[Federal Register Volume 72, Number 82 (Monday, April 30, 2007)]
[Notices]
[Pages 21270-21271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0155]


Defining and Implementing Quality in Clinical Investigations: 
From Design to Completion; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop cosponsored with the Drug Information Association (DIA) 
entitled ``Defining and Implementing Quality in Clinical 
Investigations: From Design to Completion.'' The purpose of the public 
workshop is to solicit constructive information on identifying 
attributes of quality in clinical investigations, approaches to quality 
from design to completion, and methods for measuring quality and 
ensuring data integrity during the conduct of clinical investigations. 
The public workshop will discuss the definition of quality, mechanisms 
for implementing quality in clinical investigations, and methods to 
improve the accuracy and reliability of collected data, which will 
enhance human subject protection. FDA also is requesting comments on 
these topics.
    Dates and Time: The public workshop will be held on May 10 and May 
11, 2007, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Washington 
Marriott Hotel, 1221 22d St. NW., Washington, DC 20037.
    Contact Person: Kathleen Donner, DIA, 215-293-5810, FAX: 215-442-
6199, or e-mail: [email protected].
    Registration: Registration will be accepted by mail, fax, or e-mail 
until May 10, 2007, and also onsite. Mail, fax, or e-mail your 
registration information (including name, title, firm name, address, 
telephone, and fax numbers) to the contact person (see Contact Person). 
You may also register online at www.diahome.org (``Educational 
Offerings,'' keyword 07013). (FDA has verified the Web site address, 
but FDA is not responsible for any subsequent changes to the Web site 
after this document publishes in the Federal Register.) There is a 
registration fee for the workshop: $1,165.00 for industry, $475.00 for 
charitable nonprofit organizations or academia, and $200.00 for Federal 
Government employees. The registration fees will be used to cover costs 
of the workshop, including program materials and food.
    If you need special accommodations due to a disability, please 
contact Kathleen Donner (see Contact Person) at least 7 days in 
advance.
    Comments: The deadline for submitting comments regarding this 
public workshop is July 10, 2007.
    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Submit a single copy 
of electronic comments or two paper copies of any mailed comments, 
except that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION: The purpose of the public workshop entitled 
``Defining and Implementing Quality in Clinical Investigations: From 
Design to Completion'' is to solicit constructive information on 
identifying attributes of quality in clinical investigations, 
approaches to quality from design to completion, and methods for 
measuring quality and ensuring data integrity during the conduct of 
clinical investigations.
    Over time, clinical investigations have evolved dramatically. In 
particular, clinical investigations are no longer primarily conducted 
at a single center; the use of electronic recordkeeping in the studies 
has increased dramatically; and the conduct of clinical investigations 
has become more complex. The public workshop will address the 
challenges of and potential solutions for maintaining quality during 
the conduct of clinical investigations to protect human subjects. The 
following

[[Page 21271]]

topics will be discussed: (1) The definition of quality, (2) mechanisms 
for implementing quality in clinical investigations, and (3) methods to 
improve the accuracy and reliability of collected data. As part of the 
Human Subject Protection/Bioresearch Monitoring Initiative (http:// 
www.fda.gov/ oc/ initiatives/ criticalpath/ ), this public workshop 
will help improve the safe conduct of clinical investigations and 
maximize efficiency in clinical investigations without compromising 
quality.

    Dated: April 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8137 Filed 4-27-07; 8:45 am]
BILLING CODE 4160-01-S