[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Proposed Rules]
[Pages 55503-55507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AA74


National Vaccine Injury Compensation Program: Revisions to the 
Vaccine Injury Table

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: Through this proposed rule, the Secretary proposes to change 
the Vaccine Injury Table (Table) to create distinct and separate 
listings for hepatitis A, trivalent influenza, meningococcal, and human 
papillomavirus (HPV) vaccines. The Table includes a list of covered 
vaccines under the National Vaccine Injury Compensation Program (VICP). 
The VICP provides a system of no-fault compensation for certain 
individuals who have been injured by covered childhood vaccines. This 
proposed rule is technical in nature. The four categories of vaccines 
described in this notice are already covered vaccines under the VICP 
(starting in 2004) and are currently listed in a placeholder category 
(box XIII) in the Table. This document proposes to list these vaccines 
as separate categories on the Table, with no associated injuries noted 
at this time, in order to make the Table more clear to the public.

[[Page 55504]]


DATES: Comments on this proposed rule must be submitted by March 14, 
2011. 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.

ADDRESSES: You may submit comments, identified by the Regulatory 
Information Number (RIN) 0907-AA74, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: [email protected]. Include RIN 0907-AA74 in the 
subject line of the message.
     Mail: Geoffrey Evans, M.D., Director, Division of Vaccine 
Injury Compensation, Healthcare Systems Bureau, Health Resources and 
Services Administration, Room 11C-26, Parklawn Building, 5600 Fishers 
Lane, Rockville, Maryland 20857.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. All comments received will be available 
for public inspection and copying without charge, including any 
personal information provided, at Parklawn Building, 5600 Fishers Lane, 
Room 11C-26, Rockville, Maryland 20857, weekdays (Federal holidays 
excepted) between the hours of 8:30 a.m. and 5 p.m.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D. at the mail or e-
mail address above or by telephone at (301) 443-6593.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986, Title III of Public Law 99-660, as amended (42 U.S.C. 300aa-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 Title 
XXI of the Public Health Service (PHS) Act for a covered vaccine, a 
petitioner must establish a vaccine-related injury or death, either by 
proving: (1) That the first symptom of an injury/condition, as defined 
by the Vaccine Injury Table's (Table's) Qualifications and Aids to 
Interpretation (QAI), occurred within the time period listed on the 
Table (copy of the Table can be found at http:[sol][sol]www.hrsa.gov/
vaccinecompensation), and is therefore the injury or death presumed to 
be caused by a vaccine (unless another cause is found); or (2) proof of 
vaccine causation, if the injury/condition is not on the Table or did 
not meet the QAIs or the time frame 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 Public Health 
Service (PHS) Act, 42 U.S.C. 300aa-14(e)(2). Consistent with section 
13632(a)(3) of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 
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. See 42 CFR 100.3(c)(5). 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)(3) and 2114(e)(2) of the PHS Act, 42 U.S.C. 
300aa-14(c)(3) and 300aa-14(e)(2).
    The prerequisites for adding the hepatitis A, trivalent influenza, 
meningococcal, and human papillomavirus (HPV) vaccines to the VICP have 
already occurred. The Secretary previously published notices announcing 
that each of these categories of vaccines is covered under the VICP 
(under the Table's provisional category) and explaining that the 
Secretary planned on adding these vaccines as separate categories to 
the Table through rulemaking, as proposed in this notice. On December 
1, 2004, the Secretary published a notice in the Federal Register 
announcing that hepatitis A vaccines were covered under the VICP, with 
an effective date of December 1, 2004. 69 FR 69945. On April 12, 2005, 
the Secretary published a notice in the Federal Register announcing 
that trivalent influenza vaccines were covered under the VICP, with an 
effective date of July 1, 2005. 70 FR 19092. On April 20, 2007, the 
Secretary published a notice in the Federal Register announcing that 
meningococcal vaccines and human papillomavirus vaccines were covered 
under the VICP, with an effective date of February 1, 2007. 72 FR 
19937.
    Although the vaccines described in this notice are officially 
covered by the VICP, their placement in the provisional box XIII, 
rather than as distinct and separate listings, has sometimes led to 
confusion regarding their coverage status. We propose to add these four 
vaccines in their own separate categories to the Table in order to help 
the public identify clearly that these vaccines are covered by the 
VICP.
    To date, the Secretary has not identified any illness, disease, 
injury, or condition caused by these four vaccines. For this reason, 
the Secretary proposes adding these four categories of vaccines to the 
Table with ``[n]o condition specified.'' If the Secretary learns of any 
such illness, disease, injury, or condition, she would consider 
amending the Table. The Secretary views this proposed rule as technical 
in nature because it will, if implemented, move the four categories of 
vaccine described in this notice from the placeholder category 
(category XIII) to separate and distinct listings on the Table with no 
associated Table injuries. If implemented, the proposals in this rule 
would not change the fact that these four categories of vaccine are 
covered under the VICP and will not change the rights of any current or 
potential VICP petitioners. The Advisory Commission on Childhood 
Vaccines (ACCV) voted unanimously to approve this proposal at its 
December 4, 2009 meeting.

