Final Revised Vaccine Information Materials for Pneumococcal Conjugate Vaccine (PCV13), 79340-79341 [2015-31989]
Download as PDF
<![CDATA[
79340
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
President) 600 Atlantic Avenue, Boston,
Massachusetts 02210–2204:
1. Pentucket Bank Holdings, MHC,
and Pentucket Bancorp, Inc., both in
Haverhill, Massachusetts; to become
bank holding companies by acquiring
100 percent of the voting shares of
Pentucket Bank, Haverhill,
Massachusetts.
B. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Eastern Michigan Financial
Corporation, Croswell, Michigan; to
merge with Ruth Bank Corporation, and
thereby indirectly acquire voting shares
of Ruth State Bank, both in Ruth,
Michigan.
C. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. First Bancshares Corporation,
Gladstone, Michigan; to acquire 100
percent of the voting shares of Northern
Michigan Bank & Trust, Escanaba,
Michigan.
D. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. CSBO Holdings, Inc., Employee
Stock Ownership Plan, Ridgway,
Colorado; to become a bank holding
company by acquiring 51 percent of the
voting shares of CSBO Holdings, Inc.,
Ridgway, Colorado, and thereby
indirectly acquire voting shares of
Citizens State Bank of Ouray, Ouray,
Colorado.
Board of Governors of the Federal Reserve
System, December 15, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–31889 Filed 12–18–15; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
mstockstill on DSK4VPTVN1PROD with NOTICES
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
VerDate Sep<11>2014
17:38 Dec 18, 2015
Jkt 238001
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than January
4, 2016.
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Janet McCauslin, Chillicothe,
Missouri; John Littrell, Brookfield,
Missouri, as a group acting in concert,
and Allen D. Powell Bank Share Trust,
and Allen Powell, as trustee, both of
Linneus, Missouri; to acquire voting
shares of Capital Bancshares, Inc., and
thereby indirectly acquire voting shares
of Bank of Brookfield-Purdin, N.A., both
in Brookfield, Missouri.
Board of Governors of the Federal Reserve
System, December 15, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–31888 Filed 12–18–15; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0014]
Final Revised Vaccine Information
Materials for Pneumococcal Conjugate
Vaccine (PCV13)
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 May 20, 2015, CDC
published a notice in the Federal
Register (80 FR 29009) seeking public
comments on proposed updated vaccine
information materials for pneumococcal
conjugate vaccine (PCV13). 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 pneumococcal conjugate
vaccine (PCV13) are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2015–0014).
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Beginning no later than March 1,
2016, each health care provider who
administers pneumococcal conjugate
vaccine (PCV13) to any child or adult in
the United States shall provide copies of
the relevant vaccine information
materials contained in this notice, 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
DATES:
E:\FR\FM\21DEN1.SGM
21DEN1
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices
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 pneumococcal conjugate vaccine
(PCV13) 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
pneumococcal conjugate vaccine
(PCV13) 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–2015–0014). The Vaccine
Information Statement (VIS) is
‘‘Pneumococcal Conjugate Vaccine
(PCV13): What You Need to Know,’’
publication date November 5, 2015.
With publication of this notice, as of
March 1, 2016, all health care providers
will be required to provide copies of
these updated pneumococcal conjugate
vaccine (PCV13) information materials
prior to immunization 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2015–31989 Filed 12–18–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0841; Docket No. CDC–2015–
0115]
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 efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Management
Information System for Comprehensive
Cancer Control Programs data
collection. CDC uses the electronic MIS
to collect information about cancer
prevention and control activities
conducted by states, territories, and
tribal organizations.
DATES: Written comments must be
received on or before February 19, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0115 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, 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 Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
SUMMARY:
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
17:38 Dec 18, 2015
Jkt 238001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
79341
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Management Information System for
Comprehensive Cancer Control
Programs (OMB No. 0920–0841, exp. 3/
31/2016)—Revision—National Center
for Chronic Disease Prevention and
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79340-79341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31989]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0014]
Final Revised Vaccine Information Materials for Pneumococcal
Conjugate Vaccine (PCV13)
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 May 20, 2015, CDC
published a notice in the Federal Register (80 FR 29009) seeking public
comments on proposed updated vaccine information materials for
pneumococcal conjugate vaccine (PCV13). 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
pneumococcal conjugate vaccine (PCV13) are available to download from
https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0014).
DATES: Beginning no later than March 1, 2016, each health care provider
who administers pneumococcal conjugate vaccine (PCV13) to any child or
adult in the United States shall provide copies of the relevant vaccine
information materials contained in this notice, 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
[[Page 79341]]
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 pneumococcal conjugate vaccine (PCV13) 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 pneumococcal conjugate vaccine (PCV13)
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-2015-0014). The Vaccine Information Statement
(VIS) is ``Pneumococcal Conjugate Vaccine (PCV13): What You Need to
Know,'' publication date November 5, 2015.
With publication of this notice, as of March 1, 2016, all health
care providers will be required to provide copies of these updated
pneumococcal conjugate vaccine (PCV13) information materials prior to
immunization 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. 2015-31989 Filed 12-18-15; 8:45 am]
BILLING CODE 4163-18-P
