80 FR 34910 - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 117 (June 18, 2015)

Page Range		34910-34912
FR Document		2015-14983

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use.'' The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of non-microbial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for non-microbial based in vitro diagnostics for infection.

Federal Register, Volume 80 Issue 117 (Thursday, June 18, 2015)

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34910-34912]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1968]


Non-Microbial Biomarkers of Infection for In Vitro Diagnostic 
Device Use; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Non-Microbial Biomarkers of 
Infection for In Vitro Diagnostic Device Use.'' The purpose of this 
workshop is to receive input from stakeholders and discuss approaches 
to the study of non-microbial biomarkers for differentiating viral from 
bacterial infections and for diagnosis and assessment of sepsis. 
Comments and suggestions generated through this workshop will 
facilitate further development of regulatory science for establishing 
appropriate comparator methods and clinically relevant performance 
standards for non-microbial based in vitro diagnostics for infection.

DATES: The public workshop will be held on October 16, 2015, from 8 
a.m. to 5 p.m. Registration to attend the meeting must be made by 4 
p.m. on October 6, 2015. Registration from those individuals interested 
in presenting comments should be received by September 16, 2015. See 
the SUPPLEMENTARY INFORMATION section for instructions on how to 
register for the meeting. Submit either electronic or written comments 
by 4 p.m. on November 13, 2015.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 
20852. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Natasha Townsend, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5525, Silver 
Spring, MD 20993-0002, 301-796-5927, FAX: 301-847-2512, email: 
natasha.townsend@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    There has been increasing interest in the development of non-
microbiological biomarkers to aid in determining whether patient signs 
and symptoms consistent with infection are attributable to an 
infectious or non-infectious cause,

[[Page 34911]]

and if infectious, whether of viral or bacterial etiology. Interest has 
ranged from aiding in the diagnosis of relatively mild outpatient upper 
respiratory symptoms to the assessment of critically ill patients. 
Progress in this area has been hindered by a lack of consensus on 
important issues in clinical trial design for new analytes; these 
issues include appropriate clinical trial designs (including acceptable 
comparator methods, e.g., for ascertaining viral or bacterial 
infections), clinical definitions of different disease states, and 
acceptable device performance (i.e., benefit/risk in different disease 
states and target populations). Devices that can differentiate a 
bacterial etiology from other causes of illness (e.g., viral, fungal, 
or non-infectious etiologies) can significantly impact antibiotic 
stewardship and potentially antimicrobial resistance.

II. Purpose and Scope of the Public Workshop

    The purpose of the public workshop is to discuss the use of non-
microbial biomarkers as indicators of infection, potential clinical 
trial designs that can be used to establish effectiveness, and benefit/
risk considerations for use. Specifically, FDA seeks input from health 
care practitioners, industry, government, academia, and other 
stakeholders on these topics. This discussion is viewed as essential 
for establishing the appropriate methods to study the safety and 
effectiveness of these analytes for different possible uses.
    This public workshop will consist of brief presentations providing 
information to frame the goals of the workshop and interactive 
discussions via several panel sessions. The presentations will focus on 
current and anticipated uses for non-microbial biomarkers of infection 
and a review of different approaches that have been considered for 
clinical trials. Following the presentations there will be a moderated 
discussion where participants and additional panelists will be asked to 
provide their individual perspectives. Topics to be discussed include: 
(1) Clinical uses for non-microbial biomarkers of infection, (2) 
comparator methods for studies differentiating viral from bacterial 
infection, (3) performance standards, (4) statistical methods 
appropriate for sepsis biomarker trials, and (5) unique considerations 
when studying pediatric populations.
    In advance of the meeting, FDA will place a summary of the issues 
it believes need consideration on file in the public docket (docket 
number found in brackets in the heading of this document) and will post 
it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments 
on this document for presentation at the public workshop is September 
11, 2015, although comments related to this document can be submitted 
until November 13, 2015.

