[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62139-62140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2016-0015]
Final Revised Vaccine Information Materials for Hepatitis A and
Hepatitis B Vaccines
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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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 February 8, 2016, CDC
published a notice in the Federal Register (81 FR 6520) seeking public
comments on proposed updated vaccine information materials for
hepatitis A and hepatitis B vaccines. Following review of comments
submitted and consultation as required under the law, CDC has finalized
the materials for hepatitis A and hepatitis B vaccines. Copies of the
final vaccine information materials for hepatitis A and hepatitis B
vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number
CDC-2016-0015).
DATES: Beginning no later than November 1, 2016, each health care
provider who administers hepatitis A or hepatitis B 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 ([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
[[Page 62140]]
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 hepatitis A and hepatitis B 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 hepatitis A and hepatitis B 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-2016-0015). The Vaccine Information Statements
(VIS) are ``Hepatitis A Vaccine: What You Need to Know'' and
``Hepatitis B Vaccine: What You Need to Know,'' publication date July
20, 2016.
With publication of this notice, by November 1, 2016, all health
care providers must discontinue use of the previous edition of each and
provide copies of these updated hepatitis A and hepatitis B 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. 2016-21573 Filed 9-7-16; 8:45 am]
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