Notice2021-27929
Final Revised Vaccine Information Materials
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 27, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 245 (Monday, December 27, 2021)</title>
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[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73285-73286]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html">https://www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html</a>.
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 <a href="https://www.cdc.gov/vaccines/hcp/vis/index.html">https://www.cdc.gov/vaccines/hcp/vis/index.html</a> or <a href="http://www.regulations.gov">http://www.regulations.gov</a>
(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]
BILLING CODE 4163-18-P
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