[Federal Register: August 24, 2006 (Volume 71, Number 164)]
[Notices]
[Page 50065-50066]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au06-61]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4163-18-P