Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) Vaccine, 23299-23300 [2016-09167]
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Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Type of respondent
IHC focus group ..............................................
Pathology Chairs ............................................
Laboratory Directors .......................................
Laboratory Managers .....................................
Laboratory Supervisors ..................................
Histotechnologists ..........................................
Pathologists ....................................................
Pathology Chairs ............................................
Laboratory Directors .......................................
Laboratory Managers .....................................
Laboratory Supervisors ..................................
Histotechnologists ..........................................
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. 2016–09190 Filed 4–19–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0089]
Final Revised Vaccine Information
Materials for 9-valent HPV (Human
Papillomavirus) 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 October 22, 2015, CDC published a
notice in the Federal Register (80 FR
64002) seeking public comments on
proposed updated vaccine information
materials for 9-valent HPV (Human
Papillomavirus) Gardasil®-9 vaccine.
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 9-valent HPV
Gardasil®-9 vaccine are available to
download from https://www.cdc.gov/
vaccines/hcp/vis/ or https://
www.regulations.gov (see Docket
Number CDC–2015–0089).
DATES: Beginning no later than July 1,
2016, each health care provider who
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SUMMARY:
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administers 9-valent HPV (Human
Papillomavirus) Gardasil®-9 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 March 31, 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
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Number of
responses per
respondent
1
Average
burden per
response
(in hours)
1
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 9-valent HPV (Human
Papillomavirus) Gardasil®-9 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 9-valent
E:\FR\FM\20APN1.SGM
20APN1
23300
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
HPV Gardasil®-9 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–2015–0089). The Vaccine
Information Statement (VIS) is ‘‘HPV
(Human Papillomavirus) Vaccine: What
You Need to Know [Gardasil®-9],’’
publication date March 31, 2016.
With publication of this notice, as of
July 1, 2016, all health care providers
will be required to provide copies of
these updated 9-valent HPVGardasil®-9
vaccine information materials prior to
immunization in conformance with
CDC’s March 31, 2016 Instructions for
the Use of Vaccine Information
Statements.
Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for
Disease Control and Prevention.
[FR Doc. 2016–09167 Filed 4–19–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Community Preventive
Services Task Force
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the
Community Preventive Services Task
Force (Task Force). The Task Force is an
independent, nonpartisan, nonfederal,
and unpaid panel. Its members
represent a broad range of research,
practice, and policy expertise in
prevention, wellness, health promotion,
and public health, and are appointed by
the CDC Director. The Task Force was
convened in 1996 by the Department of
Health and Human Services (HHS) to
identify community preventive
programs, services, and policies that
increase healthy longevity, save lives
and dollars and improve Americans’
quality of life. CDC is mandated to
provide ongoing administrative,
research, and technical support for the
operations of the Task Force. During its
meetings, the Task Force considers the
findings of systematic reviews on
existing research and issues
recommendations. Task Force
recommendations are not mandates for
compliance or spending. Instead, they
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provide information about evidencebased options that decision makers and
stakeholders can consider when
determining what best meets the
specific needs, preferences, available
resources, and constraints of their
jurisdictions and constituents. The Task
Force’s recommendations, along with
the systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
DATES: The meeting will be held on
Wednesday, June 22, 2016 from 8:30
a.m. to 6:00 p.m. EDT and Thursday,
June 23, 2016 from 8:30 a.m. to 1:00
p.m. EDT.
ADDRESSES: The Task Force Meeting
will be held at CDC Edward R. Roybal
Campus, Tom Harkin Global
Communications Center (Building 19),
and 1600 Clifton Road NE., Atlanta, GA
30329. You should be aware that the
meeting location is in a Federal
government building; therefore, Federal
security measures are applicable. For
additional information, please see
Roybal Campus Security Guidelines
under SUPPLEMENTARY INFORMATION.
Information regarding meeting logistics
will be available on the Community
Guide Web site
(www.thecommunityguide.org).
