[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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