81 FR 23301 - Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 76 (April 20, 2016)

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 October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for Meningococcal ACWY vaccines. Copies of the final vaccine information materials for Meningococcal ACWY vaccines are available to download from http://www.cdc.gov/ vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). CDC will publish the final vaccine information materials for Serogroup B Meningococcal vaccines when they are completed.

[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Page 23301]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09166]



[[Page 23301]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0059]


Final Revised Vaccine Information Materials for Meningococcal 
ACWY 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 October 14, 2015, CDC 
published a notice in the Federal Register (80 FR 61819) seeking public 
comments on proposed updated vaccine information materials for 
Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following 
review of comments submitted and consultation as required under the 
law, CDC has finalized the materials for Meningococcal ACWY vaccines. 
Copies of the final vaccine information materials for Meningococcal 
ACWY vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket 
Number CDC-2015-0059). CDC will publish the final vaccine information 
materials for Serogroup B Meningococcal vaccines when they are 
completed.

DATES: Beginning no later than July 1, 2016, each health care provider 
who administers Meningococcal ACWY 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 March 31, 
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 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 Meningococcal ACWY 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 
meningococcal ACWY 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-2015-0059). The Vaccine 
Information Statement (VIS) is ``Meningococcal ACWY Vaccines (MenACWY 
and MPSV4): What You Need to Know,'' publication date March 31, 2016.
    With publication of this notice, as of July 1, 2016, all health 
care providers will be required to provide copies of these updated 
meningococcal ACWY vaccine information materials prior to immunization 
in conformance with CDC's March 31, 2016 Instructions for the Use of 
Vaccine Information Statements.

    Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-09166 Filed 4-19-16; 8:45 am]
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