Proposed Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines, 6520-6521 [2016-02395]
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Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices
collects information regarding the
vendor’s preference for delivery ports.
The information is used to evaluate
offers [on the basis of shipment through
the port resulting in the lowest cost to
the Government.
B. Annual Reporting Burden
Respondents: 100.
Responses per Respondent: 4.
Annual Responses: 400.
Hours per Response: 0.25.
Total Burden Hours: 100.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary; whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control Number ‘‘9000–0057,
Evaluation of Export Offers’’ in all
correspondence.
Dated: February 3, 2016.
Lorin S. Curit,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2016–02448 Filed 2–5–16; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. CDC–2016–0015]
Proposed Revised Vaccine Information
Materials for Hepatitis A and Hepatitis
B 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)
SUMMARY:
VerDate Sep<11>2014
17:51 Feb 05, 2016
Jkt 238001
(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 hepatitis A and hepatitis
B vaccines.
DATES: Written comments must be
received on or before April 8, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0015, 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,
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
PO 00000
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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 updated
versions of the hepatitis A and hepatitis
B 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 revised vaccine information
materials entitled ‘‘Hepatitis A Vaccine:
What You Need to Know’’ and
‘‘Hepatitis B Vaccine: What You Need to
Know.’’ Copies of the proposed vaccine
information materials are available at
https://www.regulations.gov (see Docket
Number CDC–2016–0015). Comments
submitted will be considered in
finalizing these materials. When the
final materials are published in the
Federal Register, the notice will include
E:\FR\FM\08FEN1.SGM
08FEN1
6521
Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Notices
an effective date for their mandatory
use.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sandra Cashman,
Executive Secretary, Centers for Disease
Control and Prevention.
Administration for Children and
Families
[FR Doc. 2016–02395 Filed 2–5–16; 8:45 am]
Submission for OMB Review;
Comment Request
BILLING CODE 4163–18–P
Title: Same-sex relationships: Updates
to Healthy Marriage and Relationship
Education.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) will
examine how healthy marriage
programs currently approach, and could
approach, serving sexual minority
populations, that is, lesbian, gay, and
bisexual populations. ACF expects to
collect and analyze data from a range of
information collection efforts—
including interviews with program
administrators, program managers,
healthy marriage and relationship
programming experts, and focus groups
with program applicants and program
attendees—to propose methods and
practices for serving such couples/
individuals/youth.
Respondents: Current program
applicants and participants, program
managers and facilitators, and experts in
the field.
ANNUAL BURDEN ESTIMATES
Total/
annual
number of
respondents
Instrument
(and appendix No.)
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Focus Group Guide for Adult Applicants (Instrument #1) ...............................
Focus Group Guide for Adult Attendees (Instrument #2) ...............................
Focus Group Guide for Youth (Instrument #3) ................................................
Interview Guide with Experts (Instrument #4) .................................................
Interview Guide with Program Managers (Instrument #5) ..............................
Interview Guide with Facilitators (Instrument #6) ............................................
Staff Recruitment Script ...................................................................................
Estimated Annual Burden Hours: 190.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: 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. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2016–02358 Filed 2–5–16; 8:45 am]
BILLING CODE 4184–73–P
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18
36
36
12
10
10
90
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: National Center on Early Head
Start-Child Care Partnerships (NCEHS–
CCP) Evaluation.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) in the
Department of Health and Human
Services (HHS) has awarded 275 Early
Head Start expansion and Early Head
Start–child care partnership grants
(EHS–CCP) in 50 states; Washington,
DC; Puerto Rico; and the Northern
Mariana Islands. These grants will allow
new or existing Early Head Start
programs to partner with local child
care centers and family child care
providers to expand high-quality early
learning opportunities for infants and
toddlers from low-income families.
NCEHS–CCP will support the
effective implementation of new EHS–
CCP grants by disseminating
information through training and
technical assistance (T/TA) and
resources and materials. NCEHS–CCP is
primarily targeted to T/TA providers
working directly with the EHS–CCP
grantees (including Office of Head Start
PO 00000
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Number of
responses per
respondent
1
1
1
1
1
1
1
Average
burden hours
per response
1.5
1.5
1.5
1
1
1
.25
Annual burden
hours
27
54
54
12
10
10
23
(OHS) and Office of Child Care (OCC)
National Centers, regional training and
technical assistance (T/TA) specialists,
and implementation planners and fiscal
consultants). State and federal agencies
(including OHS and OCC federal staff,
Child Care and Development Fund
(CCDF) administrators, Head Start state
and national collaboration office
directors), as well as EHS–CCP grantees
will also find helpful information on
partnerships through NCEHS–CCP’s
resources.
NCEHS–CCP at ZERO TO THREE is
proposing to conduct a descriptive
study of NCEHS–CCP that will provide
information that will document the
activities and progress of NCEHS–CCP
toward its goals and objectives. Findings
from the evaluation will be translated
into action steps to inform continuous
quality improvement of NCEHS–CCP.
The proposed data collection
activities for the descriptive study of
NCEHS–CCP will include the following
components:
• Stakeholder survey. Web-based
surveys will be conducted in the spring
of 2016 and 2018 with key stakeholders
(including regional T/TA specialists,
CCDF administrators, Head Start state
and national collaboration office
directors, and implementation planners
and fiscal consultants). The stakeholder
survey will collect information about
the types of support they received from
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 81, Number 25 (Monday, February 8, 2016)]
[Notices]
[Pages 6520-6521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02395]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2016-0015]
Proposed Revised Vaccine Information Materials for Hepatitis A
and Hepatitis B 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 the proposed
updated vaccine information statements for hepatitis A and hepatitis B
vaccines.
DATES: Written comments must be received on or before April 8, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0015, 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, 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 updated versions of the hepatitis A and
hepatitis B 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 revised vaccine
information materials entitled ``Hepatitis A Vaccine: What You Need to
Know'' and ``Hepatitis B Vaccine: What You Need to Know.'' Copies of
the proposed vaccine information materials are available at https://www.regulations.gov (see Docket Number CDC-2016-0015). Comments
submitted will be considered in finalizing these materials. When the
final materials are published in the Federal Register, the notice will
include
[[Page 6521]]
an effective date for their mandatory use.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-02395 Filed 2-5-16; 8:45 am]
BILLING CODE 4163-18-P