Economic and Regulatory Impact

    Executive Order 12866, as amended by Executive Orders 13258 and 
13422, 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, as amended 
by Executive Orders 13258 and 13422, requires that all regulations 
reflect consideration of alternatives, of costs, of benefits, of 
incentives, of equity, and of available information. Regulations must 
meet certain standards, such as avoiding an unnecessary burden. 
Regulations which 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 proposed rule. Therefore, in 
accordance with the

[[Page 55505]]

Regulatory Flexibility Act of 1980 (RFA), and the Small Business 
Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the 
Secretary certifies that this proposed rule will not, if implemented, 
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, 
as amended by Executive Orders 13258 and 13422, and would have no major 
effect on the economy or Federal expenditures. The Secretary has 
determined that this proposed 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 and on the private sector such as to require consultation 
under the Unfunded Mandates Reform Act of 1995.
    The Secretary has reviewed this proposed rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' This rule would not ``have 
substantial direct effects on the States, or on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''
    The proposals made in this notice of proposed rulemaking, if 
implemented, would not adversely 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.

Impact of the New Rule

    This proposed rule is technical in nature. Because the vaccines 
being added to the Table as separate categories are already included on 
the Table under Category XIII, this Table will have no effect on 
current or potential petitioners other than to help clarify which 
vaccines are covered by the VICP. If implemented, the proposals made in 
this notice would not prevent otherwise eligible individuals with 
claims of injuries or deaths allegedly resulting from the hepatitis A, 
trivalent influenza, meningococcal and human papillomavirus (HPV) 
vaccines from filing claims with the VICP and would not otherwise 
affect such petitioners.

Paperwork Reduction Act

    This proposed rule does not have any information collection 
requirements.

    Dated: May 12, 2010.
Mary Wakefield,
Administrator, Health Resources and Services Administration.

    Approved: June 8, 2010.
Kathleen Sebelius,
Secretary.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

    Accordingly, 42 CFR part 100 is proposed to be amended as set forth 
below:

PART 100--VACCINE INJURY COMPENSATION

    1. The authority citation for 42 CFR part 100 continues to read as 
follows:

    Authority:  Secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-
3782 (42 U.S.C. 300aa-1 note); sec. 2114(c) and (e) of the PHS Act 
(42 U.S.C. 300aa-14(c) and (e)); sec. 2115(a)(3)(B) of the PHS Act 
(42 U.S.C. 300aa-15(a)(3)(B)); sec. 904(b) of Pub. L. 105-34, 111 
Stat. 873; sec. 1503 of Pub. L. 105-277, 112 Stat. 2681-741; and 
sec. 523(a) of Pub. L. 106-170, 113 Stat. 1927-1928.

    2. Amend Sec.  100.3 by revising the Vaccine Injury Table following 
paragraph (a), revising paragraph (c) (1), redesignating paragraph (c) 
(5) as paragraph (c) (8) and revising newly designated paragraph (c) 
(8), and adding new paragraphs (c) (5), (c) (6), and (c) (7), to read 
as follows:


Sec.  100.3  Vaccine injury table

    (a) * * *

                          Vaccine Injury Table
------------------------------------------------------------------------
                                                       Time period for
                                                      first symptom or
                                                      manifestation of
                              Illness, disability,       onset or of
           Vaccine             injury or condition       significant
                                     covered          aggravation after
                                                           vaccine
                                                       administration
------------------------------------------------------------------------
I. Vaccines containing        A. Anaphylaxis or     4 hours.
 tetanus toxoid (e.g., DTaP,   anaphylactic shock.
 DTP, DT, Td, or TT).
                              B. Brachial Neuritis  2-28 days.
                              C. 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.
II. Vaccines containing       A. Anaphylaxis or     4 hours.
 whole cell pertussis          anaphylactic shock.
 bacteria, extracted or
 partial cell pertussis
 bacteria, or specific
 pertussis antigen(s) (e.g.,
 DTP, DTaP, P, DTP-Hib).
                              B. Encephalopathy     72 hours.
                               (or encephalitis).
                              C. 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.
III. Measles, mumps, and      A. Anaphylaxis or     4 hours.
 rubella vaccine or any of     anaphylactic shock.
 its components (e.g., MMR,
 MR, M, R).
                              B. Encephalopathy     5-15 days (not less
                               (or encephalitis).    than 5 days and not
                                                     more than 15 days).

