Proposed Revised Vaccine Information Materials, 1977-1978 [2021-00266]
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Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
Place: Teleconference, Centers for
Disease Control and Prevention, Room
1080, 8 Corporate Square Boulevard,
Atlanta, Georgia 30329–4027.
Agenda: To review and evaluate grant
applications.
FOR FURTHER INFORMATION CONTACT:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road, NE, Mailstop US8–1,
Atlanta, Georgia 30329–4027, (404) 718–
8833, ganderson@cdc.gov.
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Register notices pertaining to
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committee management activities, for
both the Centers for Disease Control and
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Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–00282 Filed 1–8–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2021–0001]
Proposed Revised Vaccine Information
Materials
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),
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 proposed updated
vaccine information statements for
vaccines covered by the National
Vaccine Injury Compensation Program
(VICP).
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Written comments must be
received on or before March 12, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0001, by any of the following methods:
DATES:
VerDate Sep<11>2014
22:36 Jan 08, 2021
Jkt 253001
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Written comments should be
addressed to Suzanne Johnson-DeLeon
(VISComments@cdc.gov), National
Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
Mailstop H24–6, 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:
Suzanne Johnson-DeLeon, National
Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
Mailstop H24–6, 1600 Clifton Road NE,
Atlanta, Georgia 30329; VISComments@
cdc.gov.
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 patient’s
parent or legal representative in the case
the patient is 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 (VISs), 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,
PO 00000
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Fmt 4703
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1977
(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
provision of vaccine information
materials before vaccine administration
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/.
CDC is proposing updated versions to
simplify, streamline, and standardize
the content and formatting of the
vaccine information statements.
As proposed, each of the updated
VISs contains the same seven sections.
Formatting of the documents is
identical, using the same fonts and
layout.
Section 1 (‘‘Why get vaccinated?’’)
provides an overview of the disease(s)
prevented by the vaccine. This section
is being updated to provide a clearer,
more plain-language description of the
disease and its impact.
Section 2 (e.g., ‘‘Hepatitis A vaccine’’)
describes the vaccine and
recommendations for its use. A general
description of the usually-recommended
schedule is provided and groups of
people for whom the vaccine is
typically recommended are identified.
Updates to the text in this section
remove some of the more specific
details related to schedules and
numbers of doses, which can vary
depending on an individual patient’s
circumstances.
Section 3 (‘‘Talk with your health care
provider’’) highlights conditions and
medical history that should be brought
to the vaccine provider’s attention when
deciding whether the vaccine is
appropriate for an individual patient.
Previously entitled ‘‘Some people
should not get this vaccine,’’ this
section has been refocused to be broader
E:\FR\FM\11JAN1.SGM
11JAN1
jbell on DSKJLSW7X2PROD with NOTICES
1978
Federal Register / Vol. 86, No. 6 / Monday, January 11, 2021 / Notices
in scope. Some of the conditions listed
in this section are contraindications or
precautions to vaccination, while others
are intended to prompt the patient and
provider to ask additional questions and
investigate further.
Section 4 (‘‘Risks of a vaccine
reaction’’) sets forth adverse events that
could occur after vaccination. Included
are discussion of the risk of severe
allergic reaction and the remote
possibility of serious injury or death.
Language for this section has been
standardized across VISs to the extent
possible while still adhering to vaccinespecific information from the
recommendations of the Advisory
Committee on Immunization Practices
(ACIP).
The complete text of section 5 (‘‘What
if there I a serious problem?’’), section
6 (‘‘The National Vaccine Injury
Compensation Program’’), and section 7
(‘‘How can I learn more?’’), as proposed,
matches exactly across all of the vaccine
information materials, except for the
VIS for rotavirus vaccine which
includes additional information related
to the risk of intussusception (a very
serious adverse event that is specific to
rotavirus vaccine) in sections 5 and 6.
Text in all sections of the VISs is
updated using plain language terms and
concepts, and removing some of the
more detailed numerical and statistical
data, to make the documents more
easily understandable to the general
public. Because the vaccine information
statements are intended for patient
education, content that is relevant for
providers but not for patients is
removed. Language has been updated to
reflect a provider-neutral approach,
reflecting the fact that vaccines may be
administered by medical professionals
in a variety of specialty fields (e.g.,
using the term ‘‘health care provider’’
instead of ‘‘doctor’’ or ‘‘nurse’’).
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.
Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2021–0001). Comments
submitted will be considered in
VerDate Sep<11>2014
22:36 Jan 08, 2021
Jkt 253001
finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
an effective date for their mandatory
use.
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2021–00266 Filed 1–8–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0356]
Submission for OMB Review;
Formative Data Collections for ACF
Research and Evaluation
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) proposes
to extend data collection under the
existing overarching generic clearance
for Formative Data Collections for ACF
Research and Evaluation (OMB #0970–
0356). There are no changes to the
proposed types of information
collection or uses of data, but the
request does include an increase to the
estimated number of respondents and,
therefore, the overall burden estimate.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: ACF programs promote the
ADDRESSES:
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economic and social well-being of
families, children, individuals, and
communities. OPRE studies ACF
programs, and the populations they
serve, through rigorous research and
evaluation projects. These include
evaluations of existing programs,
evaluations of innovative approaches to
helping low-income children and
families, research syntheses, and
descriptive and exploratory studies.
