E7-5917. Meeting: Vaccine Safety Evaluation: Post-Marketing Surveillance

AGENCY:

Department of Health and Human Services, Office of the Secretary.

ACTION:

Notice.

SUMMARY:

The National Vaccine Program Office is hereby giving notice that, in conjunction with the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, is hosting a 2-day meeting titled: Vaccine Safety Evaluation: Post-marketing Surveillance. The meeting is open to the public.

DATES:

The meeting will be held on April 10, 2007, from 9 a.m. to 6 p.m., and on April 11, 2007, from 9 a.m. to 5 p.m.

ADDRESS:

National Institutes of Health, 9000 Rockville Pike, Natcher Auditorium—Building 45, Bethesda, Maryland 20892.

FOR FURTHER INFORMATION CONTACT:

Dr. Kenneth Bart, National Vaccine Program Office, Department of Health and Human Services, Room 443-H, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

The principal theme of the meeting is, “What should an ideal post-licensure vaccine safety system be?” As part of a continuing effort to maximize the safety of vaccines, the meeting will review what the United States is currently doing in post-marketing surveillance of vaccine safety and their strengths and weaknesses. In addition, with the participation of international experts, we expect to learn about what has worked in other countries, new methodologies that are being experimented with, and areas where new research could be directed.

Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry onto the National Institutes of Health (NIH) campus. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed material distributed to meeting attendees should submit materials to the contact person listed above prior to close of business April 2, 2007. Additionally, should you wish to make a brief presentation, please contact Dr. Kenneth Bart using the contact information provided above.

Due to security measures at the NIH campus, pre-registration will greatly ease entrance onto the campus. Any individual who wish to attend the meeting should submit that request via e-mail to [e-mail]. Please note that registration must be completed by close of business on April 2, 2007.

Additional information, including a draft agenda, can be found at: http://www.hhs.gov/​nvpo.

Dated: March 27, 2007.

Bruce Gellin,

Director, National Vaccine Program Office.