[Federal Register Volume 66, Number 214 (Monday, November 5, 2001)]
[Proposed Rules]
[Page 55908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27645]


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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: Revisions and 
Additions to the Vaccine Injury Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Proposed rule; notice of public hearing.

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SUMMARY: This document announces a public hearing to receive 
information and views on the Notice of Proposed Rulemaking (NPRM) 
entitled ``National Vaccine Injury Compensation Program: Revisions and 
Additions to the Vaccine Injury Table.''

DATES: The public hearing will be held on December 6, 2001, from 10 
a.m. to 12 p.m.

ADDRESSES: The public hearing will be held in Conference Room C in the 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas E. Balbier, Jr., Director, 
Division of Vaccine Injury Compensation, at (301) 443-6593.

SUPPLEMENTARY INFORMATION: The Secretary has made findings as to a 
condition that can reasonably be determined in some circumstances to be 
caused by vaccines containing live, oral, rhesus-based rotavirus. Based 
on these findings, the Secretary proposes to amend the Vaccine Injury 
Table (Table) by adding to the Table vaccines containing live, oral, 
rhesus-based rotavirus as a distinct category, with intussusception 
listed as a covered Table injury. This proposal is based upon the 
recommendation by the Centers for Disease Control and Prevention (CDC) 
that Rotashield, the only U.S.-licensed rotavirus vaccine, no longer be 
administered to infants in the United States based on review of data 
indicating a strong association between Rotashield and intussusception 
in the 1 to 2 weeks following vaccination.
    The Secretary further proposes the following amendments: (1) 
Removing residual seizure disorder from the Table's Qualifications and 
Aids to Interpretation; (2) removing hemophilus influenzae type b 
polysaccharide (unconjugated) vaccines from the Table; (3) removing 
early onset Hib disease from the Table's Qualifications and Aids to 
Interpretation; and (4) adding pneumococcal conjugate vaccines to the 
Table with no condition specified. This latter item is based upon the 
CDC's recent recommendation of this vaccine for routine administration 
to children, as well as the enactment of the excise tax for this 
category of vaccines.
    These proposed changes would have effect only for petitions for 
compensation under the National Vaccine Injury Compensation Program 
(VICP) filed after the amendments to the existing regulations become 
effective.
    The NPRM was published in the Federal Register, July 13, 2001: Vol. 
66, No. 135, Pages 36735-36739. The public comment period closes 
January 9, 2002.
    A public hearing will be held during the 180-day public comment 
period. This hearing is to provide an open forum for the presentation 
of information and views concerning all aspects of the NPRM by 
interested persons.
    In preparing a final regulation, the Secretary will consider the 
administrative record of this hearing along with all other written 
comments received during the comment period specified in the NPRM. 
Individuals or representatives of interested organizations are invited 
to participate in the public hearing in accord with the schedule and 
procedures set forth below.
    The hearing will be held on December 6, 2001, beginning at 10 a.m., 
in Conference Room C in the Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland, 20857. Upon entering the Parklawn Building, 
persons who wish to attend the hearing will be required to call Ms. 
Emma Boyd at (301) 443-6593 to be escorted to Conference Room C.
    The presiding officer representing the Secretary, HHS will be Mr. 
Thomas E. Balbier, Jr., Director, Division of Vaccine Injury 
Compensation, Office of Special Programs (OSP), Health Resources and 
Services Administration.
    Persons who wish to participate are requested to file a notice of 
participation with the Department of Health and Human Services (HHS) on 
or before November 16, 2001. The notice should be mailed to Division of 
Vaccine Injury, OPS, Rm 8A-46, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland, 20857. To ensure timely handling any outer 
envelope should be clearly marked ``NPRM Hearing.'' The notice of 
participation should contain the interested person's name, address, 
telephone number, any business or organizational affiliation of the 
person desiring to make a presentation, a brief summary of the 
presentation, and the approximate time requested for the presentation. 
Groups that have similar interests should consolidate their comments as 
part of one presentation. Time available for the hearing will be 
allocated among the persons who properly file notices of participation. 
If time permits, interested parties attending the hearing who did not 
submit a notice participation in advance will be allowed to make an 
oral presentation at the conclusion of the hearing.
    Persons who find that there is insufficient time to submit the 
required information in writing may give oral notice of participation 
by calling Mr. Thomas E. Balbier, Jr., Director, Division of Vaccine 
Injury Compensation, at (301) 443-6593 no later than November 16, 2001. 
Those persons who give oral notice of participation should also submit 
written notice containing the information described above to HHS by the 
close of business November 19, 2001.
    After reviewing the notices of participation and accompanying 
information, HHS will schedule each appearance and notify each 
participant by mail or telephone of the time allotted to the person(s) 
and the approximate time the person's oral presentation is scheduled to 
begin.
    Written comments and transcript of the hearing will be made 
available for public inspection as soon as they have been prepared, on 
weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 
5 p.m. at the Division of Vaccine Injury Compensation, Room 8A-46, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

    Dated: October 29, 2001.
Elizabeth M. Duke,
Acting Administrator.
[FR Doc. 01-27645 Filed 11-2-01; 8:45 am]
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