[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23299-23300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09167]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0089]
Final Revised Vaccine Information Materials for 9-valent HPV
(Human Papillomavirus) Vaccine
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 October 22, 2015, CDC
published a notice in the Federal Register (80 FR 64002) seeking public
comments on proposed updated vaccine information materials for 9-valent
HPV (Human Papillomavirus) Gardasil[supreg]-9 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 9-valent HPV Gardasil[supreg]-9 vaccine are available to
download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0089).
DATES: Beginning no later than July 1, 2016, each health care provider
who administers 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9
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 March 31, 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 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 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 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 9-valent
[[Page 23300]]
HPV Gardasil[supreg]-9 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-2015-0089). The Vaccine
Information Statement (VIS) is ``HPV (Human Papillomavirus) Vaccine:
What You Need to Know [Gardasil[supreg]-9],'' publication date March
31, 2016.
With publication of this notice, as of July 1, 2016, all health
care providers will be required to provide copies of these updated 9-
valent HPVGardasil[supreg]-9 vaccine information materials prior to
immunization in conformance with CDC's March 31, 2016 Instructions for
the Use of Vaccine Information Statements.
Dated: April 15, 2016.
Veronica Kennedy,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2016-09167 Filed 4-19-16; 8:45 am]
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