83 FR 11532 - Final Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella) and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines

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

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

Page Range		11532-11532
FR Document		2018-05299

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 October 18, 2016, CDC published a notice in the Federal Register seeking public comments on proposed updated vaccine information materials for MMR vaccine and MMRV vaccine. 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 MMR and MMRV vaccine are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http:// www.regulations.gov (see Docket Number CDC-2016-0094).

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

[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Page 11532]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2016-0094]


Final Revised Vaccine Information Materials for MMR (Measles, 
Mumps, and Rubella) and MMRV (Measles, Mumps, Rubella, and Varicella) 
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), 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 18, 2016, CDC published 
a notice in the Federal Register seeking public comments on proposed 
updated vaccine information materials for MMR vaccine and MMRV vaccine. 
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 MMR and MMRV vaccine are available to 
download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2016-0094).

DATES: Beginning no later than June 1, 2018, each health care provider 
who administers MMR or MMRV 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 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 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 MMR and MMRV 
vaccines 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-2016-0094). The Vaccine Information Statements 
(VISs) are ``MMR Vaccine (Measles, Mumps, and Rubella): What You Need 
to Know'' and ``MMRV Vaccine (Measles, Mumps, Rubella, and Varicella): 
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 editions and provide 
copies of these updated 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. 2018-05299 Filed 3-14-18; 8:45 am]
 BILLING CODE 4163-18-P

