[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Notices]
[Page 33308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-15758]


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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