[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35848-35851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB00


National Vaccine Injury Compensation Program: Addition of 
Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury 
Table

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

ACTION: Final rule.

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SUMMARY: On July 24, 2013, the Secretary of Health and Human Services 
(the Secretary) published in the Federal Register a Notice of Proposed 
Rulemaking (NPRM) proposing changes to the regulations governing the 
National Vaccine Injury Compensation Program (VICP). Specifically, the 
Secretary proposed revisions to the Vaccine Injury Table (Table). The 
basis for this change is consistent with the Secretary's findings that 
intussusceptions can reasonably be determined in some circumstances to 
be caused by rotavirus vaccines. The Secretary is now making this 
amendment to the Table and to the Qualifications and Aids to 
Interpretation (QAI), described below under Background Information, as 
proposed in the NPRM. These regulations will apply only to petitions 
for compensation under the VICP filed after this final rule becomes 
effective.

DATES: This final rule is effective July 23, 2015.

FOR FURTHER INFORMATION CONTACT: Dr. Avril M. Houston, Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau, 
HRSA, Parklawn Building, Room 11C-06, 5600 Fishers Lane, Rockville, MD 
20857, or by telephone: (800) 338-2382. This is a toll-free number.

SUPPLEMENTARY INFORMATION:

I. Background Information

    Under Title XXI of the Public Health Service Act, as amended (PHS 
Act), individuals who demonstrate a vaccine-related injury or death may 
receive compensation through the VICP. To be eligible for compensation 
from the VICP, a petitioner must demonstrate that the injured or 
deceased individual received a vaccine set forth in the Table (a 
``covered vaccine'') and sustained a vaccine-related injury or death. A 
petitioner can prove a vaccine-related injury or death in three ways. 
First, the petitioner can show, by a preponderance of the evidence, 
that the vaccine recipient suffered an injury listed in the Table 
corresponding with the vaccine received, that the onset of such injury 
occurred within the timeframe specified in the Table, and that the 
injury meets the requirements set forth in the Table's QAI. A Table 
injury or death is given the legal presumption that it was caused by 
the vaccination. Sections 2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) 
of the PHS Act. Second, if the petitioner cannot demonstrate a Table 
injury, the petitioner can prevail by proving, by a preponderance of 
the evidence, that the vaccine caused the injury or death (off-Table 
injury). Third, a petitioner can prevail by proving, by a preponderance 
of the evidence, that the vaccine significantly aggravated a pre-
existing condition. In all three cases, a petitioner must also show 
that the injury was sufficiently severe by demonstrating that such 
person suffered the residual effects of the injury for more than 6 
months; died from the administration of the vaccine; or that the 
alleged injury resulted in inpatient hospitalization and surgical 
intervention. Section 2111(c)(1)(D) of the PHS Act. If the petitioner 
can prove a Table injury, off-Table injury, or significant aggravation 
of a pre-existing condition, the petitioner is entitled to compensation 
unless it is affirmatively shown that the injury was caused by some 
factor unrelated to the vaccination.
    Under section 2114(e)(2) of the PHS Act, when the Centers for 
Disease Control and Prevention (CDC) recommends a vaccine for routine 
administration to children, the Secretary is required to amend the 
Table to include such vaccine. Coverage becomes effective when an 
excise tax is imposed on the vaccine. Additionally, the Secretary is 
authorized to include specific injuries on the Table with respect to 
each covered vaccine, including the timeframe when the first symptom or 
manifestation of the onset of such adverse event may occur. The 
Secretary may also define such injuries through the QAI. Under section 
2114(c) of the PHS Act, the Secretary may make such modifications to 
the Table by promulgating regulations, with notice and opportunity for 
a public hearing, and at least 180 days of public comment.

II. Discussion of the Final Rule

    As discussed in the NPRM (78 FR 44512, July 24, 2013), the 
Secretary has reviewed the currently available data regarding the 
Rotarix and RotaTeq vaccines and the risk of intussusception. The 
background of the RotaShield experience in the U.S. and the published 
literature from Mexico, Brazil, Australia, and the U.S. supports a 
small attributable risk of intussusception after the first and second 
doses of Rotarix and RotaTeq (with a greater amount of data supporting 
an association with the first dose of both vaccines). Evidence shows 
the increased risk within the 1-7 days following immunization with 
peaks in the fourth and fifth days. As a consequence, the Secretary is 
amending the Table to add the injury of intussusception to the general 
Table category of ``rotavirus vaccines'' to allow a presumption of 
causation for claims that meet the requirements set forth in the Table 
for that injury. To allow for a generous timeframe that will capture 
any cases related to the vaccine after day 7, the Secretary has 
assigned an onset interval of 1-21 days under sections 2114(c) and (e) 
of the PHS Act.
    The Secretary will stay informed of new information in the 
scientific and medical field about intussusception and

