Proposed Vaccine Information Materials for Rotavirus Vaccine, 48706-48707 [2010-19782]
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48706
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Vaccine Information
Materials for Rotavirus Vaccine
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the CDC must
develop vaccine information materials
that all health care providers are
required to give to patients/parents prior
to administration of specific vaccines.
CDC seeks written comment on
proposed new vaccine information
materials for rotavirus vaccine.
DATES: Written comments are invited
and must be received on or before
October 12, 2010.
ADDRESSES: Written comments should
be addressed to Anne Schuchat, M.D.,
Director, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–05, 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–52, 1600 Clifton
Road, NE., Atlanta, Georgia 30333,
telephone (404) 639–8809.
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.
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
sroberts on DSKD5P82C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:52 Aug 10, 2010
Jkt 220001
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
trivalent influenza vaccines.
Instructions for use of the vaccine
information materials and copies of the
materials can be found on the CDC Web
site at: https://www.cdc.gov/vaccines/
pubs/VIS/. In addition, single cameraready copies may be available from
State health departments. A list of State
health department contacts for obtaining
copies of these materials is included in
a December 17, 1999 Federal Register
notice (64 FR 70914).
Proposed Rotavirus Vaccine
Information Materials
With the publication in 2009 of
updated Advisory Committee on
Immunization Practices (ACIP)
recommendations for rotavirus vaccine,
incorporating information about both
the pentavalent and newer monovalent
formulations, CDC, as required under 42
U.S.C. 300aa-26, is proposing vaccine
information materials covering rotavirus
vaccine, which are included in this
notice. Interim materials have been
available for use pending completion of
the formal development process.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Development of Vaccine Information
Materials
The vaccine information materials
referenced in this notice are being
developed in consultation with the
Advisory Commission on Childhood
Vaccines, the Food and Drug
Administration, and parent and health
care provider groups.
In addition, we invite written
comment on the proposed vaccine
information materials that follow,
entitled ‘‘Rotavirus Vaccine: What You
Need to Know.’’ Comments submitted
will be considered in finalizing these
materials. When the final materials are
published in the Federal Register, the
notice will include an effective date for
their mandatory use.
We also propose to revise the June 9,
2010 Instructions for the Use of Vaccine
Information Statements to update
references to these vaccine information
materials.
*
*
*
*
*
Proposed Rotavirus Vaccine
Information Statement:
Rotavirus Vaccine: What You Need To
Know
1. What is rotavirus?
Rotavirus is a virus that causes severe
diarrhea, mostly in babies and young
children. It is often accompanied by
vomiting and fever. Rotavirus is not the
only cause of severe diarrhea, but it is
one of the most serious. Before rotavirus
vaccine was used, rotavirus was
responsible for:
• More than 400,000 doctor visits,
• More than 200,000 emergency room
visits,
• 55,000 to 70,000 hospitalizations,
and
• 20–60 deaths in the United States
each year.
Almost all children in the U.S. are
infected with rotavirus before their 5th
birthday.
Children are most likely to get
rotavirus diarrhea between November
and May, depending on the part of the
country.
2. Rotavirus Vaccine
Better hygiene and sanitation have not
reduced rotavirus diarrhea very much in
the United States. The best way to
protect your baby is with rotavirus
vaccine.
Rotavirus vaccine is an oral
(swallowed) vaccine, not a shot.
Rotavirus vaccine will not prevent
diarrhea or vomiting caused by other
germs, but it is very good at preventing
diarrhea and vomiting caused by
rotavirus. Most babies who get the
vaccine will not get rotavirus diarrhea at
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
all, and almost all of them will be
protected from severe rotavirus
diarrhea.
Babies who get the vaccine are also
much less likely to be hospitalized or to
see a doctor because of rotavirus
diarrhea.
A virus (or parts of the virus) called
porcine circovirus is in both rotavirus
vaccines. This virus is not known to
infect people and there is no known
safety risk. For more information, see
https://www.fda.gov, and search for
‘‘porcine circovirus.’’
3. Who should get rotavirus vaccine and
when?
There are two brands of rotavirus
vaccine. A baby should get either 2 or
3 doses, depending on which brand is
used.
