[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49929-49930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2018-0091]


Proposed Revised Vaccine Information Materials for Meningococcal 
ACWY and DTaP (Diphtheria, Tetanus, Pertussis) 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), 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 meningococcal ACWY and DTaP (diphtheria, tetanus, 
acellular pertussis) vaccines.

DATES: Written comments must be received on or before December 3, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0091, 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 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, National Center for 
Immunization and Respiratory Diseases, Centers for Disease Control and 
Prevention, Mailstop A-19, 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 (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 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 of the meningococcal ACWY and 
DTaP

[[Page 49930]]

(diphtheria, tetanus, acellular pertussis) vaccine information 
statements.
    Changes to the meningococcal ACWY VIS are minimal. Reference to the 
MPSV4 vaccine, no longer available in the United States, is removed. 
HIV infection is added as an indication for vaccination, and wording 
related to meningococcal ACWY vaccination during pregnancy is updated.
    Proposed revisions to the DTaP VIS reflect new recommendations of 
the Advisory Committee on Immunization Practices (ACIP), including 
updated information about contraindications and precautions. Minor 
changes are proposed to simplify and streamline the sections about what 
to do if there is a reaction and finding additional information about 
the vaccine and the Vaccine Injury Compensation Program. The most 
recent previous final version of the DTaP VIS was published in 2007; 
proposed revisions to this document will help to bring it in line with 
the structure and general approach of more recently-published VISs for 
other vaccines.
    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 ``Meningococcal ACWY Vaccine: What You Need to 
Know'' and ``DTaP (Diphtheria, Tetanus, Pertussis) Vaccine: What You 
Need to Know.'' Copies of the proposed vaccine information materials 
are available at http://www.regulations.gov (see Docket Number CDC-
2018-0091). 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: September 27, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-21491 Filed 10-2-18; 8:45 am]
 BILLING CODE 4163-18-P