[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62139-62140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0015]


Final Revised Vaccine Information Materials for Hepatitis A and 
Hepatitis B Vaccines

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), CDC must develop vaccine information materials that 
all health care providers are required to give to patients/parents 
prior to administration of specific vaccines. On February 8, 2016, CDC 
published a notice in the Federal Register (81 FR 6520) seeking public 
comments on proposed updated vaccine information materials for 
hepatitis A and hepatitis B vaccines. Following review of comments 
submitted and consultation as required under the law, CDC has finalized 
the materials for hepatitis A and hepatitis B vaccines. Copies of the 
final vaccine information materials for hepatitis A and hepatitis B 
vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number 
CDC-2016-0015).

DATES: Beginning no later than November 1, 2016, each health care 
provider who administers hepatitis A or hepatitis B vaccine to any 
child or adult in the United States shall provide copies of the 
relevant vaccine information materials referenced in this notice, in 
conformance with the August 9, 2016 CDC Instructions for the Use of 
Vaccine Information Statements prior to providing such vaccinations.

FOR FURTHER INFORMATION CONTACT: Suzanne Johnson-DeLeon ([email protected]), 
National Center for Immunization and Respiratory Diseases, Centers for 
Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., 
Atlanta, Georgia 30329.

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 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 (VICP).
    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). 
Section 2126 requires that the materials

[[Page 62140]]

be developed, or revised, after notice to the public, with a 60-day 
comment period, and in consultation with the Advisory Commission on 
Childhood Vaccines, appropriate health care provider and parent 
organizations, and the Food and Drug Administration. The law also 
requires that the information contained in the materials be based on 
available data and information, be presented in understandable terms, 
and include:
    (1) A concise description of the benefits of the vaccine,
    (2) A concise description of the risks associated with the vaccine,
    (3) A statement of the availability of the National Vaccine Injury 
Compensation Program, and
    (4) Such other relevant information as may be determined by the 
Secretary.
    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 then, the following vaccines have been added to the 
National Vaccine Injury Compensation Program, requiring use of vaccine 
information materials for them as well: Hepatitis B, Haemophilus 
influenzae type b (Hib), varicella (chickenpox), pneumococcal 
conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus 
(HPV), and seasonal influenza vaccines. Instructions for use of the 
vaccine information materials are found on the CDC Web site at: http://www.cdc.gov/vaccines/hcp/vis/index.html.

Revised Vaccine Information Materials

    The hepatitis A and hepatitis B vaccine information materials 
referenced in this notice were developed in consultation with the 
Advisory Commission on Childhood Vaccines, the Food and Drug 
Administration, and parent and healthcare provider organizations. 
Following consultation and review of comments submitted, the vaccine 
information materials covering hepatitis A and hepatitis B vaccines 
have been finalized and are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov 
(see Docket Number CDC-2016-0015). The Vaccine Information Statements 
(VIS) are ``Hepatitis A Vaccine: What You Need to Know'' and 
``Hepatitis B Vaccine: What You Need to Know,'' publication date July 
20, 2016.
    With publication of this notice, by November 1, 2016, all health 
care providers must discontinue use of the previous edition of each and 
provide copies of these updated hepatitis A and hepatitis B vaccine 
information materials prior to immunization in conformance with CDC's 
August 9, 2016 Instructions for the Use of Vaccine Information 
Statements.

    Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-21573 Filed 9-7-16; 8:45 am]
 BILLING CODE 4163-18-P