[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60149-60150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0016]


Final Revised Vaccine Information Materials for Seasonal 
Influenza 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 HHS/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 new vaccine information materials 
for inactivated and live attenuated influenza vaccines. 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 inactivated and live attenuated influenza 
vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number 
CDC-2015-0016).

DATES: Beginning no later than March 1, 2016, each health care provider 
who administers any seasonal influenza vaccine to any child or adult in 
the United States shall provide copies of the relevant revised vaccine 
information materials contained in this notice, in conformance with the 
August 7, 2015 CDC Instructions for the Use of Vaccine Information 
Statements prior to providing such vaccinations. These revised vaccine 
information materials may also be used earlier than that date. Prior to 
March 1, 2016, the previous edition of these two VISs can be used.

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

[[Page 60150]]

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 revised inactivated and live attenuated influenza 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 inactivated and live 
attenuated influenza 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-2015-0016). The Vaccine 
Information Statements (VIS), are: ``Influenza (Flu) Vaccine 
(Inactivated or Recombinant): What you need to know'' (publication date 
August 7, 2015) and ``Influenza (Flu) Vaccine (Live, Intranasal): What 
you need to know'' (publication date August 7, 2015).
    With publication of this notice, as of March 1, 2016, all health 
care providers will be required to provide copies of these updated 
inactivated and live attenuated influenza vaccine information materials 
prior to immunization in conformance with HHS/CDC's August 7, 2015 
Instructions for the Use of Vaccine Information Statements. Prior to 
that date, the previous edition of these two VISs can be used.

    Dated: September 29, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the 
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-25159 Filed 10-2-15; 8:45 am]
 BILLING CODE 4163-18-P