Final Revised Vaccine Information Materials for Td, Tdap, Hib, and Rotavirus Vaccines, 32127 [2015-13694]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2014–0007]
Final Revised Vaccine Information
Materials for Td, Tdap, Hib, and
Rotavirus Vaccines
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 June 25, 2014, CDC published a
notice in the Federal Register (79 FR
36068) seeking public comments on
proposed new vaccine information
materials for Td, Tdap, Haemophilus
influenzae type b (Hib), and rotavirus
vaccines. 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
Td, Tdap, Hib, and rotavirus are
available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2014–0007).
DATES: Beginning no later than
November 1, 2015, each health care
provider who administers any Td, Tdap,
Hib, or rotavirus vaccine 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 April
15, 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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:31 Jun 04, 2015
Jkt 235001
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/.
New Vaccine Information Materials
The Td, Tdap, Hib, and rotavirus
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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
32127
healthcare provider organizations.
Following consultation and review of
comments submitted, the vaccine
information materials covering Td,
Tdap, Hib, and rotavirus 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–2014–0007). The Vaccine
Information Statements (VIS), are: ‘‘Td
Vaccine: What You Need to Know’’
(publication date February 24, 2015),
‘‘Tdap Vaccine: What You Need to
Know’’ (publication date February 24,
2015), ‘‘Haemophilus influenzae type b
Vaccine: What You need to Know’’
(publication date April 2, 2015), and
‘‘Rotavirus Vaccine: What You Need to
Know’’ (publication date April 15,
2015).
With publication of this notice, as of
November 1, 2015, all health care
providers will be required to provide
copies of these updated Td, Tdap, Hib,
and rotavirus vaccine information
materials prior to immunization in
conformance with CDC’s April 15, 2015
Instructions for the Use of Vaccine
Information Statements.
Dated: June 1, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–13694 Filed 6–4–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0042; 60Day–15–
0981]
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 Assessing and Evaluating
Human Systems Integration needs in
mining. CDC objective is to conduct
SUMMARY:
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Page 32127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13694]
[[Page 32127]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2014-0007]
Final Revised Vaccine Information Materials for Td, Tdap, Hib,
and Rotavirus Vaccines
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 June 25, 2014, CDC
published a notice in the Federal Register (79 FR 36068) seeking public
comments on proposed new vaccine information materials for Td, Tdap,
Haemophilus influenzae type b (Hib), and rotavirus vaccines. 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 Td, Tdap, Hib, and rotavirus are available to
download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2014-0007).
DATES: Beginning no later than November 1, 2015, each health care
provider who administers any Td, Tdap, Hib, or rotavirus vaccine 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 April 15, 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 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/.
New Vaccine Information Materials
The Td, Tdap, Hib, and rotavirus 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 Td, Tdap, Hib, and rotavirus 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-2014-0007). The Vaccine Information Statements
(VIS), are: ``Td Vaccine: What You Need to Know'' (publication date
February 24, 2015), ``Tdap Vaccine: What You Need to Know''
(publication date February 24, 2015), ``Haemophilus influenzae type b
Vaccine: What You need to Know'' (publication date April 2, 2015), and
``Rotavirus Vaccine: What You Need to Know'' (publication date April
15, 2015).
With publication of this notice, as of November 1, 2015, all health
care providers will be required to provide copies of these updated Td,
Tdap, Hib, and rotavirus vaccine information materials prior to
immunization in conformance with CDC's April 15, 2015 Instructions for
the Use of Vaccine Information Statements.
Dated: June 1, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2015-13694 Filed 6-4-15; 8:45 am]
BILLING CODE 4163-18-P
