[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Page 9485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04027]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Developing an Evidentiary Standards Framework for Safety
Biomarkers Qualification; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA), in co-sponsorship with
the Foundation for the National Institutes of Health Biomarkers
Consortium (FNIH BC), is announcing a public workshop entitled
``Developing an Evidentiary Standards Framework for Safety Biomarkers
Qualification Workshop.'' The purpose of the workshop is to discuss the
evidentiary standards needed to support biomarker qualification with a
particular emphasis on drug safety markers. The 2-day workshop will
focus on the standards relevant to the qualification of a range of
safety biomarkers and examine case studies in several different organ
systems.
DATES: The public workshop will be held on April 14, 2016, from 9 a.m.
to 5 p.m. and April 15, 2016, from 8 a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at the Bethesda North
Marriott Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD
20852.
FOR FURTHER INFORMATION CONTACT: Janelle Lewis, Foundation for the
National Institutes of Health, 9650 Rockville Pike, Bethesda, MD 20814,
301-594-2919, FAX: 301-480-2752, email: [email protected].
SUPPLEMENTARY INFORMATION: The need for evidentiary standards to
qualify biomarkers was identified in FDA's Critical Path Initiative as
essential to improving the efficiency and effectiveness of drug
development. Evidentiary standards vary among different types of
biomarkers and according to the context(s) of use (COU) for which
qualification is being considered, and there are specific challenges
involved in qualifying drug safety biomarkers. This workshop is aimed
at creating alignment among scientific stakeholders including FDA, the
National Institutes of Health (NIH), the biopharmaceutical industry,
academic researchers, and patient groups regarding a proposed framework
for determining the levels of evidence required to qualify biomarkers
for use in drug development, with an emphasis on biomarkers used in
determinations of drug safety assessments. Development of a general
framework for biomarker qualification will be discussed, along with
specific application to different COUs related to drug safety,
including consideration of several specific case studies involving
qualification of clinical markers of toxicity in different organ
systems.
Registration: There is no fee to attend the workshop, but attendees
must register in advance. Space is limited, and registration will be on
a first-come, first-served basis. Persons interested in attending this
workshop must register online at www.fnih.org/evidentiarystandardsworkshop by April 1, 2016. For those persons
without Internet access, please contact Janelle Lewis at the Foundation
for the NIH (see FOR FURTHER INFORMATION CONTACT) to register.
Attendees are responsible for their own hotel accommodations.
Attendees making reservations at the Bethesda North Marriott Hotel and
Conference Center (see ADDRESSES) are eligible for a reduced rate of
$226 per night (equivalent to the government per diem rate), not
including applicable taxes. To receive the reduced rate, follow the Web
link that will be provided to you upon completion of online
registration.
If you need special accommodations due to a disability, please
contact Janelle Lewis (see FOR FURTHER INFORMATION CONTACT) at the
Foundation for the NIH at least 7 days in advance of the workshop.
Dated: February 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04027 Filed 2-24-16; 8:45 am]
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