Proposed Revised Vaccine Information Materials for Meningococcal ACWY and Serogroup B Meningococcal Vaccines, 61819 [2015-26076]
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Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
[FR Doc. 2015–26012 Filed 10–13–15; 8:45 am]
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 https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe (crw4@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.
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SUPPLEMENTARY INFORMATION:
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 9000–0076,
Novation/Change of Name
Requirements, in all correspondence.
Edward Loeb,
Acting Director, Federal Acquisition Policy
Division, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0059]
Proposed Revised Vaccine Information
Materials for Meningococcal ACWY
and Serogroup B Meningococcal
Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), 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 serogroup B meningococcal
vaccines.
SUMMARY:
Written comments must be
received on or before December 14,
2015.
DATES:
You may submit comments,
identified by Docket No. CDC–2015–
0059, by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Written comments should be
addressed to Suzanne Johnson-DeLeon,
National Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
tkelley on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
16:39 Oct 13, 2015
Jkt 238001
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
61819
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/.
HHS/CDC is proposing updated
versions of the meningococcal ACWY
and serogroup B meningococcal vaccine
information statements.
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
Vaccines (MenACWY and MPSV4):
What You Need to Know’’ and
‘‘Serogroup B Meningococcal Vaccine
(MenB): What You Need to Know.’’
Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2015–0059).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: October 7, 2015.
Sandra Cashman,
Acting Director, Division of the Executive
Secretariat, Office of the Chief of Staff,
Centers for Disease Control and Prevention.
[FR Doc. 2015–26076 Filed 10–13–15; 8:45 am]
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HUMAN SERVICES
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14OCN1
]]>Agencies
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Page 61819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26076]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0059]
Proposed Revised Vaccine Information Materials for Meningococcal
ACWY and Serogroup B Meningococcal Vaccines
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42
U.S.C. 300aa-26), 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
serogroup B meningococcal vaccines.
DATES: Written comments must be received on or before December 14,
2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0059, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Written comments should be addressed to Suzanne
Johnson-DeLeon, 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 https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Skip Wolfe (crw4@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/.
HHS/CDC is proposing updated versions of the meningococcal ACWY and
serogroup B meningococcal vaccine information statements.
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 Vaccines (MenACWY and MPSV4):
What You Need to Know'' and ``Serogroup B Meningococcal Vaccine (MenB):
What You Need to Know.'' Copies of the proposed vaccine information
materials are available at https://www.regulations.gov (see Docket
Number CDC-2015-0059).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: October 7, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-26076 Filed 10-13-15; 8:45 am]
BILLING CODE 4163-18-P
