80 FR 35848 - National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 120 (June 23, 2015)
Federal Register Volume 80, Issue 120 (June 23, 2015)
| Page Range | 35848-35851 | |
| FR Document | 2015-14771 |
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)] [Rules and Regulations] [Pages 35848-35851] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14771] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![35848 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations
‘‘Exclusive’’. This document removes for this change is consistent with the the vaccine; or that the alleged injury
MR series 11000 and 12000 from being Secretary’s findings that resulted in inpatient hospitalization and
designated as ‘‘Exclusive’’. All other intussusceptions can reasonably be surgical intervention. Section
parameters of the Final Rule remain the determined in some circumstances to be 2111(c)(1)(D) of the PHS Act. If the
same as published on June 5, 2015. caused by rotavirus vaccines. The petitioner can prove a Table injury, off-
DATES: Effective June 23, 2015. Secretary is now making this Table injury, or significant aggravation
FOR FURTHER INFORMATION CONTACT: amendment to the Table and to the of a pre-existing condition, the
Barry S. Lineback, Telephone: (703) Qualifications and Aids to petitioner is entitled to compensation
603–2118. Interpretation (QAI), described below unless it is affirmatively shown that the
under Background Information, as injury was caused by some factor
SUPPLEMENTARY INFORMATION: This
proposed in the NPRM. These unrelated to the vaccination.
document corrects § 51–6.4 by removing Under section 2114(e)(2) of the PHS
MR series 11000 and 12000 from regulations will apply only to petitions
for compensation under the VICP filed Act, when the Centers for Disease
paragraphs (b), (c)(4), and (d) so the Control and Prevention (CDC)
series are no longer designated as after this final rule becomes effective.
DATES: This final rule is effective July recommends a vaccine for routine
‘‘Exclusive’’. All other parameters of the administration to children, the Secretary
Final Rule remain the same as 23, 2015.
is required to amend the Table to
published on June 5, 2015. FOR FURTHER INFORMATION CONTACT: Dr.
include such vaccine. Coverage becomes
Avril M. Houston, Director, Division of
List of Subjects in 41 CFR Part 51–6 effective when an excise tax is imposed
Injury Compensation Programs,
Procurement procedures. on the vaccine. Additionally, the
Healthcare Systems Bureau, HRSA,
Secretary is authorized to include
For the reasons set out in the Parklawn Building, Room 11C–06, 5600
specific injuries on the Table with
preamble, the Committee amends 41 Fishers Lane, Rockville, MD 20857, or
respect to each covered vaccine,
CFR part 51–6 as follows: by telephone: (800) 338–2382. This is a
including the timeframe when the first
toll-free number. symptom or manifestation of the onset
PART 51–6—PROCUREMENT SUPPLEMENTARY INFORMATION:
PROCEDURES of such adverse event may occur. The
I. Background Information Secretary may also define such injuries
■ 1. The authority citation for part 51– through the QAI. Under section 2114(c)
Under Title XXI of the Public Health of the PHS Act, the Secretary may make
6 continues to read as follows: Service Act, as amended (PHS Act),
Authority: 41 U.S.C. 8501–8506.
such modifications to the Table by
individuals who demonstrate a vaccine- promulgating regulations, with notice
related injury or death may receive and opportunity for a public hearing,
§ 51–6.4 [Amended]
compensation through the VICP. To be and at least 180 days of public
■ 2. In § 51–6.4, in paragraphs (b), (c)(4), eligible for compensation from the
and (d), remove ‘‘, 11000 (11000– comment.
VICP, a petitioner must demonstrate
11999); 12000 (12000–12999)’’. that the injured or deceased individual II. Discussion of the Final Rule
Dated: June 17, 2015. received a vaccine set forth in the Table As discussed in the NPRM (78 FR
Barry S. Lineback, (a ‘‘covered vaccine’’) and sustained a 44512, July 24, 2013), the Secretary has
Director, Business Operations. vaccine-related injury or death. A reviewed the currently available data
[FR Doc. 2015–15284 Filed 6–22–15; 8:45 am]
petitioner can prove a vaccine-related regarding the Rotarix and RotaTeq
injury or death in three ways. First, the vaccines and the risk of intussusception.