[[Page 35849]]

rotavirus vaccines and may propose changes in the future if such 
information warrants changes to the Table. In addition, the Secretary 
recognizes that one goal of the VICP is to provide compensation to 
petitioners harmed by vaccines through a less adversarial system. 
Therefore, the Secretary feels that adding the Table injury of 
intussusception after the first and second doses of rotavirus vaccines 
with a window of 1-21 days is appropriate.
    The QAI section of the Table defines the injury of 
``intussusception'' as the invagination of a segment of intestine into 
the next segment of intestine, resulting in bowel obstruction, 
diminished arterial blood supply, and blockage of the venous blood 
flow. This is characterized by a sudden onset of abdominal pain that 
may be manifested by anguished crying, irritability, vomiting, 
abdominal swelling, and/or passing of stools mixed with blood and 
mucus. The definition for presumption of vaccine causation only applies 
to the first and second dose of vaccine, and excludes intussusception 
occurring with or after the third dose. The third dose of rotavirus 
vaccines lacks sufficient evidence showing risk.
    The definition also delineates the alternative causes of 
intussusception which, if present in a case, would prevent it from 
qualifying as a Table injury. The alternative causes were classified 
into four categories: infectious diseases; anatomic lead points; 
anatomic bowel abnormalities; and underlying gastrointestinal or 
systemic diseases. Cases of intussusception where the onset was within 
14 days after an infectious disease secondary to non-enteric or enteric 
adenovirus, other enteric viruses (such as Enterovirus), enteric 
bacteria (such as Campylobacter jejuni), or enteric parasites (such as 
Ascaris lumbricoides) would not qualify as a Table injury. Proof of 
these alternate causes may be demonstrated by clinical signs and 
symptoms and need not be confirmed by culture or serologic testing.
    Cases of intussusception in a person with a pre-existing condition 
identified as the lead point for intussusception, such as intestinal 
masses and cystic structures (e.g., polyps; tumors; Meckel's 
diverticulum; lymphoma; or duplication cysts), would not qualify as a 
Table injury. Additionally, cases of intussusception in a person with 
abnormalities of the bowel, including congenital anatomic 
abnormalities, anatomic changes after abdominal surgery, and other 
anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or 
abnormal intestinal blood vessels (such as Henoch Scholein purpura, 
hematoma, or hemangioma); or in a person with underlying conditions or 
systemic diseases associated with intussusception (such as cystic 
fibrosis, celiac disease, or Kawasaki disease) would not qualify as a 
Table injury.
    Petitioners may be eligible for compensation for vaccine-related 
cases of intussusception in which the onset is before 1 day or beyond 
21 days, or where the condition does not satisfy the criteria under the 
QAI for intussusception (an ``off-Table'' claim); however, the 
petitioners will be required to prove causation-in-fact. Regardless of 
whether the claim satisfies the criteria in the Table, all petitioners 
must demonstrate sufficient severity of the injury by proving that the 
injured person: 1) suffered the residual effects or complications of 
the alleged vaccine-related injury for more than 6 months after 
vaccine's administration; 2) died from administration of the vaccine; 
or 3) sustained inpatient hospitalization and surgery as a result of 
the alleged vaccine-related injury. Section 2111(c)(1)(D), PHS Act (42 
U.S.C. 300aa-11(c)(1)(D)). In the case of rotavirus vaccine 
administration and subsequent intussusception, the Secretary does not 
consider a reduction of intussusception with therapeutic enemas to be 
``surgical intervention.''
    Petitions must also be filed within the applicable statute of 
limitations. The general statute of limitations applicable to petitions 
filed with the VICP, set forth in section 2116(a) of the PHS Act (42 
U.S.C. 300aa-16(a)), continues to apply. In addition, section 2116(b) 
of the PHS Act identifies a specific exception to this statute of 
limitations that applies when the effect of a revision to the Table 
makes a previously ineligible person eligible to receive compensation 
or when an eligible person's likelihood of obtaining compensation 
significantly increases. Under this section, individuals who may be 
eligible to file petitions based on the revised Table may file a 
petition for compensation not later than two years after the effective 
date of the revision if the injury or death occurred not more than 
eight years before the effective date of the revision of the Table (42 
U.S.C. 300aa-16(b)).

