[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Notices]
[Pages 61110-61114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Vaccine Information Materials for Pneumococcal Conjugate, 
Diphtheria, Tetanus, acellular Pertussis and Hepatitis B 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 (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. On March 6, 2001, CDC published a 
notice in the Federal Register (66 FR 13540) seeking public comments on 
proposed new vaccine information materials for pneumococcal conjugate 
vaccine, and revised vaccine information materials for diphtheria, 
tetanus, acellular pertussis (DTaP/DT) vaccines and hepatitis B 
vaccine. Following review of the comments submitted and consultation as 
required under the law, CDC has finalized these vaccine information 
materials. The final materials are contained in this notice.

DATES: Beginning no later than December 15, 2002, each health care 
provider who administers any vaccine that contains pneumococcal 
conjugate vaccine shall, prior to administration of each dose, provide 
a copy of the pneumococcal conjugate vaccine information materials 
contained in this notice to the parent or legal representative of any 
child to whom such provider intends to administer the vaccine.
    Beginning as soon as practicable, each health care provider who 
administers any vaccine that contains diphtheria, tetanus, acellular 
pertussis or hepatitis B vaccine shall, prior to administration of each 
dose of the vaccine, provide a copy of the relevant vaccine information 
materials contained in this notice to the parent or legal 
representative of any child to whom such provider intends to administer 
the vaccine and to any adult to whom such provider intends to 
administer hepatitis B vaccine, in lieu of providing earlier versions 
of these materials.

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, telephone (404) 639-8200.

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 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, also known as Vaccine Information 
Statements (VIS), prior to administration of any of these vaccines. 
Since June 1, 1999, health care providers are also required to provide 
copies of vaccine information materials for the following vaccines that 
were added to the National Vaccine Injury Compensation Program: 
hepatitis B, haemophilus influenzae type b (Hib), and varicella 
(chickenpox) vaccines.

Pneumococcal Conjugate Vaccine Information Materials

    Following the addition of pneumococcal conjugate vaccine to the 
National Vaccine Injury Compensation Program, CDC, as required under 42 
U.S.C. 300aa-26, proposed vaccine information materials covering that 
vaccine which were published in a Federal Register notice on March 6, 
2001 (66 FR 13540). With publication of this notice, as of December 15, 
2002, health care providers will also be required to provide copies of 
pneumococcal conjugate vaccine information materials

Revised Vaccine Information Materials for Diphtheria, Tetanus, 
acellular Pertussis (DTaP/DT) Vaccines and Hepatitis B Vaccine

    Proposed revised vaccine information materials for diphtheria, 
tetanus, acellular pertussis (DTaP/DT) vaccines and hepatitis B vaccine 
were also published in the March 6, 2001 Federal Register notice.

New/Revised Vaccine Information Materials

    The new/revised vaccine information materials were drafted in 
consultation with the Advisory Commission on Childhood Vaccines, the 
Food and Drug Administration, the American Academy of Pediatrics, 
American Pharmaceutical Association, Association of American Indian 
Physicians, Every Child by Two, Immunization Action Coalition, 
Immunization, Education and Action Committee, Infectious Diseases 
Society of America, National Association for Pediatric Nurse Associates 
and Practitioners and the National Vaccine Advisory Committee. Also, 
CDC provided copies of the draft materials to other organizations and 
sought their consultation; however, those organizations did not provide 
comments.
    Following consultation and review of comments submitted, these 
vaccine information materials have been finalized and are contained in 
this notice. They are entitled ``Pneumococcal Conjugate Vaccine: What 
You Need to Know,'' ``Diphtheria,

[[Page 61111]]

Tetanus & Pertussis Vaccines: What You Need to Know,'' and ``Hepatitis 
B Vaccine: What You Need to Know.'' CDC has also revised the 
Instructions for the Use of Vaccine Information Statements.
    Instructions for use of the vaccine information materials and 
copies of the materials can be found on the CDC website at: http://www.cdc.gov/nip/publications/VIS/. In addition, single camera-ready 
copies are 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).
* * * * *

