[Federal Register Volume 59, Number 17 (Wednesday, January 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1587]
[[Page Unknown]]
[Federal Register: January 26, 1994]
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Part II
Department of Health and Human Services
_______________________________________________________________________
Centers for Disease Control and Prevention
_______________________________________________________________________
Proposed New Vaccine Information Materials; Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Proposed New Vaccine Information Materials
AGENCY: Centers for Disease Control and Prevention (CDC), Public Health
Service, HHS.
ACTION: Notice with comment period.
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SUMMARY: As required by Public Law 99-660, CDC developed extensive
vaccine information materials for distribution by health care providers
to parents prior to administration of particular vaccines to children.
In response to concerns expressed regarding the length and readability
of the materials and the process for development of the materials, the
law was revised by Public Law 103-183 to provide for simplification of
the vaccine information materials. CDC is publishing for public comment
proposed new vaccine information materials which comply with the
revised law.
DATES: Written comments are invited and must be received on or before
March 28, 1994.
ADDRESSES: Written comments should be addressed to Walter A. Orenstein,
M.D., Director, National Immunization Program, Centers for Disease
Control and Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta,
Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Walter A. Orenstein, M.D., Director,
National Immunization Program, Centers for Disease Control and
Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia
30333, (404) 639-8200.
SUPPLEMENTARY INFORMATION: Title III of Public Law 99-660 (the National
Childhood Vaccine Injury Act of 1986) added a new Title XXI to the
Public Health Service Act. Section 2126 of the Public Health Service
Act (42 U.S.C. 300aa-26) required the Secretary of Health and Human
Services to develop by rule extensive vaccine information materials for
distribution by health care providers to the legal representatives of
any child receiving particular vaccines (i.e., diphtheria, tetanus,
pertussis, measles, mumps, rubella, and poliomyelitis vaccines). These
vaccine information materials were developed as required by section
2126 of the Public Health Service Act and were issued as a final rule
on October 15, 1991 (56 FR 51798; codified at 42 CFR part 110). Since
April 15, 1992, any health care provider who intends to administer one
of the covered vaccines is required to provide copies of vaccine
information materials that comply with the requirements of section 2126
prior to administration of these vaccines.
Based on concerns expressed by providers and others concerning the
length and readability of the vaccine information materials (each of
the three existing vaccine information pamphlets is 10 pages long) and
the lengthy development and revision process required by the rulemaking
process (development of the materials took approximately three years),
the Department proposed legislation to amend section 2126 to provide
for simplification of the vaccine information materials. Congress in
section 708 of Public Law 103-183, which was enacted on December 14,
1993, revised section 2126 to: (1) Delete the requirement for
development and revision of the vaccine information materials by
rulemaking; (2) simplify the information to be included in the
materials; and (3) clarify that the materials must not only be provided
to the parent or legal representative of a child receiving a covered
vaccine, but also must be provided to any adult who receives a covered
vaccine.
Section 2126, as amended by Public Law 103-183, requires that
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.
New vaccine information materials which comply with the provisions
of the revised section 2126 have been drafted and are contained in this
Notice. We invite comment on these draft information materials. During
the 60-day comment period, CDC also intends to consult with the
Advisory Commission on Childhood Vaccines, health care provider and
parent organizations, and the Food and Drug Administration, as mandated
under section 2126.
CDC intends to repeal the vaccine information materials currently
contained in Appendix A of 42 CFR part 110 when the new vaccine
information materials developed under the revised section 2126 of the
PHS Act, as revised by Public Law 103-183, are finalized.
CDC invites written comment on the following proposed vaccine
information materials, entitled ``Diphtheria, Tetanus, and Pertussis
Vaccine (DTP): What You Need to Know Before Your Child Gets the
Vaccine,'' ``Measles, Mumps, and Rubella Vaccine (MMR): What You Need
to Know Before Your Child Gets the Vaccine,'' ``Polio Vaccine: What You
Need to Know Before Your Child Gets the Vaccine,'' and ``Tetanus and
Diphtheria Vaccine (Td): What You Need to Know Before You Get the
Vaccine.''
Diphtheria, Tetanus, and Pertussis Vaccine (DTP): What You Need to Know
Before Your Child Gets the Vaccine
What Are Diphtheria, Tetanus, and Pertussis?
