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 


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Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 7131 

used to rapidly reverse the effects of 

opioid overdose and training of licensed 

healthcare professionals and emergency 

responders on their use. 

Need and Proposed Use of the 

Information: For this program, 

performance measures have been 

drafted to provide data useful to the 

program and to enable HRSA to provide 

aggregate program data required by 

Congress under the Government 

Performance and Results Act (GPRA) of 

1993 (Pub. L. 103–62). These measures 

cover the principal topic areas of 

interest to the Federal Office of Rural 

Health Policy including: (1) The number 

of counties served by the program; (2) 

the number and type of devices 

purchased and distributed and the 

location of the distribution; (3) the 

number of training sessions and the 

number of individuals trained; and (4) 

the number of individuals who were 

administered Narcan and the outcome. 

These measures will speak to the 

Office’s progress toward meeting the set 

goals. 

Likely Respondents: Rural Opioid 

Overdose Reversal Grant Program award 

recipients. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this Information 

Collection Request are summarized in 

the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Rural Opioid Overdose Reversal Grant Program ................ 18 1 18 4 72 

Total .............................................................................. 18 1 18 4 72 

HRSA specifically requests comments 

on: (1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2016–02571 Filed 2–9–16; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Council on Blood 

Stem Cell Transplantation (ACBSCT). 

Date and Time: March 3, 2016, from 

12:00 p.m. to 4:00 p.m. Eastern Standard 

Time. 

Place: The meeting will be via audio 

conference call and Adobe Connect Pro. 

Status: The meeting will be open to 

the public. 

Purpose: Pursuant to Public Law 109– 

129, 42 U.S.C. 274k (section 379 of the 

Public Health Service Act, as amended), 

the ACBSCT advises the Secretary of 

Health and Human Services and the 

Administrator, Health Resources and 

Services Administration (HRSA), on 

matters related to the activities of the 

C.W. Bill Young Cell Transplantation 

Program (Program) and the National 

Cord Blood Inventory Program. 

Agenda: The Council will hear a 

report from the ACBSCT Work Group on 

Cord Blood. The Council also will hear 

presentations and discussions on topics 

including the National Institutes of 

Health’s Late Effects Initiative and the 

Center for International Blood and 

Marrow Transplant Research. Agenda 

items are subject to changes as priorities 

indicate. 

After Council discussions, members 

of the public will have an opportunity 

to provide comment. Because of the 

Council’s full agenda and timeframe in 

which to cover the agenda topics, public 

comment may be limited. All public 

comments will be included in the 

record of the ACBSCT meeting. Meeting 

summary notes will be posted on the 

HRSA’s Program Web site at http://

bloodcell.transplant.hrsa.gov/ABOUT/

Advisory_Council/index.html. 

The draft meeting agenda will be 

posted on https://www.blsmeetings.net/ 

ACBSCT/. Those participating at this 

meeting should register by visiting 

https://www.blsmeetings.net/ACBSCT/. 

The deadline to register for this meeting 

is Tuesday, March 1, 2016. For all 

logistical questions and concerns, please 

contact Anthony Rodell, Seamon 

Corporation, at (301) 658–3457 or send 

an email to arodell@

SeamonCorporation.com. 

The public can join the meeting by: 

1. (Audio Portion) Calling the 

Conference Phone Number (1–800–988– 

9777) and providing the Participant 

Code (6253775); and 

2. (Visual Portion) Connecting to the 

ACBSCT Adobe Connect Pro Meeting 

using the following URL and entering as 

GUEST: https://

hrsa.connectsolutions.com/acbsct_

webinar/ (copy and paste the link into 

your browser if it does not work 

directly). 

Participants should call and connect 

15 minutes prior to the meeting in order 

for logistics to be set up. If you have 

never attended an Adobe Connect 

meeting, please test your connection 

using the following URL: https://

hrsa.connectsolutions.com/common/

help/en/support/meeting_test.htm and 

get a quick overview by following URL: 

http://www.adobe.com/go/connectpro_

overview. Call (301) 443–0437 or send 

an email to ptongele@hrsa.gov if you are 

having trouble connecting to the 

meeting site. 

Public Comment: It is preferred that 

persons interested in providing an oral 

presentation email a written request, 

along with a copy of their presentation, 

to Patricia Stroup, MBA, MPA, 

Executive Secretary, Advisory Council 

on Blood Stem Cell Transplantation, 


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