[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44512-44518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AB00


National Vaccine Injury Compensation Program

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Secretary has made findings as to intussusceptions that 
can reasonably be determined in some circumstances to be caused or

[[Page 44513]]

significantly aggravated by rotavirus vaccines. Based on these 
findings, the Secretary proposes to amend the Vaccine Injury Table 
(Table) by regulation. These proposed regulations will apply only for 
petitions for compensation under the National Vaccine Injury 
Compensation Program (VICP) filed after the final regulations become 
effective. The Secretary is seeking public comment on the proposed 
revisions to the Table.

DATES: Written comments must be submitted on or before January 21, 
2014. A public hearing on this proposed rule will be held before the 
end of the public comment period. A separate notice will be published 
in the Federal Register to provide the details of this hearing. Subject 
to consideration of the comments received, the Secretary intends to 
publish a final regulation.

ADDRESSES: You may submit comments 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.'' Submit your comments as an attachment to your message or 
cover letter. (Attachments should be in Microsoft Word or WordPerfect; 
however, Microsoft Word is preferred).
    2. By 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, Parklawn Building, Room 14-101, 5600 Fishers 
Lane, 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: Parklawn Building, Room 14-101, 5600 
Fishers Lane, Rockville, MD 20857. Please call in advance to schedule 
your arrival with one of our HRSA Regulations Office staff members at 
telephone number (301) 443-1785. This is not a toll-free number.
    Because of staffing and resource limitations, and to ensure that no 
comments are misplaced, HRSA cannot accept comments by facsimile (FAX) 
transmission. In commenting, by any of the above methods, please refer 
to file code (HRSA 0906-AB00). All comments received on a 
timely basis will be available for public inspection without charge, 
including any personal information provided, in Room 14-101 of the 
Health Resources and Services Administration's offices at 5600 Fishers 
Lane, Rockville, MD., on Monday through Friday of each week from 8:30 
a.m. to 5 p.m. (excluding federal holidays). Phone: (301) 443-1785. 
This is not a toll-free number.

FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine 
Injury Compensation Program's Web site, http://www.hrsa.gov/vaccinecompensation/, or contact Dr. Catherine Shaer, Acting Chief 
Medical Officer, National Vaccine Injury Compensation Program, 
Healthcare Systems Bureau, Health Resources and Services 
Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane, 
Rockville, MD 20857. Phone calls can be directed to (855) 266-2427. 
This is a toll-free number.

SUPPLEMENTARY INFORMATION: 

Background

    Under Title XXI of the Public Health Service (PHS) Act, individuals 
who demonstrate a vaccine-related injury or death may receive 
compensation through the National Vaccine Injury Compensation Program 
(VICP). To gain entitlement to compensation in the VICP, a petitioner 
must demonstrate that the injured or deceased individual received a 
vaccine set forth in the Vaccine Injury Table (a ``covered vaccine'') 
and sustained a vaccine-related injury or death. A petitioner can prove 
a vaccine-related injury or death in two ways: (1) The petitioner can 
show that the vaccine recipient suffered an injury listed in the 
Vaccine Injury Table corresponding with the vaccine received, and that 
the onset of such injury occurred within the time period specified in 
the Table (a ``Table injury''). As set out in sections 
2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) of the PHS Act, a Table 
injury or death is given the legal presumption that it was caused by 
the vaccination. (2) 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 (an ``off-
Table injury''). In either case, 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) of the PHS Act. If the petitioner can prove a Table 
injury or off-Table injury, the petitioner is entitled to compensation 
unless it is affirmatively shown by the Secretary 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 
Vaccine Injury 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 adverse events on the 
Table with respect to each covered vaccine, including the time period 
when the first symptoms or manifestations of onset or other significant 
aggravation of such adverse event may occur. 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.

