[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)]
[Notices]
[Page 63106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25753]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Measles, Mumps, Rubella (MMR) Vaccine Information 
Materials

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice with comment period.

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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 revised from 3 months to 4 weeks, the vaccine information 
materials covering measles, mumps and rubella vaccine must be revised. 
CDC seeks written comment on proposed revised vaccine information 
materials for MMR vaccine.

DATES: Written comments are invited and must be received on or before 
December 9, 2002.

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: The National Childhood Vaccine Injury Act of 
1986 (Public Law 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, whether public or 
private, 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 covered by this statutory requirement are diphtheria, 
tetanus, pertussis, measles, mumps, rubella, polio, hepatitis B, 
Haemophilus influenzae type b (Hib), varicella (chickenpox), and 
pneumococcal conjugate vaccine. Copies of the current vaccine 
information statements (VIS) for these vaccines, and instructions for 
their use, can be found on the CDC Web site at: http://www.cdc.gov/nip/
publications/vis/.

Measles, Mumps & Rubella Vaccine

    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 
website on June 13, 2002. Following comments received during the 
consultation process mandated by the statute, we are proposing slightly 
different language to further clarify this recommendation through 
publication of this notice announcing proposed revised MMR vaccine 
information materials.
    We invite written comment on the proposed revisions to the vaccine 
information materials, entitled ``Measles, Mumps & Rubella Vaccines: 
What You Need to Know.'' Comments submitted will be considered in 
finalizing these materials. When the final materials are published in 
the Federal Register, the notice will include an effective date for 
their use. In the meantime, the interim MMR materials, dated June 13, 
2002, which reflect the revised recommendation, can be used in lieu of 
the 12/16/98 version of the MMR materials.
* * * * *

Proposed Measles, Mumps & Rubella Vaccine Information Materials

    The vaccine information materials, entitled ``Measles, Mumps & 
Rubella Vaccines: What You Need to Know,'' and dated 12/16/98 and 6/13/
02 (interim), are proposed to be revised as follows:
    Section 3, ``Some people should not get MMR vaccine or should 
wait.'' Delete the third bullet and replace it with the following:
    ``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.''
    Section 5, ``What if there is a moderate or severe reaction?'' At 
the end of the last bullet, add the website address for the Vaccine 
Adverse Event Reporting System.
* * * * *

    Dated: October 4, 2002.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention.
[FR Doc. 02-25753 Filed 10-9-02; 8:45 am]
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