National Vaccine Injury Compensation Program:

Federal Register: September 13, 2010 (Volume 75, Number 176)

Proposed Rules

Page 55503-55507

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr13se10-15

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.

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.

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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: gevans@hrsa.gov. 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

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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

1. Vaccines containing

   1. Anaphylaxis or

      4 hours. tetanus toxoid (e.g., DTaP, anaphylactic shock.

      DTP, DT, Td, or TT).

   2. Brachial Neuritis 2-28 days.

   3. 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.

2. Vaccines containing

   1. 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).

   2. Encephalopathy

      72 hours.

      (or encephalitis).

   3. 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.

3. Measles, mumps, and

   1. Anaphylaxis or

      4 hours. rubella vaccine or any of

      anaphylactic shock. its components (e.g., MMR,

      MR, M, R).

   2. Encephalopathy

      5-15 days (not less

      (or encephalitis). than 5 days and not more than 15 days).

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   3. 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.

4. Vaccines containing

   1. Chronic arthritis 7-42 days. rubella virus (e.g., MMR,

      MR, R).

   2. 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.

5. Vaccines containing

   1. Thrombocytopenic 7-30 days. measles virus (e.g., MMR,

      purpura.

      MR, M).

   2. Vaccine-Strain

      6 months.

      Measles Viral

      Infection in an immunodeficient recipient.

   3. 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.

6. Vaccines containing

   1. 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.

   2. 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.

   3. 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.

7. Vaccines containing

   1. Anaphylaxis or

      4 hours. polio inactivated virus

      anaphylactic shock.

      (e.g., IPV).

   2. 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.

8. Hepatitis B. vaccines. A. Anaphylaxis or

   4 hours. anaphylactic shock.

   2. 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.

9. Hemophilus influenzae

   No Condition

   Not applicable. type b polysaccharide

   Specified. conjugate vaccines.

10. Varicella vaccine........ No Condition

    Not applicable.

    Specified.

11. Rotavirus vaccine....... No Condition

    Not applicable.

    Specified.

12. Pneumococcal conjugate No Condition

    Not applicable. vaccines.

    Specified.

13. Hepatitis A vaccines.. No Condition

    Not applicable.

    Specified.

14. Trivalent influenza

    No Condition

    Not applicable. vaccines.

    Specified.

15. Meningococcal vaccines.. No Condition

    Not applicable.

    Specified.

16. Human papillomavirus

    No Condition

    Not applicable.

    (HPV) vaccines.

    Specified.

17. 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

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    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