[Federal Register Volume 61, Number 24 (Monday, February 5, 1996)]
[Proposed Rules]
[Pages 4248-4249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2322]



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[[Page 4249]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 100

RIN 0906-AA36


National Vaccine Injury Compensation Program: Revisions and 
Additions to the Vaccine Injury Table--II

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--II.''

DATES: The public hearing will be held on February 29, 1996, from 1:00 
p.m. to 5:00 p.m.

ADDRESSES: The public hearing will be held in Conference Room D 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 National Childhood Vaccine Injury Act 
(Public Law 99-660, as amended, Title XXI of the Act) provides a system 
of no-fault compensation for certain individuals who have been injured 
by specific childhood vaccines: namely, diphtheria, tetanus, pertussis, 
polio, measles, mumps or rubella vaccines. Section 2114 of the Act 
contains a Vaccine Injury Table (the Table) which lists these vaccines 
and the time periods in which certain adverse events, e.g., injuries, 
disabilities, illnesses, or death, must occur in order for claimants to 
be entitled to a presumption that the event was vaccine-related. The 
Table was amended by regulation pursuant to Section 312 of the Act in 
the Final Rule published in the Federal Register on February 8, 1995 
(60 FR 7678). The Secretary has proposed further revisions of the 
Vaccine Injury Table and accompanying Qualifications and Aids to 
Interpretation based on the findings of an Institute of Medicine 
report, which was released in late 1993, and the recommendations made 
by two advisory bodies, the National Vaccine Advisory Committee and the 
Advisory Commission on Childhood Vaccines. Among other changes, this 
proposed rule will add vaccines against Hepatitis B and hemophilus 
influenzae type b to the Table. The NPRM was published in the Federal 
Register, November 8, 1995: Vol. 60, No. 216, Pages 56289-56300. The 
public comment period closes May 6, 1996.
    In view of the importance of the Vaccine Injury Compensation 
Program and the effect of the NPRM, the Secretary has determined that, 
in addition to the 180-day period for written comments on the NPRM, an 
informal public hearing will be held. 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 February 29, 1996, beginning at 1:00 
p.m., in Conference D in the Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857. The hearing will be held following the noon 
adjournment of the February 28-29 meeting of the Advisory Commission on 
Childhood Vaccines.
    The presiding officer representing the Secretary, HHS, will be Mr. 
Thomas E. Balbier, Jr., Director, Division of Vaccine Injury 
Compensation, Bureau of Health Professions (BHPr), Health Resources and 
Services Administration.
    Persons who wish to participate are requested to file a notice of 
participation with the Department on or before February 15, 1996. The 
notice should be mailed to Division of Vaccine Injury Compensation, 
BHPr, Room 8A-35, 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 of 
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 February 15, 1996. 
Those persons who give oral notice of participation should also submit 
written notice containing the information described above to the 
Department by the close of business February 22, 1996.
    After reviewing the notices of participation and accompanying 
information, the Department 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 transcripts 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 
5:00 p.m. at the Division of Vaccine Injury Compensation, Room 8A-35, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

    Dated: January 30, 1996.
Ciro V. Sumaya,
Administrator.
[FR Doc. 96-2322 Filed 2-2-96; 8:45 am]
BILLING CODE 4160-15-M