[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Pages 1977-1978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0001]


Proposed Revised Vaccine Information Materials

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), 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 proposed updated vaccine information 
statements for vaccines covered by the National Vaccine Injury 
Compensation Program (VICP).

DATES: Written comments must be received on or before March 12, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0001, 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 ([email protected]), National Center for Immunization 
and Respiratory Diseases, Centers for Disease Control and Prevention, 
Mailstop H24-6, 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: Suzanne Johnson-DeLeon, National 
Center for Immunization and Respiratory Diseases, Centers for Disease 
Control and Prevention, Mailstop H24-6, 1600 Clifton Road NE, Atlanta, 
Georgia 30329; [email protected].

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 patient's parent or legal representative in the 
case the patient is 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 (VISs), 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 provision of 
vaccine information materials before vaccine administration 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/index.html.
    CDC is proposing updated versions to simplify, streamline, and 
standardize the content and formatting of the vaccine information 
statements.
    As proposed, each of the updated VISs contains the same seven 
sections. Formatting of the documents is identical, using the same 
fonts and layout.
    Section 1 (``Why get vaccinated?'') provides an overview of the 
disease(s) prevented by the vaccine. This section is being updated to 
provide a clearer, more plain-language description of the disease and 
its impact.
    Section 2 (e.g., ``Hepatitis A vaccine'') describes the vaccine and 
recommendations for its use. A general description of the usually-
recommended schedule is provided and groups of people for whom the 
vaccine is typically recommended are identified. Updates to the text in 
this section remove some of the more specific details related to 
schedules and numbers of doses, which can vary depending on an 
individual patient's circumstances.
    Section 3 (``Talk with your health care provider'') highlights 
conditions and medical history that should be brought to the vaccine 
provider's attention when deciding whether the vaccine is appropriate 
for an individual patient. Previously entitled ``Some people should not 
get this vaccine,'' this section has been refocused to be broader

[[Page 1978]]

in scope. Some of the conditions listed in this section are 
contraindications or precautions to vaccination, while others are 
intended to prompt the patient and provider to ask additional questions 
and investigate further.
    Section 4 (``Risks of a vaccine reaction'') sets forth adverse 
events that could occur after vaccination. Included are discussion of 
the risk of severe allergic reaction and the remote possibility of 
serious injury or death. Language for this section has been 
standardized across VISs to the extent possible while still adhering to 
vaccine-specific information from the recommendations of the Advisory 
Committee on Immunization Practices (ACIP).
    The complete text of section 5 (``What if there I a serious 
problem?''), section 6 (``The National Vaccine Injury Compensation 
Program''), and section 7 (``How can I learn more?''), as proposed, 
matches exactly across all of the vaccine information materials, except 
for the VIS for rotavirus vaccine which includes additional information 
related to the risk of intussusception (a very serious adverse event 
that is specific to rotavirus vaccine) in sections 5 and 6.
    Text in all sections of the VISs is updated using plain language 
terms and concepts, and removing some of the more detailed numerical 
and statistical data, to make the documents more easily understandable 
to the general public. Because the vaccine information statements are 
intended for patient education, content that is relevant for providers 
but not for patients is removed. Language has been updated to reflect a 
provider-neutral approach, reflecting the fact that vaccines may be 
administered by medical professionals in a variety of specialty fields 
(e.g., using the term ``health care provider'' instead of ``doctor'' or 
``nurse'').
    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. Copies of the proposed vaccine information materials are 
available at http://www.regulations.gov (see Docket Number CDC-2021-
0001). 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.

Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-00266 Filed 1-8-21; 8:45 am]
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