Human drugs, biological products, and medical devices: Unapproved/new uses; information dissemination Meeting,
[Federal Register: June 30, 1998 (Volume 63, Number 125)]
[Proposed Rules]
[Page 35551]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn98-33]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 99
Single Issue Focus Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
SUMMARY: The Food and Drug Administration's Office of Consumer Affairs is announcing a Single Issue Focus Meeting. The meeting will provide an opportunity for consumers, patient advocates, health professionals, and industry to learn about and comment on the proposed rule published in the Federal Register of June 8, 1998, on section 401 of the Food and Drug Administration Modernization Act of 1997 and the dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices. Dates: The meeting will be held on Wednesday, July 8, 1998, from 1:30 p.m. to 4:30 p.m. Send information regarding registration by July 6, 1998. ADDRESSES: The meeting will be held at the Wilbur J. Cohen Bldg., Snow Room, 330 Independence Ave., SW., Washington, DC. Metro Stop: Blue or Orange Line to Federal Center, SW. FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, Office of Consumer Affairs (HFE-40), Food and Drug Administration, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, 301-827-4417, FAX 301- 443-9767, E-mail: SMTP[Manders1@bangate.fda.gov]. SUPPLEMENTARY INFORMATION: Send registration information (including name, title, organization, address, telephone, fax number, and any requests for oral presentations) to the contact person (address above) by July 6, 1998. Any requests for oral presentations should include a brief summary of the presentation and the approximate amount of time requested for the presentation. The agency requests that persons or groups having similar interests consolidate their presentations and present them through a single representative. Every effort will be made to accommodate all registrants and requests for oral presentations. However because space and time is limited, admittance is on a ``first come, first serve basis,'' and the agency may not be able to accommodate all requests for oral presentations.
If you need special accommodations due to a disability, please contact Michael D. Anderson (address above) by July 6, 1998.
Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.
Dated: June 23, 1998. William B. Schultz, Deputy Commissioner for Policy.
[FR Doc. 98-17293Filed6-29-98; 8:45 am]
BILLING CODE 4160-01-F
