83 FR 14391 - National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 65 (April 4, 2018)

Page Range		14391-14395
FR Document		2018-06770

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 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.

Federal Register, Volume 83 Issue 65 (Wednesday, April 4, 2018)

[Federal Register Volume 83, Number 65 (Wednesday, April 4, 2018)]
[Proposed Rules]
[Pages 14391-14395]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-06770]

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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).

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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 http://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, http://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 http://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.
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\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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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
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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.
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[FR Doc. 2018-06770 Filed 4-3-18; 8:45 am]
BILLING CODE 4150-28-P

Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules 14391

hearings prior to adoption and submittal Management and Budget under required information to the U.S. Senate,
of this rule, in accordance with the Executive Orders 12866 (58 FR 51735, the U.S. House of Representatives, and
requirements of CAA sections 110(a)(2) October 4, 1993) and 13563 (76 FR 3821, the Comptroller General of the United
and 110(l). January 21, 2011); States prior to publication of the rule in
We are also approving Rules 130, 220, • Is not an Executive Order 13771 (82 the Federal Register. A major rule
and 230 because we have determined FR 9339, February 2, 2017) regulatory cannot take effect until 60 days after it
these rules satisfy all of the statutory action because SIP approvals are is published in the Federal Register.
and regulatory requirements for an NSR exempted under Executive Order 12866. This action is not a ‘‘major rule’’ as
permit program (including the PSD • Does not impose an information defined by 5 U.S.C. 804(2).
program) as set forth in the applicable collection burden under the provisions Under section 307(b)(1) of the Clean
provisions of part C of title I of the Act of the Paperwork Reduction Act (44 Air Act, petitions for judicial review of
and in 40 CFR 51.165 and 40 CFR U.S.C. 3501 et seq.); this action must be filed in the United
51.307. The revisions to these rules also • Is certified as not having a States Court of Appeals for the
resolve the limited disapproval issues significant economic impact on a appropriate circuit by June 4, 2018.
from the October 2016 action. substantial number of small entities Filing a petition for reconsideration by
Our TSD, which can be found in the under the Regulatory Flexibility Act (5 the Administrator of this final rule does
docket for this rule, contains a more U.S.C. 601 et seq.); not affect the finality of this action for
detailed discussion of the approval • Does not contain any unfunded the purposes of judicial review nor does
criteria. mandate or significantly or uniquely it extend the time within which a
affect small governments, as described petition for judicial review may be filed,
C. Public Comment and Proposed in the Unfunded Mandates Reform Act
Action and shall not postpone the effectiveness
of 1995 (Pub. L. 104–4); of such rule or action. This action may
As authorized in section 110(k)(3) of • Does not have Federalism not be challenged later in proceedings to
the Act, the EPA proposes to fully implications as specified in Executive enforce its requirements. (See section
approve the submitted rules because Order 13132 (64 FR 43255, August 10, 307(b)(2).)
they fulfill all relevant requirements. 1999);
We will accept comments from the • Is not an economically significant List of Subjects in 40 CFR Part 52
public on this proposal until May 4, regulatory action based on health or Environmental protection, Air
2018. If we take final action to approve safety risks subject to Executive Order pollution control, Incorporation by
the submitted rules, our final action will 13045 (62 FR 19885, April 23, 1997); reference, Intergovernmental relations,
incorporate these rules into the federally • Is not a significant regulatory action New Source Review, Particulate matter,
enforceable SIP. subject to Executive Order 13211 (66 FR Reporting and recordkeeping
28355, May 22, 2001); requirements.
III. Incorporation by Reference • Is not subject to requirements of
Section 12(d) of the National Authority: 42 U.S.C. 7401 et seq.
In this rule, the EPA is proposing to
include in a final EPA rule regulatory Technology Transfer and Advancement Dated: March 26, 2018.
text that includes incorporation by Act of 1995 (15 U.S.C. 272 note) because Deborah Jordan,
reference. In accordance with application of those requirements would Acting Regional Administrator, Region IX.
requirements of 1 CFR 51.5, the EPA is be inconsistent with the Clean Air Act; [FR Doc. 2018–06878 Filed 4–3–18; 8:45 am]
proposing to incorporate by reference and BILLING CODE 6560–50–P
the NSCAPCD rules described in Table • Does not provide EPA with the
1 of this preamble. The EPA has made, discretionary authority to address, as
and will continue to make, these appropriate, disproportionate human
DEPARTMENT OF HEALTH AND
materials available through health or environmental effects, using
HUMAN SERVICES
www.regulations.gov and at the EPA practicable and legally permissible
Region IX Office (please contact the methods, under Executive Order 12898 42 CFR Part 100
person identified in the FOR FURTHER (59 FR 7629, February 16, 1994).
INFORMATION CONTACT section of this In addition, the SIP is not approved RIN 0906–AB14
preamble for more information). to apply on any Indian reservation land
or in any other area where EPA or an National Vaccine Injury Compensation
IV. Statutory and Executive Order Indian tribe has demonstrated that a Program: Adding the Category of
Reviews tribe has jurisdiction. In those areas of Vaccines Recommended for Pregnant
Under the Clean Air Act, the Indian country, the rule does not have Women to the Vaccine Injury Table
Administrator is required to approve a tribal implications and will not impose AGENCY: Health Resources and Services
SIP submission that complies with the substantial direct costs on tribal Administration (HRSA), HHS.
provisions of the Act and applicable governments or preempt tribal law as ACTION: Notice of proposed rulemaking
Federal regulations. 42 U.S.C. 7410(k); specified by Executive Order 13175 (65 (NPRM).
40 CFR 52.02(a). Thus, in reviewing SIP FR 67249, November 9, 2000).
submissions, the EPA’s role is to The Congressional Review Act, 5 SUMMARY: As required by a recent
approve state choices, provided that U.S.C. 801 et seq., as added by the Small amendment to the VICP’s authorizing
they meet the criteria of the Clean Air Business Regulatory Enforcement statute, the Secretary of the Department
amozie on DSK30RV082PROD with PROPOSALS

