[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Notices]
[Pages 60149-60150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25159]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2015-0016]
Final Revised Vaccine Information Materials for Seasonal
Influenza 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), the HHS/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 May
20, 2015, CDC published a notice in the Federal Register (80 FR 29009)
seeking public comments on proposed new vaccine information materials
for inactivated and live attenuated influenza vaccines. 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 inactivated and live attenuated influenza
vaccines are available to download from http://www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number
CDC-2015-0016).
DATES: Beginning no later than March 1, 2016, each health care provider
who administers any seasonal influenza vaccine to any child or adult in
the United States shall provide copies of the relevant revised vaccine
information materials contained in this notice, in conformance with the
August 7, 2015 CDC Instructions for the Use of Vaccine Information
Statements prior to providing such vaccinations. These revised vaccine
information materials may also be used earlier than that date. Prior to
March 1, 2016, the previous edition of these two VISs can be used.
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
[[Page 60150]]
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 revised inactivated and live attenuated influenza 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 inactivated and live
attenuated influenza 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-2015-0016). The Vaccine
Information Statements (VIS), are: ``Influenza (Flu) Vaccine
(Inactivated or Recombinant): What you need to know'' (publication date
August 7, 2015) and ``Influenza (Flu) Vaccine (Live, Intranasal): What
you need to know'' (publication date August 7, 2015).
With publication of this notice, as of March 1, 2016, all health
care providers will be required to provide copies of these updated
inactivated and live attenuated influenza vaccine information materials
prior to immunization in conformance with HHS/CDC's August 7, 2015
Instructions for the Use of Vaccine Information Statements. Prior to
that date, the previous edition of these two VISs can be used.
Dated: September 29, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-25159 Filed 10-2-15; 8:45 am]
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