Final Revised Vaccine Information Materials for Serogroup B Meningococcal Vaccine, 62136-62137 [2016-21574]

Download as PDF 62136 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices co-trustee of the Jason P. LaFrance GW Investments Trust, and Jason P. LaFrance, Little Rock, Arkansas, as cotrustee of the Jason P. LaFrance GW Investments Trust and as trustee of the Amy Beth LaFrance GW Investments Trust and the Amy LaFrance Bancroft GW Investments Revocable Trust, Little Rock, Arkansas, and Daniel B. Andrews, Sherwood, Arkansas; to acquire voting shares of Greenwoods Financial Group, Inc., Lake Mills, Wisconsin, and thereby join the existing LaFrance Family Control Group that was approved to acquire 10 percent or more of the outstanding shares of Greenwoods Financial Group, Inc. Greenwoods Financial Group, Inc. controls The Greenwood’s State Bank, Lake Mills, Wisconsin. Comments on this application must be received by September 16, 2016. Board of Governors of the Federal Reserve System, September 1, 2016. Robert deV. Frierson, Secretary of the Board. President) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Andrew C. Rector, Fort Worth, Texas, individually; and Andrew C. Rector, Linda Lloyd Rector 2009 Irrevocable Trust, Tracy T. Rector 2009 Irrevocable Trust, Scott Willis Rector 2009 Irrevocable Trust, and Andrew Campbell Rector 2009 Irrevocable Trust, all of Fort Worth, Texas, and Kathy Rector, Azle, Texas, as a group acting in concert, to acquire shares of Horizon Bankshares, Inc., and therefore indirectly The National Bank of Texas at Fort Worth, both of Fort Worth, Texas. Board of Governors of the Federal Reserve System, September 2, 2016. Robert deV. Frierson, Secretary of the Board. [FR Doc. 2016–21596 Filed 9–7–16; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [FR Doc. 2016–21505 Filed 9–7–16; 8:45 am] BILLING CODE 6210–01–P [Docket No. CDC–2015–0059] FEDERAL RESERVE SYSTEM Final Revised Vaccine Information Materials for Serogroup B Meningococcal Vaccine mstockstill on DSK3G9T082PROD with NOTICES Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than September 23, 2016. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Robert Quintana, Las Vegas, New Mexico; to acquire shares of FNB Financial Corporation, and thereby indirectly acquire Community 1st Bank Last Vegas, both of Las Vegas, New Mexico. B. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 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 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for meningococcal ACWY and serogroup B meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for serogroup B meningococcal vaccine. Copies of the final vaccine information materials for serogroup B meningococcal vaccine are available to download from http:// www.cdc.gov/vaccines/hcp/vis/ index.html or http:// www.regulations.gov (see Docket Number CDC–2015–0059). Final updated vaccine information materials for meningococcal ACWY were published in the Federal Register on April 20, 2016 (81 FR 23301). SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Beginning no later than December 1, 2016, each health care provider who administers serogroup B meningococcal 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 August 9, 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 DATES: E:\FR\FM\08SEN1.SGM 08SEN1 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 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. Revised Vaccine Information Materials The serogroup B meningococcal 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 serogroup B meningococcal vaccine have been finalized and are available to download from http://www.cdc.gov/ vaccines/hcp/vis/index.html or http:// www.regulations.gov (see Docket Number CDC–2015–0059). The Vaccine Information Statement (VIS) is ‘‘Serogroup B Meningococcal (MenB) Vaccine: What You Need to Know,’’ publication date August 9, 2016. With publication of this notice, as of December 1, 2016, all health care providers will be required to provide copies of these updated serogroup B meningococcal vaccine information materials prior to immunization in conformance with CDC’s August 9, 2016 Instructions for the Use of Vaccine Information Statements. Dated: September 1, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. mstockstill on DSK3G9T082PROD with NOTICES [FR Doc. 2016–21574 Filed 9–7–16; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 19:34 Sep 07, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2015–0029] Final Revised Vaccine Information Materials for Polio 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 March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from http://www.cdc.gov/ vaccines/hcp/vis/index.html or http:// www.regulations.gov (see Docket Number CDC–2015–0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed. DATES: Beginning no later than November 1, 2016, each health care provider who administers polio 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 August 9, 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 SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 62137 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. Revised Vaccine Information Materials The polio 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. E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62136-62137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0059]


Final Revised Vaccine Information Materials for Serogroup B 
Meningococcal 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 14, 2015, CDC 
published a notice in the Federal Register (80 FR 61819) seeking public 
comments on proposed updated vaccine information materials for 
meningococcal ACWY and serogroup B meningococcal vaccines. Following 
review of comments submitted and consultation as required under the 
law, CDC has finalized the materials for serogroup B meningococcal 
vaccine. Copies of the final vaccine information materials for 
serogroup B meningococcal vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov 
(see Docket Number CDC-2015-0059). Final updated vaccine information 
materials for meningococcal ACWY were published in the Federal Register 
on April 20, 2016 (81 FR 23301).

DATES: Beginning no later than December 1, 2016, each health care 
provider who administers serogroup B meningococcal 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 August 9, 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

[[Page 62137]]

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.

Revised Vaccine Information Materials

    The serogroup B meningococcal 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 serogroup B meningococcal vaccine have 
been finalized and are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket 
Number CDC-2015-0059). The Vaccine Information Statement (VIS) is 
``Serogroup B Meningococcal (MenB) Vaccine: What You Need to Know,'' 
publication date August 9, 2016.
    With publication of this notice, as of December 1, 2016, all health 
care providers will be required to provide copies of these updated 
serogroup B meningococcal vaccine information materials prior to 
immunization in conformance with CDC's August 9, 2016 Instructions for 
the Use of Vaccine Information Statements.

    Dated: September 1, 2016.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-21574 Filed 9-7-16; 8:45 am]
 BILLING CODE 4163-18-P