7128 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 

the grantees may be experiencing in 

implementing their projects on a timely 

manner, and, for writing Annual Report 

to Congress. 

Respondents: Refugee Microenterprise 

Development Program 22. 

Refugee Home-Based Child Care 

Microenterprise Development Program 

23 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden hours 

per 

respondents 

Total burden 

hours 

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 

Hours: 180 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2016–02625 Filed 2–9–16; 8:45 am] 

BILLING CODE 4184–01–P 

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. 


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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 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 (nonFDA 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: 

Allison.Kumar@fda.hhs.gov; 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: 

Lakshmi.Kannan@fda.hhs.gov. 

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 organbased 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. 

Æ Strength of current scientific 

evidence; 

Æ different contexts of use; and 

Æ correlation to clinical outcome 

assessments. 

• Challenges and recommendations 

related to TBI biomarker development. 

Æ Intent of use; 

Æ device output-including variations 

with technology, qualitative v. 

quantitative, individual v. composite 

score; 

Æ analytical performance- including 

quality of the measurement (precision, 

linearity); 

Æ clinical reference standard; 

Æ clinical and functional validation; 

and 

Æ appropriate statistical approaches/

methods. 

• Strategies for improving data 

standardization, sharing, and 

application of big data analytics 

methods in the field of biomarker 

development. 

Æ 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); 

Æ platforms and methods used to 

build big data infrastructure; 


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7130 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 

Æ barriers to broader biomarker data 

aggregation, dissemination, and 

application; and 

Æ 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: 

susan.monahan@fda.hhs.gov 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (HRSA) announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this ICR should be 

received no later than April 11, 2016. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N–39, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Rural Opioid Overdose Reversal Grant 

Program OMB No. 0906–xxxx–New. 

Abstract: This program is authorized 

by Section 711(b) of the Social Security 

Act (U.S.C. 912(b), as amended and the 

Consolidated and Further Continuing 

Appropriations Act (Pub. L. 114–113). 

The purpose of this grant program is to 

reduce the incidences of morbidity and 

mortality related to opioid overdoses in 

rural communities through the purchase 

and placement of emergency devices 


asabaliauskas on DSK9F6TC42PROD with NOTICES2