[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)] [Notices] [Page 33308] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-15758] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Meeting
Agency
Food and Drug Administration, HHS.
Action
Notice of meeting.
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Summary
The Food and Drug Administration (FDA) is announcing a meeting concerning the public availability of information on clinical trials for investigational devices intended to treat serious or life- threatening conditions and the availability of this information in a publicly available data bank. This meeting is being held to assist the agency in preparing a report to Congress required under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is inviting written comments and information that may assist FDA in this endeavor.
Dates
The meeting will be held on July 8, 1999, from 1:30 p.m. to 4:30 p.m.; registration will begin at 1 p.m.
Addresses
The meeting will be held at 9200 Corporate Blvd., conference room 020B, Rockville, MD.
For Further Information Contact
Robert R. Gatling, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190, ext. 140, FAX 301- 594-2977, or e-mail ``rrg@cdrh.fda.gov''. Those persons interested in attending the meeting should fax or e- mail their registration including name, title, firm name, address, telephone, and fax number to Linda J. Lyons at 301-594-1190, ext. 108 or by fax at 301-594-2977. There is no charge to attend this meeting, but advance registration is requested due to limited seating. If you need special accommodations due to a disability, please contact Linda J. Lyons at least 7 days in advance. Comments at the meeting may be limited in time depending on the number of presenters. Presenters should contact Linda J. Lyons by July 5, 1999.
Supplementary Information
FDAMA (Pub. L. 105-115) was enacted on November 21, 1997. Section 113(a) of FDAMA amends section 402 of the Public Health Service Act (PHS Act) (42 U.S.C. 282) by adding a new section 402(j). This new section directs the Secretary of Health and Human Services (the Secretary), acting through the Director of the National Institutes of Health (NIH), to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
Section 113(b) of FDAMA (collaboration and report) directs the Secretary, the Director of NIH, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device investigations within the scope of the data bank under new section 402(j) of the PHS Act. In addition, section 113(b) of FDAMA directs the Secretary to prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report on the following: 1. The public health need, if any, for inclusion of device investigations within the scope of the data bank under section 402(j) of the PHS Act; 2. The adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations is required to be publicly disclosed; and, 3. Such other issues relating to section 402(j) of the PHS Act as the Secretary determines to be appropriate. Elsewhere in this issue of the Federal Register, FDA is inviting written comments and information that may assist FDA in preparing their report to Congress. Those questions should also be considered by those making presentations at the public meeting.
Dated: June 14, 1999. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 99-15758 Filed 6-21-99; 8:45 am] BILLING CODE 4160-01-F