III. Comments and Responses

    The comment period for this regulation ran for 6 months (July 24, 
2013-January 21, 2014) and included two public hearings that were held 
on January 13, 2014, and April 28, 2014. The Secretary received ten 
comments as a result of this process. None of the commenters objected 
to the Secretary's proposal to add intussusception as an injury for 
rotavirus vaccines to the Table, and the overwhelming majority of 
commenters expressed their support for the proposal. In addition, 
commenters raised four additional points. Below is a summary of those 
points and the Secretary's responses to them.

1. Notice to Potential Petitioners

    COMMENT: A commenter suggested that the Secretary make additional 
efforts to increase public awareness about expanding the Table and to 
increase the general public awareness about the VICP.
    RESPONSE: The Secretary will continue efforts to increase the 
general public's awareness about the VICP, including revisions to the 
Table.

2. Demonstrating Severity of Injury

    COMMENT: One commenter suggested that the definition of surgical 
intervention be broadened to include therapeutic enema treatment.
    RESPONSE: Defining the term ``surgical intervention'' is beyond the 
scope of the Table amendments. While the preamble to both the NPRM and 
final rule includes the Secretary's view that a reduction of 
intussusception with an enema is not a ``surgical intervention,'' such 
language is not included in the regulatory text. Further, the 
definition of ``surgical intervention'' is decided by the court.

3. Onset Time Frame

    COMMENT: A commenter stated that none of the data for either 
vaccine supports an association with intussusception for days 8-21 
after dose 2 and suggested that the Secretary consider revising the 
time frame for qualification as a Table injury after dose 2 to 1-7 
days.
    RESPONSE: The Secretary has considered the approach suggested by 
the commenter and also the recommendation of the Advisory Commission on 
Childhood Vaccines (ACCV). The ACCV unanimously recommended the 
proposed change of 1-21 days for all rotavirus vaccines.
    The ACCV's ``Guiding Principles for Recommending Changes to the 
Vaccine Injury Table,'' consist of two overarching principles: (1) the 
Table should be scientifically and medically credible; and (2) where 
there is credible scientific and medical evidence both to support and 
to reject a proposed change (addition or deletion) to the Table, the 
change should, whenever possible, be made to the benefit of 
petitioners. The Guiding Principles were established in 2006 to assist 
the ACCV in evaluating

[[Page 35850]]

proposed Table revisions and determining whether to recommend Table 
changes to the Secretary. The ACCV followed these Guiding Principles in 
making its recommendations to the Secretary for revising this Table. 
Therefore, the Secretary has decided that the 1-21 day timeframe for 
both vaccines is the best approach to capture any cases related to the 
vaccine after day 7.

4. Published Studies since the Publication of the NPRM

    COMMENT: A commenter identified studies that have been published 
since the initial NPRM was published.
    RESPONSE: The Secretary has reviewed these studies and found that 
the most recent data have shown a small but statistically significant 
increased risk of intussusception within 7 days after the first and 
second doses of the licensed rotavirus vaccines. However, as discussed 
above, following the Guiding Principles, the ACCV unanimously 
recommended the proposed change of 1-21 days for all rotavirus 
vaccines. Therefore, the Secretary has decided that the 1-21 day 
timeframe for both vaccines is the best approach to capture any cases 
related to the vaccine after day 7.

IV. Regulatory Impact Analysis

    HHS has examined the impact of this rulemaking as required by 
Executive Order 12866 on Regulatory Planning and Review, Executive 
Order 13563 on Improving Regulation and Regulatory Review, the 
Congressional Review Act (5 U.S.C. 804(2)), the Regulatory Flexibility 
Act (RFA), section 202 of the Unfunded Mandates Reform Act of 1995, 
section 654(c) of the Treasury and General Government Appropriations 
Act of 1999, and Executive Order 13132 on Federalism.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive, and equity effects). In addition, under 
the Regulatory Flexibility Act, if a rule has a significant economic 
effect on a substantial number of small entities, the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, costs, benefits, incentives, equity, and 
available information. Regulations must meet certain standards, such as 
avoiding an unnecessary burden. Regulations that are ``significant'' 
because of cost, adverse effects on the economy, inconsistency with 
other agency actions, effects on the budget, or novel legal or policy 
issues, require special analysis.
    The Secretary has determined that no resources are required to 
implement the requirements in this rule. Compensation will be made in 
the same manner used prior to the revisions of this final rule. The 
only purpose of this rule is to lessen the burden of proof for 
potential petitioners. 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 Secretary has also determined that this rule does not meet the 
criteria for a major rule as defined by Executive Order 12866, and it 
would not have a major effect on the economy or federal expenditures. 
The Secretary has determined that this 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, or on the private sector such as 
to require consultation under the Unfunded Mandates Reform Act of 1995.
    The Secretary finds that the provisions of this rule will not have 
an adverse effect on family well-being, because this rule does not 
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 rule is not being treated as a ``significant regulatory 
action'' under section 3(f) of Executive Order 12866. Accordingly, the 
rule has not been reviewed by the Office of Management and Budget. As 
stated above, this rule would modify the Table based on legal 
authority.

