[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Page 79343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31990]



[[Page 79343]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0001]


Final Revised Vaccine Information Materials for Multiple 
Pediatric Vaccines (``Your Child's First 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), 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 January 9, 2015, CDC 
published a notice in the Federal Register (80 FR 1416) seeking public 
comments on proposed updated vaccine information materials for multiple 
pediatric vaccines (``Your Baby's First Vaccines''). Following review 
of comments submitted and consultation as required under the law, CDC 
has finalized the materials. A copy of the final vaccine information 
materials for multiple pediatric vaccines (``Your Child's First 
Vaccines'') is available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number 
CDC-2015-0001).

DATES: Beginning no later than March 1, 2016, each health care provider 
who chooses to use the multiple pediatric vaccines Vaccine Information 
Statement (``Your Child's First Vaccines'') when administering multiple 
pediatric vaccines to any child in the United States shall provide 
copies of the relevant vaccine information materials contained in this 
notice rather than the previous edition (dated October 22, 2014) 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 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 multiple pediatric vaccines 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 multiple 
pediatric vaccines (``Your Child's First 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-2015-0001). The Vaccine Information Statement (VIS) is 
``Your Child's First Vaccines: What You Need to Know'' (publication 
date November 5, 2015).
    With publication of this notice, as of March 1, 2016, all health 
care providers who choose to use the multiple pediatric vaccines 
Vaccine Information Statement (``Your Child's First Vaccines'') when 
administering multiple pediatric vaccines to any child in the United 
States shall provide copies of the relevant vaccine information 
materials contained in this notice rather than the previous edition 
(dated October 22, 2014) 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. 2015-31990 Filed 12-18-15; 8:45 am]
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