[Federal Register Volume 62, Number 138 (Friday, July 18, 1997)]
[Notices]
[Pages 38536-38537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Vaccine Injury Compensation Program: Public Hearing 
Regarding Vaccine Administration Guidelines

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of public hearing.

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SUMMARY: This document announces a public hearing to receive 
information and views on the section entitled, ``Guidelines'' in 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 September 11, 1997, at 1:00 
p.m. Requests to testify should be submitted by August 28, 1997.

ADDRESSES: The public hearing will be held in Conference Rooms D and E 
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

[[Page 38537]]

of 1986 (Pub. L. 99-660) created 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 313 of Public Law 99-660 called for the 
Secretary of Health and Human Services to arrange for a study of the 
risks associated with certain of these vaccines and to establish 
guidelines based on the results of the 313 study ``respecting the 
administration'' of the vaccines that were reviewed, which guidelines 
shall include:

    (i) The circumstances under which any such vaccine should not be 
administered;
    (ii) The circumstances under which administration of any such 
vaccine should be delayed beyond its usual time of administration; 
and
    (iii) The groups, categories, or characteristics of potential 
recipients of such vaccine who may be at significantly higher risk 
of major adverse reactions to such vaccine than the general 
population of potential recipients.

    We have examined the recommendations of the Advisory Committee on 
Immunization Practices (ACIP) of the Centers for Disease Control and 
Prevention (CDC), as set forth in the Morbidity and Mortality Weekly 
Reports Recommendations and Reports, dated September 6, 1996, entitled, 
``Update: Vaccine Side Effects, Adverse Reactions, Contraindications 
and Precautions.'' Members of the public may obtain copies of the 
report by writing to MS Publications, C.S.P.O. Box 9120, Waltham, MA 
02254, telephone 1-800-843-6356, 617-893-3800 (Massachusetts). The cost 
of the publication is $4.00. It may be obtained without charge through 
use of the World-Wide Web (WWW). The address is ``http://www.cdc.gov/
epo/mmwr/mmwr_rr.html.'' As stated by the Secretary in the February 
20, 1997, Federal Register (62 Fed. Reg. 7687), we have found that the 
ACIP recommendations are consistent with the findings that the 
Department made as part of section 313 NPRM (60 FR 56289, Nov. 8, 
1995), and that they satisfy the statutory requirements for guidelines. 
Accordingly, we proposed that the ACIP recommendations will constitute 
the guidelines called for by section 313.
    Section 313 calls for consultation with the Advisory Commission on 
Childhood Vaccines (ACCV) and notice and opportunity for public hearing 
with respect to these guidelines. The ACIP recommendations were 
submitted to the ACCV at its meeting of June 6-7, 1996.
    The hearing will be held on September 11, 1997, beginning at 1:00 
p.m., in Conference Rooms D and E in the Parklawn Building, 5600 
Fishers Lane, Rockville, Maryland 20857. The hearing will be held 
following the noon adjournment of the September 10-11 meeting of the 
ACCV.
    The presiding officer representing the Secretary of 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 August 28, 1997. 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 ``Guidelines.'' 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 August 28, 1997. 
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 September 4, 1997.
    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: July 14, 1997.
Claude Earl Fox,
Acting Administrator.
[FR Doc. 97-18908 Filed 7-17-97; 8:45 am]
BILLING CODE 4160-15-U