BILLING CODE 6353–01–P
petitioner can show, by a The background of the RotaShield
preponderance of the evidence, that the experience in the U.S. and the
vaccine recipient suffered an injury published literature from Mexico,
DEPARTMENT OF HEALTH AND listed in the Table corresponding with Brazil, Australia, and the U.S. supports
HUMAN SERVICES the vaccine received, that the onset of a small attributable risk of
42 CFR Part 100 such injury occurred within the intussusception after the first and
timeframe specified in the Table, and second doses of Rotarix and RotaTeq
RIN 0906–AB00 that the injury meets the requirements (with a greater amount of data
set forth in the Table’s QAI. A Table supporting an association with the first
National Vaccine Injury Compensation injury or death is given the legal dose of both vaccines). Evidence shows
Program: Addition of Intussusception presumption that it was caused by the the increased risk within the 1–7 days
as Injury for Rotavirus Vaccines to the vaccination. Sections 2111(c)(1)(C)(i), following immunization with peaks in
Vaccine Injury Table 2113(a)(1)(B), and 2114(a) of the PHS the fourth and fifth days. As a
AGENCY: Health Resources and Services Act. Second, if the petitioner cannot consequence, the Secretary is amending
Administration (HRSA), Department of demonstrate a Table injury, the the Table to add the injury of
Health and Human Services (HHS). petitioner can prevail by proving, by a intussusception to the general Table
ACTION: Final rule. preponderance of the evidence, that the category of ‘‘rotavirus vaccines’’ to
vaccine caused the injury or death (off- allow a presumption of causation for
SUMMARY: On July 24, 2013, the Table injury). Third, a petitioner can claims that meet the requirements set
Secretary of Health and Human Services prevail by proving, by a preponderance forth in the Table for that injury. To
(the Secretary) published in the Federal of the evidence, that the vaccine allow for a generous timeframe that will
mstockstill on DSK4VPTVN1PROD with RULES
Register a Notice of Proposed significantly aggravated a pre-existing capture any cases related to the vaccine
Rulemaking (NPRM) proposing changes condition. In all three cases, a petitioner after day 7, the Secretary has assigned
to the regulations governing the must also show that the injury was an onset interval of 1–21 days under
National Vaccine Injury Compensation sufficiently severe by demonstrating sections 2114(c) and (e) of the PHS Act.
Program (VICP). Specifically, the that such person suffered the residual The Secretary will stay informed of
Secretary proposed revisions to the effects of the injury for more than 6 new information in the scientific and
Vaccine Injury Table (Table). The basis months; died from the administration of medical field about intussusception and
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![Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations 35851
Time period for first symptom or manifestation
Vaccine Illness, disability, injury or condition covered of onset or of significant aggravation after
vaccine administration
* * * * * * *
XI. Rotavirus vaccines ...................................... A. Intussusception ............................................ 1–21 days
B. Any acute complication or sequela (includ- Not applicable
ing death) of an illness, disability, injury, or
condition referred to above which illness,
disability, injury, or condition arose within
the time period prescribed.
* * * * * * *
(b) * * * cystic fibrosis, celiac disease, or particular community was suspended
(3) Intussusception. (i) For purposes Kawasaki disease). on the suspension date or for further
of paragraph (a) of this section, * * * * * information, contact Bret Gates, Federal
intussusception means the invagination [FR Doc. 2015–14771 Filed 6–22–15; 8:45 am] Insurance and Mitigation
of a segment of intestine into the next BILLING CODE 4165–15–P Administration, Federal Emergency
segment of intestine, resulting in bowel Management Agency, 500 C Street SW.,
obstruction, diminished arterial blood Washington, DC 20472, (202) 646–4133.
