[Federal Register Volume 71, Number 44 (Tuesday, March 7, 2006)]
[Notices]
[Pages 11434-11435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Exchange Workshop on Food and Drug Administration 
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), Baltimore District, in 
cooperation with the Society of Clinical Research Associates (SoCRA), 
is announcing a workshop on FDA clinical trial statutory and regulatory 
requirements. This 2-day workshop for the clinical research community 
targets sponsors, monitors, clinical investigators, institutional 
review boards, and those who interact with them for the purpose of 
conducting FDA regulated clinical research. The workshop will include 
both industry and FDA perspectives on proper conduct of clinical trials 
regulated by FDA.
    Date and Time: The public workshop is scheduled for Wednesday, May 
17, 2006, from 8:30 a.m. to 5 p.m. and Thursday, May 18, 2006, from 
8:30 a.m. to 4 p.m.
    Location: The public workshop will be held at the Radisson Plaza 
Lord Baltimore, 20 West Baltimore St., Baltimore, MD 21201, 410-539-
8400, FAX: 410-625-1060.
    Contact: Marie Falcone, Food and Drug Administration, U.S. 
Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-
717-3703, FAX: 215-597-5798, e-mail: [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) and the registration fee 
of $550 (member), $625 (nonmember), or $500 (Government employee 
nonmember). (The registration fee for nonmembers includes a 1-year 
membership.) The registration fee for FDA employees is waived. Make the 
registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To 
register via the Internet go to http://www.socra.org/FDA_Conference.htm. (FDA has verified the Web site address, but is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register).
    The registrar will also accept payment by major credit cards. For 
more information on the meeting, or for questions on registration, 
contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or e-mail: 
[email protected]. Attendees are responsible for their own 
accommodations. To make reservations at the Radisson Plaza Lord 
Baltimore hotel at the reduced conference rate, contact the Radisson 
Plaza Lord Baltimore hotel (see Location) before April 17, 2006. The 
registration fee will be used to offset the expenses of hosting the 
conference, including meals, refreshments, meeting rooms, and 
materials.
    Space is limited, therefore interested parties are encouraged to 
register early. Limited onsite registration may be available. Please 
arrive early to ensure prompt registration. If you need special 
accommodations due to a disability, please contact Marie Falcone (see 
Contact) at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials 
statutory and regulatory requirements helps fulfill the Department of 
Health and Human Services and FDA's important mission to protect the 
public health by educating researchers on proper conduct of clinical 
trials. Topics for discussion at the workshop include the following: 
(1) FDA regulation of the conduct of clinical research;
    (2) Medical device, drug, biological product and food aspects of 
clinical research;
    (3) Investigator initiated research;
    (4) Preinvestigational new drug application meetings and FDA 
meeting process;
    (5) Informed consent requirements;
    (6) Ethics in subject enrollment;
    (7) FDA regulation of institutional review boards;
    (8) Electronic records requirements;
    (9) Adverse event reporting;
    (10) How FDA conducts bioresearch inspections; and
    (11) What happens after the FDA inspection.
    FDA has made education of the research community a high priority to 
ensure the quality of clinical data and protect research subjects. The 
workshop helps to implement the objectives of section 903 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan 
for Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed to small 
businesses.


[[Page 11435]]


    Dated: March 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3229 Filed 3-6-06; 8:45 am]
BILLING CODE 4160-01-S