[Federal Register Volume 71, Number 110 (Thursday, June 8, 2006)]
[Notices]
[Page 33311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8896]



[[Page 33311]]

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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) Minneapolis District, 
in cooperation with the Association of Clinical Research Professionals 
(ACRP), 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, 
August 23, 2006, from 8 a.m. to 5 p.m. and Thursday, August 24, 2006, 
from 8:30 a.m. to 12 noon.
    Location: The public workshop will be held at The Northland Inn, 
7025 Northland Dr., Brooklyn Park, MN 55428, 800-441-6422 or 763-536-
8300, FAX: 763-536-8790.
    Contact: Amy C. Johnson, Public Affairs Specialist, Food and Drug 
Administration, 212 3rd Ave. South Minneapolis, MN 55401, 612-758-7131, 
FAX: 612-334-4134, e-mail: [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) and the registration fee 
of $220 (ACRP Minnesota chapter member), $280 (nonmember), or $220 
(Government employee). Make registration fee payable to ACRP, and mail 
to the attention of Paul Below, 441 Timberland Dr., Burnsville, MN 
55337. To register via the Internet please go to http://mnacrp.org/ or 
contact the ACRP webmaster at [email protected]. (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 Paul Below for ACRP at 441 Timberland Dr., 
Burnsville, MN 55337, 952-882-4083, FAX: 952-223-1665, e-mail: 
[email protected].
    Attendees are responsible for their own accommodations. To make 
reservations at the Northland Inn at a rate of $119.00 plus tax, please 
contact the Northland Inn (see Location).
    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 Amy Johnson (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. Medical device and drug aspects of clinical research 
requirements,
    2. Pre-investigational device and pre-investigational drug meetings 
with FDA,
    3. Investigator initiated research,
    4. Electronic documentation and data capture,
    5. Ethical issues in subject enrollment,
    6. Informed consent requirements,
    7. Adverse event reporting,
    8. FDA regulation of institutional review boards,
    9. How FDA conducts bioresearch inspections,
    10. FDA Enforcement actions associated with clinical research, and
    11. How FDA promotes confidence in clinical research.
    FDA has made education of the research community a high priority to 
ensure the quality of clinical data and protect research subjects. The 
workshop will also help 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.

    Dated: May 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8896 Filed 6-7-06; 8:45 am]
BILLING CODE 4160-01-S