11532 Federal Register / Vol. 83, No. 51 / Thursday, March 15, 2018 / Notices

The purpose of this analysis is to cdc.gov), National Center for rotavirus, hepatitis A, meningococcal,
facilitate public comment on the Immunization and Respiratory Diseases, human papillomavirus (HPV), and
proposed Consent agreement, and the Centers for Disease Control and seasonal influenza vaccines.
Commission does not intend this Prevention, Mailstop A–19, 1600 Clifton Instructions for use of the vaccine
analysis to constitute an official Road NE, Atlanta, Georgia 30329. information materials are found on the
interpretation of the proposed Consent SUPPLEMENTARY INFORMATION: The CDC website at: http://www.cdc.gov/
Agreement or to modify its terms in any National Childhood Vaccine Injury Act vaccines/hcp/vis/index.html.
way. of 1986 (Pub. L. 99–660), as amended by Revised Vaccine Information Materials
By direction of the Commission. section 708 of Public Law 103–183,
added section 2126 to the Public Health The vaccine information materials
Donald S. Clark,
Service Act. Section 2126, codified at 42 referenced in this notice were
Secretary.
U.S.C. 300aa–26, requires the Secretary developed in consultation with the
[FR Doc. 2018–05252 Filed 3–14–18; 8:45 am] Advisory Commission on Childhood
BILLING CODE 6750–01–P
of Health and Human Services to
develop and disseminate vaccine Vaccines, the Food and Drug
information materials for distribution by Administration, and parent and
all health care providers in the United healthcare provider organizations.
DEPARTMENT OF HEALTH AND Following consultation and review of
HUMAN SERVICES States to any patient (or to the parent or
legal representative in the case of a comments submitted, the vaccine
child) receiving vaccines covered under information materials covering MMR
Centers for Disease Control and and MMRV vaccines have been
Prevention the National Vaccine Injury
Compensation Program (VICP). finalized and are available to download
[Docket No. CDC–2016–0094] Development and revision of the from http://www.cdc.gov/vaccines/hcp/
vaccine information materials, also vis/index.html or http://
Final Revised Vaccine Information www.regulations.gov (see Docket
Materials for MMR (Measles, Mumps, known as Vaccine Information
Statements (VIS), have been delegated Number CDC–2016–0094). The Vaccine
and Rubella) and MMRV (Measles, Information Statements (VISs) are
Mumps, Rubella, and Varicella) by the Secretary to the Centers for
Disease Control and Prevention (CDC). ‘‘MMR Vaccine (Measles, Mumps, and
Vaccines Rubella): What You Need to Know’’ and
Section 2126 requires that the materials
AGENCY: Centers for Disease Control and be developed, or revised, after notice to ‘‘MMRV Vaccine (Measles, Mumps,
Prevention (CDC), Department of Health the public, with a 60-day comment Rubella, and Varicella): What You Need
and Human Services (HHS). period, and in consultation with the to Know,’’ publication date February 12,
ACTION: Notice. Advisory Commission on Childhood 2018.
With publication of this notice, by
Vaccines, appropriate health care
SUMMARY: Under the National June 1, 2018, all health care providers
provider and parent organizations, and
Childhood Vaccine Injury Act (NCVIA), must discontinue use of the previous
the Food and Drug Administration. The
CDC must develop vaccine information editions and provide copies of these
law also requires that the information
materials that all health care providers updated vaccine information materials
contained in the materials be based on
are required to give to patients/parents prior to immunization in conformance
available data and information, be
prior to administration of specific with CDC’s February 23, 2018
presented in understandable terms, and
vaccines. On October 18, 2016, CDC Instructions for the Use of Vaccine
include:
published a notice in the Federal Information Statements.
(1) A concise description of the
Register seeking public comments on benefits of the vaccine, Dated: March 12, 2018.
proposed updated vaccine information (2) A concise description of the risks Sandra Cashman,
materials for MMR vaccine and MMRV associated with the vaccine, Executive Secretary, Centers for Disease
vaccine. Following review of comments (3) A statement of the availability of Control and Prevention.
submitted and consultation as required the National Vaccine Injury [FR Doc. 2018–05299 Filed 3–14–18; 8:45 am]
under the law, CDC has finalized the Compensation Program, and BILLING CODE 4163–18–P
materials. Copies of the final vaccine (4) Such other relevant information as
information materials for MMR and may be determined by the Secretary.
MMRV vaccine are available to The vaccines initially covered under DEPARTMENT OF HEALTH AND
download from http://www.cdc.gov/ the National Vaccine Injury HUMAN SERVICES
vaccines/hcp/vis/index.html or http:// Compensation Program were diphtheria,
www.regulations.gov (see Docket tetanus, pertussis, measles, mumps, Centers for Disease Control and
Number CDC–2016–0094). rubella, and poliomyelitis vaccines. Prevention
DATES: Beginning no later than June 1, Since April 15, 1992, any health care [60Day–FY–1072; Docket No. CDC–2018–
2018, each health care provider who provider in the United States who 0020]
administers MMR or MMRV vaccine to intends to administer one of these
any child or adult in the United States covered vaccines is required to provide Proposed Data Collection Submitted
shall provide copies of the relevant copies of the relevant vaccine for Public Comment and
vaccine information materials information materials prior to Recommendations
referenced in this notice, dated February administration of any of these vaccines.
sradovich on DSK3GMQ082PROD with NOTICES

12, 2018, in conformance with the AGENCY: Centers for Disease Control and
Since then, the following vaccines have Prevention (CDC), Department of Health
February 23, 2018 CDC Instructions for been added to the National Vaccine
the Use of Vaccine Information and Human Services (HHS).
Injury Compensation Program, requiring ACTION: Notice with comment period.
Statements prior to providing such use of vaccine information materials for
vaccinations. them as well: Hepatitis B, Haemophilus SUMMARY: The Centers for Disease
FOR FURTHER INFORMATION CONTACT: influenzae type b (Hib), varicella Control and Prevention (CDC), as part of
Suzanne Johnson-DeLeon (msj1@ (chickenpox), pneumococcal conjugate, its continuing effort to reduce public

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Document Created: 2018-03-15 02:38:01
Document Modified: 2018-03-15 02:38:01

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.
Dates		Beginning no later than June 1, 2018, each health care provider who administers MMR or MMRV 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.
Contact		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.
FR Citation		83 FR 11532

83 FR 11532 - Final Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella) and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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