[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]


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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) * * *

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                                                  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