[Federal Register Volume 68, Number 44 (Thursday, March 6, 2003)]
[Notices]
[Pages 10727-10729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Revised Vaccine Information Materials for Measles, Mumps and 
Rubella Vaccines; Revised Instructions for Use of Vaccine Information 
Statements

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. Since the recommended interval 
between receiving rubella-containing vaccine and becoming pregnant has 
been amended from 3 months to 4 weeks, the vaccine information 
materials covering measles, mumps and rubella vaccine needed to be 
revised. On October 10, 2002, CDC published a notice in the Federal 
Register (67 FR 63106) seeking public comments on the proposed revised 
vaccine information materials for measles, mumps and rubella vaccines. 
The 60 day comment period ended on December 9, 2002. Following review 
of the comments submitted and consultation as required under the law, 
CDC has finalized these vaccine information materials. The final 
materials, and revised instructions for their use and for use of 
materials for other covered vaccines, are contained in this notice.

DATES: Beginning as soon as practicable, each health care provider who 
administers any vaccine that contains measles, mumps or rubella vaccine 
shall, prior to administration of each dose of the vaccine, provide a 
copy of the vaccine information materials contained in this notice, 
dated January 15, 2003, 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 the 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

[[Page 10728]]

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. As 
new vaccines have been added to the National Vaccine Injury 
Compensation Program, materials for those vaccines have also been 
developed. Since June 1, 1999, health care providers are required to 
provide copies of vaccine information materials for the following 
vaccines: hepatitis B, haemophilus influenzae type b (Hib), and 
varicella (chickenpox) vaccines. And, effective December 15, 2002, use 
of vaccine information materials for pneumococcal conjugate vaccine was 
mandated.

Revised Vaccine Information Materials for Measles, Mumps & Rubella 
(MMR) Vaccines

    The Advisory Committee on Immunization Practices revised its 
recommendations for administration of rubella-containing vaccines to 
change the recommended interval between receiving MMR vaccine and 
becoming pregnant from 3 months to 4 weeks (``Revised ACIP 
Recommendations for Avoiding Pregnancy After Receiving a Rubella-
Containing Vaccine'' MMWR 50/49, Dec 14, 2001). Interim vaccine 
information materials reflecting this change were posted on the CDC Web 
site on June 13, 2002. We proposed slightly different language to 
further clarify this recommendation when the proposed revised MMR 
vaccine information materials were published for public comment in the 
Federal Register on October 10, 2002 (67 FR 63106).
    Following consultation and review of comments submitted, these 
vaccine information materials have been finalized and are contained in 
this notice. They are entitled ``Measles, Mumps & Rubella Vaccines: 
What You Need to Know,'' and are dated January 15, 2003. CDC has also 
revised the Instructions for the Use of Vaccine Information Statements. 
The revised instructions, dated January 15, 2003, are included in this 
notice. These instructions and copies of the materials for all covered 
vaccines can also be found on the CDC Web site at: http://www.cdc.gov/nip/publications/VIS/. In addition, single camera-ready copies of the 
materials, and the instructions for their use, 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).
* * * * *

Instructions for the Use of Vaccine Information Statements

Required Use

1. Provide VIS When Vaccination Is Given
    As required under the National Childhood Vaccine Injury Act (42 
U.S.C. 300aa-26), all health care providers in the United States who 
administer any vaccine containing diphtheria, tetanus, pertussis, 
measles, mumps, rubella, polio, hepatitis B, Haemophilus influenzae 
type b (Hib), varicella (chickenpox), or pneumococcal conjugate vaccine 
shall, prior to administration of each dose of the vaccine, provide a 
copy to keep of the relevant current edition vaccine information 
materials that have been produced by the Centers for Disease Control 
and Prevention (CDC):

--To the parent or legal representative* of any child to whom the 
provider intends to administer such vaccine, or
--To any adult to whom the provider intends to administer such vaccine.
    The materials shall be supplemented with visual presentations or 
oral explanations, as appropriate.
    If there is not a single VIS for a combination vaccine (e.g., 
hepatitis A/Hepatitis B), use the VISs for both component vaccines.

    * ``Legal representative'' is defined as a parent or other 
individual who is qualified under State law to consent to the 
immunization of a minor.
2. Record Information for Each VIS Provided
    Health care providers shall make a notation in each patient's 
permanent medical record at the time vaccine information materials are 
provided indicating:
    (1) The edition date of the materials, and
    (2) The date these materials were provided.
    This recordkeeping requirement supplements the requirement of 42 
U.S.C. 300aa-25 that all health care providers administering these 
vaccines must record in the patient's permanent medical record or in a 
permanent office log:
    (3) The name, address and title of the individual who administers 
the vaccine,
    (4) The date of administration, and
    (5) The vaccine manufacturer and lot number of the vaccine used.

Additional Recommended Use

    Health care providers may also want to give parents copies of all 
vaccine information materials prior to the first immunization visit, 
such as at the first well baby visit.

Applicability of State Law

    Health care providers should consult their legal counsel to 
determine additional State requirements pertaining to immunization. The 
Federal requirements to provide the vaccine information materials 
supplement any applicable State laws.

