80 FR 24228 - National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking Proceedings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 83 (April 30, 2015)

Page Range		24228-24229
FR Document		2015-10110

In accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting rulemaking proceedings to add diabetes mellitus as an injury associated with the measles-mumps- rubella vaccine to the Vaccine Injury Table.

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015)

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Proposed Rules]
[Pages 24228-24229]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100


National Vaccine Injury Compensation Program: Statement of 
Reasons for Not Conducting Rulemaking Proceedings

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

ACTION: Denial of petition for rulemaking.

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SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health 
Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given 
concerning the reasons for not conducting rulemaking proceedings to add 
diabetes mellitus as an injury associated with the measles-mumps-
rubella vaccine to the Vaccine Injury Table.

DATES: Written comments are not being solicited.

FOR FURTHER INFORMATION CONTACT: Avril M. Houston, MD, MPH, Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau, 
HRSA, Parklawn Building, Room 11C-06, 5600 Fishers Lane, Rockville, 
Maryland 20857, or by telephone at (301) 443-6593.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986, Title III of Public Law 99-660 (42 U.S.C. 300 aa-10 et seq.) 
established the National Vaccine Injury Compensation Program (VICP) for 
persons found to be injured by vaccines. Under this federal program, 
petitions for compensation are filed with the United States Court of 
Federal Claims (Court). The Court, acting through special masters, 
makes findings as to eligibility for, and amount of, compensation. In 
order to gain entitlement to compensation under the VICP for a covered 
vaccine, a petitioner must establish a vaccine-related injury or death, 
either by proving that the first symptom of an injury/condition, as 
defined by the Qualifications and Aids to Interpretation, occurred 
within the time period listed on the Vaccine Injury Table (Table), and, 
therefore, is presumed to be caused by a vaccine (unless another cause 
is found), or by proof of vaccine causation, if the injury/condition is 
not on the Table or did not occur within the time period specified on 
the Table.
    The statute authorizing the VICP provides for the inclusion of 
additional vaccines in the VICP when they are recommended by the 
Centers for Disease Control and Prevention (CDC) for routine 
administration to children. See section 2114(e)(2) of the PHS Act, 42 
U.S.C. 300aa-14(e)(2). Consistent with section 13632(a)(3) of Public 
Law 103-66, the regulations governing the VICP provide that such 
vaccines will be included in the Table as of the effective date of an 
excise tax to provide funds for the payment of compensation with 
respect to such vaccines. 42 CFR 100.3(c)(8). The statute authorizing 
the VICP also authorizes the Secretary to create and modify a list of 
injuries, disabilities, illnesses, conditions, and deaths (and their 
associated time frames) associated with each category of vaccines 
included on the Table. See sections 2114(c) and 2114(e)(2) of the PHS 
Act, 42 U.S.C. 300aa-14(c) and 300aa-14(e)(2). Finally, section 
2114(c)(2) of the PHS Act, 42 U.S.C. 300aa-14(c)(2), provides that:

``[a]ny person (including the Advisory Commission on Childhood 
Vaccines) [the Commission] may petition the Secretary to propose 
regulations to amend the Vaccine Injury Table. Unless clearly 
frivolous, or initiated by the Commission, any such petition shall 
be referred to the Commission for its recommendations. Following--

    (A) receipt of any recommendation of the Commission, or

[[Page 24229]]

    (B) 180 days after the date of the referral to the Commission,
    [w]hichever occurs first, the Secretary shall conduct a 
rulemaking proceeding on the matters proposed in the petition or 
publish in the Federal Register a statement of reasons for not 
conducting such proceeding.''

