[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74927-74928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21138]


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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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    The Food and Drug Administration (FDA) Los Angeles 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, 
February 7, 2007, from 8:30 a.m. to 5 p.m. and Thursday, February 8, 
2007, from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the Wyndham San Diego 
at Emerald Plaza, 400 West Broadway, San Diego, CA 92101, 619-239-4500, 
FAX: 619-239-3274.
    Contact: Marshalette Edwards, Food and Drug Administration, 1431 
Harbor Bay Parkwy., Alameda, CA 94502, 510-337-6794, FAX: 510-337-6703 
e-mail: [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) and the registration fee 
of $575 (member), $650 (nonmember), $525 (Government employee 
nonmember) or $450 (Government employee member) to SoCRA , P.O. Box 
101, Furlong, PA 18925. 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.To register via the Internet 
go to http://www.socra.org/html/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 via e-mail: 
[email protected]. Attendees are responsible for their own 
accommodations. To make reservations at the Wyndham San Diego at 
Emerald Plaza at the reduced conference rate, contact the hotel (see 
Location) before January 7, 2007. 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 Marshalette Edwards 
(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 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) pre-investigational new drug 
application meetings and the 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

[[Page 74928]]

bioresearch inspections; and (11) what happens after the FDA 
inspection.
    FDA has made the 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 406 
of the FDA Modernization 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.

    Dated: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21138 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S