DTP vaccine (DTP) is named for 3 diseases: Diphtheria, Tetanus, and
Pertussis. Each of these diseases can lead to serious problems, even
death. Your child can be protected from diphtheria, tetanus, and
pertussis by the vaccine. These diseases--especially pertussis--are
still found in our country, mostly because some people do not get
enough doses of the vaccines.
Diphtheria is spread from person to person. It can cause a membrane
to form in the nose, throat, or airway. Diphtheria can cause breathing
problems, heart failure, or paralysis.
Tetanus, also called lockjaw, is caused by a germ that enters the
body through a cut or wound. Tetanus causes serious, painful spasms of
all muscles, ``locking'' of the jaw so the sick person cannot open his
mouth or swallow, and death.
Pertussis, also called whooping cough, is caused by a germ that
easily passes from person to person. It can cause serious spells of
coughing and choking for several weeks. For infants, having pertussis
makes it hard to eat, drink, or breathe. It can lead to pneumonia,
seizures, and sometimes even to lasting brain damage.
Should Everyone Get the DTP Vaccine?
Experts believe that almost all young children should get DTP or
DTaP (a new form of the vaccine). To help your doctor/nurse know what
is best for your child, please answer these questions.
Has the child getting the vaccine had DTP or DTaP in the past?
________Yes (please answer all the questions)
________No (you can skip these 6 questions)
------------------------------------------------------------------------
Yes No
------------------------------------------------------------------------
1.Did the child have an allergic problem that
required a medical visit right after DTP or DTaP
in the past?..................................... {time} {time}
2.Did the child have an illness of the brain that
led to a hospital stay within 7 days of DTP or
DTaP?............................................ {time} {time}
3.Did the child cry non-stop for more than 3 hours
right after a DTP or DTaP? That is, did the
crying go on even when the baby was cared for?... {time} {time}
4.Did the child faint or collapse within 2 days
(48 hours) of DTP or DTaP?....................... {time} {time}
5.Did the child have a very high fever within 2
days (48 hours) of DTP or DTaP?.................. {time} {time}
6.Did the child have a seizure within 3 days (72
hours) of DTP or DTaP?........................... {time} {time}
------------------------------------------------------------------------
Please tell your doctor/nurse if the child getting the vaccine:
Has signs of illness today.
Has ever had a seizure.
Has a parent, brother, or sister who has had seizures.
If the answer is ``yes'' to any of these questions, your doctor/
nurse might suggest getting DTP or DTaP, coming back for it later, not
getting it at all, keeping the fever down after getting the shot, or
using DT (a vaccine that protects from diphtheria and tetanus, but not
from pertussis).
When Should Your Child Get the DTP Vaccine?
To be protected against diphtheria, tetanus, and pertussis, most
children need a total of 5 doses of vaccine. Children should get
vaccine at:
2 months of age
4 months of age
6 months of age
15 to 18 months of age
4 to 6 years of age
A vaccine called DTaP vaccine is now available. DTaP or DTP may be
used for the 4th and 5th shots.
These vaccines may be given at the same time as other childhood
vaccines.
Every 10 years all through life, everyone needs a booster with
tetanus and diphtheria vaccine (Td).
Are There Risks With DTP?
The DTP vaccine is the best way to protect your child against these
3 serious diseases. But there are risks with any medicine, including
vaccines. There is a very small chance that serious problems, even
death, could occur after getting vaccines. The risk from the vaccine is
much smaller than the risk from the diseases.
About half the children who get DTP will not have any problems at
all. Some will have minor problems like: soreness, redness, or swelling
where the shot is given; fever; fussiness; drowsiness; less appetite.
Rarely, after DTP such problems have been noted as: crying non-stop for
3 hours or more; fever of 105 deg.F or higher; seizures (usually caused
by fever); collapse or fainting. None of these problems is known to
cause any lasting harm, but they are scary. Very rarely, DTP causes
long seizures, decreased consciousness, or coma that does not last.
Also very rarely, DT, Td, and the diphtheria-tetanus part of DTP and
DTaP cause severe allergic problems or Guillain-Barre Syndrome (sudden
weakness and numbness that may go on to paralysis). Lasting brain
damage after DTP has not been proven. If DTP ever causes lasting brain
damage, it is very rare.
