81 FR 7128 - Advancing the Development of Biomarkers in Traumatic Brain Injury; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 27 (February 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 27 (February 10, 2016)
| Page Range | 7128-7130 | |
| FR Document | 2016-02592 |
[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)] [Notices] [Pages 7128-7130] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02592] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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; [[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, 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
![7128 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
the grantees may be experiencing in manner, and, for writing Annual Report Refugee Home-Based Child Care
implementing their projects on a timely to Congress. Microenterprise Development Program
Respondents: Refugee Microenterprise 23
Development Program 22.
ANNUAL BURDEN ESTIMATES
Average
Number of
Number of burden hours Total burden
Instrument responses per
respondents per hours
respondents respondents
Refugee Microenterprise Development Program ............................................ 22 8 4 88
Refugee Home-Based Child Care Microenterprise Development Program .... 23 7 4 92
Total Burden ............................................................................................. ........................ ........................ ........................ 180
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND the docket unchanged. Because your
Hours: 180 HUMAN SERVICES comment will be made public, you are
In compliance with the requirements solely responsible for ensuring that your
Food and Drug Administration comment does not include any
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the [Docket No. FDA–2016–N–0343] confidential information that you or a
third party may not wish to be posted,
Administration for Children and
Advancing the Development of such as medical information, your or
Families is soliciting public comment
Biomarkers in Traumatic Brain Injury; anyone else’s Social Security number, or
on the specific aspects of the confidential business information, such
Public Workshop; Request for
information collection described above. as a manufacturing process. Please note
Comments
Copies of the proposed collection of that if you include your name, contact
information can be obtained and AGENCY: Food and Drug Administration, information, or other information that
comments may be forwarded by writing HHS. identifies you in the body of your
to the Administration for Children and ACTION: Notice of public workshop; comments, that information will be
Families, Office of Planning, Research request for comments. posted on http://www.regulations.gov.
and Evaluation, 370 L’Enfant • If you want to submit a comment
Promenade SW., Washington, DC 20447, SUMMARY: The Food and Drug
Administration (FDA) is announcing the with confidential information that you
Attn: ACF Reports Clearance Officer. do not wish to be made available to the
following public workshop entitled,
Email address: infocollection@ public, submit the comment as a
‘‘Advancing the Development of
acf.hhs.gov. All requests should be written/paper submission and in the
Biomarkers in Traumatic Brain Injury.’’
identified by the title of the information This workshop aims to examine manner detailed (see ‘‘Written/Paper
collection. potential biomarkers, discuss the Submissions’’ and ‘‘Instructions’’).
The Department specifically requests challenges and solutions related to Written/Paper Submissions
comments on: (a) Whether the proposed biomarker development methodologies,
collection of information is necessary and establish strategies for data Submit written/paper submissions as
for the proper performance of the standardization, sharing and analysis of follows:
functions of the agency, including big data sets for traumatic brain injury • Mail/Hand delivery/Courier (for
whether the information shall have (TBI). By convening the relevant written/paper submissions): Division of
practical utility; (b) the accuracy of the stakeholders, the goal is to obtain input Dockets Management (HFA–305), Food
agency’s estimate of the burden of the on the scientific, clinical, patient, and and Drug Administration, 5630 Fishers
regulatory considerations associated Lane, Rm. 1061, Rockville, MD 20852.
proposed collection of information; (c)
the quality, utility, and clarity of the with TBI biomarker development to • For written/paper comments
information to be collected; and (d) improve diagnosis and clinical utility submitted to the Division of Dockets
for TBI. Management, FDA will post your
ways to minimize the burden of the
DATES: The public workshop will be comment, as well as any attachments,
collection of information on
held on March 3, 2016, from 8 a.m. to except for information submitted,
respondents, including through the use
5 p.m. Submit either electronic or marked and identified, as confidential,
of automated collection techniques or if submitted as detailed in
other forms of information technology. written comments on the public
workshop by May 3, 2016. ‘‘Instructions.’’
Consideration will be given to
ADDRESSES: You may submit comments Instructions: All submissions received
comments and suggestions submitted must include the Docket No. FDA–
within 60 days of this publication. as follows:
2016–N–0343 for ‘‘Advancing the
Electronic Submissions
asabaliauskas on DSK9F6TC42PROD with NOTICES2
Robert Sargis, Development of Biomarkers in
Reports Clearance Officer. Submit electronic comments in the Traumatic Brain Injury.’’ Received
following way: comments will be placed in the docket
[FR Doc. 2016–02625 Filed 2–9–16; 8:45 am]
• Federal eRulemaking Portal: http:// and, except for those submitted as
BILLING CODE 4184–01–P
www.regulations.gov. Follow the ‘‘Confidential Submissions,’’ publicly
instructions for submitting comments. viewable at http://www.regulations.gov
Comments submitted electronically, or at the Division of Dockets
including attachments, to http:// Management between 9 a.m. and 4 p.m.,
www.regulations.gov will be posted to Monday through Friday.
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![7130 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices
Æ barriers to broader biomarker data comment session and topic-focused Dated: February 1, 2016.
aggregation, dissemination, and sessions. During online registration you Leslie Kux,
application; and may indicate if you wish to present Associate Commissioner for Policy.
