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The Safety of Measles-Mumps-Rubella (MMR) Vaccine; Notice of Award of Funds

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Information about this document as published in the Federal Register.

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A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the award of fiscal year (FY) 2002 funds for a cooperative agreement program for the Safety of Measles-Mumps-Rubella Vaccine. This program addresses the “Healthy People 2010” focus areas of Immunization and Infectious Diseases.

The purpose of the program is to ensure the safety of vaccines contained in the recommended childhood immunization schedule, specifically the safety of the measles-mumps-rubella vaccine (MMR) by performing the following:

1. Determine the presence of measles vaccine strain gene sequences in intestinal tissue obtained from children with autistic spectrum disorder (ASD).

2. Determine the presence of measles vaccine strain gene sequences in Start Printed Page 63433intestinal tissue obtained from matched controls.

3. Compare results between the two groups.

4. Provide the results of these studies to practicing physicians and other health care professionals.

Measurable outcomes of the program will be in alignment with the following performance goals for the National Immunization Program: (1) Reduce the number of indigenous cases of vaccine-preventable diseases, (2) ensure that two year olds are appropriately vaccinated, and (3) work with global partners to reduce the cumulative global measles related mortality rate.

B. Eligible Applicants

Assistance will be provided only to the American Academy of Pediatrics (AAP). No other applications are solicited. The potential role of the MMR vaccine as a cause of autism has divided segments of the medical, scientific and public communities and threatens to adversely effect the MMR immunization program in the United States as it has in the United Kingdom and Ireland, where MMR immunization rates have dropped sharply from above 95 percent to just over 70 percent. This sharp decrease came as a result of two published papers alleging an association between the MMR vaccine and Autism. To provide definitive data as to the potential link between measles antigen in the intestine and autistic disorder, groups and organizations which feel strongly that there either is or is not an association between MMR and autistic disorder must be involved in this study to ensure acceptance of the results. Groups that must be involved in this study include autism community representatives (MIND Institute, Cure Autism Now, Autism Society of America); research groups at Harvard University, Columbia University, Coombe Women's Hospital, Dublin, Ireland; CDC; other government representatives; and members of the general medical and scientific communities. AAP is the only organization that can ensure that these diverse groups, organizations and individuals come together to implement and complete this proposal. This is because AAP is the only major scientific and professional body with credibility among all of the groups with a stake in the outcome. AAP has made significant scientific contribution in the investigation of the possible association of MMR vaccine and Autism. AAP has been the only organization that has pulled these groups together in the past to evaluate MMR vaccine and autistic spectrum disorder. In June 2000, AAP convened a conference at which parents, practitioners, and scientists presented information on MMR and ASD. AAP then formed a multidisciplinary panel of experts who reviewed data on the pathogenesis, epidemiology, and genetics of ASD and the available data on the hypothesized associations with Intestinal Bowel Disease, measles, and MMR vaccine. AAP's findings were published in the May 2001 issue of Pediatrics. ['Measles-mumps-rubella vaccine and autistic spectrum disorder: report from the new challenges in childhood immunizations conference convened in Oak Beach, Illinois, June 12-13, 2000”. Pediatrics 2001; 107(5) url:http//www.pediatrics.org/​cgi.content/​full/​107/​5/​e84/​].

Additionally, because of AAP's broad scope of contacts, the organization's respect among pediatricians and other healthcare providers, data from this project can be facilitated and disseminated rapidly. The immunization recommendations and guidelines developed by AAP are considered among the most reliable and up-to-date information available to the pediatric community. When study findings are disseminated by AAP, immunization practices could be affected significantly.

C. Funds

Approximately $450,000 is being awarded FY 2002. It is expected that the award will begin on or about August 30, 2002 and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

D. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address—http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For business management technical assistance, contact: Ms. Peaches Brown, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146. Telephone number 770-488-2738. E-mail address: prb0@cdc.gov.

For program technical assistance, contact: Maureen Kolasa, Epidemiologist, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop E-52, Atlanta, Georgia 30333. Telephone number 404-639-8759. E-mail address: mxk2@cdc.gov.

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Dated: October 4, 2002.

Sandra R. Manning,

CGFM, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

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[FR Doc. 02-25952 Filed 10-10-02; 8:45 am]

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