Impact of the New Rule

    This rule will have the effect of making it easier for future VICP 
petitioners alleging the injury of intussusception as the result of a 
rotavirus vaccine that meets the criteria in the Table to receive the 
Table's presumption of causation (which relieves them of having to 
prove that the vaccine actually caused or significantly aggravated the 
injury).

Paperwork Reduction Act of 1995

    This final rule has no information collection requirements.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

    Dated: May 27, 2015.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
    Approved: June 5, 2015.
Sylvia M. Burwell,
Secretary.
    Therefore, for the reasons stated in the preamble, the Department 
of Health and Human Services amends 42 CFR part 100 as follows:

PART 100--VACCINE INJURY COMPENSATION

0
1. The authority citation for part 100 is revised 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. Amend Sec.  100.3 as follows:
0
a. Amend paragraph (a) by revising Item XI in the table.
0
b. Add paragraph (b)(3).
    The revision and addition read as follows:


Sec.  100.3  Vaccine injury table.

    (a) * * *

[[Page 35851]]



------------------------------------------------------------------------
                                                        Time period for
                                                       first symptom or
                                       Illness,        manifestation of
                                  disability, injury      onset or of
             Vaccine                 or condition         significant
                                        covered        aggravation after
                                                            vaccine
                                                        administration
------------------------------------------------------------------------
 
                              * * * * * * *
XI. Rotavirus vaccines..........  A. Intussusception  1-21 days
                                  B. Any acute        Not applicable
                                   complication or
                                   sequela
                                   (including death)
                                   of an illness,
                                   disability,
                                   injury, or
                                   condition
                                   referred to above
                                   which illness,
                                   disability,
                                   injury, or
                                   condition arose
                                   within the time
                                   period prescribed.
 
                              * * * * * * *
------------------------------------------------------------------------

    (b) * * *
    (3) Intussusception. (i) For purposes of paragraph (a) of this 
section, intussusception means the invagination of a segment of 
intestine into the next segment of intestine, resulting in bowel 
obstruction, diminished arterial blood supply, and blockage of the 
venous blood flow. This is characterized by a sudden onset of abdominal 
pain that may be manifested by anguished crying, irritability, 
vomiting, abdominal swelling, and/or passing of stools mixed with blood 
and mucus.
    (ii) For purposes of paragraph (a) of this section, the following 
shall not be considered to be a Table intussusception:
    (A) Onset that occurs with or after the third dose of a vaccine 
containing rotavirus;
    (B) Onset within 14 days after an infectious disease associated 
with intussusception, including viral disease (such as those secondary 
to non-enteric or enteric adenovirus, or other enteric viruses such as 
Enterovirus), enteric bacteria (such as Campylobacter jejuni), or 
enteric parasites (such as Ascaris lumbricoides), which may be 
demonstrated by clinical signs and symptoms and need not be confirmed 
by culture or serologic testing;
    (C) Onset in a person with a pre-existing condition identified as 
the lead point for intussusception such as intestinal masses and cystic 
structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or 
duplication cysts);
    (D) Onset in a person with abnormalities of the bowel, including 
congenital anatomic abnormalities, anatomic changes after abdominal 
surgery, and other anatomic bowel abnormalities caused by mucosal 
hemorrhage, trauma, or abnormal intestinal blood vessels (such as 
Henoch Scholein purpura, hematoma, or hemangioma); or
    (E) Onset in a person with underlying conditions or systemic 
diseases associated with intussusception (such as cystic fibrosis, 
celiac disease, or Kawasaki disease).
* * * * *
[FR Doc. 2015-14771 Filed 6-22-15; 8:45 am]
 BILLING CODE 4165-15-P