Pneumococcal Conjugate Vaccine: What You Need to Know

1. Why get vaccinated?

    Infection with Streptococcus pneumoniae bacteria can cause serious 
illness and death. Invasive pneumococcal disease is responsible for 
about 200 deaths each year among children under 5 years old. It is the 
leading cause of bacterial meningitis in the United States. (Meningitis 
is an infection of the covering of the brain).
    Each year pneumococcal infection causes severe disease in children 
under five years old. Before a vaccine was available, pneumococcal 
infection each year caused:
    [sbull] Over 700 cases of meningitis
    [sbull] 13,000 blood infections, and
    [sbull] About 5 million ear infections
    It can also lead to other health problems, including:
    [sbull] Pneumonia,
    [sbull] Deafness,
    [sbull] Brain damage.
    Children under 2 years old are at highest risk for serious disease. 
Pneumococcus bacteria are spread from person to person through close 
contact.
    Pneumococcal infections can be hard to treat because the bacteria 
have become resistant to some of the drugs that have been used to treat 
them. This makes prevention of pneumococcal infections even more 
important. Pneumococcal conjugate vaccine can help prevent serious 
pneumococcal disease, such as meningitis and blood infections. It can 
also prevent some ear infections. But ear infections have many causes, 
and pneumococcal vaccine is effective against only some of them.

2. Pneumococcal conjugate vaccine

    Pneumococcal conjugate vaccine is approved for infants and 
toddlers. Children who are vaccinated when they are infants will be 
protected when they are at greatest risk for serious disease.
    Some older children and adults may get a different vaccine called 
pneumococcal polysaccharide vaccine. There is a separate Vaccine 
Information Statement for people getting this vaccine.

3. Who should get the vaccine and when?

    [sbull] Children under 2 years of age:

--2 months
--4 months
--6 months
--12-15 months

    Children who weren't vaccinated at these ages can still get the 
vaccine. The number of doses needed depends on the child's age. Ask 
your health care provider for details.
    [sbull] Children between 2 and 5 years of age:
    Pneumococcal conjugate vaccine is also recommended for children 
between 2 and 5 years old who have not already gotten the vaccine and 
are at high risk of serious pneumococcal disease.
    This includes children who:

--Have sickle cell disease,
--Have a damaged spleen or no spleen,
--Have HIV/AIDS,
--Have other diseases that affect the immune system, such as diabetes, 
cancer, or liver disease, or who
--Take medications that affect the immune system, such as chemotherapy 
or steroids, or
--Have chronic heart or lung disease.

    The vaccine should be considered for all other children under age 5 
years, especially those at higher risk of serious pneumococcal disease. 
This includes children who:

--Are under 3 years of age,
--Are of Alaska Native, American Indian or African American descent, or
--Attend group day care.

    The number of doses needed depends on the child's age. Ask your 
health care provider for more details.
    Pneumococcal conjugate vaccine may be given at the same time as 
other vaccines.

4. Some children should not get pneumococcal conjugate vaccine or 
should wait.

    Children should not get pneumococcal conjugate vaccine if they had 
a severe (life-threatening) allergic reaction to a previous dose of 
this vaccine, or have a severe allergy to a vaccine component. Tell 
your health-care provider if your child has ever had a severe reaction 
to any vaccine, or has any severe allergies.
    Children with minor illnesses, such as a cold, may be vaccinated. 
But children who are moderately or severely ill should usually wait 
until they recover before getting the vaccine.

5. What are the risks from pneumococcal conjugate vaccine?

    In studies (nearly 60,000 doses), pneumococcal conjugate vaccine 
was associated with only mild reactions:
    [sbull] Up to about 1 infant out of 4 had redness, tenderness, or 
swelling where the shot was given.
    [sbull] Up to 1 out of 3 had a fever of over 100.4[deg]F, and up to 
about 1 in 50 had a higher fever (over 102.2[deg]F).
    [sbull] Some children also became fussy or drowsy, or had a loss of 
appetite.
    So far, no moderate or severe reactions have been associated with 
this vaccine. However, a vaccine, like any medicine, could cause 
serious problems, such as a severe allergic reaction. The risk of this 
vaccine causing serious harm, or death, is extremely small.

