[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14583-14584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5633]


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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) Chicago 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 May 16, 2007, 
from 8:30 a.m. to 5 p.m. and May 17, 2007, from 8:30 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the Oak Brook Hills 
Marriott Resort, 3500 Midwest Rd., Oak Brook, IL 60523, 630-850-5555, 
FAX: 630-850-5569.
    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 $575 (member), $650 (nonmember), or $525 (Federal 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 to www.socra.org 
(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 Oak Brook Hills Marriott 
Resort, at the reduced conference rate, contact the Oak Brook Hills 
Marriott Resort (see Location) before April 24, 2007, citing meeting 
code SCRSCRA. 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 include the following: (1) FDA regulation 
of the conduct of clinical research; (2) medical device, drug, 
biological and food product 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

[[Page 14584]]

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.

    Dated: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5633 Filed 3-27-07; 8:45 am]
BILLING CODE 4160-01-S