[Federal Register: April 30, 2007 (Volume 72, Number 82)]
[Notices]
[Page 21270-21271]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap07-75]
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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: Kathleen.Donner@diahome.org.
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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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