[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]
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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