Coverage for Rotavirus Vaccines on the Vaccine Injury Table

    The general category of rotavirus vaccines was added for coverage 
under the VICP, effective October 22, 1998. The prerequisites for 
adding rotavirus vaccines to the VICP were satisfied by the enactment 
of the Omnibus Consolidated and Emergency Supplemental Appropriations 
Act of 1999, Pub. L. 105-277 (October 21, 1998), which imposed an 
excise tax of 75 cents per dose on ``any vaccine against rotavirus 
gastroenteritis,'' and the publication of the CDC recommendation of the 
vaccine for ``routine use in children'' in the ``Morbidity and 
Mortality Weekly Report'' (MMWR), 1999:48 (March 19, 1999).
    When the general category of rotavirus vaccines was added to the 
Table, it was added with ``no condition specified.'' 64 FR 40517. In 
other words, at the time rotavirus vaccines were first included for 
coverage under the Program, the Secretary had not identified any 
adverse events to include in the Table. Therefore, individuals who 
received the rotavirus vaccine did not receive a legal presumption of 
causation for any claimed injury and were required to prove that the 
vaccine actually caused the claimed injury.

History of Rotashield Vaccine

    On August 31, 1998, the Food and Drug Administration (FDA) licensed 
a live, oral, rhesus-based rotavirus tetravalent vaccine (trade name

[[Page 44514]]

``Rotashield'') for use in infants between the ages of 6 weeks and 1 
year. Distribution of the vaccine began on October 1, 1998. At the 
time, this was the only U.S.-licensed rotavirus vaccine on the market. 
Following a review by the Advisory Committee on Immunization Practices 
(ACIP), the CDC published its rotavirus recommendation in the March 19, 
1999, issue of the MMWR (1999:48), calling for doses to be administered 
at 2, 4, and 6 months of age, with the first dose to be administered 
between 6 weeks and 6 months. The series was not to be initiated in 
children who were 7 months of age or older due to an increased rate of 
febrile (fever) reactions after the first dose among older infants.
    Over the next eight months, the Secretary's Vaccine Adverse Event 
Reporting System (VAERS) began receiving reports of intussusception (a 
type of bowel obstruction that occurs when the bowel folds into itself) 
in infants receiving the Rotashield vaccine after the first dose. Based 
on an analysis of 15 reports, the CDC, in the July 16, 1999, issue of 
the MMWR, recommended that health care providers and parents postpone 
use of this rotavirus vaccine. The CDC undertook additional 
epidemiological studies to determine if there was a true association 
between the vaccine and intussusception. Also, at that time, the 
manufacturer, in consultation with the FDA, voluntarily ceased further 
distribution of the vaccine. Upon further consideration, and following 
consultation with CDC officials in preparation for the upcoming ACIP 
meeting, the manufacturer announced the withdrawal of the Rotashield 
vaccine (which was still the only U.S.-licensed rotavirus vaccine at 
that time) from the market on October 15, 1999, and requested the 
immediate return of all doses of the vaccine.
    At its October 22, 1999, meeting, the ACIP reviewed scientific data 
from several sources, including a 19-state case-control study which 
showed a statistically significant rate of intussusception among 
recipients of the live, oral, rhesus-based rotavirus vaccine in the 2 
week period following vaccine administration, with the highest risk 
period in the 3-14 days after the first dose of vaccine, and a much 
smaller risk in the same time period after dose two. Beyond 14 days, 
there did not appear to be more cases than might occur by chance alone. 
The ACIP concluded that intussusception occurs with significantly 
increased frequency in the first 14 days following administration of 
the Rotashield vaccine and withdrew its recommendation for use of this 