Availability of Copies

    Single camera-ready copies of the vaccine information materials are 
available from State health departments. Copies are also available on 
the Centers for Disease Control and Prevention's Web site at http://www.cdc.gov/nip/publications/VIS. Copies are available in English and 
in other languages.

Current Editions of VISs

Diphtheria, Tetanus, Pertussis (DTaP/DT): 7/30/01
Tetanus Diphtheria (Td): 6/10/94
Measles, Mumps, Rubella (MMR): 1/15/03
Hepatitis B: 7/11/01
Polio: 1/1/00
Haemophilus influenzae type b: 12/16/98
Varicella (chickenpox): 12/16/98
Pneumococcal conjugate: 9/30/02

Reference 42 U.S.C. 300aa-26
1/15/03
* * * * *

Measles, Mumps & Rubella Vaccines: What You Need to Know

1. Why Get Vaccinated?
    Measles, mumps, and rubella are serious diseases.

[[Page 10729]]

Measles
    [sbull] Measles virus causes rash, cough, runny nose, eye 
irritation, and fever.
    [sbull] It can lead to ear infection, pneumonia, seizures (jerking 
and staring), brain damage, and death.
Mumps
    [sbull] Mumps virus causes fever, headache, and swollen glands.
    [sbull] It can lead to deafness, meningitis (infection of the brain 
and spinal cord covering), painful swelling of the testicles or 
ovaries, and, rarely, death.
Rubella (German Measles)
    [sbull] Rubella virus causes rash, mild fever, and arthritis 
(mostly in women).
    [sbull] If a woman gets rubella while she is pregnant, she could 
have a miscarriage or her baby could be born with serious birth 
defects.
    You or your child could catch these diseases by being around 
someone who has them. They spread from person to person through the 
air.
    Measles, mumps, and rubella (MMR) vaccine can prevent these 
diseases.
    Most children who get their MMR shots will not get these diseases. 
Many more children would get them if we stopped vaccinating.
2. Who Should Get MMR Vaccine and When?
    Children should get 2 doses of MMR vaccine:

--The first at 12-15 months of age.
--And the second at 4-6 years of age.

    These are the recommended ages. But children can get the second 
dose at any age, as long as it is at least 28 days after the first 
dose.
    Some adults should also get MMR vaccine:
    Generally, anyone 18 years of age or older, who was born after 
1956, should get at least one dose of MMR vaccine, unless they can show 
that they have had either the vaccines or the diseases.
    Ask your doctor or nurse for more information.
    MMR vaccine may be given at the same time as other vaccines.
3. Some People Should Not Get MMR Vaccine or Should Wait
    [sbull] People should not get MMR vaccine who have ever had a life-
threatening allergic reaction to gelatin, the antibiotic neomycin, or a 
previous dose of MMR vaccine.
    [sbull] People who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
MMR vaccine.
    [sbull] Pregnant women should wait to get MMR vaccine until after 
they have given birth. Women should avoid getting pregnant for 4 weeks 
after getting MMR vaccine.
    [sbull] Some people should check with their doctor about whether 
they should get MMR vaccine, including anyone who:

--Has HIV/AIDS, or another disease that affects the immune system.
--Is being treated with drugs that affect the immune system, such as 
steroids, for 2 weeks or longer.
--Has any kind of cancer.
--Is taking cancer treatment with x-rays or drugs.
--Has ever had a low platelet count (a blood disorder).

    [sbull] People who recently had a transfusion or were given other 
blood products should ask their doctor when they may get MMR vaccine.
    Ask your doctor or nurse for more information.
4. What Are the Risks From MMR Vaccine?
    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of MMR vaccine 
causing serious harm, or death, is extremely small.
    Getting MMR vaccine is much safer than getting any of these three 
diseases.
    Most people who get MMR vaccine do not have any problems with it.

Mild Problems

    Fever (up to 1 person out of 6).
    Mild rash (about 1 person out of 20).
    Swelling of glands in the cheeks or neck (rare).
    If these problems occur, it is usually within 7-12 days after the 
shot. They occur less often after the second dose.

Moderate Problems

    Seizure (jerking or staring) caused by fever (about 1 out of 3,000 
doses).
    Temporary pain and stiffness in the joints, mostly in teenage or 
adult women (up to 1 out of 4).
    Temporary low platelet count, which can cause a bleeding disorder 
(about 1 out of 30,000 doses).
    Severe Problems (Very Rare).
    Serious allergic reaction (less than 1 out of a million doses).
    Several other severe problems have been known to occur after a 
child gets MMR vaccine.
    But this happens so rarely, experts cannot be sure whether they are 
caused by the vaccine or not. These include:

--Deafness.
--Long-term seizures, coma, or lowered consciousness.
--Permanent brain damage.
5. 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. A high fever or seizure, if it occurs, would 
happen 1 or 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 or visit their Web site at http://www.vaers.org.
6. 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 you 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/osp/vicp.
7. How Can I Learn More?
    Ask your doctor or nurse. They can give you the vaccine package 
insert or suggest other sources of information.
    Call your local or state health department's immunization program.
    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
MMR (1/15/03)
42 U.S.C. 300aa-26
* * * * *

    Dated: February 28, 2003.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 03-5248 Filed 3-5-03; 8:45 am]
BILLING CODE 4163-18-P