Final Revised Vaccine Information Materials for Multiple Pediatric Vaccines (“Your Child's First Vaccines”), 79343 [2015-31990]
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Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
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’’)
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)(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 https://www.cdc.gov/
vaccines/hcp/vis/ or https://
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.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Suzanne Johnson-DeLeon (msj1@
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,
VerDate Sep<11>2014
17:38 Dec 18, 2015
Jkt 238001
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: https://www.cdc.gov/
vaccines/hcp/vis/.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
79343
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 https://www.
cdc.gov/vaccines/hcp/vis/ or
https://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]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1653–NC]
Medicare Program; Request for
Information Regarding the Awarding
and the Administration of Medicare
Administrative Contractor Contracts
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Request for information.
AGENCY:
This request for information
solicits public comment on the
processes and procedures that we could
use to leverage new legal authorities
to— incentivize and reward exceptional
Medicare Administrative Contractor
(MAC) contract performance; publish
performance information on each MAC,
SUMMARY:
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[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
-----------------------------------------------------------------------
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 https://www.cdc.gov/vaccines/hcp/vis/ or https://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 (msj1@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, 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: https://www.cdc.gov/vaccines/hcp/vis/.
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 https://www.cdc.gov/vaccines/hcp/vis/ or https://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]
BILLING CODE 4163-18-P