[[Page 55506]]

 
                              C. 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.
IV. Vaccines containing       A. Chronic arthritis  7-42 days.
 rubella virus (e.g., MMR,
 MR, R).
                              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.
V. Vaccines containing        A. Thrombocytopenic   7-30 days.
 measles virus (e.g., MMR,     purpura.
 MR, M).
                              B. Vaccine-Strain     6 months.
                               Measles Viral
                               Infection in an
                               immunodeficient
                               recipient.
                              C. 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.
VI. Vaccines containing       A. Paralytic Polio
 polio live virus (OPV).
                                 --in a non-        30 days.
                                  immunodeficient
                                  recipient.
                                 --in an            6 months.
                                  immunodeficient
                                  recipient.
                                 --in a vaccine     Not applicable.
                                  associated
                                  community case.
                              B. Vaccine-Strain
                               Polio Viral
                               Infection
                                 --in a non-        30 days.
                                  immunodeficient
                                  recipient.
                                 --in an            6 months.
                                  immunodeficient
                                  recipient.
                                 --in a vaccine     Not applicable.
                                  associated
                                  community case.
                              C. 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.
VII. Vaccines containing      A. Anaphylaxis or     4 hours.
 polio inactivated virus       anaphylactic shock.
 (e.g., IPV).
                              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.
VIII. Hepatitis B. vaccines.  A. Anaphylaxis or     4 hours.
                               anaphylactic shock.
                              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.
IX. Hemophilus influenzae     No Condition          Not applicable.
 type b polysaccharide         Specified.
 conjugate vaccines.
X. Varicella vaccine........  No Condition          Not applicable.
                               Specified.
XI. Rotavirus vaccine.......  No Condition          Not applicable.
                               Specified.
XII. Pneumococcal conjugate   No Condition          Not applicable.
 vaccines.                     Specified.
XIII. Hepatitis A vaccines..  No Condition          Not applicable.
                               Specified.
XIV. Trivalent influenza      No Condition          Not applicable.
 vaccines.                     Specified.
XV. Meningococcal vaccines..  No Condition          Not applicable.
                               Specified.
XVI. Human papillomavirus     No Condition          Not applicable.
 (HPV) vaccines.               Specified.
XVII. Any new vaccine         No Condition          Not applicable.
 recommended by the Centers    Specified.
 for Disease Control and
 Prevention for routine
 administration to children,
 after publication by the
 Secretary of a notice of
 coverage.
------------------------------------------------------------------------

* * * * *
    (c) * * * (1) Except as provided in paragraph (c) (2), (3), (4), 
(5), (6), or (7) of this section, the revised Table of Injuries set 
forth in paragraph (a) of this section and the Qualifications and Aids 
to Interpretation set forth in paragraph (b) of this section apply to 
petitions for compensation under the Program filed

[[Page 55507]]

with the United States Court of Federal Claims on or after March 24, 
1997. Petitions for compensation filed before such date shall be 
governed by section 2114(a) and (b) of the Public Health Service Act as 
in effect on January 1, 1995, or by Sec.  100.3 as in effect on March 
10, 1995 (see 60 FR 7678, et seq., February 8, 1995), as applicable.
* * * * *
    (5) Hepatitis A vaccines (Item XIII of the Table) are included on 
the Table as of December 1, 2004.
    (6) Trivalent influenza vaccines (Item XIV of the Table) are 
included on the Table as of July 1, 2005.
    (7) Meningococcal vaccines and human papillomavirus (HPV) vaccines 
(Items XV and XVI of the Table) are included on the Table as of 
February 1, 2007.
    (8) Other new vaccines (Item XVII of the Table) will be included in 
the Table as of the effective date of a tax enacted to provide funds 
for compensation paid with respect to such vaccines. An amendment to 
this section will be published in the Federal Register to announce the 
effective date of such a tax.

[FR Doc. 2010-22745 Filed 9-10-10; 8:45 am]
BILLING CODE 4165-15-P