[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]
 BILLING CODE 4163-18-P