[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45998-45999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Sixth Annual Coalition Against Major Diseases/Food and Drug 
Administration Scientific Workshop; 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 the sixth 
annual scientific workshop co-sponsored by the Agency and the Coalition 
Against Major Diseases (CAMD) Consortium of the Critical Path Institute 
(C-Path). The purpose of this public workshop is to initiate 
constructive discussion among scientists from FDA, the CAMD Consortium, 
and other interested parties regarding ongoing efforts to develop tools 
and methods to facilitate drug development for Alzheimer's disease and 
Parkinson's disease.

DATES: The public scientific workshop will be held on October 15, 2015, 
from 8 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
scientific 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.

FOR FURTHER INFORMATION CONTACT: Jacqueline Brooks-Leighton, Food and 
Drug Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240-402-
5292, FAX: 301-796-9907, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA and C-Path seek to leverage their combined strengths to create 
new tools and methods to increase the efficiency of the drug 
development process and bring new treatments for Alzheimer's disease 
and Parkinson's disease. This annual public workshop brings together 
representatives from the pharmaceutical industry, the academic research 
community, patient advocacy groups, and governmental institutions; 
including, the National Institute of Aging, the National Institute of 
Neurological Disorders and Stroke, and the European Medicines Agency.
    The objectives of the workshop include:

1. Understanding the accomplishments of CAMD scientific projects
2. Discussing how these tools are currently or will be applied in drug 
development
3. Obtaining commitment for sharing information/data to begin 
quantifying benefits of these tools
4. Facilitating robust and open discussion among all parties of drug 
development in Alzheimer's and Parkinson's diseases

II. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Individuals who 
wish to participate in the scientific workshop (in person or via the 
Internet) must register on or before October 1, 2015, by visiting 
https://www.SignUp4.net/public/ap.aspx?EID=SIXT10E.
    Early registration is recommended; registration is free and will be 
on a first-come, first-served basis. However, FDA may limit the number 
of participants from each organization based on space limitations. 
Onsite registration on the day of the scientific workshop will be based 
on space availability. The registration deadline is October 14, 2015. 
An agenda will be provided approximately 2 weeks before the scientific 
workshop at the FDA Meeting Information page, which is available online 
at: http://www.fda.gov/Drugs/NewsEvents/ucm410863.htm.
    If you need special accommodations because of a disability, please 
contact Jacqueline Brooks-Leighton (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the scientific workshop.
    A live webcast of this scientific workshop will be viewable at 
Adobe Connect Link: https://collaboration.fda.gov/camd101515/ on the 
day of the scientific workshop. A video record of the scientific 
workshop will be available at the same Web address for 1 year.

III. 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 20852. A 
transcript

[[Page 45999]]

will also be available in either hard copy 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.

    Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18969 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P