[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Rules and Regulations]
[Pages 59528-59530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100

RIN 0906-AA55


National Vaccine Injury Compensation Program: Removal of Separate 
Category for Vaccines Containing Live, Oral, Rhesus-Based Rotavirus 
From the Vaccine Injury Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: Through this interim final rule, the Secretary removes the 
category of vaccines containing live, oral, rhesus-based rotavirus, 
Category XII, from the Vaccine Injury Table (Table). 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 interim final rule is technical in nature. 
Even prior to the publication of this final rule, Category XII, the 
category that is being removed from the Table, only applied to vaccines 
that were administered on or before August 26, 2002. Given the 
applicable statute of limitations and the fact that Category XII 
limited its application to vaccines administered on or before August 
26, 2002, the Secretary believes that no persons have claims that could 
be pursued under that category. Petitioners may still be able to file 
petitions relating to rotavirus vaccines under Category XI of the 
Table, the category of ``rotavirus vaccines,'' which does not include 
any associated injuries. Although the Secretary believes that the 
changes made in this interim final rule are noncontroversial as they do 
not affect the rights of any potential petitioners with the VICP, the 
Department is seeking public comment on this interim final rule. 
Written comments must be submitted on or before November 10, 2008. The 
Department will consider the comments received and will decide whether 
to amend the Table based on such comments.

DATES: This regulation is effective November 10, 2008.

ADDRESSES: You may submit written comments, identified by the 
Regulatory Information Number (RIN) 0906-AA55 by an any of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: [email protected]. Include RIN 0906-AA55 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 (HRSA), 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., Director, 
Division of Vaccine Injury Compensation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Parklawn Building, Room 
11C-26, 5600 Fishers Lane, Rockville, Maryland 20857; telephone number 
(301) 443-6593.

SUPPLEMENTARY INFORMATION:
    The National Childhood Vaccine Injury Act of 1986, title III of 
Public Law 99-660 (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 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 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)(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).
    Because the prerequisites for adding rotavirus vaccines to the VICP 
occurred, the Secretary published a final rule in the Federal Register 
(FR) on July 27, 1999, adding vaccines against rotavirus to the Table 
(64 FR 40517). Because the Secretary had not identified any illness, 
disease, injury or condition caused by vaccines against rotavirus, the 
category of vaccines was added to the Table with ``[n]o condition 
specified.'' The Secretary made clear that if he learned of any such 
illness, disease, injury or condition, he would consider amending the 
Table.
    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 amending the Table by 
adding to the Table vaccines containing live, oral, rhesus-based 
rotavirus (trade name Rotashield) as a distinct category, with 
intussusception listed as a covered Table injury. This proposal was 
based upon the recommendation by the CDC that Rotashield, the only 
rotavirus vaccine licensed in the United States (U.S.) at the time, no 
longer be administered to infants in the U.S. based on review of data 
indicating a strong association between Rotashield and intussusception 
in the 1 to 2 weeks following vaccination.
    In a final rule published July 25, 2002, the Secretary made the 
changes proposed in the earlier rule (67 FR 48558). After these 
amendments, the Table included two categories of

[[Page 59529]]

rotavirus vaccines. The first, the general category of rotavirus 
vaccines (current Category XI), did not include an associated injury. 
This category of vaccines was effective as of October 22, 1998, the 
effective date of the excise tax enacted for rotavirus vaccines. See 42 
CFR 100.3(a), 100.3(c)(3). The second, the more specific category of 
vaccines containing live, oral, rhesus-based rotavirus (current 
Category XII), contained an associated injury of intussusception with 
an onset interval of 0-30 days. This category of vaccines was also 
effective on October 22, 1998, but only applied to vaccines 
administered on or before August 26, 2002 (the effective date of the 
final rule imposing this category). Because the manufacturer of the 
only U.S.-licensed rotavirus vaccine 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 Category XII would arise after the rule's 
publication. Because that 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, 
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. 
Such individuals were still able to file claims under the Table's 
general category for rotavirus vaccines. No claims had been filed under 
the general category of rotavirus vaccines from August 2004 to January 
2008. Licensure of a new rotavirus vaccine in 2006 led to one claim 
filed under this general category since January 2008.
    The Secretary views this rule as technical in nature because he 
does not believe that any potential petitioners would be able to file a 
claim relying on the Table condition set forth in Category XII if it 
were retained on the Table. As explained above, petitioners are already 
limited to filing claims relying on this Category if the underlying 
rotavirus vaccine was administered on or before August 26, 2002. 
Moreover, petitioners are only entitled to the presumption of causation 
conferred by the Table injury associated with Category XII if the 
injury of intussusception's first symptom or manifestation of onset 
occurred within 0-30 days after the vaccine's administration. Because 
the applicable statute of limitations requires petitioners to file 
claims within three years of the injury's first symptom or 
manifestation of onset (or four years from such onset and two years 
from the date of death, in death cases), the Secretary believes that 
any person with a potential Table claim under Category XII would be 
time-barred. The statute of limitations available to certain 
petitioners for vaccines or injuries newly added to the Table under 
section 2116(b) of the PHS Act, 42 U.S.C. 300aa-16(b), would no longer 
be available for potential claims concerning the rotavirus vaccine 
because that section imposes a limitations period of two years from the 
effective date of the Table change.
    Although the CDC in 1999 recommended that the only then-available 
rotavirus vaccine licensed in the U.S. (which was a live, oral, rhesus-
based product), no longer be administered to infants in the U.S., FDA 
has subsequently licensed two additional rotavirus vaccines, and the 
excise tax passed for rotavirus vaccines remains in effect. Thus, the 
general category of rotavirus vaccines continues to be covered under 
the VICP under the Table's Category XI for all newly licensed rotavirus 
vaccines. No corresponding injury/condition is listed in this category 
since no injuries have been associated with these products.
    Because the Table category of rotavirus vaccines with the 
associated injury of intussusception is no longer available to 
prospective petitioners, this interim final rule is an effort to 
minimize confusion relating to available Table categories.
    All petitions filed concerning rotavirus vaccines are still subject 
to the applicable statute of limitations. The filing limitations 
applicable to petitions filed with the VICP are set out in section 
2116(a) of the PHS Act (42 U.S.C. 300aa-16(a)). Although section 
2116(b) of the PHS Act lays out specific exceptions to these statutes 
of limitations that apply 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, this change would not trigger that section.