6. What if there is a moderate or severe reaction? What should I look 
for?

    Look for any unusual condition, such as a serious allergic 
reaction, high fever, or unusual behavior.
    Serious allergic reactions are extremely rare with any vaccine. If 
one were to occur, it would most likely be within a few minutes to a 
few hours after the shot. Signs can include:

--Difficulty breathing
--Hoarseness or wheezing
--Hives
--Paleness
--Weakness
--A fast heart beat
--Dizziness
--Swelling of the throat
What should I do?
    [sbull] Call a doctor or get the person to a doctor right away.
    [sbull] Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
    [sbull] Ask your health care provider to file a Vaccine Adverse 
Event Reporting System (VAERS) form. Or call VAERS yourself at 1-800-
822-7967, or visit their Web site at http://www.vaers.org.

7. The Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a federal program has been created to help pay for the care 
of those who have been harmed. For details about the National Vaccine 
Injury Compensation Program, call 1-800-338-2382 or visit their Web 
site at http://www.hrsa.gov/bhpr/vicp.

[[Page 61112]]

8. How can I learn more?

    [sbull] Ask your health care provider. They can give you the 
vaccine package insert or suggest other sources of information.
    [sbull] Call your local or state health department's immunization 
program.
    [sbull] Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://
www.cdc.gov/nip

    U.S. Department of Health & Human Services, Centers for Disease 
Control and Prevention, National Immunization Program.
    Vaccine Information Statement, Pneumococcal Conjugate Vaccine, (9/
30/02), 42 U.S.C. 300aa-26.
* * * * *

Diphtheria, Tetanus & Pertussis Vaccines: What You Need to Know

1. Why get vaccinated?

    Diphtheria, tetanus, and pertussis are serious diseases caused by 
bacteria. Diphtheria and pertussis are spread from person to person. 
Tetanus enters the body through cuts or wounds.
    Diphtheria causes a thick covering in the back of the throat.
    [sbull] It can lead to breathing problems, paralysis, heart 
failure, and even death.
    Tetanus (Lockjaw) causes painful tightening of the muscles, usually 
all over the body.
    [sbull] It can lead to ``locking'' of the jaw so the victim cannot 
open his mouth or swallow. Tetanus leads to death in about 3 out of 10 
cases.
    Pertussis (Whooping Cough) causes coughing spells so bad that it is 
hard for infants to eat, drink, or breathe. These spells can last for 
weeks.
    [sbull] It can lead to pneumonia, seizures (jerking and staring 
spells), brain damage, and death.
    Diphtheria, tetanus, and pertussis vaccine (DTaP) can prevent these 
diseases. Most children who are vaccinated with DTaP will be protected 
throughout childhood. Many more children would get these diseases if we 
stopped vaccinating.
    DTaP is a safer version of an older vaccine called DTP. DTP is no 
longer used in the United States.

2. Who should get DTaP vaccine and when?

    Children should get 5 doses of DTaP vaccine, one dose at each of 
the following ages:

--2 months
--4 months
--6 months
--15-18 months
--4-6 years

    DTaP may be given at the same time as other vaccines.

3. Some children should not get DTaP vaccine or should wait

    [sbull] Any child who has had a life-threatening allergic reaction 
after a dose of DTaP should not get any more doses.
    [sbull] Any child who suffered a brain or nervous system disease 
within 7 days after a dose of DTaP should not get any more doses.
    [sbull] Talk with your doctor if your child:

--had a seizure or collapsed after a previous dose of DTaP,
--cried non-stop for 3 hours or more after a previous dose of DTaP,
--had a high fever (over 105oF) after a previous dose of DTaP.

    [sbull] Children who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
DTaP vaccine.
    Ask your health care provider for more information. Children who 
should not get the pertussis part of the vaccine can get a vaccine 
called DT, which doesn't contain pertussis.

4. Older children and adults

    DTaP should not be given to anyone 7 years of age or older. 
Pertussis can still strike older children, adolescents, and adults, but 
the pertussis vaccine is currently licensed only for children under 7.
    Adolescents and adults still need protection from tetanus and 
diphtheria. A booster shot called Td is recommended at 11-12 years of 
age. It should be repeated every 10 years. There is a separate Vaccine 
Information Statement for Td vaccine.

