Proposed Revised Vaccine Information Materials for Pneumococcal Conjugate Vaccine (PCV13), 29009-29010 [2015-12239]
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Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015–12229 Filed 5–19–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0016]
Proposed Revised Vaccine Information
Materials for Seasonal Influenza
Vaccines
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)
(42 U.S.C. 300aa–26), 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 the
proposed updated vaccine information
statements for inactivated and live
attenuated influenza vaccines.
DATES: Written comments must be
received on or before July 20, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0016, 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
(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.
Instructions: All submissions received
must include the agency name and
docket number. All relevant comments
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
23:50 May 19, 2015
Jkt 235001
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: Skip
Wolfe (crw4@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
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
29009
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/.
HHS/CDC is proposing updated
versions of the inactivated and live
attenuated seasonal influenza vaccine
information statements.
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
entitled ‘‘Influenza (Flu) Vaccine
(Inactivated or Recombinant): What you
need to know’’ and ‘‘Influenza (Flu)
Vaccine (Live, Intranasal): What you
need to know.’’ Copies of the proposed
vaccine information materials are
available at https://www.regulations.gov
(see Docket Number CDC–2015–0016).
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.
Dated: May 14, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–12240 Filed 5–19–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0014]
Proposed 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 with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the Centers for
SUMMARY:
E:\FR\FM\20MYN1.SGM
20MYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
29010
Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices
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 the
proposed updated vaccine information
statement for pneumococcal conjugate
vaccine (PCV13).
DATES: Written comments must be
received on or before July 20, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0014, 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
(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.
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: Skip
Wolfe (crw4@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
VerDate Sep<11>2014
23:50 May 19, 2015
Jkt 235001
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/.
HHS/CDC is proposing an updated
version of the pneumococcal conjugate
vaccine (PCV13) vaccine information
statement.
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
entitled ‘‘Pneumococcal Conjugate
Vaccine (PCV13): What You Need to
Know.’’ A copy of the proposed vaccine
information materials is available at
https://www.regulations.gov (see Docket
Number CDC–2015–0014). 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.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
Dated: May 15,2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–12239 Filed 5–19–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0247]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Meetings With
Sponsors and Applicants for
Prescription Drug User Fee Act
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection contained in
the guidance for industry on formal
meetings with sponsors and applicants
for Prescription Drug User Fee Act
(PDUFA) products.
DATES: Submit either electronic or
written comments on the collection of
information by July 20, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
Under the
PRA, (44 U.S.C. 3501–3520), Federal
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29009-29010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0014]
Proposed 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 with comment period.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42
U.S.C. 300aa-26), the Centers for
[[Page 29010]]
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 the proposed updated vaccine information statement for
pneumococcal conjugate vaccine (PCV13).
DATES: Written comments must be received on or before July 20, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0014, 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 (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.
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: Skip Wolfe (crw4@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/.
HHS/CDC is proposing an updated version of the pneumococcal
conjugate vaccine (PCV13) vaccine information statement.
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 entitled ``Pneumococcal Conjugate Vaccine (PCV13): What You
Need to Know.'' A copy of the proposed vaccine information materials is
available at https://www.regulations.gov (see Docket Number CDC-2015-
0014). 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.
Dated: May 15,2015.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2015-12239 Filed 5-19-15; 8:45 am]
BILLING CODE 4163-18-P