DTaP causes fewer of the minor problems than DTP does. Experts do
not know if the rare serious problems reported after DTP happen less
often after DTaP.
If a serious or unusual problem occurs after getting any vaccine,
call a doctor or get the person to a doctor right away.
What is the Injury Compensation Program?
The National Vaccine Injury Compensation Program is a U.S.
government program that gives compensation (payment) for some persons
thought to be injured by vaccines. For facts about this program, call
this toll-free number: 1-800-338-2382.
If you believe that the person getting the vaccine had a serious
problem because of the vaccine, tell the doctor/nurse or health
department. Ask him or her to report the problem on a Vaccine Adverse
Event Report form. If you want to report it yourself, you can get the
form by calling this toll-free number: 1-800-822-7967.
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention
DTP 00/00/94 (Proposed)
42 U.S.C. 300aa-26
Measles, Mumps, and Rubella Vaccine (MMR) What You Need to Know Before
Your Child Gets the Vaccine
What are Measles, Mumps, and Rubella?
MMR vaccine is named for 3 diseases: Measles, Mumps, and Rubella.
Each of these diseases can lead to serious problems, even death. Your
child can be protected from measles, mumps, and rubella by the vaccine.
These diseases are still found in our country, mostly because some
people do not get the vaccines.
Measles is spread easily from person to person, causing a rash,
cough, and high fever. When children catch measles, some of them also
get ear infections, pneumonia, diarrhea, seizures, hearing loss, or
brain damage.
Mumps also is easily passed from person to person. It usually
causes fever, headache, and swollen glands under the jaw. It can also
cause meningitis (an inflammation of the brain and spinal cord
coverings), inflammation of the brain, or hearing loss. Men can get
painful, swollen testicles from mumps.
Rubella is also called German measles. It also passes from person
to person. It causes a mild fever, swollen glands, and a rash.
Sometimes it also causes arthritis (inflamed joints), especially in
women. If a pregnant woman catches rubella, it is very dangerous for
her unborn baby. Many women who have rubella when they are pregnant
will lose their babies or have babies born with deafness, blindness,
heart disease, brain damage, or other serious problems.
Should Everyone Get the MMR Vaccine?
Experts believe that almost all young children should get MMR. To
help your doctor/nurse know what is best for your child, please answer
the following questions.
------------------------------------------------------------------------
Yes No
------------------------------------------------------------------------
Is the person getting the vaccine:
1. Someone who had an allergic problem that
required a medical visit right after MMR in
the past?.................................... {time} {time}
2. Less able than others to fight infection
because of:..................................
A disease such as cancer or leukemia?..... {time} {time}
Special cancer treatments such as x-rays
or drugs?................................ {time} {time}
Drugs such as prednisone or other
steroids?................................ {time} {time}
An inborn or inherited disease?........... {time} {time}
(Children with HIV infection or AIDS should get
MMR)
3. Pregnant? Does she think she is pregnant or
might get pregnant in the next 3 months?..... {time} {time}
4. Allergic to eggs or neomycin (an
antibiotic)?................................. {time} {time}
------------------------------------------------------------------------
Please tell your doctor/nurse if the person getting the vaccine:
Has signs of illness today.
Has a parent, brother, or sister who has had seizures.
Has ever had a seizure.
Has gotten immune globulin or other blood products (such
as a transfusion) during the past several months?
If the answer is ``yes'' to any of these questions, your doctor/
nurse might suggest getting the shot, coming back for it later, or not
getting it at all.
When Should Your Child Get the MMR Vaccine?
Most children should have a total of 2 MMR vaccines. They should
get vaccine at:
12 to 15 months of age AND
when starting school OR when starting middle school or junior high
school
These vaccines may be given at the same time as other childhood
vaccines.
People who do not know if they are protected against measles,
mumps, and rubella should ask their doctor/nurse about getting MMR.
Are There Risks With MMR?
The MMR vaccine is the best way to protect your child against these
3 serious diseases. But there are risks with any medicine, including
vaccines. There is a very small chance that serious problems, even
death, could occur after getting vaccines. The risk from the vaccine is
much smaller than the risk from the diseases.