The doses are recommended at these
ages:
First Dose: 2 months of age
Second Dose: 4 months of age
Third Dose: 6 months of age (if needed)
The first dose may be given as early
as 6 weeks of age, and should be given
by age 14 weeks 6 days. The last dose
should be given by 8 months of age.
Rotavirus vaccine may be given at the
same time as other childhood vaccines.
sroberts on DSKD5P82C1PROD with NOTICES
4. Some Babies Should Not Get
Rotavirus Vaccine or Should Wait
• A baby who has had a severe (lifethreatening) allergic reaction to a dose
of rotavirus vaccine should not get
another dose. A baby who has a severe
(life threatening) allergy to any
component of rotavirus vaccine should
not get the vaccine. Tell your doctor if
your baby has any severe allergies that
you know of, including a severe allergy
to latex.
• Babies with ‘‘severe combined
immunodeficiency’’ (SCID) should not
get rotavirus vaccine.
• Babies who are moderately or
severely ill at the time the vaccination
is scheduled should probably wait until
they recover. This includes babies who
have moderate or severe diarrhea or
vomiting. Ask your doctor or nurse.
Babies with mild illnesses should
usually get the vaccine.
• Check with your doctor if your
baby’s immune system is weakened
because of:
—HIV/AIDS, or any other disease that
affects the immune system
—Treatment with drugs such as longterm steroids
—Cancer, or cancer treatment with xrays or drugs
In the late 1990s a different type of
rotavirus vaccine was used. This
vaccine was found to be associated with
VerDate Mar<15>2010
16:52 Aug 10, 2010
Jkt 220001
an uncommon type of bowel obstruction
called ‘‘intussusception,’’ and it was
taken off the market.
The new rotavirus vaccines have not
been associated with intussusception.
However, babies who have had
intussusception, from any cause, are at
higher risk for getting it again. If your
baby has ever had intussusception,
discuss this with your doctor.
5. What are the risks from rotavirus
vaccine?
A vaccine, like any medicine, could
possibly cause serious problems, such
as severe allergic reactions. The risk of
any vaccine causing serious harm, or
death, is extremely small.
Most babies who get rotavirus vaccine
do not have any problems with it.
• Babies might become irritable, or
have mild, temporary diarrhea or
vomiting after a dose of rotavirus
vaccine.
• Rotavirus vaccine does not appear
to cause any serious side effects.
6. What if there is a moderate or severe
reaction?
What should I look for?
• Any unusual condition, such as a
high fever or behavior changes. Signs of
a serious allergic reaction can include
difficulty breathing, hoarseness or
wheezing, hives, paleness, weakness, a
fast heart beat or dizziness.
What should I do?
• Call a doctor, or get the person to
a doctor right away.
• Tell your doctor what happened,
the date and time it happened, and
when the vaccination was given.
• Ask your doctor, nurse, or health
department to report the reaction by
filing a Vaccine Adverse Event
Reporting System (VAERS) form.
Or you can file this report through the
VAERS web site at https://
www.vaers.hhs.gov, or by calling 1–800–
822–7967.
VAERS does not provide medical
advice.
7. The National Vaccine Injury
Compensation Program
The National Vaccine Injury
Compensation Program (VICP) was
created in 1986.
Persons who believe they may have
been injured by a vaccine can learn
about the program and about filing a
claim by calling 1–800–338–2382 or
visiting the VICP Web site at https://
www.hrsa.gov/vaccinecompensation.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
48707
8. How can I learn more?
• Your provider can give you the
vaccine package insert or suggest other
sources of information.
• Call your local or state health
department.
• Contact the Centers for Disease
Control and Prevention (CDC):
—Call 1–800–232–4636 (1–800–CDC–
INFO) or
—Visit CDC’s Web site at https://
www.cdc.gov/vaccines.
Department of Health and Human
Services, Centers for Disease Control
and Prevention, Vaccine Information
Statement, Rotavirus Vaccine, (00/00/
0000) (Proposed), 42 U.S.C. 300aa–26.
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2010–19782 Filed 8–10–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Proposed Vaccine Information
Materials for Pneumococcal Conjugate
Vaccine and Human Papillomavirus
Vaccines
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with Comment Period.
