[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