Meeting Accessability: This meeting is
open to the public, limited only by
space availability. All meeting attendees
must RSVP to ensure the required
security procedures are completed to
gain access to the CDC’s Global
Communications Center.
U.S. citizens must RSVP by June 20,
2016.
Non U.S. citizens must RSVP by May
23, 2016 due to additional security steps
that must be completed. Failure to RSVP
by the dates identified could result in
the inability to attend the Task Force
meeting due to the strict security
regulations on federal facilities.
Meeting Accessibility: This meeting is
available to the public via Webcast. The
Webcast URL will be sent to you upon
receipt of your RSVP. All meeting
attendees must RSVP to receive the
webcast information which will be
emailed to you upon receipt of
registration to the CPSTF@cdc.gov
mailbox.
For Further Information and to RSVP
Contact: Onslow Smith, Center for
Surveillance, Epidemiology and
Laboratory Services, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS–E–69, Atlanta, GA 30329,
phone: (404) 498–6778, email: CPSTF@
cdc.gov.
SUPPLEMENTARY INFORMATION:
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Purpose: The purpose of the meeting
is for the Task Force to consider the
findings of systematic reviews and issue
findings and recommendations. Task
Force recommendations provide
information about evidence-based
options that decision makers and
stakeholders can consider when
determining what best meets the
specific needs, preferences, available
resources, and constraints of their
jurisdictions and constituents.
Matters to be discussed: Cancer
prevention and control, cardiovascular
disease prevention and control, diabetes
prevention and control, and increasing
physical activity.
Roybal Campus Security Guidelines:
The Edward R. Roybal Campus is the
headquarters of the U.S. Centers for
Disease Control and Prevention and is
located at 1600 Clifton Road NE.,
Atlanta, Georgia. The meeting is being
held in a Federal government building;
therefore, Federal security measures are
applicable.
All meeting attendees must RSVP by
the dates outlined under Meeting
Accessability. In planning your arrival
time, please take into account the need
to park and clear security. All visitors
must enter the Edward R. Roybal
Campus through the front entrance on
Clifton Road. Your car may be searched,
and the guard force will then direct
visitors to the designated parking area.
Upon arrival at the facility, visitors must
present government issued photo
identification (e.g., a valid federal
identification badge, state driver’s
license, state non-driver’s identification
card, or passport). Non-United States
citizens must complete the required
security paperwork prior to the meeting
date and must present a valid passport,
visa, Permanent Resident Card, or other
type of work authorization document
upon arrival at the facility. All persons
entering the building must pass through
a metal detector. Visitors will be issued
a visitor’s ID badge at the entrance to
Building 19 and may be escorted to the
meeting room. All items brought to
HHS/CDC are subject to inspection.
Dated: April 16, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for
Disease Control and Prevention.
[FR Doc. 2016–09164 Filed 4–19–16; 8:45 am]
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]]>Agencies
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23299-23300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0089]
Final Revised Vaccine Information Materials for 9-valent HPV
(Human Papillomavirus) 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 October 22, 2015, CDC
published a notice in the Federal Register (80 FR 64002) seeking public
comments on proposed updated vaccine information materials for 9-valent
HPV (Human Papillomavirus) Gardasil[supreg]-9 vaccine. 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 9-valent HPV Gardasil[supreg]-9 vaccine are available to
download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0089).
DATES: Beginning no later than July 1, 2016, each health care provider
who administers 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9
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 March 31, 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 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 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 9-valent
[[Page 23300]]
HPV Gardasil[supreg]-9 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-2015-0089). The Vaccine
Information Statement (VIS) is ``HPV (Human Papillomavirus) Vaccine:
What You Need to Know [Gardasil[supreg]-9],'' publication date March
31, 2016.
With publication of this notice, as of July 1, 2016, all health
care providers will be required to provide copies of these updated 9-
valent HPVGardasil[supreg]-9 vaccine information materials prior to
immunization in conformance with CDC's March 31, 2016 Instructions for
the Use of Vaccine Information Statements.
Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-09167 Filed 4-19-16; 8:45 am]
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