Act. Accordingly, this action merely Fairness Act of 1996, generally provides of Health and Human Services
approves state law as meeting Federal that before a rule may take effect, the (Secretary) proposes to amend the
requirements and does not impose agency promulgating the rule must National Vaccine Injury Compensation
additional requirements beyond those submit a rule report, which includes a Program (VICP) Vaccine Injury Table
imposed by state law. For that reason, copy of the rule, to each House of the (Table) to include vaccines
this action: Congress and to the Comptroller General recommended by the Centers for Disease
• Is not a significant regulatory action of the United States. EPA will submit a Control and Prevention (CDC) for
subject to review by the Office of report containing this action and other routine administration in pregnant

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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules 14393

acellular pertussis vaccine,1 and (2) the subject to an excise tax after publication also recommended by the CDC for
seasonal influenza vaccine.2 These by the Secretary of a notice of coverage. routine administration to children, are
categories of vaccines are already They viewed this option as a simple subject to an excise tax. However, in the
covered under the VICP, as the CDC approach to revising the Table, rather future, when any new vaccine not
recommends them for routine than adding a new general Item XVII to already covered under the VICP is
administration to children and they are the Table for vaccines recommended for recommended by the CDC for routine
subject to an excise tax. routine administration in pregnant administration in pregnant women,
women. Therefore, the Secretary is subject to an excise tax, and added to
Discussion of Proposed Table Changes
proposing to amend the existing the Table (and/or any additional
Congress enacted a mechanism for language in Item XVII of the Table to associated injury), the alternate statute
modification of the statutory Table, include ‘‘and/or pregnant women’’ after of limitations afforded by 42 U.S.C.
through the promulgation of regulatory ‘‘children’’ in accordance with the 300aa–16(b) would apply, if the effect of
changes by the Secretary, after ACCV’s recommendation which would the revision would be to make an
consultation with the Advisory add to that general category of the Table, individual, who was not eligible before
Commission on Childhood Vaccines any new vaccine recommended by the the revision, eligible to seek
(ACCV). As required by statute, the CDC for routine administration in compensation under the Program or to
Secretary is proposing to revise the pregnant women, after imposition of an significantly increase the individual’s
Table to include new vaccines excise tax and publication of a notice of likelihood of obtaining compensation.
recommended by the CDC for routine coverage.
administration in pregnant women, and HHS seeks comments regarding the Based on the requirements of the
seeks comment on the means of proposed method of revising the Table, Administrative Procedure Act, HHS
effectuating this revision. The Secretary that is, to amend the existing language publishes an NPRM in the Federal
also proposes retaining the two injuries in Item XVII to include ‘‘and/or Register before a regulation is
currently associated with Item XVII of pregnant women’’ after ‘‘children’’ promulgated. The public is invited to
the Table, SIRVA and vasovagal which would add to that general submit comments on this proposed rule.
syncope, as Table injuries for vaccines category of the Table any new vaccine HHS specifically requests the public’s
recommended by the CDC for routine recommended by the CDC for routine views on the proposed option for adding
administration in pregnant women. In administration in pregnant women after new vaccines recommended by the CDC
its 2012 Report, ‘‘Adverse Effects of imposition of an excise tax and for routine administration in pregnant
Vaccines: Evidence and Causality,’’ the publication of a notice of coverage. HHS women to the Table. In addition, a
Institute of Medicine considered SIRVA notes that an important consideration in public hearing will be held for this
and vasovagal syncope as mechanistic proposing changes to the Table is the proposed rule. After the 180-day public
injuries resulting from the injection of a clarity of such changes. comment period has ended, the
vaccine and not from the contents of a Petitions must be filed within the comments received and HHS’s
