Final Revised Vaccine Information Materials for Varicella Vaccine, 11536-11537 [2018-05298]
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Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
from the 9/11 terrorist attacks. Thus, the
CDC seeks a one-year OMB approval to
collect information using focus groups.
The WTCHP employs the Research-toCare (RTC) model strategic framework
employed to prioritize, conduct, and
assess research that informs excellence
in clinical care for the population of
responders and survivors affected by the
9/11 attack in New York City. The RTC
model assumes the collective
involvement of WTCHP stakeholders,
including members, researchers,
clinicians, and program administrators.
It accounts for a variety of inputs that
can affect the progress and impact of
WTCHP research. These inputs include
people and organizations (e.g., program
members, providers, clinical centers of
excellence, extramural researchers, and
program staff), resources (e.g.,
technology, data centers, the NYC 9/11
Health Registry) and regulatory rules,
principally the Zadroga Act.
The program supports activities such
as research prioritization, conduct of
research, delivery of medical care, and
iterative assessments of the translation
of research to improvements in health
care services and chronic disease
management. These activities aim to
produce tangible outputs such as
research findings on WTC-related
conditions, healthcare protocols, peerreviewed publications, quality
assessment reports, and member and
provider education products. Finally,
the model anticipates short-,
intermediate-, and long-term
measurement of outcomes and serves as
a communication tool for program
planning and evaluation.
In 2016, NIOSH contracted with the
Research and Development (RAND)
Corporation to evaluate the WTCHP
RTC model including the research
investments to date and the
effectiveness with which the Program
translates its research to different
stakeholder groups. This work will
ultimately provide guidance for the
WTCHP on strategic directions, as well
as produce generalizable knowledge
about the translation of research into
improved outcomes for individuals and
populations exposed to disasters such as
the 9/11 attacks. In the formative stage
of our assessment, we propose to hold
a series of focus groups with different
stakeholder groups to explore their
perspectives on translational research in
the context of the WTCHP. The focus
groups will each consist of a welldefined stakeholder group, and will last
approximately two hours.
These focus groups are necessary to
gather background information on the
relationship between different
stakeholders and the WTCHP that will
inform the development of more
detailed interview protocols to be used
with stakeholders in the next phase of
this evaluation. Specific topics to be
addressed in the focus groups will
include:
• Conceptualizations of research and
‘‘translational research.’’
• Relevance of WTCHP research
topics, potential gaps, and stakeholder
priorities.
• Uses and usefulness of WTCHP
research.
• Barriers to conduct and use of
WTCHP research.
• Understanding of and perspectives
on the relevance and usefulness of the
Research-to-Care model.
The total estimated burden hours is
360. There are no costs to the
respondent other than their time and
local travel to the location of the focus
group.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
(in hours)
Type of respondents
Form name
WTCH Researchers ............................
WTCH Research Users ......................
WTCH Funders (NIOSH) ....................
Focus Group Protocol ........................
Focus Group Protocol ........................
Focus Group Protocol ........................
40
70
10
1
1
1
3
3
3
120
210
30
Total .............................................
.............................................................
........................
........................
........................
360
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–05242 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. CDC–2016–0029]
Final Revised Vaccine Information
Materials for Varicella Vaccine
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
17:34 Mar 14, 2018
Jkt 244001
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 March 15, 2016, CDC
published a notice in the Federal
Register (81 FR 13794) seeking public
comments on proposed updated vaccine
information materials for polio vaccine
and varicella vaccine. Following review
of comments submitted and
consultation as required under the law,
CDC has finalized the materials for
varicella vaccine. Copies of the final
vaccine information materials for
varicella vaccine are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2016–0029).
SUMMARY:
PO 00000
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Sfmt 4703
Beginning no later than June 1,
2018, each health care provider who
administers varicella 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.
DATES:
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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15MRN1.SGM
15MRN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices
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 varicella vaccine information
materials referenced in this notice were
VerDate Sep<11>2014
17:34 Mar 14, 2018
Jkt 244001
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 varicella
vaccine have been finalized and are
available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2016–0029). The Vaccine
Information Statement (VIS) is
‘‘Varicella (Chickenpox) Vaccine: 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
edition and provide copies of these
updated varicella 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. 2018–05298 Filed 3–14–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2018–0024, NIOSH–
302]
Draft—National Occupational Research
Agenda for Respiratory Health
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for comment.
AGENCY:
The National Institute for
Occupational Safety and Health of the
Centers for Disease Control and
Prevention announces the availability of
a draft NORA Agenda entitled National
Occupational Research Agenda for
Respiratory Health for public comment.
To view the notice and related
materials, visit https://
www.regulations.gov and enter CDC–
2018–0024 in the search field and click
‘‘Search.’’
SUMMARY:
Table of Contents
• DATES:
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11537
• ADDRESSES:
• FOR FURTHER INFORMATION
CONTACT:
• SUPPLEMENTARY INFORMATION:
• BACKGROUND:
DATES: Electronic or written comments
must be received by May 14, 2018.
ADDRESSES: You may submit comments,
identified by CDC–2018–0024 and
docket number NIOSH–302, by any of
the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All submissions received
in response to this notice must include
the agency name and docket number
[CDC–2018–0024; NIOSH–302]. All
relevant comments received will be
posted without change to https://
www.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. All
information received in response to this
notice will also be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, OH 45226–1998.
FOR FURTHER INFORMATION CONTACT:
Emily Novicki NORACoordinator@
cdc.gov), National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
Mailstop E–20, 1600 Clifton Road NE,
Atlanta, GA 30329, phone (404) 498–
2581 (not a toll free number).
SUPPLEMENTARY INFORMATION: The
National Occupational Research Agenda
(NORA) is a partnership program
created to stimulate innovative research
and improved workplace practices. The
national agenda is developed and
implemented through the NORA sector
and cross-sector councils. Each council
develops and maintains an agenda for
its sector or cross-sector.
Background: The National
Occupational Research Agenda for
Respiratory Health is intended to
identify the research, information, and
actions most urgently needed to prevent
occupational injuries. The National
Occupational Research Agenda for
Respiratory Health provides a vehicle
for stakeholders to describe the most
relevant issues, gaps, and safety and
health needs for the sector. Each NORA
research agenda is meant to guide or
promote high priority research efforts on
a national level, conducted by various
entities, including: Government, higher
education, and the private sector.
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11536-11537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2016-0029]
Final Revised Vaccine Information Materials for Varicella Vaccine
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 March 15, 2016, CDC published a
notice in the Federal Register (81 FR 13794) seeking public comments on
proposed updated vaccine information materials for polio vaccine and
varicella vaccine. Following review of comments submitted and
consultation as required under the law, CDC has finalized the materials
for varicella vaccine. Copies of the final vaccine information
materials for varicella vaccine are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov
(see Docket Number CDC-2016-0029).
DATES: Beginning no later than June 1, 2018, each health care provider
who administers varicella 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
[[Page 11537]]
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 varicella 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
varicella vaccine 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-2016-0029). The Vaccine
Information Statement (VIS) is ``Varicella (Chickenpox) Vaccine: 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 edition and provide
copies of these updated varicella 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. 2018-05298 Filed 3-14-18; 8:45 am]
BILLING CODE 4163-18-P
