Proposed Revised Vaccine Information Materials for Meningococcal ACWY and DTaP (Diphtheria, Tetanus, Pertussis) Vaccines, 49929-49930 [2018-21491]

Download as PDF Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices indirectly acquire American Bank of Commerce, both of Provo, Utah. DEPARTMENT OF HEALTH AND HUMAN SERVICES Board of Governors of the Federal Reserve System, September 28, 2018. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2018–21544 Filed 10–2–18; 8:45 am] FEDERAL RESERVE SYSTEM Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 October 15, 2018. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Breck C. Collingsworth, Lincoln, Nebraska, individually and as part of a group acting in concert with Susan Chrastil, Crete, Nebraska; to acquire voting shares of TCM Company, Crete, Nebraska, and thereby indirectly acquire shares of City Bank & Trust Co., Lincoln, Nebraska. Board of Governors of the Federal Reserve System, September 28, 2018. Yao-Chin Chao, Assistant Secretary of the Board. daltland on DSKBBV9HB2PROD with NOTICES BILLING CODE 6210–01–P VerDate Sep<11>2014 18:05 Oct 02, 2018 Jkt 247001 [Docket No. CDC–2018–0091] Proposed Revised Vaccine Information Materials for Meningococcal ACWY and DTaP (Diphtheria, Tetanus, Pertussis) Vaccines BILLING CODE 6210–01–P [FR Doc. 2018–21543 Filed 10–2–18; 8:45 am] Centers for Disease Control and Prevention Under the National Childhood Vaccine Injury Act (NCVIA), 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 meningococcal ACWY and DTaP (diphtheria, tetanus, acellular pertussis) vaccines. DATES: Written comments must be received on or before December 3, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC–2018– 0091, 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 (VISComments@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. 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, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A–19, 1600 Clifton Road NE, Atlanta, Georgia 30329; VISComments@cdc.gov. SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99–660), as amended by section 708 of Public Law 103–183, SUMMARY: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 49929 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 patient’s parent or legal representative in the case the patient is 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 provision of vaccine information materials before vaccine administration 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 website at: https://www.cdc.gov/ vaccines/hcp/vis/. CDC is proposing updated versions of the meningococcal ACWY and DTaP E:\FR\FM\03OCN1.SGM 03OCN1 49930 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices (diphtheria, tetanus, acellular pertussis) vaccine information statements. Changes to the meningococcal ACWY VIS are minimal. Reference to the MPSV4 vaccine, no longer available in the United States, is removed. HIV infection is added as an indication for vaccination, and wording related to meningococcal ACWY vaccination during pregnancy is updated. Proposed revisions to the DTaP VIS reflect new recommendations of the Advisory Committee on Immunization Practices (ACIP), including updated information about contraindications and precautions. Minor changes are proposed to simplify and streamline the sections about what to do if there is a reaction and finding additional information about the vaccine and the Vaccine Injury Compensation Program. The most recent previous final version of the DTaP VIS was published in 2007; proposed revisions to this document will help to bring it in line with the structure and general approach of more recently-published VISs for other vaccines. 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 ‘‘Meningococcal ACWY Vaccine: What You Need to Know’’ and ‘‘DTaP (Diphtheria, Tetanus, Pertussis) Vaccine: What You Need to Know.’’ Copies of the proposed vaccine information materials are available at https://www.regulations.gov (see Docket Number CDC–2018–0091). 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: September 27, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. daltland on DSKBBV9HB2PROD with NOTICES [FR Doc. 2018–21491 Filed 10–2–18; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 18:05 Oct 02, 2018 Jkt 247001 U.S.C. 552a) provides certain protections for individuals applying for and receiving federal benefits. The law Centers for Medicare & Medicaid governs the use of computer matching Services by federal agencies when records in a system of records (meaning, federal Privacy Act of 1974; Matching Program agency records about individuals retrieved by name or other personal AGENCY: Centers for Medicare & identifier) are matched with records of Medicaid Services, Department of other federal or non-federal agencies. Health and Human Services. The Privacy Act requires agencies ACTION: Notice of a new matching involved in a matching program to: program. 1. Enter into a written agreement, SUMMARY: In accordance with subsection which must be prepared in accordance (e)(12) of the Privacy Act of 1974, as with the Privacy Act, approved by the amended, the Department of Health and Data Integrity Board of each source and Human Services (HHS), Centers for recipient federal agency, provided to Medicare & Medicaid Services (CMS) is Congress and the Office of Management providing notice of a new matching and Budget (OMB), and made available program between CMS and the to the public, as required by 5 U.S.C. Department of Veterans Affairs (VA), 552a(o), (u)(3)(A), and (u)(4). Veterans Health Administration (VHA), 2. Notify the individuals whose ‘‘Verification of Eligibility for Minimum information will be used in the Essential Coverage Under the Patient matching program that the information Protection and Affordable Care Act they provide is subject to verification Through a Veterans Health through matching, as required by 5 Administration Plan.’’ U.S.C. 552a(o)(1)(D). 3. Verify match findings before DATES: The deadline for comments on this notice is November 2, 2018. The re- suspending, terminating, reducing, or making a final denial of an individual’s established matching program will commence not sooner than 30 days after benefits or payments or taking other adverse action against the individual, as publication of this notice, provided no required by 5 U.S.C. 552a(p). comments are received that warrant a 4. Report the matching program to change to this notice. The matching program will be conducted for an initial Congress and the OMB, in advance and annually, as required by 5 U.S.C. term of 18 months (from approximately 552a(o) (2)(A)(i), (r), and (u)(3)(D). October 2018 to April 2020) and within 5. Publish advance notice of the 3 months of expiration may be renewed matching program in the Federal for one additional year if the parties Register as required by 5 U.S.C. make no change to the matching 552a(e)(12). program and certify that the program This matching program meets these has been conducted in compliance with requirements. the matching agreement. ADDRESSES: Interested parties may Barbara Demopulos, submit written comments to: CMS CMS Privacy Advisor, Division of Security, Privacy Act Officer, Division of Privacy Policy and Governance, Information Security, Privacy Policy & Governance, Security and Privacy Group, Office of Information Security & Privacy Group, Information Technology, Centers for Medicare Office of Information Technology, CMS, & Medicaid Services. 7500 Security Blvd., Baltimore, MD Participating Agencies 21244–1870, Mailstop: N3–15–25, or by The Department of Health and Human email to: walter.stone@cms.hhs.gov. Comments received will be available for Services (HHS), Centers for Medicare & review at this location, by appointment, Medicaid Services (CMS) is the recipient agency, and the Department of during regular business hours, Monday Veterans Affairs (VA), Veterans Health through Friday from 9:00 a.m. to 3:00 Administration (VHA) is the source p.m. agency. FOR FURTHER INFORMATION CONTACT: If Authority for Conducting the Matching you have questions about the matching Program program, you may contact Jack Lavelle, Senior Advisor, Marketplace Eligibility The statutory authority for the and Enrollment Group, Center for matching program is 42 U.S.C. 18001. Consumer Information and Insurance Purpose(s) Oversight, CMS, 7501 Wisconsin Ave., Bethesda, MD 20814, (410) 786–0639, or The purpose of the matching program by email at Jack.Lavelle1@cms.hhs.gov. is to assist CMS in determining SUPPLEMENTARY INFORMATION: The individuals’ eligibility for financial Privacy Act of 1974, as amended (5 assistance in paying for private health DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49929-49930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21491]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2018-0091]


