Evidentiary Considerations for Integration of Biomarkers in Drug Development; Notice of Public Meeting; Request for Comments, 46287 [2015-19037]
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
In compliance with the requirements
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to the Administration for Children and
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and Evaluation, 370 L’Enfant
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Consideration will be given to
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Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–18987 Filed 8–3–15; 8:45 am]
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46287
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
after this document publishes in the
Federal Register).
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
[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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
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 https://
www.pharmacy.umaryland.edu/cersibio
markers. (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:
Category
Cost
Industry Representatives .............................................................................................................................................................
Charitable Nonprofit/Academic ....................................................................................................................................................
Government .................................................................................................................................................................................
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).
tkelley on DSK3SPTVN1PROD with NOTICES
II. Comments
Interested persons may submit
electronic comments to https://
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.
VerDate Sep<11>2014
18:45 Aug 03, 2015
Jkt 235001
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 https://
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[Funding Announcement Number: HHS–
2016–IHS–SDPI–0001; Catalog of Federal
Domestic Assistance Number: 93.237]
Special Diabetes Program for Indians;
Community-Directed Grant Program;
Announcement Type: New and
Competing Continuation
Key Dates
Application Deadline Date: October 7,
2015.
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$50
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[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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:
------------------------------------------------------------------------
Category Cost
------------------------------------------------------------------------
Industry Representatives............................ $50
Charitable Nonprofit/Academic....................... 50
Government.......................................... 0
------------------------------------------------------------------------
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 https://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 https://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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