[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Page 79343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31990]
[[Page 79343]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0001]
Final Revised Vaccine Information Materials for Multiple
Pediatric Vaccines (``Your Child's First Vaccines'')
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)(42
U.S.C. 300aa-26), the CDC must develop vaccine information materials
that all health care providers are required to give to patients/parents
prior to administration of specific vaccines. On January 9, 2015, CDC
published a notice in the Federal Register (80 FR 1416) seeking public
comments on proposed updated vaccine information materials for multiple
pediatric vaccines (``Your Baby's First Vaccines''). Following review
of comments submitted and consultation as required under the law, CDC
has finalized the materials. A copy of the final vaccine information
materials for multiple pediatric vaccines (``Your Child's First
Vaccines'') is available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number
CDC-2015-0001).
DATES: Beginning no later than March 1, 2016, each health care provider
who chooses to use the multiple pediatric vaccines Vaccine Information
Statement (``Your Child's First Vaccines'') when administering multiple
pediatric vaccines to any child in the United States shall provide
copies of the relevant vaccine information materials contained in this
notice rather than the previous edition (dated October 22, 2014) in
conformance with the November 5, 2015 CDC Instructions for the Use of
Vaccine Information Statements prior to providing such vaccinations.
FOR FURTHER INFORMATION CONTACT: 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.
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 parent or legal representative in the case of 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 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 Web site at: http://www.cdc.gov/vaccines/hcp/vis/index.html.
Revised Vaccine Information Materials
The multiple pediatric vaccines 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 covering multiple
pediatric vaccines (``Your Child's First Vaccines'') have been
finalized and are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket
Number CDC-2015-0001). The Vaccine Information Statement (VIS) is
``Your Child's First Vaccines: What You Need to Know'' (publication
date November 5, 2015).
With publication of this notice, as of March 1, 2016, all health
care providers who choose to use the multiple pediatric vaccines
Vaccine Information Statement (``Your Child's First Vaccines'') when
administering multiple pediatric vaccines to any child in the United
States shall provide copies of the relevant vaccine information
materials contained in this notice rather than the previous edition
(dated October 22, 2014) in conformance with CDC's November 5, 2015
Instructions for the Use of Vaccine Information Statements.
Dated: December 16, 2015.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2015-31990 Filed 12-18-15; 8:45 am]
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