[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37400-37401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


1998 FDA Science Forum--Biotechnology: Advances, Applications, 
and Regulatory Challenges

Agency: Food and Drug Administration, HHS.

Action: Notice of meeting.

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    The Food and Drug Administration's (FDA's) Office of Science is 
announcing the following meeting: ``1998 FDA Science Forum--
Biotechnology: Advances, Applications, and Regulatory Challenges.'' The 
Forum will bring FDA research and review scientists together with 
representatives of industry, academia, Government agencies, consumer 
groups, and the public to discuss the impact of the enormous advances 
in biotechnology on product development and regulation.
    Date and Time: The meeting will be held on Tuesday and Wednesday, 
December 8 and 9, 1998; registration from 7:00 a.m. to 8:30 a.m.; 
meeting from 8:30 a.m. to 6:00 p.m. on December 8, and 8:30 a.m. to 
5:00 p.m. on December 9.
    Location: The meeting will be held at the Washington Convention 
Center, rms. 29-32 (lower level) and Hall C (upper level) 900 Ninth 
Street, NW., Washington, DC 20001.
    Contact: American Association of Pharmaceutical Scientists at 
<[email protected]>, 703-518-8429, or Susan A. Homire, Food and Drug 
Administration, Office of Science (HF-32), 5600 Fishers Lane, 
Rockville, MD, 20857, 301-827-3366, e-mail <[email protected]>.
    Registration: Registration information will be available in mid-
July. Attendance will be limited; therefore, interested parties are 
encouraged to register early.
    If you need special accommodations due to a disability, please 
contact the American Association of Pharmaceutical Scientists at least 
3 weeks in advance.
    Agenda: The program will encompass bioengineered products, novel 
therapeutic and preventive approaches, diagnostics and detection 
methodologies, and safety and efficacy

[[Page 37401]]

assessment. Regulatory issues related to standards and product quality 
and the impact of the Food and Drug Administration Modernization Act 
(FDAMA) will also be addressed. The Forum will feature plenary lectures 
and focused discussion groups that include FDA, industry, and 
university leaders in the field, on the following topics: (1) 
``Biofarming and biopharming'' (bioengineered plants and animals as 
sources of foods and drugs); (2) diagnostics and detection methods; (3) 
microbial pathogens, antibiotics, and resistance; (4) therapeutic and 
preventive agents: Novel therapies, gene therapy, cell and tissue 
engineering, and vaccines; (5) new models/methods for safety and 
efficacy assessment; and (6) regulatory challenges: Standards, product 
quality, FDAMA and impact on biotechnology regulation, and public 
acceptance of novel products.
    The meeting is co-sponsored by FDA, the American Association of 
Pharmaceutical Scientists, and the FDA Chapter of Sigma Xi, the 
Scientific Research Society.

    Dated: June 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18399 Filed 7-9-98; 8:45 am]
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