[Federal Register Volume 65, Number 161 (Friday, August 18, 2000)]
[Notices]
[Page 50544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21010]



[[Page 50544]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Food and Drug Administration/Industry Exchange Conference and 
Workshop on Clinical Trial Requirements; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), Office of the 
Commissioner, Office of Regulatory Affairs, Center for Drug Evaluation 
and Research, Center for Biologic Evaluation and Research, and Center 
for Devices and Radiological Health, in cooperation with the 
Pharmaceutical Quality Institute (PQI) is announcing a conference 
entitled ``Clinical Trials 2000.'' The conference concerns FDA's 
requirements for the conduct of clinical trials in support of new drug 
applications, abbreviated new drug applications, biologics license 
applications, premarket approval applications, and 510(k) product 
marketing applications. The conference is targeted towards those 
individuals engaged in patient recruitment for clinical trials; and 
those conducting, recording, reporting, and overseeing clinical trials 
including clinical investigators, supporting medical staff, 
institutional review board members, testing laboratories, software 
developers, sponsors, monitors, and contract research organizations.
    Date and Time: Thursday, October 5, 2000, 8:30 a.m. to 4:45 p.m. 
and Friday, October 6, 2000, 8:30 a.m. to 12 noon.
    Location: Doubletree Hotel, 1750 Rockville Pike, Rockville, MD.
    Contact:
    For information regarding this notice, workshop content, and who 
should attend: Diann Shaffer, Food and Drug Administration, Baltimore 
District, 900 Madison Ave., Baltimore, MD 21201-2199, 410-962-3590, FAX 
410-962-2219 or e-mail: [email protected].
    For registration information: Satish K. Laroia, Registrar, PQI, 33 
Aspen Circle, Edison, NJ 08820, 973-812-9033, FAX 732-549-7487. As an 
alternative, the registration form and agenda can also be obtained from 
the Internet at www.fda.gov/cder/calendar/meeting/Clintrials 2000.
    Registration: The full conference and workshop registration fee is 
$349, or $325 each for three or more from the same affiliation 
registering at the same time. The fee includes breakfast on both days, 
all refreshment breaks, and lunch on the first day, and conference 
materials. One-day registration is also available (see registration 
form for details). For registration forms and other registration 
details contact Satish K. Laroia (address above). As an alternative, 
the registration form and agenda can be obtained from the Internet at 
www.fda.gov/cder/calendar. Registration is due by September 25, 2000. 
Space is limited, therefore, interested parties are encouraged to 
register early. Limited onsite registration may be available. Please 
arrive early to ensure prompt registration. Persons needing hotel rooms 
at the Doubletree Hotel should call 301-468-1100 or 800-222-TREE and 
mention that they are attending the FDA/PQI workshop. A special rate is 
available until September 13, 2000, or until the room block is 
exhausted, whichever comes first.
    If you need special accommodations due to a disability, please 
contact PQI at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshops are designed to help achieve 
objectives set forth in section 406 of the Food and Drug Administration 
Modernization Act of 1997 (21 U.S.C. 393) and discussed in the FDA Plan 
for Statutory Compliance, which include working more closely with 
stakeholders; maximizing the availability of, and clarifying 
information about the process for generating data for review and 
submissions; and ensuring access to needed scientific and technical 
expertise.
    The workshops also are consistent with the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121), as outreach 
activities by Government agencies directed to small businesses.
    The topics to be discussed include the following: (1) Overview and 
direction of FDA programs for regulating clinical research involving 
human drugs, biologics, and medical devices; (2) Anatomy of an FDA 
clinical investigator inspection; (3) What happens after an FDA 
inspection; (4) Clinical equipoise and recruitment for clinical trials; 
(5) Human subject protection; (6) Institutional review boards; (7) 
Special requirements for the Department of Health and Human Services 
funded studies; (8) Modification of FDA's Privacy Act systems notice; 
(9) Effective contract research organization-sponsor partnerships; (10) 
Industry perspective in case studies on contract research 
organization--sponsor partnerships; (11) Gene therapy products; (12) 
Cellular product studies; (13) Fraud within clinical trials; (14) 
Preparing for an FDA audit; (15) Computerized systems used in clinical 
trials; and (16) Providing regulatory submissions in electronic format.

    Dated: August 11, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-21010 Filed 8-17-00; 8:45 am]
BILLING CODE 4160-01-F