[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45271-45272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Review and Qualification of Clinical Outcome Assessments; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to discuss measurement principles for clinical outcome
assessments (COAs) for use in clinical trials for new drugs. COAs
include patient-reported outcome (PRO) measures, clinician-reported
outcome (ClinRO) measures, and observer-reported outcome (ObsRO)
measures. This public workshop is intended to provide information for
and gain perspectives from patient advocates, health care providers,
researchers, regulators, individuals from academia, industry, and other
interested persons on various aspects of the development and
implementation of COAs in the evaluation of treatment benefit.
Regulatory review issues regarding context of use and documentation of
the measurement properties of a COA will be covered during panel
discussions. The input from this public workshop will be published in
the form of a white paper or a series of manuscripts.
DATES: Date and Time: The public workshop will be held on October 19,
2011, from 8:30 a.m. to 5 p.m. Participants are encouraged to arrive
early to ensure time for parking and routine security check before the
workshop.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Attendees are responsible for their own accommodations.
The public workshop will also be available to be viewed online via
Web cast at https://collaboration.fda.gov/coaworkshop/. Persons
interested in participating by Web cast must register online by October
17, 2011.
Contact Person: Shauna Shupe, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, rm. 6417, Silver Spring, MD 20993-0002, 301-796-0900, e-mail:
[email protected].
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited to 150 attendees. Workshop space will be filled in order of
receipt of registration. Those accepted into the workshop will receive
confirmation. Registration will close after the workshop is filled.
Registration at the site is not guaranteed but may be possible on a
space available basis on the day of the public workshop beginning at
7:30 a.m.
To register electronically, e-mail registration information
(including name, title, firm name, address, telephone, and FAX number)
to [email protected]. For those without Internet access, please
call Shauna Shupe (see Contact Person) to register.
If you need special accommodations due to a disability, please
contact Shauna Shupe at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The Center for Drug Evaluation and Research
(CDER) reviews COAs including PRO measures, (ClinRO) measures, and
ObsRO measures when submitted with an investigational new drug
application, a new drug application, or a biologics licensing
application. The FDA guidance for industry entitled ``Patient-Reported
Outcome Measures: Use in Medical Product Development to Support
Labeling Claims,'' available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf,
explains how FDA reviews PRO measures.
CDER also reviews a COA when submitted for qualification as a drug
development tool (DDT). Qualification of a COA is a regulatory
determination that the COA is well-suited for a specific context of use
in drug development. Following a public announcement of the
qualification decision by FDA, the COA will be publicly available for
use in any appropriate drug development program. Because the
qualification process is separate from the drug marketing application
process, qualification is conducive to public-private partnerships
engaging in this COA development effort. Such collaborative approaches
may increase the efficiency of COA development when more than one
entity is interested in the use of a COA for a specific context of use.
The FDA draft guidance for industry entitled ``Qualification Process
for Drug Development Tools,'' available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf, provides the draft process for CDER participation in the
consultation, advice, and qualification review for COAs and other DDTs.
This workshop will focus on FDA review principles specific to all
type of COAs, i.e., PRO, ClinRO, and ObsRO measures. More specifically,
the workshop will provide researchers involved in the drug development
process with information on the following topics concerning FDA review
of COAs for treatment benefit evaluation:
COA measurement principles;
COA nomenclature;
[[Page 45272]]
Determination of COA context of use;
Practical considerations to develop and implement COAs to
document treatment benefit; and
Description of interagency collaborations and public-
private partnerships for COA development.
The Agency encourages patient advocates, health care providers,
researchers, regulators, individuals from academia, industry, and other
interested persons to attend this public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm206132.htm approximately 45 days after
the workshop.
The workshop helps to achieve objectives set forth in section 406
of the Food and Drug Administration Modernization Act of 1997 (21
U.S.C. 393) which includes working closely with stakeholders and
maximizing the availability and clarity of information to stakeholders
and the public. The workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as
outreach activities by government Agencies to small businesses.
Dated: July 20, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19140 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P