Æ possible strategies to address these during a public comment session or [FR Doc. 2016–02592 Filed 2–9–16; 8:45 am]
barriers. participate in a specific session, and BILLING CODE 4164–01–P
Registration: Registration is free and which topics you wish to address. FDA
available on a first-come, first-served has included general topics in this
basis. Persons interested in attending DEPARTMENT OF HEALTH AND
document. FDA will do its best to
this public workshop must register HUMAN SERVICES
accommodate requests to make public
online by 4 p.m. (EST), February 22,
2016. Early registration is recommended comments and participate in the
Health Resources and Services
because facilities are limited and, focused sessions. Individuals and Administration
therefore, FDA may limit the number of organizations with common interests are
participants from each organization. If urged to consolidate or coordinate their Agency Information Collection
time and space permits, onsite presentations, and request time for a Activities: Proposed Collection: Public
registration on the day of the public joint presentation, or submit requests for Comment Request
workshop will be provided beginning at designated representatives to participate
AGENCY: Health Resources and Services
7 a.m. in the focused sessions. Following the
Administration, HHS.
If you need special accommodations close of registration, FDA will
due to a disability, please contact Susan ACTION: Notice.
determine the amount of time allotted to
Monahan, Office of Communication and each presenter and the approximate SUMMARY: In compliance with the
Education, Center for Devices and time each oral presentation is to begin, requirement for opportunity for public
Radiological Health, Food and Drug and will select and notify participants comment on proposed data collection
Administration, 301–796–5661, email: by February 25, 2016. All requests to projects (Section 3506(c)(2)(A) of the
susan.monahan@fda.hhs.gov no later make oral presentations must be Paperwork Reduction Act of 1995), the
than February 16, 2016. received by the close of registration on Health Resources and Services
To register for the public workshop, Administration (HRSA) announces
please visit FDA’s Medical Devices February 22, 2016, by 4 p.m. (EST). If
selected for presentation, any plans to submit an Information
News & Events—Workshops & Collection Request (ICR), described
Conferences calendar at http:// presentation materials must be emailed
to Lakshmi Kannan (see FOR FURTHER below, to the Office of Management and
www.fda.gov/MedicalDevices/
INFORMATION CONTACT) no later than Budget (OMB). Prior to submitting the
NewsEvents/WorkshopsConferences/
February 25, 2016. No commercial or ICR to OMB, HRSA seeks comments
default.htm. (Select this meeting/public
promotional material will be permitted from the public regarding the burden
workshop from the posted events list.)
to be presented or distributed at the estimate, below, or any other aspect of
Please provide complete contact
public workshop. the ICR.
information for each attendee, including
name, title, affiliation, address, email, DATES: Comments on this ICR should be
FDA is holding this public workshop received no later than April 11, 2016.
and telephone number. Those without to obtain information on development of
Internet access should contact Susan ADDRESSES: Submit your comments to
TBI biomarkers and data paperwork@hrsa.gov or mail the HRSA
Monahan to register. Registrants will standardization. In order to permit the
receive confirmation after they have Information Collection Clearance
widest possible opportunity to obtain Officer, Room 14N–39, Parklawn
been accepted. You will be notified if
public comment, FDA is soliciting Building, 5600 Fishers Lane, Rockville,
you are on a waiting list.
Streaming Webcast of the Public either electronic or written comments MD 20857.
Workshop: This public workshop will on all aspects of the public workshop FOR FURTHER INFORMATION CONTACT: To
also be Webcast. The webcast link will topics. The deadline for submitting request more information on the
be available on the workshop Web page comments related to this public proposed project or to obtain a copy of
after February 25, 2016. Please visit workshop is May 3, 2016. the data collection plans and draft
FDA’s Medical Devices News & Transcripts: Please be advised that as instruments, email paperwork@hrsa.gov
Events—Workshops & Conferences soon as a transcript is available, it will or call the HRSA Information Collection
calendar at http://www.fda.gov/ be accessible at http:// Clearance Officer at (301) 443–1984.
MedicalDevices/NewsEvents/ www.regulations.gov. It may be viewed SUPPLEMENTARY INFORMATION: When
WorkshopsConferences/default.htm. at the Division of Dockets Management submitting comments or requesting
(Select this public workshop from the (see ADDRESSES). A transcript will also information, please include the
posted events list.) If you have never be available in either hardcopy or on information request collection title for
attended a Connect Pro event before, CD–ROM, after submission of a reference.
test your connection at https:// Freedom of Information request. The Information Collection Request Title:
collaboration.fda.gov/common/help/en/ Freedom of Information office address is Rural Opioid Overdose Reversal Grant
support/meeting_test.htm. To get a Program OMB No. 0906–xxxx–New.
available on the Agency’s Web site at Abstract: This program is authorized
quick overview of the Connect Pro
http://www.fda.gov. A link to the
asabaliauskas on DSK9F6TC42PROD with NOTICES2
program, visit http://www.adobe.com/ by Section 711(b) of the Social Security
go/connectpro_overview. (FDA has transcripts will also be available Act (U.S.C. 912(b), as amended and the
verified the Web site addresses in this approximately 45 days after the public Consolidated and Further Continuing
document, but FDA is not responsible workshop on the Internet at http:// Appropriations Act (Pub. L. 114–113).
for any subsequent changes to the Web www.fda.gov/MedicalDevices/ The purpose of this grant program is to
sites after this document publishes in NewsEvents/WorkshopsConferences/ reduce the incidences of morbidity and
the Federal Register.) default.htm. (Select this public mortality related to opioid overdoses in
Requests for Oral Presentations: This workshop from the posted events list). rural communities through the purchase
public workshop includes a public and placement of emergency devices
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Document Created: 2016-02-10 00:19:33
Document Modified: 2016-02-10 00:19:33
| 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 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. | |
| 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] | |
| FR Citation | 81 FR 7128 |
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