5. What are the risks from DTaP vaccine?

    Getting diphtheria, tetanus, or pertussis disease is much riskier 
than getting DTaP vaccine.
    However, a vaccine, like any medicine, is capable of causing 
serious problems, such as severe allergic reactions. The risk of DTaP 
vaccine causing serious harm, or death, is extremely small.
Mild Problems (Common)
    [sbull] Fever (up to about 1 child in 4)
    [sbull] Redness or swelling where the shot was given (up to about 1 
child in 4)
    [sbull] Soreness or tenderness where the shot was given (up to 
about 1 child in 4)
    These problems occur more often after the 4th and 5th doses of the 
DTaP series than after earlier doses.
    Another mild problem is swelling of the arm or leg in which the 
shot was given, after the 4th or 5th dose (up to about 1 child in 30).
    Other mild problems include:
    [sbull] Fussiness (up to about 1 child in 3)
    [sbull] Tiredness or poor appetite (up to about 1 child in 10)
    [sbull] Vomiting (up to about 1 child in 50)
    These problems generally occur 1-3 days after the shot.
Moderate Problems (Uncommon)
    [sbull] Seizure (jerking or staring) (about 1 child out of 14,000)
    [sbull] Non-stop crying, for 3 hours or more (up to about 1 child 
out of 1,000)
    [sbull] High fever, over 1050F (about 1 child out of 16,000)
Severe Problems (Very Rare)
    [sbull] Serious allergic reaction (less than 1 out of a million 
doses)
    [sbull] Several other severe problems have been reported after DTaP 
vaccine. These include:

--Long-term seizures, coma, or lowered consciousness
--Permanent brain damage.

    These are so rare it is hard to tell if they are caused by the 
vaccine.
    Controlling fever is especially important for children who have had 
seizures, for any reason. It is also important if another family member 
has had seizures.
    You can reduce fever and pain by giving your child an aspirin-free 
pain reliever when the shot is given, and for the next 24 hours, 
following the package instructions.

6. What if there is a moderate or severe reaction?

What should I look for?
    Any unusual conditions, such as a serious allergic reaction, high 
fever or behavior changes. Signs of a serious allergic reaction include 
difficulty breathing, hoarseness or wheezing, hives, paleness, 
weakness, a fast heart beat or dizziness within a few minutes to a few 
hours after the shot. If a high fever or seizure occurs, it is usually 
within 2 weeks after the shot.
What should I do?
    [sbull] Call a doctor, or get the person to a doctor right away.
    [sbull] Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
    [sbull] Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

[[Page 61113]]

7. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a federal program has been created to help pay for the care 
of those who have been harmed.
    For details about the National Vaccine Injury Compensation Program, 
call 1-800-338-2382 or visit the program's Web site at http://www.hrsa.gov/bhpr/vicp.

8. How can I learn more?

    [sbull] Ask your health care provider. They can give you the 
vaccine package insert or suggest other sources of information.
    [sbull] Call your local or state health department's immunization 
program.
    [sbull] Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://www.cdc.gov/nip.

    U.S. Department of Health & Human Services, Centers for Disease 
Control and Prevention, National Immunization Program.
    Vaccine Information Statement, DTaP/DT, (7/30/01), 42 U.S.C. 300aa-
26.
* * * * *

Hepatitis B Vaccine: What You Need to Know

1. Why get vaccinated?

Hepatitis B is a serious disease.
    The hepatitis B virus can cause short-term (acute) illness that 
leads to:
    [sbull] Loss of appetite
    [sbull] Diarrhea and vomiting
    [sbull] Tiredness
    [sbull] Jaundice (yellow skin or eyes)
    [sbull] Pain in muscles, joints, and stomach
    It can also cause long-term (chronic) illness that leads to:
    [sbull] Liver damage (cirrhosis)
    [sbull] Liver cancer
    [sbull] Death
    About 1.25 million people in the U.S. have chronic hepatitis B 
virus infection. If you are infected as a young child, you are much 
more likely to develop chronic illness.
    Each year it is estimated that:
    [sbull] 200,000 people, mostly young adults, get infected with 
hepatitis B virus
    [sbull] More than 11,000 people have to stay in the hospital 
because of hepatitis B
    [sbull] 4,000 to 5,000 people die from chronic hepatitis B
    Hepatitis B vaccine can prevent hepatitis B. It is the first anti-
cancer vaccine because it can prevent a form of liver cancer.

2. How is hepatitis B virus spread?

    Hepatitis B virus is spread through contact with the blood and body 
fluids of an infected person.
    A person can get infected in several ways, such as:
    [sbull] During birth when the virus passes from an infected mother 
to her baby
    [sbull] By having sex with an infected person
    [sbull] By injecting illegal drugs
    [sbull] By being stuck with a used needle on the job
    [sbull] By sharing personal items, such as a razor or toothbrush 
with an infected person
    People can get hepatitis B infection without knowing how they got 
it. About 1/3 of hepatitis B cases in the United States have an unknown 
source.