Most people who get MMR will not have any problems at all. Some
will have minor problems like: soreness, redness, or swelling where the
shot is given; mild fever; rash; a little swelling of the glands in the
cheeks, neck, or under the jaw. Occasionally, pain, stiffness, or
swelling in the joints (arthritis) may occur, usually 1-3 weeks after
getting the vaccine. The arthritis usually does not last long.
Occasionally, it lasts or comes and goes for months or longer. Young
women are more likely than children to have joint problems.
Rarely, more serious problems may come within 3 weeks of getting
MMR. Usually they do not cause lasting harm. These rare problems
include: Severe allergic problems; seizures (usually caused by fever);
and low number of platelets (a type of blood cells). Other rare serious
problems have been seen after MMR was given, but it is not known if the
vaccine caused the problems. These problems are even more rare than the
ones above and include hearing loss and inflammation of the brain that
could lead to lasting damage.
If a serious or unusual problem occurs after getting any vaccine,
call a doctor or get the person to a doctor right away.
What Is the Injury Compensation Program?
The National Vaccine Injury Compensation Program is a U.S.
government program that gives compensation (payment) for some persons
thought to be injured by vaccines. For facts about this program, call
this toll-free number: 1-800-338-2382.
If you believe that the person getting the vaccine had a serious
problem because of the vaccine, tell the doctor/nurse or health
department. Ask him or her to report the problem on a Vaccine Adverse
Event Report form. If you want to report it yourself, you can get the
form by calling this toll-free number: 1-800-822-7967.
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention
MMR 00/00/94 (Proposed)
42 U.S.C. 300aa-26
Polio Vaccine What you Need To Know Before Your Child Gets the Vaccine
What Is Polio?
Polio is a serious disease that can cause life-long paralysis (that
is, victims cannot move parts of their bodies). Some polio victims
cannot breathe without the help of a machine. They may even die. Your
child can be protected from polio by the vaccine. Polio is very rare in
our country, mostly because people are protected by polio vaccine.
There are 2 kinds of polio vaccine:
OPV or Oral Polio Vaccine. OPV is given by mouth as drops. Most
experts recommend OPV for healthy children.
IPV or Inactivated Polio Vaccine. IPV is a shot.
Should Everyone Get the Polio Vaccine?
Experts believe that almost all young children should get polio
vaccine. To help your doctor/nurse know what is best for your child,
please answer the following questions.
------------------------------------------------------------------------
Yes No
------------------------------------------------------------------------
1. Is the person getting the vaccine or anyone
else in the home less able to fight infections
because of:
A disease such as cancer or leukemia?......... {time} {time}
Special cancer treatments such as x-rays or
drugs?....................................... {time} {time}
Drugs such as prednisone or other steroids?... {time} {time}
An inborn or inherited disease?............... {time} {time}
AIDS or HIV infection?........................ {time} {time}
If the answer to any of these questions is
``yes,'' your doctor/nurse will probably give IPV
instead of OPV
2. Is the person getting the vaccine pregnant or
think she is?.................................... {time} {time}
If so, she can come back for the vaccine when she
is not pregnant. If she needs to be protected
against polio right away, she may get OPV or IPV
3. Does the person getting the vaccine have a
serious allergy to neomycin, streptomycin, or
polymyxin B (antibiotics)?....................... {time} {time}
If so, he or she can get OPV, but not IPV
4. Does the person getting the vaccine have
frequent close contact with anyone who never got
the polio vaccine?............................... {time} {time}
------------------------------------------------------------------------
If so, the person who never got the polio vaccine should talk to
her/his doctor/nurse about getting IPV.
When Should Your Child Get the Polio Vaccine?
Most children should have a total of 4 polio vaccines. They should
get vaccine at:
2 months of age
4 months of age
6 to 18 months of age
4 to 6 years of age
These vaccines may be given at the same time as other childhood
vaccines.
Before travel to countries where polio still occurs, adults and
children should get at least 1 more dose of either OPV (if they had OPV
before) or IPV. Your doctor/nurse can tell you how many doses are
needed.
Are There Risks With Polio Vaccine?
The polio vaccine is the best way to protect your child against
this serious disease. But there are risks with any medicine, including
vaccines. There is a very small chance that serious problems, even
death, could occur after getting vaccines. The risk from the vaccine is
much smaller than the risk from the disease.
