[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50065-50066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Updated Vaccine Information Statements for Influenza Vaccines; 
Revised Instructions for Use of Vaccine Information Statements

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 
U.S.C. 300aa-26), the CDC must develop vaccine information materials 
that all health care providers are required to give to patients/parents 
prior to administration of specific vaccines. Since January 1, 2006, 
use of trivalent influenza vaccine information materials has been 
required. This notice announces availability of updated influenza 
vaccine information materials for use in the upcoming 2006-07 influenza 
season.

DATES: Each health care provider who administers any trivalent 
influenza vaccine to any child or adult in the United States during the 
2006-07 influenza season shall provide copies of the relevant influenza 
vaccine information materials referenced in this notice, dated June 30, 
2006, to the patient/parent/legal representative in conformance with 
the June 30, 2006

[[Page 50066]]

CDC Instructions for the Use of Vaccine Information Statements.

FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director, 
National Immunization Program, Centers for Disease Control and 
Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia 
30333, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Pub. L. 99-660), as amended by section 708 of Public Law 103-183, 
added section 2126 to the Public Health Service Act. Section 2126, 
codified at 42 U.S.C. 300aa-26, requires the Secretary of Health and 
Human Services to develop and disseminate vaccine information materials 
for distribution by all health care providers in the United States, 
whether public or private, to any patient (or to the parent or legal 
representative in the case of a child) receiving vaccines covered under 
the National Vaccine Injury Compensation Program. Development and 
revision of the vaccine information materials, also known as Vaccine 
Information Statements (VIS), have been delegated by the Secretary to 
the Centers for Disease Control and Prevention (CDC).
    The vaccines initially covered under the National Vaccine Injury 
Compensation Program were diphtheria, tetanus, pertussis, measles, 
mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any 
health care provider in the United States who intends to administer one 
of these covered vaccines is required to provide copies of the relevant 
vaccine information materials prior to administration of any of these 
vaccines. Since June 1, 1999, health care providers are also required 
to provide copies of vaccine information materials for the following 
vaccines that were added to the National Vaccine Injury Compensation 
Program: hepatitis B, haemophilus influenzae type b (Hib), and 
varicella (chickenpox) vaccines. In addition, use of vaccine 
information materials for pneumococcal conjugate vaccine has been 
required since December 15, 2002, materials for trivalent influenza 
vaccines since January 1, 2006 and materials for hepatitis A vaccine 
since July 1, 2006.

Updated Influenza Vaccine Information Materials

Inactivated Influenza Vaccine Information Statement

Live, Intranasal Influenza Vaccine Information Statement

    Initial vaccine information materials developed under 42 U.S.C. 
300aa-26 for trivalent inactivated influenza vaccine and for trivalent 
live, intranasal influenza vaccine were published in the Federal 
Register on November 10, 2005 (70 FR 68461). The edition date of those 
materials was October 20, 2005. This notice announces availability of 
the 2006-07 editions of these influenza vaccine information materials. 
The only substantive revisions that appear in these updated materials 
are the addition of the influenza season date of 2006-07, the VIS 
edition date of 6/30/2006 and an update to note the expanded 
recommended schedule for administration of inactivated influenza 
vaccine to all children 6-59 months of age and to the household 
contacts and out-of-home caregivers of such children (with either 
inactivated or live, intranasal influenza vaccine as applicable).

Instructions for the Use of Vaccine Information Statements

    The CDC Instructions for the Use of Vaccine Information Statements 
have been updated to note the new edition dates of the influenza 
vaccine information materials. Those updated instructions, dated June 
30, 2006, can be downloaded at the CDC Web site at: http://www.cdc.gov/nip/publications/VIS.
    In addition, copies of the updated influenza materials can be 
downloaded in PDF format at the same Web site. Alternatively, single 
camera-ready copies are available from State health departments. A list 
of State health department contacts for obtaining copies of these 
materials is included in a December 17, 1999 Federal Register notice 
(64 FR 70914).

    Dated: August 16, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E6-14030 Filed 8-23-06; 8:45 am]
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