AGENCY:
Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the CDC must
develop vaccine information materials
that all health care providers are
required to give to patients/parents prior
to administration of specific vaccines.
CDC seeks written comment on
proposed new vaccine information
materials for pneumococcal conjugate
vaccine and human papillomavirus
vaccines.
DATES: Written comments are invited
and must be received on or before
October 12, 2010.
ADDRESSES: Written comments should
be addressed to Anne Schuchat, M.D.,
Director, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–05, 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Skip
Wolfe, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, Mailstop E–52, 1600 Clifton
SUMMARY:
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48706-48707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19782]
[[Page 48706]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Proposed Vaccine Information Materials for Rotavirus Vaccine
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42
U.S.C. 300aa-26), the CDC must develop vaccine information materials
that all health care providers are required to give to patients/parents
prior to administration of specific vaccines. CDC seeks written comment
on proposed new vaccine information materials for rotavirus vaccine.
DATES: Written comments are invited and must be received on or before
October 12, 2010.
ADDRESSES: Written comments should be addressed to Anne Schuchat, M.D.,
Director, National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention, Mailstop E-05, 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Skip Wolfe, National Center for
Immunization and Respiratory Diseases, Centers for Disease Control and
Prevention, Mailstop E-52, 1600 Clifton Road, NE., Atlanta, Georgia
30333, telephone (404) 639-8809.
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.
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 trivalent influenza vaccines. Instructions for use of the
vaccine information materials and copies of the materials can be found
on the CDC Web site at: https://www.cdc.gov/vaccines/pubs/VIS/. In
addition, single camera-ready copies may be available from State health
departments. A list of State health department contacts for obtaining
copies of these materials is included in a December 17, 1999 Federal
Register notice (64 FR 70914).
Proposed Rotavirus Vaccine Information Materials
With the publication in 2009 of updated Advisory Committee on
Immunization Practices (ACIP) recommendations for rotavirus vaccine,
incorporating information about both the pentavalent and newer
monovalent formulations, CDC, as required under 42 U.S.C. 300aa-26, is
proposing vaccine information materials covering rotavirus vaccine,
which are included in this notice. Interim materials have been
available for use pending completion of the formal development process.
Development of Vaccine Information Materials
The vaccine information materials referenced in this notice are
being developed in consultation with the Advisory Commission on
Childhood Vaccines, the Food and Drug Administration, and parent and
health care provider groups.
In addition, we invite written comment on the proposed vaccine
information materials that follow, entitled ``Rotavirus Vaccine: What
You Need to Know.'' Comments submitted will be considered in finalizing
these materials. When the final materials are published in the Federal
Register, the notice will include an effective date for their mandatory
use.
We also propose to revise the June 9, 2010 Instructions for the Use
of Vaccine Information Statements to update references to these vaccine
information materials.
* * * * *
Proposed Rotavirus Vaccine Information Statement:
Rotavirus Vaccine: What You Need To Know
1. What is rotavirus?
Rotavirus is a virus that causes severe diarrhea, mostly in babies
and young children. It is often accompanied by vomiting and fever.
Rotavirus is not the only cause of severe diarrhea, but it is one of
the most serious. Before rotavirus vaccine was used, rotavirus was
responsible for:
More than 400,000 doctor visits,
More than 200,000 emergency room visits,
55,000 to 70,000 hospitalizations, and
20-60 deaths in the United States each year.
Almost all children in the U.S. are infected with rotavirus before
their 5th birthday.
Children are most likely to get rotavirus diarrhea between November
and May, depending on the part of the country.
2. Rotavirus Vaccine
Better hygiene and sanitation have not reduced rotavirus diarrhea
very much in the United States. The best way to protect your baby is
with rotavirus vaccine.
Rotavirus vaccine is an oral (swallowed) vaccine, not a shot.
Rotavirus vaccine will not prevent diarrhea or vomiting caused by
other germs, but it is very good at preventing diarrhea and vomiting
caused by rotavirus. Most babies who get the vaccine will not get
rotavirus diarrhea at
[[Page 48707]]
all, and almost all of them will be protected from severe rotavirus
diarrhea.
