[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Notices]
[Pages 46231-46232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13114]


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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) Detroit 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, 
November 15, 2006, from 8:30 a.m. to 5 p.m. and Thursday, November 16, 
2006, from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the Sheraton 
Indianapolis Hotel & Suites, 8787 Keystone Crossing, Indianapolis, IN 
46240, 317-846-2700, FAX: 317-574-6775.
    Contact: Nancy Bellamy, Food and Drug Administration, 300 River 
Pl., suite 5900, Detroit, MI, 48207, 313-393-8143, FAX: 313-393-8139, 
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), or $525 (Government employee 
nonmember). (Registration fee for nonmembers includes a 1-year 
membership.) The registration fee for FDA employees is waived. Make the 
registration fee payable to SoCRA, 530 West Butler Ave., suite 109, 
Chalfont, PA, 18914. To register via the Internet go tohttp://
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 Sheraton Indianapolis Hotel 
& Suites, at the reduced conference rate, contact the Sheraton 
Indianapolis Hotel & Suites (see Location) before October 22, 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 Nancy Bellamy (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 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 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.


[[Page 46232]]


    Dated: August 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13114 Filed 8-10-06; 8:45 am]
BILLING CODE 4160-01-S