    On April 9, 2014, a private citizen submitted an email inquiry to 
the Secretary of Health and Human Services (HHS) regarding the VICP. 
This email asked why the condition of diabetes mellitus (DM) is not a 
listed injury on the Vaccine Injury Table (Table) in association with 
the measles, mumps, and rubella (MMR) vaccination, explaining that it 
is identified by the manufacturer as a possible adverse result of the 
MMR vaccine. The email also asked whether the Secretary would consider 
amending the Table to add DM as an injury for MMR vaccines. As such, 
the email was considered to be a petition to the Secretary to propose 
regulations to amend the Table to add the injury of DM for the category 
of MMR vaccines. Accordingly, pursuant to the VICP statute, the 
petition was referred to the Commission on June 5, 2014. The Commission 
voted unanimously to recommend that the Secretary not proceed with 
rulemaking to amend the Table as requested in the petition.
    DM is a chronic disease in which there is a high level of sugar in 
the blood. There are two types: Type 1 and Type 2. Type 1 Diabetes is 
one of the most common chronic diseases in childhood. It is caused by 
insulin deficiency following destruction of the insulin producing 
pancreatic beta cells, resulting in absolute insulin deficiency. Type 2 
Diabetes is characterized by hyperglycemia and insulin resistance and 
relative impairment in insulin secretion. Through the years, there have 
been many studies evaluating the risk of Type 1 Diabetes after MMR 
vaccination. However, HRSA's search of published literature did not 
reveal any studies discussing a causal relationship between Type 2 
Diabetes and the MMR vaccine. The Secretary notes that vaccine package 
inserts list adverse events reported to vaccine manufacturers during 
clinical trials even though they may not have been shown to have been 
caused by the vaccines.
    In 2008, the Secretary contracted with the Institute of Medicine 
(IOM) to review the epidemiological, clinical, and biological evidence 
regarding adverse health events associated with specific vaccines 
covered by the VICP.\1\ The IOM committee reviewed the relevant studies 
through 2011 and concluded that ``[t]he evidence favors rejection of a 
causal relationship between MMR vaccine and Type 1 Diabetes.'' 
Specifically, the epidemiologic studies consistently reported a null 
association, or no association between the MMR vaccine and Type 1 
Diabetes. The IOM committee concluded that the mechanistic evidence 
regarding an association between MMR vaccine and Type 1 Diabetes was 
lacking.
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    \1\ IOM, Adverse Effects of Vaccines: Evidence and Causality 
(Washington, DC: The National Academies Press, 2012):204-211.
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    In 2012, the Cochrane Collaboration reviewed and assessed studies 
in the Cochrane Central Register of Controlled Trials.\2\ The specific 
conclusion was that MMR vaccine was unlikely associated with Type 1 
Diabetes. A recent study by Duderstadt et al. (2012) \3\ was not 
reviewed by the IOM Committee and the Cochrane Collaboration. This was 
a retrospective cohort study among U.S. military personnel, which 
evaluated whether vaccination increased the risk of Type 1 Diabetes. 
The result was that there was no increased risk of diagnosed Type 1 
Diabetes after administration of any studied vaccines, including the 
MMR vaccine. Current scientific literature consistently shows that 
there is no causal association between MMR vaccination and Type 1 
Diabetes. As noted above, the VICP's search of published literature did 
not reveal any studies discussing a causal relationship between Type 2 
Diabetes and the MMR vaccine.
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    \2\ Demicheli, V., A. Rivetti, et al. ``Vaccines for Measles, 
Mumps and Rubella in Children.'' Cochrane Database System Rev 2: 
CD004407 (2012): 19.
    \3\ Duderstadt, S., C. Rose Jr., T. Real, J. Sabatier, B. 
Stewart, G. Ma, U. Yerubandi, A. Eick, J. Tokars, M. McNeil. 
``Vaccination and Risk of Type 1 Diabetes Mellitus in Active 
Component U.S. Military, 2002-2008. Vaccine 30:813-819, (2012).
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    In light of the literature discussed above, I have determined that 
there is no reliable scientific evidence of a causal association 
between MMR vaccine and DM. Therefore, I will not amend the Table to 
add DM as an injury associated with the MMR vaccine.

    Dated: April 23, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-10110 Filed 4-29-15; 8:45 am]
 BILLING CODE 4165-15-P