OPRE’s research serves to provide
further understanding of current
programs and service populations,
explore options for program
improvement, and assess alternative
policy and program designs. OPRE
anticipates undertaking a variety of new
research projects related to welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, family and
youth services, home visiting, child
welfare, and other areas of interest to
ACF. Under this generic clearance, ACF
engages in a variety of formative data
collections with researchers,
practitioners, technical assistance
providers, service providers, and
potential participants throughout the
field to fulfill the following goals: (1)
Inform the development of ACF
research, (2) maintain a research agenda
that is rigorous and relevant, (3) ensure
that research products are as current as
possible, and (4) inform the provision of
technical assistance. ACF uses a variety
of techniques including semi-structured
discussions, focus groups, surveys, and
telephone or in-person interviews, in
order to reach these goals.
Following standard OMB
requirements, OPRE will submit a
change request for each individual data
collection activity under this generic
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, and any supplementary
documents. OMB should review
requests within 10 days of submission.
Respondents: Example respondents
include: key stakeholder groups
involved in ACF projects and programs,
state or local government officials,
service providers, participants in ACF
programs or similar comparison groups,
experts in fields pertaining to ACF
research and programs, or others
involved in conducting ACF research or
evaluation projects.
E:\FR\FM\11JAN1.SGM
11JAN1
]]>Agencies
[Federal Register Volume 86, Number 6 (Monday, January 11, 2021)]
[Notices]
[Pages 1977-1978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2021-0001]
Proposed Revised Vaccine Information Materials
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), 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 proposed updated vaccine information
statements for vaccines covered by the National Vaccine Injury
Compensation Program (VICP).
DATES: Written comments must be received on or before March 12, 2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0001, 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 ([email protected]), National Center for Immunization
and Respiratory Diseases, Centers for Disease Control and Prevention,
Mailstop H24-6, 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: Suzanne Johnson-DeLeon, National
Center for Immunization and Respiratory Diseases, Centers for Disease
Control and Prevention, Mailstop H24-6, 1600 Clifton Road NE, Atlanta,
Georgia 30329; [email protected].
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 patient's parent or legal representative in the
case the patient is 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 (VISs), 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 provision of
vaccine information materials before vaccine administration 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/.
CDC is proposing updated versions to simplify, streamline, and
standardize the content and formatting of the vaccine information
statements.
As proposed, each of the updated VISs contains the same seven
sections. Formatting of the documents is identical, using the same
fonts and layout.
Section 1 (``Why get vaccinated?'') provides an overview of the
disease(s) prevented by the vaccine. This section is being updated to
provide a clearer, more plain-language description of the disease and
its impact.
Section 2 (e.g., ``Hepatitis A vaccine'') describes the vaccine and
recommendations for its use. A general description of the usually-
recommended schedule is provided and groups of people for whom the
vaccine is typically recommended are identified. Updates to the text in
this section remove some of the more specific details related to
schedules and numbers of doses, which can vary depending on an
individual patient's circumstances.
Section 3 (``Talk with your health care provider'') highlights
conditions and medical history that should be brought to the vaccine
provider's attention when deciding whether the vaccine is appropriate
for an individual patient. Previously entitled ``Some people should not
get this vaccine,'' this section has been refocused to be broader
[[Page 1978]]
in scope. Some of the conditions listed in this section are
contraindications or precautions to vaccination, while others are
intended to prompt the patient and provider to ask additional questions
and investigate further.
Section 4 (``Risks of a vaccine reaction'') sets forth adverse
events that could occur after vaccination. Included are discussion of
the risk of severe allergic reaction and the remote possibility of
serious injury or death. Language for this section has been
standardized across VISs to the extent possible while still adhering to
vaccine-specific information from the recommendations of the Advisory
Committee on Immunization Practices (ACIP).
The complete text of section 5 (``What if there I a serious
problem?''), section 6 (``The National Vaccine Injury Compensation
Program''), and section 7 (``How can I learn more?''), as proposed,
matches exactly across all of the vaccine information materials, except
for the VIS for rotavirus vaccine which includes additional information
related to the risk of intussusception (a very serious adverse event
that is specific to rotavirus vaccine) in sections 5 and 6.
Text in all sections of the VISs is updated using plain language
terms and concepts, and removing some of the more detailed numerical
and statistical data, to make the documents more easily understandable
to the general public. Because the vaccine information statements are
intended for patient education, content that is relevant for providers
but not for patients is removed. Language has been updated to reflect a
provider-neutral approach, reflecting the fact that vaccines may be
administered by medical professionals in a variety of specialty fields
(e.g., using the term ``health care provider'' instead of ``doctor'' or
``nurse'').
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. Copies of the proposed vaccine information materials are
available at https://www.regulations.gov (see Docket Number CDC-2021-
0001). 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.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2021-00266 Filed 1-8-21; 8:45 am]
BILLING CODE 4163-18-P
