[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11536-11537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0029]


Final Revised Vaccine Information Materials for Varicella Vaccine

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), 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 March 15, 2016, CDC published a 
notice in the Federal Register (81 FR 13794) seeking public comments on 
proposed updated vaccine information materials for polio vaccine and 
varicella vaccine. Following review of comments submitted and 
consultation as required under the law, CDC has finalized the materials 
for varicella vaccine. Copies of the final vaccine information 
materials for varicella vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov 
(see Docket Number CDC-2016-0029).

DATES: Beginning no later than June 1, 2018, each health care provider 
who administers varicella vaccine to any child or adult in the United 
States shall provide copies of the relevant vaccine information 
materials referenced in this notice, dated February 12, 2018, in 
conformance with the February 23, 2018 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

[[Page 11537]]

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 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 website at: http://www.cdc.gov/vaccines/hcp/vis/index.html.

Revised Vaccine Information Materials

    The varicella 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 
varicella vaccine 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-2016-0029). The Vaccine 
Information Statement (VIS) is ``Varicella (Chickenpox) Vaccine: What 
You Need to Know,'' publication date February 12, 2018.
    With publication of this notice, by June 1, 2018, all health care 
providers must discontinue use of the previous edition and provide 
copies of these updated varicella vaccine information materials prior 
to immunization in conformance with CDC's February 23, 2018 
Instructions for the Use of Vaccine Information Statements.

    Dated: March 12, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-05298 Filed 3-14-18; 8:45 am]
 BILLING CODE 4163-18-P