80 FR 29009 - Proposed Revised Vaccine Information Materials for Seasonal Influenza Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 97 (May 20, 2015)

Page Range		29009-29009
FR Document		2015-12240

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.

Federal Register, Volume 80 Issue 97 (Wednesday, May 20, 2015)

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Page 29009]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12240]


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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

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 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: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Written comments should be addressed to Suzanne 
Johnson-DeLeon ([email protected]), 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 http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Skip Wolfe ([email protected]), 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: http://www.cdc.gov/vaccines/hcp/vis/index.html.
    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 http://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

Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices 29009

enhance the quality, utility, and clarity received will be posted without change administration of any of these vaccines.
of the information to be collected; and to http://regulations.gov, including any Since then, the following vaccines have
(d) ways to minimize the burden of the personal information provided. For been added to the National Vaccine
collection of information upon the access to the docket to read background Injury Compensation Program, requiring
respondents, including the use of documents or comments received, go to use of vaccine information materials for
automated collection techniques or http://www.regulations.gov. them as well: Hepatitis B, Haemophilus
other forms of information technology. FOR FURTHER INFORMATION CONTACT: Skip influenzae type b (Hib), varicella
Comments submitted in response to Wolfe (crw4@cdc.gov), National Center (chickenpox), pneumococcal conjugate,
this notice will be summarized and for Immunization and Respiratory rotavirus, hepatitis A, meningococcal,
included in the Agency’s subsequent Diseases, Centers for Disease Control human papillomavirus (HPV), and
request for OMB approval of the and Prevention, Mailstop A–19, 1600 seasonal influenza vaccines.
proposed information collection. All Clifton Road NE., Atlanta, Georgia Instructions for use of the vaccine
comments will become a matter of 30329. information materials are found on the
public record. CDC Web site at: http://www.cdc.gov/
SUPPLEMENTARY INFORMATION: The vaccines/hcp/vis/index.html.
Sharon B. Arnold, National Childhood Vaccine Injury Act HHS/CDC is proposing updated
Deputy Director. of 1986 (Pub. L. 99–660), as amended by versions of the inactivated and live
[FR Doc. 2015–12229 Filed 5–19–15; 8:45 am] section 708 of Public Law 103–183, attenuated seasonal influenza vaccine
BILLING CODE 4160–90–P added section 2126 to the Public Health information statements.
Service Act. Section 2126, codified at 42 The vaccine information materials
U.S.C. 300aa-26, requires the Secretary referenced in this notice are being
DEPARTMENT OF HEALTH AND of Health and Human Services to developed in consultation with the
HUMAN SERVICES develop and disseminate vaccine Advisory Commission on Childhood
information materials for distribution by Vaccines, the Food and Drug
Centers for Disease Control and all health care providers in the United Administration, and parent and health
Prevention States to any patient (or to the parent or care provider groups.
[Docket No. CDC–2015–0016] legal representative in the case of a We invite written comment on the
child) receiving vaccines covered under proposed vaccine information materials
Proposed Revised Vaccine Information the National Vaccine Injury entitled ‘‘Influenza (Flu) Vaccine
Materials for Seasonal Influenza Compensation Program (VICP). (Inactivated or Recombinant): What you
Vaccines Development and revision of the need to know’’ and ‘‘Influenza (Flu)
vaccine information materials, also Vaccine (Live, Intranasal): What you
AGENCY: Centers for Disease Control and known as Vaccine Information need to know.’’ Copies of the proposed
Prevention (CDC), Department of Health Statements (VIS), have been delegated vaccine information materials are
and Human Services (HHS). by the Secretary to the Centers for available at http://www.regulations.gov
ACTION: Notice with comment period. Disease Control and Prevention (CDC). (see Docket Number CDC–2015–0016).
Section 2126 requires that the materials Comments submitted will be considered
SUMMARY: Under the National be developed, or revised, after notice to
Childhood Vaccine Injury Act (NCVIA) in finalizing these materials. When the
the public, with a 60-day comment final materials are published in the
(42 U.S.C. 300aa–26), the Centers for period, and in consultation with the
Disease Control and Prevention (CDC) Federal Register, the notice will include
Advisory Commission on Childhood an effective date for their mandatory
within the Department of Health and Vaccines, appropriate health care
Human Services (HHS) develops use.
provider and parent organizations, and Dated: May 14, 2015.
vaccine information materials that all the Food and Drug Administration. The
health care providers are required to law also requires that the information
Ron A. Otten,
give to patients/parents prior to contained in the materials be based on Acting Deputy Associate Director for Science,
administration of specific vaccines. available data and information, be
Centers for Disease Control and Prevention.
HHS/CDC seeks written comment on the presented in understandable terms, and [FR Doc. 2015–12240 Filed 5–19–15; 8:45 am]
proposed updated vaccine information include: BILLING CODE 4163–18–P
statements for inactivated and live (1) A concise description of the
attenuated influenza vaccines. benefits of the vaccine,
DATES: Written comments must be (2) A concise description of the risks DEPARTMENT OF HEALTH AND
received on or before July 20, 2015. associated with the vaccine, HUMAN SERVICES
ADDRESSES: You may submit comments, (3) A statement of the availability of Centers for Disease Control and
identified by Docket No. CDC–2015– the National Vaccine Injury Prevention
0016, by any of the following methods: Compensation Program, and
• Federal eRulemaking Portal: http:// (4) Such other relevant information as [Docket No. CDC–2015–0014]
www.regulations.gov. Follow the may be determined by the Secretary.
instructions for submitting comments. The vaccines initially covered under Proposed Revised Vaccine Information
• Mail: Written comments should be the National Vaccine Injury Materials for Pneumococcal Conjugate
addressed to Suzanne Johnson-DeLeon Compensation Program were diphtheria, Vaccine (PCV13)
mstockstill on DSK4VPTVN1PROD with NOTICES

(msj1@cdc.gov), National Center for tetanus, pertussis, measles, mumps, AGENCY: Centers for Disease Control and
Immunization and Respiratory Diseases, rubella and poliomyelitis vaccines. Prevention (CDC), Department of Health
Centers for Disease Control and Since April 15, 1992, any health care and Human Services (HHS).
Prevention, Mailstop A–19, 1600 Clifton provider in the United States who ACTION: Notice with comment period.
Road NE., Atlanta, Georgia 30329. intends to administer one of these
Instructions: All submissions received covered vaccines is required to provide SUMMARY: Under the National
must include the agency name and copies of the relevant vaccine Childhood Vaccine Injury Act (NCVIA)
docket number. All relevant comments information materials prior to (42 U.S.C. 300aa–26), the Centers for

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Document Created: 2018-02-21 10:29:14
Document Modified: 2018-02-21 10:29:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before July 20, 2015.
Contact		Skip Wolfe ([email protected]), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329.
FR Citation		80 FR 29009

80 FR 29009 - Proposed Revised Vaccine Information Materials for Seasonal Influenza Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 97 (May 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention