Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments, 34910-34912 [2015-14983]
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34910
Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices
and perspective on benefit may provide
useful context during this assessment.
FDA believes use of this benefit-risk
framework in an IDE application will
facilitate the incorporation of evidence
and knowledge from different
domains—clinical, nonclinical, and
patient—to support a comprehensive,
balanced decision-making approach.
FDA envisions this will facilitate a
common understanding between FDA
and sponsors/sponsor-investigators by
highlighting which factors are critical in
the benefit-risk assessment for a specific
application, and clearly explaining how
these factors influence a regulatory
decision. FDA also believes
implementation of this guidance
document will improve the
predictability, consistency, and
transparency of the review process for
IDE applications.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Factors to Consider When Making
Benefit-Risk Determinations for Medical
Device Investigational Device
Exemptions (IDEs).’’ It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Factors to Consider
When Making Benefit-Risk
Determinations for Medical Device
Investigational Device Exemptions’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1783 to
identify the guidance you are
requesting.
VerDate Sep<11>2014
16:53 Jun 17, 2015
Jkt 235001
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR part 50.23
(Exception from general requirements
for informed consent) have been
approved under OMB control number
0910–0586; the collections of
information in 21 CFR part 56.115 (IRB
records) have been approved under
OMB control number 0910–0130; and
the collections of information in 21 CFR
part 50, subpart B (Informed Consent of
Human Subjects) and 56 (Institutional
Review Boards) have been approved
under OMB control number 0910–0755.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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. 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: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14982 Filed 6–17–15; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Non-Microbial Biomarkers of Infection
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
for In Vitro Diagnostic Device Use.’’ The
purpose of this workshop is to receive
input from stakeholders and discuss
approaches to the study of nonmicrobial 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 nonmicrobial 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 https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
https://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,
E:\FR\FM\18JNN1.SGM
18JNN1
Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
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 nonmicrobial 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
VerDate Sep<11>2014
16:53 Jun 17, 2015
Jkt 235001
brackets in the heading of this
document) and will post it at https://
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 https://
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/
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
34911
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://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 nonmicrobial 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 https://
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
E:\FR\FM\18JNN1.SGM
18JNN1
34912
Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices
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 https://
www.regulations.gov.
V. Transcripts
As soon as a transcript is available, it
will be accessible at https://
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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Human Immunodeficiency Virus (HIV)
Organ Policy Equity (HOPE) Act
Safeguards and Research Criteria for
Transplantation of Organs Infected
With HIV
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice of availability and
request for comments.
AGENCY:
The HOPE Act requires the
Secretary of Health and Human Services
(the Secretary) to develop and publish
criteria for research involving
transplantation of HIV-infected (HIV+)
donor organs in HIV+ recipients. The
goals of these criteria are, first, to ensure
that research using organs from HIV+
donors is conducted under conditions
protecting the safety of research
participants and the general public; and
second, that the results of this research
provide a basis for evaluating the safety
of solid organ transplantation (SOT)
from HIV+ donors to HIV+ recipients.
The National Institutes of Health (NIH),
U.S. Department of Health and Human
Services, invites the public to submit
comments regarding the proposed HOPE
Act criteria.
DATES: To ensure that comments will be
considered, comments must be received
no later than 5:00 p.m. on August 17,
2015.
ADDRESSES: Comments may be
submitted by any of the following
methods:
SUMMARY:
Category
Deceased donor with newly diagnosed HIV infection.
Living HIV+ donor .........................
tkelley on DSK3SPTVN1PROD with NOTICES
Recipient (HIV+) Eligibility .............
16:53 Jun 17, 2015
FOR FURTHER INFORMATION CONTACT:
Dr.
Jonah Odim, 240–627–3540.
There is
little evidence base for HIV+ to HIV+
organ transplantation, and it is only in
liver and kidney transplantation that
there is substantial experience with
transplantation of organs from HIVuninfected (HIV¥) donors to HIV+
recipients. The criteria for conducting
clinical research in HIV+ to HIV+ organ
transplantation are set forth in six broad
categories (Donor Eligibility, Recipient
Eligibility, Transplant Hospital Criteria,
Organ Procurement Organization (OPO)
Responsibilities, Prevention of
Inadvertent Transmission of HIV, and
Study Design/Required Outcome
Measures) and are summarized in the
table below. These criteria are in
addition to current policies and
regulations governing organ
transplantation and human subjects
research. The goals of these criteria are,
first, to ensure that research using
organs from HIV+ donors is conducted
under conditions protecting the safety of
research participants and the general
public; and second, that the results of
this research provide a basis for
evaluating the safety of SOT from HIV+
donors to HIV+ recipients.
SUPPLEMENTARY INFORMATION:
Criteria
Donor Eligibility:
Deceased donor with known history of HIV infection.
VerDate Sep<11>2014
• Email: HOPEAct@mail.nih.gov.
• Fax: 301–451–5671.
• Regular Mail: Dr. Jonah Odim, 5601
Fishers Lane, Room 6B21, MSC 9827,
Bethesda, MD 20892–9827.
• Hand Delivery, Overnight Mail,
FedEx, and UPS: Dr. Jonah Odim, 5601
Fishers Lane, Room 6B21, MSC 9827,
Rockville, MD 20852.
Cluster of differentiation 4 (CD4)+ T-cell count ≥200/microliter (μL) or ≥14%.
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).
CD4+ T-cell count ≥200/μL or ≥14%.
Viral load: no requirement.
No active OI.
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.
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
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 progressive multifocal leukoencephalopathy (PML).
Jkt 235001
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]]>Agencies
[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34910-34912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14983]
-----------------------------------------------------------------------
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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to https://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 https://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 https://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 https://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 https://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 https://www.regulations.gov.
V. Transcripts
As soon as a transcript is available, it will be accessible at
https://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 https://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