vaccine in infants. The CDC adopted and published the Committee's 
decision in the November 5, 1999, issue of the MMWR.
    By December 2000, VAERS had received over 100 reports of confirmed 
intussusception cases, 58 of which had onset within 7 days of vaccine 
receipt. Of the cases reported, approximately one-half required 
surgical intervention. Nearly all of the other cases of bowel 
obstruction were relieved through barium enema, a radiological 
procedure used to both diagnose and often rectify the telescoped bowel 
segment, or resolved spontaneously without any intervention. At least 
one death associated with rotavirus vaccine was reported to VAERS.
    The Secretary reviewed the epidemiological data, and in a notice of 
proposed rulemaking published on July 13, 2001, the Secretary announced 
his findings that the condition of intussusception could reasonably be 
determined in some circumstances to be caused by vaccines containing 
live, oral, rhesus-based rotavirus (66 FR 36735). Based on those 
findings, the Secretary proposed to amend the Table by adding the 
specific category of vaccines containing live, oral, rhesus-based 
rotavirus as a distinct category, with intussusception listed as a 
covered Table injury. This proposal was based on data indicating a 
strong association between Rotashield and intussusception in the two 
weeks following vaccination.
    In a final rule published July 25, 2002 (67 FR 48558), the 
Secretary made final the changes proposed in the earlier notice. After 
these amendments, the Table included two categories of rotavirus 
vaccines. The first, the general category of rotavirus vaccines, did 
not include an associated injury. This category of vaccines was 
effective as of October 22, 1998, the effective date of the excise tax 
imposed for rotavirus vaccines. See 42 CFR 100.3(a), 100.3(c)(3). The 
second, more specific category of vaccines containing live, oral, 
rhesus-based rotavirus, contained an associated injury of 
intussusception with an onset interval of 0-30 days. The live, oral, 
rhesus-based rotavirus vaccine was covered in the VICP effective 
October 22, 1998, but the Table injury could only be claimed by those 
petitioners that had the vaccine administered on or before August 26, 
2002 (the effective date of the final rule adding this category of 
vaccine), and beginning on August 26, 1994, the period of the eight-
year ``look back'' prescribed in the statute. Because the manufacturer 
of the only U.S.-licensed rotavirus vaccine at the time voluntarily 
ceased distribution of the vaccine in July 1999, and because the CDC 
recommended that this vaccine no longer be routinely administered to 
children in the United States in October 1999, the Secretary concluded 
that it was unlikely that potential claims under this specific category 
would arise after the rule's publication. Because of this, the final 
rule limited the Table injury of intussusception to live, oral, rhesus-
based rotavirus vaccines administered on or before the effective date 
of the final rule (August 26, 2002). Individuals who sought 
compensation for injuries related to such a vaccine administered after 
the effective date of the final rule were not entitled to the 
presumption of a Table injury for intussusception, but such individuals 
could still file claims under the Table's general category for 
rotavirus vaccines.
    Through an interim final rule published October 9, 2008 (73 FR 
59528), the Secretary removed the specific category of vaccines 
containing live, oral, rhesus-based rotavirus from the Table. Given the 
applicable statute of limitations and the fact that this category 
limited its application to vaccines administered on or before August 
26, 2002, the Secretary believed that any potential Table claim under 
this category would have been time-barred, so no persons could have had 
claims under that category.

