Final Revised Vaccine Information Materials for Seasonal Influenza Vaccines, 60149-60150 [2015-25159]
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60149
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Safety and Health Managers ..........................
Occupational Safety and Health Program
Survey.
Informed Consent Form .................................
Non Responder Interview ..............................
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. 2015–25194 Filed 10–2–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Initial review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting for the initial
review of applications in response to
Funding Opportunity Announcement
(FOA) PS16–001, Minority HIV/AIDS
Research Initiative (MARI) to Build HIV
Prevention Treatment and Research
Capacity in Disproportionately Affected
Black and Hispanic Communities and
Among Historically Underrepresented
Researchers.
DATES: 10:00 a.m.–5:00 p.m., December
9–10, 2015 (Closed).
ADDRESSES: Teleconference.
FOR FURTHER INFORMATION CONTACT:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
CDC, 1600 Clifton Road NE., Mailstop
E60, Atlanta, Georgia 30333, Telephone:
(404) 718–8833.
SUPPLEMENTARY INFORMATION:
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
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18:34 Oct 02, 2015
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applications received in response to
‘‘Minority HIV/AIDS Research Initiative
(MARI) to Build HIV Prevention
Treatment and Research Capacity in
Disproportionately Affected Black and
Hispanic Communities and Among
Historically Underrepresented
Researchers’’, FOA PS16–001.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2015–25274 Filed 10–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2015–0016]
Final Revised Vaccine Information
Materials for Seasonal Influenza
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 HHS/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 May 20, 2015, CDC
published a notice in the Federal
Register (80 FR 29009) seeking public
comments on proposed new vaccine
information materials for inactivated
and live attenuated influenza vaccines.
Following review of comments
submitted and consultation as required
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
4,404
1
20/60
4,404
792
1
1
2/60
5/60
under the law, CDC has finalized the
materials. Copies of the final vaccine
information materials for inactivated
and live attenuated influenza vaccines
are available to download from https://
www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2015–0016).
DATES: Beginning no later than March 1,
2016, each health care provider who
administers any seasonal influenza
vaccine to any child or adult in the
United States shall provide copies of the
relevant revised vaccine information
materials contained in this notice, in
conformance with the August 7, 2015
CDC Instructions for the Use of Vaccine
Information Statements prior to
providing such vaccinations. These
revised vaccine information materials
may also be used earlier than that date.
Prior to March 1, 2016, the previous
edition of these two VISs can be used.
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
E:\FR\FM\05OCN1.SGM
05OCN1
60150
Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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 revised inactivated and live
attenuated influenza 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
inactivated and live attenuated
influenza vaccine have been finalized
and are available to download from
https://www.cdc.gov/vaccines/hcp/vis/
index.html or https://
www.regulations.gov (see Docket
Number CDC–2015–0016). The Vaccine
Information Statements (VIS), are:
‘‘Influenza (Flu) Vaccine (Inactivated or
Recombinant): What you need to know’’
(publication date August 7, 2015) and
VerDate Sep<11>2014
18:34 Oct 02, 2015
Jkt 238001
‘‘Influenza (Flu) Vaccine (Live,
Intranasal): What you need to know’’
(publication date August 7, 2015).
With publication of this notice, as of
March 1, 2016, all health care providers
will be required to provide copies of
these updated inactivated and live
attenuated influenza vaccine
information materials prior to
immunization in conformance with
HHS/CDC’s August 7, 2015 Instructions
for the Use of Vaccine Information
Statements. Prior to that date, the
previous edition of these two VISs can
be used.
Centers for Medicare & Medicaid
Services
When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395 –5806 or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
[Document Identifier: CMS–10565]
SUPPLEMENTARY INFORMATION:
Dated: September 29, 2015.
Sandra Cashman,
Acting Director, Division of the Executive
Secretariat, Office of the Chief of Staff,
Centers for Disease Control and Prevention.
[FR Doc. 2015–25159 Filed 10–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by November 4, 2015.
SUMMARY:
PO 00000
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ADDRESSES:
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Off-cycle
Submission of Summaries of Model of
Care Changes; Use: All Medicare
Advantage (MA) Special Needs Plans
(SNPs) must be approved by the
National Committee for Quality
Assurance (NCQA). The SNPs must
submit Models of Care (MOC) as a
component of the Medicare Advantage
application process. Approval is based
E:\FR\FM\05OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60149-60150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0016]
Final Revised Vaccine Information Materials for Seasonal
Influenza 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 HHS/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 May
20, 2015, CDC published a notice in the Federal Register (80 FR 29009)
seeking public comments on proposed new vaccine information materials
for inactivated and live attenuated influenza 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 inactivated and live attenuated influenza
vaccines are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number
CDC-2015-0016).
DATES: Beginning no later than March 1, 2016, each health care provider
who administers any seasonal influenza vaccine to any child or adult in
the United States shall provide copies of the relevant revised vaccine
information materials contained in this notice, in conformance with the
August 7, 2015 CDC Instructions for the Use of Vaccine Information
Statements prior to providing such vaccinations. These revised vaccine
information materials may also be used earlier than that date. Prior to
March 1, 2016, the previous edition of these two VISs can be used.
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
[[Page 60150]]
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 revised inactivated and live attenuated influenza 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 inactivated and live
attenuated influenza 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-2015-0016). The Vaccine
Information Statements (VIS), are: ``Influenza (Flu) Vaccine
(Inactivated or Recombinant): What you need to know'' (publication date
August 7, 2015) and ``Influenza (Flu) Vaccine (Live, Intranasal): What
you need to know'' (publication date August 7, 2015).
With publication of this notice, as of March 1, 2016, all health
care providers will be required to provide copies of these updated
inactivated and live attenuated influenza vaccine information materials
prior to immunization in conformance with HHS/CDC's August 7, 2015
Instructions for the Use of Vaccine Information Statements. Prior to
that date, the previous edition of these two VISs can be used.
Dated: September 29, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-25159 Filed 10-2-15; 8:45 am]
BILLING CODE 4163-18-P