particular formulation of a vaccine. applicable statute of limitations. With responses to the comments will be
Thus, these conditions are listed as the proposed change, the general statute addressed in the preamble of the final
Table injuries for any new vaccine of limitations applicable to petitions rule. HHS will publish the final rule in
recommended by the CDC for routine filed with the VICP, set forth in 42 the Federal Register.
administration to children (after the U.S.C. 300aa–16(a) continue to apply.
imposition of an excise tax and Specifically, in the case of an injury, the Additional VICP Provisions in the 21st
publication by the Secretary of a notice claim must be filed within 36 months Century Cures Act
of coverage) to account for any newly after the first symptoms appeared. In the
developed injected vaccines that While not seeking comment on these
case of a death, the claim must be filed
potentially may lead to SIRVA or within 24 months of the death and changes in response to this NPRM, the
syncope. Therefore, the Secretary within 48 months after the onset of the Secretary notes that the 21st Century
proposes including these injuries on the vaccine-related injury from which the Cures Act included additional
Table for new vaccines recommended death occurred. amendments to the Vaccine Act. The
by the CDC for routine administration in In addition, 42 U.S.C. 300aa–16(b) 21st Century Cures Act also amended
pregnant women. allows petitioners an alternative statute section 2111 of the PHS Act (42 U.S.C.
On September 8, 2017, the Program of limitations of 2 years from the date 300aa–11) to permit both a woman who
consulted the ACCV regarding options of the Table change for injuries or received a covered vaccine while
for adding this new category of vaccines deaths that occurred up to 8 years before pregnant and any live-born child who
to the Table. The ACCV voted the Table change if the revision makes was in utero at the time such woman
unanimously to amend the existing a petitioner eligible to seek received the vaccine to be considered
language in Item XVII of the Table to compensation or significantly increases persons to whom the covered vaccine
include ‘‘and/or pregnant women’’ after the likelihood of a petitioner obtaining was administered. See section
‘‘children’’ permitting coverage under compensation. However, the alternate 3093(c)(2) of the 21st Century Cures Act,
the VICP of any new vaccine statute of limitations afforded by 42 adding 42 U.S.C. 300aa–11(f). The
recommended by CDC for routine U.S.C. 300aa–16(b) is not applicable at amendments to this section also provide
administration in pregnant women and this time for this proposed Table that a covered vaccine administered to
change. At present, there are no a pregnant woman constitutes more
amozie on DSK30RV082PROD with PROPOSALS

1 Centers for Disease Control and Prevention.
vaccines to add to the Table under the than one vaccine administration—one to
MMWR Morbid Mortal Wkly Rep. 2011 Oct revised general category because the the mother and one to each live-born
21:60(41); 1424–26. Available from: https://
www.cdc.gov/mmwr/preview/mmwrhtml/ only vaccines the CDC recommends for child who was in utero at the time such
mm6041a4.htm. routine administration in pregnant woman was administered the vaccine.
2 Centers for Disease Control and Prevention.
women are already covered on the See section 3093(c)(3) of the 21st
Pregnancy and vaccination: Guidelines for Table—(1) the diphtheria, tetanus, and Century Cures Act, amending 42 U.S.C.
vaccinating pregnant women. Last updated Aug
2016. Website: https://www.cdc.gov/vaccines/ pertussis vaccine and (2) the seasonal 300aa–11(b)(2). These provisions do not
pregnancy/hcp/guidelines.html#flu1. influenza vaccine—because they are require regulatory actions to implement.

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Federal Register / Vol. 83, No. 65 / Wednesday, April 4, 2018 / Proposed Rules 14395

Time period for first
symptom or mani-
Illness, disability, injury or condition festation of onset or
Vaccine covered of significant aggra-
vation after vaccine
administration

XVII. Any new vaccine recommended by the Centers for Disease Control and A. Shoulder Injury Related to Vaccine ≤48 hours.
Prevention for routine administration to children and/or pregnant women, after Administration.
publication by the Secretary of a notice of coverage. B. Vasovagal syncope ........................... ≤1 hour.

