[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Pages 7128-7130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02592]



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.


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 
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].


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 
     Examine potential candidate biomarkers for TBI-
neuroimaging, biofluid-based, and other emerging biomarkers such as 
    [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 
    [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 
    [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;

[[Page 7130]]

    [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, 
    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 
    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]