[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12010-12011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Clinical Outcomes Assessment Development and Implementation: 
Opportunities and Challenges; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Clinical Outcomes Assessment Development and 
Implementation: Opportunities and Challenges.'' The purpose of the 
public workshop is to provide updates on accomplishments, challenges, 
and ongoing efforts in the use of clinical outcome assessments (COAs), 
and plan for the future of COA development and utilization in drug 
development programs, including how to incorporate the patient voice in 
drug development using well-defined and reliable patient-centered 
outcome measures. The public workshop will also discuss standards for 
COA use and collaborative processes for COA development and 
dissemination.
    Date and Time: The public workshop will be held on April 1, 2015, 
from 8:30 a.m. to 5 p.m. Participants are encouraged to arrive early to 
ensure time for parking and routine security checks 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 workshop 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 
Webcast at https://collaboration.fda.gov/COApublicworkshop2015. Persons 
interested in participating by Webcast must register online by March 
27, 2015.
    Contact Person: Michelle Campbell, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, Rm. 6471, Silver Spring, MD 20993-0002, 240-402-6019, email: 
[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 in to 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. If registration is filled, attendance to the workshop will be 
available only through the Webcast.
    To register, visit http://www.fda.gov/Drugs/NewsEvents/ucm431040.htm. For those without Internet access, please call Michelle 
Campbell (See Contact Person) to register.
    If you need special accommodations due to a disability, please 
contact Michelle Campbell (See Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: The Center for Drug Evaluation and Research 
(CDER) reviews COAs, including patient-reported outcome measures, 
clinician-reported outcome measures, and observer-reported outcome 
measures, when submitted with an investigational new drug application, 
a new drug application, or a biologics licensing application. CDER also 
reviews a COA when submitted for qualification as a drug development 
tool. 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.
    This workshop will focus on current challenges and opportunities in 
COA development and use, including establishing appropriate standards 
for use; current efforts to encourage inclusion of well-defined and 
reliable patient-centered outcome measures in drug development; use of 
collaborative efforts in developing and utilizing COAs through various 
partnerships; and future efforts to address challenges and gaps of COA 
development and use for patient-centered drug development and medical 
product labeling.
    For more information on this public workshop, visit http://www.fda.gov/Drugs/NewsEvents/ucm431040.htm.
    The Agency encourages patient advocates, health care providers, 
researchers, regulators, individuals from academia, industry, and other 
interested persons to attend this public workshop.

[[Page 12011]]

    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/ucm431040.htm approximately 45 days after 
the workshop.

    Dated: February 27, 2015.
Leslie Kux,
 Associate Commissioner for Policy.
[FR Doc. 2015-05017 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P