Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines, 23301 [2016-09166]
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Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0059]
Final Revised Vaccine Information
Materials for Meningococcal ACWY
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), 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 14, 2015, CDC published a
notice in the Federal Register (80 FR
61819) seeking public comments on
proposed updated vaccine information
materials for Meningococcal ACWY and
Serogroup B Meningococcal vaccines.
Following review of comments
submitted and consultation as required
under the law, CDC has finalized the
materials for Meningococcal ACWY
vaccines. Copies of the final vaccine
information materials for
Meningococcal ACWY vaccines are
available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2015–0059). CDC will
publish the final vaccine information
materials for Serogroup B
Meningococcal vaccines when they are
completed.
DATES: Beginning no later than July 1,
2016, each health care provider who
administers Meningococcal ACWY
vaccine to any child or adult in the
United States shall provide copies of the
relevant vaccine information materials
referenced in this notice, in
conformance with the March 31, 2016
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
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:53 Apr 19, 2016
Jkt 238001
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 Meningococcal ACWY vaccine
information materials referenced in this
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
23301
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
meningococcal ACWY 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–2015–0059). The Vaccine
Information Statement (VIS) is
‘‘Meningococcal ACWY Vaccines
(MenACWY and MPSV4): What You
Need to Know,’’ publication date March
31, 2016.
With publication of this notice, as of
July 1, 2016, all health care providers
will be required to provide copies of
these updated meningococcal ACWY
vaccine information materials prior to
immunization in conformance with
CDC’s March 31, 2016 Instructions for
the Use of Vaccine Information
Statements.
Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for
Disease Control and Prevention.
[FR Doc. 2016–09166 Filed 4–19–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: The Tribal TANF Financial
Report (ACF–196T).
OMB No.: 0970–0345.
Description: Tribes use Form ACF–
196T to report expenditures for the
Tribal TANF grant. Authority to collect
and report this information is found in
the Personal Responsibility and Work
Opportunity Reconciliation Act of 1996
(PRWORA), Public Law 104–193. Tribal
entities with approved Tribal plans for
implementation of the TANF program
are required by Section 412(h) of the
Social Security Act to report financial
data. Form ACF–196T provides for the
collection of data regarding Federal
expenditures. Failure to collect this data
would seriously compromise the
Administration for Children and
Families’ (ACF) ability to monitor
expenditures. This information is also
used to estimate outlays and may be
used to prepare ACF budget
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Page 23301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09166]
[[Page 23301]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0059]
Final Revised Vaccine Information Materials for Meningococcal
ACWY 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), 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 14, 2015, CDC
published a notice in the Federal Register (80 FR 61819) seeking public
comments on proposed updated vaccine information materials for
Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following
review of comments submitted and consultation as required under the
law, CDC has finalized the materials for Meningococcal ACWY vaccines.
Copies of the final vaccine information materials for Meningococcal
ACWY vaccines are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket
Number CDC-2015-0059). CDC will publish the final vaccine information
materials for Serogroup B Meningococcal vaccines when they are
completed.
DATES: Beginning no later than July 1, 2016, each health care provider
who administers Meningococcal ACWY vaccine to any child or adult in the
United States shall provide copies of the relevant vaccine information
materials referenced in this notice, in conformance with the March 31,
2016 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 Meningococcal ACWY 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
meningococcal ACWY 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-2015-0059). The Vaccine
Information Statement (VIS) is ``Meningococcal ACWY Vaccines (MenACWY
and MPSV4): What You Need to Know,'' publication date March 31, 2016.
With publication of this notice, as of July 1, 2016, all health
care providers will be required to provide copies of these updated
meningococcal ACWY vaccine information materials prior to immunization
in conformance with CDC's March 31, 2016 Instructions for the Use of
Vaccine Information Statements.
Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-09166 Filed 4-19-16; 8:45 am]
BILLING CODE 4163-18-P