Subsequent Rotavirus Vaccines

    On February 3, 2006, the FDA licensed a pentavalent human-bovine 
reassortant rotavirus vaccine (trade name ``RotaTeq''). Following a 
review by ACIP, the CDC published its recommendation for routine 
vaccination of U.S. infants with three doses of this rotavirus vaccine 
administered orally at ages 2, 4, and 6 months (MMWR 2006:55; RR12). On 
April 3, 2008, the FDA licensed a monovalent rotavirus vaccine derived 
from the human rotavirus strain (trade name ``Rotarix''). In June 2008, 
the CDC updated its recommendation to include use of the newly licensed 
Rotarix (MMWR 2009:58; RR02). The prelicensure clinical trials for 
RotaTeq examined 70,000 infants, and did not identify an increased risk 
of intussusception in the 1-42 days post immunization. In addition, the 
prelicensure clinical trials for Rotarix examined over 60,000 infants, 
and found no increased risk in the 1-31 days after vaccination with 
either dose. Because of the prior association of intussusception with 
Rotashield, multiple post-marketing studies regarding RotaTeq, Rotarix, 
and intussusception were conducted to evaluate the possibility of a 
small risk

[[Page 44515]]

of intussusception as utilization increased.

RotaTeq Scientific History

    In February 2007, the FDA notified health care providers and 
consumers about 28 post-marketing reports of intussusception following 
administration of RotaTeq. The notification stated that of the reported 
28 cases of intussusception, the number that may have been caused by 
the vaccine, or occurred by coincidence, was unknown. The FDA issued 
this notification both to encourage the reporting of any additional 
cases of intussusception that may have occurred in the past or will 
occur in the future after administration of RotaTeq, and to remind 
people that intussusception may be a potential complication of RotaTeq.
    In 2008, the Vaccine Safety Datalink (VSD) published their 
experience from the first 111,521 doses of RotaTeq given from 2006 to 
2007, and in 2012, the VSD and the CDC published data in ``The Journal 
of the American Medical Association'' (JAMA), from 786,725 doses of 
RotaTeq given from 2006 to 2010. There was no identifiable risk in the 
1-7 day or 1-30 day periods following administration of RotaTeq in 
either analysis. The final post-marketing study of RotaTeq in the U.S. 
was performed by Merck and found no association with intussusception 
and RotaTeq. Post-marketing clinical trials of RotaTeq performed after 
U.S. licensure included two smaller efficacy studies from Africa and 
Asia. The African study had no cases of intussusception in either 
vaccine or placebo groups, and the Asian study had one case 97 days 
following the third dose of the placebo, and no cases in the vaccine 
group.
    A 2011 post-marketing study of RotaTeq published in ``Vaccine,'' 
from the Australian National Immunization Program, suggests an 
association between RotaTeq and intussusception. Approximately 295,000 
doses of RotaTeq were given in two states. In 1-3 month old infants, 
the expected number of intussusception cases was exceeded for the 1-7 
and 1-21 day periods following the first dose of RotaTeq. In the 1-7 
days following the first dose, three cases were found, compared to an 
expected 0.57 cases (relative risk of 5.26 [confidence interval (CI), 
1.1-15.4]). (Relative risk is the ratio of the chance of a disease 
developing among members of a population exposed to a factor compared 
with a similar population not exposed to the factor.) [Confidence 
Intervals are a measure of estimation that represents the possible 
range of values in a population estimated from a given sample drawn 
from that population (in this case ranging from a relative risk value 
of 1.1 to 15.4)].
    When the 1-21 day interval following the first dose was examined, 
six cases of intussusception were found, compared to an expected 1.71 
cases (relative risk 3.5 [CI, 1.3-7.6]). There was no increase from the 
expected cases after dose two of RotaTeq, and actually a decrease from 
expected cases after dose three. Also important to note is that there 
was no evidence of increased risk of intussusception when examining the 
entire period of 1-9 months of age.

