[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.

-----------------------------------------------------------------------

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