Proposed Revised Vaccine Information Materials for Meningococcal 
ACWY and DTaP (Diphtheria, Tetanus, Pertussis) 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), 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 meningococcal ACWY and DTaP (diphtheria, tetanus, 
acellular pertussis) vaccines.

DATES: Written comments must be received on or before December 3, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0091, 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 ([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 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, National Center for 
Immunization and Respiratory Diseases, Centers for Disease Control and 
Prevention, Mailstop A-19, 1600 Clifton Road NE, Atlanta, Georgia 
30329; [email protected].

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 patient's parent or legal representative in the 
case the patient is 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 provision of 
vaccine information materials before vaccine administration 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 website at: https://www.cdc.gov/vaccines/hcp/vis/.
    CDC is proposing updated versions of the meningococcal ACWY and 
DTaP

[[Page 49930]]

(diphtheria, tetanus, acellular pertussis) vaccine information 
statements.
    Changes to the meningococcal ACWY VIS are minimal. Reference to the 
MPSV4 vaccine, no longer available in the United States, is removed. 
HIV infection is added as an indication for vaccination, and wording 
related to meningococcal ACWY vaccination during pregnancy is updated.
    Proposed revisions to the DTaP VIS reflect new recommendations of 
the Advisory Committee on Immunization Practices (ACIP), including 
updated information about contraindications and precautions. Minor 
changes are proposed to simplify and streamline the sections about what 
to do if there is a reaction and finding additional information about 
the vaccine and the Vaccine Injury Compensation Program. The most 
recent previous final version of the DTaP VIS was published in 2007; 
proposed revisions to this document will help to bring it in line with 
the structure and general approach of more recently-published VISs for 
other vaccines.
    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 ``Meningococcal ACWY Vaccine: What You Need to 
Know'' and ``DTaP (Diphtheria, Tetanus, Pertussis) Vaccine: What You 
Need to Know.'' Copies of the proposed vaccine information materials 
are available at https://www.regulations.gov (see Docket Number CDC-
2018-0091). 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: September 27, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-21491 Filed 10-2-18; 8:45 am]
 BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.