Rotarix Scientific History

    Rotarix was given in the other two states evaluated in the 
Australian post-marketing study, totaling approximately 302,000 doses. 
The study demonstrated an increased risk in both the 1-7 day and the 1-
21 day windows following the first dose of Rotarix (relative risk of 
3.45 [CI 0.7-10] and 1.53 [CI, 0.4-3.9], respectively). Neither of 
these risks showed statistical significance. There were no excess cases 
of intussusception associated with dose two of Rotarix. Similar to 
RotaTeq, the number of observed cases in the post-vaccine windows was 
small, with three cases observed in the 1-7 days after first dose 
vaccination versus 0.9 cases expected for the 1-3 month old infants. 
Since Rotarix constitutes a small percentage of total rotavirus vaccine 
given in the U.S. (3 million doses of Rotarix versus 35 million doses 
of RotaTeq as of 2010), comparable U.S. post-licensure studies of 
Rotarix are not currently available.
    Post-marketing studies (case series and case-control analysis) 
performed in Mexico and Brazil, and published in ``The New England 
Journal of Medicine'' in 2011, identified an association between 
Rotarix and intussusception. In Mexico, there was an increased rate of 
intussusception during the 1-7 day period after the first dose of 
Rotarix with an incidence rate ratio of 5.3 (CI, 3-9.3). (Incidence 
rate ratio compares two incidence rates. Incidence rate is the number 
of new cases per population in a given time period.) There was no 
increase in the rate 1-7 days after the second dose, but a small 
increase by a factor of two was identified in the second and third week 
following the second dose. This contrasts with the Brazil data where 
there was no increase in the rate of intussusception found after the 
first dose of Rotarix, but a small elevation of the rate was identified 
1-7 days following the second dose (incidence ratio of 2.6 [CI, 1.3-
5.2]). The reason behind the variation between the data from Mexico and 
Brazil is unclear, but one potential explanation could be a result of 
Brazil's administering Rotarix and the oral polio virus vaccine (OPV) 
together, which has been shown to decrease the immunogenicity of the 
first dose of Rotarix, perhaps making the second dose function more 
like the initial dose.
    The commentary in ``The New England Journal of Medicine'' in 2011 
regarding the Rotarix data from Mexico and Brazil summarized the small 
attributable risk of intussusception as 1/51,000 vaccinated infants in 
Mexico and 1/68,000 vaccinated infants in Brazil. [Attributable risk is 
the difference in rate of a condition (intussusception in this case) 
between an exposed population (those who received rotavirus vaccine in 
this case) and an unexposed population.] The article raised the 
possibility that any live, oral, rotavirus vaccine, along with natural 
rotavirus infection, could carry a detectable risk of intussusception, 
although the risk is demonstrably quite low, based on the available 
studies. It is also biologically plausible that the different vaccines 
have differing intrinsic risks of intussusception based on the distinct 
strains in each vaccine, and that the same vaccine could manifest 
different risks in different populations. It is also possible that with 
small risks overall (resulting in a small number of excess 
intussusception cases in the specific narrow age groups receiving 
vaccine) and variability in background numbers of cases of 
intussusception year to year, an increase in overall burden of 
intussusception in infants aged < 1 year may not be detectable. The 
article raised the point that the small increase of intussusception 
after vaccination does not seem to increase the overall burden of 
intussusception, and that perhaps the rotavirus vaccination has a 
preventive role in long-term intussusception risk.
    Because of these findings, the prescribing information in the U.S. 
for Rotarix was amended in September 2010 to reflect the above 
increased risk and the potential implications for U.S. infants. 
(GlaxosmithKline Biologicals Package Insert (PI) and Patient Package 
Information (PPI)). The PI and PPI were further amended in February 
2011 to include ``history of intussusception'' as a contraindication to 
vaccination. (Statement available for viewing at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm245491.htm). A 
``history of intussusception'' was also made a contraindication for 
Rotateq in July 2011.

[[Page 44516]]

    In addition, a large post-marketing surveillance study of 
intussusception in Mexico published in ``The Pediatric Infectious 
Disease Journal'' in July 2012 reported an ``attributable risk of 3 to 
4 additional cases of intussusception per 100,000 vaccinated infants 
after receipt if Rotarix.

CDC Response

    In November 2010, the CDC issued a statement noting that some, but 
not all, studies suggest RotaTeq and Rotarix may possibly cause a small 
increase in the risk of intussusception; however, the CDC concluded 
that the benefits of these vaccines far outweigh this possible risk. 
The CDC continues to recommend routine rotavirus vaccination of U.S. 
infants to prevent severe rotavirus disease in U.S. infants and 
children. (Statement available for viewing at http://www.cdc.gov/vaccines/vpd-vac/rotavirus/intussusception-studies-acip.htm).
    The FDA's mini-sentinel ``Post-Licensure Rapid Immunizations Safety 
Monitoring Program'' (PRISM) is currently performing a study to assess 
the risk of intussusception from both Rotarix and RotaTeq vaccines in 
the United States. This self-controlled and case-centered study targets 
approximately 1 million infants. Results are expected late in 2012.