supply, and blockage of the venous DEPARTMENT OF HOMELAND SUPPLEMENTARY INFORMATION: The NFIP
blood flow. This is characterized by a SECURITY enables property owners to purchase
sudden onset of abdominal pain that Federal flood insurance that is not
may be manifested by anguished crying, Federal Emergency Management otherwise generally available from
irritability, vomiting, abdominal Agency private insurers. In return, communities
swelling, and/or passing of stools mixed agree to adopt and administer local
with blood and mucus. 44 CFR Part 64 floodplain management measures aimed
(ii) For purposes of paragraph (a) of at protecting lives and new construction
[Docket ID FEMA–2015–0001; Internal
this section, the following shall not be from future flooding. Section 1315 of
Agency Docket No. FEMA–8385]
considered to be a Table the National Flood Insurance Act of
intussusception: Suspension of Community Eligibility 1968, as amended, 42 U.S.C. 4022,
(A) Onset that occurs with or after the prohibits the sale of NFIP flood
third dose of a vaccine containing AGENCY: Federal Emergency insurance unless an appropriate public
rotavirus; Management Agency, DHS. body adopts adequate floodplain
(B) Onset within 14 days after an ACTION: Final rule. management measures with effective
infectious disease associated with enforcement measures. The
intussusception, including viral disease SUMMARY: This rule identifies communities listed in this document no
(such as those secondary to non-enteric communities where the sale of flood longer meet that statutory requirement
or enteric adenovirus, or other enteric insurance has been authorized under for compliance with program
viruses such as Enterovirus), enteric the National Flood Insurance Program regulations, 44 CFR part 59.
bacteria (such as Campylobacter jejuni), (NFIP) that are scheduled for Accordingly, the communities will be
or enteric parasites (such as Ascaris suspension on the effective dates listed suspended on the effective date in the
lumbricoides), which may be within this rule because of third column. As of that date, flood
demonstrated by clinical signs and noncompliance with the floodplain insurance will no longer be available in
symptoms and need not be confirmed management requirements of the the community. We recognize that some
by culture or serologic testing; program. If the Federal Emergency of these communities may adopt and
(C) Onset in a person with a pre- Management Agency (FEMA) receives submit the required documentation of
existing condition identified as the lead documentation that the community has legally enforceable floodplain
point for intussusception such as adopted the required floodplain management measures after this rule is
intestinal masses and cystic structures management measures prior to the published but prior to the actual
(such as polyps, tumors, Meckel’s effective suspension date given in this suspension date. These communities
diverticulum, lymphoma, or duplication rule, the suspension will not occur and will not be suspended and will continue
cysts); a notice of this will be provided by to be eligible for the sale of NFIP flood
(D) Onset in a person with publication in the Federal Register on a insurance. A notice withdrawing the
abnormalities of the bowel, including subsequent date. Also, information suspension of such communities will be
congenital anatomic abnormalities, identifying the current participation published in the Federal Register.
anatomic changes after abdominal status of a community can be obtained In addition, FEMA publishes a Flood
surgery, and other anatomic bowel from FEMA’s Community Status Book Insurance Rate Map (FIRM) that
abnormalities caused by mucosal (CSB). The CSB is available at http:// identifies the Special Flood Hazard
mstockstill on DSK4VPTVN1PROD with RULES
hemorrhage, trauma, or abnormal www.fema.gov/fema/csb.shtm. Areas (SFHAs) in these communities.
intestinal blood vessels (such as Henoch DATES: The effective date of each The date of the FIRM, if one has been
Scholein purpura, hematoma, or community’s scheduled suspension is published, is indicated in the fourth
hemangioma); or the third date (‘‘Susp.’’) listed in the column of the table. No direct Federal
(E) Onset in a person with underlying third column of the following tables. financial assistance (except assistance
conditions or systemic diseases FOR FURTHER INFORMATION CONTACT: If pursuant to the Robert T. Stafford
associated with intussusception (such as you want to determine whether a Disaster Relief and Emergency
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Document Created: 2018-02-22 11:15:09
Document Modified: 2018-02-22 11:15:09
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This final rule is effective July 23, 2015. | |
| 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. | |
| FR Citation | 80 FR 35848 | |
| RIN Number | 0906-AB00 | |
| CFR Associated | Biologics; Health Insurance and Immunization |
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