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

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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