approved by the Court. In negotiated settlements, 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 subsections 2114(c) and
(e) of the Public Health Service (PHS) Act (42 U.S.C. 300aa-14(c) and
(e)). Prior to the 21st Century Cures Act (Pub. L. 114-255), the only
vaccines covered under the VICP were those recommended for routine
administration to children by the CDC (for example, vaccines that
protect against seasonal influenza), subject to an excise tax by
Federal law, and added to the Program by the Secretary. The Table
currently includes 17 vaccine categories, with 16 categories for
specific vaccines, as well as the corresponding illness, disability,
injury, or condition covered; and the requisite time period when the
first symptom or manifestation of onset or of significant aggravation
after the vaccine administration must begin to receive the Table's
legal presumption of causation. One category of the Table, ``Item
XVII,'' includes ``Any new vaccine recommended by the Centers for
Disease Control and Prevention for routine administration to children,
after publication by the Secretary of a notice of coverage.'' Two
injuries--Shoulder Injury Related to Vaccine Administration (SIRVA) and
vasovagal syncope--are listed as associated injuries for this category.
Through this general category, new vaccines recommended by the CDC for
routine administration to children and subject to an excise tax are
covered under the VICP prior to being added to the Table as a separate
vaccine category through Federal rulemaking.
The 21st Century Cures Act amended section 2114(e) of the PHS Act
(42 U.S.C. 300aa-14(e)) to expand the types of vaccines covered under
the VICP. See section 3093(c)(1) of the 21st Century Cures Act. The
revised statute requires that the Secretary revise the Table to include
vaccines recommended by the CDC for routine administration in pregnant
women (and subject to an excise tax by Federal law). See section
2114(e)(3) of the PHS Act (42 U.S.C. 300aa-14(e)(3)). Currently, the
CDC recommends only two vaccines for routine administration in pregnant
women: (1) The tetanus, diphtheria, and
[[Page 14393]]
acellular pertussis vaccine,\1\ and (2) the seasonal influenza
vaccine.\2\ These categories of vaccines are already covered under the
VICP, as the CDC recommends them for routine administration to children
and they are subject to an excise tax.
---------------------------------------------------------------------------
\1\ Centers for Disease Control and Prevention. MMWR Morbid
Mortal Wkly Rep. 2011 Oct 21:60(41); 1424-26. Available from:
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6041a4.htm.
\2\ Centers for Disease Control and Prevention. Pregnancy and
vaccination: Guidelines for vaccinating pregnant women. Last updated
Aug 2016. Website: https://www.cdc.gov/vaccines/pregnancy/hcp/guidelines.html#flu1.
---------------------------------------------------------------------------
Discussion of Proposed Table Changes
Congress enacted a mechanism for modification of the statutory
Table, through the promulgation of regulatory changes by the Secretary,
after consultation with the Advisory Commission on Childhood Vaccines
(ACCV). As required by statute, the Secretary is proposing to revise
the Table to include new vaccines recommended by the CDC for routine
administration in pregnant women, and seeks comment on the means of
effectuating this revision. The Secretary also proposes retaining the
two injuries currently associated with Item XVII of the Table, SIRVA
and vasovagal syncope, as Table injuries for vaccines recommended by
the CDC for routine administration in pregnant women. In its 2012
Report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the
Institute of Medicine considered SIRVA and vasovagal syncope as
mechanistic injuries resulting from the injection of a vaccine and not
from the contents of a particular formulation of a vaccine. Thus, these
conditions are listed as Table injuries for any new vaccine recommended
by the CDC for routine administration to children (after the imposition
of an excise tax and publication by the Secretary of a notice of
coverage) to account for any newly developed injected vaccines that
potentially may lead to SIRVA or syncope. Therefore, the Secretary
proposes including these injuries on the Table for new vaccines
recommended by the CDC for routine administration in pregnant women.
On September 8, 2017, the Program consulted the ACCV regarding
options for adding this new category of vaccines to the Table. The ACCV
voted unanimously to amend the existing language in Item XVII of the
Table to include ``and/or pregnant women'' after ``children''
permitting coverage under the VICP of any new vaccine recommended by
CDC for routine administration in pregnant women and subject to an
excise tax after publication by the Secretary of a notice of coverage.
They viewed this option as a simple approach to revising the Table,
rather than adding a new general Item XVII to the Table for vaccines
recommended for routine administration in pregnant women. Therefore,
the Secretary is proposing to amend the existing language in Item XVII
of the Table to include ``and/or pregnant women'' after ``children'' in
accordance with the ACCV's recommendation which would add to that
general category of the Table, any new vaccine recommended by the CDC
for routine administration in pregnant women, after imposition of an
excise tax and publication of a notice of coverage.
HHS seeks comments regarding the proposed method of revising the
Table, that is, to amend the existing language in Item XVII to include
``and/or pregnant women'' after ``children'' which would add to that
general category of the Table any new vaccine recommended by the CDC
for routine administration in pregnant women after imposition of an
excise tax and publication of a notice of coverage. HHS notes that an
important consideration in proposing changes to the Table is the
clarity of such changes.
Petitions must be filed within the applicable statute of
limitations. With the proposed change, the general statute of
limitations applicable to petitions filed with the VICP, set forth in
42 U.S.C. 300aa-16(a) continue to apply. Specifically, in the case of
an injury, the claim must be filed within 36 months after the first
symptoms appeared. In the case of a death, the claim must be filed
within 24 months of the death and within 48 months after the onset of
the vaccine-related injury from which the death occurred.
