Developing an Evidentiary Standards Framework for Safety Biomarkers Qualification; Public Workshop, 9485 [2016-04027]

Download as PDF Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102–3). Dated: February 18, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016–04091 Filed 2–24–16; 8:45 am] BILLING CODE 4120–01–P 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. The Food and Drug Administration (FDA), in cosponsorship 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:07 Feb 24, 2016 Jkt 238001 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 9485 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS–4040–0010 60D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY: Electronic Government Office, HHS. ACTION: Notice. In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040–0010. The ICR will expire on September 30, 2016. The 4040–0010 is composed of the following forms: Project Abstract; Project Performance Site Location(s); and Key Contacts. The ICR also requests categorizing these forms as common forms, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. DATES: Comments on the ICR must be received on or before April 25, 2016. ADDRESSES: Submit your comments to ed.calimag@hhs.gov or (202) 690–7569. SUMMARY: E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[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.

-----------------------------------------------------------------------

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
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