Final Revised Vaccine Information Materials for Polio Vaccine, 62137-62138 [2016-21575]
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Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / 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 serogroup B meningococcal
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
serogroup B meningococcal 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–2015–0059). The Vaccine
Information Statement (VIS) is
‘‘Serogroup B Meningococcal (MenB)
Vaccine: What You Need to Know,’’
publication date August 9, 2016.
With publication of this notice, as of
December 1, 2016, all health care
providers will be required to provide
copies of these updated serogroup B
meningococcal vaccine information
materials prior to immunization in
conformance with CDC’s August 9, 2016
Instructions for the Use of Vaccine
Information Statements.
Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
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[FR Doc. 2016–21574 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0029]
Final Revised Vaccine Information
Materials for Polio Vaccine
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
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 polio vaccine. Copies of
the final vaccine information materials
for polio vaccine are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2015–0029). CDC will
publish the final vaccine information
materials for varicella vaccine when
they are completed.
DATES: Beginning no later than
November 1, 2016, each health care
provider who administers polio 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 August 9, 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
SUMMARY:
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62137
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 polio 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.
E:\FR\FM\08SEN1.SGM
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62138
Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
Following consultation and review of
comments submitted, the vaccine
information materials covering polio
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–2015–0029). The Vaccine
Information Statement (VIS) is ‘‘Polio
Vaccine: What You Need to Know,’’
publication date July 20, 2016.
With publication of this notice, by
November 1, 2016, all health care
providers must discontinue use of the
previous edition and provide copies of
these updated polio vaccine information
materials prior to immunization in
conformance with CDC’s August 9, 2016
Instructions for the Use of Vaccine
Information Statements.
Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2016–21575 Filed 9–7–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0955; Docket No. CDC–2016–
0089]
Proposed Data Collections 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
requires by the Paperwork Reduction
Act of 1995. This notice invites
comments on Early Hearing Detection
and Intervention Pediatric Audiology
Links to Services (EDHI–PALS)
DATES: Written comments must be
received on or before November 7, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0089 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instruction
for submitting comments.
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SUMMARY:
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19:34 Sep 07, 2016
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• 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 Regulation.gov, including any
personal information provided. For
access to the docket to read the
background documents or comments
received, go to Regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Leroy A. Richardson, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329.
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, and each reinstatement of
previously approved information
collection before submitting the collect
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; and (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
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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
Early Hearing Detection and
Intervention—Pediatric Audiology
Links to Service (EHDI–PALS) Survey
(OMB No. 0920–0955, Expiration 03/31/
2017)—Extension—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Human Development
and Disability, located within NCBDDD,
promotes the health of babies, children,
and adults, with a focus on preventing
birth defects and developmental
disabilities and optimizing the health
outcomes of those with disabilities.
Since the passage of the Early Hearing
Detection and Intervention (EHDI) Act,
98% of newborn infants are now
screened for hearing loss prior to
hospital discharge. However, many of
these infants have not received needed
hearing tests and follow up services
after their hospital discharges. The 2013
national average loss to follow-up/loss
to documentation rate is at 32%. This
rate remains an area of critical concern
for state EHDI programs and CDC–EHDI
team’s goal of timely diagnosis by 3
months of age and intervention by 6
months of age. Many states cite the lack
of audiology resources as the main
factor behind the high loss to follow-up.
To compound the problem, many
pediatric audiologists may be proficient
evaluating children age 5 and older but
are not proficient with diagnosing
infants or younger children because
children age 5 and younger require a
different skill set. There is still no
existing literature or database available
to help states verify and quantify their
states’ true follow up capacity until this
project went live in 2013.
Meeting since April 2010, the EHDI–
PALS workgroup has sought consensus
on the loss to follow-up/loss to
documentation issue facing the EHDI
programs. A survey based on standard
of care practice was developed for state
EHDI programs to quantify the pediatric
audiology resource distribution within
their state, particularly audiology
facilities that are equipped to provide
follow up services for children age five
and younger. After three years of data
collection, data suggested that children
residing in certain regions of the US
who were loss to follow up were due to
the distance parents had to travel to
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[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62137-62138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0029]
Final Revised Vaccine Information Materials for Polio 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) (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 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 polio vaccine. Copies of the final vaccine information
materials for polio vaccine are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov
(see Docket Number CDC-2015-0029). CDC will publish the final vaccine
information materials for varicella vaccine when they are completed.
DATES: Beginning no later than November 1, 2016, each health care
provider who administers polio 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 August 9,
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 polio 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.
[[Page 62138]]
Following consultation and review of comments submitted, the vaccine
information materials covering polio 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-2015-
0029). The Vaccine Information Statement (VIS) is ``Polio Vaccine: What
You Need to Know,'' publication date July 20, 2016.
With publication of this notice, by November 1, 2016, all health
care providers must discontinue use of the previous edition and provide
copies of these updated polio vaccine information materials prior to
immunization in conformance with CDC's August 9, 2016 Instructions for
the Use of Vaccine Information Statements.
Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-21575 Filed 9-7-16; 8:45 am]
BILLING CODE 4163-18-P