In addition, 42 U.S.C. 300aa-16(b) allows petitioners an
alternative statute of limitations of 2 years from the date of the
Table change for injuries or deaths that occurred up to 8 years before
the Table change if the revision makes a petitioner eligible to seek
compensation or significantly increases the likelihood of a petitioner
obtaining compensation. However, the alternate statute of limitations
afforded by 42 U.S.C. 300aa-16(b) is not applicable at this time for
this proposed Table change. At present, there are no vaccines to add to
the Table under the revised general category because the only vaccines
the CDC recommends for routine administration in pregnant women are
already covered on the Table--(1) the diphtheria, tetanus, and
pertussis vaccine and (2) the seasonal influenza vaccine--because they
are also recommended by the CDC for routine administration to children,
are subject to an excise tax. However, in the future, when any new
vaccine not already covered under the VICP is recommended by the CDC
for routine administration in pregnant women, subject to an excise tax,
and added to the Table (and/or any additional associated injury), the
alternate statute of limitations afforded by 42 U.S.C. 300aa-16(b)
would apply, if the effect of the revision would be to make an
individual, who was not eligible before the revision, eligible to seek
compensation under the Program or to significantly increase the
individual's likelihood of obtaining compensation.
Based on the requirements of the Administrative Procedure Act, HHS
publishes an NPRM in the Federal Register before a regulation is
promulgated. The public is invited to submit comments on this proposed
rule. HHS specifically requests the public's views on the proposed
option for adding new vaccines recommended by the CDC for routine
administration in pregnant women to the Table. In addition, a public
hearing will be held for this proposed rule. After the 180-day public
comment period has ended, the comments received and HHS's responses to
the comments will be addressed in the preamble of the final rule. HHS
will publish the final rule in the Federal Register.
Additional VICP Provisions in the 21st Century Cures Act
While not seeking comment on these changes in response to this
NPRM, the Secretary notes that the 21st Century Cures Act included
additional amendments to the Vaccine Act. The 21st Century Cures Act
also amended section 2111 of the PHS Act (42 U.S.C. 300aa-11) to permit
both a woman who received a covered vaccine while pregnant and any
live-born child who was in utero at the time such woman received the
vaccine to be considered persons to whom the covered vaccine was
administered. See section 3093(c)(2) of the 21st Century Cures Act,
adding 42 U.S.C. 300aa-11(f). The amendments to this section also
provide that a covered vaccine administered to a pregnant woman
constitutes more than one vaccine administration--one to the mother and
one to each live-born child who was in utero at the time such woman was
administered the vaccine. See section 3093(c)(3) of the 21st Century
Cures Act, amending 42 U.S.C. 300aa-11(b)(2). These provisions do not
require regulatory actions to implement.
[[Page 14394]]
Economic and Regulatory Impact
HHS has examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (September 19,
1980), section 1102(b) of the Social Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995 (March 22, 1995), Executive Order
13132 on Federalism (August 4, 1999), the Congressional Review Act, and
Executive Order 13771 on Reducing Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866, 13563, and 13771
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). As discussed below, HHS estimates that this proposed rulemaking
is not ``economically significant'' as measured by the $100 million
threshold, and hence not a major rule under the Congressional Review
Act.
The Secretary has determined that no substantial additional
administrative and compensation resources are required to implement the
requirements in this proposed 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 actually 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 Notice of Proposed Rulemaking 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:
(1) The tetanus, diphtheria, and acellular pertussis vaccine; and (2)
the seasonal influenza vaccine. These vaccines are already on the Table
because they are recommended for routine administration to children and
have an excise tax imposed on them. Therefore, this 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 to require consultation under the Unfunded
Mandates Reform Act of 1995.
The provisions of this proposed 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 654(c) of the
Treasury and General Government Appropriations Act of 1999.
This proposed rule is not being treated as a ``significant
regulatory action'' as defined under section 3(f) of Executive Order
12866. As stated above, this proposed rule will modify the Table based
on legal authority.
Executive Order 13771, titled ``Reducing Regulation and Controlling
Regulatory Costs,'' was issued on January 30, 2017. It has been
determined that this proposed rule is a not significant and thus is
exempt from regulatory or deregulatory action for the purposes of
Executive Order 13771.
Impact of the New Rule
This proposed rule will allow any new vaccines that in the future
are recommended by the CDC for routine administration in pregnant women
and subject to a Federal excise tax to be covered under the VICP after
the Secretary issues a notice of coverage, without requiring further
rulemaking. In addition, this proposed 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 Table's 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 proposed rule has no information collection requirements.
Dated: March 16, 2018.
George Sigounas,
Administrator, Health Resources and Services Administration.
Approved: March 28, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
Accordingly, 42 CFR part 100 is proposed to be amended as set forth
below:
PART 100--VACCINE INJURY COMPENSATION
0
1. The authority citation for 42 CFR part 100 continues to read as
follows:
Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C.
300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a);
and sec. 13632(a)(3) of Public Law 103-66.
0
2. In Sec. 100.3 amend the Table in paragraph (a) by adding ``and/or
pregnant women'' after ``children'' to the existing language in Item
XVII of the Table as follows:
Sec. 100.3 Vaccine injury table.
(a) * * *
[[Page 14395]]
------------------------------------------------------------------------
Time period for first
Illness, symptom or manifestation
disability, of onset or of
Vaccine injury or significant aggravation
condition after vaccine
covered administration
------------------------------------------------------------------------
XVII. Any new vaccine A. Shoulder <=48 hours.
recommended by the Centers Injury Related ........................
for Disease Control and to Vaccine <=1 hour.
Prevention for routine Administration.
administration to children B. Vasovagal
and/or pregnant women, after syncope.
publication by the Secretary
of a notice of coverage.
------------------------------------------------------------------------
[FR Doc. 2018-06770 Filed 4-3-18; 8:45 am]
BILLING CODE 4150-28-P