71 FR 164 pgs. 50065-50066 - Updated Vaccine Information Statements for Influenza Vaccines; Revised Instructions for Use of Vaccine Information Statements
Type: NOTICEVolume: 71Number: 164Pages: 50065 - 50066
FR document: [FR Doc. E6-14030 Filed 8-23-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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 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