81 FR 13794 - Proposed Revised Vaccine Information Materials for Polio and Varicella Vaccines

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

Federal Register Volume 81, Issue 50 (March 15, 2016)

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for polio and varicella vaccines.

[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Page 13794]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0029]


Proposed Revised Vaccine Information Materials for Polio and 
Varicella Vaccines

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 
U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) 
within the Department of Health and Human Services (HHS) develops 
vaccine information materials that all health care providers are 
required to give to patients/parents prior to administration of 
specific vaccines. HHS/CDC seeks written comment on the proposed 
updated vaccine information statements for polio and varicella 
vaccines.

DATES: Written comments must be received on or before May 16, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0029, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Written comments should be addressed to Suzanne 
Johnson-DeLeon, National Center for Immunization and Respiratory 
Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 
1600 Clifton Road NE., Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and docket number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Skip Wolfe ([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.
    HHS/CDC is proposing updated versions of the polio and varicella 
vaccine information statements.
    The vaccine information materials referenced in this notice are 
being developed in consultation with the Advisory Commission on 
Childhood Vaccines, the Food and Drug Administration, and parent and 
health care provider groups.
    We invite written comment on the proposed vaccine information 
materials entitled ``Polio Vaccine: What You Need to Know'' and 
``Varicella Vaccine: What You Need to Know.'' Copies of the proposed 
vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC-2016-0029). Comments 
submitted will be considered in finalizing these materials. When the 
final materials are published in the Federal Register, the notice will 
include an effective date for their mandatory use.

    Dated: March 9, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-05776 Filed 3-14-16; 8:45 am]
 BILLING CODE 4163-18-P