Babies who get the vaccine are also much less likely to be
hospitalized or to see a doctor because of rotavirus diarrhea.
A virus (or parts of the virus) called porcine circovirus is in
both rotavirus vaccines. This virus is not known to infect people and
there is no known safety risk. For more information, see https://www.fda.gov, and search for ``porcine circovirus.''
3. Who should get rotavirus vaccine and when?
There are two brands of rotavirus vaccine. A baby should get either
2 or 3 doses, depending on which brand is used.
The doses are recommended at these ages:
First Dose: 2 months of age
Second Dose: 4 months of age
Third Dose: 6 months of age (if needed)
The first dose may be given as early as 6 weeks of age, and should
be given by age 14 weeks 6 days. The last dose should be given by 8
months of age.
Rotavirus vaccine may be given at the same time as other childhood
vaccines.
4. Some Babies Should Not Get Rotavirus Vaccine or Should Wait
A baby who has had a severe (life-threatening) allergic
reaction to a dose of rotavirus vaccine should not get another dose. A
baby who has a severe (life threatening) allergy to any component of
rotavirus vaccine should not get the vaccine. Tell your doctor if your
baby has any severe allergies that you know of, including a severe
allergy to latex.
Babies with ``severe combined immunodeficiency'' (SCID)
should not get rotavirus vaccine.
Babies who are moderately or severely ill at the time the
vaccination is scheduled should probably wait until they recover. This
includes babies who have moderate or severe diarrhea or vomiting. Ask
your doctor or nurse. Babies with mild illnesses should usually get the
vaccine.
Check with your doctor if your baby's immune system is
weakened because of:
--HIV/AIDS, or any other disease that affects the immune system
--Treatment with drugs such as long-term steroids
--Cancer, or cancer treatment with x-rays or drugs
In the late 1990s a different type of rotavirus vaccine was used.
This vaccine was found to be associated with an uncommon type of bowel
obstruction called ``intussusception,'' and it was taken off the
market.
The new rotavirus vaccines have not been associated with
intussusception.
However, babies who have had intussusception, from any cause, are
at higher risk for getting it again. If your baby has ever had
intussusception, discuss this with your doctor.
5. What are the risks from rotavirus vaccine?
A vaccine, like any medicine, could possibly cause serious
problems, such as severe allergic reactions. The risk of any vaccine
causing serious harm, or death, is extremely small.
Most babies who get rotavirus vaccine do not have any problems with
it.
Babies might become irritable, or have mild, temporary
diarrhea or vomiting after a dose of rotavirus vaccine.
Rotavirus vaccine does not appear to cause any serious
side effects.
6. What if there is a moderate or severe reaction?
What should I look for?
Any unusual condition, such as a high fever or behavior
changes. Signs of a serious allergic reaction can include difficulty
breathing, hoarseness or wheezing, hives, paleness, weakness, a fast
heart beat or dizziness.
What should I do?
Call a doctor, or get the person to a doctor right away.
Tell your doctor what happened, the date and time it
happened, and when the vaccination was given.
Ask your doctor, nurse, or health department to report the
reaction by filing a Vaccine Adverse Event Reporting System (VAERS)
form.
Or you can file this report through the VAERS web site at https://www.vaers.hhs.gov, or by calling 1-800-822-7967.
VAERS does not provide medical advice.
7. The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) was created
in 1986.
Persons who believe they may have been injured by a vaccine can
learn about the program and about filing a claim by calling 1-800-338-
2382 or visiting the VICP Web site at https://www.hrsa.gov/vaccinecompensation.
8. How can I learn more?
Your provider can give you the vaccine package insert or
suggest other sources of information.
Call your local or state health department.
Contact the Centers for Disease Control and Prevention
(CDC):
--Call 1-800-232-4636 (1-800-CDC-INFO) or
--Visit CDC's Web site at https://www.cdc.gov/vaccines.
Department of Health and Human Services, Centers for Disease
Control and Prevention, Vaccine Information Statement, Rotavirus
Vaccine, (00/00/0000) (Proposed), 42 U.S.C. 300aa-26.
Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-19782 Filed 8-10-10; 8:45 am]
BILLING CODE 4163-18-P