[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Proposed Rules]
[Pages 24228-24229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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