83_FR_11587 83 FR 11536 - Final Revised Vaccine Information Materials for Varicella Vaccine

83 FR 11536 - Final Revised Vaccine Information Materials for Varicella Vaccine

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

Federal Register Volume 83, Issue 51 (March 15, 2018)

Page Range11536-11537
FR Document2018-05298

Under the National Childhood Vaccine Injury Act (NCVIA), 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 varicella vaccine. Copies of the final vaccine information materials for varicella vaccine are available to download from http:// www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2016-0029).

Federal Register, Volume 83 Issue 51 (Thursday, March 15, 2018) 
[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11536-11537]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05298]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0029]


Final Revised Vaccine Information Materials for Varicella 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), 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 varicella vaccine. Copies of the final vaccine information 
materials for varicella vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov 
(see Docket Number CDC-2016-0029).

DATES: Beginning no later than June 1, 2018, each health care provider 
who administers varicella vaccine to any child or adult in the United 
States shall provide copies of the relevant vaccine information 
materials referenced in this notice, dated February 12, 2018, in 
conformance with the February 23, 2018 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

[[Page 11537]]

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 website at: http://www.cdc.gov/vaccines/hcp/vis/index.html.

Revised Vaccine Information Materials

    The varicella 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 
varicella 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-2016-0029). The Vaccine 
Information Statement (VIS) is ``Varicella (Chickenpox) Vaccine: What 
You Need to Know,'' publication date February 12, 2018.
    With publication of this notice, by June 1, 2018, all health care 
providers must discontinue use of the previous edition and provide 
copies of these updated varicella vaccine information materials prior 
to immunization in conformance with CDC's February 23, 2018 
Instructions for the Use of Vaccine Information Statements.

    Dated: March 12, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-05298 Filed 3-14-18; 8:45 am]
 BILLING CODE 4163-18-P

11536 Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices from the 9/11 terrorist attacks. Thus, the produce tangible outputs such as groups will each consist of a well- CDC seeks a one-year OMB approval to research findings on WTC-related defined stakeholder group, and will last collect information using focus groups. conditions, healthcare protocols, peer- approximately two hours. The WTCHP employs the Research-to- reviewed publications, quality These focus groups are necessary to Care (RTC) model strategic framework assessment reports, and member and gather background information on the employed to prioritize, conduct, and provider education products. Finally, relationship between different assess research that informs excellence the model anticipates short-, stakeholders and the WTCHP that will in clinical care for the population of intermediate-, and long-term inform the development of more responders and survivors affected by the measurement of outcomes and serves as detailed interview protocols to be used 9/11 attack in New York City. The RTC a communication tool for program with stakeholders in the next phase of model assumes the collective planning and evaluation. this evaluation. Specific topics to be involvement of WTCHP stakeholders, In 2016, NIOSH contracted with the addressed in the focus groups will including members, researchers, Research and Development (RAND) include: clinicians, and program administrators. Corporation to evaluate the WTCHP • Conceptualizations of research and It accounts for a variety of inputs that RTC model including the research ‘‘translational research.’’ can affect the progress and impact of investments to date and the • Relevance of WTCHP research WTCHP research. These inputs include effectiveness with which the Program topics, potential gaps, and stakeholder people and organizations (e.g., program translates its research to different priorities. members, providers, clinical centers of stakeholder groups. This work will excellence, extramural researchers, and ultimately provide guidance for the • Uses and usefulness of WTCHP program staff), resources (e.g., WTCHP on strategic directions, as well research. technology, data centers, the NYC 9/11 as produce generalizable knowledge • Barriers to conduct and use of Health Registry) and regulatory rules, about the translation of research into WTCHP research. principally the Zadroga Act. improved outcomes for individuals and • Understanding of and perspectives The program supports activities such populations exposed to disasters such as on the relevance and usefulness of the as research prioritization, conduct of the 9/11 attacks. In the formative stage Research-to-Care model. research, delivery of medical care, and of our assessment, we propose to hold The total estimated burden hours is iterative assessments of the translation a series of focus groups with different 360. There are no costs to the of research to improvements in health stakeholder groups to explore their respondent other than their time and care services and chronic disease perspectives on translational research in local travel to the location of the focus management. These activities aim to the context of the WTCHP. The focus group. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Total Number of burden per Type of respondents Form name responses per burden respondents response respondent (in hours) (in hours) WTCH Researchers ............................ Focus Group Protocol ........................ 40 1 3 120 WTCH Research Users ...................... Focus Group Protocol ........................ 70 1 3 210 WTCH Funders (NIOSH) .................... Focus Group Protocol ........................ 10 1 3 30 Total ............................................. ............................................................. ........................ ........................ ........................ 360 Leroy A. Richardson, SUMMARY: Under the National DATES: Beginning no later than June 1, Chief, Information Collection Review Office, Childhood Vaccine Injury Act (NCVIA), 2018, each health care provider who Office of Scientific Integrity, Office of the CDC must develop vaccine information administers varicella vaccine to any Associate Director for Science, Office of the materials that all health care providers child or adult in the United States shall Director, Centers for Disease Control and provide copies of the relevant vaccine Prevention. are required to give to patients/parents prior to administration of specific information materials referenced in this [FR Doc. 2018–05242 Filed 3–14–18; 8:45 am] notice, dated February 12, 2018, in vaccines. On March 15, 2016, CDC BILLING CODE 4163–18–P published a notice in the Federal conformance with the February 23, 2018 Register (81 FR 13794) seeking public CDC Instructions for the Use of Vaccine comments on proposed updated vaccine Information Statements prior to DEPARTMENT OF HEALTH AND providing such vaccinations. HUMAN SERVICES information materials for polio vaccine and varicella vaccine. Following review FOR FURTHER INFORMATION CONTACT: Centers for Disease Control and of comments submitted and Suzanne Johnson-DeLeon (msj1@ Prevention consultation as required under the law, cdc.gov), National Center for CDC has finalized the materials for Immunization and Respiratory Diseases, [Docket No. CDC–2016–0029] varicella vaccine. Copies of the final Centers for Disease Control and sradovich on DSK3GMQ082PROD with NOTICES Final Revised Vaccine Information vaccine information materials for Prevention, Mailstop A–19, 1600 Clifton Materials for Varicella Vaccine varicella vaccine are available to Road NE, Atlanta, Georgia 30329. download from http://www.cdc.gov/ SUPPLEMENTARY INFORMATION: The AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health vaccines/hcp/vis/index.html or http:// National Childhood Vaccine Injury Act and Human Services (HHS). www.regulations.gov (see Docket of 1986 (Pub. L. 99–660), as amended by Number CDC–2016–0029). section 708 of Public Law 103–183, ACTION: Notice. added section 2126 to the Public Health VerDate Sep<11>2014 17:34 Mar 14, 2018 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1

Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices 11537 Service Act. Section 2126, codified at 42 developed in consultation with the • ADDRESSES: U.S.C. 300aa–26, requires the Secretary Advisory Commission on Childhood • FOR FURTHER INFORMATION of Health and Human Services to Vaccines, the Food and Drug CONTACT: develop and disseminate vaccine Administration, and parent and • SUPPLEMENTARY INFORMATION: information materials for distribution by healthcare provider organizations. • BACKGROUND: all health care providers in the United Following consultation and review of DATES: Electronic or written comments States to any patient (or to the parent or comments submitted, the vaccine must be received by May 14, 2018. legal representative in the case of a information materials covering varicella ADDRESSES: You may submit comments, child) receiving vaccines covered under vaccine have been finalized and are identified by CDC–2018–0024 and the National Vaccine Injury available to download from http:// docket number NIOSH–302, by any of Compensation Program (VICP). www.cdc.gov/vaccines/hcp/vis/ the following methods: Development and revision of the index.html or http:// • Federal eRulemaking Portal: vaccine information materials, also www.regulations.gov (see Docket https://www.regulations.gov Follow the known as Vaccine Information Number CDC–2016–0029). The Vaccine instructions for submitting comments. Statements (VIS), have been delegated Information Statement (VIS) is • Mail: National Institute for by the Secretary to the Centers for ‘‘Varicella (Chickenpox) Vaccine: What Occupational Safety and Health, NIOSH Disease Control and Prevention (CDC). You Need to Know,’’ publication date Docket Office, 1090 Tusculum Avenue, Section 2126 requires that the materials February 12, 2018. MS C–34, Cincinnati, Ohio 45226–1998. be developed, or revised, after notice to With publication of this notice, by Instructions: All submissions received the public, with a 60-day comment June 1, 2018, all health care providers in response to this notice must include period, and in consultation with the must discontinue use of the previous the agency name and docket number Advisory Commission on Childhood edition and provide copies of these [CDC–2018–0024; NIOSH–302]. All Vaccines, appropriate health care updated varicella vaccine information relevant comments received will be provider and parent organizations, and materials prior to immunization in posted without change to https:// the Food and Drug Administration. The conformance with CDC’s February 23, www.regulations.gov, including any law also requires that the information 2018 Instructions for the Use of Vaccine personal information provided. For contained in the materials be based on Information Statements. access to the docket to read background available data and information, be Dated: March 12, 2018. documents or comments received, go to presented in understandable terms, and https://www.regulations.gov. All Sandra Cashman, include: information received in response to this (1) A concise description of the Executive Secretary, Centers for Disease Control and Prevention. notice will also be available for public benefits of the vaccine, examination and copying at the NIOSH (2) A concise description of the risks [FR Doc. 2018–05298 Filed 3–14–18; 8:45 am] Docket Office, 1150 Tusculum Avenue, associated with the vaccine, BILLING CODE 4163–18–P Room 155, Cincinnati, OH 45226–1998. (3) A statement of the availability of FOR FURTHER INFORMATION CONTACT: the National Vaccine Injury DEPARTMENT OF HEALTH AND Emily Novicki NORACoordinator@ Compensation Program, and (4) Such other relevant information as HUMAN SERVICES cdc.gov), National Institute for may be determined by the Secretary. Occupational Safety and Health, Centers The vaccines initially covered under Centers for Disease Control and for Disease Control and Prevention, the National Vaccine Injury Prevention Mailstop E–20, 1600 Clifton Road NE, Compensation Program were diphtheria, [Docket Number CDC–2018–0024, NIOSH– Atlanta, GA 30329, phone (404) 498– tetanus, pertussis, measles, mumps, 302] 2581 (not a toll free number). rubella, and poliomyelitis vaccines. SUPPLEMENTARY INFORMATION: The Since April 15, 1992, any health care Draft—National Occupational Research National Occupational Research Agenda provider in the United States who Agenda for Respiratory Health (NORA) is a partnership program intends to administer one of these AGENCY: National Institute for created to stimulate innovative research covered vaccines is required to provide Occupational Safety and Health and improved workplace practices. The copies of the relevant vaccine (NIOSH) of the Centers for Disease national agenda is developed and information materials prior to Control and Prevention (CDC), implemented through the NORA sector administration of any of these vaccines. Department of Health and Human and cross-sector councils. Each council Since then, the following vaccines have Services (HHS). develops and maintains an agenda for been added to the National Vaccine its sector or cross-sector. ACTION: Request for comment. Injury Compensation Program, requiring Background: The National use of vaccine information materials for SUMMARY: The National Institute for Occupational Research Agenda for them as well: Hepatitis B, Haemophilus Occupational Safety and Health of the Respiratory Health is intended to influenzae type b (Hib), varicella Centers for Disease Control and identify the research, information, and (chickenpox), pneumococcal conjugate, Prevention announces the availability of actions most urgently needed to prevent rotavirus, hepatitis A, meningococcal, a draft NORA Agenda entitled National occupational injuries. The National human papillomavirus (HPV), and Occupational Research Agenda for Occupational Research Agenda for seasonal influenza vaccines. Respiratory Health for public comment. Respiratory Health provides a vehicle for stakeholders to describe the most sradovich on DSK3GMQ082PROD with NOTICES Instructions for use of the vaccine To view the notice and related information materials are found on the materials, visit https:// relevant issues, gaps, and safety and CDC website at: http://www.cdc.gov/ www.regulations.gov and enter CDC– health needs for the sector. Each NORA vaccines/hcp/vis/index.html. 2018–0024 in the search field and click research agenda is meant to guide or ‘‘Search.’’ promote high priority research efforts on Revised Vaccine Information Materials a national level, conducted by various The varicella vaccine information Table of Contents entities, including: Government, higher materials referenced in this notice were • DATES: education, and the private sector. VerDate Sep<11>2014 17:34 Mar 14, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1


Document Created: 2018-03-15 02:37:47
Document Modified: 2018-03-15 02:37:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesBeginning no later than June 1, 2018, each health care provider who administers varicella vaccine to any child or adult in the United States shall provide copies of the relevant vaccine information materials referenced in this notice, dated February 12, 2018, in conformance with the February 23, 2018 CDC Instructions for the Use of Vaccine Information Statements prior to providing such vaccinations.
ContactSuzanne 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.
FR Citation83 FR 11536 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR