Final Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella) and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines, 11532 [2018-05299]
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11532
Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
The purpose of this analysis is to
facilitate public comment on the
proposed Consent agreement, and the
Commission does not intend this
analysis to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–05252 Filed 3–14–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2016–0094]
Final Revised Vaccine Information
Materials for MMR (Measles, Mumps,
and Rubella) and MMRV (Measles,
Mumps, Rubella, and Varicella)
Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA),
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 October 18, 2016, CDC
published a notice in the Federal
Register seeking public comments on
proposed updated vaccine information
materials for MMR vaccine and MMRV
vaccine. Following review of comments
submitted and consultation as required
under the law, CDC has finalized the
materials. Copies of the final vaccine
information materials for MMR and
MMRV vaccine are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2016–0094).
DATES: Beginning no later than June 1,
2018, each health care provider who
administers MMR or MMRV vaccine to
any child or adult in the United States
shall provide copies of the relevant
vaccine information materials
referenced in this notice, dated February
12, 2018, in conformance with the
February 23, 2018 CDC Instructions for
the Use of Vaccine Information
Statements prior to providing such
vaccinations.
FOR FURTHER INFORMATION CONTACT:
Suzanne Johnson-DeLeon (msj1@
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:34 Mar 14, 2018
Jkt 244001
cdc.gov), 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,
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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/.
Revised Vaccine Information Materials
The 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 covering MMR
and MMRV vaccines have been
finalized and are available to download
from https://www.cdc.gov/vaccines/hcp/
vis/ or https://
www.regulations.gov (see Docket
Number CDC–2016–0094). The Vaccine
Information Statements (VISs) are
‘‘MMR Vaccine (Measles, Mumps, and
Rubella): What You Need to Know’’ and
‘‘MMRV Vaccine (Measles, Mumps,
Rubella, and Varicella): What You Need
to Know,’’ publication date February 12,
2018.
With publication of this notice, by
June 1, 2018, all health care providers
must discontinue use of the previous
editions and provide copies of these
updated vaccine information materials
prior to immunization in conformance
with CDC’s February 23, 2018
Instructions for the Use of Vaccine
Information Statements.
Dated: March 12, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2018–05299 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–FY–1072; Docket No. CDC–2018–
0020]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
SUMMARY:
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Page 11532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05299]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2016-0094]
Final Revised Vaccine Information Materials for MMR (Measles,
Mumps, and Rubella) and MMRV (Measles, Mumps, Rubella, and Varicella)
Vaccines
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA), 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 October 18, 2016, CDC published
a notice in the Federal Register seeking public comments on proposed
updated vaccine information materials for MMR vaccine and MMRV vaccine.
Following review of comments submitted and consultation as required
under the law, CDC has finalized the materials. Copies of the final
vaccine information materials for MMR and MMRV vaccine are available to
download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2016-0094).
DATES: Beginning no later than June 1, 2018, each health care provider
who administers MMR or MMRV vaccine to any child or adult in the United
States shall provide copies of the relevant vaccine information
materials referenced in this notice, dated February 12, 2018, in
conformance with the February 23, 2018 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 website at: https://www.cdc.gov/vaccines/hcp/vis/.
Revised Vaccine Information Materials
The 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 covering MMR and MMRV
vaccines have been finalized and are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov
(see Docket Number CDC-2016-0094). The Vaccine Information Statements
(VISs) are ``MMR Vaccine (Measles, Mumps, and Rubella): What You Need
to Know'' and ``MMRV Vaccine (Measles, Mumps, Rubella, and Varicella):
What You Need to Know,'' publication date February 12, 2018.
With publication of this notice, by June 1, 2018, all health care
providers must discontinue use of the previous editions and provide
copies of these updated vaccine information materials prior to
immunization in conformance with CDC's February 23, 2018 Instructions
for the Use of Vaccine Information Statements.
Dated: March 12, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-05299 Filed 3-14-18; 8:45 am]
BILLING CODE 4163-18-P