Justification for Omitting Notice of Proposed Rulemaking

    This amendment to 42 CFR 100.3 is technical in nature. As explained 
above, the Secretary believes that no persons have claims that could be 
pursued under the category that is being removed from the Table through 
this interim final rule. For this reason, the Secretary has determined 
under 5 U.S.C. 553 and Departmental policy that it is unnecessary and 
impractical to follow proposed rulemaking procedures.

Economic and Regulatory Impact

Regulatory Flexibility Act and Executive Order 12866

    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 Interim Final Rule. 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 Interim Final 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 the Interim Final Rule is not a ``major rule'' 
within the meaning of the statute providing for Congressional Review of 
Agency Rulemaking, 5 U.S.C. 801.

Unfunded Mandates Reform Act of 1995

    Similarly, it will not have effects on State, local, and tribal 
governments and on the private sector such as to require

[[Page 59530]]

consultation under the Unfunded Mandates Reform Act of 1995.

Federalism Impact Statement

    The Secretary has also reviewed this Interim Final Rule in 
accordance with Executive Order 13132 regarding federalism, and has 
determined that it does not have ``federalism implications.'' The 
Interim Final 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.''

Impact on Family Well-Being

    This Interim Final Rule will not adversely affect the following 
family elements of family well-being: 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. As stated above, this Interim Final Rule 
will modify the Table included in the regulations governing the VICP 
based on legal authority.

Impact of the New Rule

    This Interim Final Rule is technical in nature and will not prevent 
otherwise eligible individuals with claims of injuries or deaths 
allegedly resulting from rotavirus vaccines (including vaccines 
containing live, oral, rhesus-based rotavirus) from filing claims with 
the VICP.

Paperwork Reduction Act

    This rule has no information collection requirements.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

    Dated: July 30, 2007.
Elizabeth M. Duke,
Administrator, HRSA.
    Approved: June 23, 2008.
Michael O. Leavitt,
Secretary, HHS.

    Editorial Note: This document was received in the Office of the 
Federal Register on Monday, October 6, 2008.

0
Accordingly, 42 CFR part 100 is amended as set forth below.

PART 100--VACCINE INJURY COMPENSATION

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

    Authority: Sec. 215 of the PHS Act (42 U.S.C. 216); secs. 312 
and 313 of Public Law 99-660, 100 Stat. 3779-3782 (42 U.S.C. 300aa-1 
note); sec. 2114(c) and (e) of the PHS Act, 100 Stat. 3766 and 107 
Stat. 645-646 (42 U.S.C. 300aa-14(c) and (e)); sec. 904(b) of Public 
Law 105-34, 111 Stat. 873; sec. 1503 of Public Law 105-277, 112 
Stat. 2681-741; and sec. 523(a) of Public Law 106-170, 113 Stat. 
1927-1928.


Sec.  100.3  [Amended]

0
2. Section 100.3 is amended as follows:
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A. In paragraph (a) in the Vaccine Injury Table remove Item XII and 
redesignate Items XIII and XIV as XII and XIII respectively.
0
B. In paragraph (c)(3) remove the second sentence; in paragraph (c)(4) 
remove the words ``(Item XIII of the Table)'' and add in their place 
``(Item XII of the Table)''; in paragraph (c)(5) remove the words 
``(Item XIV of the Table)'' and add in their place ``(Item XIII of the 
Table)''.

 [FR Doc. E8-24017 Filed 10-8-08; 8:45 am]
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