Document ID: FDA-2015-N-2390-0001
Agency: fda
Document Type: Notice
Title: Evidentiary Considerations for Integration of Biomarkers in Drug
Development; Notice of Public Meeting; Request for Comments
Posted Date: 2015-08-04T04:00Z

[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Page 46287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19037]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2390]

Evidentiary Considerations for Integration of Biomarkers in Drug 
Development; Notice of Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), in collaboration with 
the University of Maryland's Center of Excellence in Regulatory Science 
and Innovation and the Critical Path Institute, is announcing a public 
workshop entitled ``Evidentiary Considerations for Integration of 
Biomarkers in Drug Development.'' The purpose of the meeting is to 
discuss current scientific approaches to biomarker development, 
acceptance, and utility in drug and biologic (hereafter referred to as 
therapeutic product) development programs.

DATES: The meeting will be held on August 21, 2015, from 9 a.m. to 5 
p.m.

ADDRESSES: The meeting will be held at the University of Maryland, 
Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. For additional 
travel and hotel information, please refer to 
www.pharmacy.umaryland.edu/cersibiomarkers. (FDA has verified the Web 
site addresses throughout this notice, but FDA is not responsible for 
subsequent changes to the Web sites after this document publishes in 
the Federal Register).

FOR FURTHER INFORMATION CONTACT: Ann Anonsen, University of Maryland, 
Fischell Dept. of Bioengineering, 2207 Jeong H. Kim Bldg., College 
Park, MD 20742, 301-405-0285, FAX: 304-405-9953, aanonsen@umd.edu.

SUPPLEMENTARY INFORMATION: 

I. Background

    The purpose of this public workshop is to facilitate a unique 
opportunity for relevant stakeholders from industry, academia, and FDA 
to discuss biomarker development and provide a framework for 
evidentiary considerations required for biomarker qualification. The 
objective of the workshop is to discuss evidentiary considerations for 
use of clinical safety and enrichment biomarkers in drug development.

A. Registration

    There is a registration fee to attend this meeting. The 
registration fee is charged to help defray the costs for facilities, 
materials, and food. Seats are limited, and registration will be on a 
first-come, first-served basis.
    To register, please complete registration online at http://www.pharmacy.umaryland.edu/cersibiomarkers. (FDA has verified the Web 
address, but FDA is not responsible for subsequent changes to the Web 
site after this document publishes in the Federal Register). The costs 
of registration for the different categories of attendees are as 
follows:

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                      Category                               Cost
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Industry Representatives............................                 $50
Charitable Nonprofit/Academic.......................                  50
Government..........................................                   0
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B. Accommodations

    Attendees are responsible for their own hotel accommodations. If 
you need special accommodations due to a disability, please contact Ann 
Anonsen (see FOR FURTHER INFORMATION CONTACT).

II. Comments

    Interested persons may submit electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify all comments with the corresponding 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19037 Filed 8-3-15; 8:45 am]
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