3. Who should get hepatitis B vaccine and when?

    (1) Everyone 18 years of age and younger
    (2) Adults over 18 who are at risk
    Adults at risk for hepatitis B infection include people who have 
more than one sex partner, men who have sex with other men, injection 
drug users, health care workers, and others who might be exposed to 
infected blood or body fluids.
    If you are not sure whether you are at risk, ask your doctor or 
nurse.
    People should get 3 doses of hepatitis B vaccine according to the 
following schedule. If you miss a dose or get behind schedule, get the 
next dose as soon as you can. There is no need to start over.

                                        Hepatitis B Vaccination Schedule
----------------------------------------------------------------------------------------------------------------
                                                                         Who?
                                     ---------------------------------------------------------------------------
                                       Infant whose mother is    Infant whose mother is
                                       infected with hepatitis     not infected with           Older child,
                                               B virus             hepatitis B virus       adolescent, or adult
----------------------------------------------------------------------------------------------------------------
When:
    First Dose......................  Within 12 hours of birth  Birth-2 months of age..  Any time.
    Second Dose.....................  1-2 months of age.......  1-4 months of age (At    1-2 months after first
                                                                 least 1 month first      dose.
                                                                 after dose).
    Third Dose......................  6 months of age.........  6-18 months of age.....  4-6 months after first
                                                                                          dose.
----------------------------------------------------------------------------------------------------------------
--The second dose must be given at least 1 month after the first dose.
--The third dose must be given at least 2 months after the second dose and at least 4 months after the first.
--The third dose should not be given to infants younger than 6 months of age.

    Adolescents 11 to 15 years of age may need only two doses of 
hepatitis B vaccine, separated by 4-6 months. Ask your health care 
provider for details.
    Hepatitis B vaccine may be given at the same time as other 
vaccines.

4. Some people should not get hepatitis B vaccine or should wait

    People should not get hepatitis B vaccine if they have ever had a 
life-threatening allergic reaction to baker's yeast (the kind used for 
making bread) or to a previous dose of hepatitis B vaccine.
    People who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting 
hepatitis B vaccine.
    Ask your doctor or nurse for more information.

5. What are the risks from hepatitis B vaccine?

    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of a vaccine 
causing serious harm, or death, is extremely small.
    Getting hepatitis B vaccine is much safer than getting hepatitis B 
disease.
    Most people who get hepatitis B vaccine do not have any problems 
with it.

[[Page 61114]]

Mild Problems
    [sbull] Soreness where the shot was given, lasting a day or two (up 
to 1 out of 11 children and adolescents, and about 1 out of 4 adults)
    [sbull] Mild to moderate fever (up to 1 out of 14 children and 
adolescents and 1 out of 100 adults)
Severe Problems
    [sbull] Serious allergic reaction (very rare)

6. What if there is a moderate or severe reaction?

What should I look for?
    Any unusual condition, such as a serious allergic reaction, 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. If such a reaction were to 
occur, it would be within a few minutes to a few hours after the shot.
What should I do?
    [sbull] Call a doctor or get the person to a doctor right away.
    [sbull] Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
    [sbull] Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

7. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a federal program has been created to help pay for the care 
of those who have been harmed.
    For details about the National Vaccine Injury Compensation Program, 
call 1-800-338-2382 or visit the program's Web site at http://www.hrsa.gov/bhpr/vicp.

8. How can I learn more?

    [sbull] Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
    [sbull] Call your local or state health department's immunization 
program.
    [sbull] Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 or 1-888-443-7232 (English)
--Call 1-800-232-0233 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://www.cdc.gov/nip or CDC's Hepatitis Branch Web site at http://www.cdc.gov/ncidod/diseases/hepatitis

    U.S. Department of Health & Human Services, Centers for Disease 
Control and Prevention, National Immunization Program.
    Vaccine Information Statement, Hepatitis B, (7/11/01), 42 U.S.C. 
300aa-26.

    Dated: September 23, 2002.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 02-24574 Filed 9-26-02; 8:45 am]
BILLING CODE 4163-18-P