OPV. Almost all people who get OPV will not have any problems at
all. Extremely rarely, a person will get polio from the first dose of
vaccine and, even more rarely, from a later dose.
Children who recently got OPV have the vaccine virus in their
throats for a week and in their stool for a month or sometimes longer.
People who have close contact (for example, kissing or changing
diapers) with someone who got OPV can get infected by the virus.
Extremely rarely, if they have not already gotten the vaccine against
polio, they can get polio disease. If you have a child getting OPV and
you never got the polio vaccine, ask your doctor/nurse about getting
IPV for yourself.
IPV. Inactivated polio vaccine is not known to cause any problems
other than a little soreness or redness where the shot is given.
If a serious or unusual problem occurs after getting any vaccine,
call a doctor or get the person to a doctor right away.
What is the Injury Compensation Program?
The National Vaccine Injury Compensation Program is a U.S.
government program that gives compensation (payment) for some persons
thought to be injured by vaccines. For facts about this program, call
this toll-free number: 1-800-338-2382.
If you believe that the person getting the vaccine had a serious
problem because of the vaccine, tell the doctor/nurse or health
department. Ask him or her to report the problem on a Vaccine Adverse
Event Report form. If you want to report it yourself, you can get the
form by calling this toll-free number: 1-800-822-7967.
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention
Polio 00/00/94 (Proposed)
42 U.S.C. 300aa-26
Tetanus and Diphtheria Vaccine (Td) What You Need To Know Before You
Get the Vaccine
What Are Tetanus and Diphtheria?
Td vaccine is named for 2 diseases: Tetanus and diphtheria. These
diseases can lead to serious problems, even death. You can be protected
from tetanus and diphtheria by the vaccine. These diseases are still
found in our country, mostly because some people do not get enough
doses of the vaccines.
Tetanus, also called lockjaw, is caused by a germ that enters the
body through a cut or wound. Tetanus causes serious, painful spasms of
all muscles, ``locking'' of the jaw so the sick person cannot open his
mouth or swallow, and death.
Diphtheria is spread from person to person. It can cause a membrane
to form in the nose, throat, or airway. Diphtheria can cause breathing
problems, heart failure, or paralysis.
Should Everyone Get the Td Vaccine?
Td is made for people 7 years of age and older.
If you had an allergic problem that required a medical visit right
after any vaccine for tetanus or diphtheria (for example, DT, DTP,
DTaP), talk to your doctor/nurse about the problem before getting Td.
Tell your doctor/nurse if you:
Have signs of illness today.
Are pregnant or think you may be pregnant.
When Should You Get the Td Vaccine?
To be protected against tetanus and diphtheria, a Td dose is needed
every 10 years all through life.
Are There Risks With Td?
The Td vaccine is the best way to protect yourself against these
serious diseases. But there are risks with any medicine, including
vaccines. There is a very small chance that serious problems, even
death, could occur after getting vaccines. The risk from the vaccine is
much smaller than the risk from the diseases.
Most people who get Td will not have any problems at all. Some will
have minor problems like soreness, redness, or swelling where the shot
was given. Most persons 7 years of age and older have had doses of DTP,
DTaP, and/or DT, and should be given Td only once every 10 years. If
adults get this vaccine very often, they can have a lot of soreness and
swelling where the shot was given. Very rarely, Td causes severe
allergic problems or Guillain-Barre Syndrome (sudden weakness and
numbness that may go on to paralysis).
If a serious or unusual problem occurs after getting any vaccine,
call a doctor or get the person to a doctor right away.
What Is the Injury Compensation Program?
The National Vaccine Injury Compensation Program is a U.S.
government program that gives compensation (payment) for some persons
thought to be injured by vaccines. For facts about this program, call
this toll-free number: 1-800-338-2382.
If you believe that the person getting the vaccine had a serious
problem because of the vaccine, tell the doctor/nurse or health
department. Ask him or her to report the problem on a Vaccine Adverse
Event Report form. If you want to report it yourself, you can get the
form by calling this toll-free number: 1-800-822-7967.
U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention
Td 00/00/94 (Proposed)
42 U.S.C. 300aa-26
Dated: January 18, 1994.
Walter R. Dowdle,
Deputy Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 94-1587 Filed 1-25-94; 8:45 am]
BILLING CODE 4160-18-P