Proposed Rule

    The Secretary has reviewed all 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 recently published literature from Mexico, Brazil, and 
Australia 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). Therefore, the Secretary proposes that the injury of 
intussusception be added 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. Current U.S. 
studies of RotaTeq do not show a statistically identifiable risk of 
intussusception, but the number of study patients exposed to the 
vaccine in the U.S. may not be large enough (even with the results 
expected from the ongoing PRISM study) to rule out a very small 
attributable risk to the vaccine. Platforms like VSD in the U.S. have 
not been able to evaluate the possible small risk associated with 
Rotarix to date because of the low numbers of doses of Rotarix 
administered in settings captured by the surveillance program. To allow 
for a generous timeframe, the Secretary proposes that the Table injury 
for intussusception have an onset interval of 1-21 days under sections 
2114(c) and (e) of the PHS Act, since evidence shows the increased risk 
within the 1-7 days following immunization with peaks in the fourth and 
fifth days.
    The Qualifications and Aids to Interpretation section of the table 
will define 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 
Qualifications and Aids to Interpretation 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 an enema 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 2 years after the effective 
date of the revision if the injury or death occurred not more than 8 
years before the effective date of the revision of the Table (42 U.S.C. 
300aa-16(b)).
    The Advisory Commission on Childhood Vaccines (ACCV) voted 
unanimously to approve this proposal at its December 9, 2011, meeting. 
The Secretary, while moving forward with this proposal, understands 
that additional science is still forthcoming and recognizes the 
importance of keeping the Vaccine Injury Table in conformance with 
science. In addition, the Secretary recognizes that one goal of

[[Page 44517]]

the VICP is to provide generous compensation to petitioners harmed by 
vaccines through a less adversarial system. Although post-marketing 
studies in the U.S. have not identified an increased risk of 
intussusception associated with rotavirus vaccine, a small risk cannot 
be ruled out. Therefore, the Secretary feels that the balance between 
science and policy is best met by acting now, on the basis of the 
studies outside the U.S. that have detected an increased risk of 
intussusception following Rotarix and RotaTeq vaccines, rather than 
waiting to see if the PRISM, VSD, and other studies further bolsters 
the already published findings.

Economic and Regulatory Impact

    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. This proposed rule only lessens 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 proposed 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 Department has determined that the proposed rule is 
not a ``major rule'' within the meaning of the statute providing for 
Congressional Review of Agency Rulemaking, 5 U.S.C. Sec.  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 affect 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 proposed rule would modify the Vaccine Injury 
Table based on legal authority.

Impact of the New Rule

    To date, 17 petitions have been filed alleging a vaccine-related 
injury of intussusception caused or aggravated by a rotavirus vaccine, 
not including the currently unavailable Rotashield vaccine. This 
proposed rule will have the effect of decreasing the burden of proof 
for future petitioners. Under this proposed rule, future petitioners 
alleging the injury of intussusception as the result of a rotavirus 
vaccine that meets the criteria in the Vaccine Injury Table will be 
afforded a presumption of causation. This proposed rule will not change 
the burden of proof applicable to petitioners alleging other injuries 
related to a rotavirus vaccine who must rely on a causation-in-fact 
analysis.

Paperwork Reduction Act of 1980

    This proposed rule has no information collection requirements.

List of Subjects in 42 CFR Part 100

    Biologics, Health Insurance, and Immunization.

    Dated: June 26, 2013.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: July 17, 2013.
Kathleen Sebelius,
Secretary.
    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:  Sec. 215 of the Public Health Service Act (42 U.S.C. 
216); sec. 2115 of the PHS Act; 100 Stat. 3767, as revised (42 
U.S.C. 300aa-15); Sec.  100.3 Vaccine Injury Table, issued under 
secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 (42 U.S.C. 
300aa-1 note); and sec. 2114(c) and (3) of the PHS Act, 100 Stat. 
3766 and 107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e)); sec. 904(b) 
of Pub. L. 105-34, 111 Stat. 873; and sec. 523(a) of Pub. L. 106-
170, 113 Stat. 1860.

0
2. Amend Sec.  100.3 in the paragraph (a) table by revising Item XI and 
by adding paragraph (b)(3) to read as follows:


Sec.  100.3  Vaccine injury table.

    (a) * * *

                                              Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
                                                                               Time period for first symptom or
                                              Illness, disability, injury,       manifestation of onset or of
                  Vaccine                         or condition covered          significant aggravation after
                                                                                    vaccine administration
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
XI. Rotavirus vaccines.....................  A. Intussusception............  1-21 days.
                                             B. Any acute complication or    Not applicable.
                                              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.

[[Page 44518]]

 
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (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. 2013-17786 Filed 7-23-13; 8:45 am]
BILLING CODE 4165-15-P