Document ID: FDA-2016-N-0001-0021
Agency: fda
Document Type: Notice
Title: Developing an Evidentiary Standards Framework for Safety Biomarkers
Qualification; Public Workshop
Posted Date: 2016-02-25T05:00Z

[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: jlewis@fnih.org.

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]
 BILLING CODE 4164-01-P