III. Attendance and Registration

    Registration is free and available on a first-come, first-served 
basis. Persons interested in attending this public workshop must 
register online by 4 p.m. on October 6, 2015. Early registration is 
recommended because facilities are limited and, therefore, FDA may 
limit the number of participants from each organization. If time and 
space permits, onsite registration on the day of the public workshop 
will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
susan.monahan@fda.hhs.gov, no later than 4 p.m. on October 2, 2015.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Susan Monahan to register. Registrants 
will receive confirmation after they have been accepted. You will be 
notified if you are on a waiting list.

A. Streaming Webcast of the Public Workshop

    This public workshop will also be Webcast. Persons interested in 
viewing the Webcast must register online by 4 p.m. on October 6, 2015. 
Early registration is recommended because Webcast connections are 
limited. Organizations are requested to register all participants, but 
to view using one connection per location. Webcast participants will be 
sent technical system requirements after registration and will be sent 
connection access information after October 8, 2015. If you have never 
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in 
this document, but FDA is not responsible for any subsequent changes to 
the Web sites after this document publishes in the Federal Register.)

B. Requests for Oral Presentations

    This public workshop includes a public comment session. During 
online registration you may indicate if you wish to present during a 
public comment session, and which topics you wish to address. FDA has 
included general topics in this document which are addressed in section 
II. FDA will do its best to accommodate requests to make public 
comments. Individuals and organizations with common interests are urged 
to consolidate or coordinate their presentations and request time for a 
joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. All requests to make oral 
presentations must be received by September 16, 2015. FDA will 
determine the amount of time allotted to each presenter and the 
approximate time each oral presentation is to begin, and will select 
and notify participants by September 22, 2015. If selected for 
presentation, any presentation materials must be emailed to Yvonne Shea 
at yvonne.shea@fda.hhs.gov no later than 5 p.m. on October 2, 2015. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.

IV. Comments

    FDA is holding this public workshop to obtain information on 
approaches for establishing the performance of non-microbial biomarkers 
of infection for in vitro diagnostic device use. In order to permit the 
widest possible opportunity to obtain public comment, FDA is soliciting 
either electronic or written comments on all aspects of the public 
workshop topics. The deadline for submitting comments related to this 
public workshop is 4 p.m. on November 13, 2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
topics as

[[Page 34912]]

described in section II of this document, please identify the topic you 
are addressing. 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.

V. Transcripts

    As soon as a transcript is available, it will be accessible at 
http://www.regulations.gov. It may also be viewed in person at the 
Division of Dockets Management (see ADDRESSES). A transcript will also 
be available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to the 
Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 
A link to the transcripts will also be available approximately 45 days 
after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select 
this public workshop from the posted events list.)

    Dated: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14983 Filed 6-17-15; 8:45 am]
BILLING CODE 4164-01-P

