[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73285-73286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0001]


Final Revised Vaccine Information Materials

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), the 
Centers for Disease Control and Prevention (CDC) within the Department 
of Health and Human Services (HHS) develops vaccine information 
materials that all healthcare providers are required to give to any 
patient (or to the patient's parent or legal representative in the case 
where the patient is a minor child) prior to administration of specific 
vaccines. On January 11, 2021, CDC published a notice in the Federal 
Register (86 FR 1977) seeking public comments on proposed updated 
vaccine information materials for vaccines covered by the National 
Vaccine Injury Compensation Program. Following review of comments 
submitted and consultation as required under the law, CDC has finalized 
the materials. By March 31, 2022, all healthcare providers must 
discontinue use of the previous editions and provide copies of these 
updated vaccine information materials prior to immunization.

DATES: No later than March 31, 2022, each healthcare provider who 
administers a vaccine covered by the National Vaccine Injury 
Compensation Program to any child or adult in the United States shall 
discontinue use of previous editions and provide copies of the updated 
vaccine information materials referenced in this notice, in conformance 
with the CDC Instructions for Use of Vaccine Information Statements 
dated October 15, 2021, prior to administering such vaccinations.

FOR FURTHER INFORMATION CONTACT: Suzanne Johnson-DeLeon, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention, Mailstop: H 24-6, 1600 Clifton Road NE, 
Atlanta, Georgia 30329. Telephone: (404) 639-8817.

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 (the Secretary) to develop and disseminate vaccine 
information materials for distribution by all healthcare providers in 
the United States to any patient (or to the patient's parent or legal 
representative in the case where the patient is a minor child) 
receiving vaccines covered under the National Vaccine Injury 
Compensation Program.
    Development and revision of the vaccine information materials, also 
known as Vaccine Information Statements, have been delegated by the 
Secretary to the Centers for Disease Control and Prevention (CDC). 
Section 2126 requires 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 
healthcare provider and parent organizations, and the Food and Drug 
Administration. Section 2126 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 
healthcare 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 website at: https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html.

Revised Vaccine Information Materials

    The revised 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 pertaining to 
vaccines covered under the National Vaccine Injury Compensation Program 
have been finalized and are available to download from https://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov 
(see Docket Number CDC-2021-0001). The revised Vaccine Information 
Statements are the following:

    ``DTaP (Diphtheria, Tetanus, and Pertussis) Vaccine: What You 
Need to Know,'' publication date August 6, 2021.
    ``Hepatitis A Vaccine: What You Need to Know,'' publication date 
October 15, 2021.
    ``Hepatitis B Vaccine: What You Need to Know,'' publication date 
October 15, 2021.
    ``Haemophilus influenzae type b (Hib) Vaccine: What You Need to 
Know,'' publication date August 6, 2021.
    ``HPV (Human Papillomavirus) Vaccine: What You Need to Know,'' 
publication date August 6, 2021.
    ``Influenza (Flu) Vaccine (Live, Intranasal): What You Need to 
Know,'' publication date August 6, 2021.
    ``Influenza (Flu) Vaccine (Inactivated or Recombinant): What You 
Need to Know,'' publication date August 6, 2021.
    ``MMR Vaccine (Measles, Mumps, and Rubella): What You Need to 
Know,'' publication date August 6, 2021.
    ``MMRV Vaccine (Measles, Mumps, Rubella, and Varicella): What 
You Need to Know,'' publication date August 6, 2021.
    ``Meningococcal ACWY Vaccine: What You Need to Know,'' 
publication date August 6, 2021.
    ``Meningococcal B Vaccine: What You Need to Know,'' publication 
date August 6, 2021.
    ``Pneumococcal Conjugate Vaccine (PCV13): What You Need to 
Know,'' publication date August 6, 2021.
    ``Polio Vaccine: What You Need to Know,'' publication date 
August 6, 2021.
    ``Rotavirus Vaccine: What You Need to Know,'' publication date 
October 15, 2021.
    ``Tdap (Tetanus, Diphtheria, and Pertussis) Vaccine: What You 
Need to Know,'' publication date August 6, 2021.
    ``Td (Tetanus and Diphtheria) Vaccine: What You Need to Know,'' 
publication date August 6, 2021.

[[Page 73286]]

    ``Varicella (Chickenpox) Vaccine: What You Need to Know,'' 
publication date August 6, 2021.
    ``Your Child's First Vaccines: What You Need to Know,'' 
publication date October 15, 2021.

    With publication of this notice, by March 31, 2022, all healthcare 
providers must discontinue use of the previous editions and provide 
copies of these updated vaccine information materials prior to 
immunization in conformance with CDC Instructions for Use of Vaccine 
Information Statements dated October 15, 2021.

    Dated: December 20, 2021.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-27929 Filed 12-23-21; 8:45 am]
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