[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7128-7130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0343]
Advancing the Development of Biomarkers in Traumatic Brain
Injury; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled, ``Advancing the Development of
Biomarkers in Traumatic Brain Injury.'' This workshop aims to examine
potential biomarkers, discuss the challenges and solutions related to
biomarker development methodologies, and establish strategies for data
standardization, sharing and analysis of big data sets for traumatic
brain injury (TBI). By convening the relevant stakeholders, the goal is
to obtain input on the scientific, clinical, patient, and regulatory
considerations associated with TBI biomarker development to improve
diagnosis and clinical utility for TBI.
DATES: The public workshop will be held on March 3, 2016, from 8 a.m.
to 5 p.m. Submit either electronic or written comments on the public
workshop by May 3, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0343 for ``Advancing the Development of Biomarkers in
Traumatic Brain Injury.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 7129]]
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
The public workshop will be held at FDA's White Oak Campus, 10903
New Hampshire Ave., Building 31, Rm. 1503 (the Great Room, sections B
and C), 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.
FOR FURTHER INFORMATION CONTACT: Allison Kumar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5408, Silver Spring, MD 20993, 301-796-6369, email:
[email protected]; or Lakshmi Kannan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5402, Silver Spring, MD 20993, 240-402-7735, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Each year, TBI contribute to a substantial number of deaths and
cases of permanent disability; yet both accurate diagnostics and
effective treatments remain stubbornly elusive. Diagnosis of TBI in the
acute setting remains a major obstacle, as ``gold standard'' diagnostic
criteria for TBI have not yet been established, despite the
availability of several published diagnostic criteria. Many of these
criteria determine the severity of the injury and classify TBI as mild,
moderate, and severe. Recently, the importance of apparently mild
injuries has been recognized as a major public health crisis for people
including military personnel, children and young adults in sport
activities throughout their normal life. This group of mild TBI (mTBI)
patients represents the greatest challenges to accurately diagnose and
to predict outcome because neuroimaging tools such as computed
tomography (CT) are not sensitive enough for detection beyond
identifying structural abnormalities. The use of CT can only detect the
presence of structural lesions (i.e., hematomas) which require
immediate medical attention or to rule out head injury complications
from more severe trauma. Unlike other organ-based diseases such as
myocardial infarction, prostate cancer, and polycystic kidney disease
where biomarkers are clinically essential to guide diagnosis,
prognosis, and treatment, there are no definitive biomarkers tests
available for TBI. Over the last decade there have been a myriad of
studies exploring many promising biomarkers including neuroimaging and
bio fluid-based for all forms of TBI severity; however, none have
become part of the standard protocols for diagnosis of TBI. In
addition, there are currently no FDA qualified biomarkers for clinical
use in TBI. Therefore, there is an unmet need for TBI biomarkers in the
clinical setting to: (1) Aid in early diagnosis and stratify the
severity of injury, (2) improve prognosis, (3) monitor ongoing
pathological processes, and (4) evaluate the efficacy of treatments.
II. Topics for Discussion at the Public Workshop
The public workshop seeks to engage stakeholders from academia,
industry, government agencies, heath care, and patient care groups to
discuss the scientific, clinical, patient, and regulatory
considerations associated with potential and emerging biomarkers in TBI
to improve diagnosis, clinical trial design, and outcome measures. This
discussion is essential for encouraging and expediting the development
of biomarker tests as scientifically validated tools for clinical
utility particularly in mTBI, as well as in the full spectrum of TBI.
This public workshop consists of brief presentations and
interactive discussions through several panel sessions. Following the
presentations, we plan to hold moderated discussions where participants
and additional panelists can provide their individual perspectives.
Specifically, this workshop is designed to address the following
topics:
Examine potential candidate biomarkers for TBI-
neuroimaging, biofluid-based, and other emerging biomarkers such as
electroencephalogram.
[cir] Strength of current scientific evidence;
[cir] different contexts of use; and
[cir] correlation to clinical outcome assessments.
Challenges and recommendations related to TBI biomarker
development.
[cir] Intent of use;
[cir] device output-including variations with technology,
qualitative v. quantitative, individual v. composite score;
[cir] analytical performance- including quality of the measurement
(precision, linearity);
[cir] clinical reference standard;
[cir] clinical and functional validation; and
[cir] appropriate statistical approaches/methods.
Strategies for improving data standardization, sharing,
and application of big data analytics methods in the field of biomarker
development.
[cir] Explore existing and potential big datasets and registries
for TBI (e.g. TBI Endpoints Development Initiative Meta Dataset,
National Institute of Neurological Disorders and Stroke Common Data
Elements, Federal Interagency Traumatic Brain Injury Research);
[cir] platforms and methods used to build big data infrastructure;
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[cir] barriers to broader biomarker data aggregation,
dissemination, and application; and
[cir] possible strategies to address these barriers.
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. (EST), February 22, 2016. 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, Office of Communication and Education, Center
for Devices and Radiological Health, Food and Drug Administration, 301-
796-5661, email: [email protected] no later than February 16,
2016.
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 meeting/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.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The webcast link will be available on the workshop Web
page after February 25, 2016. 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.) 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.)
Requests for Oral Presentations: This public workshop includes a
public comment session and topic-focused sessions. During online
registration you may indicate if you wish to present during a public
comment session or participate in a specific session, and which topics
you wish to address. FDA has included general topics in this document.
FDA will do its best to accommodate requests to make public comments
and participate in the focused sessions. 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. Following the close of registration, 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 February 25, 2016. All requests to make oral presentations must be
received by the close of registration on February 22, 2016, by 4 p.m.
(EST). If selected for presentation, any presentation materials must be
emailed to Lakshmi Kannan (see FOR FURTHER INFORMATION CONTACT) no
later than February 25, 2016. No commercial or promotional material
will be permitted to be presented or distributed at the public
workshop.
FDA is holding this public workshop to obtain information on
development of TBI biomarkers and data standardization. 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 May 3, 2016.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed 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. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. 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: February 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02592 Filed 2-9-16; 8:45 am]
BILLING CODE 4164-01-P