34912 Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices

described in section II of this document, DEPARTMENT OF HEALTH AND • Email: HOPEAct@mail.nih.gov.
please identify the topic you are HUMAN SERVICES • Fax: 301–451–5671.
addressing. Received comments may be
National Institutes of Health • Regular Mail: Dr. Jonah Odim, 5601
seen in the Division of Dockets
Fishers Lane, Room 6B21, MSC 9827,
Management between 9 a.m. and 4 p.m.,
Human Immunodeficiency Virus (HIV) Bethesda, MD 20892–9827.
Monday through Friday, and will be Organ Policy Equity (HOPE) Act
posted to the docket at http:// • Hand Delivery, Overnight Mail,
Safeguards and Research Criteria for FedEx, and UPS: Dr. Jonah Odim, 5601
www.regulations.gov. Transplantation of Organs Infected Fishers Lane, Room 6B21, MSC 9827,
V. Transcripts With HIV Rockville, MD 20852.
AGENCY: National Institutes of Health, FOR FURTHER INFORMATION CONTACT: Dr.
As soon as a transcript is available, it
Department of Health and Human Jonah Odim, 240–627–3540.
will be accessible at http://
Services.
www.regulations.gov. It may also be SUPPLEMENTARY INFORMATION: There is
ACTION: Notice of availability and
viewed in person at the Division of little evidence base for HIV+ to HIV+
request for comments.
Dockets Management (see ADDRESSES). organ transplantation, and it is only in
A transcript will also be available in SUMMARY: The HOPE Act requires the liver and kidney transplantation that
either hardcopy or on CD–ROM, after Secretary of Health and Human Services there is substantial experience with
submission of a Freedom of Information (the Secretary) to develop and publish transplantation of organs from HIV-
request. Written requests are to be sent criteria for research involving uninfected (HIV¥) donors to HIV+
to the Division of Freedom of transplantation of HIV-infected (HIV+) recipients. The criteria for conducting
Information (ELEM–1029), Food and donor organs in HIV+ recipients. The clinical research in HIV+ to HIV+ organ
Drug Administration, 12420 Parklawn goals of these criteria are, first, to ensure transplantation are set forth in six broad
Dr., Element Bldg., Rockville, MD that research using organs from HIV+ categories (Donor Eligibility, Recipient
20857. A link to the transcripts will also donors is conducted under conditions Eligibility, Transplant Hospital Criteria,
be available approximately 45 days after protecting the safety of research Organ Procurement Organization (OPO)
the public workshop on the Internet at participants and the general public; and Responsibilities, Prevention of
second, that the results of this research Inadvertent Transmission of HIV, and
http://www.fda.gov/MedicalDevices/
provide a basis for evaluating the safety Study Design/Required Outcome
NewsEvents/WorkshopsConferences/
of solid organ transplantation (SOT) Measures) and are summarized in the
default.htm. (Select this public from HIV+ donors to HIV+ recipients.
workshop from the posted events list.) table below. These criteria are in
The National Institutes of Health (NIH), addition to current policies and
Dated: June 12, 2015. U.S. Department of Health and Human regulations governing organ
Leslie Kux, Services, invites the public to submit transplantation and human subjects
Associate Commissioner for Policy.
comments regarding the proposed HOPE research. The goals of these criteria are,
Act criteria. first, to ensure that research using
[FR Doc. 2015–14983 Filed 6–17–15; 8:45 am]
DATES: To ensure that comments will be organs from HIV+ donors is conducted
BILLING CODE 4164–01–P
considered, comments must be received under conditions protecting the safety of
no later than 5:00 p.m. on August 17, research participants and the general
2015. public; and second, that the results of
ADDRESSES: Comments may be this research provide a basis for
submitted by any of the following evaluating the safety of SOT from HIV+
methods: donors to HIV+ recipients.

Category Criteria

Donor Eligibility:
Deceased donor with known his- Cluster of differentiation 4 (CD4)+ T-cell count ≥200/microliter (μL) or ≥14%.
tory of HIV infection. HIV–1 ribonucleic acid (RNA) <50 copies/milliliter (mL); No history of viral load >1000 copies/mL in the
prior 12 months.
No active opportunistic infection (OI).
Deceased donor with newly diag- CD4+ T-cell count ≥200/μL or ≥14%.
nosed HIV infection. Viral load: no requirement.
No active OI.
Living HIV+ donor ......................... Well-controlled HIV infection.
CD4+ T-cell count (lifetime nadir) ≥200/μL.
CD4+ T-cell count ≥500/μL for the 6-month period before donation.
HIV–1 RNA <50 copies/mL.
No OI.
Pre-transplant donor allograft biopsy showing no evidence of disease that would increase the risk of
post-transplant organ failure or poor graft function.
Recipient (HIV+) Eligibility ............. CD4+ T-cell count ≥200/μL (kidney).
CD4+ T-cell count ≥100μL (liver) within 16 weeks prior to transplant; or ≥200μL with history of OI
tkelley on DSK3SPTVN1PROD with NOTICES

HIV–1 RNA <50 copies/mL and on a stable antiretroviral regimen.
No active OI or neoplasm.
No history of chronic cryptosporidiosis, primary central nervous system (CNS) lymphoma, or progres-
sive multifocal leukoencephalopathy (PML).

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Document Created: 2018-02-22 11:12:22
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop; request for comments.
Dates		The public workshop will be held on October 16, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be made by 4 p.m. on October 6, 2015. Registration from those individuals interested in presenting comments should be received by September 16, 2015. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the meeting. Submit either electronic or written comments by 4 p.m. on November 13, 2015.
Contact		Natasha Townsend, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993-0002, 301-796-5927, FAX: 301-847-2512, email: [email protected]
FR Citation		80 FR 34910

80 FR 34910 - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 117 (June 18, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration