[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79340-79341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0014]


Final Revised Vaccine Information Materials for Pneumococcal 
Conjugate Vaccine (PCV13)

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. On May 20, 2015, CDC 
published a notice in the Federal Register (80 FR 29009) seeking public 
comments on proposed updated vaccine information materials for 
pneumococcal conjugate vaccine (PCV13). Following review of comments 
submitted and consultation as required under the law, CDC has finalized 
the materials. Copies of the final vaccine information materials for 
pneumococcal conjugate vaccine (PCV13) are available to download from 
http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0014).

DATES: Beginning no later than March 1, 2016, each health care provider 
who administers pneumococcal conjugate vaccine (PCV13) to any child or 
adult in the United States shall provide copies of the relevant vaccine 
information materials contained in this notice, in conformance with the 
November 5, 2015 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 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

[[Page 79341]]

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 pneumococcal conjugate vaccine (PCV13) 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 pneumococcal conjugate vaccine (PCV13) 
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-2015-0014). The Vaccine Information Statement 
(VIS) is ``Pneumococcal Conjugate Vaccine (PCV13): What You Need to 
Know,'' publication date November 5, 2015.
    With publication of this notice, as of March 1, 2016, all health 
care providers will be required to provide copies of these updated 
pneumococcal conjugate vaccine (PCV13) information materials prior to 
immunization in conformance with CDC's November 5, 2015 Instructions 
for the Use of Vaccine Information Statements.

    Dated: December 16, 2015.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2015-31989 Filed 12-18-15; 8:45 am]
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