[FR Doc. 2018–06770 Filed 4–3–18; 8:45 am] Synopsis proceedings for new technologies and
BILLING CODE 4150–28–P 1. Background. Section 7, entitled services.
‘‘New Technologies and Services,’’ 4. By its terms, § 7 could apply to any
reads in its entirety as follows: petition or application that includes a
(a) It shall be the policy of the United proposal involving the use of new
FEDERAL COMMUNICATIONS States to encourage the provision of new technologies and services. Accordingly,
COMMISSION technologies and services to the public. the Commission proposes to interpret
Any person or party (other than the § 7 to include petitions for rulemaking
47 CFR Part 1 or waiver of the Commission’s rules as
Commission) who opposes a new
technology or service proposed to be well as applications for authorization of
[GN Docket No. 18–22; FCC 18–18] permitted under this Act shall have the any type of technology or service within
burden to demonstrate that such the Commission’s statutory purview,
Encouraging the Provision of New whether radio-based, wired, or
proposal is inconsistent with the public
Technologies and Services to the otherwise. The Commission also
interest.
Public (b) The Commission shall determine proposes to interpret § 7 to apply to any
AGENCY: Federal Communications whether any new technology or service petitions or applications that properly
Commission. proposed in a petition or application is could be resolved either by the
in the public interest within one year Commission or by any Bureau or Office
ACTION: Proposed rule.
after such petition or application is pursuant to delegated authority.
SUMMARY: In this document, the filed. If the Commission initiates its Whether the Commission itself, or a
Commission is committed to improving own proceeding for a new technology or particular Bureau or Office acting on
the process for enabling the service, such proceeding shall be delegated authority, would address the
introduction of new technologies and completed within 12 months after it is § 7-related issue would depend on the
services that serve the public interest initiated. particular filing, the nature of the
and made available to the public on a 2. Discussion. In this NPRM, the request, and the kind of decision(s) and
timely basis. Therefore, the Commission Commission proposes to adopt rules course(s) of action regarding the
proposes guidelines and procedures to describing guidelines and procedures to proposed new technology or service that
implement. implement the stated policy goal of may be deemed appropriate under the
section 7 ‘‘to encourage the provision of circumstances.
DATES: Comments are due May 4, 2018. new technologies and services to the 5. The Commission proposes adopting
Reply comments are due May 21, 2018. public.’’ Although the forces of a new subpart in part 1 that sets forth
FOR FURTHER INFORMATION CONTACT: Paul competition and technological growth specific procedures and timetables for
Murray, Office of Engineering and work together to enable the action with respect to requests in
Technology, 202–418–0688, development and deployment of many petitions or applications for § 7
Paul.Murray@fcc.gov. new technologies and services to the consideration. These procedures and
SUPPLEMENTARY INFORMATION: This is a public, the Commission has at times timetables are designed to ensure that
summary of the Commission’s Notice of been slow to identify and take action to the Commission or Bureau/Office
Proposed Rulemaking, GN Docket No. ensure that important new technologies identifies and moves swiftly to promote
18–22, FCC 18–18, adopted February 22, or services are made available as quickly new technologies and services that are
2018, and released February 23, 2018. as possible. The Commission has sought in the public interest. These new rules
The full text of this document is to overcome these impediments by would not replace or substitute for the
available for inspection and copying streamlining many of its processes, but Commission’s existing rules for
during normal business hours in the all too often regulatory delays can processing petitions and applications
FCC Reference Center (Room CY–A257), adversely impact newly proposed (e.g., the part 1 rules for rulemaking
445 12th Street SW, Washington, DC technologies or services. proceedings and for applications
20554. The full text may also be 3. Section 7 reflects clear involving common carriers or wireless
downloaded at: https:// Congressional intent to encourage and radio services, the part 25 rules for
transition.fcc.gov/Daily_Releases/Daily_ expedite provision of technological satellite service applications, the part 73
Business/2018/db0223/FCC-18- innovation that would serve the public and 74 rules for broadcast service
amozie on DSK30RV082PROD with PROPOSALS

18A1.pdf. People with Disabilities: To interest. To better align purpose and applications, among many other rule
request materials in accessible formats practice, the Commission propose a set parts dealing with applications).
for people with disabilities (braille, of rules that will allow the Commission Instead, they would specify additional
large print, electronic files, audio to effectively breathe life into section 7. steps to ensure that timely decisions are
format), send an email to fcc504@fcc.gov As noted above, this law applies to new made on § 7 requests suited to serve the
or call the Consumer & Governmental technologies or services proposed to be public interest.
Affairs Bureau at 202–418–0530 (voice), permitted in a petition or application, as 6. Section 7 establishes a timeline by
202–418–0432 (tty). well as to Commission-initiated which the Commission must determine

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Document Created: 2018-11-01 09:11:49
Document Modified: 2018-11-01 09:11:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of proposed rulemaking (NPRM).
Dates		Written comments must be submitted on or before October 1, 2018.
Contact		Please visit the National Vaccine Injury Compensation Program's website, http://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.
FR Citation		83 FR 14391
RIN Number		0906-AB14