[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Page 37400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18397]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antimicrobial Drugs and Resistance; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the development of drug products for the treatment
of resistant bacteria, including selective spectrum agents. The purpose
of the meeting is to provide information on the agency's plans for
future public scientific discussions of issues unique to the
development of these drug products and to invite members of the public
to provide comments on the agency's plans.
DATES: The public meeting will be held on Tuesday, July 28, 1998, from
2 p.m. to 6 p.m.
ADDRESSES: The public meeting will be held in conference rooms G and H,
Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Thomas H. Hassall, Center for Drug
Evaluation and Research (HFD-104), Food and Drug Administration, 9201
Corporate Blvd., Rockville, MD 20850, 301-827-2489.
SUPPLEMENTARY INFORMATION: FDA will hold a public meeting on July 28,
1998, to discuss its plans for a presentation at a fall 1998 advisory
committee meeting and possible future meetings on the development of
drug products to treat resistant bacteria, including selective spectrum
agents. At the fall 1998 advisory committee meeting, FDA plans to
discuss issues unique to the development of such products, including
clinical trial design and labeling issues. At the meeting, FDA will
present its thoughts on the issues that should be presented to the
advisory committee and will solicit public input on the structure of
the discussion and additional issues that should be presented.
There is no registration for this meeting, however, space is
limited. Persons interested in attending the meeting should contact the
person listed above.
An agenda for the public meeting will be available 2 weeks before
the meeting, via the Internet using the World Wide Web (WWW). To
connect to the CDER home page, type ``http://www.fda.gov/cder'' and go
to the ``What's Happening'' section.
Dated: July 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18397 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F