24228 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Proposed Rules

ENVIRONMENTAL PROTECTION because the Agency views this as a Maryland 20857, or by telephone at
AGENCY noncontroversial submittal and (301) 443–6593.
anticipates no adverse comments. A SUPPLEMENTARY INFORMATION: The
40 CFR Part 62 detailed rationale for the approval is set National Childhood Vaccine Injury Act
[EPA–R06–OAR–2013–0763; FRL–9927–01- forth in the direct final rule. If no of 1986, Title III of Public Law 99–660
Region 6] relevant adverse comments are received (42 U.S.C. 300 aa–10 et seq.) established
in response to this action, no further the National Vaccine Injury
Approval and Promulgation of State activity is contemplated. If EPA receives Compensation Program (VICP) for
Plans for Designated Facilities and relevant adverse comments, the direct persons found to be injured by vaccines.
Pollutants; Texas, Oklahoma, final rule will be withdrawn and all Under this federal program, petitions for
Arkansas, New Mexico, and the City of public comments received will be compensation are filed with the United
Albuquerque, New Mexico; Control of addressed in a subsequent final rule States Court of Federal Claims (Court).
Emissions From Existing Sewage based on this proposed rule. The EPA The Court, acting through special
Sludge Incinerator Units will not institute a second comment masters, makes findings as to eligibility
period. Any parties interested in for, and amount of, compensation. In
AGENCY: Environmental Protection commenting on this action should do so
Agency (EPA). order to gain entitlement to
at this time. Please note that if EPA compensation under the VICP for a
ACTION: Proposed rule. receives relevant adverse comment on covered vaccine, a petitioner must
SUMMARY: The Environmental Protection an amendment, paragraph, or section of establish a vaccine-related injury or
Agency (EPA) is proposing to approve this rule and if that provision may be death, either by proving that the first
Clean Air Act (CAA) section 111(d)/129 severed from the remainder of the rule, symptom of an injury/condition, as
negative declarations for the States of EPA may adopt as final those provisions defined by the Qualifications and Aids
Texas, Oklahoma, Arkansas, New of the rule that are not the subject of an to Interpretation, occurred within the
Mexico, and the City of Albuquerque, adverse comment. time period listed on the Vaccine Injury
For additional information, see the
New Mexico, for existing sewage sludge Table (Table), and, therefore, is
direct final rule, which is located in the
incinerator (SSI) units. These negative presumed to be caused by a vaccine
rules section of this Federal Register.
declarations certify that existing SSI (unless another cause is found), or by
units subject to the requirements of Dated: April 16, 2015. proof of vaccine causation, if the injury/
sections 111(d) and 129 of the CAA do Ron Curry, condition is not on the Table or did not
not exist within the jurisdictions of Regional Administrator, Region 6. occur within the time period specified
Texas, Oklahoma, Arkansas, and New [FR Doc. 2015–10041 Filed 4–29–15; 8:45 am] on the Table.
Mexico (including the City of BILLING CODE 6560–50–P The statute authorizing the VICP
Albuquerque). provides for the inclusion of additional
DATES: Written comments must be vaccines in the VICP when they are
received on or before June 1, 2015. DEPARTMENT OF HEALTH AND recommended by the Centers for Disease
ADDRESSES: Comments may be mailed to HUMAN SERVICES Control and Prevention (CDC) for
Mr. Guy Donaldson, Chief, Air Planning routine administration to children. See
Section (6PD–L), Environmental 42 CFR Part 100 section 2114(e)(2) of the PHS Act, 42
Protection Agency, 1445 Ross Avenue, U.S.C. 300aa–14(e)(2). Consistent with
National Vaccine Injury Compensation section 13632(a)(3) of Public Law 103–
Suite 1200, Dallas, Texas 75202–2733. Program: Statement of Reasons for
Comments may also be submitted 66, the regulations governing the VICP
Not Conducting Rulemaking provide that such vaccines will be
electronically or through hand delivery/ Proceedings
courier by following the detailed included in the Table as of the effective
instructions in the ADDRESSES section of AGENCY: Health Resources and Services date of an excise tax to provide funds
the direct final rule located in the rules Administration (HRSA), Department of for the payment of compensation with
section of this Federal Register. Health and Human Services (HHS). respect to such vaccines. 42 CFR
ACTION: Denial of petition for
100.3(c)(8). The statute authorizing the
FOR FURTHER INFORMATION CONTACT: Mr.
rulemaking. VICP also authorizes the Secretary to
Kenneth Boyce, (214) 665–7259,
create and modify a list of injuries,
boyce.kenneth@epa.gov.
SUMMARY: In accordance with section disabilities, illnesses, conditions, and
SUPPLEMENTARY INFORMATION: In the
2114(c)(2)(B) of the Public Health deaths (and their associated time
final rules section of this Federal frames) associated with each category of
Service Act, 42 U.S.C. 300aa–
Register, EPA is approving the negative vaccines included on the Table. See
14(c)(2)(B), notice is hereby given
declarations submitted by the Texas sections 2114(c) and 2114(e)(2) of the
concerning the reasons for not
Commission on Environmental Quality PHS Act, 42 U.S.C. 300aa–14(c) and
conducting rulemaking proceedings to
(TCEQ), the Oklahoma Department of 300aa–14(e)(2). Finally, section
add diabetes mellitus as an injury
Environmental Quality (ODEQ), the 2114(c)(2) of the PHS Act, 42 U.S.C.
associated with the measles-mumps-
Arkansas Department of Environmental 300aa–14(c)(2), provides that:
rubella vaccine to the Vaccine Injury
Quality (ADEQ), New Mexico
Table. ‘‘[a]ny person (including the Advisory
Environment Department (NMED) and
rmajette on DSK2VPTVN1PROD with PROPOSALS

the City of Albuquerque, New Mexico, DATES: Written comments are not being Commission on Childhood Vaccines) [the
solicited. Commission] may petition the Secretary to
certifying that there are no existing propose regulations to amend the Vaccine
sewage sludge incinerator (SSI) units FOR FURTHER INFORMATION CONTACT: Injury Table. Unless clearly frivolous, or
within their respective jurisdictions. Avril M. Houston, MD, MPH, Director, initiated by the Commission, any such
These negative declarations meet the Division of Injury Compensation petition shall be referred to the Commission
requirements of 40 CFR 62.06. EPA is Programs, Healthcare Systems Bureau, for its recommendations. Following—
approving the negative declaration as a HRSA, Parklawn Building, Room 11C– (A) receipt of any recommendation of the
direct final rule without prior proposal 06, 5600 Fishers Lane, Rockville, Commission, or

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Document Created: 2018-02-21 10:14:59
Document Modified: 2018-02-21 10:14:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Denial of petition for rulemaking.
Dates		Written comments are not being solicited.
Contact		Avril M. Houston, MD, MPH, Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 11C-06, 5600 Fishers Lane, Rockville, Maryland 20857, or by telephone at (301) 443-6593.
FR Citation		80 FR 24228