Proposed Revised Vaccine Information Materials for Td, Tdap, Haemophilus influenzae type b, and Rotavirus Vaccines, 36068-36069 [2014-14805]
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36068
Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices
At present, the NYTS is the most
comprehensive source of nationally
representative tobacco data among
students in grades 9–12, moreover, the
NYTS is the only source of such data for
students in grades 6–8. The NYTS has
provided national estimates of tobacco
use behaviors, information about
exposure to pro- and anti-tobacco
influences, information about racial and
ethnic disparities in tobacco-related
topics, and most recently, estimates of
use of emerging products such as water
pipes (hookahs) and electronic
cigarettes (e-cigarettes). Information
collected through the NYTS is used to
identify trends over time, to inform the
development of tobacco cessation
programs for youth, and to evaluate the
effectiveness of existing interventions
and programs.
CDC plans to request OMB approval
to conduct additional cycles of the
NYTS in 2015, 2016, and 2017. The
survey will be conducted among
nationally representative samples of
students attending public and private
youth, it may be necessary in the future
to make additional requests to OMB for
changes in the NYTS instruments to
reflect the varying landscape.
Results of the NYTS will continue to
be used for public health program
planning and evaluation. Information
collected through the NYTS is expected
to provide measures and data for
monitoring progress on one of the 20
tobacco-related objectives for Healthy
People 2020 and serve as
complementary data for five other
tobacco-related objectives.
OMB approval will be requested for
three years. Changes described in the
Revision request include changes to
instrument content, a decrease in the
average annualized number of
respondents, and a decrease in the
average annualized burden hours. There
are no changes in the estimated burden
per response for any type of respondent.
Participation is voluntary and there are
no costs to respondents other than their
time.
schools in grades 6–12, and will be
administered to students as an optically
scannable, eight-page booklet of
multiple-choice questions. Information
supporting the NYTS also will be
collected from state-, district-, and
school-level administrators and
teachers. During the 2015–2017
timeframe, a number of changes will be
incorporated that reflect the
collaboration between CDC and the
Food and Drug Administration that has
been ongoing since 2011 to assist the
agency with measuring progress toward
meeting strategic goals established by
the Family Smoking Prevention and
Tobacco Control Act. The 2015 survey
will examine the following topics: Use
of cigarettes, smokeless tobacco, cigars,
pipes, bidis, snus, hookahs, electronic
vapor products, and dissolvable tobacco
products; knowledge and attitudes;
media and advertising; access to tobacco
products; secondhand smoke exposure;
and cessation. Given the dynamic
nature of the tobacco control
environment, particularly related to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
State Administrators ..........................
Students ............................................
State-level Recruitment Script for
the NYTS.
District-level Recruitment Script for
the NYTS.
School-level Recruitment Script for
the NYTS.
Data Collection Checklist for the
NYTS.
National Youth Tobacco Survey ......
Total ...........................................
...........................................................
District Administrators .......................
School Administrators .......................
Teachers ...........................................
Leroy 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. 2014–14789 Filed 6–24–14; 8:45 am]
30/60
18
150
1
30/60
75
220
1
30/60
110
973
1
15/60
243
20,077
1
45/60
15,058
........................
........................
........................
15,504
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2014–0007]
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
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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
SUMMARY:
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Total burden
hours
1
AGENCY:
VerDate Mar<15>2010
Average
burden per
response
(in hours)
35
Proposed Revised Vaccine Information
Materials for Td, Tdap, Haemophilus
influenzae type b, and Rotavirus
Vaccines
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Number of
responses per
respondent
Sfmt 4703
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
materials for tetanus/diphtheria vaccine
(Td), tetanus/diphtheria and acelullar
pertussis vaccine (Tdap), Haemophilus
influenzae type b (Hib) vaccine, and
rotavirus vaccine.
DATES: Written comments must be
received on or before August 25, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2014–
0007, 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
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Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop A–19, 1600 Clifton
Road NE., Atlanta, Georgia 30333.
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.
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,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:01 Jun 24, 2014
Jkt 232001
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 and copies of the
materials can be found on the CDC Web
site at: https://www.cdc.gov/vaccines/
hcp/vis/.
HHS/CDC is proposing updated
versions of the Td, Tdap, Hib, and
rotavirus vaccine information
statements. We also propose to revise
the August 26, 2013 Instructions for the
Use of Vaccine Information Statements
to include a reference to these vaccine
information materials.
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 ‘‘Td Vaccine: What You Need to
Know;’’ ‘‘Tdap Vaccine: What You Need
to Know;’’ ‘‘Haemophilus influenzae
type b Vaccine: What You need to
Know;’’ and ‘‘Rotavirus Vaccine: What
You Need to Know.’’ Copies of the
proposed vaccine information materials
are available at https://
www.regulations.gov (see Docket
Number CDC–2014–0007). 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.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2014–14805 Filed 6–24–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0120]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 25,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0599. Also
include the FDA 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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Cosmetic Labeling Regulations—21 CFR
Part 701 (OMB Control Number 0910–
0599)—Extension
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) and the Fair
Packaging and Labeling Act (the FPLA)
require that cosmetic manufacturers,
packers, and distributors disclose
information about themselves or their
products on the labels or labeling of
their products. Sections 201, 301, 502,
601, 602, 603, 701, and 704 of the FD&C
Act (21 U.S.C. 321, 331, 352, 361, 362,
363, 371, and 374, respectively) and
sections 4 and 5 of the FPLA (15 U.S.C.
1453 and 1454) provide authority to
FDA to regulate the labeling of cosmetic
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]]>Agencies
[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36068-36069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2014-0007]
Proposed Revised Vaccine Information Materials for Td, Tdap,
Haemophilus influenzae type b, and Rotavirus Vaccines
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 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 materials for tetanus/diphtheria vaccine (Td),
tetanus/diphtheria and acelullar pertussis vaccine (Tdap), Haemophilus
influenzae type b (Hib) vaccine, and rotavirus vaccine.
DATES: Written comments must be received on or before August 25, 2014.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2014-
0007, 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
[[Page 36069]]
Immunization and Respiratory Diseases, Centers for Disease Control and
Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia
30333.
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 and copies of the materials can be found
on the CDC Web site at: https://www.cdc.gov/vaccines/hcp/vis/.
HHS/CDC is proposing updated versions of the Td, Tdap, Hib, and
rotavirus vaccine information statements. We also propose to revise the
August 26, 2013 Instructions for the Use of Vaccine Information
Statements to include a reference to these vaccine information
materials.
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 ``Td Vaccine: What You Need to Know;'' ``Tdap
Vaccine: What You Need to Know;'' ``Haemophilus influenzae type b
Vaccine: What You need to Know;'' and ``Rotavirus Vaccine: What You
Need to Know.'' Copies of the proposed vaccine information materials
are available at https://www.regulations.gov (see Docket Number CDC-
2014-0007). 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.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease
Control and Prevention.
[FR Doc. 2014-14805 Filed 6-24-14; 8:45 am]
BILLING CODE 4163-18-P
